British Fertility Society statement following the Hampton Review of the Human Fertilisation and Embryology Authority (HFEA) by the Better Regulation Executive
7 December 2009
The British Fertility Society (BFS) is pleased that the Better Regulation Executive has now published their review of the HFEA. The BFS, on behalf of its membership, gave evidence to the review team along with representatives from other stakeholders in May 2009. While the BFS agrees with much in the Hampton review there are concerns in six specific areas, which were raised with the Better Regulatory Executive at the time of the consultation, but have not been included in their report.
Regulation and risk assessment
The BFS reported concerns that the HFEA was not always even handed in the regulation of some IVF clinics in the absence of any justifiable increased risk to patient safety or regulatory compliance.
Efficiency, effectiveness and accountability
The BFS reported that whilst IVF clinics were often expected to comply with HFEA regulations in very short timescales, the regulator did not respond quickly for requests for help or information.
Collection of information
The BFS outlined that much of the data collected by the HFEA has little to do with its regulatory function. There is clear evidence that the collection of such a large data set for the HFEA is a drain on clinic resources, and there is limited evidence that the majority of this is of benefit to patients.
Ease of use of HFEA forms
The BFS did not feel these were easy to use or understand either for centre staff, or for patients. Their general view was that attempts to simplify and clarify had often resulted in the opposite.
Giving information and advice
The BFS felt that getting advice from the HFEA had been a mixed experience. Globally communication with the sector has improved significantly, but on an individual basis, members reported that getting advice from the HFEA was not always easy, calls were often not returned, and that queries were frequently referred to an individual with limited availability.
Pre-implantation Genetic Diagnosis (PGD)
The BFS agreed with other stakeholders that patients were being disadvantaged by the complexity of PGD regulation, and the time taken to gain a licence for a particular condition. They felt that PGD was excessively regulated and that much of this process served no real purpose, other than regulation for regulations sake.
In conclusion, it is of concern to the BFS that although it gave its evidence with other stakeholders in good faith and in the spirit of cooperation with the Hampton Principles, that the report published does not seem to highlight in any detail the issues raised.
The BFS will be contacting the Better Regulation Executive to discuss this matter further. Moreover, it will continue to work in close cooperation with the HFEA to ensure the needs of patients and professionals working in this area are adequately represented.
Finally, the BFS would like to express its absolute support for the concept of regulation in the IVF sector as stated many times previously1, but the BFS considers it important that regulation is proportionate, fair, equitable, cost effective and serves a useful function for the sector being regulated, the patients receiving treatment and society as a whole.
Notes for editors
1http://www.fertility.org.uk/news/pressrelease/07_01-HFEA%20and%20Regulation_16_2.html
The full copy of the Hampton Report on the HFEA is available at: http://www.berr.gov.uk/files/file53852.pdf
The British Fertility Society is a national multidisciplinary organisation representing professionals practising in the field of reproductive medicine. For general information, please visit our website: http://www.fertility.org.uk/
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