Lords Sitting of 22 July 2004

Preamble
The House met at eleven of the clock (Prayers having been read earlier at the Judicial Sitting by the Lord Bishop of Portsmouth): The CHAIRMAN OF COMMITTEES on the Woolsack.

Royal Assent
The Chairman of Committees (Lord Brabazon of Tara): My Lords, I have to notify the House, in accordance with the Royal Assent Act 1967, that the Queen has signified her Royal Assent to the following Acts:

Finance Act 2004

Scottish Parliament (Constituencies) Act 2004

Statute Law (Repeals) Act 2004

Carers (Equal Opportunities) Act 2004

Patents Act 2004

Health Protection Agency Act 2004

Traffic Management Act 2004

Asylum and Immigration (Treatment of Claimants, etc.) Act 2004

Energy Act 2004

Fire and Rescue Services Act 2004

Cattle Movements: Livestock Register
Lord Livsey of Talgarth Lord Livsey of Talgarth asked Her Majesty's Government:
What action they are taking to convert the present cattle identification system into a fully electronic record of all cattle movements in the United Kingdom.
The Parliamentary Under-Secretary of State, Department for Environment, Food and Rural Affairs (Lord Whitty): My Lords, we are developing a GB-wide livestock register for registering cattle and other farmed livestock species and recording their movements. This register will incorporate the existing functions of the cattle tracing system and continue to provide a full electronic record of cattle births, deaths and movements. The livestock register will build on the measures already in place to enhance the existing cattle tracing system and promote improved electronic uptake.
Lord Livsey of Talgarth: My Lords, will the Minister note the urgent conclusions and recommendations of the House of Commons Public Accounts Committee in its report Identifying and tracking livestock in England? It concluded that one in seven cattle were "lost in the system", which means that those cattle cannot be found. It also concluded that the current cattle tracing systems are more expensive and less
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efficient than those in other EU states. It also identified £16 million of savings, and found that the present system is bureaucratic and places a burden on farmers, involving triple handwritten entries. At present there are 1.2 million unresolved anomalies in the system, and the current IT system has three components. Does the Minister accept that the Public Accounts Committee states that markets have a pivotal role and that a fully electronic system should be implemented? Can he say when implementation will happen?
Lord Whitty: My Lords, I accept the careful analysis of the Public Accounts Committee on these issues but not always the rhetoric of its chairman. The noble Lord's repetition of the term "lost" is an exaggeration of what the Public Accounts Committee found. It found that there were gaps in the records amounting to that number of cattle, but that does not mean that those cattle were lost either currently or in the system. The numbers also included relatively recent movements which would not have been recorded, and even that number has decreased substantially.
I acknowledge that there are serious faults in the cattle tracing system. Its heavy reliance on paper information at various points from farmers adds to the burden on farmers and the inefficiency of the system. That is why we are trying to move to a wider livestock register and a fully electronic system. But when proposing an absolutely electronic system, one has to bear in mind that less than one-third of farmers currently have electronic expertise. A two-way system is required for the scheme to work effectively.
Lord Elton: My Lords, if the cattle were not lost, could they be readily found in the case of an outbreak? That is the object of the exercise.
Lord Whitty: Yes, my Lords. The issue was that, in virtually all cases, there was a gap in the records at some point from the livestock's date of birth until now. By now, however, the vast majority could have been found. Even so, for the purposes of traceability and disease control, it is not an adequate situation.
Lord Clark of Windermere: My Lords, is the legislation requiring farmers to maintain books on the movement of cattle and other animals extant? If so, who is responsible for monitoring it?
Lord Whitty: My Lords, there are still restrictions on movements. They have been reduced substantially compared with the aftermath of the foot and mouth outbreak. Farmers are supposed to record the movement of cattle through the cattle tracing service. The enforcement of actual movements is a local authority responsibility.
Baroness Byford: My Lords, I follow my noble friend's question. It is a very serious situation that these cattle are untraceable, and there will be a problem if disease breaks out. The Minister should acknowledge that. More directly, in response to a

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Question that I asked him, the Minister said that the IT projects would not be available until 2006 or 2007. Is he not concerned at the delay? What is its cause?
Lord Whitty: My Lords, the cattle tracing system is fairly substantial and it takes time to move to a full livestock system. It is not sensible to cut corners on such IT systems. The issue is not untraceability but inadequate total records. Although that could be a disease control problem, it would not be a problem in controlling an immediate outbreak if the records were from some time ago. Of course any error is deeply regrettable and adds to control problems.
Lord Livsey of Talgarth: My Lords, does the Minister acknowledge the importance of the need for supermarkets and consumers to know where their beef, for example, comes from? Surely supermarkets could pay for, and the markets could operate, a proper IT system from the field to the plate.
Lord Whitty: My Lords, supermarkets are increasingly operating their own traceability systems and have greatly raised the status of such systems among their suppliers. I do not think that we could ask them to maintain these systems beyond their own supply chain. They have certainly already made an improvement themselves.
Lord Christopher: My Lords, I hope that we do not give supermarkets more power than they have already. Beyond that, however, I wonder whether we are asking ourselves the right question. I do not underestimate the importance of records, but the extent of livestock movement in Britain seems greater than it has ever been. I wonder about the need for it. Is it higher than in Europe? Why is it happening? Has any research been done?
Lord Whitty: My Lords, I find that in this House we rarely ask ourselves the right question. It is true that, as became very apparent during the foot and mouth epidemic, many livestock movements occur uniquely in this country, and that applies particularly to sheep movements. There are far more sheep movements in this country between farm and supermarket buyer and between markets than there are in other countries. Although they have been reduced post foot and mouth, there is still a substantial number of them, including long-distance ones. The whole food chain must address that issue for reasons of animal welfare and disease control and for environmental factors.
Baroness O'Cathain: My Lords, can the Minister confirm whether BT offered to put a computer in every farm in the country but Defra turned down the offer? Surely if farmers could be brought on board to try to register all cattle, it would relieve Defra and the Government from an IT commitment. As I have said many times in this House, the Government are not exactly the best people for running IT systems.
Lord Whitty: My Lords, I am not aware of any such specific offer from BT, but over the past few years
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there has been a significant number of schemes offering farmers IT equipment and training. Even so, the take-up has been relatively low. That definitely needs to be addressed by industry and government.

Nurse Education
11.9 a.m.
Baroness Gardner of Parkes Baroness Gardner of Parkes asked Her Majesty's Government:
Whether they will review the entrance qualifications currently required for nurse education.
The Parliamentary Under-Secretary of State, Department of Health (Lord Warner): My Lords, the Nursing and Midwifery Council sets the entry requirements for pre-registration nursing and midwifery training and is the independent statutory regulator. I understand that, from August 2004, the council has reviewed the entry requirements for pre-registration nursing and midwifery education. Applicants must provide evidence of literacy and numeracy skills, good health and good character. Higher education institutions must ensure that applicants have met the above entry requirements.
Baroness Gardner of Parkes: My Lords, I thank the Minister for that reply. I do not know whether he is aware that I asked the noble Baroness, Lady Ashton, this question as a supplementary on 19 April. The question was originally tabled by the late Lady Brigstocke, who is sadly missed. The noble Baroness, Lady Ashton, replied that she would ensure that her noble friend had the opportunity to respond directly on the question of nurses; but I have heard nothing. That is why I tabled the Question.
Does the Minister agree that many people will never reach the number of A-levels required? He did not make clear in his reply whether they are still required. We are all delighted that nursing has reached the point where there are graduate nurses and nurse practitioners, and we want to see as many of those as possible. However, there are still many caring young people who would enter the nursing profession if there was something more of what the noble Baroness, Lady Ashton, described as a "modern apprenticeship" system.
Lord Warner: My Lords, one of the reasons for these changes is that the circumstances have changed. Certainly, the age profile of applicants has risen significantly; the average age of entrants to nursing and midwifery training is 28. The noble Baroness is right that we want to ensure that a wider range of people, particularly those with life skills, returning to nursing after other career changes can enter the profession; which is why more flexibility is being introduced. Of course, one of the other reasons for the changes is the increased protection for members of the public, as the character of the trainee nurse is assessed on application.
Lord Selsdon: My Lords, will the Minister remind the House what the total nursing population is of the

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United Kingdom? How short of nurses might we be? How many nurses in the system are non-British nationals?
Lord Warner: My Lords, I can bore the House again now. The Government have increasingly improved the number of nurses available; there have been 67,000 plus nurses since the Government came to office. I am grateful to the noble Lord for giving me the opportunity to remind the House of those figures. We have an increasing number of applicants for nursing, the acceptances for both pre-registration diploma training and pre-registration degree courses have been increasing, and there are more healthcare applicants entering training for qualification. There is a surge in all those areas, and the number of entering and returning nurses has gone up substantially.
Lord Swinfen: My Lords—
The Earl of Listowel: My Lords, are the Government recruiting sufficient midwives? Are the Government sufficiently successful at retaining midwives in their posts to provide a good quality service?
Lord Warner: My Lords, the Government continue to attract people into midwifery training, along with nursing training, in reasonable numbers. As I reminded the House before, the birth rate has been falling, so the number of babies born each year is reduced.
Lord Swinfen: My Lords, would the Minister be kind enough to answer my noble friend's question about the proportion of overseas nationals who are nursing in this country?
Lord Warner: My Lords, the Question is about entry to training, not about the number of nurses.
Lord Alderdice: My Lords, does the Minister accept that there are two unfortunate side effects of the perfectly natural and appropriate drives to increase the level of education of nurses and graduate nurses? First, there is a higher and higher expectation of those who achieve graduate status that they will move along a career path that moves them up and frequently, sadly, out of direct contact with patients and into management. Secondly, there is a sense that those who wanted to care for patients through the whole of their career are less valued because of the high premium being put on the higher standards of education. There is a genuine dilemma here, which requires to be addressed.
Lord Warner: My Lords, the Nursing and Midwifery Council has been trying to take account of the fact that a wide range of people are coming forward to enter nursing. It is worth bearing in mind the changing profile of the students. As I said earlier, the average age has gone up. In 2003, the average age for entering the programmes was 28 years, which is a lot further up the age scale than in the days when the great majority of those entering
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nurse training were 18 and 19 year-olds. We have an increasing number of mature applicants changing career without formal educational qualifications, but with extensive life skills. That meets some of the noble Lord's concerns. Alongside that, there are increasing numbers of students entering with A-levels, so there is a mixed picture around the profile of people entering nurse training.
Baroness Emerton: My Lords, would the Minister be prepared to consider a review of the correlation of theory to practice, in terms of having more supervision for students coming from universities and colleges into the clinical areas? Nursing is a combination of arts and science, and it is about delivering holistic care; basic care; caring for the nutrition and the comfort of the patient; and for hygiene; as well as the advanced technical procedures that must be carried out. It seems that there is a gap between the universities and colleges and the clinical areas, where clinical areas are so busy that they are unable to give supervision. A review would be extremely helpful for the profession.
Lord Warner: My Lords, that is a matter for the profession and for the Nursing and Midwifery Council to consider. The Government always take seriously the points made by the noble Baroness. I remind her that the Department of Health is working with its partners to produce the partnership quality assurance framework, so that we can be sure that the nurse training arrangements, among other professional training arrangements, meet proper quality assurance requirements.

Nepal
11.17 a.m.
The Earl of Sandwich The Earl of Sandwich asked Her Majesty's Government:
How they will further help the people of Nepal to find a peaceful solution to their political difficulties and internal conflict.
The Minister of State, Foreign and Commonwealth Office (Baroness Symons of Vernham Dean): My Lords, the United Kingdom remains committed to supporting Nepal and trying to resolve the conflict through work to improve Nepalese counter-insurgence capability, developing human rights, building political capacity, and providing humanitarian assistance. The United Kingdom has run conflict prevention programmes of £10 million over the past two financial years. DfID is running a bilateral programme of £6 million in 2003–04, which is expected to increase in 2004–05 and 2005–06 to £35 million and £47 million respectively.
The Earl of Sandwich: My Lords, it is encouraging to hear from the noble Baroness how much DfID is doing in conflict prevention and poverty reduction. Maoism, or the version of Maoism that exists in Nepal, thrives on unrepresentative government and a degree of political confusion. Is our embassy doing enough, alongside DfID, the Indian Government and

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the European Union, to encourage all political parties, including Congress, to enter the process, and to urge those parties to reduce tension in the country and give the Nepali people a sense of confidence in democratic government?
Baroness Symons of Vernham Dean: My Lords, I believe that our embassy is properly engaged in this process. We are encouraged by the formation of a multiparty government in Nepal under Prime Minister Deuba. We are looking forward to supporting the Nepalese in their progress towards a negotiated peace settlement. The noble Lord is right to point out that the Nepali Congress Party's decision to remain outside government is unfortunate, but it is not in itself an obstacle to peace negotiations or to peace. We hope that the new government will maintain those links to the Congress Party as the negotiation strategy continues to develop. I remind the noble Earl that in addition to our ambassador, Sir Jeffrey James is the UK Special Representative for Nepal, and he visits the country three times a year.
Lord Avebury: My Lords, regarding the development plan announced in May, of which the noble Baroness has given details today, does she not agree that some donor programmes, particularly in the west of the country, have had to be suspended because of the conflict? Will the Government, in their spending programme, give priority to all measures for bringing the conflict to an end? Is any of the £80 million specifically earmarked for the facilitation or promotion of dialogue between the government and armed rebels?
Baroness Symons of Vernham Dean: My Lords, I agree that security is a real problem. As we know from this conflict and conflicts elsewhere, if security is not present on the ground it is very difficult for civil society to flourish and democratic processes to take root properly. That is why it is so important that part of the money we are devoting to conflict prevention is going towards a counter-insurgence capability.
Of course, that is not the sole answer, but it is important to look at those security issues. I assure the noble Lord that they are being looked at in concert with the issues around building civil society.
Baroness Chalker of Wallasey: My Lords, does the Minister accept that the supply of arms and equipment to the Nepalese Government will not by itself solve the conflict? That simply is not effective as a weapon against terrorism. Only with training in stable government and civil liberties and extending it way outside Kathmandu, which is somewhat of an island in Nepal, can the rule of law be re-established and common sense reign in that country. Will the Minister encourage a move in that direction?
Baroness Symons of Vernham Dean: My Lords, yes. I agree wholeheartedly with what the noble Baroness, Lady Chalker, said. The package of assistance that we
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are giving in respect of military aid includes a very strong element of human rights training for the armed forces. Our aim has been to improve the professionalism of the army so that it can respond accurately and—if I may say—appropriately and proportionately to Maoist violence, as well as be trained in defending a democratic constitutional state from any takeover by armed Maoist insurrectionists.
Lord Bramall: My Lords, following on from what the Minister said, does she not agree that one of the problems is that the military action that has to be taken to make the rebels realise that they, too, cannot win by military means alone is not always done in the most sensible way? With all our experience, is there not more that we can do to help the Royal Nepalese Army to win the hearts and minds of the villagers as well as giving the rebels a nasty jolt?
Baroness Symons of Vernham Dean: My Lords, I believe that that is exactly the thought behind the way in which we are approaching our relationship with the Nepalese military authorities. There has to be a strong inculcation into those authorities that it is not just the use of force by itself, but that force is used in an appropriate and proportional way.
For example, the counter-insurgency capabilities have included things such as bomb disposal equipment so that a clear benefit can be demonstrated to civil society. Some of the helicopters that have gone to Nepal were used only last weekend to assist from the air, showing how the people of Nepal could be best helped by the sort of military equipment that we are giving. The training element is crucial.
Lord Lea of Crondall: My Lords, following up on the question from the noble and gallant Lord, the Prime Minister has often referred to failed states and failing states. Unfortunately, does one not have to reach the conclusion that Nepal is now a failing state? It might be better to get behind the label Maoist and follow up the thought about hearts and minds to set out a much more comprehensive political strategy, possibly in conjunction with the Indian Government, to see how we can talk more directly to some of those people.
Baroness Symons of Vernham Dean: My Lords, I am sorry to say that I have to disagree with my noble friend. It is not fair to say that Nepal is a failing state in the sense that we usually use that term. Mr Deuba's appointment and the formation of a multi-party government represent the first window of opportunity for a return to negotiations with the Maoists since 2001.
It is important that we should back those efforts. We have been working very closely with our international partners to that end. We have been working through the EU and with our colleagues not only in the United States but also in India.

Pig Welfare
11.24 a.m.
Lord Carter Lord Carter asked Her Majesty's Government:
What steps they are taking to ensure that imports of pork and processed pork conform to United Kingdom legal minimum standards with respect to pig welfare.
Lord Whitty: My Lords, the vast majority of imports of pork and pork products into the UK are from other EU member states. All member states have to implement and comply with Directive 91/630/EC, as amended, which sets out minimum standards for the welfare of pigs. In certain respects, the UK has adopted higher standards, but the EU is now phasing in equivalent standards.
Lord Carter: My Lords, I thank my noble friend for that Answer. Is he aware that the figures from the Meat and Livestock Commission show that 70 per cent of the pork and pork products imported into this country in 2003 did not conform to UK legal minimum standards of animal welfare? Do the Government support the best practice guidelines, which ask retailers and food service companies to be clear and transparent in the standards that they require from their suppliers and ask them clearly to label the products that they sell, including the country of origin?
Lord Whitty: My Lords, on the second point, the industry has helpfully produced that industry code. The Government certainly support the principles of that approach. As regards the 70 per cent figure, it is clear that any trade within the EU is subject to EU standards. Therefore, 70 per cent of the imports are not to UK standards or do not have to be to UK standards, although some EU imports are direct to our retailers, which often require that the pork is produced to UK standards. So the 70 per cent figure is probably a slight exaggeration, but it is true that the UK standards are not mandatory.
Lord Roberts of Conwy: My Lords, what further steps can the Government take to ensure that the country of origin of imported pig meat is clearly identified on meat packages? Is the Minister aware that the Meat and Livestock Commission has samples, which I have seen, where one needs a magnifying glass to find the country of origin and certain packages where the country of origin is not identified at all but the meat is known to be produced in this country for packaging by well known importers?
Lord Whitty: My Lords, under EU law at present it would not be possible for us to require country-of-origin labelling. Currently, there are discussions within the EU on future labelling requirements, which include country of origin. We have supported proposals in those discussions to allow the requirement that country of origin is labelled. Of course, in practice, quite frequently the supermarkets voluntarily designate country of origin.
Lord Livsey of Talgarth: My Lords, will the Minister note that the British Pig Executive has said that other
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EU countries are not enforcing welfare standards? It says that because of that those countries have a competitive edge on UK producers in the market by undercutting them, which is devastating the pig industry. Will the Minister introduce a labelling system on imports that do not meet those standards and indicate a lower welfare production system than is the case in the UK?
Lord Whitty: My Lords, I have just answered a question in relation to labelling and what the Government can and cannot do about it. But at point of sale quite a lot of pork is clearly labelled with country of origin under voluntary arrangements.
Enforcing standards in other EU countries is not the central point. The vast majority of EU countries, particularly in the pork sector of agriculture, manage effective enforcement. In certain respects relating to stalls and tethers we are ahead of EU requirements. It is also true that some EU countries, including big suppliers to this country like the Netherlands, also have slightly higher than minimum EU standards. So we are not alone in that respect.
Lord Plumb: My Lords, although the Food Standards Agency is currently looking at legislation, does the Minister accept that it has already indicated that it will be 2010 before a report is produced? Why is it going to take that long when it is perfectly obvious that consumers want food labelling anyway? Is he aware of the voluntary scheme that has been started in Ireland? The country of origin is clearly marked on imported products as it is known that a lot of those products come from countries where the welfare standards are nowhere near as high as they are either in Ireland or in this country. Does the noble Lord support his ministerial colleague in Ireland, who is seeking the compulsory labelling of beef and insisting that meat products sold over the counter or in restaurants should carry a label showing the country of origin? Surely that is a clear lead for the rest of Europe.
Lord Whitty: My Lords, in discussions within Europe both the Irish and ourselves have taken the view that we should change the position so that we would no longer be prevented requiring a label showing the country of origin. Those discussions continue and will conclude well before 2010 and, it is to be hoped, will lead to changes in the labelling requirements from the EU so as allow us to introduce mandatory labelling. However, a vast amount of voluntary labelling can be done, in particular under the code referred to by my noble friend Lord Carter, which impinges in this area. Many supermarkets and meat producers already do that.
On differential standards, it is important to recognise that the vast bulk of pork imports to this country come from the Netherlands and Denmark. Both of those countries have pretty high standards of pork care. Moreover, European standards will, if you like, catch up with British standards. We have already incurred the expenses attached to meeting such standards, whereas our competitors will now have to face the expense of meeting those requirements.

Mental Health
11.32 a.m.
The Chairman of Committees: My Lords, I beg to move the Motion standing in my name on the Order Paper.
Moved, That the Commons message of yesterday be now considered, and that a committee of twelve Lords be appointed to join with the committee appointed by the Commons to consider and report on any draft Mental Health Bill presented to both Houses by a Minister of the Crown;
That, as proposed by the Committee of Selection, the Lords following be named of the committee:

B. Barker,

L. Carlile of Berriew,

L. Carter,

B. Cumberlege,

B. Eccles of Moulton,

B. Finlay of Llandaff,

B. Flather,

B. Fookes,

B. McIntosh of Hudnall,

B. Pitkeathley,

L. Rix,

L. Turnberg;

That the committee have power to agree with the Commons in the appointment of a Chairman;
That the committee have leave to report from time to time;
That the committee have power to appoint specialist advisers;
That the committee have power to adjourn from place to place within the United Kingdom;
That the quorum of the committee shall be two;
That the reports of the committee from time to time shall be printed, notwithstanding any adjournment of the House;
That the committee do report on the draft Bill by 31 March 2005; and
That the committee do meet with the committee appointed by the Commons on Wednesday 15 September at 10 o'clock.—(The Chairman of Committees.)
On Question, Motion agreed to; and a message was ordered to be sent to the Commons to acquaint them therewith.

Business of the House: Standing Order 41
The Lord President (Baroness Amos)The Lord President (Baroness Amos) rose to move, That Standing Order 41 (Arrangement of the Order Paper) be dispensed with on 8 September next to allow the Motion standing in the name of the Baroness Byford to be taken before the Committee stage of the Christmas Day (Trading) Bill.
Sustainable and Secure Buildings Bill
Read a third time, and passed.

Regional Assembly and Local Government Referendums Order 2004
11.33 a.m.
The Minister of State, Office of the Deputy Prime Minister (Lord Rooker)The Minister of State, Office of the Deputy Prime Minister (Lord Rooker) rose to move, That the draft order laid before the House on 24 June be approved [24th Report from the Joint Committee and 14th Report from the Merits Committee].
The noble Lord said: My Lords, before I go into the detail of this order, the House deserves an explanation because, contrary to what is set out on the Order Paper, I shall not be moving the five Motions en bloc, and in fact I do not intend to move the final two Motions.
Concerns were raised in the debate in the other place about all-postal ballots, drawing on some of the experiences of postal voting in recent pilots. There were differences of view on all-postal ballots. This week the Electoral Commission has also announced that it intends to publish its evaluation report of the June pilots and recommendations for future use of all-postal ballots before Parliament returns in September.
The debates in the other place also demonstrated again the solid support and expectations for an early referendum in the north-east region of England. None of the concerns raised about all-postal ballots related to the north-east. There the experiences of all-postal ballots, both in June and in earlier local election pilots, have been very positive. The picture is now one of considerable experience of all-postal ballots that consistently have been widely welcomed by the voters in that region. We have been reflecting overnight on these developments, and on the range of opinions expressed during the debate on the orders. We are a listening Government.
Except where there is a pressing expectation and support for an early all-postal referendum, we have concluded that the right course now is not to proceed with the orders setting up referendums on 4 November, but to await the report of the Electoral Commission. We have therefore decided not to proceed with the orders for the north-west and Yorkshire and the Humber. Our commitment to referendums in these regions remains unchanged.
Once Parliament returns in September we will make a Statement on how we intend to proceed in these regions, following our detailed assessment of the Electoral Commission's report which, as I have said, will be available before Parliament returns. We are clear, however, that by not proceeding now with these two orders, there cannot be any referendums on 4 November in either of those two regions. Whatever the Electoral Commission reports and whatever is decided—good, bad or indifferent—there is no prospect whatsoever of referendums being held on 4 November in those two regions. I want to make that clear. As I proceed to set out the chronology of the dates, it will be quite clear why it is not possible, whatever may be said by the commission or anyone else.
In contrast for the north-east, all that we have heard confirms that it is right now to proceed with the orders providing for all-postal referendums in the north-east on 4 November. That is what the people there want and expect and, I hope, is what will he made possible by noble Lords today.
I therefore beg to move formally the first Motion and speak to the following three Motions—the Regional Assembly and Local Government Referendums (Counting Officers' Charges) Order; the Regional Assembly and Local Government Referendums (Expenses Limits for Permitted Participants) Order; and the Regional Assembly and Local Government Referendums (Date of Referendums, Referendum Question and Explanatory Material)(North East Region) Order. However, as I have said, I will not be moving the other two orders.
The four orders to which I am speaking set out the rules and procedures for the referendums, including the postal ballot; the amounts counting officers can receive for their fees and expenses in connection with the referendums; the spending limit for those campaigning in the referendums; the date of the referendums; the options for unitary local government that voters will be asked to choose between; and the explanatory material that will he provided to voters at the time they vote. I shall take each of those matters in turn.
So far as the Regional Assembly and Local Government Referendums Order is concerned, this covers the details of the procedure for the conduct of all-postal referendums. I have already said that we believe that the north-east's experience of all-postal voting is different from the other regions. We are confident that problems highlighted in the media coverage of the June election pilots would not apply to the referendum in the north-east. That is because no candidates will he seeking election, and so the risk of fraud will be reduced. There will be a much longer lead-in time for the printing and dispatch of ballot papers in the referendums: six weeks instead of one week, because candidates do not need to be nominated.
Whereas in June there were reports that votes could not be counted because witnessed declarations of identity were incomplete, the Government intend to use security statements, which do not require a witness signature, for this autumn's referendums. The decision was made on the advice of the Electoral Commission that,
"the traditional form of declaration adds nothing to the security of the process but introduces significant risks".
There would be more assistance and delivery points in the referendums, one per 50,000 electors, to be opened on the date of the referendum between 7 a.m. and 10 p.m. and the preceding seven working days for normal working hours.
For those who cannot reasonably be expected to make it to an assistance and delivery point for reasons of physical impairment. there would he a requirement on counting officers to attend, or make arrangements for one of their clerks to attend on the voter at an agreed time and place.
I turn to expenditure limits. These are set out in the Local Government Referendums (Expenses Limits for Permitted Participants) Order. Political parties would he subject to a sliding scale of limits, determined by their vote share at the last European elections.
As the Explanatory Memorandum to the Regional Assembly and Local Government Referendums (Counting Officers' Charges) Order makes clear, the cost of holding the referendum will he approximately £1·52 per elector on a 100 per cent turnout. It will also be possible to claim additional resources from the Electoral Commission via an exceptions process if the counting officer can demonstrate a strong case.
Turning to the date, the north-east has set a referendum date of 4 November. The Deputy Prime Minister has considered whether the level of interest in holding a referendum had changed materially since he took soundings about the referendums last year. No evidence was presented that caused us to think that fewer people were interested in having a referendum than a year ago.
On 25 May, the Boundary Committee made its final recommendations for single tier local government in the three northern regions. As required by the Regional Assemblies (Preparations) Act 2003, the committee recommended two options for each county area. The options put forward were a product of a year-long review by the committee, during which time it considered more than 8,000 representations and conducted some 130 meetings.
We have considered the final recommendations and the 650 or so representations that we received. In the light of that consideration, we can accept, reject or modify the committee's recommendations, but we have had regard to the same statutory criteria under which the committee operated, most importantly in regard to the need to reflect the identities and interests of local communities and the need to secure effective and convenient local government. We have accepted the Boundary Committee's recommendations for the north-east region.
The options that we have adopted will give electors a clear and distinctive choice between different patterns of unitary local government. It is important that the choice is presented simply, clearly and neutrally in the ballot paper. It is also important that voters are provided with sufficient explanatory information to enable them to make an informed choice.
We have worked closely with the Electoral Commission to ensure that the ballot question and accompanying explanatory material is informative and neutral.
Finally, I should draw your Lordships' attention to article 6 of the orders. These change the period in which applications can be made to the Electoral Commission by permitted participants who want to be the designated organisation for either the Yes or No campaign.
The Political Parties, Elections and Referendums Act 2000 provides a default timetable for a referendum period, with a power to change some of the timings as

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appropriate. It would be standard practice to have 28 days for participants to apply for designated organisation status; 14 days for the Electoral Commission to consider those applications; and for that decision to be made at least 28 days before the date of the referendum. That gives 10 weeks.
However, as campaign expenditure and publications are regulated only during the referendum period, the Government believe that the referendum period should start once the orders are effective. As this means the campaign period would extend over the summer, when many people are on holiday, we have extended the period for permitted participants to apply to be designated from 28 days to 42 days. There will then be 14 days for the Electoral Commission to consider applications for designation and around 42 days before the close of poll on 4 November. That gives 14 weeks overall.
Finally, let me take a moment to explain the timing of the publication of the draft Bill. During the course of the passage through the House of the Regional Assemblies (Preparations) Bill we had many debates about the draft Bill. We said at the time that we would use our best endeavours to have a draft Bill available before the referendums took place, which is a fairly reasonable consideration. This was in order that people could consider it well before the day—we were not going to publish it the day before the referendum—in order that they might see what the powers and functions would be generally. It is a draft Bill; it is not perfect.
Nevertheless, it was never our intention to have the draft Bill scrutinised effectively before the orders were passed; the orders trigger the draft Bill. If the House, in its wisdom, approves today the three administrative orders and the order for the north-east, the draft Bill will be published immediately. It is already available but, technically, it will be published once the orders are approved.
Needless to say, Parliament returns in September, when the Select Committees will be available in the other place to scrutinise the draft Bill. As we have always said, the public scrutiny can start immediately because, subject to the orders being approved, the draft Bill will be published later today.
So our preparations are complete subject to the approval of the orders by the House. We are not making the decision in this House on whether there should be an elected regional assembly in the north-east, and the Government are not making the decision on whether there should be an elected regional assembly in the north-east: the people of the north-east will make that decision. That is what it is all about. We want a fair and vigorous campaign—there will be pros and cons for both parties—but if the House does not approve the orders we will deny the people of the north-east that choice. I hope the orders will be approved. I commend the order to the House.
Moved, That the draft order laid before the House on 24 June be approved [24th Report from the Joint Committee and 14th Report from the Merits Committee].—(Lord Rooker.)
11.45 a.m.
Baroness Hanham Baroness Hanham rose to move, as an amendment to the above Motion in the name of the Lord Rooker, at end to insert "but this House regrets Her Majesty's Government's decision to lay six orders relating to regional assemblies before the publication of a draft regional assemblies Bill; and before publication of the Electoral Commission's report on the all-postal ballots used in the pilot areas during the elections of 10 June".
The noble Baroness said: My Lords, the Minister is an honourable man and it must have choked him to death to make this statement today. Yesterday in the House of Commons there was a debate on the orders for elected assemblies in all three regions. Twelve hours later, after burning the midnight oil, using the scalpels and looking into the future, it became obvious to the Government that there was not a cat's chance in hell that they were going to win the referendums in Yorkshire and Humber and in the north-west. The only region in which the Deputy Prime Minister has ever been clear that he might perhaps have a chance is the north-east—and that is where he is now basing his hopes for this completely ridiculous form of local government. He hopes that the north-east will become a Trojan horse for a policy which is rapidly becoming more and more ridiculous as time goes on.
The orders have been laid at the wire of parliamentary time; they could not have been delayed longer. After today, there would have been no one in Parliament to consider them. The Minister said that the draft Bill will be laid once the orders have been approved—but that will be after Parliament is in recess.
The draft Bill will contain details of the powers that will pass to one regional assembly if the people of the north-east are unwise enough to vote for it. But the passing of powers is a matter for Parliament. How can it possibly be that a Bill which indicates the passing of power from Parliament to local government—because that is what the Government have always said this is—is not a matter for Parliament?
It has been a matter of great amazement to me and to my colleagues in the other place that the draft Bill has not appeared before now. Now it will appear during the Recess in order that the people of the north-east of England, during their holidays on the beach, will be able to scour it for information about what the regional assembly might or might not be about to do.
The build-up to these regional assemblies has been quite extraordinary. We have debated in Parliament, both here and in the other place, the European Parliamentary and Local Elections (Pilots) Bill, which turned out, of course, to be the forerunner of the Bill for the referendum. It is clear that, as a result of the European elections, the Deputy Prime Minister has got cold feet. He cannot see how the referendums in the north-west and Yorkshire and Humber could take place "safely"—a word used by the right honourable Nick Raynsford in the other place when he was weaseling his way out. He said that the Government would, of course, listen to what the Electoral

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Commission had to say if it decided that it would not be possible for those referendums to take place safely—but, of course, there might be reasons why the views of the Electoral Commission should not be taken into account.
Thanks to the chairman of the Electoral Commission, its report on the pilots —which is absolutely germane to the referendum which will take place—will be available at the end of August. It was not due to be available until mid-September. So there is now this possibility, which the Government must make absolutely certain becomes a reality, that Parliament will have the opportunity to debate both the Electoral Commission's decisions and the draft Bill in September. That is very late in the process for this single election.
Government information has been circulated in all three regional areas. I have seen the leaflets. It must have cost a fortune. The elections have been set up; there are No campaigns and Yes campaigns, and people have been spending money well in advance. And it is all for nothing. The Minister says that these elections may take place—something was said about the difficulties caused by party conferences. But party conference dates have been known since last year, so the timetabling of the election has nothing to do with them.
All the evidence that we have had on these elections showed that Yorkshire and Humber and the north-west were going nowhere. Very possibly the election in north-east will go nowhere as well. This leaves people in limbo. People in the north-east, the north-west, and Yorkshire and Humber have been led to believe that this great new part of local government would be theirs for the asking and that they would need only to vote in favour to have an elected regional assembly with great powers over planning, housing, skills, jobs—everything would come pouring in. Now the Government have reneged on that. I am not sorry they have reneged—I think that that is a very good thing. It will come as no surprise to Members of this House to know that we think that regional assemblies are a complete nonsense and are very pleased that the Government will not go ahead with them. It is also reasonable to presume that there is no possible question of these regional assembly elections in those two regions ever taking place, and certainly not before the election.
These orders include all-postal voting in the north-east. We have not welcomed this and it is certainly part of the reason why the Government have had to draw back today. All-postal voting is not an answer to elections, particularly not to election turn-out. It is clear that there are very serious problems with postal voting and that it does not necessarily carry what the Government think it does. But once again, they are hell-bent on going down this route. There is one deposit box for every 50,000 people, scattered across the north-east. If anybody knows the north-east, and plenty here do, they will know that it is a pretty wide county. One among 50,000 people will mean that they are quite far apart.
This is a terrible day for Parliament. I believe that there is an abuse of Parliament here. Yesterday the Government were going ahead with all three referendums. They have now had cold feet and have withdrawn. This is the only opportunity for the House to make any comment on what the Government are doing. I believe that there will be a Statement in the other place this afternoon, but that is too late for anybody to influence matters.
The questions that will be asked in the north-east will be myriad; those asked in the two regions where the referendum will not now take place will, I hope, cover the Government in such embarrassment that they never raise their head on these matters again.
My honourable friend Bernard Jenkin was quite prescient about this. He said yesterday:
"Here we are, with the date for the referendums set, the Government spending millions of pounds of public money on its propaganda campaign, 'yes' and 'no' campaigns set up and running in the three northern regions, but still facing the fact that the referendums may never be held".
I do not know whether the BBC took up what he said, but at seven o'clock this morning it had a very clear idea of what the Government would say today, well in advance of this House and the House of Commons sitting.
The Government are very good at spin; they have always tried to make sure that when they are in a hole, they can dig themselves out through the means of the press having got there first. So there are no surprises. My honourable friend Bernard Jenkin did not think there were any surprises yesterday, and he was right. The referendums will not take place. The referendum in north-east England will be the only opportunity for the Deputy Prime Minister.
I hope that the voters in north-east England now realise what a cynical set-up this is. I recommend that they reject the Deputy Prime Minister's offer of this referendum and put regional government where it belongs—in the ground, and possibly the Deputy Prime Minister with it. I beg to move.
Moved, as an amendment to the Motion, at end to insert "but this House regrets Her Majesty's Government's decision to lay six orders relating to regional assemblies before the publication of a draft regional assemblies Bill; and before publication of the Electoral Commission's report on the all-postal ballots used in the pilot areas during the elections of 10 June".— (Baroness Hanham.)
11.56 a.m.
Baroness Hamwee: My Lords, one might call this cynical, one might call it pragmatic—possibly, probably, both. But let us not lose focus on the importance of addressing the orders before the House. I think we may be a little tempted to look only at the fact that two of them are now off the agenda.
I had the radio on at a quarter to six this morning, when I heard the very distinctive voice of the noble Lord, Lord Haskins. I caught the end of what he said, which was something like, "Then you can go and wave a fist at a bureaucrat nearby instead of a central

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government bureaucrat". He may have been talking about regional government or he may have been talking about something else, but it seemed not a bad way of summing up what your Lordships are being asked to consider this morning.
I thank the Minister for the helpful timetable from him and from Nick Raynsford showing what might happen if the orders are passed and a referendum is to be held on 4 November and with regard to the problems inherent in postponing what will now be a single referendum in the event of a report from the Electoral Commission on the safety or otherwise of postal ballots. I thought that the printed timetable that was circulated was very honest on the Government's part in referring to the problems of running into a general election. That is another argument for a fixed-term Parliament so that we all know where we are.
Will the Minister say more about the position in the north-east if the Electoral Commission makes an unfavourable report about postal ballots? I may have been distracted when he dealt with that point, but I have checked with a couple of people, and I think it would be helpful if he could be clear about it.
Lord Rooker: My Lords, perhaps we can talk about it now. We said before today's debate that if the Electoral Commission gave such an account in its reports later this year, we would not proceed with any of them. That still applies, although obviously the report will be more relevant to the north-east. If it is evidence-based, the undertaking not to proceed with an all-postal voting referendum still applies. There is no pulling back from that commitment.
Noon
Baroness Hamwee: My Lords, that is helpful, although I hope that the Government will take note of what the Electoral Commission has to say about the other areas. After all, experiences in one region should be read as potential risks in another.
The amendment moved by the noble Baroness, Lady Hanham, uses the word "regrets". I regret that, procedurally, she has not dealt with the matter as straightforwardly as she did from the Dispatch Box. She made it quite clear that she opposed the order, but, as I understand it, the amendment is not fatal. I regret that the Conservative Benches have not expressed in procedure what we know they really think. They oppose regional government, even though they keep on talking about it and referring to it as local government. We on these Benches will not align ourselves with them, which will come as no surprise to them or others.
Nevertheless, there are areas of concern. The Government are in somewhat of a pickle of their own making. Enough warnings were given about all-postal ballots in June. The powers in the Bill need to be clarified. Those powers need wide discussion, because people need to know what they are voting for. The timetable of this House does not allow us to do a huge amount about that, but I have asked my noble friend
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the Chief Whip of the Liberal Democrats to try to secure through the usual channels a debate on the Bill as early as we reasonably can in order that we can have a rational, measured discussion of what is proposed.
Certainly, we would welcome extension of the powers beyond those that are set out in the White Paper. We have said often enough that they are far too restricted. I have heard that transport and learning and skills are now far more embedded in the agenda than they were at the time of the White Paper. I understand from my noble friend Lady Maddock that whenever one talks about regional government in the north-east, the question of the A l comes up. Transport is hugely important.
On the ballot, I take the point that when it is not a question of individuals standing, there is less risk of fraud, but the experience in June was one of confusion and inconvenience. The Government show a touching faith in the ability of the Royal Mail, which in SW14 is now taking five days to deliver mail from SW1. If I have not received everything that the Minister sent to me on this issue, I apologise—I know I have not received some of it. Perversely, in London, most ballot papers arrived before information from the Greater London Returning Officer, which shows the kind of difficulties that are inherent in the process.
We heard that one assistance and delivery point per 50,000 people will be set up. However, that is almost the size of a parliamentary constituency even in an urban area. I understand that the Berwick-upon-Tweed constituency has 58,000 people—it is certainly more than 50,000. Some rural constituencies are very large geographical areas. Could the Minister pass on any views from local authorities on keeping those points open for long hours, seven days a week, as it will he the returning officers, who are part of the local authority system, who will be dealing with the ballots?
The Royal National Institute of the Blind, which will have briefed many noble Lords on this issue, has argued for longer opening hours. I would certainly argue for more points. I welcome too the change in arrangements for witnesses. On 10 June, I had to refuse to witness the signature of somebody who turned up at a polling station, because it was claimed that that person was known to me. She was not, and I felt that it was appalling not to be able to assist someone to go and vote. She was within yards of the ballot box, but neither the presiding officer nor I, as a teller outside, could help her.
I mentioned the RNIB's briefing. There is not time this morning to go through it in the detail that I would like, but I would like the Minister to say something about making the ballot more accessible and about helping people to read information. We should not have it in 8-point print; I doubt that any noble Lords have the speeches that they read in the Chamber in such small print. I want to hear about how we get information into alternative formats and how people can get to assistance points.
I was pleased to hear that, in Liverpool, the electoral office approached the Liverpool Voluntary Society for the Blind and asked for advice on how best to ensure

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that blind and partially sighted people know how to vote. Electoral officers there also asked the society to provide awareness training for electoral staff. I mention that not just so that I can crow about the local authority concerned but because it is a useful model that could be followed.
The mock-up ballot paper that I have seen shows a map. It was the ballot paper for Durham, and I do not know how widely it has been made available. I do not know whether it is possible under the terms of the order, but I would press for a far more detailed map. It did not even show towns; there were shapes of districts. One would need to be very geographically and spatially aware to read a map that just showed interlocking shapes and know what the shapes referred to. I know that we are not going ahead with it now, but I also saw maps for Wyre and west Lancashire. They were more conventional and showed the detail. That is what we should have.
As I said, one might say that it was cynical or pragmatic. A Bill will be published, and we will do our best to debate it before, perhaps, the north-east goes to the polls on 4 November. The north-east will not now be distracted by arguments in the media about other regions and will be able to concentrate on its own region. Our fear throughout has been that the Government were going the right way to make the worst of the argument. They must provide the best basis on which voters can decide.
The noble Baroness, Lady Hanham, referred to voters being "unwise enough" to decide on an Assembly. I know what I hope that the outcome will be, but I would not presume to judge the wisdom of the voters. We should agree to the orders today and leave them to make up their mind.
The Lord Bishop of Chelmsford: My Lords, these matters affect the whole country. Those of us on these Benches have, with our ecumenical partners, been active participants in the regional institutions set up in recent years. We can bring quite a bit of experience to such matters.
When I was Bishop of Guildford, the south-east of England region ran from Milton Keynes to Canterbury. I am now in Chelmsford, in a region that comes within the area of Essex County Council, has two unitary authorities, and is part of the east of England region, while the economic, social and political realities of our area are determined in London. So there are significant and important questions about the way in which the people are represented in these matters.
As for the issue of ballots, is it wise for us to proceed with postal ballots in advance of the assessments of the Electoral Commission? What is actually going on? What is the real meaning of the announcement that the proposals surrounding regional government are now in retreat? That is very important for the country. We need to know where we are in relation to those issues, not only in the north-east but throughout the country. Where are we going? What is the Government's view on these things? What are we supposed to relate to, in terms of public policy and perception? There are big questions.
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In the east of England, and especially in the county of Essex, there are major development issues in front of us. Two of the major areas for the Government's housing development in the south-east of England are in my diocese. There are big questions, and people in local government constantly ask me about the shape of regional political practice.
If we proceed to the ballot in the north-east of England, how are we going to interpret the result? I have in front of me the map showing north Durham, east Durham and south Durham. I know the region, because I lived in Durham for nine years. What happens, and how will the result be interpreted, if there is a 30 per cent poll with south Durham voting one way on the issue and north and east Durham voting the other way? What is going to happen? Are we moving into new structures for government in our country on the basis of ballots set up in this manner, without a way of understanding how the Government will interpret how people respond? If we do not have clarity about how the response is to be interpreted, the rest of us who, in the dim and distant future, see the possibility of ballots coming our way, even in the south-east of England—although I find it extremely difficult to conceive that we shall ever arrive at that point in the south-east—
Lord Smith of Clifton: My Lords, I am afraid that the right reverend Prelate is misinformed. The latest "state of the nation" survey, undertaken by the Joseph Rowntree Reform Trust, recorded in the south-east the highest score requiring regional government.
The Lord Bishop of Chelmsford: My Lords, those who represent the people in local government in the south-east of England —and yesterday I was in one of our local borough council offices—are very closely in touch with the views of their people. If ballots were held, the people might express a different opinion.
I want to know how the results are going to be interpreted and what the implication is for the rest of us in the development of these policies. The matter is very serious and significant, and it is very important that the Government respond.
Lord Judd: My Lords, I intervene as someone who strongly supports the Government in their intentions on regional government. The Opposition have again today said that they regard regional government—and I hope that I quote them correctly—as "complete nonsense". I personally believe that that position is complete nonsense.
The fact is that regional government is with us to stay, and the issue is how we have democratic institutions that match that regional administration and government and can hold it accountable. I believe that history will regard us harshly if we try to sidestep the challenge to ensure that our democratic institutions match the administrative reality.
Those issues, however, have been debated at some length in the House already. My intervention today is made as somebody who lives in the north-west region, as somebody who lives in Cumbria, and as somebody

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who has the privilege of chairing what is known as the Social Responsibility Forum in Cumbria. That body brings together all the Churches of Cumbria, stretching from the Society of Friends—which I hope will not mind being described as a Church—to the Roman Catholics, including even some of the charismatic Churches as well.
Carrying that responsibility last year, and having listened to the very well informed and concerned discussions that have taken place in that forum on a number of occasions among people who are in their professional work closely in touch with a far wider range of the population than simply the churchgoers themselves, I am able to say that the Government's decision not to proceed with the order for the north-west today will be warmly welcomed, with considerable relief. It is a wise decision and I congratulate the Government on having the courage to make it.
12.15 p.m.
I shall briefly highlight some of the reasons why I believe that it is a wise decision. As currently envisaged, the referendum would give people a say on whether they want to be part of an elected north-west regional assembly, but the reality is that they have never been consulted on which region Cumbria should be in. Many Cumbrians, particularly those from the north of the county, feel little affinity with the north-west region as it stands, but see themselves as much closer to areas of the north-east region, particularly Northumberland, which has many similar concerns and issues. Our principal regional hospital is in Newcastle; our television in the north of Cumbria is Border Television and Tyne Tees Television. Those are two examples of the social reality that I am describing.
The voice of Cumbria, on an elected north-west assembly, would be very small—perhaps two to three seats out of about 25. That causes considerable anxiety among many Cumbrians, who fear that their concerns may be marginalised by a metropolitan power base. That relates to the point that I have just made, as Cumbria would have a stronger voice in the north-east, where the population base is much smaller than it is in the proposed, huge, north-west region.
A truly democratic referendum, as I am sure my noble friend would agree, would surely rely on securing a reasonable turnout to vote. That will happen only if people are properly informed about the referendum and feel that they can understand and engage with the issues. Yet the consultation process to date is regarded by many as having been totally inadequate. The Boundary Committee was supposed to leaflet every household in Cumbria early this year to consult on proposals for part two of the referendum—options for unitary local government—yet this was not effectively done.
Publicity for the referendum has so far been poor. Here I must differ from the perceptions of the noble Baroness who spoke for the Opposition. It is our experience, in the Social Responsibility Forum, that few public meetings have been organised. Indeed,
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Churches Together in Cumbria is having to fill the gap. Much more work needs to be done by the Government to ensure that the issues and options are understood.
The process for counting the vote in part two of the referendum—as things stood—would have been unsatisfactory for the people of Cumbria. The Cumbria and Lancashire votes were to be counted as a single entity because one of the options for unitary local government straddles the county boundary. But the population of Cumbria is less than half a million, while that of Lancashire is more than 1.1 million. The feeling is that Cumbria's voice would not be heard fairly. In an extreme case, even if the entire population of Cumbria were to vote for one option, something else could be imposed on them by the Lancashire vote.
My last point is this. The preferred option of four of the current Cumbrian local authorities—Allerdale, Copeland, Carlisle and Eden—and of many people within the county is for three unitary authorities in Cumbria, based on the pairing of existing district councils, which has not been included in part two of the proposed referendum at all. I do not want to put it too strongly, but this seems to us to be fairly certain to guarantee a high level of discontent, whichever of the two options is chosen.
As he has made the wise decision, I ask my noble friend to take these points and considerations on board in looking to the way forward. For example, he could consider an option put to me yesterday by a noble Lord who is a close friend and colleague. It is a very sensible idea that envisages a statutory requirement for any north-west regional assembly—if it were to go ahead in the way that the Government are proposing at the moment—to have a special consultative committee for Cumbrian affairs.
Lord Hanningfield: My Lords, in rising to support my noble friend Lady Hanham, I agree with the noble Baroness, Lady Hamwee, that we need a debate about this issue in this House as soon as possible. Therefore, I do not intend to detain the House very long today on these issues. Some of the speeches that have been made were of a more general character and we need a debate on the powers of the regions in the Bill that is being published today and on other issues, particularly the issues of boundaries. Noble Lords will know that I have made many speeches in this House about the eastern region, to which Essex does not belong. Essex is much more related to other parts of the country. I shall not go into that today.
I am concerned that over the past year we have had a considerable number of debates on postal voting and the regional assemblies. From these Benches, my noble friend Lady Hanham and I have consistently said that it will all end in chaos. That is where we are today: in chaos. We are in the most chaotic situation. I want to highlight one area.
As most noble Lords know, I am very involved in local government. Local government delivers services. It cares for hundreds of thousands of elderly people in their homes, it looks after children in need, it supports schools, it repairs roads and it looks after libraries.

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Local government will be in limbo in the two regions that are now being deferred. Noble Lords do not know what has been going on over the past two years in, say, Cheshire. Cheshire does not want to be in a north-western region. Local authorities in Cheshire have been organising a big campaign to which a lot of energy and resources have been devoted. They have had to neglect the basic services areas that I just mentioned.
Lancashire, Cumbria—which has just been mentioned—and the metropolitan areas of Yorkshire have been spending time on this regional assembly, which has now been deferred. What is going to happen? Are they to sit there for the next month or year, or five years, waiting for a possible referendum to the detriment of all the people to whom they are providing services? These people want to know. Why did the Minister not suggest that we have the ballots by conventional methods with people going to the ballot box? There needs to be an end to the doubt about what is happening in local government.
Local government is about services. In the north-west there would probably have been a 75 per cent No vote. Let us have that ballot and let the people in the north-west vote No so that they can get on with their business again. Let us have a ballot in the east of England. There would be a 90 per cent No vote in the east of England. Let us get it out of the way and get on with our business again. This is the real problem. It is uncertainty, uncertainty, uncertainty.
The Prime Minister's mantra is education, education, education. In local governments throughout the England, it is uncertainty, uncertainty, uncertainty. That is no good. Local government is for people and services. I hope the Minister will comment on that today. The uncertainty must be ended. It may be ended in the north-east on 4 November. It will not be ended in the rest of the country. Local government must know so that it can get on and support services for the people. I would like the Minister to comment on that area today. Please let us have a debate as soon as possible in September about the whole issue.
Lord Shutt of Greetland: My Lords, I ought to declare an interest as a director of the Joseph Rowntree Reform Trust, which has supported the campaign for regional government in England and the two groups in the north-east and in Yorkshire which have been keen on promoting devolution.
This is a sad and strange day. In fact, it is a poor do. There is no greater strength than the advocacy on these Benches for genuine regional devolution. Talking about boundaries is the road to nowhere. It is the road to nothing happening. We know that we have devolved government but the fact is that it is not democratic. The devolved government is there with the civil servants and it is a matter of getting democracy with that.
I cannot fathom the business about postal votes at all. We still have the ballot boxes. They have not been put on the tip. The ballot boxes still exist. So if there is a problem about postal votes in Yorkshire, Lancashire
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and the north-west, we could vote in the normal way that we have done for donkey's years, by marking ballot papers and sticking them in ballot boxes. This business about postal votes and so on is hogwash. We know how to vote if we are keen to have a vote. We have polling stations and we go to them and register our vote. The biggest problem in all this is the lack of enthusiasm. I do not think that the Government's heart is in this. This is the big problem.
Let us compare this with what happened in Scotland. There was the Scottish Constitutional Convention. Noble Lords will remember the phrase, "the settled will of the Scottish people". What attempt has been made to get the settled will of the folk in the regions of England? Where is the hand of the Government?
On an earlier occasion, I said that, although I had great reservations about this, I was prepared to support it because I did not think that the powers were good enough but it was something to build on and we might be able to improve things as the years go by.
There are now three problems for the Government. If this only concerns the north-east, there is the problem of powers. The powers are insufficient. We have heard all along that they are insufficient. Members of the Cabinet who look after education, health and so on have said that those matters cannot be devolved as they wish to retain the powers and are not prepared to devolve them.
There is a problem about local government because it has been brought into the equation. The Conservative Party conveniently confuses local government and regional government. But, again, there has not been real leadership in defining what regional government is and how important it is.
Moreover, as far as the north-east is concerned, there is a problem because there will not be referendums in Yorkshire and Humberside and the north-west. That is a further handicap to winning a ballot in the north-east. I invite the Minister to respond to this. If one were part of the No campaign campaigning in the north-east, one would be saying, "The powers are not that bright, they are lousing up your local government and, by the way, they are not doing this now in Yorkshire and Humber and the north-west but they think you lot here in the north-east will fall for it". There must be a fair answer to that for the people who are trying to campaign in the north-east because they have their hands tied behind their backs three times now.
I hope that the listening Government and the listening Minister have listened and will have some answers, particularly now that we have a reduced situation of trying to campaign just in the north-east.
Lord Tordoff: My Lords, I ought to declare an interest in that it appears that I am not going to be a voter in Yorkshire. My second interest is, I suppose, dead. I chaired a group of Liberal candidates in the north-west that produced a booklet on regional government for the north-west. That was in 1965. I suspect that it might he slightly out of date. I know for

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certain that there are only two copies left, one under my bed and one under the bed of the noble Lord, Lord Greaves. Noble Lords may be pleased or otherwise to know that the noble Lord, Lord Greaves, is walking in the Pyrenees so he will not detain us today.
An interesting point arises out of the document that we produced, which was raised by the noble Lord, Lord Judd; namely, where you put Cumbria. We put it with the north-east at that time. The other problem is what you do with the south-east of England, which is like a Polo mint—unconnected communities with a hole in the middle which is Greater London. I thought I heard the Minister say that the subventions of cash to the campaigns would be based on the electoral votes in the European elections. For the life of me I cannot see the connection between those two things. These are totally different issues. To assess the amount of money going to various parties on that basis seems to me to be very peculiar. Perhaps the Government could explain that.
12.30 p.m.
Lord Rooker: My Lords, I shall take advice on that latter point. I do not know the background to that but under the order there has to be some basis for subventions to political parties. We are talking about a referendum; there are no personalities involved. The recent European elections were conducted on a party list basis and therefore did not involve counting votes for personalities. They constitute a fair way of conducting the process. A referendum is not like an election. I say to the noble Lord, Lord Tordoff, that that is probably the connection in that regard.
I shall resist getting into the boundary argument. Noble Lords will know that I have expressed my personal views on the matter. I believe that some counties come under the wrong regions. However, we are not discussing regional boundaries. We said that they were never closed but that we had no plans to change them. We have inherited the regions created for administrative purposes by the previous government. We have no current plans to change them. We said that the matter could always be revisited but that it was not a precursor to regional government.
I am very conscious that the noble Lord, Lord Shutt of Greetland, said that this matter was a poor do. I am constantly reminded of his lack of enthusiasm for the original plan. I remember him saying, "I want to be enthused". I could not enthuse him regarding the proposals because they did not go far enough. The noble Lord then said, and repeated today, "I shall take this because I can build on it". I believe that there is general acceptance of that point. I shall not discuss what might happen to the No and Yes campaigns in the various regions as it would be totally inappropriate for a Minister to try to imagine that. Nor will I comment on what parliamentary colleagues will say in the other place later today when Nick Raynsford makes a Statement.
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I wish to make two points to the noble Lord, Lord Hanningfield. First, there is no chaos. We have a clear policy, which I enunciated this morning, on the way we are proceeding. The legal framework is there. The preparations are made. We are confident about the administration. There is plenty of time. As I explained, because no candidates are involved in the ballots, six weeks are available to deal with the ballot papers, rather than the week that was formerly the case.
As a reasonable person I accept that there is a blight on local government. I accept that, given what the leader of a county council has said in the past and what others have said when talking about local government reorganisation. As I said in my original speech, in September the Government will make a further statement on the way forward following the publication of the Electoral Commission's report, although I cannot say that that will be a definitive statement. Proposals have been made for local government reorganisation in terms of unitary authorities because we are not prepared to have an extra tier of government in those regions. However, we have said that that is part of the regional assembly process, it is not a local government reorganisation for its own sake.
Lord Hanningfield: My Lords, can we then have a debate on these issues as soon as possible? I hope that the Minister will agree to that.
Lord Rooker: My Lords, I know it is a cliché but it is a matter for the usual channels. The usual channels decide that matter. Noble Lords sitting behind me and at the side of me decide what is debated. I am just a humble day-to-day mechanistic Minister who does what he is told and turns up on the right day. When the usual channels have fixed a day, they say, "Turn up and this is the subject".
Obviously, this matter will be debated. A draft Bill will be published today, not a Bill. We have said that we will introduce a Bill to go through a parliamentary process only if there is a Yes vote. That is the position. The Government have published a draft Bill with all the necessary extras. We can debate that at a suitable opportunity.
I say to my noble friend Lord Judd that I cannot say anything about turnout. That is a matter to be decided at the time. We hope that there will be a high turnout. Pilots have indicated that postal voting raises turnout. Raising turnout is good for democracy. I have my personal views about elections. I believe that if there were PR, the turnout would be even higher because people's votes would count. However, that is not the Government's view. I say that before my noble friend the Chief Whip jumps on me. My noble friend Lord Judd referred to the social reality. I fully accept the points that he made regarding the discussions in Cumbria not being a solution. He warmly welcomed our decision not to proceed with the relevant order at this time. Obviously, I cannot foresee what will occur in the future.

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The right reverend Prelate the Bishop of Guildford-cum-Chelmsford, or Chelmsford-ex-Guildford—they call them retreads in the other place but I cannot use that phrase here—raised issues regarding the eastern region. I ask him to take on board the following point. So far as I am aware there has never been any local government reorganisation in this country conducted by either of the parties in power that has been submitted to the people's choice before it occurs. That has never happened. I fully accept that we are to that extent in uncharted waters. As regards the abolition of counties and the metropolitan county councils and the boundary changes that took place in the early 1970s following the proposals of the noble Lord, Lord Walker, there was no question of people's choice. Parliament decided and Parliament dictated what was good for people in those matters. In the case that we are discussing we are putting forward proposals and options because of the issue of unitary government. It is a piloting process by definition as it will occur in one region out of nine. The process in London is not quite the same.
We are not in retreat as regards regional government, far from it. We have a regional agenda that will proceed, particularly regarding planning and the housing boards that we have already announced. They are not dependent on elected regional assemblies. I have said that the Bill will be draft only.
A slightly earlier version of the ballot paper and explanatory material that I sent to colleagues at the end of last week had been fully tested by the Electoral Commission in a series of in-depth interviews with voters in three regions. They found the text was helpful in explaining the concepts involved in the move from two-tier to single-tier government and, together with the mapping—which was considered to be clear and helpful—would enable people to make an informed choice. In addition, large-scale maps will be available at council offices, public libraries and at assistance and delivery points. Therefore, larger-scale maps will be available. I do not accept that what is in the order is just a blob. It contains the detail of which councils are covered.
As regards ballot paper size and eligibility, counting officers can assist partially sighted and blind people to vote either in their own homes or at an assistance and delivery point. A tactile voting device is available for voters. Counting officers can make available a copy of a ballot paper in large format by way of example, but not a proper ballot paper in large format because of the security of the ballot.
Baroness Hamwee: My Lords, before the Minister finishes with that little section, I want to say that I assume that the returning officer may send out information outside the order. I hear what the Minister said about the Electoral Commission's work, but I urge the Government to think whether there is any possibility of providing more information about the detail of what the boundaries mean, in a way that voters will see without having to go to council offices and so on.
Lord Rooker: My Lords, obviously there will be leaflets through every door, and I hope that they will
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fully explain the boundaries. People know where they pay their council tax, and that local authority will he either put with another or joined with others.
I want to deal with the point about party conferences. In Committee in another place, we were asked why the referendum date was in November. We could not lay the date order any earlier, given when the Boundary Committee reported. We gave a commitment during the preparations Bill that there would be a 10-week referendum period, and we did not think it appropriate for ballot papers to be dispatched during the party conference season, or for the close of poll to be during the school half-term holidays. That gave us the referendum date of 4 November.
The matter was not decided by the BBC, but by the Cabinet between 9·30 and 10·30 this morning. That was when the final decision was made. It is riot a terrible day for Parliament. If the noble Baroness, Lady Hanham, wants to say that it is a terrible day for Parliament and that she disagrees with what we are doing, that is one thing; to say that it is a terrible day for Parliament but that she agrees with what we are doing—that is what she said—seems a bit of a contradiction.
People can vote by ballot box. The pattern of postal voting is that people are sent the postal ballot paper at home. If they wish, they can go to a polling booth and put their vote in a ballot box. That is part of the process. We do not tend to advertise it, but that is what happens in the pilots. They can put the vote in an envelope and post it back but, if they want to put their vote in the ballot box, they can do so. We said 1:50,000; that is a matter for local offices. If they warn to take account of distances in rural areas and have other boxes, no doubt they can do so.
So far, £1.9 million has been spent on raising awareness. We will now obviously withdraw from all expenditure relating to the referendums in the two regions, as that makes a lot of sense. The draft Bill will be available once the House has decided—in other words, I hope that it will be available before the Statement in the other place, which I understand will be at approximately 1.15.
It is a good day for democracy. We are asking several million people in one of our regions to decide whether they want a different form of government in the region, with its local consequences, from what they have now. That is all that we are asking them to decide, and it is their decision to make. I ask the House to pass the orders without a vote, because we are letting the people decide.
Baroness Hanham: My Lords, we have had a debate, which is what my amendment was originally about, but it was tabled long before the shambolic events of this morning. In some way or another, we have managed to talk about the Government's mess, and there is no way round it—it is a mess of the highest order. The Government know it; the Minister knows that, at the bottom of his heart, they have now written off regional government. It is sad for those in the north-east, who will be put under a microscope and

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will be taking part in a very cynical election. They will be guinea pigs for a regional assembly that will never be extended to anywhere else. What a day.
I had considered pressing the amendment to a vote. However, as there are too few Members on the Government's Benches to enable them to win it, I shall not do so.
Noble Lords: Oh!
Baroness Hanham: My Lords, the Government want to lose the vote; it would suit them very well to lose the north-east with it. It has been an interesting debate on a dreadful day—a really terrible day for this really terrible Government.
Lord Judd: My Lords, will the noble Baroness not for a moment contemplate the political context in which she has made her remarks? The Opposition love to bandy around criticism of the Government for being arrogant and insensitive. On this occasion the Government, having listened to anxieties that exist, made the courageous decision to change their plans. They are then accused of being in a mess. The Opposition really must make up their mind.
Baroness Hanham: My Lords, I am tempted not to reply to that, but this is not the Opposition's mess. It is the Government's mess. To whom are the Government listening? They made their decision overnight, at the end of an extremely long haul on regional government. They could have made the decision at any time. It was they who laid the orders right to the wire in Parliament. The problem is the Government's fault, not the Opposition's. I beg leave to withdraw the amendment.
The Deputy Speaker (Baroness Lockwood): My Lords, is it your Lordships' pleasure that the amendment be withdrawn?
Noble Lords: No!
12.46 p.m.
The Deputy Speaker: My Lords, the Question is that the amendment shall be agreed to. As many as are of that opinion will say, "Content". To the contrary, "Not-Content". Clear the Bar.
Division called.
Tellers for the "Contents" have not been appointed pursuant to Standing Order 54. A division therefore cannot take place, and I declare that the "Not-Contents" have it.
Amendment negatived.
On Question, Motion agreed to.

Regional Assembly and Local Government Referendums (Expenses Limits for Permitted Participants) Order 2004
12.51 p.m.
Lord Rooker: My Lords, I beg to move the Motion standing in my name on the Order Paper.
Moved, That the draft order laid before the House on 24 June be approved [24th Report from the Joint Committee].—(Lord Rooker.)
On Question, Motion agreed to.

Regional Assembly and Local Government Referendums (Counting Officers' Charges) Order 2004
Lord Rooker: My Lords, I beg to move the Motion standing in my name on the Order Paper.
Moved, That the draft order laid before the House on 24 June be approved [24th Report from the Joint Committee].—(Lord Rooker.)
On Question, Motion agreed to.

Regional Assembly and Local Government Referendums (Date of Referendums, Referendum Question and Explanatory Material) (North East Region) Order 2004
Lord Rooker: My Lords, I beg to move the Motion standing in my name on the Order Paper.
Moved, That the draft order laid before the House on 8 July be approved [25th Report from the Joint Committee and 15th Report from the Merits Committee].—(Lord Rooker.)
On Question, Motion agreed to.

Regional Assembly and Local Government Referendums (Date of Referendums, Referendum Question and Explanatory Material)(North West Region) Order 2004
Lord Rooker: My Lords, not moved.
Regional Assembly and Local Government Referendums (Date of Referendums, Referendum Question and Explanatory Material) (Yorkshire and the Humber Region) Order 2004
Lord Rooker: My Lords, not moved.

Human Tissue Bill
12.52 p.m.
Lord Warner: My Lords, I beg to move that this Bill be now read a second time.
The Bill is brought forward as a response to the scandals revealed by the Alder Hey and Bristol inquiries. There can be no doubt that many people suffered when they discovered that the organs of their loved ones had been kept without their knowledge.
Lord Jenkin of Roding: My Lords, perhaps I may raise with the Minister a matter about which I have given him notice and which refers to exactly the points he has mentioned—the availability of the relevant documents to the House. Usefully, the Explanatory Notes on the Bill refer to the several reports, including those that the noble Lord has just mentioned, and other documents which have led to this legislation.
Two of those documents seem to me to be required reading: the advice to the Government by the Chief Medical Officer for England and the consultation document Human Bodies, Human Choices. But on inquiry at the Printed Paper Office earlier this week I was surprised to discover that neither was available. The clerk on duty helpfully was able to locate the documents on the Internet and to print them out for me. The CMO's advice runs to 48 sheets and the consultation report runs to nearly 200 sheets. On asking whether there was a summary, I was told that there was not. Yet, on reading the consultation document, it is clear that there is a summary. I have not yet seen it.
This is not good enough. I had always thought that it was standard practice for departments promoting legislation to ensure that all relevant documents are available. The Minister's private secretary, whom I telephoned last evening, offered her apologies and indeed those of the noble Lord, Lord Warner. However, I should be grateful if he would explain to the House why the system failed in the present case.
I am told that, following my call to the department, the boxes of papers were delivered at about 6 p.m. yesterday. I understand from discussion with other noble Lords that most of them did not see the papers until this morning. They will be useful in Committee, in September, but ought they not to have been available last week?
Lord Warner: My Lords, we did our best to recover from the situation in which I personally found myself yesterday following the telephone call from the noble Lord. My private office tried as much as we could to help him and remedy the situation. It is unfortunate that the department did not ensure that all the documents were available, and all I can do is apologise to the House. As the noble Lord said, these documents will be particularly useful in Committee. We have tried to remedy the shortcoming and make them available. If any noble Lords are having difficulties over access to the documents, perhaps they could let me know and
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I will try to ensure that we get them to you as quickly as possible and before the summer holidays. On that basis, I shall continue my speech.
As I said, the Bill is brought forward as a response to the scandals revealed by the Alder Hey and Bristol inquiries. There can be no doubt that many people suffered when they discovered that the organs of their loved ones had been kept without their knowledge. We must not underestimate the pain endured by those who came to realise—often many years later—that the body of the child, husband or mother whom they had buried was incomplete. We must ensure that that does not happen again, and this legislation is key to ensuring just that. However, it does much more than that. This Bill will provide the comprehensive statutory framework needed to ensure the appropriate use of human organs and tissue. It will make consent the clear controlling mechanism for the retention and use of organs and tissue and it will establish a regulatory body to oversee a range of related activity in this area such as post-mortems, tissue banking and the public display of human bodies.
At the same time, we must recognise that many important benefits accrue from the use of tissue both from living patients and following post-mortems. There has been uncertainty in recent years among researchers about whether and when they can use tissue in research, whatever its source, and this uncertainty has undoubtedly inhibited research. So we are legislating in part to provide the protection and confidence needed to support research and development in science and medicine. But this must be a partnership between medicine and society and the partnership must be built on communication, understanding and consent. The Bill will ensure that the rights and expectations of patients, families and society are met, while meeting broader social needs such as the importance of medical research, education, training and public health.
The need for this new legislation on human organs and tissue was recognised some three years ago. Before setting out the detail of the Bill, I think it would be helpful to recall some of the background. In 1999 and 2000 the inquiries at Bristol and Alder Hey left us in no doubt about the scale on which tissue and organs were being retained without the knowledge of families following post-mortems.
The practice was not limited to those particular hospitals or to children's post-mortems. The report of the Isaacs inquiry more recently confirmed that large numbers of adult brains had been retained, again without the knowledge or consent of families, following coroners' post-mortems. A census of organ retention by NHS pathology services carried out by the Chief Medical Officer in 2000 revealed that more than 100,000 hearts, brains, lungs and other organs were being kept. In Northern Ireland the Human Organs Inquiry confirmed that similar practices had occurred there. Part of the tragedy was that, ironically, in many cases the families concerned said that they would readily have accepted the use of their loved ones' tissue or organs for medical research, if only they had been asked.
In the light of all that, we asked the Chief Medical Officer, Sir Liam Donaldson, to report and make recommendations on the retention and use of human

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tissue and organs. One thing that had by then become clear, as the reports emerged, was that post-mortem practice had developed over many years in ways that were no longer in keeping with what we have come to expect. While practice was directed at supporting medical knowledge and research, it was, in this area, failing to respect the interests of families. It had become routine for tissue taken at post-mortem to be kept for archives, research and education but without proper discussion with those close to the deceased.
The situation was set out very clearly for us when the Chief Medical Officer reported in January 2001. Sir Liam made 17 recommendations, all of which we accepted in England and Wales. The Human Organs Inquiry made broadly similar recommendations in Northern Ireland.
In implementing Sir Liam's recommendations, we aimed to provide, first, support and advice for those affected; we put in place stabilising measures by means of advice and guidance; we set in train a review that would secure a proper framework for the future; and we are helping to develop professional and public understanding as a way of ensuring that changes in the law go hand in hand with changes in practice and culture.
Therefore, immediately following publication of the report, in April 2001 we established the Retained Organs Commission, whose task was to provide advocacy, oversee the return of organs and tissue to families and give guidance to trusts. The commission closed in April this year, having carried out its responsibilities with admirable sensitivity and commitment.
In April 2003, we published guidance and consent forms for post-mortems, together with advice that helps to clarify the law as it currently stands. We have other work in hand that includes providing information and support to bereaved families, and we are supporting further training and development for health professionals.
The Bill will support and underpin those developments. But the Bill is not just about how we deal with the deceased. The review of the law covered the whole area of the use of human tissue, from the living as well as from the deceased, and its use for transplantation, research and other purposes, such as donation for teaching and education. Those are all important matters, and it was vital that we approached this in a comprehensive, joined-up way to ensure that all research, education, transplantation and other uses can progress confidently and on a sound legal basis.
Regrettably, we have undoubtedly lost opportunities for valuable health research, partly because of the lack of confidence in post-mortem practice but also because of uncertainty among pathologists and tissue banks as to what can be used and for what purposes. The law across the field, as it stands, is unclear, out of date and close to unworkable. It is important that those working in medical research—an area well represented in this House—
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understand the public confidence and trust that must be established if they are to do their valuable work confidently in the future.
The proposals set out in the Bill have been prepared following extensive consultation. In July 2002, we published a major, comprehensive consultation report called Human Bodies, Human Choices. We received around 250 responses but we also held workshops and conferences with a wide range of interested groups and individuals covering consent, regulation, transplantation, next-of-kin issues and penalties.
We published the results of the consultation in April 2003, and we published the broad proposals in September, following which we held a further round of stakeholder meetings with families, clinicians, researchers, heads of Royal Colleges, anatomists and other organisations, including the BMA, ROC, Wellcome Trust, UK Transplant, Human Genetics Commission, and the Welsh Assembly's Organ Retention Advisory Group. The degree of support and consensus that we found has been hugely encouraging, and we have been able to build on that. I am grateful to all the groups and individuals—some through the pain of their own experience—who contributed to this work.
The Bill, therefore, is about balancing the rights and expectations of families with broader public health considerations. It will make consent the clear basis for the keeping and use of tissue and organs. It will restore confidence so that important health research can proceed with the support of patients, families and the public.
Part 1 of the Bill deals with the question of consent. Here, we are proposing a comprehensive framework in relation to all medical uses of human bodies, organs and tissue and in relation to public display. That should allow us to draw a line under the events of the past and be confident that proper legal and ethical standards will apply in all situations where tissue can be kept and used for the public benefit. The Bill will establish clearly that, other than in cases of a coroner's investigation, the decision about the use of tissue or organs will lie squarely with the individuals themselves. Where the individual's wishes were not given before his death, the role of the family or person closest to the deceased will also be made clear and explicit. And there will be offences relating to keeping or using tissue or organs without consent.
Clause 1 of the Bill sets out where consent will be needed for scheduled purposes. Those purposes include carrying out a hospital post-mortem and the subsequent keeping and use of tissue or organs for transplantation, research, education and training, and so on. For certain, particularly sensitive, purposes—that is, for donation of the whole body for anatomical examination and for use for public display, such as Professor von Hagen's "Bodyworlds" exhibition—the specific consent of the individuals themselves will always be required.
The Bill will not affect the coroner's authority to order a post-mortem for his purposes related to establishing the cause of death, nor his ability to ask

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for tissue or organs to he retained should they be needed, again, for his purposes. That is made absolutely clear in Clause 11. But once the coroner's work is complete, further retention or use of tissue or organs for scheduled purposes would be subject to the Bill and to the requirement for consent.
In the case of tissue from living patients, we recognise that some purposes are so intrinsic to general diagnostic and clinical care that the consent that the patient gives to the procedure itself can be regarded as sufficient for those other purposes. Those are set out in Part 2 of Schedule 1 and include clinical audit, quality control, education and training. Therefore, consent will not he needed in those cases, nor for public health monitoring.
Noble Lords will be aware that, following extensive discussion with the medical and research community, amendments were made in another place that made clear that health-related training and education fall squarely into Part 2 of Schedule 1. Following extensive discussion with a range of medical research interests, including many eminent people in that sphere, amendments were also made in another place to provide for the use, without consent, of residual tissue from living patients in research, provided that the tissue is effectively anonymised and the research approved by a research ethics committee.
I know that some research interests have some anxieties about what is meant here by "anonymised". In fact, the word "anonymised" is not used in the Bill. The Bill states at Clause 1(9)(b) that the person conducting the research should not be,
"in possession, and not likely to come into possession, of information from which the person … can be identified".
Clearly that does not mean that the tissue must be irretrievably unlinked from the medical record. In many cases, it will he vital to maintain that link, and the Bill allows for that.
Therefore, the amendments made were important ones that recognised the practical aspects of the use of samples recovered during diagnostic and surgical procedures. I hope that medical research interests will recognise that we have responded to their concerns in a practical way while preserving the integrity of the new consent arrangements that the public wish to see in this legislation. I would say to those who want to go further in this area that they need to reflect very carefully on how their actions will he seen by a wider public and they need to recognise that the Government must maintain a balance on this issue.
The Bill goes on to make clear that failing to obtain consent where it is required, whether from patients themselves or, in the case of the deceased, from other appropriate people, may be a criminal offence and subject to penalty. There will be safeguards to ensure that people cannot commit an offence inadvertently. For example, a researcher will receive tissue from others, perhaps a tissue bank. He will, therefore, quite reasonably be relying on the regulated system to deliver tissue that has the appropriate consent for the purpose. The "end-user" researcher would not be held
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responsible if, having asked for tissue with appropriate consent in place, this subsequently proved not to be the case.
The Bill does not set out the form consent should take in any particular situation. Let me state clearly that the Bill does not require consent to be specific to each research project for which tissue might he used. Consent can be broad. Consent to research can be generic and enduring.
As at present, consent can take different forms in different circumstances, and primary legislation is not the place in which to attempt to define them all. The consent arrangements provided for in the Bill will be described more fully in guidance to be issued by the new authority. This guidance will be set out in a statutory code of practice and this will be subject to parliamentary approval. Like other codes and regulations under the Bill, it will be subject to wide consultation and will clearly need to reflect the pragmatic nature of current good practice. Research ethics committees will continue to have a role in considering whether legal and ethical standards have been met in the context of the specific projects that they consider.
The Bill introduces certain new provisions with regard to consent. It provides for an individual to nominate another person to take decisions about tissue or organ retention, storage and use after his or her death. So, for example, I can either make my consent known prior to my death, such as through my donor card or by entry on the donor register, or I can nominate another person who may make those decisions when I die. It is where I have not made my own wishes known, and have not nominated another person, that my next of kin would be empowered to make those decisions and their actual consent would be needed, as opposed to the rather unclear position currently pertaining under the Human Tissue Act 1961.
There is one further important point that I should make about Part 1 of the Bill. Clause 9 deals with "existing holdings"; that is tissue and organs currently stored from a variety of sources for the purposes set out in Schedule 1. That includes all tissue banks and archives. The Bill simply provides for that to be lawfully kept and used. There will be no consent requirement for existing holdings. It has to be recognised that there is immense value in current archives. Thus it is important that we allow for research options to remain open, but for respectful and appropriate disposal to take place where necessary. We have provided for the new Human Tissue Authority to give guidance on the use and disposal of this tissue.
I turn to Part 2 of the Bill. Anything more than a cursory view of this area will show how complex, sensitive and important it is. We are, therefore, proposing a regulatory system to oversee the implementation of this overarching legislation. A new Human Tissue Authority will be created with the task of ensuring that the use of whole bodies, and of tissue and organs, is in keeping with the legal and ethical standards that we expect. The general remit is set out at Clause 14,

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covering the removal, retention and use for purposes set out in Schedule I, and disposal of all tissue and organs, as well as their import and export.
Clause 16 sets out the licensing role of the authority, which will be responsible for licensing and inspecting anatomical examination, post-mortem practice, and the storage of tissue and organs, whether for research or for human application; that is, transplantation. Licensing for storage will regulate at the level of tissue banks. Licensing will not apply in the case of each researcher who holds a few samples for a particular project.
What will also need to be licensed is the use of bodies for public display. We are all aware of Professor Von Hagen's "Bodyworlds" exhibition of plastinated human bodies, and licences will in future be needed for all such displays, other than where the bodies or parts are of historic interest, being over 100 years old.
The new authority will consist of members appointed by the Secretary of State—including members appointed by the National Assembly for Wales and the relevant department in Northern Ireland—following transparent procedures in keeping with what have become known as the Nolan principles. At least half of the authority will be lay members but, clearly, professional expertise will also be needed.
The new authority will issue codes of practice and it will have the power to vary, revoke or suspend licences where the necessary conditions are not met. There will be powers to inspect premises that are licensed or where there is reason to believe that an offence may have been committed. There is considerable detail in the Bill, naturally, about the procedures for licensing, appeals, inspections and enforcement that follow current best practice in ensuring a fair, transparent and rigorous regulatory system. The licensing sanctions in the Bill are clear and strong, and they are backed with criminal sanctions for carrying on activities without a licence. But while the licensing system will be firm and clear, it will also include the flexibility, through the use of statutory codes of practice, to ensure that it is able to respond over time to technical, scientific and social developments in this area.
In proposing a new Human Tissue Authority we are already streamlining the regulatory arrangements in this area. By reviewing the law and regulation across the whole field, we have been able to bring under one agency matters that are currently dealt with under three. Currently we have the Inspector of Anatomy; the Unrelated Live Transplant Regulatory Authority (ULTRA), which regulates the donation of organs between an unrelated donor and recipient; and some of the duties of the former Retained Organs Commission (ROC). Moreover, the Bill also extends to tissue banks that are currently subject to a non-statutory, voluntary regulatory scheme. This scheme will become mandatory under the EU Tissue and Cells Directive and the new authority will be the competent authority under that directive.
With the announcement today of the next steps on the review of arms' length bodies, we will be able to go even further with streamlining the number of
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regulatory bodies. This will involve the new Human Tissue Authority being merged with the Human Fertilisation and Embryology Authority. The merged body will be called the Regulatory Authority for Fertility and Tissue. The merger will take place when the current review of the Human Fertilisation & Embryology Act 1990 is complete. That Act is being reviewed for other policy reasons and it will be sensible and convenient to establish the merged body at that point.
In the mean time, we will continue with the establishment of the HTA and begin work on that quickly. Work on the development of procedures, protocols, and codes of practice for consultation will go ahead as planned. A key factor here is that the EU Tissue and Cells Directive, under which the authority will be a competent authority, must be implemented by April 2006. But we will establish the Human Tissue Authority on this interim basis in a way that will facilitate the later merger. This means looking at shared back office functions, staff and premises and possibly some common membership.
In its comprehensive approach, the Bill also makes provision for dealing with human tissue in particular circumstances, and here I turn to Part 3. For example, we expect that it will play a part in expanding the scope for transplants using organs from donors who have died, where organs are retrieved quickly after death to enable transplantation to go ahead. A provision is included (Clause 44) to make it clear that steps may be taken to preserve organs while it is established, possibly from the next of kin, whether there is consent to donation for transplantation. At the same time we will make it clear—in Clause 32—that commercial dealing in all tissue for transplantation will be illegal. That extends the current prohibition under the Human Organ Transplants Act, which relates only to organs.
The Bill has in addition one provision—Clause 50—which exceptionally applies also to Scotland since it deals with genetics policy, which is wholly reserved to Westminster. This makes it an offence to have human material intending to analyse its DNA without consent or for certain specified purposes. This provision responds to a recommendation of the Human Genetics Commission, which has been concerned in particular about the emerging market for commercial DNA testing for the purposes of discovering family relationships without consent.
Finally, the Bill will allow certain national museums to remove human remains from their collections; for example, in response to claims from the descendants of indigenous people—Clause 52. The statutory constitution of these museums currently prevents them from returning these remains even where they may wish to do so. We will remove this barrier, recognising the consensus both within government and the museum community that museums should be free to respond positively to claims from those indigenous people whose ancestors' remains are currently held in our national museums. On this point, I know that concerns have very recently been raised about ancient human remains in museums—for example, Egyptian mummies—and the possibility of gratuitous claims for

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their return. The Department for Culture, Media and Sport will be working over the summer with interested parties to see how best to deal with these.
It has been said that this Bill is complex—some have even suggested that it is convoluted. But, as I have tried to explain, it is a Bill which covers much ground that is currently fraught with difficulties. It repeals and replaces the current incoherent set of statutes—the Human Tissue Act 1961, the Anatomy Act 1984, and the Human Organ Transplants Act 1989, as well as corresponding Northern Ireland legislation. I believe that some of the criticism that has been made is unjustified.
This Bill provides a statutory basis for the other aspects of law that currently can be managed only through common law, such as the uses that can be made of stored surplus tissue. It supports the implementation of the EU directive on tissue and cells and resolves a number of current problematic issues, taking account of distinctions between tissue from the living and deceased, coroners, and hospital post-mortems, tissue from children, adults and mentally incapacitated persons, and use for clinical and research purposes.
It establishes a single coherent regulatory mechanism and provides for a number of discrete areas such as the offence of non-consensual use of DNA, trafficking in tissue or organs, and the returning of human remains.
In conclusion, the Human Tissue Bill provides, for the first time in this area, a comprehensive and coherent approach to the use of human bodies, organs and tissue. It brings together various existing provisions of statute and common law and provides a sounds framework for the future. I believe that it will bring confidence both to those who have been affected by the failings of the past and will reassure our medical and research communities that their important work is not jeopardised. For these reasons, I commend the Bill to the House.
Moved, That the Bill be now read a second time.—(Lord Warner.)
1.23 p.m.
Lord Clement-Jones: My Lords, I start by thanking the Minister for his very lucid exposition of, as he rightly said, a fairly complex Bill. From the outset, the Minister was right to remind us why the Bill is now before us. It is over five years since the Alder Hey inquiry was set up and some three and a half years after Mr Redfearn's report and Sir Liam Donaldson's accompanying guidelines and census were presented to this House and the other place.
Clearly, the unethical activities of Professor Van Velzen were the greatest cause for concern and demonstrated the widest gaps in the then current law, but it is clear from the census carried out by the CMO at the time that Alder Hey was just the tip of the iceberg: the scale of organ retention where consent had not been obtained was immense.
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The intention behind ministerial statements at the time, to which I responded positively from these Benches, and the Bill now before us, is that parents would never again suffer the anguish that they have suffered in so many cases where their children's organs were retained without their consent, but also that public trust in the post-mortem process and in medical research is rebuilt. Extraordinary collections of children's organs had been built up, not only at Alder Hey but elsewhere.
The question now before us is whether the Bill does the job Ministers promised us it would do and whether it is proportionate in its effects.
This Bill needs to strike a balance, as the Minister said, between the rights and privacy of patients and their families on the one hand, and the importance of ensuring that bio-medical research, monitoring, education and training that saves lives and cures disease on the other can take place with full public understanding of what is involved.
Throughout this process we need to consider the needs of patients, not only to have their wishes respected and consent gathered, but also to have access to the best possible treatments and care that medical research can give them.
However, if these ends are to be achieved, the fundamental provisions of the Bill relating to matters such as consent, accountability, and provisions for training, education and research must be absolutely crystal clear.
A great deal of progress has been made in the Bill since its introduction into the other place. On these Benches we now support its overall architecture and broad content, and I welcome a great deal of what the Minister had to say today.
During the passage of the Bill in the other place Ministers emphasised the golden thread contained in Part 1 requiring consent from an appropriate person for tissue usage, retention and storage except in certain defined circumstances covered by Schedule 1. These circumstances have now been broadened by amendments in the other place, so that several provisions which inhibited medical training and education and scientific research have been changed, leaving the Bill in far better shape than when it started its passage through Parliament. We welcome in particular on these Benches changes which allow tissue for living patients to be used without consent for the purposes of medical education and training.
However, there are still a large number of outstanding issues where the Bill's provisions need to be clarified. First, it is clear from exchanges on Report in the other place that there is some confusion regarding the concept of anonymisation. I accept from the Minister that Clause 1(8) does not refer to the concept. But the Government said that residual tissues could be used for research without consent if the research were approved by a research ethics committee and if the samples were anonymised prior to their use.
However, there are circumstances where it may be desirable to reverse this anonymisation if the results should be, say, communicated to an individual patient

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for some reason or the identity of a patient needs to be known and the individual traced. The Minister in the Commons, Ms Rosie Winterton, in response to questioning from my honourable friend Dr Harris, said:
"Anonymisation does not mean that the patient and the tissue would be permanently unlinked. Further information could be sought from the records, but the researcher should not get identifying information".—[Official Report, Commons, 28/6/04; col. 97.]
I shall not enter into whether that is genuine anonymisation or whether it should have some other language, such as pseudo-anonymisation.
However, regardless of the correct term, the process being described has little benefit for patient privacy and negative implications for medical researchers. In that case—and I understand this is the briefing that has been given—if a researcher looking at tissue needs to collect information from a patient's clinical record, he or she must ask a third party colleague to consult the record and relay an answer. The argument is that this allows researchers to access necessary information but in reality it only allows them access if they know exactly what to ask for.
In short, the people who can put this information to the best use for medical research purposes—the researchers at the lab bench examining tissue samples—are the very people who are prohibited from having access to the necessary clinical information. So this approach achieves very little in terms of patient protection, as research being conducted on human tissue will already have been approved by research ethics committees. Moreover, researchers are medical professionals already bound by codes of confidentiality.
So, while this provision of the Bill may at face value sound as though it protects patients' rights, it adds very little. Patient protection could be achieved by giving more responsibility to the research ethics committees and allowing them to approve use of clinical records in conjunction with tissue samples when merited by the research project involved. Ms Winterton also suggested that to make use of information gained through the research process, consent would have to be obtained. She said:
"It is likely that the research ethics committee would say that in order to be able use any information that came from the research, consent would have to be sought from the individual. Research ethics committees would have to consider the matter when granting permission for research in the first place".—[Official Report, Commons, 28/6/04; col. 97–8.]
The context of that discussion centred on disclosing information discovered through research to the patient, if it had a bearing on the prognosis. However, the Minister's language was unclear. If consent must be sought before information relating to the research can be used for any purpose, that would undermine the changes made to the Bill in another place that allowed for such research without obtaining consent. I hope that the Minister will be able to clarify that when he winds up.
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Many other points about anonymisation need clarification. One is whether any distinction will be made between what is considered to be public health monitoring and what is considered to be epidemiological research. We need greater clarification about whether, in a public health circumstance, tissue may be traced back to the individual who donated it, even where consent was not obtained but the research was being done with approval from a research ethics committee. One can think of several examples, such as the SARS virus or another emerging threat, where that might be necessary.
Other issues arise from Schedule 1. There was concern in many scientific circles about the interplay between Parts 1 and 2 when it comes to education and training about research techniques. That is specifically not included in Part 2 of the schedule, so consent will be required although, as the Minister in another place acknowledged, research ethics committees will have approved the research. Again, I should be grateful if the Minister would respond on that.
Then we come to that issue of post-mortems and coroners. There are issues about the duration and extent of the coroner's authority. The Minister, Dr Ladyman, said on Report in the other place that a coroner's authority would last only as long as his functions were required. Nevertheless, as the Bill stands, it leaves open questions about coroners and forensic investigation in to the cause of death. In a sense, that is ironic, given that some of the greatest abuses were uncovered in the Alder Hey report as a result of post-mortems. Under the Bill, it would be an offence to hold on to tissue, including slides and blocks, after a post-mortem examination is concluded, except in the case of ongoing criminal inquiry. If the coroner is satisfied with the findings and can establish the cause of death, no samples are retained.
Unfortunately, coroners are not infallible and, although a cause of death can often be initially established, later discoveries, developments or events can call the original conclusion into question. By prohibiting the retention of tissue, physical evidence of death is destroyed. Cases where such a scenario arises are not unknown; on occasion, a death that is originally ruled a suicide or result of natural causes is later questioned. That is an important area.
All that points to it being vital to align the new coroners' rules with the Bill. It is extremely unsatisfactory that that is not being done simultaneously with the Bill's passage through Parliament.
Some of the Bill's finer points were not discussed in the other place due to lack of time. One of those was concern that, where the Bill mentions DNA, it does not mention the other types of genetic material or tests that can yield the same results. The wording of the Bill should include RNA, which effectively contains the same information as DNA, as well as protein sequencing tests, from which DNA sequences can be deduced. I believe that the Government are considering that, although the Minister did not refer to it.
Those points are not exhaustive of the work remaining to be done. Concerns remain in other areas, including provisions for consent to be applied to those

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with diminished mental capacity. That issue is very delicate, especially as we will have to ensure that the Bill's provisions can be easily matched with what is to come in the Mental Capacity Bill. I recognise that there is provision for regulations to be made, but we need more detail about what those regulations may contain. I am not sure whether a best interests test is the correct one to apply, and those regulations should be subject to affirmative resolution of both Houses.
We also need to look ahead to the establishment of the Human Tissue Authority and its interaction with other arm's-length bodies. I note the Minister's statement about merger with the HFEA, but should there not be a limit on the size of the board of the merged authority? Why are there to be two inspectorates, the inspectorate of anatomy and pathology and that for organ tissue for human use, especially when we are trying to reduce the amount of regulation across the NHS?
In conclusion, the fact is that legislation by itself is not enough. As Sir Liam Donaldson said at the time,
"There needs to he a complete sea-change in the way we perceive donations of organs … Patients and relatives need to be in control. We need to give people time to think about consent. They need to know exactly what they are consenting to and they must have the right to say what happens during the post mortem. There needs to he a new contract between patients and the NHS".
I agree with those sentiments, but I am not yet sure that the Bill quite fits them.
My view is that the strongest of the guiding principles originally set out by the CMO is the aspect of a gift relationship. We must be mindful of the needs of medical training and research, but we must never take donation for granted. It follows that we need proper counselling services in place and comprehensive training in the new consent regime—a massive exercise—and a programme of communication to the public, especially about consent, research use and medical training and education. But we have a great shortage of trained pathologists. Has the cost of obtaining necessary consents been factored in? What is envisaged? Are the estimated costs of implementation of the Bill's provisions adequate in those circumstances? It would be useful to hear more about that from the Minister.
I look forward to the Minister's response and to Committee, when I shall continue to be actively involved. I also greatly look forward to the maiden speeches of my noble friends Lord Roberts of Llandudno and Lady Neuberger, and to that of the noble Baroness, Lady Murphy, from the Cross-Benches.
1.34 p.m.
The Lord Bishop of Portsmouth: My Lords, I hope that what follows is an appropriate contribution to this preliminary debate on a Bill that this Bench strongly supports. It is good to have the prospect of three maiden speeches from such distinguished contributors. If I may single out one, it was a close friend of mine and colleague at Manchester University, Professor Barnabas Lindars, who had the privilege of teaching the noble Baroness,
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Lady Neuberger, and was present at what I hope it is appropriate for a bishop to regard as her ordination as a rabbi. I mean that with the greatest respect.
I shall begin with a story, a true story, that illustrates one aspect of the downside of things as they stand at the moment, which reflect specifically what the Isaacs report of 2003 revealed in general terms as all too common and regrettable practice. Like some of what we shall be deliberating on later, it relates to areas of human experience that are not always easy to describe or digest.
A priest was taking a funeral in south London a few years ago and found to his horror that the body, revealed when the casket was opened in church, had had two polished shoes neatly placed at one end attached to no legs, which were unaccountably missing from the corpse.
I use that story to show that it was inevitably the pastoral side of the Alder Hey and Bristol Royal Infirmary inquiries that most exercised my colleagues and their clergy in Liverpool and Bristol although, of course, they and my other colleagues on this Bench were and are also concerned about the intrinsic issues. What were the local clergy to do when the family asked for a second and even third funeral for the same child, whose body parts, thought in all innocence to have been buried at the same time as the child, were emerging, one by grisly one, from the hospitals in which it had died? It is very hard to speak those words without emotions running quite deep.
What was being said about who or what a person was, if full burial rites were to be repeated in that way? Who exactly was being buried each time? Yet, pastorally, how could grieving families be denied what to them was an essential recognition of, and closure with, the wrong done to their children? Clearly, such situations should not be allowed to arise again. The way to prevent them is to ensure that consent is always obtained before tissue is removed, retained or used. The ethical principle being brought into play here is that of respecting individual autonomy.
The Bill before us bases itself on this principle and fully recognises the autonomy of individuals by requiring explicit consent for post-mortems, other than those required by the coroner; for the removal of tissue for research or transplant; for the use of cadavers for anatomical examination and for their public display. The Bill rightly requires consent for all those uses and rightly requires accountability and transparency in their use, together with penalties for their abuse. Those are all ways of showing respect for the living by finding out individual wishes and for the departed by honouring those wishes after they have died.
I was glad to hear the Minister's reassurances about the Department for Culture, Media and Sport's plans over the repatriation of human remains. It will need to handle this with some care in getting across the meaning behind those actions to the public, as with other aspects of the Bill. Those include the questions rightly raised by the noble Lord, Lord Clement-Jones, particularly in relation to mental capacity. I wish to

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express my appreciation for the exception clause relating to religious relics, particularly on behalf of the Roman Catholic community.
In conclusion, let me address the question of autonomy as an ethical principle. The ascendancy of autonomy as overriding in medicine can put a stranglehold on good practice and be a block to important research. Although I fully support the principle of respect for each individual, and his or her very particular wishes and needs, I would always argue strongly for us all as individuals to seek and to serve the common good. Where respect for autonomy turns into a selfish demand for "my rights" or is translated into a set of regulations that cannot be flexible and responsive to circumstances, which change as we all know, and which are as particular and unique as individuals are, then the language of rights must be adjusted. The need for research, training, education, clinical audit and quality assurance, alluded to by the Minister at the beginning of the debate and by the noble Lord, Lord Clement-Jones, are all very real and designed to serve the common good.
It was always an abiding concern that this Bill might overreact to the horrors of Alder Hey and Bristol and that those bad cases would lead to bad law—in the context of the many difficulties accruing to conducting research in this country due to regulations that already exist. But it is fortunate, and to be applauded, that the Bill has recognised the need for flexibility in precisely these areas and others; for example, by not requiring consent for the proper use of residual tissue from living patients. Therefore, I believe that the Bill manages to strike a balance between respect for autonomy and serving the common good. Although there may well be areas where we shall argue over various points of detail as the Bill passes through this House, I believe that this laudable and timely package, which is fully responsive to the nuances of our present circumstances, should be wholeheartedly supported.
1.44 p.m.
Lord Newton of Braintree: My Lords, I wish to mention that I am chairman of the Royal Brompton & Harefield NHS Hospital Trust and simply to observe that, while that clearly gives me an interest, I would be the last to claim that it makes me an expert. I shall be very brief, for two reasons. First, the list is longer than anticipated therefore the House may welcome some brief speeches and obviously wants also to hear from the distinguished maiden speakers on the list. Secondly, I had not expected to find myself in this pole position in a debate with so many expert contributions to come. Bearing in mind the talent, medical and other, on the list, I had expected to listen, learn and support rather than inform, instruct and lead. My response, having anticipated a modest contribution at the end, will be to make a modest contribution at the beginning.
There is widespread support for the broad aim and purpose of the Bill, and there is no question about whether it is right to legislate in this area. The questions are about how far the Bill as it stands, despite the improvements, sufficiently achieves those
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aims and whether it does so with sufficient clarity to avoid replacing one set of problems with another. There remain some real issues, as has already emerged, despite the work that has been done in another place. In particular, there are issues about whether the Bill deals with the most common cause of the distressing experiences that are said to have led to its drafting without, at the same time, introducing unwarranted restrictions that could and probably would eventually harm public health and welfare.
I have an extensive briefing note from the president of the Royal College of Pathologists, Professor James Underwood. Given my position in the debate, I could ruthlessly plagiarise it and use it to make all the points that it contains. I shall not do that; I shall simply say that, having read it and bearing in mind the concerns expressed to me by pathologists at the Royal Brompton & Harefield hospitals, I am wholly persuaded that there will be much need for the detailed examination and amendment at which this House excels, particularly perhaps in respect of Schedule I, on scheduled purposes, but by no means only on that.
I hope in due course to play some small part in the Committee consideration. Meanwhile, I propose straight away to defer to those better equipped to play a larger and more expert part, and to resume the posture of one whose primary purpose, as I have said, is to listen and learn. I look forward to listening to and learning from the noble Lord, Lord Turnberg.
1.47 p.m.
Lord Turnberg: My Lords, I am grateful to the noble Lord, Lord Newton. I declare my interest as a one-time clinical scientist, current vice-president of the Academy of Medical Sciences and scientific adviser to the Association of Medical Research Charities. I look forward to no less than three maiden speeches. It says much for the attractiveness of the subject of human tissues that it can bring in such a bevy of excellent speakers on the last day of term.
The Bill has been improved enormously during its passage through the other place, not least due to a considerable amount of effort by Ministers and officials who have listened patiently to the scientific community and the medical patient charities. They are definitely a listening Government and long may they continue. The Bill is now much more balanced and offers realistic protection of the rights and interests of patients and their relatives, while allowing research of importance to future patients and the public to continue.
Of course the Bill is not perfect. There are a number of areas where clarification or amendment may be necessary. Perhaps I may highlight some of those areas, although I hope that we will have time over the long recess to consider them in more detail. The Bill very reasonably and rationally distinguishes between tissues and organs taken from dead bodies and samples taken from living patients at operation—appendices, tonsils, cancers and the like. One might think that all that was needed in the Bill was a stringent set of regulations for post-mortem organ retention in

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response to the Alder Hey and Bristol scandals, and that the useful research of tissues taken at operation could have been left out of the Bill.
After all, if one wants to do research now on such tissues, one must always have ethics committee approval, and that will be given only where consent has been, or will be, obtained from patients, or where the tissues have been anonymised. I am sorry to use such an awkward term. We might ask whether we need the Bill to say more or less the same thing, while introducing an additional bureaucratic layer and some confusion about the exact meaning of the terms "consent" and "anonymity", which are confusing for ethics committees and researchers alike.
Everyone accepts that much important research is carried out on human tissues left over after operations, and I believe that patients and the public are generally content that tissues can be used for the greater good providing that certain safeguards are in place, such as ethics committee oversight and approval; a guarantee of confidentiality, so that no harm or embarrassment could befall them; and wherever possible that consent is obtained. My fears for research and teaching in the Bill—and I reiterate that the Bill has already gone a long way towards addressing many of my fears, but my residual fears—relate to how "consent" and "anonymity" are interpreted.
"Consent" at one time could be taken in the restricted sense, as consent now for current, specific research. In many instances, however, the research could be undertaken years later and be of a type not envisaged at the time, and for which obtaining consent now is impractical. Can consent be taken to be enduring and of a general type for all types of research? We are given some reassurance on that, but it is not absolutely clear how it will he handled.
What about anonymity? Does that mean absolute anonymity, with no possibility of anyone ever being able to break the code? In many research programmes, it is necessary to link findings to tissues and to clinical details in particular patients, and you can do that only if you can find out who the patients are. Will anonymity be taken to mean absolute anonymity? We have heard some reassurance from the Minister, but we need to be absolutely clear on that. On whom will the interpretation at the time be dependent? If it is not possible to remove from the Bill tissues taken from living patients, and I suspect that it will not be, it will be the HTA that will be doing the interpreting. What criteria will it adopt, and what will the as yet unwritten regulations have to say about that? There is much free-floating anxiety in the scientific community and among patient groups about how this will play out. I hope that we will have further clarity on this issue.
Then, there is the question of the High Court being asked to make a judgment on whether public interest is of such overwhelming importance as to outweigh the interests of an individual who cannot give consent. When we dealt in the Health and Social Care Act with the use of data or information about patients used for research where it was not possible to obtain consent, we set up the Patient Information Advisory Group to
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make such judgments. I wonder whether that type of arrangement might be seen as less legalistic and expensive than the proposal to take such cases to the High Court.
A number of other aspects of the Bill deserve attention. The section on DNA research, to which the noble Lord, Lord Clement-Jones, has already referred, needs to take account of other types of genetic research such as RNA, karyotyping and the like, and the problem of how to separate education and training for research from education more generally when those are treated separately and differently under Parts 1 and 2 of Schedule I. No doubt those and other issues will provide many happy hours of thought and discussion over the coming months.
1.54 p.m.
Lord Roberts of Llandudno: My Lords, as all other speakers when they first address this House must say, I appreciate very much the warmth of welcome and the kindness of Members on every side. It has meant so much to me and to the other noble Lords who will be speaking for the first time this afternoon. I thank the staff for their helpfulness and efficiency; they give such tremendous support. Thank you—it is beyond all expectation.
I come here as one with a great measure of nervousness. I am sure that I am not the only maiden speaker to refer to that. I have already made many mistakes: I have stood when I should have sat down; I have crossed where I should not have crossed; and I have brought guests into places where they should not have been. I have not, as yet, whispered "Content" when everyone else says "Not Content", but that might happen. I ask, as everyone else does, for the forgiveness and indulgence of the House. Noble Lords will know that no offence is ever meant.
I come from a beautiful part of Wales; the Conwy Valley. That seems to be quite a breeding ground for life Peers. I rather think that we have more life Peers to the square mile than any other part of rural Britain. At the top of the Conwy valley there is the Gwydyr forest area and Gwydyr castle. Of course, the noble Lord, Lord Thomas, represents that area. Then there is the whole swathe of the valley, and the noble Lord, Lord Elis-Thomas, represents it. Then you come the historic town of Conwy, and the noble Lord, Lord Roberts of Conwy, represents that, and that is where my heart is really. The castle in Conwy was named by John Wesley as the noblest ruin in the whole of Europe. The historic is represented, and now I venture to speak for the premier seaside resort in Wales: Llandudno. I will argue perhaps some other time if noble Lords are not in agreement with that.
It is not only my little patch of Wales. You can look further afield; you can go to Dwyfor in the old south Carmarthenshire, where the greatest of us all, Lloyd-George, or Earl Lloyd-George of Dwyfor, came from. He was nominated to this House in 1945, but did not live long enough to take his seat. That is Lloyd-George country. I am reminded that he was the great advocate of more power for Wales, and a

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stronger devolution. We will discuss that later when the Richard commission brings its report, as it has already to the Welsh Assembly. I am in a distinguished lineage of all those people.
Not far from Wales, you can cross over to Merseyside and Liverpool. That is where so many Welsh people earned their living and some went on to make their fortunes. Welsh people depended so much on Liverpool over the years, especially the hospitals and medical services of Liverpool. That is where the name Alder Hey comes in. It has already been mentioned, and it will be mentioned many times again. I have in my hand a summary of the report of the children's inquiry there. Liverpool had that tremendous hospital on Merseyside that has done so much for the young people and children of Wales. That time came, that blip, when we discovered that between 1948 and 1995 children's remains had been retained without parental consent. There were hearts, body parts, eye tissues, brains. On 30 January 2001, the report was published, and it makes very disturbing reading indeed.
I was involved with one family, and had taken the funeral service of their three-week old baby in 1980. In 2001, on his 21st birthday, we had a second funeral for those parts of his body that had not been accounted for the first time. There was trauma and shock, and total confusion. Others did not only have two funerals; I know of a little child who had three funerals. Some families do not cope with that. I know one or two families who have not been able to continue as they were before as a family unit. There was an inquiry, and 402 sets of parents replied. They complained to us. I hope that the Minister will see this when the Bill finally passes through this House. They said that they wanted more information about the illnesses, the threat and the death of their children. There must be communication.
Moreover, where consent was obtained, some parents complained of undue pressure to sign consent forms. Parents would also like to know to what purpose the organs of their children were used. Finally, they would like to be communicated with in non-medical language so that they will understand the situation and what has happened. We have all those questions to consider.
For children, the question of consent is with their parents. Adults give their own consent. This is National Transplant Week and it has not had much impact. There needs to be greater publicity and information before people will realise the demand: there is a target that by 2010 there will be 16 million potential donors on the register. But how will that be achieved? I am concerned that people know that they can respond and can consent. In consenting voluntarily, a person does more than just say, "My life might be of benefit to somebody else". He or she also says, "By doing this, I can also play another part in society and in community".
I ask that we support this measure and discuss it further. Later, there will be time to dot the "i"s and cross the "t"s. But today it is a great pleasure to support this Bill.
2.2 p.m.
Lord Winston: My Lords, it is a great pleasure to speak after the noble Lord, Lord Roberts of Llandudno. He made a wonderful, compassionate, elegant and humorous maiden speech, to which the House listened with great pleasure and delight. We know that we will hear much more common sense and good advice from the noble Lord in the future.
I have to tell the noble Lord that my experience of Llandudno was not quite the same as his. He of course has a wonderful reputation in the Methodist community and his works in public causes, such as for the blind, are well known, which is a marvellous addition to this House. My experience in Llandudno was on a Friday evening after "Any Questions". As an orthodox Jew, I could not leave until after dark on the Saturday evening, which was quite difficult for me.
I should also tell him that there are other rules that he almost broached during his speech. In brandishing anything in this Chamber—even a document—I believe that one can be called to order, which I found out to my cost in my first week here. I picked up my mobile telephone and offered it to a Member of the House on the other side. I was immediately admonished by not only my Front Bench but also the Front Bench opposite.
It is wonderful that the noble Lord had the good sense to take his oath in fluent Welsh. But I understand that he practised a little beforehand. I did not have the courage to do mine in classical Hebrew. But that would not have been allowed in this House either: Welsh is.
This is a curious Bill, with which I have great problems. Of course, everyone will agree that it has been brought with the greatest of good intentions. I have no doubt that everyone in the House feels strongly that the relatives of people who have lost dear ones need to be protected in the way that other Members have already said. I agree with that.
There seems to be a very major distinction between the tissues and organs of dead people derived at post-mortem and the tissues of people who are living. Like my noble friend Lord Turnberg, I agree that much of the legislation in that respect is unnecessary. I feel very sorry for my noble friend the Minister who has done an outstanding job listening to our concerns. Without him, this Bill would have been a good deal more provocative.
The truth is that this Bill has required a huge amount of change and a vast amount of improvement. Much time has been spent on it in the Department of Health. I believe that initially the drafting was astonishingly faulty. It is extraordinary that the Royal Colleges, the Academy of Medical Sciences, the Royal Society, the Royal College of Pathologists, numerous research and development organisations and every medical school in the NHS have been so agonised by this Bill when the drafting in the initial stages could have been much more focused on the real need.
The truth is that much of the Bill represents a considerable overreaction. Although the Minister will tell us that the medical profession is broadly in line and

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very happy now with the redrafting, my view is that privately it is not true. Most professionals are deeply disturbed by the Bill. They are very concerned about the impact on research, training and teaching.
There are a number of issues where the Bill is clearly deficient that will no doubt be brought up in detail in Committee. We have already mentioned DNA, but there is no mention, for example, of chromosome analysis. A key area in which I am involved is the Medical Research Council's foetal tissue bank. There is no mention of foetal tissue in the Bill. Yet that is a very important resource for medical research. And who gives consent for that? Clearly, it cannot be the foetus. Is it the mother? But we may want to look at the chromosomes of the father, if there is a translocation, in order to trace genetics in that way, either in an anonymised fashion or however is appropriate. That is the kind of problem that is being missed.
Would we be allowed to use photographs of tissue that had been derived for teaching purposes? That is very serious. I learnt a great deal of my pathology from photographs of slides. But if photographs are going to be used, why not use the slides and review different areas of the histology and cytology?
There is also the curious issue of ancient remains. I mention this as someone heavily involved in the development of the National History Museum. While I doubt that we would want to give back Australopithecus afarensis—Lucy—to Hadar in Ethiopia, we might be persuaded that it is necessary with other more recent remains from Cro-Magnon man. Or would we? Where does one draw the line in the modern museum and those sorts of resources?
Whether we like it or not, the truth is that we are living, to my mind and in many people's perceptions, in a society that is increasingly over-regulated and where we are often at the risk of losing trust and common sense in legislation. That is a real problem and is absolutely true of the health service. It is a matter of deep concern that patients do not trust us as much as they should. That is not because of human tissue research—I do not think that Alder Hey has left a deep scar on my patients. Rather the confusion around the MMR vaccine, concerns about CJD and worries about oral contraceptives are far more important. People are more worried about political statements and about those scientists who advise government. There is a deep mistrust of politicians rather than a mistrust of the medical profession. As every review reports, scientists and doctors are much more trusted than politicians. Noble Lords ought to bear that in mind when we consider these matters and seek to put them in some kind of focus.
In the modern health service we are rightly forced to look at evidence-based medicine. That is what we must both act on and react to. I am afraid that what is happening with legislation of this kind is that we are no longer looking at the evidence, but at the reactions of certain groups—pressure groups, focus groups and some people who are deeply disturbed. What we have not done, again and again, is conduct proper social science in the form of peer review research to look at
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the real impact of these problems in our society. I think that that is something the Government should commission before introducing Bills of this kind.
For example, I think it is very unwise to introduce an order on the anonymity of donors, as we did the other day, without first having carried out proper social science research to assess exactly what will be the impact on that group. I say that because we might be doing grave damage to all sorts of people who really should not have to face such dangers in the future.
What is curious here is the sudden revelation made by the Government that, in the future, the Human Tissue Authority is going to be linked in some way with the Human Fertilisation and Embryology Authority. A year ago I would not have dreamt of wanting to revisit the legislation so ably introduced in 1990 by the government of the day. It was a spectacular Act of Parliament and at the time one that was deeply protective of an important branch of medicine. But it is now clear that the legislation might well need to be revisited since so much has changed.
What we can see is very clear. I have no wish to damage the Human Fertilisation and Embryology Authority, but to be frank, it is an incredibly bureaucratic body. It is very expensive to run. It has cost health service departments and other departments large sums of money. For example, my own unit spends money on at least two salaries in order simply to send our returns and statistics to the Human Fertilisation and Embryology Authority which, in the past, it appears that the authority has lost or misused so that we have not been able even to retrace the figures. We have not been able to get the kind of statistics we need for simple research.
Sometimes the authority makes what people feel are quite arbitrary decisions about different ethical issues, but that is a matter for another debate. Moreover, it has what is clearly a very flawed inspection process. Inspections are carried out by people from other units who obviously have a vested interest rather than by those who are independent of the authority.
Above all—and this is my point—let us look at British standing in embryological research. We invented in vitro fertilisation. Embryology in this country led the world. Looking at the research record today, it is clear that that research has been greatly inhibited rather than stimulated. Patients need such research, and it is that which worries me about the Bill now before the House. In that respect, it causes me deep concern.
Some 35 years ago, while waiting to take up a substantive appointment, I was asked by my then boss to do some research on the organism trichomonas vaginalis, a common organism thought to be sexually transmitted in some people. In order to carry out the research I had to review the cervical smears of a large number of women. Around 3,000 cervical smears were reviewed, which was possible because I was regarded as a suitable person as a result of my experience with microscopy. I noticed certain cellular changes in the cervical cells of some of the women, but no changes in others. In order to make sense of this finding, I had to

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retrace the records of the patients and check at what time they had attended and to find out how long they had had symptoms. The women whose notes indicated symptoms and those who were symptom free fell into two different cohorts.
After a while it was clear that the organism I was looking at took various forms, some of which were large-celled and others with small cells. I do not want to make a long story of this, but that research led eventually to an understanding of the way in which viruses and other organisms can affect the early development of cancer of the cervix. Indeed, that was one of the first observations of its kind. That paper, of all the papers I have produced in my career, received the highest number of recalls for reprint, well over 1,000 from all over the world. I was an unknown research worker, but that paper launched my career. However, I think that it would have been completely impossible to produce in today's climate, even though no one was in any way damaged by that research; indeed, it led only to gain.
I beg the Government to be absolutely clear that that is of paramount importance when we come to consider this Bill in Committee.
2.14 p.m.
Lord Patel: My Lords, it is always difficult to follow my noble friend Lord Winston, but I shall try.
Overall, I welcome and support the Bill. It has gone through significant changes from the original Bill, and the professional organisations and the medical and scientific research community are much happier with it. Much of the credit for those changes goes to the Minister, and I thank him for that. There remain, however, some concerns, many of which, I hope, can be alleviated by reassurance, but some may require further amendment to the Bill. I am encouraged by the comments made by the Minister in his opening presentation of the Bill, particularly in relation to anonymisation and linkage.
Much of what I have to say follows discussions with and briefs from the research councils, the Royal College of Pathologists, the Public Health Genetics Unit and medical professional organisations, all of which still have residual concerns.
The concerns that I have fall within the categories of research and anonymisation; education and training; research involving mentally incapacitated individuals; the timing of when the Bill comes into force in relation to codes of practice and clarification of some of the definitions in the Bill. I also have comments on the constitution and method of working of the Human Tissue Authority, which now, after this morning's report and the Minister's announcement, has changed somewhat.
In relation to research and anonymisation, the Bill must make it clear that reversible and linked anonymisation will be permitted, particularly to allow for epidemiological research of the kind that may well fall
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outside the category of public health monitoring, as already mentioned by the noble Lord, Lord Clement-Jones.
The requirement of identifying information to be withheld from the researcher has considerable practical implications if the clinician or the pathologist involved in the clinical care or the examination of the tissue is also the one involved in the research, which is not uncommon. The Minister made encouraging comments on this and we will discuss it further in Grand Committee.
The requirement for the research ethical committees to give ethical approval for the use of anonymised tissue for research has implications for the capacity and expertise required within the research ethical committees to do this, and that matter will have to be addressed.
In relation to education and training, the changes to Parts 1 and 2 of Schedule 1 are welcome. However, the distinction made between education and training relating to human health and that which relates to the functioning of the human body and disorders requires further legislative and professional guidance. Again, other noble Lords have referred to this.
The introduction in Clause 6 of a provision to enable adults who lack capacity to consent to be involved in research is welcome. However, the Bill as drafted may impede research into conditions associated with emergency medical care and critical care.
I am also concerned that inconsistencies may develop between the Mental Capacity Bill, clinical trials regulations and the Human Tissue Bill. I welcome the fact that the Bill makes consent the fundamental principle underpinning the lawful storage of human tissues. The scope and specificity of appropriate and qualifying consent established by the Bill remains unclear, notwithstanding the clarification given today by the Minister. I shall read carefully in Hansard what he had to say. A broad definition of "consent" on the face of the Bill might be more appropriate, rather than the standards of consent being part of the discretionary powers of the Human Tissue Authority.
Let me now briefly mention concerns in relation to the definitions in the Bill and inconsistencies. The noble Lord, Lord Turnberg, has already mentioned, for example, the definition of DNA and analysis. RNA analysis can yield similar information to that derived from DNA. There appears to be inconsistency in the definition of a "child" as defined in Clause 59 of the Bill and the one defined in Section 8 of the Family Law Reform Act 1969.
Clause 32, which relates to the definition of a "controlled material", excludes material which is the subject of property because of an application of human skill. The interpretation of the case law in this area is not straightforward. Importantly, Clause 11 excludes from the Bill anything done for purposes of the functions of coroners, the major issue which prompted this legislation. The House needs to be

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reassured that the Coroners Rules 1984 will be amended to have the same effect as this Bill, for it is important that there is consistency.
Clauses 14 and 46 relating to the import and export of tissues will be difficult to implement in practice. Histopathologists routinely exchange histological slides for expert second opinions across the UK, including Scotland, and overseas. Such practice would fall within the scope of this legislation and regulatory system. It cannot be the intention to prohibit it, otherwise it will affect patient care.
I recognise that today is not the right time to go into details of these and other concerns. I hope that we will have the opportunity to do this when the Bill is considered in Grand Committee. I am sure that many of the concerns of the research and professional communities can be alleviated by reassurance. I look forward to further discussions in the future. In the mean time, I wholeheartedly support the general tenet of the Bill and congratulate the Minister on bringing a much improved Human Tissue Bill to this House.
2.21 p.m.
Lord Jenkin of Roding: My Lords, I begin by acknowledging, with thanks, the apology that the Minister made in response to my intervention at the beginning of the debate. I hope that by drawing this to the attention of the officials in his department he will make sure that we do not receive all the documents on the morning of a debate.
There have been a number of extremely expert speakers so far, not least the noble Lords, Lord Turnberg, Lord Winston, and Lord Patel. I join my noble friend Lord Newton of Braintree in addressing the House as a layman. I spent some years on the council of the Imperial Cancer Research Fund, but that was very much as a layman.
It is clear from the purport of the papers and reports that led to the introduction of the Bill that there were very serious breaches of the existing law in the two hospitals investigated—the Bristol Royal Infirmary and Alder Hey in Liverpool. I accept entirely that the practice that was there disclosed turned out to be much more widely spread than had been anticipated. These were serious breaches of the law; there were also serious breaches of best practice by the consultants concerned. That is what they were; no lives were lost as a result of that, so far as I am aware.
When the reports were published and the matter became a matter of public comment, the then Ministers at the Department of Health, by using some very unrestrained language, managed to turn the whole affair into a national horror story. I believe that this was quite unnecessary. I also believe that events subsequent to that have been coloured by those comments. The first comment on the report by the right honourable Alan Milburn, the then Secretary of State for Health, was that it was "gruesome". One wonders whether he had the slightest idea of what happens in a post-mortem examination. Perhaps modern television programmes could have shown him. The fact is that this got off on the wrong foot from the beginning.
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I do not doubt that many of the relatives, particularly of children who had died and whose tissues had been removed and retained without consent, were very distressed indeed to learn what had happened. I believe that in their distraught reactions, as graphically recorded in the Kennedy and Redfern reports and also in the minutes of the Chief Medical Officer's summit meeting held on 11 January 2001, these people deserve our profound sympathy. There is no doubt that they suffered grievously.
Equally, I have little doubt that it was Ministers' desire to fall over backwards to respond to that distress that led to the Bill, as originally introduced, being seriously out of balance.
The need for balance was expressly recognised on page 1 of the consultation document. I shall read the relevant paragraph because it is quite important. The consultation document emphasises,
"the need to strike an acceptable balance between the rights and expectations of individuals and families and broader considerations, such as the importance of research, education, training, pathology and public health surveillance to the population as a whole".
That is a perfectly fair statement of what Ministers were aiming at. However, that is not what happened. Here I disagree with the right reverend Prelate the Bishop of Portsmouth. One only has to look at what has happened. As soon as the Bill was published, the entire research community was up in arms. As originally drafted, the Bill in a number of major respects appeared to place huge, new obstacles in the way of using tissues and organs for medical research, going far beyond what was necessary to remedy the perceived shortcomings of the existing law and practice.
Happily, as has already been mentioned in a number of speeches, amendments in another place have gone some way towards meeting those representations. However, as has been made clear in today's debate, much more needs to be done if an acceptable balance is to be struck.
With a number of your Lordships, I had the advantage of attending a meeting in the Moses Room earlier this week. It was addressed by Professor Carol Dezateux of the Institute of Child Health and the MRC, by Professor Alex Markham of Cancer Research UK, and by Dr Mark Walport of the Wellcome Trust and others. It was immediately apparent to me that a number of serious concerns remained about the Bill, which it will be for this House to address.
Also present were a number of charities representing patients' groups: the Parkinson's Disease Society; the National Kidney Research Fund; Cancer Research UK; the Primary Immunodeficiency Association; the Tuberous Sclerosis Association; the Foundation for the Study of Infant Deaths; the British Heart Foundation; the Motor Neurone Disease Association; the Genetics Interest Group; and, I have no doubt, others. I was reminded of the enormously important role that those bodies played in leading this House to a sensible conclusion on the legislation regulating stem cell research.

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All those groups want medical research to continue in the hope of finding the causes of diseases with which they are concerned and of discovering new treatments and new drugs. Their spokespeople echoed the concerns of the researchers and the Government must listen to them.
Most of the issues raised will be for later stages of the Bill, but I note that a number of noble Lords have already gone into detail about the various forms of consent and the issues of anonymisation, which the Select Committee on Science and Technology, chaired by the noble Lord, Lord Oxburgh, has to address in the human genetic databases report. Some noble Lords have also discussed what should be covered by the proposed licensing system and so on.
One of the major issues that we must address and on which there needs to be wide consultation with the research community—I am glad to hear that a lot of consultation has already taken place—is the proposed regulations and the codes of practice that are due to be introduced. Those regulations and codes of practice should, if possible, be agreed and in place before the commencement of the Act. We shall no doubt deal with those and other matters when we come back in September—and, I suspect, in October.
I come back to my first point. Because the Bill fell over backwards to reflect and remedy the severe distress of the relatives, the legitimate concerns of the researchers were seriously underestimated. The result has been that the passage of this Bill has taken the form of a long, hard-fought struggle on the part of the research community, supported by the medical charities and patients' groups, to redress the balance. I do not believe that that is the right way to legislate on such an immensely important matter. The process has not ended and, like other noble Lords, I hope that we shall do our best to return a better balanced Bill to another place, with many of the changes which have already been identified incorporated in it.
2.31 p.m.
Baroness Neuberger: My Lords, it is a great honour to become a Member of this august House, whose work I have always admired for its expertise, its dedicated public service and its collegiality. I, like my noble friend Lord Roberts, am enormously grateful for all the kindness and help that I have received since I have been in this House for not quite two weeks. I am particularly grateful to all those on all sides of the House who have stretched out an arm and said, "Don't go there!" and those who have said, "Sit down now!" Like my noble friend Lord Roberts, I know that no offence was intended, and no doubt I shall make many more such errors.
I am also enormously grateful to the staff, who have been unfailingly kind and courteous and particularly good—for someone without a sense of direction—in getting me from A to B. In the day of my introduction to your Lordships' House, when I was unable to work out where the River Thames was, my daughter was much amused to see me walking straight into the
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cleaning cupboard from which a member of staff kindly rescued me. She rather hoped, but was not sure, that I would be better able to deal with some of the issues coming up before your Lordships' House than getting around your Lordships' House. One's family has a habit of cutting one down to size; mine has been remarkably effective.
I welcome the Bill and the intentions behind it. Like those who have already spoken. however, I believe that there are ways in which it could he improved. Some of those are controversial, and a maiden speech must not be controversial—though, for those who know me, I do not promise always to be tame and bland. There are, however, three issues to which I should like to draw the attention of your Lordships' House.
First, while I welcome the fact that the Bill is predicated on the issue of consent, it is important that consent is spelled out rather more precisely. In saying that, I am much influenced by what I saw when chairing a committee of inquiry for the Medical Research Council in the mid-1990s, looking at radiation in MRC-supported research in the 1950s and 1960s.
The inquiry was prompted by serious allegations of abuses of patients' rights, most of which were unfounded. But one study that we investigated was measuring the population exposure to strontium 90. This was, of course, long before the incidents at Alder Hey and Bristol. As a matter of course at that time, pathologists removed thigh bones during autopsies on babies and children and sent them for further study and analysis. While the parents had normally given their consent for an autopsy to be performed, they had no idea that that meant that bones would be removed in that way. When the matter was exposed on television 30 years or more later, it caused great and palpable distress to many parents whose babies had died so many years previously. One woman had been refused access to her daughter to dress her in her christening robe for burial, no doubt so that she would not be able to discover what had been done to her daughter's limbs.
The parents that we talked to felt cheated and abused. They had given consent in the belief that it would help to uncover the causes of their children's death. They did not realise that they were implicitly allowing the removal of significant body parts for reasons that were completely different. Like the right reverend Prelate the Bishop of Portsmouth, I believe that that raises huge pastoral issues with which we need to deal—certainly where precision around the question of consent might help.
If we require that consent be given to the extraction of tissues, it is important that we make it clear that it is fully informed consent. We must recognise that there is widespread ignorance about what an autopsy involves. I welcome the way that the Bill imposes a duty on the Human Tissue Authority to provide public information about this. However, I would prefer to see greater precision about the nature of that information and how it is to be delivered, particularly as we have now heard the Minister announce that there will be a merger with the

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Human Fertilisation and Embryology Authority. To reassure the noble Lord, Lord Winston, I was a very independent member of that authority in the old days. The issues with which those two bodies are concerned are rather different and I would like to know how the information will be delivered.
Information does not lessen the importance of the principle that where somebody gives consent, he should fully understand what he is consenting to. While many scientists and doctors—the noble Lord, Lord Turnberg, argued for this—urge that consent often be generic and enduring, it is important that that should he only one option for people. People may want to know more precisely to what they are consenting with the gift that they are making of their own bodies and their tissue. If we do not uphold the principle of informed consent, we may well find ourselves back with the scandals of Alder Hey and Bristol.
My second concern—my noble friend Lord Clement-Jones has already drawn attention to this—is the way that coroners' post-mortems are at present excluded in the legislation by Clause 11. This would exclude 90 per cent of the post-mortems carried out in the UK. It is not as if these post-mortems have been free of public concern. In my pastoral experience, I found that they can cause considerable distress, particularly if they are much delayed. The exclusion leaves unresolved at least a part of the major issues that led to this legislation—the discovery that tissue, including whole organs, had been retained largely, although not only, as a result of coroners' post-mortems, such as at Bristol. The primary reasons for the post-mortems were to investigate the cause of death rather than research. But if coroners are not included in this legislation, and new coroners' rules do not appear at the same time—as the noble Lord, Lord Patel, suggested—with the purposes and authority of coroners' rules and practices made clear and precise, parents and relatives will still not he able to rely on the law for assurance that they will be fully notified about retained material from coroners' post-mortems.
My third point is one that is of great concern to many of the scientific and medical bodies that have shown an interest in this legislation. I am particularly grateful to the Nuffield Council on Bioethics, the BMA and the Royal College of Pathologists for their guidance. While the Bill has been amended to ensure that identifiable residual tissue taken from living individuals can be used for medical education and research, there is still real confusion between activities that are categorised as public health monitoring, those that are clinical audit and those that are research. Since the first two can be undertaken without consent using identifiable tissue and the third may not, real problems may well occur.
One has only to sit in on research ethics committees, as I did for nearly two years in the early 1990s, to know that health professionals very often have real difficulty in deciding into precisely which category the studies that they wish to carry out fall. Unless clear and precise definition is provided, either on the face of the Bill or in codes of practice, some people may feel that they are inadvertently committing a criminal offence by categorising as public health monitoring something
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that ought properly to be categorised as research. Even more likely, and even more worrying, is that other people will be so worried that they might be breaking the law in one way or another that they are likely to discard remaining tissue that could have been extremely valuable for future research.
This is important legislation. No doubt it is capable of improvement to make it even more useful and reassuring to the public and to doctors and scientists alike. I am bound to avoid being controversial at this stage, so I shall end by once again expressing my delight at being able to participate in a debate on a subject of great importance for our society and its attitude to scientific research and informed consent.
2.39 p.m.
Baroness O'Neill of Bengarve: My Lords, it is a great pleasure to follow the noble Baroness, Lady Neuberger, and her outstanding maiden speech. It was humane and wise and everything that those of us who have known the noble Baroness for many years, and known of her great contribution through the King's Fund and in other fora, would have expected. We look forward to future occasions where she can be her real and controversial self. The other maiden speech from the Liberal Democrat Benches was also a great pleasure to hear and an example of outstanding humanity in reflecting on these issues.
I have for some years been hoping to see legislation brought forward on the use of human tissues. Ten years ago I took part in drafting the Nuffield Council on Bioethics report, Human Tissue: Ethical and legal issues. That experience left me keenly aware of the patchiness of existing legislation, of areas that existing law leaves unclear and of the importance of consent. I have continued to take an interest in the topic and must declare an interest—a non-financial interest—as the lay chair of the Addenbrooke's tissue bank management committee.
When the Nuffield Council on Bioethics reported in 1995, the government were unfortunately not particularly interested in dealing with gaps in the legislation concerning the use of human tissues. Sadly, subsequent events brought a number of further issues—largely to do with tissues removed post mortem—to wider and critical public attention. However, in my view the present Bill is still disappointing because it does not deal clearly enough with the issues identified well before the events at Alder Hey or Bristol or with the small minority of cases in which tissue is removed post mortem. We should remember the very great difference in the numbers of instances in which tissue is removed from living patients and when that is done post mortem. The difficulties that occurred at Alder Hey arose primarily as a result of lack of legal clarity about the subsequent use of tissues that had been lawfully removed under coroners' authority in order to determine the cause of death.
I ask the Minister why this Bill has been brought forward before legislation to revise the Coroners' Rules. I believe that such legislation is in preparation and has been in preparation for some time. I t is hard to understand why the two pieces of legislation are being

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brought forward in this sequence. It appears to be the wrong order. Why was it thought more urgent to reorganise the vast range of uses of human tissues taken from patients for clinical reasons than to clarify and limit coroners' authority to determine subsequent use of tissue lawfully removed post mortem? If we are worried about the events of Alder Hey—clearly we have reason to be—our first move should surely be to address those issues rather than to write new laws for the entire range of pathology services for living patients within and beyond the NHS.
Nor, unfortunately, does the Bill as drafted achieve its central purpose of providing clarity about which action will be lawful and which unlawful. It has been widely said that the drafting of the Bill is rebarbative and that the problem, unfortunately, is not just stylistic but structural. The danger, I fear, is that many whose work will be regulated by the Bill will not be able to grasp what it requires because of that unfortunate structure.
Since the Bill proposes considerable criminal penalties, the result is likely to be an atmosphere of intimidation in which professionals and institutions responsible for the custodianship of human tissues used in clinical care and research are fearful of criminal penalties even for actions that they believe to be medically important. If the interests of patients and donors were genuinely—systematically—opposed to those of the research community, it might be reasonable to regulate very tightly all research on tissues taken from the living and accept that very little research using human tissues would or should be done. However, that is not the situation. The study of human tissue benefits present and future patients and we should constantly ask ourselves, when considering the Bill at subsequent stages, whether the interests of patients and public health are secured or put at risk by the drafting.
It may be said—I believe that it has been said—that the nature of the drafting does not really matter because the proposed Human Tissue Authority will clarify what is meant and provide acceptable guidelines for those responsible for the proper custody and use of human tissues. I do not believe that that is adequate reassurance when a Bill criminalises so many complex actions. If we are establishing criminal offences, it should be clear in the Bill which sorts of action will attract fines and prison sentences and which will not. I believe that it is not clear. The constant references to beliefs and intentions in defining offences throughout the Bill makes it particularly important that this legislation be comprehensible to clinicians, pathologists, tissue banks and others whose responsibilities it will shape and govern.
I believe that the structural difficulties reach very deep. They begin with the fact that the Bill is organised round an attempt to authorise and regulate only scheduled purposes while failing to prohibit or to regulate purposes outwith the schedule. There are some sorts of action—I do not wish to name them here—where one has to ask whether action is permissible even if consent has been given with all
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careful process. I believe that the Bill says nothing about those sorts of action. If we are legislating in this area, it is of great importance that we do not begin by regulating what we think is legitimate and imposing heavy criminal penalties on those who put a foot wrong while failing to impose criminal penalties for things that many of us would find seriously disturbing.
There are other areas of difficulty, and many that need clarification. Despite the wholesale rewriting in another place, as other noble Lords have said, the list of scheduled purposes—that is the scheduled purposes in the two parts of Schedule 1—remains confusing and, I think, incomplete. I offer two small examples of many but they are not small in practice.
First, the schedule tries to draw a very sharp line between education or training relating to research and other education or training relating to human health, the former requiring consent while the latter does not. However, I have yet to meet anyone knowledgeable who thinks that this distinction can be well drawn in all cases. Advanced clinical training is often done by involving students in clinical research. Secondly, the list of scheduled purposes allows for public health monitoring not requiring consent but it does not appear to allow for other research that is important for public health purposes. It does not, in particular, allow for the unconsented use of data and of tissues for secondary data analysis.
There are many well known examples but I give one that I think will mean something to all of us. When new variant CJD first appeared in the early nineties, it was not known whether it was or was not a clinically new disease. The only way in which it could be established that it was a clinically new disease was to look back at brain tissue from persons who had previously died in many European countries from genetic and sporadic CJD. It was, of course, discovered that it was a new clinical disease. It would not have been possible to seek consent from the very unfortunate people who died of the older forms of CJD in order to ensure that the study of these tissues was indeed the study of a different sort of tissue from that of those who had tragically contracted new variant CJD.
That sort of example must give us all pause in thinking about the interests of patients. That is why I am so glad that the medical research charities are speaking up about the importance of that. We must not forget patients. I fear that the list could go on. We are aware that the Bill has been modified in its passage in another place and greatly improved. None the less, I think that a great deal will have to be changed if we are to end up with workable, let alone satisfactory, legislation.
It has been said that this Bill constructs a sledgehammer to crack the proverbial nut, but that, unfortunately, it misses the nut. I do not think that we can reshape the hammer to ensure that it really hits the nut because for that we would also need to reform the Coroner's Rules, but I hope that with close attention we may be able to do a little to mitigate the damage potentially caused by hyper complex legislation.
2.49 p.m.
Baroness Warwick of Undercliffe: My Lords, I, too, compliment the noble Baroness, Lady Neuberger, on an exceptional maiden speech. Despite being uncharacteristically uncontroversial, she has set out the agenda for our future debates on this Bill. I congratulate her.
After what has been said by so many speakers already, I hardly need to remind the House that universities have a leading role in clinical teaching and research involving the use of human tissues and organs. I declare an interest as chief executive of Universities UK.
I fully support the Government's aim of introducing legislation that will prevent a recurrence of the distress caused by retention of tissue and organs without proper consent by providing robust safeguards. In bringing forward legislation to regulate the storage and use of human organs and tissues for purposes such as teaching, research, transplantation, public health monitoring and public display, the Government have rightly placed the primary emphasis on improving public confidence in the ethical and professional standards that underpin such uses.
I warmly welcome the amendments made to the Bill on Report in the Commons. They addressed the majority of concerns articulated by those working in universities and clinical settings regarding the unintended and unduly restrictive aspects of the legislation in relation to the conduct of medical research. Nevertheless, as so many others have said in the debate, further steps still need to be taken, to ensure both that the Bill is effective and that it achieves the clarity and public confidence that we all wish to see.
As other noble Lords have said, a number of concerns have been expressed by the key bodies with an interest in the future of clinical research, including the Academy of Medical Sciences, the Association of Medical Research Charities, Cancer Research UK, the MRC, the Wellcome Trust and the Royal Society. Those concerns range from the need to clarify that consent to use tissue for research is both generic and enduring. through to the need to clarify the roles, duties and liabilities of designated individuals named on licences from the Human Tissue Authority.
A concern of which I am mindful is the need for greater clarity regarding the process of ethical approval. It will be necessary to establish who is authorised to grant such approval. Without clearer guidance, research ethics committees are likely to err on the side of caution, with the consequence that research with direct patient benefit would be unnecessarily inhibited.
What unites those various concerns is the need to provide reassurance that the implications for clinical teaching and research have been thought through fully. Despite the improvements which have been made to the Bill, there are still too many issues where the consequences for teaching and research do not seem to have been adequately addressed. One issue of particular importance is the need for reassurance regarding the
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process by which secondary legislation will be conducted. It is imperative that there is appropriate consultation with the medical and scientific community in that regard. Various steps could be taken to address that need. I support the proposal made by the Royal Society that legislation should explicitly state that the membership of the Human Tissue Authority should include representatives of the scientific research community.
Given the critical importance, however, of the codes of practice in determining the detailed processes of authorisation and consent, and in light of the level of uncertainty which clearly still prevails, I urge my noble friend the Minister to take a further step. In order to provide the certainty required, the most appropriate way forward is for there to be parliamentary debate on how the codes of practice will work. I hope that my noble friend will feel able to accept that, or at least confirm that the essential secondary legislation and codes of practice will be in place before the substantive provisions of the Bill commence.
Lastly, there is a specific issue which may not have been fully appreciated. The legislation has significant implications for a wide range of staff, and there is a need to consider the role of those not directly involved in clinical research. Non-research clinicians are a vital link in the chain of medical research, due to the role which they play in securing consent to obtain human tissue for future research purposes. We therefore need to ensure that appropriate provision is made for advising such staff on all relevant aspects of the consent process.
Considerable progress has been made in achieving a balance between the rights of patients and their families, and the need for biomedical research for public and patient benefit. I urge the Minister to build on that achievement by providing the comprehensive reassurance and clarity required during the scrutiny of the Bill in this House.
2.54 p.m.
Baroness Cumberlege: My Lords, I should like to start by declaring two interests: first, I chair St George's Hospital Medical School and, secondly, I am a trustee of Cancer Research UK. I should also like to join those of your Lordships who joined up to the lay brigade.
I seek some advice from the Minister. It used to be a House convention that to be allowed to contribute to other parts of a Bill one had to speak at the Second Reading. There were two purposes to that. First, the Minister found out who was interested in the legislation and, secondly, it let interest groups know who they could contact to express their concerns. I just wonder if that convention has withered, because if it has I would not be here this afternoon to speak. Like my noble friend Lord Newton, I would be here to listen and support. But although I would not have spoken I would have attended this afternoon because these issues are so important and crucial and we have had a debate that has been enriched by two maiden speeches of the highest quality. I am grateful for those and there is one to come from the noble Baroness, Lady Murphy.

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I have the privilege to serve on the Select Committee examining the issues surrounding stem cell research and cloning along with the noble Baroness, Lady O'Neill, from whom I learned so much. As is usual practice with such committees we took evidence and in my naivety I expected enormous resistance from the scientific community to regulation. In fact, the contrary was the case. Time and again the researchers and the scientists who we interviewed said that they welcomed regulation because it enabled them to understand where they stood and how far they could go without contravening the law.
I visited Poland just after the introduction of democracy where, interestingly, there was great concern, particularly among obstetricians and gynaecologists, about the conflict between the Church and the state. It was a pincer movement because the Church banned abortions and the state encouraged them. The Polish people said how much they admired this country because we could debate these issues—everyone could have a shout and even if one did not agree with the outcome of the debate, at least one had had one's say and there was a chance for everyone to have their voices heard.
Today we are listening to the science community which has expressed a view that, again, it is not against regulation but it is against unnecessary bureaucracy—which is so damaging, which saps energy and which erodes the inquiring mind. No one today has disputed the intentions of the Bill and we all agree that a degree of regulation is possibly essential, but it is the degree which concerns us.
In his opening remarks the Minister outlined the history. Without a doubt what happened at the Royal Bristol Infirmary and at Alder Hey was off-limits. More than that it was actually illegal and it shook not only the scientific and medical worlds but society as a whole. The law was there. The problem was that it was not respected or upheld. I agree with the noble Baroness, Lady O'Neill, that we have to ensure that we are not taking on issues which are already partly resolved and that we are not simply gold-plating what is already there.
Looking back at what happened, it is interesting that the concern was centred on post-mortem practice, whereas much of the Bill is not about post-mortem practice but ante-mortem practice. I very much agree with my noble friend Lord Jenkin, who said that when the issue blew up the Government's response exacerbated the situation. However, the NHS is always diligent and is always trying to put things right. In this case, I know that at St George's every specimen was examined to ensure that it complied with the law and with good practice.
The noble Lord, Lord Winston, spoke of over-reaction. In my view, some other institutions did over-react. Medical students—young people—were paid to telephone parents to inform them that the institution still had body parts belonging to a child. I know of a woman who, 20 years previously, lost a baby in the eighth month of pregnancy and was telephoned. I am sure that she was told as kindly and compassionately
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as possible but that call reopened a tragedy that she had managed to put behind her. Again, I think that that was an over-reaction. As legislators, do we not have to be careful not to over-react but to get the balance right?
I very much respect the Minister and the department's officials, who I know have been extremely diligent in talking with and meeting groups, and they have sought to achieve that balance. But, as a former health Minister, I also know how easy it is to over-react. When a problem arises, the pressure is enormous and there is a huge clamour for the Government to do something. The classic response is an inquiry, which we know takes evidence chiefly from those affected. It addresses specific issues, sometimes, I believe, without seeing the much wider implications of assessing the unintended consequences.
Among its recommendations, an inquiry will often call for legislation. Quite properly, that is for the Government to design and for Parliament to decide. The role of Parliament is to see the issues in the round and to identify the unintended consequences. I fear that there are several unintended consequences in this Bill, and we must try to put those right in the Committee stage.
The noble Lord, Lord Clement-Jones, rightly outlined the generosity of the public in donating organs. In whatever way we legislate, we must ensure that that generosity is not put at risk. The Minister mentioned retaining confidence. Of course, that is crucial. In order to do that, I think that three main areas need to be addressed in the Bill. The first is clarity; the second is proportionality; and the third is practicality. The Bill must work in practice.
With regard to clarity, as noble Lords have said, the Bill started life with a great deal of confusion. Much of that has been reduced by the amendments made in the Commons, but I think that some areas remain foggy. Several of your Lordships mentioned those. They are linked to anonymity, the breadth and duration of consent, and the distinctions between research and training and training for research. I also believe that the definitions of certain terms in the Bill need to be clarified.
Regarding proportionality, one of this nation's great successes has been our ability to invent and discover. We have a proud record of discovery. Twenty-five of the world's 100 top-selling medicines were discovered and developed in the United Kingdom. That is more than in any other country except the United States. Clearly, we want to cherish and enhance that.
I am concerned that a great deal of research is funded through research charities on five-year grants. When I have talked to researchers, they have said that on average it takes about two years to carry out the preliminary work in order to set up a research grant. That clearly leaves them only three years in which to do the work.
If the Bill is enacted unamended, I think that research will probably take longer and I fear that the scientists will think, "Is this really worth doing?

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Worse, I may infringe the regulations either through ignorance or through inadvertent mistakes. If I do that, there is a possibility that I could be prosecuted. There is even a possibility, albeit a remote one, that I could be sent to prison". Do we really want to criminalise our research community? I think that that is disproportionate. There are other disproportionate measures; for instance, as the noble Lord, Lord Turnberg, said, having to go to the High Court for permission. However, I am sure that more of that will be explored in Committee.
Finally, I want to talk about practicalities. I am not an academic. I am a Martha rather than a Mary. I like to see practical things happen. I want to cite four examples of where the practicalities, even at this moment, are difficult. First, the current Department of Health guidelines allow 24 hours for next of kin to give consent for removal of tissue. This means that certain types of tissue—for example, brain—will be of limited or no use to researchers as the delay affects their quality. Schizophrenia researchers in Oxford have been unable to acquire a single brain for research since 1999. Will the Bill, when enacted, ensure that such research can be safeguarded? From watching the "Panorama" programme the other night on Alzheimer's, we know how much brain research is essential for our future health as a nation.
The second example concerns a group of doctors in 2002. They were associates of the International Society of Nephrology and decided to set up an international study on a rare kidney condition; a very unpleasant disease which affects many children between the age of five and 15. Two items were required: first, access to the tissue, which was then archived, and secondly, anonymous linkage to the patients, so that clinical progress could be corrected with the tissue appearances.
An application was made to the ethics committee. Ethical permission was refused on two grounds: first, that consent from the patients or their relatives must be sought, which was considered impossible by the British investigating team, as many of the patients had died; and, secondly, that the information about their clinical course could not be released, albeit anonymously, without the patient being identified personally as that infringed the Data Protection Act. The British arm of the study was therefore abandoned and only carried out in other countries. In his opening remarks the Minister mentioned research projects which had been abandoned, and probably this was one of them. If the Bill is enacted with enormous clarity, will it safeguard future studies of this kind?
Thirdly, as part of the QUASAR multicentre study for colorectal cancer, a questionnaire was sent to GPs asking their attitudes to seeking consent from their patients for the research use of archival tissue samples. About 20 per cent of the GPs replied. Of those who did, they either refused to help or said that they would expect payment for the work. A typical fee expected was £50 per patient. A further questionnaire to patients indicated that they did not want to be asked and the study was allowed to proceed without consent. It is worth noting that in its present form the Bill would
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make most teaching of cervical cytology illegal without consent as a cytological opinion requires histological confirmation of the diagnosis, so the diagnostic process must be complete. Such consent would have to be requested by a GP. Can we he confident that we shall have the co-operation of GPs once the Bill is enacted so that future cytology studies will be able to be pursued?
Lastly, in Leeds a section was introduced into the surgical consent form where the patient was asked to indicate consent or objection to the subsequent use of any residual material for research or teaching. An audit showed that only 48 per cent of specimens received in the laboratory had traceable consent forms. Of those which were found, 40 per cent did not have the "tissue" section completed. This method did not address blood samples where explicit consent for taking the sample is not recorded.
Interestingly, in the Leeds study, of the completed forms, only 0·8 per cent of participants objected to research use. Bearing in mind the generosity and the willingness of the general population to recognise and value research, is it not possible to design some sort of mechanism, possibly using a swipe card so that we are not into mounds of paper, indicating a general consent?
My purpose in highlighting these examples is to question whether the new measures in the Bill will ease rather than exacerbate research. I very much look forward to the Minister's response, to the work the Government will do in Committee—and I, too, have heard the comment made by the noble Baroness, Lady 0' Neill, that this Bill has been described as a sledgehammer that misses the nut. Perhaps a little more skill and a lighter touch would he of benefit to our population as a whole.
3.11 p.m.
Lord Redesdale: My Lords, I rise to speak extremely briefly. I feel like an interloper in these debates. I have just worked out that the last time I spoke on a health debate was when the noble Baroness, Lady Cumberlege, was a Minister—which was one or two years ago. This debate is very broad and covers many emotive subjects. However, I have a very small point—given the tone of the debate, some might call it slightly insignificant—to raise. I say that especially as the debate has attracted three maiden speakers. We have already heard two excellent maiden speeches from these Benches.
I support the Bill and will do nothing to try and derail it at any point. I am not speaking from the archaeological perspective, as archaeologists who deal with human remains which are more than 100 years old are not really covered by the legislation. Sometimes I think that archaeologists should be covered. I have friends who have gone round on buses touting bones in plastic bags for analysis. However, that has more to do with the financial strictures applying to archaeology than it does with the morals of archaeologists.
The small point I wish to address appears in Clause 52 and regards museum de-accession. The Minister has slightly shot my fox—if I may jump to

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another piece of legislation—by answering some of the questions that I wished to raise. I thank him and his colleagues in the DCMS for the help they have given on this issue, and especially for the letter of 20 July from the noble Lord, Lord McIntosh.
Museum de-accession obviously affects museums in different ways. It is important for many reasons that museums are able to remove human remains. The Museum of London, for example, faces the cost of storing thousands of bones collected during its digs in the cemeteries of London. The issue needs to be resolved. There is also a very real need to meet some of the moral ambiguities created by ethnographical collections, some of which are not very old. It would be not only against agreements drawn up in 2000 between our Prime Minister and the Prime Minister of Australia but I think morally objectionable to fail to repatriate some of those remains which, in museum terms, have been presented surprisingly recently.
However, Clause 52 causes me some concern. The American example provides some guidance. The Minister said that judicial review proceedings brought by parties seeking the return of human remains is one of the issues we will examine. The clause could cover that issue, and I know that the DCMS is looking at addressing it. In his letter, the noble Lord, Lord McIntosh, says:
"On Wednesday 28 July we plan to launch a consultation document on the future care of human remains in UK museums. Part of this consultation will focus on whether there should be a Code of Practice governing the care of human remains in museums and, if so, who should issue and enforce the Code of Practice".
He goes on to say:
"Adherence to such a Code would give museums some protection against a Judicial Review of a refusal to repatriate human remains to a claimant".
Although that seems to meet many of the concerns that I wished to express, the fact that it refers to "some protection" rather than "full protection" against judicial review, will leave museums in lingering doubt.
On that point I have one small question, which the Minister might not be able to answer now. Considering that the review is taking place in a few days, starting next week, I doubt that it will be able to come to a conclusion before the next stage of the Bill, which will leave some issues unresolved when we debate further aspects. If the Minister cannot give me an answer today, perhaps he could write to me on whether it would be appropriate for secondary legislation guidance to deal with these issues so that any threat of judicial review by parties or even governments seeking the return of, say, mummies or valuable artefacts that have human remains bound to them could be dealt with. That would avoid causing museums, whose financial reserves are limited, a degree of worry.
3.16 p.m.
Lord Walton of Detchant: My Lords, rarely, if ever, are we privileged to hear three maiden speeches in a Second Reading debate. We have already heard two exceptional such contributions from the Liberal
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Democrat Benches and I look forward with keen anticipation to hearing the contribution from my noble friend Lady Murphy.
More than 50 years ago, when I was a junior doctor training in the field of neurology, one of the most difficult and sensitive tasks that I was ever asked to perform was to talk to bereaved relatives, seeking their permission to arrange a post-mortem examination on their deceased relative, whether an adult or a child. Such individuals very occasionally refused but most often agreed to that request in the knowledge that the findings at post-mortem would be of no value to the deceased individual but might be of very great relevance to future individuals suffering from similar illnesses because of what might be discovered on examination of the organs. I clearly recall making it absolutely clear to them that the organs had to be removed and studied after death.
What has not come out in much of the publicity surrounding the so-called Alder Hey and Bristol scandals is that, in neurology, if one is to examine a brain in order to determine the diagnosis and the cause of death, the brain must be removed and then fixed in formalin for a minimum of two weeks before it can be sliced, examined and its tissues looked at under a microscope. In those two weeks, of course, the body has been buried or cremated. As a junior doctor I used to tell bereaved families that when the results of a post-mortem were known—and that might take several months, because examination of the cut brain and also the slides derived from the tissues subsequently might take several weeks or months—the general practitioner would be informed. I cannot recall a single occasion in those early years where I or the pathologist involved was ever asked to return the organs that had been examined for that purpose.
Having said that, I am gravely concerned, as others have been, about the distress caused to the parents of children in the Alder Hey Hospital from whom it was found that organs had been removed and stored without consent. I regret to say that a convention appeared to develop over the succeeding years to the effect that giving permission for a post-mortem involved the removal and retention of organs, and that was something of which many people in the general community and many patients were not aware. I agree entirely that informed consent is a crucial issue in this field.
I am talking about neurology, but the same principles apply to many other organs; hearts, kidneys, lungs and so on. If we had not been able to retain brains for examination, we would never have discovered the site of the principal changes in the brain in a disease such as Parkinsonism. We would never have discovered the chemical basis of those changes, which ultimately led to the development of a precursor of dopamine, which was missing from those brains, as a form of treatment in 1-dopa and its derivatives, which has transformed the management of that condition.
Brains too were removed from patients with Alzheimer's disease, who themselves at the time of death were incompetent and incapable of giving

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consent, with the permission of responsible relatives. Many years ago, in my city of Newcastle-upon-Tyne, the changes in those brains of patients with Alzheimer's disease were compared and contrasted with those found in the brains of non-mentally impaired elderly individuals who had undergone post-mortem for other reasons. It was those changes that led to the discovery of cells that were responsible for Alzheimer's disease and also for the biochemical changes that showed an absence of a substance called acetylcholine, which in turn led to the introduction of so-called cholinesterase drugs which, although not a cure, have had a beneficial effect in many such patients.
As my noble friend Lady O'Neill said, we would never have discovered the relationship between new variant CJD on the one hand, and bovine spongiform encephalopathy on the other, if it had not been for the fact that the brains were compared with those suffering from sporadic CJD. Nor would we have discovered the fact that a progressive and fatal form of encephalitis was due to the persistence in the brain of the measles virus over many years.
I could give innumerable other examples. It is clear that the development of new and sophisticated techniques of examination has made it absolutely vital that archival material, which has been stored in laboratories over many years, should be made available for research purposes. New techniques may reveal unexpected findings which were not apparent many years ago. Such stored material, including the gross specimens but also the histological slides for microscopic examination, is vital in the training of young pathologist and clinicians in order that they might relate the changes that are seen in sections of the brain on one hand to the clinical symptoms that the patients previously experienced on the other.
One of the best training aids for young neurologists that I have experienced in my professional career, and which I first saw when I worked in the United States in 1953, was the so-called brain cutting session, where the patient's clinical findings were described, the radiological and other investigative findings were described, and then those were compared with the changes that were discovered in the brain. That led to new light being cast on many well recognised diseases such as stroke, and also led to the recognition of conditions not previously known, which in turn had a profound effect on the management of patients subsequently presenting similar symptoms.
Of course, I favour the principle of informed consent. The days of doctor's orders are long past. The practice of medicine is a partnership in which it is up to doctors to recommend to patients what they regard as the most appropriate management of a condition; it is up to the patients to decide whether to accept that recommendation.
The same principle of informed consent must apply to the use of tissues and organs from individuals obtained at post-mortem whenever feasible—I repeat, whenever feasible. Of course, the same principles have been applied to the examination of tissue and fluids
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from living individuals—not only for the removal of growths, cancer, tonsils and other material, but also for the very common use of the biopsy method where biopsies of tissues of various kinds are taken in order to determine what disease is present.
In my experience while working many years ago on muscular dystrophy and other muscle diseases, we commonly took specimens of muscle and examined them under the microscope—muscle biopsy—with the full informed consent of the individual. That had a profound effect on our recognition of new and previously undiscovered diseases of muscle. I am glad that such biopsy specimens, blood samples and other tissue samples have now been subject to amendment of the Bill in another place so that they may be used for education and training without explicit consent.
However, the issue of research is much more crucial. The Bill requires that such tissues can be used for research only with the approval of an ethical committee, with which I heartily approve. But they must also be subject to anonymisation so that the individual patient cannot be identified. I regard that as totally impractical. If I were to go back to my old department, which I shall not do at my age, to look at biopsy specimens for research, using new techniques of examination for research purposes I would inevitably recognise the samples that had been taken from patients who were under my care.
Will any doctor who carries out research on tissue that has been removed—with their approval and that of the individual—be guilty of a criminal offence? That area must be considerably modified. The whole issue of obtaining informed consent for research in those situations could place an intolerable burden on researchers.
As my noble friend Lady O'Neill and others have said, coroners' post-mortems are very important. They can remove tissues without any consent. In the Bristol inquiry, 90 per cent of the hearts removed were for coroners' post-mortems. Under law, the coroner was entitled to retain those organs until he was satisfied that the necessary investigations had been completed. Once those investigations had been completed, if the organs were to be used for research, the whole question of explicit consent, ethical approval and so forth arose. How, after many months and sometimes years, could such permission readily be obtained? I am sure that the Coroners Rules need to be modified.
There are many provisions in the Bill that are welcome. The establishment of a human tissue authority has a great deal of merit, although I am much less sure about the proposed merger between the HTA and the HFEA. In 1989, when I first became a Member of this House, my baptism of fire was the Human Fertilisation and Embryology Bill. I believe that the responsibilities of the two authorities are likely to be very different.
It is crucial that the Human Tissue Authority should include within its membership not only a majority of lay people but also pathologists, scientists and others who may not have the same authority or expertise in relation to in vitro fertilisation, which is a very important issue.

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Turning to licensing, in a department of pathology at a university, presumably the head of department—a professor—will hold the licence and can delegate work under that licence to other members of his staff. In a regional hospital where consultants are of equal standing and no consultant as a rule supervises another, does every consultant have to have a licence? Is the licensing requirement also applicable to those working in clinical biochemistry, virology, microbiology, immunology and haematology? Must they all have licences from the authority?
Regarding tissue transplantation, I would like to have the Minister's confirmation, which I believe he gave, that stem cell lines, like other tissue lines, are excluded from consideration under the Bill. But what is the position with regard to bacteria? A swab is taken from a human orifice which is then plated on to an agar plate so that the bacteria can grow, as Sir Alexander Fleming did years ago in his laboratory in St Mary's Hospital. The plate was contaminated with penicillium notatum and resulted in the discovery of penicillin. Would every line of bacteria grown in that way need to have implicit consent? Moreover, would the same apply to viruses? Will we have to have a very important matter relating to the discovery of new diseases like SARS dealt with like this? Can the Minister clarify the point?
I believe that this Bill has come back from another place greatly improved, but it is still significantly defective in several respects. We need to know more about its relationship to the Mental Capacity Bill and about the proxy individuals who will be able to give consent on behalf of incompetent individuals. Anxieties remain which have been referred to by many noble Lords today.
I hope that the Minister will use the shining hours of the forthcoming Recess to study carefully the briefings we have received from the Royal College of Pathologists, the BMA, the Royal Society and from the BioIndustry Association. I say that because it could well be that the Government, in their wisdom, may bring forward even more sensible amendments by the time the Bill is considered in Grand Committee.
3.31 p.m.
Baroness Hayman: My Lords, it is always a pleasure and a privilege to follow the noble Lord, Lord Walton of Detchant. It is also something of a relief to be sitting where I am rather than in the place occupied by my noble friend the Minister today; that is, in the position where he will have to respond to the noble Lord on some of the very important issues that he and others have raised in the debate. That is because there are issues of real concern that have arisen not out of a desire to curtail research, but out of the well founded wish to ensure that the rights of patients and the proper respect due to human tissue both post-mortem and ante-mortem are honoured. There are also concerns that, inadvertently, significant damage will be done to medical research in this country.
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I should declare an interest as chairman of Cancer Research UK. In my latter years I have fallen among researchers, but my interest in the health service and commitment to issues of this kind did not stem from a research background. Initially I came to the health service as a consumer representative, a patient representative on the maternity services liaison committee of a district health authority. I also had the privilege of being the first lay member of the Ethics Committee of the Royal College of Obstetricians and Gynaecologists, as well as serving for many years on a local research ethics committee—a pioneer of its kind—at UCH and UCL under the chairmanship of Professor Desmond Lawrence.
I do not seek to minimise the very real dilemmas that can arise out of individual areas of research when trying to balance the interests of the community as a whole, patients in the future and the individual patients who will be affected by a particular piece of research. These are real and difficult issues which I believe must be tackled on an individual basis. The proper place for examining such issues is in the detail of research ethics committees, in particular when we are considering tissue taken from living individuals.
I understood the words of my noble friend the Minister when he said that the Bill introduces a comprehensive regime, one that will deal with tissues both post-mortem and from living individuals. Moreover, we all acknowledge that the Government have made good progress in terms of residual tissue. But I seriously worry whether adopting such a comprehensive approach is beneficial in this regard.
I say that because enormous problems were encountered in relation to post-mortem tissue, which have been eloquently described today by many who have had to deal in a pastoral capacity with the families affected. I believe that the regulatory framework had become completely out of kilter with social and ethical expectations; patients' attitudes had changed. The attitude of "least said, soonest mended" that was acceptable in the 1950s and 1960s was simply not acceptable in the latter years of the 20th century. We saw how that framework could cause great distress even in circumstances where people did not behave inappropriately or against professional standards—although, sadly, in some cases this did occur.
I welcome the fact that we are updating the whole framework. However, I am concerned that in trying to do so in a comprehensive way, as my noble friend described, we are applying—certainly this was true of the Bill when it first started life—a one-size-fits-all solution to vastly differing circumstances, and that we are, in many respects, overemphasising concerns about the appropriateness of consent and issues such as anonymity, especially in relation to living and residual tissue.
I believe that when we refer to informed consent we should pay as much attention to the information as to the tick in the box on the consent form. Information for patients and information for the public is tremendously important; it should not be given only at the time when a piece of tissue is likely to be used or to go into a tissue bank and so on.

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We have a great deal more to do to inspire public confidence in medical research. We can do so by explaining the regulatory framework; by explaining how ethics committees work; by explaining how professional self-regulation works; and by explaining how professional standards are upheld. The greatest protection for patients will not come from what we do in this House but from high standards of individual professional behaviour in the medical and scientific community. We must do all we can to engender that.
Information is tremendously important when people are being asked to consent. The giving of that information is an ongoing process and it is something to which I hope, in its short life, the HTA will address its attention. It is important that there should be overall education on these matters.
The issue of anonymity has been eloquently described by many noble Lords in their distinguished contributions. When consent has been dispensed with in respect of residual tissue, I cannot see the logic in saying that the counterpart has to be anonymity. I can understand and support the fact that approval from a research ethics committee has to be in place. I also believe that appropriate measures about confidentiality should be put in place in those circumstances. But I fear that the fetish about anonymity could cause tremendous damage to important pieces of research which are in the public interest, and perhaps in the interest of individual patients, without giving any additional protection whatever to the patient.
We sometimes lose a sense of proportion on these matters. Anyone who works in a hospital sees terrible breaches of confidentiality all the time. I had the misfortune to be in an A&E department with a member of my family some six months or a year ago. Apart from the fact that you could read on the board the names of everyone who had come in and their supposed diagnosis, I ended up knowing more about the drug-taking habits of the young man who had come in slightly after us than I would ever have wished to know or he would have wished me to know. When I was on a post-natal ward, I knew about the future contraceptive behaviour of the neighbour in the next bed, because curtains are not good barriers to auditory communication. One constantly heard all sorts of things that breached confidentiality.
We need to address those sorts of issues. We should not say that it is inconceivable in any circumstances for researchers—very well regulated, it is to be hoped, by their own professional standards—to be able to make connections that could be crucial for the research in which they are involved and for future health and discovery. That is the key. I agree absolutely with appropriate confidentiality, but I think that blanket anonymity is the wrong way forward.
I look forward to discussing these issues at what will obviously be an animated Committee stage. If the end of the 20th century saw the death of deference, it is important that we do not allow the beginning of the 21st to see the death of proportionality and common sense.
3.41 p.m.
Baroness Murphy: My Lords, first, I should also like to express my gratitude for the very warm welcome I have received from all sides of the House. As a political and parliamentary novice, it has exceeded my hopes and aspirations. The induction programme which we are now given has truly been a great help. I commend it to those of your Lordships who have not had it in the past—it is really very good.
I have also made terrible mistakes already. I thought at one point that the noble Lord, Lord Marsh, was going to ask me to dance, but he was merely pointing me in the right direction towards where I should be standing.
I know that it is customary on an occasion such as this to demonstrate one's wit, but the Human Tissue Bill does not naturally lend itself to wit in any but the worst taste. I think it was Marilyn Monroe who said, "I don't mind making jokes, but I don't want to look like one". So I fear that the House must wait for another occasion for my Victoria Wood impressions.
Rather as the noble Lord, Lord Newton, was put on early hoping to be late, I have been put on late when I was hoping to be early. Many of the points that I wanted to address have been very eloquently covered already, so I will be brief.
I welcome the Bill in its recently amended form. I think that there is now a sensible balance between protecting the rights of patients and their families and the need to safeguard good clinical practice and research. I want to highlight what a mess the current legislation is.
I spent a good many years in clinical and academic research practice with mentally incapacitated older people, trying to devise ethically sound ways in which to conduct research into their disorders and also to enable post-mortem neuroscientific brain research. I particularly welcome the guidance on consent for use of materials post-mortem. In the absence of legal clarity, my teams and I had to devise a scheme and operate in practice broadly what is now proposed. I can tell your Lordships that it is eminently practical and will be generally welcomed by clinicians and relatives. Further clarification will be needed, in regulations and the code of practice, particularly when we come to the Mental Capacity Bill but, overall, it is workable, and I believe that it can be made to work clearly. At the moment, we do not have that clarity.
As chairman of a strategic health authority, I am very pleased to see the amendments that protect clinical education, training and research use of tissue that is incidentally removed during investigations or surgery and which would otherwise be discarded. I think that that is very helpful.
Before mentioning three matters which I believe need further scrutiny or to be addressed in regulations, I shall comment on the impact of the passage of this legislation through Parliament. After the Alder Hey story broke, which noble Lords will remember was a direct consequence of the Bristol babies inquiry, there was much resentful talk in hospital corridors and canteens of how the whole profession was being

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unfairly blackened by the behaviour of one over-zealous, cavalier pathologist who was perceived to be at the dysfunctional end of a spectrum of clinical practices which, at best, were designed to protect relatives' sensibilities and, at worst, were casually thoughtless.
Since then, the climate of professional opinion has been broadly won round to supporting the Bill. That is in part due to the leadership of the senior officers of the Royal Colleges of Pathologists and of Paediatrics and Child Health in particular, but also, crucially, due to the debate about the culture of professional practice that has been stimulated by the passage of the Bill through Parliament. That has been a very good thing.
I turn briefly to three matters that remain unresolved in my mind. First, having listened to the Minister's introduction, I am not quite clear about where we are in relation to coroners' practices. My understanding of the Bill was that coroners' activities would be excluded and would be looked at later, perhaps in response to the recommendations of the third Harold Shipman inquiry, which were published last week. I am now simply not sure whether I am reading the Bill in the right way. I am told by Professor James Underwood, who I know has briefed many noble Lords here today, that not all coroners follow the existing good practice, published by the Chief Medical Officer in 2001, in relation to consent for retaining and using tissue in research after it is no longer required for post-mortem. There is still a large hole in the Bill that needs to be addressed much more clearly. I hope that we shall have an opportunity to clarify those rather vague areas.
The second matter is the so-called "altruistic" genetic testing and other testing that is carried out on mentally incapacitated adults. It is carried out not for the patient's sake, but generally for the benefit of other current and future family members. I understand that the interpretation of the patient's best interests will be addressed in regulations. It will be crucial that those regulations weave seamlessly with the forthcoming Mental Capacity Bill. Some of those tests can be extremely uncomfortable, but they may be highly important to the family's interests. Very often, those incapacitated adults would want to participate in a process, whether painful or not, that would assist their relatives. Dr Ainsley Newton, a genetics ethicist from Imperial College, has provided me with some very challenging case examples which will need to be looked at very carefully by those who draw up the regulations.
The third and final matter is anonymity; that is, the requirement on a researcher not to possess any information which might identify individuals to whom tissue belongs and the relationship between the individual's best interests and the best interests of public health. However, such eloquent examples were cited by the noble Lord, Lord Winston, the noble Baroness, Lady O'Neill, and the noble Lord, Lord Walton of Detchant, that I shall not labour that point, save to say that unless this matter is cleared up, we will be in grave danger that the Bill might preclude the kind of excellent research that they described.
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To conclude, the Bill addresses complex aspects of human biology and medical practice, which are undoubtedly difficult to draft into practical legislation without risking unintended adverse consequences. Overall, the Bill is in good shape, and the minor difficulties are surmountable without trespassing on its fine purpose. It will be a fitting memorial to the Bristol infants' brief lives.
3.49 p.m.
Lord Hughes of Woodside: My Lords, it is a real pleasure to follow the noble Baroness, Lady Murphy, who has just made an excellent maiden speech, not least because she is a noted campaigner for the health of older people, which is of special reference to some of us in your Lordships' House. Her expertise has been as a doctor, an academic and a manager, and she is currently chairman of the North East London Strategic Health Authority. That expertise was well demonstrated today in her maiden speech. There is no doubt that her presence in your Lordships' House will greatly enhance the House's reputation, and we all look forward in great anticipation of hearing from her again in future.
I join in the general welcome that the Bill has received, although in passing I must say that I am surprised or astonished at the regular and sustained criticism from almost every research academic who spoke in the debate. But perhaps one should not be surprised at that. There is no doubt that it has been necessary to bring this Bill forward, but we need to remind ourselves that it is deeply disturbing that it was necessary to do so.
We are faced with examples of a tiny minority of the medical profession, who had become so desensitized to human life and experience that they collected vast amounts of organs and tissue which could never possibly be put to any use. They were presented to the general public as if they were some collection of macabre memorabilia. That did huge damage to the medical profession; how far the damage has been done and has affected people's confidence in organ transplantation, for example, is a matter for speculation. Fortunately, the evidence so far seems to suggest that the effect has not been as bad as it might have been.
I confine my remarks today to a topic that has not so far been discussed—the question of organ transplantation, and the vexed question of whether we should maintain the present system of opting in, or move to what we used to call opting out. I am not sure that it could be described as spin, but the phrase "opting out" has now been changed to "presumed consent"—which certainly sounds a lot better than opting out.
I strongly believe in presumed consent and have done so for many years—indeed, since 1970, when I was the co-sponsor with Tam Dalyell in the House of Commons of a 10-minute rule Bill on the subject. At that time, there was unrelenting hostility to the possibility of moving towards presumed consent. That Bill did not proceed any further and, since then, there have been many other attempts to further the law in

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that regard, which, again, foundered for one reason or another. But it is my opinion that the tide of opinion is changing; people are much more open now about expressing their support for presumed consent.
On 19 November 1970, I took part in a debate on organ transplantation—during which, incidentally, I made my maiden speech. Looking back, comparatively little has changed in almost seven years. It may be—and this is my own opinion—that people such as the British Medical Association have now come out much more strongly in favour of presumed consent. Many organisations, such as the National Kidney Research Foundation and others, have also said that they are in favour of presumed consent. So the tide is turning.
The odd thing is that there has been very little change in statistics. The waiting list for the number of people for kidney transplants has hardly changed. In 1997, the figure was 5,500; currently it stands at 5,750; but what is incontrovertible is that the shortage of organs for transplant still exists, and the gap has not shrunk in any way. Very ominously, it is forecast that the rate of kidney failure will increase significantly in the next 15 years. Therefore, if for no other reason, I regret that the Government have not taken the opportunity to move in that regard, and rejected the amendment in favour of presumed consent when it was moved in the House of Commons.
I believe that the Government's reasons for not doing so are twofold, and I understand them both. First, they argue that there is no evidence that presumed consent will increase the availability of organs. Secondly, and perhaps more importantly, the Government say that the Bill is about consent. I accept that. Given that the Bill's intention is to try to restore the confidence of the general public in the medical profession, I think that it is a step too far for the Government to move from one part of the Bill that emphasises the importance of consent to a different part of the Bill in which we presume consent.
However, I believe that there is strong evidence that, where presumed consent is available, organ availability is better than it is in the UK; and I understand that the Bill refers to England and Wales. In another place, Dr Harris, who moved the amendment, among other things, said:
"The average donation rate, in donors per million of population, is 25 per cent. higher in countries with opt-out than in countries that have an opt-in system".—[Official Report, Commons, 28/6/04; col.50]
That is backed up by scientific analysis and research. He went on to mention an interesting case involving two different centres in Belgium, where the law had been changed. One centre operated on the basis of opting in and the other on the basis of opting out. There was a considerable increase in the number of organs available in the opting-out centre. This is not simply an academic exercise; we are dealing with people's lives.
On the second issue, as I have already conceded, it is incongruous and perhaps even contradictory to have a Bill that provides absolute consent in so many areas but presumed consent in another. However, my experience is such that I believe that that ought to be done.
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There has been some criticism of the fact that the Government applied a three-line Whip in the House of Commons whereas other parties operated a free vote. In the context of this Bill, however, it was legitimate to do that. The House of Commons is actually not very good when it comes to free votes. Sixty MPs voted for the amendment for presumed consent and, even more interestingly, 250 MPs did not vote at all. I have not had the opportunity to go through the names of those who voted against presumed consent to find out which party they belonged to. Quite clearly, however, a considerable number of Members—some Liberal Democrat, some Conservatives and some of no party—voted against presumed consent. The figures probably show that there is still a balance in the Commons and that no one has yet made up their mind. So I am not too concerned about the issue of a three-line Whip.
It is an incontrovertible fact that things cannot be allowed to drift. I have been engaged in this discussion for more than 30 years, but it has gone on for longer than that. In the mean time, people are dying or experiencing a much less good quality of life because of the lack of organs for transplant. We have to do something about it.
In the House of Commons, Frank Dobson, the former Secretary of State for Health, said that he had always voted against presumed consent. Indeed, he did so in the Commons on the last occasion. He suggested that perhaps there ought to be a Green Paper to revisit the issue of the best way to do this. I am never quite sure about Green Papers. They sometimes remind me of the story of the late Harold Wilson—Lord Wilson—who said, referring to Royal Commissions, that they took minutes and lasted for years. I would not want to bring in a system that meant we were doing something simply for the sake of it and fobbing off the argument for some time. We need urgent action. We urgently need to look at this.
Perhaps the Government could set up a special panel to take advice and try to gauge public opinion. The onus is on the Government to see whether we can move forward. I know that they will have a big campaign to try to encourage voluntary organ donation and so on. We have reached the point at which we must take decisive action and remember those who really matter in all this; that is, the patients. Having said that, I commend the Bill to the House.
4 p.m.
Lord Oxburgh: My Lords, I declare an interest at the outset as a former member of the Hammersmith Hospitals NHS Trust and in my former capacity as what I shall describe, since this is a medical debate, as the midwife to the birth of one of the largest and most successful medical schools in the country; namely, the Imperial College School of Medicine, of which the noble Lord, Lord Winston, is a distinguished member.
One might well imagine that at this stage of the debate there would be little more to say, and one would be right. We have heard three outstanding maiden speeches from the Liberal Democrat Benches and our

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Benches. I endorse the compliments that have been forthcoming from every side of the House. The House can retire for the Recess in the certain knowledge that many more such splendid contributions can be expected in years to come.
There has been general agreement that this is a very much better Bill now than when it started, and we are grateful to the Government for that. However, we are equally agreed that there is room for further improvement. I seek to make no excuse for what happened at Alder Hey and Bristol. People were caused needless and inexcusable levels of distress. However, it is a well known adage that hard cases make bad law. These are undeniably bad cases but we must all strive, as the noble Lord, Lord Jenkin, and my noble friend Lord Walton and others have pointed out, to ensure that these cases do not make bad law. That is a danger. The Bill appears to be light in coherent and thoughtful elucidation of principle and heavy on detailed—and often ambiguous and unhelpful—regulation.
I shall take a rather broader view. Good health is probably the most important element in what we recognise as quality of life. In pursuit of that, I am sure that there is not one Member of your Lordships' House who has not had occasion to consult a medical doctor. I suspect that the same is true of virtually everyone in the country. I wonder how many of us stop to ponder where the medical knowledge from which, I hope, we benefited came from.
At one level, the answer is relatively simple. It came from the study of countless other patients—our parents, our grandparents and their grandparents back for countless generations. I suppose that it might be hoped that by today we would know all that there is to be known about the human body. Sadly, that is far from the case. Human beings are probably the most complicated organisms ever to have populated the Earth.
Over the centuries medical knowledge has advanced in different countries and different cultures on parallel, but often quite different, tracks. That was because until the last century this progress was almost entirely empirical and reflected local ways of dealing with local problems, some of which worked and some of which did not.
Modern science and modern instrumentation have revolutionised understanding of the complicated physical, chemical and biological processes that take place in our bodies; detailed imaging and analytical processes and tools have now give some glimmerings of how they work. However, every new technique that offers new understanding simultaneously opens up and illuminates new areas of ignorance. Understanding of the human genome begins to put on a scientific basis what, of course, we have all always known; namely, that we are all different. That implies that in minute ways our bodies may function slightly differently and that they can respond quite differently to the same drug or exposure to infection. But more importantly it carries with it the prospect and, indeed, the possibility that we can cope with these much better than ever before.
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The point, simply put, is that there is still an immense amount that we do not know about the human body and the various pathogens that affect it. Nevertheless, by and large, each successive generation has had the benefits of a higher level of medical knowledge than its predecessors. That beneficial progress has to a large extent depended on the ability of the medical profession to make, to collate and to store observations made on our bodies. I believe that we have a moral obligation to ensure that that progress does not stop.
The advance of medical knowledge and the improvement of medical practice depend on the ability of our medical schools and medical research institutes to make observations on living and dead tissue and on their associated conditions. Anything that we do to inhibit that may inhibit the progress of medical research which is for the benefit of all.
It is particularly important that the potential uses of human tissues or data should not be too tightly prescribed. You can never tell in which direction the next important life saving discovery lies. I recall years ago a colleague in Cambridge completing a government questionnaire in which he was asked to explain what research he would be doing in five years' time. He responded, "I don't know—and if I did I would be doing it now". The noble Lord, Lord Winston, gave us a vivid example from his own early research career of how his work might have been inhibited. We simply cannot tell where the next brilliant idea will take us or guess what lies round the corner. I must say that I am terrified by some of the provisions of the Bill as it stands. Having embraced the general principle of the use of human tissues for appropriate research, let us not strangle it by regulation. A real danger arises if the regulation is undertaken by people who simply do not understand the problems.
It goes without saying that most of us do not wish detailed medical information about ourselves to be publicly available. It is for that reason that data and samples should be anonymised and not attributable, as far as possible, to individuals by name. However, important information will be lost if samples and data relating to the same individual cannot be related to each other. It is for that reason that the voluntary Biobank project will be so important.
Although access to information for research is important, for reasons that I think are generally accepted, it cannot be unregulated. Medical research is subject to the general oversight of ethics committees. Their working is not perfect but there is little argument that they play an essential role. Furthermore, we must accept that particular individuals may have religious or ethical objections to some aspects of medical research. They may wish to withhold permission to use their data or samples in particular ways. I believe that it is absolutely right that those wishes should be respected.
In conclusion, we have today heard a great deal about the rights of individuals but relatively little about their obligations. I personally believe that we should move slowly towards a situation in which everyone receiving medical attention should do so with

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the glad expectation that observations made on them and samples from their bodies should be made available anonymously for medical research in order to help others unless they expressly indicate to the contrary. I accept that there is a major hearts and minds job to be done but this is the direction in which we should move.
It would not be right for us now to withhold from medical researchers the information that will bring to future generations medical progress such as we have ourselves enjoyed. In this, as in so many walks of life, the debt that we owe to our parents has to be repaid to our children.
4.10 p.m.
Lord Alderdice: My Lords, I declare an interest as a psychiatrist, and as a psychiatrist married to a consultant pathologist who works in the NHS. I join other noble Lords in saying what an interesting and enriching debate it has been, particularly because of the quality of the three maiden speeches. The speeches of my noble friends Lord Roberts of Llandudno and Lady Neuberger, and of the noble Baroness, Lady Murphy, have been a great delight to listen to—very thoughtful, informed and well articulated.
Those speeches reminded me very much of why I so enjoy this House, and how I have from time to time found it a substantial contrast to another place, where I worked for some time. Indeed, I well remember a debate in that place for which I was in the Chair, and therefore the Speaker and unable to speak, as is the curious meaning of our terminology in such places. I listened to many colleagues speaking with much less knowledge, understanding or appreciation of the issues than has been evident in your Lordships' House.
That leads me to substantial anxiety about this Bill and what has happened, and to enormous sympathy for the Minister as he not only winds up the debate but tries to take through the House a Bill that is so inordinately problematic. In that regard, the noble Baroness, Lady Hayman, expressed what many of us feel, not only so far as the poor Minister is concerned. She also brought a great air of reality for those of us who work with people in the health service, and about what happens away from the rarefied atmosphere of those who devise human rights legislation or even Bills of this kind.
The Minister said that the Bill was to deal with previous legislation that was unclear, out of date and unworkable. It was also to respond to some very difficult incidents. Although those are very commendable propositions—there is little doubt that the legislation is out of date; I do not dispute that—the very number of civil servants who have come along to assist the Minister may be an indication of the complexity of the Bill in its present form. It may indicate that the matter is not simple, and that the Bill does not make it particularly so. No matter what is done with the Bill, the issue will be extremely complex. That creates the problems for his aspiration for clarity and workability.
What led us to the Bill? It was the problem that practices of presumed consent that had been around and developing for some time were no longer
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acceptable in the current climate, in some cases for good reason. Also, some practitioners had pushed themselves well beyond what was accepted even by their colleagues as conventionally appropriate. When the matter came to public concern, there was profound anguish on the part of those affected, particularly the families. That was referred to by the right reverend Prelate the Bishop of Portsmouth and my noble friend Lord Roberts.
Thereafter, it seems that the question of anguish and pastoral concern largely disappeared from the reality. In the vast majority of cases, we were dealing with people who had difficulty overcoming the bereavement that they had suffered. I have seen little evidence that their need for assistance in overcoming their bereavement has received much attention. Frankly, if, as parliamentarians, we think that passing a piece of legislation and setting up a regulatory authority will in any way deal with the anguish that there was in the past or will be in the future, we are sadly mistaken and rather infatuated with the power of Parliament. The fact is that those people have suffered and will suffer.
What happened was that their grief, which had not been fully overcome, was revealed, was laid bare, and in some cases was created not just by the events themselves but by the attempt to address the events—when people were going around telling the families things that they did not wish to know and provoking more grief for them. We have to be very careful with what we do. The first rule of medicine that we teach junior doctors is "First, do no harm. Thereafter, with a bit of fortune you may do some good". This whole business and the reaction to it has opened up the possibility that we can do harm, and we should be careful.
The question of remains—as we sometimes euphemistically describe them—was brought home clearly to me two or three weeks ago in Peru. I was in Ayacucho in the Andes, where it is said that some 70,000 were "disappeared" by the army, the Shining Path and the MRTA. Of those 70,000 only a few of the remains have been made available. I was present for the handing over of some five sets of remains to families. It was only the fourth handover since the disappearances happened many years ago. I was struck by the meaningful nature of that handover and how important it was.
But we must be very careful about reifying the notion of people and personalities into their bodies. Subsequently I have substantial questions about the notion of funeral services for body parts. When someone who is still alive has an amputation we do not have a funeral for their limb. In fact, we strongly believe that that person should not be regarded as any less a person because they have lost a limb or two or whatever. Yet, somehow when the person is dead and gone, some body part that remains around almost indefinitely qualifies for a funeral. I am not sure that psychologically and spiritually that that is the best way of dealing with it and there may be issues for colleagues such as the right reverend Prelate and my noble friend Lord Roberts to address from a spiritual and psychological point of view

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as to whether that way of addressing the matter is necessarily the best way of doing so. There is a profound paradox within that—that we are making the body parts into the persons themselves, rather than assisting people to deal with the real problem, which is not the remaining body part but the remaining grief and anguish inside themselves.
This leads me to the whole question of understanding what is going on. It is clear to me that in the drafting of the Bill there was a profound lack of understanding of what actually happens. For example, it was suggested that pathologists were not seeking consent. Of course not. In the vast majority of cases the pathologists never meet or see the patient. How could they possibly be obtaining content? The clinical worker obtains the consent—the person with the patient, the person who is often with a grieving family or with a person in great difficulties or distress over an operation. In any case it is not the pathologist who seeks the consent, although, not infrequently, clinical workers go on to carry out research, publish a paper and do not even put in the title of the paper that it was the pathologist who produced the diagnosis upon which the clinical worker had based the paper. They should not be doing that but such things happen.
Understanding what is going on is very important. The Bill has emerged from a tragedy over the way that post-mortem material was dealt with. Many fewer post-mortems are now carried out. The vast majority are carried out as coroners' cases. In fact, in Northern Ireland the paediatric pathology service virtually collapsed after all of this because people did not wish to do that type of work any more. Indeed, some of the pathologists personally suffered badly as a result of what happened. Therefore, it seems very difficult to see how there can be other than a detrimental outcome.
I asked the Minister whether he was aware of what happened in Northern Ireland. In expectation (which is always a dangerous thing) of what Parliament might decide with regard to this piece of legislation, the Department of Health, Social Services and Public Safety in Northern Ireland introduced regulations and arrangements on the question of consent before the legislation had been dealt with here. I understand, although I am open to correction, that the result of that was that many clinicians working with patients filled in the relevant form with the words "No consent". It is not entirely clear to me whether that meant that no consent was asked for or whether it meant that consent was not given when it was asked for. However, no consent was given.
It is now impossible to have a complete cancer registry in Northern Ireland for the past 12 months because it was not possible to acquire the necessary material. I know that attempts are made within the Bill to ensure that that does not happen in the future, but it has already happened. When people's consent has not been obtained, one cannot then go back and get it.
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Therefore, as I understand it, there is now a lacuna in Northern Ireland, and that says something about the anxiety that the Bill has created. It has not been possible to bring through the legislation in a reflective, calm fashion because it deals with emotions that are difficult and painful. That is why we have great sympathy for the Government and for the Minister as he tries to work on the Bill. He is dealing not only with a piece of legislation but with people's feelings on all sides, and we appreciate that that is very difficult.
One result was that when the inquiry was conducted in Northern Ireland, the health Minister at the time attempted to ensure that no one with any medical knowledge and qualifications was seriously involved in it. I think that that is an unhappy reaction. It may be helpful seriously to consider whether we can make certain that that does not happen in the future by ensuring that, for example, the Royal College of Pathologists is represented on the Inspectorate of Anatomy and Pathology or in some other way in order to make it clear that such marginalisation of those who are involved is not acceptable in England, Wales and Northern Ireland.
The noble Lord, Lord Hughes of Woodside, raised the issue of presumed consent. That is an important and difficult matter, and obviously the Government have decided not to go down that route. That is not surprising because this Bill is going in completely the opposite direction. The whole basis of the Bill is that the presumed consent on which people operated in the past requires not only to he regulated but reversed. Therefore, I suspect and fear that, by following the direction which the noble Lord has struggled manfully to do for some 30 years, he may have some more hills to climb.
I believe that the noble Lord was right to say that the real concern of the public was based on what he eloquently and floridly described as the macabre nature of the collections rather than the proper use of the material. I think that the overwhelming majority of the population is prepared to accept the latter.
Let us put ourselves in the position of some of the relatively young (although it does not make it any easier when you are older) medical or nursing staff who try to obtain consent in the context of a tragic death, or let us consider the vulnerability of someone undertaking an operative procedure. Any of us who have done that know how difficult it is and, as I said, it does not necessarily get easier with the passing of the years or with experience.
What is the easiest thing to do in those circumstances, when a person knows that, if he does not follow the procedure properly, he could face criminal convictions? The easy answer is: do not do it. What mileage is there in doing so? What mileage is there in putting oneself through that and in trying to explain to the family exactly what will happen to the brain, as was eloquently described earlier? It is not an easy or pleasant procedure or one to which a pleasant description can be attached. It is not the kind of thing that you talk about over tea, unless you happen to be married to a pathologist.

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Therefore, the easiest thing is to ignore it and not to try to seek consent. It is too difficult. But the result is that the material is then not available for the work to be done or for the research to be undertaken. We are dealing with human beings who are under clinical pressure. What is the incentive for them to put their necks in the noose? It seems to me that it is much easier not to bother. I wonder whether criminalisation is the way to ensure that people fulfil the proprieties of regulation. When we are trying to move away from criminalisation in so many areas, I find it strange that this is the kind of sanction that we think appropriate when dealing with these issues.
The difficulty is that by not seeking the consent of the patient because of anxiety and fear, we may end up doing the opposite of what the patient and the family want. When one feels anxious and says, "I'll not go down that road; they are terribly upset", who knows, a week or two later it might well have been that they would have said, "If only the body of our loved one had been used, there would have been some value in the tragic loss or the pain that I have gone through". Paradoxically, by going down that particular road, which heightens everyone's anxiety and I am not sure addresses all of the problems, we end up with the opposite of what we want.
The whole question of regulation and whether it is the best response to every problem that arises was raised by the noble Lord, Lord Winston, and others. There is a tremendous tendency for us to follow a pattern: if there is a problem and public anxiety, we set up a committee. Any good committee that does not come back with recommendations of regulations, legislation and someone to be appointed to ensure that the problem never happens again can be quite sure that it will never be appointed to a future inquiry. However, that said, it is a brave Minister who will stand up and say, "I have heard all of that but I do not think that it is appropriate". We have almost got ourselves on a treadmill in which our way of responding to every crisis is to produce more regulation. Of course, the more regulations that are produced, the more guarantee that people will break them because there will be so many regulations it will he impossible to get up in the morning and have your breakfast without doing so.
None of us, having worked on and thought through the debate, can be in any doubt that we are dealing with an extraordinarily complex and delicate set of issues. None of us can have anything other than sympathy for the Minister and his colleagues. They have tried to deal with some of the issues and now know that they have much more work to do. There is no doubt in my mind or, I think, in the minds of other noble Lords, that this is not brought forward by a government with malign intent. On the contrary, it is brought forward by a government with a concern to address some very real issues. What they have discovered is that by the moves that have been undertaken, they have unearthed even more issues. I am sure that all of us would wish them well and promise them our involvement and co-operation insofar as we can as we proceed through the Bill in the autumn.
4.27 p.m.
Earl Howe: My Lords, this has been a debate of remarkable quality, enhanced, I need hardly say, by three very distinguished maiden speeches from the noble Baronesses, Lady Neuberger and Lady Murphy, and the noble Lord, Lord Roberts. We hope that all three will play a full part in our further deliberations both in Committee and on Report. I congratulate them very warmly.
As many noble Lords remarked, the Bill is born of real and widespread human distress. It is of small comfort only that the distress was wholly unintended but in seeking to ensure that the mistakes that caused it should never happen again, we need to cleave to some basic principles. Every speaker today has articulated those principles well. They are: respect for the individual; the wider good of society; and clarity in the law. In looking for what has gone wrong over the past 30 or 40 years—things have gone very wrong—nevertheless, we do not need to overstate the case. In particular, we should not be over-critical of the medical profession. Post-mortem practice has developed over a period of years within a legal framework that in the early 1960s appeared adequate but with hindsight today looks woefully imprecise.
The good of society, as exemplified by the ever-widening body of medical knowledge, has never been a goal to be pursued regardless of ethical principle or at all costs. Yet the imperative of furthering clinical research, as a means to that public good, has given rise to unthinking routines which have served to overshadow something equally important and precious; namely, the right of every individual to regard his body as his own, to do with as he wants.
The Bill before us seeks to achieve an appropriate balance between society's good and the rights of the individual; and in so doing it aims to restore what Alder Hey, Bristol and the Isaacs inquiry eroded—trust between medical practitioners and the public.
In subscribing fully to those aims, I have no hesitation in welcoming the Bill; and I welcome in particular its emphasis on informed consent and on unambiguous regulation of the uses of human tissue across the entire spectrum of research, transplantation and teaching. I welcome the pragmatic approach which the Government have adopted to existing tissue banks, which, as many noble Lords have remarked, are of incalculable value for research in the field of public health in particular.
Subject to points of detail, which we shall discuss, I support the provision in Part 3 of the Bill relating to transplantation, DNA analysis and the de-accessioning of human remains by museums.
The amendments made in another place have without doubt corrected a number of features in the first version of the Bill, which, with the benefit of reflection, appeared unnecessarily restrictive, especially those relating to the use of residual tissue from living people for research and training purposes.
The Government are to be congratulated on listening to the concerns voiced by MPs of all parties; but at the same time one cannot help thinking that the

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five-month delay between Committee and Report stages in another place might have been avoided had the Bill been the subject of pre-legislative scrutiny. That scrutiny need not have taken very long, but it would have enabled the major players in the scientific community to make considered comments on the Bill, as opposed to commenting on a consultation document. In that way I suspect that the unintended anomalies, such as the original provisions on residual tissue and tissue trafficking, might have been identified and dealt with earlier and more rapidly.
Having said all that, and despite the very welcome improvements made to the Bill, it will not have escaped the Minister's notice that the prevailing view emerging from the debate is that we are not there yet. From the speeches made today, I think we can single out four or five principal issues which are likely to raise their heads in Committee.
The first issue relates to research carried out on tissue from living people without consent. We need to look at whether in these situations the requirement for anonymity contained in the Bill is either necessary or desirable. There is a good deal of research—as we heard from the noble Lord, Lord Walton, in particular—particularly epidemiological and genetic-related research, which requires clinical information to be correlated with data obtained from tissue specimens. Indeed, there is a real sense in which the value of the tissue falls to negligible levels unless some sort of linkage can be maintained with the donor.
The noble Baroness, Lady Hayman, made the very telling point that medical confidentiality, rather than complete anonymity, may be all that most people would wish to see preserved in circumstances of this nature. I think we need to look at that and, in particular, whether it would be beneficial for the avoidance of doubt that the ministerial assurances given both here and in another place about reversible anonymity should be translated on to the face of the Bill.
Equally, the requirement for anonymity should also be questioned in relation to doctors who wish to carry out research on their own patients. The Bill at present would appear to prohibit that, and that is surely a serious concern. It is a concern that chimes in with a theme of a number of speeches, which is that, in several important respects, the measures in the Bill appear disproportionate to the mischief that they purport to address.
In that vein, we shall also need to examine whether the definition of appropriate consent needs to be refined. When consent is obtained for the use of human tissue in research, it is not possible to state in advance the precise purpose for which the tissue may have future use. The noble Lord, Lord Turnberg, made that point. To revisit the patient or his family to obtain updated consent is simply impractical.
The Minister gave some reassurances on that point. My view is that the Bill should make it explicit that generic and enduring consent, although not mandatory, should nevertheless be legal in appropriate circumstances.
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As the Bill stands, consent is required when education or training involving human tissue relates to research techniques. On the other hand, when the education or training relates to disorders of the human body, no consent is needed. We should closely consider whether the distinction between the two sorts of education and training serves a useful purpose. In fact, the relevant wording in Schedule 1 runs rather wider than education and training in research techniques. It appears to cover training in the methodology of research, such as the use and evaluation of statistical tests. I cannot believe that that is what is intended but, if it is, we should pay heed to the warnings sounded by the noble Baroness, Lady Neuberger, and my noble friend Lady Cumberlege about the risk that researchers might be criminalised unwittingly as a result of a narrow definitional distinction. I am worried about that and about where it might lead.
The last main area of contention concerns coroners. There are two problems with Clause 11. One is that it ducks the whole issue of retained organs as it relates to coroners. We are simply asked by Ministers to await publication of the new coroners' rules sometime around the end of the year. That is not at all satisfactory.
The other problem, related to it, is the wording of the clause. The phrase,
"anything done for the purposes or functions of a coroner",
is too vague. The obvious question is: how far does a coroner's legal protection extend? Does it extend only to a coroner's core functions, which are the investigation of the circumstances and causes of a death, or does it extend more widely to anything at all done by the coroner within the ambit of the coroners' rules?
My view is that, beyond the coroner's statutory, core functions there is no reason why the rules and provisions of the Bill should not apply, especially in relation to the obtaining of consent from families for tissue to be retained in tissue banks for research purposes, after a post-mortem has been completed. I hope that it will be possible to build some meaningful provisions in to the Bill on rules for coroners. However, at the very least, families should be entitled to be informed if tissue from a dead person is retained following a coroner's post-mortem, and they should have a right to know the reasons.
Openness and informed consent should be the principles that guide us as we debate the Bill. I freely concede that if we are tempted to add to the exceptions already agreed to the consent principle, we should do so with care. That is why I cannot personally reconcile myself to the concept of presumed consent in the context of organ transplantation, despite the sincere and committed speech of the noble Lord, Lord Hughes. It is surely difficult for us to countenance the risk of repeating the errors of Alder Hey and Bristol, where it was precisely the presumption of consent that led to the distress of many thousands of families.

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We cannot say that we believe in the principle of consent as the bedrock of the Bill and, in the same breath, say that we do not need consent in that very sensitive and important area of activity. No doubt we will debate the matter further in Committee. But if confidence in the medical profession is to be as we would wish it, we cannot afford to take further risks, and this would be a big one.
One of the principal tests of the Bill's success will be whether, when it is in force, we see a better understanding on the part of patients and the public of why human tissue is of such value to medical research; why such research is for the good of us all; what pathology is; and how ethical standards are upheld and safeguarded. Those are the ways in which the consent of patients and families to donate tissue and organs for transplantation and research will become increasingly forthcoming. If that can be achieved alongside a new sense of confidence within the wider research community, this Bill will have done its job well. In common with all noble Lords, I very much hope that we can complete that virtuous circle.
4.41 p.m.
Lord Warner: My Lords, this has been an interesting, stimulating and thoughtful debate. As I come to respond and to think about the future stages of the Bill, I find the attractions of reshuffling extremely attractive.
We have had three very distinguished and lively maiden speeches. Like other noble Lords, I look forward to the future contributions of the noble Baronesses, Lady Neuberger and Lady Murphy, and the noble Lord, Lord Roberts of Llandudno. When listening to the speech of the noble Baroness, Lady Murphy, I was very impressed by the robust way in which she did not don rose-tinted spectacles about the present legislative position and recognised, from her own practical experience, the problems that had to be tackled.
I am also grateful for the many supportive remarks made in this debate about the road that we have travelled in getting this Bill—in my view—in pretty good shape. The debate recognised the importance of the principles on which it is based and, with perhaps one or two dissenting voices, of the need to provide a secure framework, which retains the confidence of the public, for medical and scientific research. I wish to correct a slip of the tongue in my opening remarks. I said that the provision for preservation of organs was in Clause 44; it is in Clause 48. I apologise for that mistake.
I remind the House again of the public concerns aroused by the report of the inquiry on Alder Hey and the Isaacs report. The latter did not just cause concern about organs and tissues from the deceased but has also had an impact on the public perceptions about organs and tissues from the living. We cannot duck out of that. Arguing the distinction between tissue from the deceased and from the living overlooks the fact that the public do not always make that same distinction. People legitimately want to know how, if I may put it this way, bits of their body are to be used by professionals. The public still feel that way, however
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much goodwill they may have towards medical researchers and the benefits of medical research for future generations.
I reiterate the importance of the Government's role of trying to maintain a balance between the needs and feelings of patients and their relatives and those of medical research, bearing in mind the contributions that can be made to future knowledge for the benefit of future generations of patients.
A number of noble Lords have asked why we cover tissue from the living and do not just concentrate on the coroner's area and tissue from deceased people. That assumes that the present arrangements are satisfactory. As I have said, and as a number of noble Lords have said, they are not satisfactory. They are muddled, and they cause concern for many medical researchers. A lot of attention has been given in this debate to the problems that some aspects of this Bill might cause for researchers. The present structure of legislation causes just as much, if not more, concern to researchers because of the uncertainty that it creates in their minds. If we do not bring greater clarity through this Bill and the statutory codes of practice, we will damage research by that failure. Doing nothing is not an option.
Many interesting and important points have been raised, and I will try to deal with as many as I can. I will write to noble Lords before the Committee stage on those issues that I fail to deal with. Noble Lords have raised the need for consent for research to be generic and enduring. We agree; as I tried to make clear in my opening remarks. While research ethics committees may, in individual research projects, sometimes ask for specific consent, as they rightly do at present, the Bill simply establishes the baseline. That clearly allows for consent to be broad and durable.
Many noble Lords have mentioned the issue of research using residual samples where the Bill allows for research without consent, provided ethical approval is given to the use of anonymised samples. The questions are twofold. First, does anonymised mean permanently unlinked? I have already tried to indicate that it does not. The Bill allows samples that are anonymised in ways that will retain their linkage to the clinical record. Secondly, is it in fact necessary for such samples to be anonymised in the first place? We maintain that it is. While we recognise that it is part of the duty of professionals to maintain confidentiality in their handling of patient information, we believe that the use of tissue samples is not an identical issue, especially the use of those samples for research when the patient has not given consent.
Through the consultation that has been taking place, we saw that people were happy for tissue to be used, but they wanted to be involved. They wanted to know what was to be done with that tissue. First and foremost, that means consent as the basis for the use of the tissue. People want knowingly to contribute and to be involved. In the situation, however, where tissue is to be used without consent, without people's knowledge, research ethics committees will represent their interests by ensuring that it is done on an ethically

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acceptable basis. More than that, it is for the protection of the patient as well as the researcher that it should be done on an anonymised basis. The researcher will have their tissue; certain clinical details and other diagnostic information. There is no reason why the researcher should also know the name of the person that the tissue has come from.
I have listened carefully to this debate, and I have heard little evidence that the knowledge of the name itself is essential to research. There may be some practical issues; there may be some systems to be changed and adapted in the way that the research is done, but the critical issue in these circumstances is that without consent, the researcher does not have the name. That will protect the researcher, who should not be put in a position where they might find themselves with tissue, clinical details and identifying names, and then discover new information about the person through their research. There is no need for that to arise. If the researcher is the treating doctor, and such new information might arise, there is no justification for not seeking consent. Again, let us be clear, tissue can be used in research if consent is sought, or if it is ethically approved for anonymised use. That provides a sensible balance.
Frankly—I say this in the most helpful way that I can—the research community needs to reflect very carefully on how it will appear to the public if it pushes too far for legislative amendments in this area. That would simply give the public the impression that they are to be bypassed in terms of obtaining consent about how tissue will be used.
Lord Winston: My Lords, I am very grateful to my noble friend the Minister for giving way. Perhaps he can clarify one issue for me. Supposing, during the course of research on a number of samples, one discovers a risk of cancer in certain patients. One might need to recall one's own patients to re-examine their smears or take another biopsy. How does that fit with the notion of anonymisation? I do not understand that and would be grateful for clarity.
Lord Warner: My Lords, I am prepared to write to my noble friend about that matter, but we are in areas of great detail that are Committee stage issues. Perhaps I may be allowed to use the time available to respond to the points that were made in the debate, which is what I was trying to do, and to set out the Government's position as clearly as possible. I should be grateful if I could be allowed to deploy those arguments as I have listened extremely patiently to the points made by noble Lords.
A number of noble Lords raised issues around the codes of practice. We should be clear that the codes of practice will be consulted on and can be debated in Parliament before they are introduced. Certainly, some of those codes will be subject to affirmative resolution, which must happen before the legislation is brought into operation. There are considerable opportunities for the detail of the consent and other arrangements to be subject to parliamentary scrutiny
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and public consultation. That will cover many of the concerns and points alluded to by my noble friend Lord Winston.
The noble Baroness, Lady O'Neill, raised the issue of the HTA's code of practice and whether it will define the limits of criminal offences in the Bill. That is not the case. Human Tissue Authority codes of practice will give practical guidance on matters within its remit and will set down the standards that it expects to be followed. Clause 28 makes it clear that failure to follow the code does not render a person liable to criminal proceedings.
Noble Lords asked whether research ethics committees will be able to manage the workload indicated by the processes involved. The research projects to be covered by research ethics committees are not different from those that are already being conducted and are already subject to REC approval. There should be no significant increase in case load. Indeed, RECs should benefit from the availability of clear and consistent guidance in that area.
A number of noble Lords raised the issue of retaining material following coroners' post-mortems, noting that it can be extremely important to retain that material for future research or diagnosis in the family. We agree entirely, but we must add that if the tissue is no longer required in respect of the coroner's needs—investigation of the cause or circumstances of death—the retention for scheduled purposes must be subject to the consent of the family. The Bill provides for that.
Noble Lords will be aware that Ministers at the Home Office have confirmed that amendments to the Coroners' Rules will be forthcoming this year. They will make clear that the coroner should inform the pathologist of what material is to be retained and for what period under his authority. The rules will also make clear that the family must be informed of any such retention. But where there is no requirement on the part of the coroner, consent is required.
The noble Baroness, Lady O'Neill, asked why the Bill is coming before the coroners' legislation. We are working closely with colleagues in the Home Office on that. As I said, the revised Coroners' Rules will be brought forward. I assure noble Lords that we will ensure that those new rules are wholly consistent with the Bill.
Noble Lords have raised a wide variety of issues and I shall try to address as many as possible in the time available. The noble Lord, Lord Clement-Jones, raised the subject of the costs of implementation. We have made provision for implementing the Bill and I think that the details are set out in paragraph 83 onwards of the Explanatory Notes. He also asked whether the Bill would affect the tracking of infectious diseases. It will not because it provides specifically for the use of tissue from the living or residual samples for use in public health monitoring, which includes epidemiological studies to track the prevalence and spread of disease.

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A number of noble Lords asked why RNA has not been linked in with DNA in the relevant provisions of the Bill. What we are most concerned about here is the kind of case where unscrupulous people obtain a tissue sample with a view to testing it for paternity, for example, without consent. While the direct testing of DNA is within the scope of the offence, so too would be the use of RNA in its scope if it is used as the means of analysing the person's DNA. However, I shall write in more detail to noble Lords about this rather complex issue.
My noble friend Lord Winston asked a number of questions about foetal tissue and the position with regard to photographs. Foetal tissue is treated in the Bill as tissue from the woman from whom it came. Her consent will be required, which must be right as a matter of law. In practice, guidance may ask that the genetic father's view may be sought when possible, but as a point of lawfulness it must be a matter for the consent of the woman. The Bill does not deal with photographs, but with the material itself and its uses for scheduled purposes. Photography is subject to professional GMC guidance, but we are concerned here with the lawful use of the tissue itself.
The noble Lord, Lord Jenkin of Roding, raised a number of points. I have to say that I refute his suggestion that the Bill represents an over-reaction. We have consulted extensively on this legislation with stakeholder communities and, as I said, there will be continuing consultation on codes, regulations and licensing procedures. We believe that the Bill strikes a reasonable balance and is not an over-reaction to the very serious concerns that have been expressed.
The noble Lord, Lord Patel, asked about the definition of "child" used in the Bill and whether it was inconsistent with the definition set out in the Family Law Reform Act 1987. We believe that there is no inconsistency. Clause 2 provides for competent children to be able to give consent to the use of their tissue. However, unlike in the case of medical treatment, the Bill does not contemplate a competent child's refusal to the use of tissue being overridden by their parents or a court. We believe that the Bill is consistent with the rules in place in relation to medical treatment, but does not replicate them exactly.
The noble Baroness, Lady Cumberlege, raised a number of issues, including the need to retain brains at post-mortem for research purposes and whether the Bill will safeguard future studies where data are needed. The Bill will support researchers who need organs for research purposes by making clear the consent process that will be needed and by enabling them to work within a clear framework. The Bill does not affect matters covered by the Data Protection Act. As I said, the Bill provides that research can proceed wherever consent is given or where research ethics committee approval is given for the use of anonymised samples.
On the subject of swipe cards, we certainly envisage that once electronic patient records are introduced, mechanisms can be used to record each patient's
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consent on that record so that it will be clear and available to all health professionals with access to it.
The noble Baroness also asked about the teaching of cytology and whether that will require consent. Clinical education and training using tissue from living patients does not require consent under the Bill.
The noble Lord, Lord Walton, raised a number of issues. On occasion I found myself grappling to understand the technology involved. However, I shall certainly better my education on these matters and write to the noble Lord. He asked whether consent to use post-mortem tissue should be obtained wherever feasible. The Bill does not inhibit any use of the research that the noble Lord described; indeed, it supports such research. Cell lines are excluded from the Bill—a point raised by him and a number of noble Lords—because it applies only to human cells coming directly from a human body. That does riot include bacteria or viruses.
My noble friend Lady Hayman made a number of points. However, her confession about some of the confidentiality breaches in her personal experience did not help her case; certainly it would suggest that we need to take very great care to ensure that tissue does not get into the wrong hands or is used without proper consent.
I have a great deal of sympathy with the concerns raised by my noble friend Lord Hughes about securing improvements in organ donation. Despite those sympathies, however, I cannot accept that the Government will take the issue forward in this Bill. My right honourable friend the Secretary of State, John Reid, made it clear in another place that the Government believe that it is not the role of Parliament to remove from individuals the right to exercise their own choice about donation, or to impose on individuals a requisition of their bodies after death.
The noble Lord, Lord Oxburgh, raised a number of issues. We recognise the need to maintain a link between samples and medical records and the Bi11 does not inhibit this. He referred to the UK BioBank, which is an important development with enormous potential. Samples for the BioBank are collected only with consent and its processes are highly consistent with what is proposed in the Bill.
I enjoyed greatly the speech of the noble Lord, Lord Alderdice, who raised the issue of criminal sanctions. Ultimately, there has to be some sanction in this area which inspires public confidence.
In conclusion, and after listening to the debate, I believe that we are still right that a fresh, coherent approach to the law in this area is needed if we are to give confidence to the public and to the professions. We will achieve this with the Bill as it deals comprehensively with the keeping and use of human tissue and organs, from the living and from those who have died. In the Government's view it does not jeopardise research; indeed, it strengthens the framework within which research can be conducted with confidence.

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I shall study carefully in Hansard all the comments that have been made in the debate and consider the documents to which reference has been made. I hope to do so on a sun lounger. We shall need to scrutinise the Bill carefully in Committee but, when we do so, we must recognise that much of the detail referred to today will rightly appear only in regulations and codes; it should not, I suggest, be written onto the face of the Bill. In its urge to scrutinise, the House can sometimes slip a little over the line by trying to put excessive detail into the legislation itself. No doubt we will have many spirited debates on the issue, but I thought that I should lay out my position right at the beginning.
I believe that the Bill will bring renewed confidence in the contribution of medicine and science to society and in our own contributions to that endeavour.
On Question, Bill read a second time, and committed to a Grand Committee.
Lord Warner: My Lords, I beg to move the Motion standing in my name on the Order Paper.
Moved, That it be an instruction to the Grand Committee to which the Human Tissue Bill has been committed that they consider the Bill in the following order:

Clause 1,

Schedule 1,

Clauses 2 to 13,

Schedule 2,

Clauses 14 to 16,

Schedule 3,

Clauses 17 to 38,

Schedule 4,

Clauses 39 to 50,

Schedule 5,

Clauses 51 to 53,

Schedule 6,

Clauses 54 to 61,

Schedule 7,

Clause 62,

Schedule 8,

Clauses 63 to 66.—(Lord Warner.)

On Question, Motion agreed to.
House adjourned at four minutes past five o'clock to Tuesday 7 September next, half-past two o'clock.