---

Public Bodies Bill [HL]

My Lords, when I came into this House almost 22 years ago, my baptism of fire was the consideration of the Human Fertilisation and Embryology Bill. I spent a great deal of time considering its provisions, based upon that splendid report produced by the noble Baroness, Lady Warnock. The purpose of the Act, as it became, was to license experiments on the human embryo up to 14 days after fertilisation, first, for improvement of the management of infertility and, secondly, to help in the prevention of the birth of children with fatal and seriously damaging disease. Those objectives were, very largely, fulfilled. We got to a stage of being able, through licences from the HFEA, to embark upon a programme of pre-implantation diagnosis of some of the severest diseases like cystic fibrosis and muscular dystrophy. It did a wonderful job. It became quite clear, however, that, because of the developments in human embryology and the enormous advances in research, it was necessary that the Act should be further amended, not only in order to prevent the birth of people with severe diseases but also to be able to use human embryo material and the stem cells derived from it for the treatment of human disease. That resulted in a number of other amendments and regulations being introduced. We then went even further with additional developments. As many in this House will know, one of the great developments recently under a licence from the HFEA has been the ability to prevent the birth of children—not yet feasible but on the verge of becoming so—with a devastating form of mitochondrial disease. I will not go into the scientific detail because it is extremely complex. I mention the word complexity because I cannot conceive that the role and responsibility of the HFEA—I entirely agree that it is not perfect; it may be slimmed down, streamlined or modified—could possibly be carried out by the Care Quality Commission, which is, under its major new responsibilities, required to inspect hospitals, care homes, general practices and all bodies concerned with the supervision of health work of all kinds. To try to carry out those responsibilities under the Care Quality Commission is simply not feasible. Last week, as the noble Earl will remember, we debated a Question on the role of the Academy of Medical Science’s report on the governance of medical research. I agree entirely with what the noble Lord, Lord Warner, said: this is a very exciting and important development, particularly in the conduct of clinical trials and the supervision of research in general. It certainly does not cover the responsibility which the HFEA is carrying out, and I therefore cannot accept the Government's proposals to put that body within the Care Quality Commission. I move on to the HTA for a moment. When I was a medical student in the early 1940s, on the top floor of my medical school there was a museum which was full of organs held in formalin in plastic bottles. They were a wonderful teaching resource, because they were organs showing the signs of disease and, for the teaching of medical students, they fulfilled a major responsibility. No one had asked the patients involved before those organs were retained for teaching purposes. The problem of the Alder Hey so-called scandal was that the permission of the individuals from whom the organs were removed had not been taken. What nobody recognised at the time was that if you were to carry out a post-mortem examination to try to determine the nature and causation of the disease from which the individual had died, there was no way in which the simple carrying out of the post mortem and visual inspection of the organs could give you the answer. The organs had to be removed; they had to be pickled in formalin; they had to be studied under the microscope, to give the answers which everyone wanted to know as the outcome of that post-mortem examination. Where members of my profession were mistaken was that it became almost accepted by doctors, pathologists and clinicians that once permission for a post mortem had been given they could assume that permission had been granted to retain the organs for such an examination. They were wrong. Hence, the Human Tissue Authority was created to control that process. It has been very successful in not only in that regard but also in issues related to the retention of tissues obtained for diagnostic purposes by biopsy. It has also been extremely successful in controlling the use of anatomical material for teaching purposes. It has fulfilled a whole series of other functions. My view is that it so necessary that that function should be continued that I do not believe, for the same reasons, that the Care Quality Commission could feasibly absorb that task. It could do so only if it took on board the scientific experts on human fertilisation and embryology on the one hand, to deal with the responsibilities of the HFEA, and the scientific experts in pathology, anatomy, molecular biology and other branches of medicine, to look at the human tissue issues and also to be able to deal with issues relating to the donation of organs for transplantation. Those complex issues are so broad in their responsibility that I do not believe that the Care Quality Commission could conceivably handle them all. That is why I give warm support to the amendments.