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Author Topic: Authority Over Assisted Reproduction: What Powers Should the HFEA Have?  (Read 450 times)
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3 May 2022 - by Dr Kirsty Horsey
The UK's Human Fertilisation and Embryology Authority (HFEA) has been tasked by the Government to advise on what changes should be made to the Human Fertilisation and Embryology Act. The Progress Educational Trust (PET) event 'Authority Over Assisted Reproduction: What Powers Should the HFEA Have?' heard from an expert panel on the issues. PET's director, Sarah Norcross, said in her introduction that this is a 'once-in-a-generation opportunity to revise the legislation'. This means that care should be taken to get this right, and to future-proof regulation as much as possible.

The chair of the HFEA told the PET annual conference in December that it would make more sense for all aspects of regulation of fertility treatment to be in one place (see BioNews 1125). In her view, the HFEA's power is poorly calibrated – especially regarding sanctions it can impose. Flexibility and a 'graduated ladder of enforcement' are preferred. This more recent PET event asked how far others agree with this.

The first speaker was Rachel Cutting, HFEA director of compliance and information. She pointed out that the HFEA does not make law but must work within it. She explained that regulation was passed initially to cement public confidence in reproductive medicine. She highlighted that much has changed in the 30 years since – fertility treatment is now more mainstream and there are far fewer taboos. However, the sector itself has changed in the last 30 years too. More treatment is now provided in the private sector and often by large clinical groups. New and innovative forms of treatment continue to be developed – including those known as 'add-ons', which can be contentious. The creation of life in a laboratory remains unique and the fundamental need for a specialist regulator hasn't changed, said Cutting. There is still a need to inspect, license and provide information to the public, but the way this happens could be improved.

It is not a question of the HFEA having greater or different powers, she said – what matters is relevant power. She added that any new law must be less prescriptive and restrictive, and more agile, than the present law. She outlined her wish for future-proof legislation that put patient protection at the fore. The HFEA plans a ladder of regulatory tools to enable proportionate sanctions, the ability to look at experimental treatments and encourage innovation, simplification of consent and confidentiality requirements, and greater patient focus by assessing the quality of care provided. She outlined that the HFEA will consult in the summer and report to the Government by the end of the year – and it will then be for the Government to decide on next steps. But she sounded two notes of caution. First, though legislative change is the aim, the process could take years rather than months. Second – and more importantly – such change carries risk: Parliament could end up making things more restrictive.

The next speaker was Dr Mohamed Taranissi, founder and medical director of the Assisted Reproduction and Gynaecology Centre in London. He asked whether the HFEA having greater powers, including the ability to impose economic sanctions such as fines, was necessary. In his view, if the HFEA wants to extend its remit to consider the clinical performance of centres then we must look at reviewing its constitution. As stipulated by legislation, the majority of the authority proper (as distinct from the HFEA's executive) are lay members. Furthermore, the chair and deputy may not be medical practitioners and may not have worked in the sector. He said that if the HFEA wants to extend its remit to look at emerging technologies and treatments, then it must have members with the right expertise and the lay majority should be reconsidered, especially if they will have powers to impose sanctions.

Dr Taranissi also pointed out that the proposal for more power and financial sanctions is not new, but was previously made by the HFEA in 2004-5 when the Government announced the last major review of the legislation. The Science and Technology Committee at the time agreed that the regulator needed a wider range of sanctions but was concerned that the focus was on penalties and not on improving standards and systems. The Government did not accept financial powers for the HFEA then, as it was satisfied that the Human Fertilisation and Embryology Act's criminal provisions and measures attached to licensing were enough.

The third speaker was Marta Jansเ-P้rez, director of embryology at British Pregnancy Advisory Service and leader of its fertility services. She was speaking from the perspective of a recently opened, inspected and licensed centre and agreed that while the legislation needs review, it remains important as it ensures clinics provide high standards of care and gives people working in the sector reassurance. She said that a review of the legislation should also mean a review of the HFEA's powers, and all should be focused on optimising patient care.

Considering specific aspects of the legislation that should be reviewed, she asked whether we should retain the current welfare of the child (WoC) assessment, saying it is beyond the remit of those treating women. Later she clarified that a strong multidisciplinary approach might be welcomed, rather than pro-forma questions, especially when a child is not yet there. Also, she argued, the law should support the growing diversity of the patient population and family forms being created – including revisiting the meaning of 'mother', 'father' and even 'partner' (for example, when there is a polyamorous relationship), as well as ensuring different genders are properly treated. Additionally, the rules on confidentiality and data sharing are currently strict, even between other healthcare providers. More openness might lead to better patient care and even facilitate WoC, she argued.

Dr Debra Bloor, director of governance at CARE Fertility and previously chief inspector at the HFEA, spoke next. She agreed with others that oversight and governance should be and often is a force for good and pointed to the reduction in multiple births (see BioNews 1132) as an example of this. She argued that the benefits of regulation are achieved most effectively when delivered by experts, remembering a time when it was proposed that the HFEA's powers could be transferred to the Care Quality Commission (CQC), but it was recognised belatedly that the CQC simply didn't have the right expertise. In her view the HFEA should continue to do what it does best, but she was less sure of its capacity in relation to innovations or clinical practice. In relation to new technology, as an example, we already have the Medicines and Healthcare Products Regulatory Agency. To transfer those kinds of responsibilities to the HFEA would be time-consuming, expensive and not straightforward, and the same applies to the Competition and Markets Authority (CMA), Advertising Standards Authority (ASA), etc – who are already in place and increasingly effective at what they do.

On the question of sanctions, she said that she believed in 2005 and still now that the sector is hugely compliant. She argued that HFEA has a brilliant track record of achieving its aims through engagement and collaboration, and worried this could be lost if that HFEA had a more punitive function, which may make the relationship between regulator and regulated more combative. However, she would like the legislation to give the HFEA more power to be flexible in interpreting the law – able to take account of changes in society, family structures, issues to do with screening and confidentiality, and in relation to consent (especially regarding parenthood), arguing that the complex catalogue of existing consents can lead to mistakes.

The final speaker was Katy Lindemann, former fertility patient and now advocate and commentator on infertility and childlessness. She began by outlining the change of emphasis of the legislation over time: whereas its initial focus was protecting the public against misuse of reproductive technology, that has somewhat shifted to considering how patients can best be protected against exploitation by commercial interests.

She argued that we should consider whether the HFEA's current powers are being used effectively. As an example she discussed what informed consent means in the context of the legislation and the impact of Supreme Court case Montgomery [2015], which clearly outlined the modern legal test for informed consent, and asked how this has been translated into the HFEA's Code of Practice (CoP). An HFEA presentation last year after a CMA review was undertaken showed that only three percent of clinic websites comply with the CoP. From a patient perspective, Lindemann argued, saying that the CMA and ASA already cover this is fine, but they only investigate non-compliance if a complaint is made. 'Compliant clinics' are not always complying, as illustrated by the HFEA's recent patient survey results (see BioNews 1141), where fewer than 50 percent of respondents felt they received enough information about costs of add-on(s), evidence for their effectiveness, or potential associated risks. In addition, despite what the law and the CoP say, the patient survey showed some of the lowest ratings for support provided by clinics (including counselling).

The Q&A with the audience at the end of the event brought some of these issues to the fore again, including the composition/constitution of the HFEA, how satellite centres can be monitored and inspected (and results made available to patients), what to do with the WoC assessment, and support for donor-conceived people (especially regarding access to information). Much of the discussion came back to the difference between what is mandated in the law, and what is only guidance.

All of the speaker the presentations, and the Q&A, showed just how important it will be for all stakeholders to engage with any HFEA consultations (and more broadly) on these issues. The voices of the sector, patients and wider society need to be heard, in order that any future law is appropriate and best suited to protect patients, families, scientific advancement and innovation.

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