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Human Fertilisation and Embryology Bill [HL]

My Lords, I beg to move that this Bill be now read a second time. The United Kingdom is at the forefront of developments in human reproductive technology. This country has a proud record of pioneering new techniques for the alleviation of infertility and for exploring new avenues of scientific research. The final breakthrough in innovation now known universally by the letters ““IVF”” took place here. Key developments in new research techniques, such as the creation of Dolly the sheep, happened in British laboratories. These and other developments have brought hope to countless thousands of people who might otherwise have been unable to have children, and offer enormous potential for the future treatment of serious disease. Alongside this enviable record of innovation stands an equally pioneering history of effective regulatory oversight. The Human Fertilisation and Embryology Authority was the first body of its kind in the world. The creation of the HFEA made for the first time an area of medical practice subject to the control of an independent regulator, replacing professional self-regulation. The UK and this Government implemented the first statutory ban on human reproductive cloning anywhere in the world. We also introduced legislation paving the way for scientists to reap the benefits of embryonic stem cell research. Specialist regulation of reproductive technologies, together with clear legal boundaries, has united scientific breakthroughs with public confidence in their development and use. Among other things, this represents a considerable triumph for parliamentary debate. The existing law, the Human Fertilisation and Embryology Act 1990, was the product of consultation, a committee of inquiry, and then extensive scrutiny here and in another place. Many Members of your Lordships’ House have played, and continue to play, a direct role as legislators and experienced practitioners in the fields of philosophy, science and medicine. The Bill provides a further opportunity for that expertise to be brought to bear. In 1990, Parliament set out the legal boundaries and parameters of a scheme of regulation. It was based on the principle of active monitoring of technologies that raised a range of profound social, legal and ethical questions. Finding answers to those questions arguably goes straight to the heart of our existence as individuals, families and society. Sincerely held views and opinions differ widely, and sometimes fundamentally, in this area. However, there was also in 1990 an evident desire for some principles and some defined limits. The 1990 Act represented a will to find common ground in a framework broadly acceptable to society. In January 2004, the Government announced a review of the law. We recognised that the 1990 Act had worked well, but, like any cutting-edge legislation, needed to be reviewed from time to time. Our aim in undertaking the review was to ensure that the law remained effective and fit for purpose in the 21st century. In particular, we thought that a review was timely given the pace of scientific developments and public attitudes associated with them. The noble Baroness, Lady Warnock, remarked that, "““we were conscious of an increasing sense of urgency that controls should be introduced where none exist, and that the law should be brought up to date, so that society may be protected from its real and very proper fear of a rudderless voyage into unknown and threatening seas””." That remark was written in 1985. Our sea charts have been partly filled in since then, but there are also new rocks and reefs. We are navigating strong currents of reproductive freedom and responsibility, patient safety, public accountability and professional autonomy, and questions of how best to safeguard the welfare of children. The Department of Health undertook a public consultation in the summer of 2005, taking account of the extensive inquiry into reproductive technologies by the Science and Technology Committee in the other place. It produced more than 500 responses from a wide range of stakeholders, including from the medical profession, patients’ representatives, faith groups, scientists, academics and other members of the public. An independently produced summary of the responses was published in March 2006. This was followed in December 2006 by the Government’s White Paper, setting out our legislative proposals to update the existing law and including the proposal to establish a single regulatory body for tissue and embryos. The resulting draft Bill, then entitled the Human Tissue and Embryos Bill, was published for pre-legislative scrutiny in May this year. A Joint Committee of both Houses was appointed to scrutinise the Bill, and considered a wide range of evidence from stakeholders as part of its deliberations. Nine members of your Lordships’ House served on the committee, bringing to bear varied experience in law and ethics, research and regulation. The Joint Committee published its report and recommendations on 1 August. The Government responded to the Joint Committee’s report on 8 October. We accepted the spirit of the report, and many of the recommendations. We recognised the strength of the committee’s reasoning in relation to replacement of the HFEA and the Human Tissue Authority by RATE, the Regulatory Authority for Tissue and Embryos. This proposal had originated in the Department of Health’s 2004 review of its arm’s-length bodies, which has, overall, been a successful programme, releasing savings for front-line care. On balance, and in the light of the Joint Committee’s report, the Government decided to drop the proposal to establish RATE. A number of noble Lords drew attention to this matter during debate on the gracious Speech, and I am pleased to note that it has been warmly received. The Government will, however, be working with both the Human Fertilisation and Embryology Authority and the Human Tissue Authority to ensure that regulation is streamlined. Separately from the Bill, we will be reviewing, together with the Treasury, the fees charged by the HFEA and the Human Tissue Authority. The Bill has benefited from pre-legislative scrutiny, and clearly demonstrates the value of that process. Development of the Government’s proposals have also benefited from the reports of other parliamentary Select Committees published during the intervening years, including, for example, the 2002 report from your Lordships’ Committee on Stem Cell Research, produced under the chairmanship of the noble and right reverend Lord, Lord Harries. The Bill is therefore the product of a considered and deliberative approach. It will update the regulation of assisted reproduction, ensuring that it is effective and reflective of modern society. The Bill is needed to ensure that legitimate medical and scientific uses of human reproductive technology can continue to flourish. The Bill will help maintain the UK’s position as a world leader in ground-breaking research for the treatment of serious diseases, including through embryonic stem cell research. Its provisions are an overhaul of the existing law and will promote public confidence together with best regulatory practice. We have not, however, proposed to abandon the basic foundations on which the existing law is based. We have not tried to fix what is not broken, nor have we thrown the baby out with the bathwater. Rather, we have kept to the fundamental underpinnings of the regulatory scheme based on the report of the committee of inquiry chaired by the noble Baroness, Lady Warnock, on which the original legislation was based. Nevertheless, technology has moved on and so have attitudes. There are, for example, novel ways of creating embryos for research, a much increased capacity to screen embryos for serious genetic diseases, and at the same time legal recognition for different family forms. These developments demand a rigorous examination in Parliament of the regulatory framework, and a resetting of the controls and boundaries for the future. The Bill was introduced on 8 November, a month after our response to the pre-legislative scrutiny report. It comprises 69 clauses and eight schedules, arranged in three parts. The first part consists of amendments to the 1990 Act, amending, for example, the definitions used. Part 2 consists of provisions relating to legal parenthood in certain circumstances, for future cases involving assisted reproduction. Part 3 contains miscellaneous and general provisions, including amendment of the Surrogacy Arrangements Act 1985. As well as the Explanatory Notes relating to the Bill, the department has also prepared an illustrative text of the 1990 Act, showing how it would look if the amendments proposed in the Bill were made. This text also incorporates changes to the 1990 Act made by various other instruments, including the regulations made earlier this year to implement the requirements of the European directive on tissues and cells. The Bill’s main provisions will ensure that all human embryos outside the body, whatever the process used in their creation, are subject to regulation. The existing law refers to the process of fertilisation, which has cast doubt on whether embryos produced by more novel processes are within the regulator’s remit. It is important for the future of embryo research that there should be clarity about what is regulated, and moreover to ensure that human embryos cannot be created and used lightly. The Bill will clarify the regulation of interspecies embryos for research. The original legislation was concerned almost entirely with human embryos. It banned the mixing of human and animal gametes, other than for the limited purposes of testing the fertility of human sperm. Beyond this, the 1990 Act does not mention embryos combining human and animal material. Technology has moved on and promising avenues of research have expanded. For example, scientists now wish to use animal eggs in place of human eggs for the purpose of creating embryos for stem cell research, in part to overcome the shortage of human eggs available for research. The aims of such research would be, for example, to explore the potential for treatment of degenerative conditions such as Parkinson’s disease. Again, it is essential that the law and regulations are clear about what falls within the Human Fertilisation and Embryology Authority’s remit. We are proposing that interspecies embryos can be created for research, subject to the HFEA’s decisions to license individual research projects as being necessary or desirable. These are exactly the same controls as apply for embryo research projects using human embryos, and subject to the same safeguards. The embryos cannot be kept beyond 14 days’ development, nor can they be placed in a woman or an animal. Besides interspecies embryos, the Bill will also increase the scope of legitimate research activities, while retaining strong regulatory controls and oversight. The existing legislation is not, for example, as clear as it could be that basic research using embryos—the type of research that underpins more advanced applied research into serious diseases—is permitted. Similarly, the restrictions on the use of data collected by the HFEA are overly restrictive and make it difficult for the success of treatments to be followed up through good research. The Bill contains enabling powers to make access to those data easier, while allowing full attention to be given to proper confidentiality controls. The Bill will impose a statutory ban on the sex selection of offspring for non-medical reasons. This will put on the face of the legislation something which is at present a matter of HFEA policy, giving Parliament the opportunity to fully debate the provisions. The Bill will also make explicit the basic parameters for screening and selecting embryos. Again, the intention is that this should be undertaken only on the grounds of avoiding serious disease, and the Bill preserves some flexibility for how that is to be determined. The current situation, which has been the subject of legal challenge, is not sufficiently clear, and again the opportunity is presented for Parliament to give a clear steer for the future. The Bill includes clear recognition of same-sex couples as legal parents of children conceived through the use of donated sperm, eggs or embryos. This will mean, for example, that the woman who gives birth and her civil partner will both be recognised as the parents of a child conceived via assisted reproduction. At present, the partner would have to apply to adopt the child. Similarly, two men will be able to apply for a parental order to become parents of a child conceived through a surrogacy arrangement. At present, parental orders are open only to married couples. In considering these matters we must ensure that we do not overstress concerns and anxieties, or depart into the realms of science fiction. Similarly, we must be careful not to overhype promising areas for future exploration. The Bill contains a number of secondary legislative powers, as well as areas of discretion for the regulator, that are intended to allow scope for flexibility where appropriate. This is to enable a rapid response to new developments as well as attention to detail in different cases. There is also in the Bill the capacity to recognise in practice when developments have become commonplace. We are, for example, imposing on the regulator an explicit duty to act always in accordance with the principles of better regulation. The Bill also provides for a more streamlined approach to administration by the regulator. For example, it removes the current requirement that the membership of HFEA licence committees must be limited only to members of the authority. I must also briefly mention two things that the Bill does not do, and that the Government have no intention of doing. It does not—as has been claimed by some observers—deviate from the Government’s position that human reproductive cloning is illegal. The Bill’s provisions replace the Human Reproductive Cloning Act 2001 by putting new controls directly into the 1990 Act. I am sure that we will have extensive discussions in Committee about precisely which activities are permitted in relation to eggs and embryos, but let me be quite clear from the outset that the Government’s policy remains not to allow reproductive cloning. Another issue on which we have been quite clear from the inception of the review of the law on assisted reproduction is donor anonymity. Under the 1990 Act as originally passed, donors are anonymous. A change was made by regulations in 2004 so that where donors of gametes or embryos were registered from 1 April 2005, the donor-conceived person will have the right of access to information, including the name of the donor, from the age of 18. The Government have made clear that we have no intention of altering this position, arrived at as a matter of principle, and put successfully into practice. In fact, the Bill will enable greater access to information by donors and donor-conceived people, recognising the importance placed on genetic origins and relationships. I look forward to an interesting debate on the extremely important issues raised by the Bill. Once more the eyes of the world are upon us. In this and subsequent stages of the Bill I believe that this House will provide, as it has in the past, the considered and expert scrutiny that is vital. Moved, That the Bill be now read a second time.—(Lord Darzi of Denham.)