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§ The Parliamentary Under-Secretary of State for Health (Ms Hazel Blears)I should like to make a statement about the use of animal products in the manufacture of vaccines. The purpose of this statement is to correct the public record and to inform Members that I have placed three detailed reports on these issues in the Library. Nothing in any of the reports alters the assessment of experts: there are no transmissible spongiform encephalopathy-related safety issues arising from the use of relevant animal-derived materials in the production of vaccines authorised for use in the United Kingdom. However, I thought it right to come to the House to apologise for any inaccurate information that has been provided, and to set out the actual position as clearly as possible. It is important in particular to provide clear assurances for the public that the vaccines that protect both children and adults from harm are manufactured to the highest and safest standards.
On 23 October 2000, my hon. Friend the Member for Pontefract and Castleford (Yvette Cooper), the former Minister for Public Health, reported to the House that an oral polio vaccine had been recalled. That action was a precautionary measure because the vaccine licensed to Medeva Pharma used UK-sourced bovine material in its routine manufacturing production. My hon. Friend informed the House that a full review would be undertaken of all the advice given to Ministers on BSE-related issues and vaccines since 1997 in order to ensure that all the information given to Parliament was correct. She also advised the House that she had asked the Government's expert advisory body, the Committee on Safety of Medicines, to produce a comprehensive assessment of BSE-related issues in vaccines.
Bovine—cattle—products are a traditional component of vaccine manufacture worldwide. Without them, it would not have been possible to have produced so many vaccines over the years that, literally, have been life-saving for millions of people. Routine childhood vaccines such as diphtheria, tetanus and pertussis, HiB?—haemophilus influenzae b—and measles, mumps and rubella, will have involved the use of cattle products at early developmental stages in their production, and some of those might have been UK sourced.
The manufacture of vaccines is an extremely complex and technical process involving a number of different stages. For example, one bovine product, foetal calf serum, is regularly used at a number of stages in the manufacturing process of viral vaccines. It is used first at the earliest point, when stores of viruses and cells are first created. They are known as master seeds and master cell banks. Secondly, it is used when material is drawn from those stores to be grown further. Such materials are known as working cells and seeds. Thirdly, it is used during the phase when greater volumes of material are grown, which is known as bulking up. At the very final stage of vaccine production, inactive ingredients such as stabilisers are added, but they are highly processed and, as I say, inactive products. It is worth adding that the Medicines Control Agency advises that UK-sourced gelatin, which can be used as a stabiliser, is no longer used in pharmaceutical manufacture.
The oral polio vaccine that was withdrawn in October 2000 was the only vaccine then in use in the United Kingdom vaccine programme for which UK-derived 536 cattle blood products had been used in the later stages of the manufacturing process. It transpired on investigation that one constituent of the vaccine had been produced using material drawn down from old stored stocks dating to 1985 which had been produced using UK calf serum. The material had been used in the routine production process, not just in the early developmental stages—the production of master and working cell and seed banks. That did not apply to other vaccines in use at the time. That is why OPV was different.
The chief medical officer has examined the circumstances of the production of that vaccine and its subsequent withdrawal. He concluded that, on a precautionary basis, the decision to withdraw was the correct one. However, he also concluded that the public health implications were reassuring for three reasons: first, because of the major dilution effect during purification and washing, which removed all but traces—estimated to a dilution of one part in 10 million—of serum; secondly, because foetal calf serum is a substance classified by the relevant 1999 European guideline as having "no detectable infectivity"; and thirdly, because the Committee on Safety of Medicines ad hoc working party on TSE and safety of vaccines concluded in October 2000 that the risk of Medeva oral polio vaccine transmitting new variant CJD was "incalculably small".
At Ministers' request, the Committee on Safety of Medicines has looked more widely at all vaccines available on the UK market. It was assisted by a working party of experts consisting of members of the Committee on Safety of Medicines and its sub-committee on biologicals, as well as experts in TSEs, vaccinology, epidemiology, paediatrics, molecular medicine, virology and biological medicines. The CSM drew the following conclusion:
there were no demonstrable TSE-related safety issues arising from the use of relevant animal-derived materials, including UK bovine (cattle) materials in the manufacture of vaccines currently available on the UK market".In other words, after an exhaustive and rigorous review, the CSM found no source for concern in relation to TSEs about the safety of vaccines used in this country.We should also remember, when considering the safety profile of these vaccines, that they are manufactured for a global market. We import from other EU States and the rest of the world, and we export UK-manufactured vaccines to them. The vaccines that are available globally have been the subject of similar safety reviews by the United States Food and Drug Administration and its Centre for Biologics Evaluation and Research, the Committee for Proprietary Medicinal Products at the European Medicines Evaluation Agency, and the Australian Therapeutic Goods Administration. They have all independently arrived at similar conclusions.
Ministers have now received three reports, which together provide a comprehensive analysis and account of the issues related to TSEs and vaccines. They have today been placed in the Library. The first is the chief medical officer's report into the issues surrounding the withdrawal of the Evans/Medeva oral polio vaccine. The second is the consolidated review of TSE agents and the safety of UK-authorised human vaccines, which was undertaken by the Committee on Safety of Medicines at Ministers' request. The third is a report by the Medicines Control Agency, which explains in detail the development of the guidance and the agency's approach to its implementation.
537 It is clear from those reports that some statements have been made in Parliament that have been either incorrect or misleading. Ministers made the statements on the basis of incorrect advice and information given to them at the time by the Medicines Control Agency, which licenses medicines for the UK market and monitors the safety of medicines in use. I repeat my apologies to the House and convey those of my predecessors for the fact that incorrect or misleading information was thus given to Parliament, albeit in good faith.
I have placed in the Library a detailed index of the written answers that are being corrected or clarified. I have today written to Members who asked those questions, explaining how events occurred and setting the record straight. Copies are available in the Library. I have also answered a written question tabled by the hon. Member for Lewes (Norman Baker) about the rules that apply to the use of animal material in the production of vaccines.
There are five areas in which statements made by Ministers based on advice and information from the MCA have been shown to be incorrect or misleading. As I have mentioned, full details of those errors are available to Members in the Library. These factual errors arose through misinterpretations, in the advice to Ministers, of the highly technical and continually evolving guidelines governing the use of animal products in medicines, together with the difficulties of establishing a clear audit trail for vaccines whose manufacture may date back decades.
The first area to clarify is that, contrary to earlier advice from the MCA, the guidelines have never entirely ruled out the use of UK-derived bovine material. Secondly, statements indicated that the MCA would not license any product that did not comply with the guidelines. In fact, the MCA can in certain circumstances license products that do not fully comply, provided that the necessary risk assessment has been carried out. Thirdly, contrary to information supplied by the MCA, not all licence holders were able to demonstrate through documentary evidence that all their materials complied with the guidelines.
Fourthly, dates cited for switching from UK-derived materials were inaccurate, and so were expiry dates given for some vaccines. Finally, statements indicated or implied that bovine-derived excipients are not used in the manufacture of vaccines. In fact, excipients, which as I said are highly processed and inactive substances and which may be derived from bovine materials, are sometimes present in finished vaccines.
Guidelines aimed at minimising the risk of transmitting animal spongiform encephalopathies via medicinal products have been in existence since 1989, first in the UK. TSE guidelines have increasingly applied Europe-wide and have evolved over time. Since March 2001, they have had the force of European law for all licensed medicinal products.
A major exercise is now taking place under the auspices of the European licensing authorities to ensure that all vaccines are assessed for compliance against a revised set of guidelines, which we expect to be introduced this summer. That will apply to all European countries, not just the UK. The revised European guidelines will allow working seeds and working cell banks for which relevant animal material has been used to comply, provided that 538 they are subjected to a properly conducted risk assessment by a competent authority in the country concerned—in the United Kingdom's case, the MCA.
Many vaccines will be technically in breach of European guidance until the new guidelines are adopted. There are 95 licensed vaccines in the United Kingdom. Of those, 26 are still completing the process. However, in the United Kingdom, the appropriate risk assessment has already been carried out on all licensed vaccines, including those 26, and no TSE-related risks have been found.
The House can be assured that public health and safety is a top priority for the Government. We will continue to ensure that the public health implications of the use of animal materials in the manufacture of all medicines are rigorously evaluated and that any concerns identified are referred to the relevant domestic and European scientific committees for consideration and resolution. If any new public health concerns come to light, we will not hesitate to act in a precautionary manner, as indeed we did in the case of the oral polio vaccine in October 2000.
Let us be in no doubt that vaccination is the single most important public health measure of modern times. Vaccines save millions of lives around the world every year. When we think about the terrible unsolved health problems of the developing world, we look to vaccines to conquer disease and death, and in our own country vaccines continue to save lives.
I am grateful for the opportunity to come to the House to correct the parliamentary record and to provide the fullest possible information to hon. Members and the public on this important subject.
§ Mr. Oliver Heald (North-East Hertfordshire)I thank the Minister for an early sight of her statement; it was a most useful quarter of an hour.
The statement is important. We all remember the fears expressed when the polio vaccine was recalled that new variant CJD might have been spread and that something like 100,000 doses of the vaccine had been used in the preceding year. So today's reassurance about the safety of the vaccines is welcome. However, it seems that the advice of the Medicines Control Agency to Ministers was comprehensively inaccurate and led to many UK vaccines breaching European guidance and—perhaps the Minister can confirm this—European law. How did that happen? What steps will she take to ensure that it does not happen again?
We have four concerns: first, that advice to Ministers is accurate; secondly, that the mechanisms by which the authorities are alerted to non-compliance of vaccines with national and international standards is robust; thirdly, that the tendering process is effective and transparent; and fourthly, that the Government's response is speedy and swift when they are alerted to such problems.
Will the Minister publish the guidance that Ministers were given, including the new guidance? Can she confirm whether the Medicines Control Agency licensed products that were not compliant with European guidance, as apparently it was allowed to do, and will she identify which products? Which licence holders were unable to show compliance with the guidance issued in Europe, as set out in her statement? What were the inaccuracies with regard to the switch from UK-derived materials and what expiry dates were wrong? Will she also outline the 539 involvement of the company that gave rise to the original concerns—PowderJect—given its dominant position in the UK market and the fact that the company's chief executive is a major donor to the Labour party?
On the particular case of the oral polio vaccine, how did the authorities discover that it was not compliant or that there were concerns about it, and on what date? Did PowderJect inform the authorities, or was it the other way around? When was Medeva made aware of the concerns of the authorities? PowderJect purchased Medeva in September 2000 and the recall occurred just a few weeks later on 20 October 2000. In its press statement, PowderJect said that it
did not, and does not, intend to manufacturethe Medeva oral polio vaccine. Did the authorities alert PowderJect to the concerns about the oral polio vaccine prior to the purchase of the company? What was the lapse of time between the authorities becoming aware of non-compliance and acting to recall the vaccine? What reassurances can the Minister give that the tendering process for vaccines will be transparent and effective in ensuring compliance and safety?Finally, the speed of the Government's response is crucial. We know that there were concerns that they did not act quickly enough over foot and mouth. What can she say to reassure us that swift and prompt action was taken in this particular case given that it involved human health rather than that of animals, important though that is?
§ Ms BlearsThe guidance available to Ministers from the European guidelines is published and available. A full description is in the report by the Committee on Safety of Medicines, which has been placed in the Library.
On whether the MCA licensed products that did not comply with guidelines, the example of lactose has been brought to my attention. As the necessary risk assessment had been carried out, it was proper for the MCA to do that. Statements were made that it was not possible to license a product that did not comply with the guidelines, but those statements were wrong, hence my correction. In fact, it was possible providing the necessary risk assessment had been carried out. It is important to be aware that in the UK a risk assessment of every vaccine has been carried out and that no risks have been found. That applies equally to lactose products.
The hon. Gentleman asked about licence holders who are unable to comply. At the moment, 26 vaccines are going through the European process. Some of them do not comply because the working seeds and working cells contain UK-derived bovine material. When the guidelines are revised later on in the summer, working seeds and working cells will comply because the guidelines are evolving. Already master seeds and master cells are outwith the guidelines. We anticipate that in the latest revision of the guidelines working seeds and working cells will be compliant. A number of vaccines are simply waiting for that revision to the guideline. Other vaccines require further documentary evidence of the audit trail of their materials before they can be fully compliant. I do not have a list of the individual licence holders who are unable to comply at the moment, but a range of manufacturers and vaccines are in that position because of the vaccines' components.
540 PowderJect was in the same position as many other manufacturers because the oral polio vaccine did not comply with guidelines. The legal advice received by the MCA was that while companies were trying to comply and going through the lengthy European process of providing documentary evidence, prosecution for non-compliance would have been a disproportionate step to take. PowderJect was treated no differently from other manufacturers that were in the same position.
On the mechanisms for alerting PowderJect, I am not aware of advice given to it in the way that the hon. Gentleman describes. On 17 August 2000, the company itself, having received an inquiry about the status of the vaccine, notified the MCA that the product had been made using material that had been exposed to UK-derived calf serum. On 18 August, the MCA began to investigate, and in the week commencing 16 October, after two months of investigations, it informed the Department of Health of the matter. Ministers decided, on the precautionary principle, to withdraw the vaccine, and it was recalled from 20 October, so it is clear that swift action was taken on the oral polio vaccine.
As I said, that was a precaution because at the time that the vaccine was withdrawn the European guideline did not have legal effect; that did not begin until March 2001. In October 2000, it had the status only of guidance, so technically there was not an offence or a breach of a legally binding guideline. It is therefore fair to say that Ministers acted very swiftly. The chronology of events is set out in the chief medical officer's report, which is in the Library. That goes into great detail about the various stages at which information was known and about what action was taken. The chief medical officer has confirmed that the correct decision was made on the oral polio vaccine.
I entirely agree with the hon. Gentleman that we must ensure that advice to Ministers is accurate. That is essential, particularly when we are dealing with issues of safety and public confidence. I agree too that mechanisms for alerting Ministers should be robust and rigorous. On the MCA, various steps have been taken. It was announced on 13 June that it is to merge with the Medical Devices Agency to create a new agency.
We are also introducing non-executive directors, which the MCA did not previously have, and appointing a chairman to the authority to make sure that its governance is more robust. On its reporting mechanisms, particularly concerning TSE issues, it has been directed to set up a database to ensure that everything is properly calculated and monitored.
We have also asked for more steps to be taken to try to check the validity of what manufacturers tell the MCA. It is an established principle that regulators would find it impossible to follow up or question the validity of every statement made to them by companies. The role of a regulator is to set a regulatory framework and to leave accountability with the producers. However, there is a case for the MCA to carry out more sampling to establish the validity of some of the information supplied by companies.
It was the information supplied by companies about the expiry dates of vaccines, which the MCA gave to Ministers, which proved to be incorrect, so it is important to follow up such information, but we must recognise that 541 it would not be appropriate or possible to check everything. Certainly we must try to make the process more robust.
The hon. Gentleman referred to the need for the tendering process to be transparent. That is important, and people ought to have access to the decision-making process.
§ Dr. Evan Harris (Oxford, West and Abingdon)I too thank the Minister for the day's notice that she gave me of this statement and for giving me three reports to read in 20 minutes, plus a statement saying that there is another important document in another building. This experience, which started just over half an hour ago, has been interesting.
Will the Minister pay tribute to my hon. Friend the Member for Lewes (Norman Baker), who has been assiduous in pursuing his concerns about the presence of bovine material in the vaccine manufacturing process? He began with a parliamentary question on 25 March 1999 to the Minister's predecessor but two, the right hon. Member for Dulwich and West Norwood (Tessa Jowell), which is when the inadvertent misinformation started. My hon. Friend also secured an Adjournment debate in March 2000 in which further inaccurate information was passed on.
I understand that my hon. Friend wrote a letter to the hon. Member for Pontefract and Castleford (Yvette Cooper), who is in her place, in May 2000. Two years later, he says that he has still not had a reply, so in addition to the supply of inaccurate information, there is a question about Ministers giving no information at all in response to questions.
I want to place on record my belief that the current vaccine programme has integrity, that it is important that people should continue to have vaccinations and that their enormous benefits outweigh any risk from TSEs, however small that may be or have been. Does the Minister accept, however, that faith in that important and effective vaccine programme is based on full openness and clarity on the issues from Ministers and their advisers to the public at large?
In her statement, the Minister said "Nothing in any of the reports alters the assessment of experts: there are no transmissible spongiform encephalopathy-related safety issues arising from the use of relevant animal-derived materials in the production of vaccines authorised for use in the United Kingdom." However, the report talks about "no demonstrable" TSE-related safety issues. It is not clear whether the Minister was talking about the vaccine programme now—I am sure that if there was a risk, the programme is much safer than it was—or whether it was always the case that there were no safety issues. It is important that that is clarified. The Minister also talked, in her statement, about the manufacture of vaccines that are currently available on the UK market, and it is not clear whether her remarks relate to vaccines that were previously available. People will have concerns about that.
The Minister did not answer the question asked by the hon. Member for North-East Hertfordshire (Mr. Heald) about whether she had published the guidance given to her. She said that Ministers were misled by advice and information from the MCA in five areas, and some of those, such as the presence or not of excipients in the finished vaccine product, are so obvious that it would be 542 useful for the House, in judging whether her actions on the MCA are sufficient, to see that guidance in its original form. We could then judge just how deficient it was, not only in what the MCA had been told by the manufacturers but in its conclusions about the basic make-up of the finished vaccine.
Will the Minister clarify certain issues relating to PowderJect? As was set out in her statement, in the chief medical officer's report and in her response just now, the MCA was informed in August 2000 that the oral polio vaccine was not compliant. Indeed, the agency established that for itself on a visit to the Speke factory in September 2000. Why did it take until 16 October for Ministers to be informed, during which period another company paid to take over Medeva and Evans vaccines? Clearly the company, and possibly the purchasers, had market-sensitive information that Ministers and other market players did not.
What action does the Minister propose to take against manufacturers such as Evans who failed to respond quickly to the request for information made in spring 2000 and who may have given misleading information? I am sure that although there was no breach of the law the Government must have some sanction, such as the withdrawal of preferred supplier status, that they could use against those companies.
Clearly we need a debate on this subject. Will the Minister ask her business managers whether we can have a proper exchange, in Government time, so that we can have a full and frank discussion of the extent to which Members of the House have been inadvertently misled by Ministers? We could use the opportunity further to reinforce the confidence that the public should have in the current vaccine programme.
§ Ms BlearsI am happy to acknowledge the contribution of the hon. Member for Lewes (Norman Baker) in pursuing these matters in parliamentary questions and in an Adjournment debate in March 2000. Following that debate, Ministers asked the Committee on Safety of Medicines to start the first of its three reviews on the matter, so the hon. Gentleman certainly played an important role.
I am grateful also to the hon. Member for Oxford, West and Abingdon (Dr. Harris) for confirming his support for the current vaccine programme and the important role that vaccinations play in public health. He is right that openness and clarity on the issue is crucial to public confidence, and that is why I am here today: to set the record straight and to reassure the public about the safety of the manufacturing of vaccines.
The hon. Gentleman asked about the conclusions of the Committee on Safety of Medicines reviews. I can confirm that there were three reviews, one of which was looking at the current vaccines that are available. There was a risk assessment of the components, and the reports looked at the matrix of where materials came from and what kind of materials were used at what stage of the production process. There was a good examination of all the current products that are used.
At the request of Ministers, the committee went on to look at the possibility raised in the Phillips report on BSE as to whether BSE might have emerged earlier than is the accepted case, in the 1970s. The committee was looking at the worst possible scenario. It said that there was no 543 reason to depart from the conclusions of the first review: that there was no demonstrable TSE risks in the use of animal derived material in the manufacture of vaccines.
Clearly, the further we go back, the less documentary evidence is available. In looking at the master seeds that were manufactured in the 1960s, it is difficult to find a paper audit trail to take source material and traceability back to that level. However, the committee asked what the situation would be had BSE been around in the 1970s and what the effect would have been on TSEs in vaccines. That matter is in the full CSM report, which is in the Library.
In terms of the advice given by the MCA to Ministers, I can do no better than say that the advice given by the MCA was contained in the incorrect answers to the parliamentary questions. That was the advice given to Ministers and clearly the parliamentary answers were prepared on the basis of that advice. That is in the public domain.
In terms of the oral polio vaccine withdrawn in October 2000, the two month gap between the MCA being notified and Department of Health of Ministers being informed was criticised in the chief medical officer's report, which, again, is in the Library. This was too long a period for action to be taken and I have set out, in my reply to the hon. Member for North-East Hertfordshire (Mr. Heald), the steps taken with regard to strengthening the advice and the systems at the MCA and the merger with the MDA.
In terms of action against individual manufacturers, I have explained that, where they are going through the process of seeking compliance with European guidelines, the advice is that prosecution would be disproportionate. Clearly, if there is a deliberate and wilful failure to present information, the MCA has a mechanism open to it through the suspension of licences.
The European committee is considering 400 different substances. It is half way through the process, and it will be some months yet before full documentary evidence is available to qualify for what is called the EQDM process. That process is ongoing and we are keen to make sure that we get as many products to comply with the guideline as quickly as we can. I am pleased that the guideline is to be varied to allow the working seeds and working cells to comply. That is a recognition that the science has developed a little faster than the legislation in this area. It is a constantly evolving process.
I am more than happy to discuss with Members the question of a debate. There is a need to make a request to the business managers in the usual way. I am keen that we are open and that we have the fullest disclosure to the public and Members of Parliament about the safety of UK-marketed vaccines. That must be in the public domain and discussed.
§ Ross Cranston (Dudley, North)I thank my hon. Friend for the frankness of her statement. I remind her that the vaccines victims support group, with which I have had a close relationship since coming to the House, supports the vaccination programme and has nothing but praise for the Government in terms of the way in which they have made up to £100,000 available for parents of children damaged by vaccine. In this area, confidence is crucial. Can she say more about the changes in procedure 544 and personnel in the MCA? Can she assure us that the changes will prevent this sort of faulty information from being given to the House in future? Finally, can she prepare summaries of these weighty documents in the Library so that hon. Members can fully understand them?
§ Ms BlearsI am grateful to my hon. and learned Friend for his support for the Government's action in relation to vaccine damage payments. We are all too well aware of the tragic nature of the cases involving those families. As he says, confidence in the vaccination programme is crucial. Vaccinations have saved millions of lives throughout the world and continue to do so.
I have outlined some changes in the procedure, organisation and governance of the MCA and the way in which it will perform in future. A decision has been taken to merge the MCA with the MDA. There will be a stronger unit and organisation and that will take account of the increasingly blurred lines between medicines and devices. As technology develops, products are becoming increasingly difficult to distinguish. In addition, we will have the non-executive directors and there will be a rigorous external perspective on the work of the MCA. There will be also be a chairman who will be able to represent the MCA, so that we have a more public presentation of the agency. It is important that there should be transparency so that the public can be confident in the procedures.
I have explained that we want to strengthen the database and the information management of the MCA; again, that issue was raised by the chief medical officer in his report. I can reassure my hon. and learned Friend that that will be done.
§ Mr. David Tredinnick (Bosworth)The hon. Lady deserves congratulations on doing something very rare for this Government—coming to the House to apologise for a mistake. What will she do to reassure the public that these products are safe? One of the greatest health failures of the Government has been their inability to persuade the public that the MMR vaccine is safe. What is she going to do to improve that desperate situation? Can she confirm that despite the Oxford survey showing that anti-oxidants are not necessarily effective in treating heart disease, generally speaking vitamin supplements can be very helpful to the health of the nation?
§ Ms BlearsThe hon. Gentleman is absolutely right that the key issue is to reassure hon. Members and the public about safety and about the rigorous way in which the issues are examined. That is why the three reports in the Library—from the chief medical officer, the Committee on Safety of Medicines and the MCA—are important. These reports must be fully available.
I say to my hon. and learned Friend the Member for Dudley, North (Ross Cranston) that the summaries at the beginning of the reports set out the main recommendations, and making those accessible is very important. At all stages of the vaccination programme, Ministers have tried to be as open and honest as possible and have tried to share the advice of the medical experts. The amount of consideration that a range of scientific experts have applied to the vaccination programme has been immense. I am sure that the hon. Member for Bosworth (Mr. Tredinnick) will be aware of the wide range of authorities involved. As I have said, the CSM, 545 in its ad hoc working group, involved epidemiologists, virologists, immunologists, paediatricians and a range of scientific experts. It is very important that the public know that the Government take the matter extremely seriously and will look at every piece of evidence as it emerges.
The hon. Gentleman referred to vitamin supplements. I have not had an opportunity to look at the issue, which is clearly of concern to him. I can assure him that all the matters that arise are considered by the Government and by experts in the field.
§ Mr. Keith Simpson (Mid-Norfolk)I am sure that the Minister and hon. Members will be grateful that the ministerial reaction to this matter came about largely as a consequence of hon. Members raising it in the form of questions and in the course of a debate. That should prove to people outside the House that Parliament often has an effective role.
I want to put two questions to the Minister. First, as a member of the Select Committee on the Environment, Food and Rural Affairs, it is clear to me that there is a read-across between health and agriculture in terms of science, disease and farming. Is the Minister satisfied that there are no other areas where the Department of Health is having to reassess statements or answers to the House concerning major health questions?
Secondly, the Minister stated that there is not a danger from TSE in vaccines. Is she also saying that there is no TSE health danger to the public if they eat lamb?
§ Ms BlearsI certainly agree with the hon. Gentleman that Parliament works and that it is a testament to the former Health Minister, my hon. Friend the Member for Pontefract and Castleford (Yvette Cooper), that following the Adjournment debate with the hon. Member for Lewes (Norman Baker), she asked the Committee on the Safety of Medicines to investigate the whole area and to review all the advice that had been given to Ministers since 1997, to try to ensure that what had been passed on to Parliament was correct. That is why I am here today—to ensure that the whole parliamentary record, which is so important, is put right.
On reassessing evidence, I can tell the hon. Gentleman that the Department does that all the time as regards such complex scientific issues. If questions were raised, in the House or elsewhere, that threw doubt on statements that had been made, of course it would be right and proper to reassess the situation. I am not aware of any current such issues. I am sure that the hon. Gentleman will be aware from his experience on the Select Committee of the constantly moving nature of the science in these areas. As we discover more, matters need constantly to be assessed and reassessed.
On the hon. Gentleman's second, more detailed, question about lamb, such matters should be considered by the Food Standards Agency, not by me.
§ Mr. Patrick McLoughlin (West Derbyshire)The Minister says that she came to the House as soon as it was practical and possible for her to do so, and we are grateful to her for that. It is vital that there be consent and agreement about the importance of vaccination and the role that it plays in the prevention of very serious diseases. Is she worried about the fact that it took the MCA two months to notify Ministers at the Department of Health? 546 Has she any idea of how many vaccines were issued during the two-month period in which alarms were first raised at the MCA?
Since knowing that she was going to make the statement, has the Minister had time to reflect on the calls made this week by the British Medical Association to take the percentage of vaccines administered out of doctors' contracts? People might have more confidence in the information that doctors give them on the urgency of taking vaccines if that was not part of doctors' contracts.
§ Ms BlearsYes, the Department is worried about the two-month gap. Indeed, in his review, the chief medical officer expressed his concern about the fact that it took the MCA two months to tell Ministers about the situation. I have outlined in my answers to other hon. Members the serious steps that we have taken as a result not only of that, but of the incorrect information that the MCA gave to Ministers over a period of time about the scope, extent and effect of the guidelines.
I do not know precisely how many vaccines have been issued. If that information is available, I undertake to provide it to the hon. Gentleman.
On the target payments for immunisation that are paid to general practitioners, there are two levels of payments—a higher level of 90 per cent. and a lower one of 70 per cent. That provides enough flexibility for GPs to be able to reach a certain level of immunisation. Any imputation that GPs would do things that they did not support to reach their target payments would be highly inappropriate. There are therefore no plans to change the situation.
§ Mr. Richard Bacon (South Norfolk)The Minister announced that the Government were wrong in five major areas. I must say that that does not surprise me. My year in this place has taught me that the Government's capacity to get things wrong is more or less limitless. However, it is good that Ministers have come to the Dispatch Box to explain where they went wrong.
The Minister referred to the question of confidence. My hon. Friend the Member for Bosworth (Mr. Tredinnick) asked about MMR as well as vitamin supplements, but when she replied her lips did not utter the word "MMR" at all. I remember that when the former Minister, the hon. Member for Pontefract and Castleford (Yvette Cooper), answered a question on MMR some time ago, she castigated one of my hon. Friends for even suggesting that there could be something wrong, on the ground that that was "irresponsible". Does the Minister understand why there is public fear about MMR? One accepts that Ministers can make statements to the House only on the basis of the scientific advice that they are given, but the controls on that advice are not always adequate. Does the Minister accept that there is a case for carrying out further research on MMR, and can she tell the House what is being done in the way of Government-sponsored research to establish whether a small sub-group may be susceptible to the MMR vaccine in a way that most are not?
§ Ms BlearsI must make it clear to the hon. Gentleman that where incorrect or misleading answers were given, they were entirely based on advice from the MCA; Ministers are right to seek advice from people in the field. I have come here today to correct those factual 547 inaccuracies. The answers did not change the scientific position; they were simply wrong in terms of dates and scopes of guidelines. Ministers rely on the advice that they receive from their scientific experts, and that is why I am here to correct the record.
The MMR vaccines are in exactly the same position as many of the other vaccines that are waiting to become compliant. Essentially, they are working seeds and working cells that contain UK bovine-sourced material. When the guidelines are revised in the next few weeks, working seeds and working cells will be deemed to be compliant if they have had a risk assessment. They have all had a risk assessment by the CSM and the MCA, and there are no demonstrable TSE safety risks in relation to them. They are in exactly the same position as many of the other vaccines that are waiting to become compliant with European guidelines. The position as regards their manufacture is thus exactly the same—that is, no TSE safety risks are involved.
On the other statements that Ministers have made on MMR, the hon. Gentleman must be aware, although he has been in the House for a relatively short time, that Ministers have always made statements on the basis of a range of scientific expert advice. In that, they are supported by the World Health Organisation, the Royal College of Nursing and the Royal College of Paediatrics and Child Health. All those expert bodies have supplied information to Ministers, whose statements have always been made on the basis of the best scientific information that is available to them. That is entirely the appropriate way for Ministers to approach such matters.
Mr.Deputy Speaker (Sir Alan Haselhurst)Order. I must say to the hon. Gentleman that when he is questioning a statement, he gets one bite at the cherry, and he did take a rather large bite.
§ Ms BlearsA great deal of research is going on in this area. It is important that we get as much knowledge and information as we possibly can. I return to the first principle that I mentioned—public confidence in the vaccination programme is key, because vaccinations have saved many, many lives.