HL Deb 11 June 1992 vol 537 cc1366-79

3.36 p.m.

The Lord Chancellor

My Lords, I rise to move that this Bill be now read a second time.

The 1990 Act was the first attempt to deal in legislation with the issues which the continuing developments in reproductive technology make possible. It is an innovative and comprehensive piece of legislation which has brought hope and reassurance to many people. We remain one of the few countries to have tackled this issue by the introduction of statutory controls. Your Lordships played an important role in determining the final form of the Human Fertilisation and Embryology Act and this House justifiably shares responsibility for its achievements.

The Bill now before your Lordships is very narrowly defined and is not about embryo research or abortion. It merely seeks to put right certain unforeseen consequences of some excessive caution in drafting one section of the 1990 Act which in other respects, so far as I understand, is working well. The Government would not be seeking this measure if a satisfactory alternative to legislation were available. For my own part, I can assure noble Lords that I am entirely satisfied that the Bill is necessary.

Your Lordships may find it helpful if I explain the background to the Bill. The Human Fertilisation and Embryology Act 1990 introduces a criminal sanction for breaches of the confidentiality provisions in Section 33 of the Act. The criminal sanction in relation to Section 33(5) of the 1990 Act applies only to the clinician who initially discloses the confidential information. Breach of this provision is a criminal offence punishable by up to two years' imprisonment or a fine or both. This sanction is in addition to the existing common law which protects confidential information. A person who made an unauthorised disclosure of information which they receive from a clinician would, as now with the 1990 Act, be subject to the constraints of the existing law on confidentiality. The Bill does not alter that position.

Information obtained during treatment for infertility can be extremely personal and private and when the 1990 Act was drafted it was considered right that a stronger duty of confidentiality than existed under the common law should be imposed in relation to it. However, since the 1990 Act came into force practical experience has shown that the provisions on the disclosure of information were in some respects too tightly drawn and they have led to unintended risks and difficulties.

As it stands, the 1990 Act prohibits licensed clinicians, with some specified exceptions, from disclosing identifying information about a patient's treatment to anyone except the patient herself, to members and employees of the Human Fertilisation and Embryology Authority or to other people covered by a licence for the purpose of licensed activities. The practical effect has been found to be that the doctor, himself or herself, cannot pass information to, say, the patient's GP, even with the patient's consent. The intention was that the patient should have maximum control over the information about her treatment. However, it has become clear that in certain circumstances the restrictions imposed by the Act went too far in this respect. As a result, if clinicians were to do all they might wish to do to protect the health of their patients, they would, under the Act, have to break the criminal law. They should not be put in this position.

Your Lordships may find it helpful if I illustrate the effect of the Act as it stands by reference to two examples. First, transmission of information can take place only if the patient personally arranges delivery. The uncertainties associated with this arrangement could endanger a woman's life in certain emergencies. For instance, in rare cases the ovaries of a woman who has received super-ovulatory drugs may be hyperstimulated, sometimes resulting in a dangerous condition which may go unrecognised, with serious consequences, because her GP or another clinician, as an "unlicensed" practitioner, has not been given details about her infertility treatment. In these circumstances, the woman's health could be endangered because the wrong treatment is given as a result of ignorance about another treatment to which the woman had been subjected.

Another example of the unintentionally over-restrictive nature of the Act is that it prevents the disclosure of information for legal purposes. This means that a licensed person may not be able to defend him or herself if sued by a patient. A doctor or other employee of a centre who is sued by a patient who has undergone licensed treatment is unable to give his or her legal adviser information about the treatment given for an identifiable individual. In the early stages of such action it is possible for anonymous information about treatment to be given but once a writ is issued the name of the patient becomes known to the doctor's solicitor and it has become apparent that no further information can then be given as the supply of any new information would constitute an offence. The doctor would therefore be left in an untenable position in comparison with the patient by whom he or she is sued, who is subject to no restraints under the Act.

This House and another place both decided that the person to whom the confidential information relates should retain as much control over the dissemination of that information as possible; I am sure this is right. But it was clearly not the intention that the consequences that I have described should result. The practice of the new statutory structure has thrown up those particular problems.

I now turn to the detail of the Bill. The Bill seeks to make certain specified relaxations on the restrictions on the disclosure of information by licensed clinicians imposed by Section 33(5) of the Human Fertilisation and Embryology Act 1990. Section 33(6) of the Act contains exceptions to the general restriction on disclosure and adds further exceptions, removing the criminal sanction from disclosure in specified circumstances and for particular purposes.

Subsection (2) of Clause 1 inserts three new paragraphs, (f), (g) and (h), into Section 33(6) of the Act. Paragraph (f) relates to the necessary, and I stress the word "necessary", disclosure of information before or in connection with proceedings, including legal proceedings and procedures for dealing with complaints. This will deal with the situation that I outlined earlier of the clinician being unable to pass identifying information to his or her solicitor. It will also permit necessary access to necessary identifying information in connection with complaints procedures, something which is also prevented at present; for example, disciplinary procedures of the General Medical Council or the like.

Paragraph (g), the second added exception, applies to the situation where a surrogate mother is involved. It enables a licensed clinician to confirm, for the purposes only of an application for a parental order under Section 30 of the Act, that the gametes of a particular person were used in treatment services which involved the child being carried by a woman other than the wife of the couple seeking the parental order. It does not relate to any other aspect of surrogacy. Without this provision the couple seeking the parental order—that is the couple who commissioned the surrogate mother—might have to prove their genetic relationship to the child through DNA testing, which is time consuming and a quite unnecessary imposition. This provision will permit the simplification of these proceedings; something which is to be welcomed bearing in mind that one at least of the couple seeking the parental order will he genetically related to the child.

Paragraph (h), the third added exception, deals with inconsistencies between the 1990 Act and the Access to Health Records Act 1990. The Access to Health Records Act gives rights of access to records in a number of cases and in particular by specified persons to the records of patients who have become incapable or who have died. The inconsistency arises because the Human Fertilisation and Embryology Act does not allow access in these circumstances, where infertility treatment has been given. Without access it would be difficult for the personal representatives, or a person appointed by a court to manage the affairs of a patient, to pursue claims where the death or incapacity was alleged to result from infertility treatment.

Subsection (3) of the Bill inserts seven subsections, (6A) to (6G), after Section 33(6) of the Act. Taking these subsections in order, (6A) prevents the disclosure of the identity of a third party whose gametes were used for the purposes of treatment services when divulging information in connection with proceedings provided for by new paragraph (f). Subsections (6B), (6C) and (6D) allow for information to be given with the consent of the individual or individuals receiving treatment. The consent aspect is an essential feature of this Bill. These subsections will enable a licensed clinician, with the patient's consent, to pass information about treatment to the GP or to others who are associated with the treatment, or to anyone specifically authorised by the patient. These subsections will also allow, again subject to consent, access to certain information for the purposes of clinical and financial audit. Exceptionally, subsection (6E) permits disclosure of information about an individual's treatment without the patient's consent in the event of a medical emergency involving that person where it is not reasonably practicable to obtain the patient's consent.

Subsection (6G) contains a regulation-making power which is subject to affirmative procedure to provide for further exceptions to Section 33(5) of the Act. With the best will in the world, I am not able to give this House a guarantee that all problems with this section of the Act have been identified for all time. In particular, new situations may arise. Having regard to our experiences in the drafting of the 1990 Act it was, therefore, considered prudent to include in the Bill a regulation-making power which enables provision to be made for future exceptions, should they be necessary in the light of further working, without the need for another Bill. I am well aware that such powers are not always welcomed by the House, but I can assure noble Lords that the regulation-making power in this Bill is very narrow. It is subject to the affirmative procedure. Should it therefore in the future be necessary to invoke this power, this House will have the opportunity to debate any regulations made and to approve or reject them.

Clause 2 of the Bill provides for the Short Title and for the extension of the Bill to Northern Ireland and to the Channel Islands. The Bill has no implications on public funds.

I should like to emphasise that the circumstances in which disclosure would be permitted are closely defined in the Bill and, except in specified circumstances, the patient's consent will be required before any identifying information can be disclosed. I should also like to acknowledge the assistance which the Government have received from the Human Fertilisation and Embryology Authority, which is a valuable and authoritative source of advice on these matters. I wish to thank the authority in particular for the advice that it has given to me in connection with the preparation of the Bill. This Bill benefits both the recipients of infertility treatment and the clinicians, whose devoted commitment to helping those who need treatment to achieve parenthood is fully acknowledged and whose position should be properly protected.

I commend this Bill to the House for your Lordship's consideration. I beg to move.

Moved, That the Bill be now read a second time.—(The Lord Chancellor.)

3.50 p.m.

Lord Carter

My Lords, the House will be extremely grateful to the noble and learned Lord the Lord Chancellor for explaining so clearly this non-contentious but rather technical Bill. I can say at the outset that from these Benches we support the Bill and similar support is forthcoming from the relevant organisations; namely, the BMA, the GMC, Progress—the Campaign for Research into Human Reproduction—and individual licensed clinicians.

The noble and learned Lord explained the provisions of the Bill in detail so there is no need for me to go through them. Also, most unusually, the noble and learned Lord helpfully circulated the Notes on Clauses before the Second Reading of the Bill. That is most helpful. In the past when I have asked for Notes on Clauses before the Second Readings of other Bills I have been told that that is not possible because the Bill may not receive a Second Reading. The fact that the Notes on Clauses have been circulated on this Bill means that the noble and learned Lord has considerable confidence in the outcome of today's debate. We must all hope that that is not misplaced. The circulation of Notes on Clauses before Second Reading is extremely sensible and helpful. I hope that this Bill is setting a precedent in that regard.

The points which I wish to mention now we may wish to explore in Committee. They are matters of detail and thus are better dealt with at length in Committee, but they are important and it may be helpful if I mention them in outline now.

We can all agree with the objectives of the Bill but in drafting to fulfil those objectives some ambiguities and a certain lack of clarity may have occurred. The first of those is in Clause 1(2) (f) which provides for disclosure without the consent of the patient where proceedings are involved. The definition of "proceedings" has caused some anxiety. Clause 1(4) states: references to proceedings include any formal procedure for dealing with a complaint". However, there are many other forms of proceedings; for example, divorce proceedings may well be involved in the matters which we are discussing.

It is hard to draft a Bill to cover all eventualities and then find that there are omissions, but in Committee we may have to try to tighten the wording so that it is quite clear to which proceedings the Bill is referring. For example, the BMA has assumed that only the proceedings of the GMC and UKCC—disciplinary procedures—are intended to be covered but I imagine that the Bill is meant to cover a much wider area. When the noble and learned Lord replies to the debate, perhaps he will deal with that point.

Clause 1(3) (6C) uses the phrase: a person who needs to know". That is always a rather difficult concept to define and could lead to an extremely wide interpretation. I give a simple example. Subsection (6C) (c) refers to the auditing of accounts. I can understand that it may be hard to specify a named accountant as regards auditing, but that could mean that the humblest member of an audit team would have access to extremely sensitive information. Perhaps the noble and learned Lord will deal with that point. I am concerned about the width of the interpretation as regards the people who need to know.

Perhaps I may give another example. Family health service authorities send inspectors to general practitioners to examine patients' records to check on payment procedures, levels of prescribing and so on. Those inspectors are usually doctors, but one presumes that that would come under the heading "Audit of clinical practice". Again, I am concerned about the width of interpretation as regards who needs to know. Obviously there needs to be some clarification of this part of the Bill, and we can deal with that in Committee.

The reference to "a specific person" in subsection (6C) has been queried by the GMC since in any disciplinary proceedings a number of people are involved. I understand that the use of Clause 1(2) (f) is meant to cover that situation, but, going back to that clause, it is clear that a great deal will rest on the word "necessarily" in line 14 on page 1 of the Bill. That was a point made by the noble and learned Lord when he opened the debate. It is not entirely clear who will decide what is and is not "necessary". When the noble and learned Lord replies, perhaps he will explain that.

My final point is in regard to the obligation to confidentiality which must be observed by anyone to whom disclosure has been made for treatment purposes. For example, the organisation Progress, which I mentioned earlier, says that it is important to be absolutely certain that disclosure, particularly if it relates to the birth of an identifiable individual who may have been born in consequence of fertility treatment, will "go no further". I presume that the Bill is intended to deal only with what may be termed as the first level of disclosure. Beyond that the normal common law relating to breach of confidence would be the next line of defence. Perhaps the noble and learned Lord will confirm whether that is correct. I understand that it would be extremely hard for the draftsman to cover disclosure beyond that specified in the Bill.

As the noble and learned Lord said, if additional exceptions are found to be necessary, they can be dealt with by regulation under the affirmative resolution procedure, with the exception of the matters specified in subsection (6G), paragraphs (a) to (b). That would seem to be a satisfactory way to deal with matters which come to light as time goes on.

Perhaps I may revert back to Clause 1(2) (f), which is concerned with proceedings. It occurred to me that perhaps subsection (6G) could be used to deal with the problem of defining "proceedings". If the Bill were drafted to specify the proceedings which are intended to be covered by the Bill, could subsection (6G) be used to add other proceedings which are omitted now through oversight but which as time goes on it becomes apparent should have been included? I can understand that the draftsmen of the Bill have relied on the word "necessarily" in Clause 1(2) (f), and I understand also the problems of drafting to cover all eventualities and then finding that there have been omissions, but I wonder whether we could use subsection (6G), by regulation, later to rectify omissions.

To conclude, as I have said, the Bill is not contentious. It relaxes certain provisions which were obviously too tightly drawn when the 1990 Act was drafted. During a short Committee stage it should be possible to deal with the points of detail which I have raised: to correct the confidentiality procedures of the 1990 Act to make the system both consistent and workable in the interests of both patient and doctor. We welcome the Bill and will certainly assist its speedy passage on to the statute book.

3.59 p.m.

Lord Hooson

My Lords, from these Benches, we support the Bill. I did not take part at all in the discussions on the 1990 Act, but I have looked at this Bill which is concerned with protecting individual rights and in particular the right of privacy in a very vital area.

First, let me say that I have never known a Bill so carefully explained beforehand, both in the explanatory background note of the noble and learned Lord the Lord Chancellor, which I found to be extremely helpful, and in the detailed Notes on Clauses issued by the Department of Health. That is no less than six foolscap pages of explanatory notes for a two-clause Bill. That is quite extraordinary but extremely helpful and illustrates the care taken.

The noble and learned Lord the Lord Chancellor has been involved personally both with the parent Act and with this Bill. Both the noble and learned Lord and the department are to be congratulated on and thanked for the obvious care and concern which has been and is being exercised in that most sensitive area where such private and personal problems can be involved.

The need for the Bill in order to relax some of the strict provisions of the 1990 Act on the disclosure of information obtained by an authorised person in the course of infertility treatment has been brought about apparently by the experience of those who practice in this field and a growing appreciation of the practical effects of too rigid a restriction on the passing of information between doctors in emergency situations and in certain legal contexts.

When I first looked at the Bill I wondered why we had not spotted the possibilities beforehand, but as I reflected on the situation I realised that it is virtually impossible to foresee the problems which could arise and which might yet arise in the future. It seems to me that the Bill has been carefully conceived and drafted to meet a restricted number of anticipated situations. But in the light of further experience, whether or not the Bill is amended, it would not surprise me that future review and amendment may prove necessary, possibly to tighten up as well as to relax the permission for disclosure.

I do not share the anxieties expressed by the noble Lord, Lord Carter, save in one specific instance. It seems to me that Clause 1(3) (6C) of the Bill may prove to be the most vulnerable part. The three circumstances set out allowing for disclosure to other than specific persons are situations for which provision must be made. However, it is disclosure to non-specific persons that is the worrying part. The protection that would be afforded to the individual affected by non-disclosure would be the normal common law provision and nothing else. It is when information can be disseminated beyond specific persons that the danger of inadvertent or deliberate future disclosure arises.

The situations expressed in subsections (6B) and (6C) are those which exercise my mind. For the life of me I cannot see a practical and sensible way of tightening the scope of disclosure in that regard. I considered whether one could table an amendment which would improve the position, but at the moment I can see no way of doing that. My present view therefore is that it is probably better for the Bill to go through as it is, with careful monitoring thereafter to see whether problems arise. Should they do so, the indications are clearly that the Executive will take urgent remedial action.

I should like to raise another point. The provision for regulation-making powers permits the making of further exceptions to Section 33(5) of the original Act. However, it does not seem to me to permit a tightening of the exceptions which we are considering in the Bill. It may be that experience will show that, whereas the previous provision was too tight, even with the greatest care we may have relaxed it a little too much. Only experience and time can show us whether that is so.

Perhaps the noble and learned Lord will give us his reflections on how the remedial action is to be obtained should experience prove that we have relaxed the provisions a little too much in the Bill. Otherwise, it is an excellent Bill and the Government are to be congratulated on bringing forward the remedial Bill so speedily.

4.3 p.m.

Lord Walton of Detchant

My Lords, I too express my warm support for the provisions of the Bill, which experience has demonstrated to be an essential measure. I am grateful to the noble and learned Lord for the clear exposition and explanation of the Bill. I should like to echo the points that he made regarding the important developments which have already resulted from the passage of the Human Fertilisation and Embryology Act 1990.

There is already clear evidence that research carried out in licensed centres under the provisions of the Act and under the careful supervision of the statutory licensing authority have had enormous benefits for human health. For example, there is evidence that through the research made possible by the Act certain women carrying genes responsible for severe inherited disease have been able to bear normal children shown not to be carrying that gene. That has already been a major development.

In making my comments this afternoon I have been greatly helped by the advice I have received from PROGRESS—the Campaign for Research into Human Reproduction—and from my former colleagues on the General Medical Council and in the British Medical Association. As the noble and learned Lord made clear, the confidentiality provisions of the existing Act make it an offence for any person to whom a licence applies to disclose to anyone not specified in the Act information about identifiable individuals obtained in connection with the provision of fertility treatment services, such an offence being punishable by a maximum of two years' imprisonment and unlimited fines. It would also result in the loss of the licence.

In an attempt to protect the confidentiality of those receiving treatment to assist conception, the existing Act has unwittingly outlawed direct communication between doctors such as can be essential in a clinical emergency. For example, a rare complication of infertility treatment involving stimulation of the woman's ovaries which is needed to precede in vitro fertilisation can be that of sudden collapse. If that were to happen in the street to a patient undergoing such treatment, the licensed centre would currently be barred from communicating the fact of ovulatory stimulation treatment to the casualty department to which the patient was taken, even if it were in the same hospital. That could have serious consequences for prompt and appropriate medical resuscitation. The patient would need to be in a fit state to give precise details of her treatment and in those circumstances that could not be guaranteed.

The Bill provides that disclosure can be made with the informed consent of the individual. In addition, disclosure can be made without consent where it is necessary in order to avert imminent danger for the health of the individual or where it is not reasonably practicable or possible to obtain the consent of that individual. As the noble and learned Lord also pointed out, also giving anxiety was a quite unintended consequence of the Act which effectively deprived licensed medical practitioners of the ability to defend themselves in legal proceedings. A clinician who provided such treatment service, if sued for negligence, would be unable to obtain legal advice or representation or to submit a defence in a court of law without risk of prosecution. Similarly, clinicians would be unable to defend themselves against allegations of, for example, sexual assault arising in the same circumstances.

The Bill provides for disclosure when it is necessary for the purposes of legal proceedings. However, as the noble Lord, Lord Carter, pointed out, my former colleagues on the General Medical Council have some anxiety regarding the definition of "proceedings" as included in Clause 1(2) (f) of the Bill. For instance, one comment is that reference to "proceedings" includes any formal procedure for dealing with a complaint. The GMC wonders whether that would cover grievances or other minor but nevertheless formal complaints procedures or whether it would be taken to include legal proceedings which are not connected with medical treatment —for example, divorce proceedings.

The General Medical Council would prefer to see a somewhat tighter definition, perhaps referring specifically to legal procedures in relation to a civil action for alleged negligence or the proceedings of a statutory body for dealing with a complaint arising from medical care or treatment. Such a body would be the General Medical Council or the United Kingdom Central Council for Nursing, Midwifery and Health Visiting.

The General Medical Council expressed some concern also in regard to the use of the phrase "need to know" in Clause 1(3) (6B). Is that too broad? Would it become an accepted justification for disclosure of information in inappropriate circumstances? It is difficult to define and is often used without explanation of who determines whether information should be disclosed. I know that the current president of the General Medical Council expressed the view to me in correspondence that he may be troubled if the phrase were enshrined in legislation giving it a legitimacy which he did not believe it deserved.

There was one final anxiety regarding a more minor matter needing verification. As the noble Lord, Lord Carter, said, Clause 1(3), subsections (6B) and (6C) contain provisions that, where consent to disclosure is given by a patient, the disclosure must be made to a specific person. As he said, that would give considerable difficulties if it were to apply to the council's disciplinary procedures where inevitably a number of members of staff who treat the information in strict confidence, the members of the Preliminary Proceedings Committee, and of the Professional Conduct Committee, must have access to details of the patient's care in order to fulfil their statutory obligations. It has been suggested by the Department of Health that this clause would not be relevant for disciplinary proceedings as disclosures could be made under Clause 1(2) (f) even where the patient had given consent to disclosure. Nevertheless, that may be a grey area which needs clarification.

These are relatively minor points in what I believe to be an extremely important and very necessary Bill. While one appreciates that this House in general is not enamoured of retroactive legislation, in this instance I am sure that an exception is justified in order to fulfil the original intentions of the Act. Therefore, I welcome the provisions made in the Bill indicating that further regulations might be subject to the affirmative resolution procedure in the event that additional exceptions might come to light through the workings of the present Act and of the statutory licensing authority. With these minor comments, I give very warm support to this Bill.

4.11 p.m.

Lord Glenarthur

My Lords, I too should very much like to welcome this Bill. I am most grateful to my noble and learned friend the Lord Chancellor for the explanations he has given. The Bill certainly seems to correct some unintended and, in practice, rather debilitating aspects of the main Act although the cautiously worded nature of the disclosure measures in the original Act are perfectly understandable.

I am a member of an ethics committee for one fertility centre that specialises in this field and which sits under the Act. It is licensed with the Human Fertilisation and Embryology Authority. Many of the cases which come before us as ethics committee members are extremely complex, difficult, and take a great deal of time to deal with. They are also particularly complex for the doctors who have to deal with them in a technical sense.

It is clearly odd that the effect of the Act as it stands is to forbid, with criminal sanctions for disclosure, those trying to help with a patient's fertility from even discussing the case with the patient's GP, as my noble and learned friend has said. Those individuals should know more than just a little about the patient concerned. The noble Lord, Lord Walton, has given one instance in the case of an emergency as to how that might apply. There are others; for example, there is the relevance of somebody of positive HIV status who currently has sperm stored in a centre and whose HIV status was not known at the time of the storage. No consultations can take place about that.

Another example is of a patient who might have leukaemia and is about to have whole body irradiation followed by future marrow transplants. There is the inability of the doctor dealing with fertility measures to speak to the haematologist who is concerned about other aspects of the case so that the management of that patient can be properly studied.

One other aspect which I do not believe has been touched on concerns the inability at present of all those involved—that is to say, the doctors dealing with the treatment and perhaps the GP as well—to discover the outcome of the treatment so that the interpretation of the results can be properly assessed by everyone. Those seem to be weaknesses.

Among other matters, this Bill puts a great deal of that to rights. That will be a bonus for patients and certainly for the medical staff because, as I have said, such cases are far from easy. I believe it will also be of help to those who sit on ethics committees who take their responsibilities with a considerable degree of seriousness not just as regards research matters and those aspects which were inserted into the Bill in this House about the interests of the child, but more generally when it comes to the overall ethical dimensions of the work which the doctors so carefully undertake.

I shall be most grateful if my noble and learned friend can help me with one aspect; namely, the method by which the patient can actually give consent. I hope he can say whether, as a result of this Act, the doctors concerned can now write directly to referring GPs and hospital specialists; whether they need to obtain consent from individuals and couples regarding consultations as well as investigations and treatment; and whether or not it is sufficient to have the consent verbally or whether it should be given in writing. It occurs to some of those concerned that if the consent should be written then the clinicians will need to be assured that a patient signs a document at the time of the initial consultation which covers all future eventualities. I hope that my noble and learned friend will be able to answer those points.

As regards the new Clause 1 (6G) which permits regulations for the future and which the noble Lord, Lord Hooson, touched on, I very much welcome that. In the year or more that I have been involved on the periphery of these matters, techniques seem to have changed dramatically. I can well see that over time it will perhaps be necessary, in order to make the Act as effective as it was originally intended, for just that kind of measure to be introduced without the full panoply of primary legislation. I very much welcome this Bill.

4.17 p.m.

The Lord Chancellor

My Lords, I am extremely grateful to all noble Lords who have spoken for the welcome that they have given to this Bill and also for the kind references to the way in which it has been presented to your Lordships. I shall say something about that because it might be dangerous to regard that as a precedent.

As I sought to explain, this is a highly technical Bill in an area where there is great scope for conflict on matters of general policy which were determined under the 1990 Act. I wished to make it as plain to your Lordships as I possibly could, in as good time as I could, just exactly what the scope of this Bill was so that no one might think that we were trespassing into areas which had been decided on with a good deal of difficulty both by your Lordships and another place. I also felt that the Bill was so technical that without a good deal of such help your Lordships might have some difficulty in appreciating just exactly what was its effect.

In a way I feel a degree of disappointment that I particularly was unable to foresee the difficulty when we were considering the 1990 Bill. But these things happen. In a way it was a desire on the part of the Government and I believe of all of your Lordships as well, that very strict confidentiality should be applied in this area because of the very personal nature of the treatment. At that time those who were involved and consulted and who had more practical experience of these matters did not see how that might impinge.

In answer to one of the points made by the noble Lord, Lord Hooson, I believe that we have tended to draw too tightly. So I expect any change to be in the form of proved necessity for relaxation rather than in tightening up. We have tried to proceed carefully, which is the reason that the power that we have taken is a power to add relaxations rather than to withdraw relaxations. There is also the problem that if one tries to withdraw a relaxation, the information that has been passed out under it will already be in the public domain. It is difficult to make such things retrospective. Those are the considerations.

Some of the matters of detail that have been raised can no doubt be dealt with in Committee, but as it seems that we have a little time, perhaps I can deal with some of them now. I shall deal, first, with the points that have been raised about consent and the form of consent. Consent does not have to be in writing, but it generally has to be for a specific person. Perhaps your Lordships would be kind enough to take a look at Clause 1. New subsection (6B) states: In the case of information relating to the provision of treatment services for any identifiable individual— (a) where one individual is identifiable, subjection (5) above does not apply to disclosure with the consent of that individual". There is therefore a general relaxation with consent in respect of subsection (5). Where two people are concerned, the consent of both is needed.

Subsection (6C) is the important provision in this connection. It states that for the purposes of subsection (6B), consent must be to a specific person. Therefore, if it is to be operative, the consent must be in favour of a specified person. That is the general rule.

If one wants the patient's consent to allow information to be given out, the consent must be for disclosure to a specified person.

Paragraphs (a), (b) and (c) of subsection (6C)—this is on page 2, line 25—relate to circumstances in which a team is likely to be involved. Therefore, as an exception to the requirement that consent must be to a specific person, we have provided that it can be given to a team. The team is defined in the phrase "needs to know".

It is first a question of consent. In effect, the patient must consent to disclosure and may refuse that consent—perhaps because the consent that is asked for is too unspecific. As I have said, a patient can refuse consent but, if consent is given, it may be on the basis that the only people to whom the information may properly be disclosed are those who need to know it for the purpose in question—the "treatment" purpose of (a), the clinical audit purpose of (b) or for the purpose of the "auditing of accounts" of (c). That is a practical step to make the provisions less burdensome to patients. One would not like to have to ask a lady who is receiving this treatment to list all the people who might take part in providing medical, surgical or obstetric services to her because it might be quite a big team. This seems the best way to deal with that. Some of those who have commented on this point to your Lordships may not have given full effect to the fact that this is not an alternative to consent —it is a form of consent. We are talking not about consent to a specific person, but to a group that is made up in this way.

I turn now to the definition of "proceedings". The intention here is to deal with the matter of proceedings in such a way as to make it possible for the licensed clinician to make a disclosure although he is not obliged to disclose. For the sake of argument, I shall take it that the clinician is a gentleman but the provisions would apply equally to the many distinguished ladies who operate in this area. The provision only withdraws the criminal sanction from the defined area. It does not oblige the clinician to make a disclosure. It states that those who make disclosures in the defined circumstances will not be subject to a criminal offence. That is all.

The main definition of "proceedings" would be legal proceedings. The idea is that if the clinician considers that the disclosure is necessary either for purposes preliminary to proceedings or for purposes of or in connection with proceedings, he would be authorised to make a disclosure. The word "proceedings" is intended to include any formal procedure for dealing with a complaint against a clinician. The secondary complaints procedures of the General Medical Council and those relating to nurses are, of course, included.

However, there might be other types of formal procedure. I refer, for example, to disciplinary procedures in the National Health Service. It would not be right for a clinician who was accused of doing something wrong in relation to one of these treatments not to be able properly to defend himself. In considering whether to make the disclosure, the clinician would have to decide whether he was entitled to do so, but if the clinician were faced with criminal proceedings over the disclosure, the ultimate judgment would be for the court. Your Lordships will not forget that, but for the exceptions, a disclosure is subject to criminal offence. We want to provide reasonable cover for licensed clinicians so that they can use their judgment in this area. However, their judgment will be confined by these matters—first, that the disclosure is necessary and, secondly, that it is for the purposes of proceedings.

The noble Lord, Lord Carter, asked whether proceedings could include divorce proceedings. I have some difficulty in seeing how such information could be particularly relevant in divorce proceedings but if it were necessary for divorce proceedings, the matter could be properly covered. However, it would be for the clinician to decide whether, in his judgment, it was appropriate to make the disclosure.

The noble Lord, Lord Carter, also asked me to say something about the effects of the provisions in relation to the common law. I can do this briefly in my present circumstances. The position is that the common law protects confidential information in a general way. The Government felt—and your Lordships agreed—that that was not sufficient and that in this area we should have an additional criminal sanction. I repeat that it is an additional sanction. When we release the criminal sanction, it does not affect the scope of the general protection of confidential information which applies to those who receive the information knowing that it is confidential.

I believe that I have dealt with the detailed points that have been raised. I should add that the authority proposes to issue guidance to licensed clinicians in this area to help them decide whether to make disclosures in particular cases. That kind of practical guidance is, of course, subject to amendment in the light of experience. I am grateful to your Lordships for your support for the power to make further exceptions if practice should demonstrate them to be necessary, subject to the affirmative procedure. I hope that I have satisfied the noble Lord, Lord Hooson, that we have proceeded in such a cautious way that only further exceptions are to be contemplated rather than going back in the way that he thought might be possible. With some confidence, as the noble Lord, Lord Carter, indicated I had earlier, I renew my Motion that your Lordships should give the Bill a Second Reading.

On Question, Bill read a second time, and committed to a Committee of the Whole House.