§ 7.5 p.m.
§ Baroness Hooper rose to move, That the draft regulations laid before the House on 17th June be approved [23rd Report from the Joint Committee].
§ The noble Baroness said: My Lords, I beg to move that the draft order laid before the House on 17th June be approved.
§ The draft regulations now before the House will provide for two exceptions to the general rule that any person keeping or using embryos, or storing gametes (that is, sperm and eggs) may do so only in accordance with a licence from the Human Fertilisation and Embryology Authority.
§ During the passage of the Bill—now the Human Fertilisation and Embryology Act 1990—in the other place it came to the Government's attention that there were situations were embryos and gametes were kept or stored for purposes other than those involving infertility treatments and embryo research. For example, there would be a need to keep and examine embryos and gametes in the course of criminal investigations connected with enforcement of the legislation itself. Also, in some organisations, sperm may be stored for research or teaching purposes only. Unless exceptions were made for these situations the licensing provisions of the Act, which were designed to regulate the use of gametes and embryos in treatment 1277 services and embryo research, would have to apply. The new authority would be obliged to inspect and license all these places.
§ It is important to appreciate that the regulations would only permit exceptions in very limited circumstances, and will not allow people to evade the stringent controls laid down in the parent Act. Furthermore, because of the importance and sensitivity of these issues, they are subject to the affirmative resolution procedure, which allows Parliament the opportunity to consider them fully.
§ The first exception, which is set out in Regulation 2, relates to the keeping or examination of embryos and the storage of gametes in connection with offences under the Act itself. Section 39 of the Act gives members and employees of the Human Fertilisation and Embryology Authority power to take possession of any thing which they have reasonable grounds to believe may be required to be used in evidence in any proceedings for an offence. If this ever became necessary, the authority would ensure that among the people taking possession of the gametes and embryos there would be an expert, with knowledge about how such material should be handled.
§ Both the Government and the Human Fertilisation and Embryology Authority are very 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 where embryos and gametes are kept in connection with an offence they are kept in proper conditions and examined only by experts in this field. For practical reasons we are therefore proposing—and these regulations provide—that these embryos and gametes should remain under the supervision of the authority. It will have knowledge of the experts working in the field, and will be able to identify where appropriate facilities exist.
§ The regulations then go on to specify several additional safeguards, of which your Lordships will no doubt be aware from reading the regulations. Once the investigation or proceedings for an offence are completed it will be for the HFEA, under whose supervision these gametes and embryos are kept and examined, to ensure that if possible they are returned to the incensed 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 hope your Lordships will appreciate that the exemption is necessary in order to allow criminal activities to be properly investigated. The vast majority of doctors and scientists working in this field are responsible and dedicated people who welcome the new controls. We expect these provisions to be invoked only very rarely, if at all. Nevertheless, it is right that these carefully considered mechanisms and safeguards should be in place in case they are ever needed.
§ The Second exception relates only to gametes—that is, sperm and eggs—stored for purposes other than infertility treatment and embryo research. It does not 1278 apply to embryos. Embryos can be stored only under licence or in circumstances where an offence may have been committed. Therefore, it may be helpful if I describe the kind of circumstances in which Regulation 3 dealing with this exception would apply. For example, the exception would apply to a university laboratory carrying out research projects concerned with the locomotion of sperm; the development of pharmaceutical products aimed at enhancing the quality of sperm which has been thawed after cryopreservation; or a medical school using sperm to study cell structure. The regulations also contain important terms and conditions which apply to gametes stored under the exemptions. If it is brought to the attention of the police or the new authority that a centre which is exempted is not complying with the conditions set out in the regulations it will be liable to prosecution. On conviction, the individuals concerned could face up to two years' imprisonment or a fine or both.
§ The draft regulations have been drawn up after a period of full consultation during which interested organisations have been given an opportunity to express their views. Some of your Lordships may recall that copies of the consultation document were made available in the Printed Paper Office. In drawing up the draft regulations now before your Lordships we have considered very carefully the comments received. I hope the House will agree that they are both reasonable and comprehensive.
§ Moved, That the draft regulations laid before the House on 17th June be approved [23rd Report from the Joint Committee].—(Baroness Hooper).
§ 7.13 p.m.
§ Lord Ennals
My Lords, I thank the noble Baroness for her very clear presentation of the case for these regulations and say that I totally support everything she has said. I believe these are the first regulations to be brought forward under the Human Fertilisation and Embryology Act 1990, and perhaps it would be appropriate to do two things. First, I thank the interim authority for the work it has done and, I believe, will continue to do until the end of this month. Perhaps the Minister can clarify whether or not that is the case. I know that the new Act comes into operation as from 1st August.
I should like to express the thanks of the House to the interim authority for the very fine job it has done under the leadership of Dame Mary Donaldson, who has been a tower of strength. At the same time, I should like to congratulate Professor Colin Campbell on his appointment as chairman of the new authority. The task that the authority has to perform is an important and sensitive one, first in understanding and preventing inherited disability and secondly in alleviating the misery of infertility, which appears to affect about one in eight couples. Infertility causes great stress and misery to an enormous number of people. Research into infertility goes side by side with treatment, and that is the pattern of development in the present work. Indeed, one reason for the Act was 1279 that treatment could not be improved without research and there would be no research without treatment.
As I understand it, 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 follow the guidelines set out in the code of practice published by the HFEA. It will provide for two exceptions as defined in the regulations to the general rule that any person keeping or using embryos or storing gametes—sperm or eggs—may do so only in accordance with the terms of a licence obtained from the HFEA.
On the occasion of this introduction of the first regulations perhaps I may put one or two questions to the Minister. If she is not able to answer them straight away I will of course be happy to receive a letter. First, on the research side, would she say whether the NHS reforms make any difference to the provision of infertility services? Will the trusts offer services to infertile couples as freely as other hospitals? Second, perhaps the Minister could outline how many organisations will be covered by the exemption in the regulations on the ground of research unrelated to the HFEA Act. Third, would the Minister comment on the need to include in the authority's reports details of the success rates of clinics? The Minister in the Commons referred to the authority's draft code of practice being presented to the Secretary of State and laid before the House. I wonder whether the Minister can give us any idea when that will happen. It will be of great interest to all those Members of the Committee who took part over many weeks in the debates on the Bill.
I conclude by warmly thanking the Minister for her presentation. I support the orders presented by the Minister to the House on this occasion.
§ Baroness Hooper
My Lords, I should like to thank the noble Lord for his comments and his welcome of the regulations. I thank him particularly for his remarks about the interim authority. I can confirm that that authority will be replaced by the new body on 1st August but that it is still in being at the moment. I can reassure the noble Lord by telling him that not only will the reforms make no difference to the way progress is made in this area but also that, because of the increased efficiency of the system the efforts made will be more effective. So far as the draft code is concerned, it is under consideration at the moment and I hope will be laid before Parliament very shortly. If I can add to those remarks in any way I shall write to the noble Lord. I would merely say once again that the regulations before your Lordships deal in a sensible, practical way with two particular circumstances and are wholly within the spirit of this important Act.
§ On Question, Motion agreed to.