The UK's Human Fertilisation and Embryology Authority (HFEA) is incompetent, poorly organised, and should be scrapped or replaced with a more flexible body, according to Robert Winston. The fertility doctor and broadcaster made his comments on BBC Radio 4's 'Today' programme, aired on 10 December. In response, HFEA chair Suzi Leather said that she did not agree with Winston's comments 'at all', and that the HFEA is 'making decisions in the way Parliament has asked us to make them'.
Winston criticised the HFEA for its 'shocking mismanagement' of recent issues, such as its decisions on 'saviour siblings', tissue-matched IVF babies conceived to treat existing sick children. And referring to the HFEA's recent decision to allow couples to select embryos free from an inherited form of bowel cancer, Winston alleged that the HFEA 'didn't even seem to remember' that it had already issued a licence for this treatment ten years ago. Winston called for the authority to be replaced, with 'something a great deal less bureaucratic, which doesn't inhibit research, which has a better consultation process with the public and which has a much more adequate inspection process'.
Winston also called for the law governing assisted reproduction and embryo research - the 1990 Human Fertilisation and Embryology Act - to be revised. He said that 'it's very strange that one form of treatment - IVF - is singled out for regulation. And not even the whole of infertility treatment is covered'. He also questioned the tight regulation of PGD (preimplantation genetic diagnosis), which allows doctors to select IVF embryos free from serious genetic diseases. PGD is regulated by the HFEA on a case-by-case basis. In contrast, a pregnancy affected by a genetic condition can be terminated without permission from a regulatory body, a situation that Winston described as 'inconsistent'.
Also speaking on the radio programme, Suzi Leather rejected Winston's criticisms, saying that regulating IVF is 'not like regulating gas and electricity prices', because of important issues of patient confidentiality. She argued that regulation gives patients confidence that they would be dealt with 'with a decent level of proficiency'. She also added that the HFEA's bureaucracy costs 'are lower than what the Treasury sets for regulators in general'. However, Ms Leather said the HFEA did accept that Parliament needed to examine issues surrounding infertility treatment again, because the HFE Act is now 14 years old. 'Science has moved on very fast and some of the treatments were not envisaged when Parliament last looked at this', she said.
In a press statement issued later that day, Ms Leather pointed out that other countries are copying the HFEA style of regulation, 'with regulators being set up in France, Canada and parts of Australia'. Fertility doctor Simon Fishel, from the Centre for Assisted Reproduction In Nottingham, told the Scientist magazine that although he thought the HFEA could be more flexible, it still had a vital regulatory role to play. But he called for an end to the inspection of fertility units by other fertility specialists, saying 'there's a potential conflict of interest where we inspect each other'.
The UK government's Department of Health is planning to review the country's fertility and embryology legislation, with a full public consultation on the issues due to take place in 2005. The outcome of a review already being undertaken by the House of Commons Science and Technology Committee will also be taken into account.