The Role of the Regulator: UK Perspectives

The first session of the Progress Educational Trust (PET)'s 2021 annual conference 'Reproducing Regulation: Who Regulates Fertility and How?' was 'The Role of the Regulator: UK Perspectives', chaired by PET's director Sarah Norcross. The speakers were Julia Chain, chair of the Human Fertilisation and Embryology Authority (HFEA); Dr Louise Strong, director of consumer protection at the UK Government's Competition and Markets Authority (CMA); Dr Raj Mathur, chair of the British Fertility Society (BFS); Professor Allan Pacey, head of oncology and metabolism, at the University of Sheffield; and Juliet Tizzard, director of policy and Partnerships at the Health Research Authority (HRA).

Julia Chain's presentation – entitled 'The HFEA 30 Years On: What Needs to Change?' – argued that vast changes in science and societal attitudes since 1990, as well as the different ways people use fertility treatments to create different types of family, mean that the law must be modernised. With around 390,000 babies born through IVF in the UK, and around 70,000 cycles per year across over 100 licensed clinics, it is imperative that legislation allows the regulator to function effectively.

There has also been a large shift towards private and commercialised fertility treatment provision and now more than 65 percent of patients self-fund their treatment in the private sector, yet the Human Fertilisation and Embryology Act, which envisaged treatment largely being provided on the NHS, is silent on 'patients', 'patient safety, and 'outcomes', which is particularly worrying given the move toward more patients being consumers. Chain singled out three areas where reform is particularly needed: patient protection, scientific development and consent, data-sharing and anonymity.

Chain said that patient-centred care was not a central pillar of the Act, something she views as important, especially in an era of increased commerciality. Reforms are necessary to allow the regulator to have better enforcement mechanisms and drive improvements in both individual providers and across the sector. She proposed a 'graduated ladder of enforcement' and powers to hold fertility treatment providers accountable – for example for mis-selling treatments. While some 'add-ons' are valuable for some patients, she said, she expressed concern that transparency around effectiveness, suitability and, ultimately, price, was not always present. While ongoing work with the CMA and Advertising Standards Authority would help, she said, the fertility regulator having 'end-to-end' powers would also help.

Scientific developments mean that the Act has become overly prescriptive where it needs to become more flexible and futureproof. Chain advocated for legislation that continues to respect the 'Warnock principles' – eg, allowing research to take place on human embryos, but with clear bright-line limits – while acknowledging that some of those have been overtaken. New legislation needs to be able to respond more nimbly to developments. Similarly, the legislation must change how it deals with consent, which Chain views as the 'cornerstone of the Act'. Consent taking procedures in the context of both patients' treatment and in donation are more costly and onerous than they should be, which may have implications on parental rights, leading to court intervention. The Act also makes data-sharing difficult, which has negative implications for research and for patients, especially if they move between clinics.

Next, Dr Strong spoke on 'The Competition and Markets Authority (CMA) Guidance, Its Impact and What Next', in the context of the CMA's recommendations published in June 2021 (see BioNews 1099). These concerned the information clinics should provide to prospective and current patients, and the compliance review starting in December. She explained that the growth of self-funding patients due to inability to access appropriate treatment on the NHS means that consumer law becomes increasingly important, particularly as many patients are not used to purchasing healthcare and are engaged in one of the most important service purchases of their lives, often all in the context of deference to medical professionals and a large understanding/power imbalance. The CMA's research had shown that cost is a massive concern for patients, yet they are often reluctant to raise issues in case they 'don't seem committed enough' to their treatment. Also, patients have lots of clinics to choose from and, while NHS patients have recourse to an Ombudsman, private fertility patients are protected by consumer law, so this should be adhered to.

The CMA advocates for fair contract terms, information to be provided upfront to allow patients to make properly informed choices and for there to be no misleading of patients by act or omission (such as 'cherrypicking' success rates). Its compliance review will start by looking at clinics' websites and their terms and conditions, alongside commissioned patient research and discussions with stakeholders. Stakeholders, including patients, will be able to report things they consider concerning via a dedicated email address. Ultimately, the review will result in a report, but may also lead to enforcement actions being taken.

In his presentation 'Help Us to Help Our Patients: How Clinics and the Regulator Can Support High-Quality Care', Dr Mathur agreed that times have changed since the HFE Act was first enacted and questioned even whether IVF needed separate regulation anymore, as it is now so commonplace as to be 'just another medical treatment'. Embryo and gamete manipulation, donation and research should be regulated, he thought, though agreeing that there was a need to modernise the law in these respects.

He noted that there was often an imbalance of power between clinic and patient and argued that patient empowerment is important, as well as 'fairness' towards and between patients, including in the NHS, where he recognised funding disparities across the country and the 'lottery' patients find themselves within. He agreed with Dr Strong on the need to present information (in both the public and private sectors) in a more patient-centred way, referring to his creation and leadership of the BFS special interest group set up to consider fairness and equity in fertility treatment provision, to help patients make the right choices and reduce burdens on clinics while facilitating research.

Finally, Professor Pacey and Juliet Tizzard, in an engaging and educational double-act, talked (or was it acted?) us through 'From Bench to Bedside: How Can We Get Proven Innovation to Patients?', to show us how research projects get off the ground. Using a fictitious rhubarb-based research project, where the hypothesis was that rhubarb pills might improve semen quality and consequently IVF outcomes, Professor Pacey described wishing to set up a randomised multi-centre study involving 200 patients taking the pills against a control group of 200 taking a placebo and asked Juliet Tizzard 'what do I have to do next?'

In response Tizzard explained the often protracted processes involved in starting such a project. As an ethics review would be required, she asked Professor Pacey to consider the ethical issues including in recruitment of subjects, the interventions they might endure, and what information they might receive before, during and – crucially – after the study, as well as how the research findings would be disseminated and made visible more broadly. There would also have to be NHS governance checks, and any 'medicines' would need the approval of a different agency, as would the scanning of patients. Licences from the HFEA and maybe the Human Tissue Authority may need to be considered. However – in better news – she explained that it was exactly the function of the HRA to co-ordinate all of that.

As Professor Pacey pointed out: 'This is all very complicated!' . He then moved the hypothetical scenario on 12 months where all of this had been done at significant additional cost, and where the media engagement he had secured had now backfired, as competitors had emerged and patients decided to buy their rhubarb pills elsewhere on the internet. This led Professor Pacey to outline a 'research culture issue', namely that reproductive medicine in the NHS is not as good as some other parts of the NHS (such as cancer) where research and clinical care go 'hand in hand’.

Overall, the session was enlightening, highlighting areas of regulation that might usefully be reformed. Julia Chain's commitment to moving on this soon (see BioNews 1124) was particularly welcome.

The Progress Educational Trust (PET) would like to thank the sponsors of its conference – the Anne McLaren Memorial Trust Fund, the Edwards and Steptoe Research Trust Fund, ESHRE, CooperSurgical, Ferring Pharmaceuticals, Hart Publishing, Merck, the Society for Reproduction and Fertility, Theramex, TMRW Life Sciences, Vitrolife and the Institute of Medical Ethics.

Register now for PET's free-to-attend online events in 2022:

• Whole Genome Sequencing at Birth: What Research Can, and Should, Be Done with a Baby's Genome? (19 January 2022)

• Adding Up What We Know: A Global Perspective on Fertility Treatment Add-Ons (26 January 2022)

• Prioritising Patient Safety: How to Minimise Risk in Fertility Treatment (9 February 2022)

• Whole Genome Sequencing at Birth: Genomic Data, A Resource from Cradle to Grave? (16 February 2022)

• Whole Genome Sequencing at Birth: Workforce Implications for Healthcare Professionals and Beyond (16 March 2022)