---

Human Fertilisation and Embryology (Quality and Safety) Regulations 2007

My Lords, I welcome the general comments of the noble Earl, Lord Howe, and the noble Baroness, Lady Barker. I certainly agree with their general view that the regulatory standards in this country are high, which means that the implementation of the directive in the UK is pretty straightforward. I also very much agree with the noble Baroness that the strength of our regulatory system makes this the place for many scientists to come to do crucial work. That was one of the strong factors in the debate on embryonic stem cell research that enabled this House to allow the change in the regulations to be made. We should ever be mindful that high-quality research and science go hand in hand with strong, proportionate regulation. The noble Baroness, Lady Barker, asked me when the legislation was due in. It was actually in force on7 April 2006. The UK, because we had legislation already in place, was given a derogation for one year. There has been a slight delay in producing the regulations and bringing them before Parliament because of the work necessary to consult and the detailed work that entailed from that consultation. The implementation enforcement date in this country is 5 July of this year. I am advised that there is a low risk of infraction proceedings. The date for Europe was 7 April 2006. I understand the comments made by both the noble Earl and the noble Baroness about not wishing for gold-plating of these regulations. My understanding is that there has not been gold-plating; establishments will only be required to meet the requirements of the directive. The noble Baroness, Lady Barker, answered the question posed by the noble Earl, Lord Howe: would this give comfort to women and couples who go to other countries in the EU? The answer must be yes, because the current situation, where many countries do not have any regulation at all, is unsatisfactory. Of course, there are issues about consistency—it is sometimes argued that some countries are better than others in ensuring that directives are implemented. In general, the regulations should give some comfort. As far as the safety culture is concerned, the noble Earl should not read into that comment that we believe that there is not a safety culture in the regulated establishments, more that we believe that there is strong regulation and a safety culture. Those remarks relate not just to the establishments covered by these regulations but more generally in healthcare. An Organisation with a Memory, which led to the establishment of the National Patient Safety Agency, is about ensuring that we get as much information as possible about safety incidents, including near misses, and learn from those errors. As a result, we can redesign our approach to clinical care; sometimes it is about the use of medicines, sometimes procedure and sometimes training. The comments reflect a general desire to make healthcare in this country as safe as possible and to learn the lessons of experience. That applies to this sector as much as other parts of the healthcare industry. I noted the comments of noble Earl, Lord Howe, on the establishment of RATE. We have already realised that RATE does not commend itself to other noble Lords. No doubt when we come back with primary legislation we will have a jolly good debate about it. The Government’s view is that bringing the two organisations together will enable us to bring together the strength of both of them and enhance regulation. I understand the issues raised about fees and the concern that they will lead to burdens on many establishments. First, it would be fair to say that the RIA gives a broad outline of the potential additional costs to them. Those costs were derived from information collected from regulators and tissue establishments during financial year 2005-06. I agree with the comments made by both noble Lords that these are approximations, and we will learn from experience. I also accept that there is a need to keep the costs to regulated establishments down as much as possible—proportionate to the issue of safety. I have no doubt that a very careful eye will be kept to ensure that costs are kept as low as possible. It is worth making the point that many of the establishments that will be regulated for the first time are actually NHS establishments. It will fall in the end to the National Health Service to pay the additional costs. Some other establishments will also now fall to be regulated, but we expect them to be minimal in number. I understand that so far 31 NHS bodies have applied to be regulated and we expect another 15 to do so. Interestingly, 11 organisations, including eight NHS bodies, have decided not to be regulated for one reason or another, but I accept the issue of cost. I should be grateful if I could write to the noble Baroness on the question of HTLV. I understand that the 30-year period for storage of data was brought about through negotiation. If the noble Baroness presses me to give a rational reason why that period was decided on, I am afraid that I cannot give one. I imagine that it was thought to be a reasonable length of time, although I understand her point about longevity. I am afraid that that is the best answer that we have in relation to that matter. On Question, Motion agreed to.