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The Department of Health decided not to transfer functions from the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) to the Care Quality Commission (CQC) and the Health Research Authority (HRA), following a public consultation from June to September 2012.
Professor Peter Braude, Emeritus Professor of Obstetrics and Gynaecology, King’s College London, said:
“I am delighted that the government has listened, and revised its plan to abolish the HFEA and the HTA and to transfer functions to the CQC. They also have taken on board the idea that however positive the view of these bodies may be, efficiency and function can be improved and that the recommendation of an external review has been accepted.
“However I am concerned with the suggestion once again of merging the HFEA and the HTA into a single body, a reincarnation of RATE (the Regulatory Authority for Tissues and Cells), a proposal appropriately and convincingly discredited by the 2007 Parliamentary Joint Committee on the Human Tissue and Embryos Bill. There has been enough money wasted trying ineffectively to reorganise these regulators – joint working and improvement by all means, but enough meddling for political ends. It is patient safety and professional probity that matters.”
Sarah Norcross, Director of the Progress Educational Trust, said:
“On one hand the government has decided to save the HFEA and the HTA from being submerged into the CQC but on the other their new review will give serious consideration to the merger of the HFEA and HTA. More importantly in my opinion is that it should aim to reduce the bureaucratic burden on researchers and IVF clinics so that both time and money are saved there as well as in the civil service.”
Professor Alison Murdoch, Professor of Reproductive Medicine, Newcastle University, said:
“I welcome the government’s acceptance that the activities of the HFEA need to be subject to an independent review. The BFS has shown that the current system of data collection is inefficient, is not fit for purpose and has published proposals for improvement. This includes procedures that would overcome the risks associated with the current flawed data collection processes about children conceived from donated gametes. The recent MOU between the CQC and the HFEA enables the sharing of information but does not overcome the bureaucratic burden associated with duplication of inspection.
“In relation to research, it is difficult to understand why a clinic would need HRA approval to undertake a trial comparing two different (approved) drugs given to women during IVF but if we wanted to compare two different (approved) culture media for the embryos in the same IVF treatment, we would still need both HRA and HFEA approval.”
Dr Allan Pacey, Senior Lecturer in Andrology at the University of Sheffield and Chairman of the British Fertility Society, said:
“The British Fertility Society is very pleased with the Department of Health proposals for the future of the HFEA and the mechanism by which activities covered by the Human Fertilisation and Embryology Acts are to be regulated.
“The HFEA was set up to respond to the concerns of the day and performed admirably in establishing a regulatory framework and successfully navigating the political, ethical and cultural issues thrown up by the emerging technology. However, it has of late hampered the progression of the UK fertility sector without providing any enhanced regulation, its principal responsibility under the Human Fertilisation and Embryology Acts.
“We along with many other respondents to the consultation therefore look forward to taking a thorough and objective review of the HFEA’s functions to ensure that UK fertility treatment and research continues to be well regulated under a far simpler system. The administrative time that could be spared by cutting duplication within the regulatory systems will amount to a significant reduction in NHS spend.
“It is important to note that the British Fertility Society is absolutely committed to upholding the principles enshrined in the Human Fertilisation and Embryology Acts, specifically those that protect the interests of patients and children, and the special status of the human embryo. We advocate a review of regulatory functions from the HFEA solely in the understanding that fertility treatments and embryo research can continue to be safe, effective and ethically sound under a ‘one-stop-shop’ system, rather than the current one which leads to vast duplication of effort.
”We believe that regulation of activities covered by the Act should be done in the most efficient and effective way, and be confined to the specific requirements of the legislation and associated regulation, recognizing that assisted conception is now an accepted element of healthcare, carried out by appropriately qualified practitioners, according to established standards.
Professor Lisa Jardine, Chair of the HFEA, said:
“I am delighted that the Government has decided that the HFEA’s dedicated expert regulation of IVF and embryo research will continue. I have always believed that the interests of the fertility patient, who of course matters most, are best served by having a specialist regulator.
“We already work closely with the HTA and I welcome this review as an opportunity to identify where we can strengthen and streamline those arrangements still further.”
Reference:
http://www.dh.gov.uk/health/2013/01/response-hfea-hta/