In its White Paper on the review of the Human Fertilisation and Embryology Act, the UK Government has reaffirmed its intention to merge the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) to form a single regulatory body - RATE - the Regulatory Authority for Tissues and Embryos. This is a very serious change with important implications. Yet since the announcement was made in 2004, as a result of a review of Arms Length Bodies, there has been little, if any, consultation about whether this is the right approach.
The British Medical Association (BMA) and the Royal College of Nursing (RCN) have raised concerns about the proposed merger and about the way in which the changes are beginning to take place - such as the appointment of a joint chair - in advance of Parliamentary debate or genuine consultation. It would be wrong, however, to say that we actively oppose the change; we simply have yet to see any good arguments for it. The arguments we have seen so far have been political - reducing by one the number of Arms Length Bodies. Financial arguments have also been made and these are important - nobody would disagree that the cost of regulatory bodies should be kept to a minimum. But similar savings could almost certainly be made without merging the two bodies, by sharing 'back office' functions and premises, for example. The White Paper says the establishment of RATE provides an opportunity for the creation of a single regulatory body relating to the whole range of tissues, but does not give any indication of the advantages of having a single body rather than two more specialised ones. It says RATE will ensure 'common principles and standards are applied wherever this is appropriate' but does not explain why closer liaison and working relationships could not deliver the same result whilst retaining a reasonable level of expertise in the areas regulated. Our concern is that this merger is being presented as a 'done deal' without any discussion or clear evidence about whether it is the most effective and efficient way of regulating these very specialised and sensitive areas of practice.
Although there are similarities between the work of the HFEA and the HTA, in that both carry out inspections and both are covered by the EU Tissues and Cells Directive, there are vast differences between the areas covered. The complex and sensitive issues arising around reproduction and embryo research are very different to the equally complex and sensitive issues around the retention and use of organs and tissue after death. Confidence in the regulator is crucial to the future success of practice in these areas. The question is whether a single body covering such a wide and diverse area of practice can gain the confidence, trust and respect of Parliament, the profession and the public.
We know that both the HFEA and the HTA have found it difficult to ensure that they have the necessary range of expertise to make informed and appropriate decisions on matters that have a serious impact on the lives of many people. It is hard to see how a single body can have the necessary knowledge and expertise to make important decisions relating to IVF, embryology, pathology, anatomy, use and storage of tissue and transplantation. It is envisaged that advisory bodies will be established to guide decision making but surely this raises questions of accountability. We risk a situation where the body that is responsible and accountable for making decisions lacks the knowledge and expertise and the body or bodies that have the knowledge and expertise lack the authority and accountability. How easy will it be for RATE - without expertise in all of these areas - to reject the advice of its advisory bodies? Will RATE itself be perceived as simply rubber stamping the decisions made by those groups set up to advise it? Does this mean that power will effectively lie with appointed advisory groups that are not accountable to Parliament? These are serious questions that require proper consideration.
The BMA and RCN are not alone in expressing concern about the way in which this proposal is being taken forward. The Royal College of Obstetricians and Gynaecologists (RCOG), for example, has also raised similar questions. We are not calling for this proposal to be scrapped; we are simply calling for a period of genuine consultation and debate about whether the creation of RATE is the best and most appropriate way to proceed rather than simply about how the change should be implemented.