PARLIAMENTARY DEBATES

HOUSE OF COMMONS

OFFICIAL REPORT

First Standing Committee on Statutory Instruments, &c.

DRAFT HUMAN FERTILISATION AND EMBRYOLOGY (SPECIAL EXEMPTIONS) REGULATIONS 1991

Thursday 4 July 1991

LONDON: HMSO

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The Committee consisted of the following Members:

Chairman: MR. JAMES HILL

Alton, Mr. David (Liverpool, Mossley Hill)

Banks, Mr. Robert (Harrogate)

Blackburn, Dr. John G. (Dudley, West)

Bottomley, Mrs. Virginia (Minister for Health)

Cohen, Mr. Harry (Leyton)

Davis, Mr. Terry (Birmingham, Hodge Hill)

Dykes, Mr. Hugh (Harrow, East)

Fenner, Dame Peggy (Medway)

French, Mr. Douglas (Gloucester)

Galloway, Mr. George (Glasgow, Hillhead)

Gorman, Mrs. Teresa (Billericay)

Gregory, Mr. Conal (York)

Hargreaves, Mr. Ken (Hyndburn)

Harman, Ms. Harriet (peckham)

Haselhurst, Mr. Alan (Saffron Walden)

Heal, Mrs. Sylvia (Mid-staffordshire)

Hughes, Mr. John (Coventry, North-East)

Patnick, Mr. Irvine (Sheffield, Hallam)

Wigley, Mr. Dafydd (Caernarfon)

Mr. F.A. Cranmer, Committee Clerk.

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3 First Standing Committee on Statutory Instruments, &c. Thursday 4 July 1991

[MR. JAMES HILL in the Chair]

DRAFT HUMAN FERTILISATION AND EMBRYOLOGY (SPECIAL EXEMPTIONS) REGULATIONS 1991

10.30 am

The Minister for Health (Mrs. Virginia Bottomley): I beg to move, That the Committee has considered the draft Human Fertilisation and Embryology (Special Exemptions) Regulations 1991. Before I discuss the regulations in detail, I shall report on the progress of the work undertaken by the new Human Fertilisation and Embryology Authority, under the chairmanship of Professor Colin Campbell. Hon. Members debated in detail the provisions of the Human Fertilisation and Embryology Act 1990. The Act provides a clear and powerful framework for this especially sensitive work. When the main provisions of the legislation come into force on 1st August 1991, treatment, research and storage centres will have to comply with stringent licensing conditions and will have to follow the guidelines set out in the code of practice that is to be published by the HFEA. The draft regulations will provide for two exceptions to the general rule that any person keeping or using embryos, or storing gametes—that is, sperm or eggs—may do so only in accordance with the terms of a licence obtained from the HFEA. During the passage of the Bill, it came to the Government's attention that, in some situations, embryos and gametes were legitimately kept or stored for purposes other than those related to infertility treatments and embryo research. For example, it is sometimes necessary to keep embryos and gametes for examination in connection with criminal investigations related to enforcement of the legislation. In addition, some organisations may store sperm only for research or teaching purposes. Unless exceptions are made to cover those situations, the licensing provisions of the Act, which were designed to regulate the use of gametes and embryos in treatment and in embryo research, would apply. The new authority would then be obliged to inspect and license all those places. That could result in the new authority using time and resources to inspect and license centres which were carrying out activities that had nothing to do with the intention of the Act. Furthermore, if a universal licensing requirement were imposed, valuable research or teaching in areas unassociated with the concerns that underlie the Act might be stifled, or impaired. The Bill was therefore amended, to enable the Secretary of State to make the exemptions proposed in the regulations. 4 It is important to understand that the regulations would permit exceptions only in very limited circumstances, and that they would not allow people to evade the controls laid down in the Act. But, because they provide exceptions in such a sensitive and difficult area, it was considered right that they should be made subject to the affirmative resolution procedure. I emphasis that these issues are not new and we are not considering the implementation of different or new procedures. The first exception relates to the keeping or examination of embryos and the storage of gametes in connection with offences under the Act. The Government and the HFEA are conscious of the implications of taking possession of embryos and gametes. In the case of embryos, the authority will be dealing with a potential human life, and, possibly, an infertile couple's hope of a child. It is therefore vital to ensure that embryos and gametes that are kept in connection with an offence, are kept in proper conditions and examined only by experts. Once the investigation or proceedings for an offence have been completed, the HFEA, under whose supervision the gametes and embryos are kept and examined, must ensure that, if possible, they are returned to the licensed premises from which they came. For example, if the case is not proved, the gametes or embryos in question could be returned to the treatment centre and, if appropriate, used for treatment services. I appreciate that some hon. Members have expressed concern about the fact that an embryo may age beyond the 14-day stage during investigation. It would be illegal to continue to keep it beyond that stage. Every effort will be made to keep the embryo in the condition in which it was taken and cryopreservation techniques could be used to achieve that. As hon. Members will be aware, it is not now possible for an embryo kept in vitro to develop beyond the eight-day stage. Some hon. Members have expressed concern about that; I can reassure them totally. I hope that hon. Members appreciate that that exemption is necessary to allow criminal activities to be investigated. Without it, those carrying out the investigation might be liable to prosecution for examining the evidence. The second exception relates only to gametes stored for purposes other than infertility treatments and embryo research. The concern that led to the Act was over sensitive infertility treatments and any work involving an embryo. The exemption does not apply, in any way, to embryos. Embryos can be stored only either under licence or in circumstances relating to the examination of an offence. The regulations would allow gametes—that is, sperm or eggs—to be stored for the purposes of research on gametes, for the development or testing of pharmaceutical or contraceptive products, and for teaching, without need for a licence from the HFEA. That represents no change from the present position; the interim licensing authorities do not license such activities. The exemption would apply, for example, to research into the locomotion of sperm being carried out by a university laboratory, to the development of pharmaceutical products aimed at enhancing the quality of sperm or to sperm being used by a medical school to study cell structures. 5 The regulations have been drawn up after a period of full consultation, during which interested organisations were given an opportunity to express their views. Copies of the consultation document were made available in the Vote Office. In drawing them up, we considered very carefully the comments that we received. I hope that hon. Members agree that they are reasonable and comprehensive.

10.37 am

Ms. Harriet Harman (Peckham): I welcome the Minister's comments and agree with all the points that she made. She is approaching the matter very sensibly. I support the regulations. During our discussions in the House, it was made clear that the intention behind the Act was not that the licensing authority should have to license itself for its investigations into breaches of its licences. The exemption provided in the regulations is absolutely justified. It was also never intended—indeed, there was no discussion on the subject—that there was would be any problems of gametes being mixed in any way, thereby allowing them to develop into an embryo. The scope of the discussion was human fertilisation and embryology. Research on gametes alone should not have to be licensed; that would skew the work of the authority in a way that was never intended. The work that the authority will undertake is very important. It was made clear during the debate in the House that the work that the authority supervised was also very important, for two reasons. It is aimed first at understanding and preventing inherited disability and secondly, at alleviating the misery of infertility. The Minister will be aware that around one in eight couples have fertility problems. An enormous number of people are affected and infertility causes them great stress and misery. Research into infertility goes side by side with treatment. That is the pattern of the development of the present work. Indeed, one reason for the Act was that treatment could not be improved without research—and there would be no research without treatment. The two are closely connected. What will happen to treatment services in the NHS under the new internal market? Is it expected that infertility services will be included within block-booked contracts for obstetrics and gynaecology and that referral will be from the GP to the hospital, as at present? Can we be sure that districts will not say, "Sorry, we are not contracting for infertility services because it is too expensive. If you want infertility treatment, you will have to go outside the national health service". If there is no block-booked contract for infertility services, what will be the attitude of district health authorities towards people applying for extra-contractual referrals? The work of the authority, and whether or not research is undertaken, is critically dependent on whether treatment is given: the two are inextricably linked. I endorse the Minister's remarks. Will the authority include in its reports information about the clinics' success rates? That is dependent, first, on whether those who attend are amenable to treatment—whether they are likely to benefit—and, secondly, on how effective the treatment is. We should not deter clinics from taking on difficult cases simply because it would lower their success rate. Neither should a veil of secrecy be drawn over the success rates of the different clinics because they vary too much. The National Association of the Childless says that small clinics 6 have a much lower success rate than medium-sized clinics, both having a lower rate than the larger clinics. The success rate ranges from 0 to 30 per cent. People who seek infertility treatment might want to take that into account. That information should be published sensitively; if it is published by the authority, people can consider it at the same time as taking account of the fact that some clinics might specialise in cases that have been turned away by everyone else, which would affect a clinic's success rate. I thank the Minister for introducing the regulation and for the support that the Government are giving to the authority. I leave the Minister with those two questions about the publication of information on success rates and about whether infertility treatment will be available under the national health service, or whether people will have to pay privately or go without.

10.43 am

Mrs. Virginia Bottomley: I thank the hon. Lady for her approach. That approach allowed us to make good progress in the Committee that scrutinized the different elements of that important legislation. I am grateful for her indorsement of the regulations, which are in the same spirit as the objectives that were expressed then, and for her reminder to the Committee of the important purposes of that work. The hon. Lady asked about the availability of infertility services in the national health service, and about the reforms under way. The new arrangements make no difference to the availability of infertility services. There has, of course, been a considerable increase in the number of gynaecologists. IVF is by no means the only form of infertility treatment available. However, it is clearly far more widely available in the private sector than in the health service. The purpose of the Human Fertilisation and Embryology Act 1990 is to regulate carefully the new and sensitive techniques. I hope, as does the hon. Lady, that we shall see a general expansion and development, especially as the effectiveness of the techniques develops. A number of NHS centres and research centres take a wider group of patients, and it is for health authorities to set their priorities and contracts appropriately. Indeed, those involved with the development of infertility services, especially with access to IVF services, should present their case and ensure that it can be considered properly by health authorities. As we see developments under the Act, I shall follow that matter carefully. The hon. Lady made a good point about information on success rates of different treatments and centres. In the Committee debates on what became the 1990 Act, many hon. Members were anxious that patients who had been through many months, even years, of treatment without success should be entitled to have as much information as was available. That is a matter for the authority. The hon. Lady will have seen the authority's draft code of practice, which we hope will be presented to the Secretary of State this month and laid before the House. I shall draw to the attention of Professor Colin Campbell, the authority's chairman, the points made by the hon. Lady, which are echoed by many who are involved with the childless. One of the aspects that we dealt with when considering the Bill was that patients should be advised of other forms of infertility service—they should 7 not believe that one treatment only is available. Having covered those points, I hope that the Committee will approve the regulations.

Question put and agreed to.

8

Resolved, That the Committee has considered the draft Human Fertilisation and Embryology (Special Exemptions) Regulations 1991.

Committee rose at thirteen minutes to Eleven o'clock.

THE FOLLOWING MEMBERS ATTENDED THE COMMITTEE:

Hill, Mr. James (Chairman)

Banks, Mr. Robert

Beith, Mr.

Blackburn, Dr.

Bottomley, Mrs. Virginia

Davis, Mr. Terry

Dykes, Mr.

French, Mr.

Gorman, Mrs.

Gregory, Mr.

Harman, Ms.

Heal, Mrs.

Hughes, Mr.John

Patrick, Mr.

Wigley, Mr.