Debate on the Address

My Lords, the gracious Speech states: "““Draft proposals will be published to reform the regulation of human embryology””." It is this that I wish to address, but I must declarean interest as the interim chair of the Human Fertilisation and Embryology Authority, which is responsible for regulating treatment and research in this field. First, I pay a warm tribute to the Human Fertilisation and Embryology Act 1990, under which the HFEA operates, which has stood the test of time in a truly remarkable way. Based on principles set out in the 1994 report of the working party chaired by the noble Baroness, Lady Warnock, the legislation has shown itself to be robust and appropriately flexible. I am sure that its fundamental principles and approach to regulation will need to be retained in any new Act. That said, it is only right that the Act should be reviewed and new proposals considered, for which the HFEA has asked for some time. I will just give a few examples of why new proposals should be welcomed: one is the rapid pace of scientific advance. In recent years, the HFEA has had to make decisions about developments which were not even envisaged by the framers of the 1990 Act. Sometimes we have had to consider long and hard whether a particular development actually fell within our legal remit. A number of our decisions have been challenged in the courts and taken right up to this House for a final decision; for example, cell nuclear replacement, which is misleadingly called therapeutic cloning. I am very glad to say that our original decisions were upheld in the courts. Nevertheless, these and heralded scientific advances raise questions about the legal definition of the embryo and the remit for regulation. We very much hope that any new Act will provide greater clarity in this area, difficult though it may prove to be. Then there is the question of pre-implantation genetic diagnosis with or without tissue typing. We authorise this for certain genetic conditions but, for example, we disallow it for sex selection except where there is a genetic condition related to gender. Is Parliament happy for the regulatory authority to make decisions in this area, or are some so fundamental that they actually need to be considered by Parliament itself? After all, embryo screening does not even appear in the 1990 Act but is now fairly routine. New proposals are necessary because the Government’s review of arm’s-length bodies signalled the coming together of the HFEA with the newly formed Human Tissue Authority to form a new body, the Regulatory Authority for Tissue and Embryos, RATE. We are fully committed to working towards that new body, but whatever its scope it is vital that in the future treatment and research involving embryos will be regulated with no less focus and professionalism than it has been in the past. When I had the privilege of chairing your Lordships’ Select Committee on stem cells, we were all struck by the high regard in which the HFEA was held, not only in this country but also abroad, where it was looked to as a model to emulate. The tight regulation in this country has meant that public confidence in both assisted reproduction and research has been retained, enabling our scientists to become world leaders in the field. I was glad to hear the Minister emphasise just that point earlier today. It is true that some clinics have felt over-regulated, and no doubt when we come to debate the proposals in this House we will hear that voice. Clearly, now that firm regulatory foundations have been laid, there is a case for a lighter touch in some areas. It is also true that some parliamentarians have felt that they should have been more involved in making these crucial decisions. As I have indicated, it is vital that Parliament should make fundamental decisions, as it did when regulations came before this House in 2002 allowing research on embryos not just for reproductive purposes but for serious diseases as well. New issues will continue to arise which are too fundamental to leave to clinical judgment but which, if they came to Parliament every time, would occupy not just days but weeks of its time. All this underlines the importance of having a regulatory body with a clear remit and authority. The HFEA also believes that some other issues will need to be considered in any new proposals, such as the regulation of internet services for gametes, confidentiality provisions to allow for longer-term follow-up studies of IVF patients and so forth. To sum up, we should first pay serious tribute to the legislators who produced the 1990 Act, which has proved remarkably robust legislation in a new and rapidly developing field. However, it is now entirely right that new proposals should be considered that will not only take into account the changes since then but try to anticipate possible scientific advances. At the same time it will be necessary to have a regulatory authority which builds on the experience of the HFEA and is no less professional in regulating a field that is becoming increasingly important to a growing number of parents seeking fertility treatment and the new possibilities opening up for them to have healthy children.