The Human Fertilisation and Embryology Act (HFE Act) was passed by the British Parliament in 1990 to regulate the then relatively new field of assisted conception. One of the provisions of the Act was that there should be a statutory licensing body, so the Human Fertilisation and Embryology Authority (HFEA) was established. The regulatory process has developed gradually over the last 16 years as the HFEA has matured and used its powers to introduce regulations. But, now that the law is under review, how would clinics like the law to be reformulated?
First and foremost, clinics wish to see the burden and the cost of regulation minimised; they are wary of regulation that either doesn't work or has outlived its use - and of regulation creep.
Clinics have to be licensed to function and to obtain the licence they must apply and be inspected. Clinics would want that the process of applying for a licence be kept as simple as possible and that data available to the HFEA, such as clinic results which are submitted regularly, be available at the inspection visit. This is still not the case some 15 years after the regulator was established. The HFEA is currently introducing the electronic submission of data which is expected to improve the situation.
Clinics would expect that the inspection process be fair and consistent in its conclusions. Inspection teams have been made up of regulatory officers from the HFEA and representatives of the medical, embryological, and counselling professions. These professionals vary in their interests and attitudes which has led to criticism that the conclusions of inspection teams have not always been consistent. Detailed check lists were tried in an attempt to overcome this problem but were cumbersome and not fully developed. The proposed introduction of self assessment and the reduced use of inspectors from the professions should improve consistency.
Clinics have to submit data on a regular basis. This has involved a lot of work over the years from which clinics would have expected to get useful feedback. The Act requires that information is recorded about who services were provided to, what treatment they received, who provided the gametes, the resultant children, any mixing of egg and sperm and any acquisition of an embryo. These five pieces of information have been expanded by the HFEA to involve the completion of two A4 pieces of paper. Some of the data being collected would appear to be out with the requirements of the Act and likely to be of dubious accuracy making subsequent analysis of doubtful value. The HFEA has recently put a lot of work into verifying the data they have and into improving the reporting system.
The HFE Act requires that clinics take account of the welfare of a child who might be born as the result of treatment and that our patients are offered counselling. There has been more emphasis on these provisions of the Act than most clinics feel is warranted. A move towards a more risk-based approach is welcome.
And finally, now that in vitro fertilisation has become 'commonplace', it may be time to consider whether treatment that doesn't involve the use of donor gametes or storage needs to be regulated to the degree that the current legislation requires.
Regulation was originally introduced because the public required reassurance as to how the new reproductive technologies were being used. This remains true today. It is very important that the regulator continues to involve the public by keeping them informed of progress in the field and encouraging them to help resolve dilemmas by contributing to public consultations. It is to the clinics' advantage that regulation maintains public confidence in the sector as without that confidence those engaged in the field would not be able to operate.