All societies like stability and England clings to its Institutions as a child holds its comfort blanket. It is a bold step for government to change the establishment and inevitably some anxiety is expressed: 'Will there be a free for all?', 'will standards fall?', 'will patients be exploited?', 'who will tell us what to do?', 'will regulation be worse?' and 'will the reputation of the UK in this field decline?'
The UK lead lies in the Human Fertilisation and Embryology Act not the HFEAand this legislation remains. Society debated the framework within which it is considered acceptable for reproductive technology to help couples have a family. The HFE Act was amended in 2008, confirming support. A principal reason for legislation is to provide clear allocation of parental responsibilities for the child. It also sets the limits on acceptable practice both for clinical treatment and for research. The sanctions associated with the legislation remain. There are not altered by the reorganisation of the Authority. We should not therefore have concerns about the proposals but see them as an opportunity for improvement and to place the diverse responsibilities of the HFEA into appropriately appointed organisations.
The existence of a significant private market for IVF has resulted in a competitive field, particularly in the south of England, contrary to ethos of the NHS. There is concern that, without the HFEA, clinics will publish selected data to promote their service. This should not occur since validated data collection and publication would be required under the Care Quality Commission similar to routine procedures for all clinical practice. Only deviations from the norm, either below or above, are those that need special scrutiny. Poor performers should be helped to improve or be stopped. Above average performers should be identified, the reason for their successes published and their good practice adopted by others.
Prior to reorganisation, a Review Group is needed to advise the government about data collection. The HFEA was established to be independent of service providers, a decision that, in retrospect, has been less than helpful. The Review Group should be independent of the HFEA and reflect clinical, scientific and social needs rather than the needs of the regulator. In 1990, blanket data collection reflected the lack of knowledge at that time. More informed data collection is now needed with rigorous justification for every item requested. Much of the data currently submitted relates to historical precedent and regulator interpretation rather than clinical, scientific or legislative need. For instance, there is no justification on clinical, scientific or ethical grounds for the collection and storage of outcome data for every egg that is mixed with sperm. Retaining identifying information about each patient having treatment is unnecessary.
Some groups are fundamentally opposed to the activities permitted under the HFE Act. Their views must be heard in context. It is to their advantage that regulation remains so strict that it is inhibitory. But their arguments are based on what they consider to be morally acceptable not on clinical or scientific concerns. IVF is now a standard low-risk clinical procedure. The outcome for children is well studied and reported. IVF is not pleasant but it is not a high risk procedure. Data from the European Society of Human Reproduction and Embryology (ESHRE) showed that the death rate in Europe from IVF in 2006 was 2 in 459170 (0.000004%). Maternal mortality related to pregnancy is 24 in 100000 (0.0002%). On safety grounds, there is no justification for more robust regulation for IVF care than good maternity care.
Permissive UK legislation has allowed this country to lead in many aspects of pre-implantation embryo research. Nothing in the proposed changes should alter this. Embryo research is being aligned with all other medical research; an appropriate delegation of responsibilities to regulators who have the skills and knowledge to undertake such oversight. The only unique consideration related to embryo research is to ensure compliance with the HFE Act, a task that should be straightforward in most cases. When the boundaries are extended beyond those previously considered by Parliament, it is right that we take the debate back to elected and accountable representatives for a decision.
Government proposals do not always come to fruition and there are legislative obstacles to overcome. Over 40,000 IVF treatments are provided in the UK each year and 1.6 per cent of all births relate to this treatment. It is no longer new and is only 'controversial' for those who want to stop it. The government will decide on the new regulatory procedures. If significant reductions in the regulatory burden are to be achieved, it is hoped that the Department of Health will listen to professionals directly involved in this field and to the patients who want to be able to make their own reproductive choices, rather than try to replicate current procedures under new names. IVF is a core medical service and bringing it within the same regulatory framework as all other clinical treatments is now appropriate.