04 October 2010
John Parsons is an Honorary Consultant Gynaecologist at King’s College Hospital and Michael Sawas is a Consultant Gynaecologist / Person Responsible at the Assisted Conception Unit, King’s College HospitalAppeared in BioNews 578
Following the passage of the Human Fertilisation and Embryology Bill 1990, the HFEA was set up to: license and monitor clinics carrying out IVF and donor insemination, and establishments undertaking human embryo research; maintain a register of licences held by clinics, research establishments and storage centres; and regulate storage of gametes (eggs and sperms) and embryos. The HFEA also has a duty to provide impartial and authoritative information to patients.
The Government argues  the licensing function of the HFEA could be moved to the proposed new research regulator and this would weaken the argument for a special fertility sector regulator. Parliament has discussed regulating fertility treatments and embryo research in detail several times since the late 1980s. On each of these occasions, they agreed human embryos have a unique status and their use for treatment and research requires special oversight.
Some say IVF treatment has become so common that its regulation should be normalised. Although public opinion has moved, there are still powerful forces wishing to stop or limit the use of assisted conception. Pope Benedict XVI said in June 2006: 'the human being has the right to be generated, not produced, to come to life, not in virtue of an artificial process, but of a human act in the full sense of the term: the union between a man and a woman'.
There is a real danger important research would be frustrated by people with similar views to Pope Benedict should the responsibility for ethical review move from the supportive environment fostered by the HFEA. We believe researchers who wish to see the HFEA broken up hope the licensing process will reduce under the aegis of a new regulator. Not only is this unlikely but, when these researchers must deal with a broader range of opinions about whether their research should be done, they are likely to regret the loss of a specialist regulator.
The HFEA plays an important role in actively improving standards by, for example, being responsible for several consultations on issues of best practice. Reducing multiple pregnancies by limiting the number of embryos transferred has been, and remains, an important part of its work. Many treatments regulated by the HFEA are funded by patients, not the NHS, and self-funding patients are attracted to clinics with good results. Would the Care Quality Commission take on the important role of ensuring clinics' results are not achieved regardless of the perinatal mortality associated with multiple pregnancy?
The HFEA acts as a focus for interactions between doctors, nurses and scientists. These interactions could take place within the British Fertility Society (BFS), but all the disciplines have vested interests. 'Trade' organisations such as the Royal College of Obstetricians and Gynaecologists, the Royal College of Nursing, the Association of Clinical Embryologists and the BFS do not have the same impartial image enjoyed by the HFEA.
Patients may also be involved and have their interests protected if interactions between these disciplines take place with the regulator. The public has learned to trust the HFEA, which acts as a bulwark between the sensational headlines in the less responsible press and those working in the field. Who would take on that role if the HFEA is abolished?
The HFEA collates results and other data from clinics providing assisted conception services. These data allow patients to compare clinics where they might go for treatment and make decisions based on reliable information. Would the Health and Social Care Information Centre, who will have responsibility for all health and social care data, prepare this information as comprehensively?
The HFEA is not perfect, at times the organisation seems over bureaucratic, but it seems to us that the HFEA plays a valuable role greater than the sum of its statutory obligations. Far better to prune it than uproot it.