Speech delivered by Sally Cheshire at the 2018 Progress Educational Trust conference
Read the full speech delivered by our Chair Sally Cheshire at the 2018 Progress Educational Trust conference, that looks back at the legacy of the 2008 HFE Act.
The HFE Act: Is it broke, and should we fix it?
Good morning. Thank you to the PET Trustees, Sarah and colleagues for the invitation to speak this morning and for the important opportunity for us to take stock of the huge changes in science and society that have taken place in the ten years since the Human Fertilisation and Embryology Act was amended. As you will know, the original Act dates back to 1990, and that piece of primary legislation, several regulations in a number of areas together with HFEA directions and guidance in our Code of Practice, still form the basis of the framework by which the UK regulates patient treatment and human embryo research, maintaining the UK’s position at the forefront of innovative but safe research and treatment.
I would like to start by saying what a privilege it is to chair the HFEA, an internationally respected organisation tasked with upholding the bargain between science and society that Baroness Mary Warnock’s Committee of Inquiry into Human Fertilisation and Embryology first considered more than 30 years ago. Her Committee’s report gave rise to the 1990 HFE Act and, as the current regulator and guardian of the Act, it seems appropriate to begin by quoting Baroness Warnock:
“People generally want some principles or other to govern the development of the new techniques. There must be some barriers that are not crossed, some limits fixed beyond which people must not be allowed to go. A society which had no inhibiting limits, especially in the areas of birth, death, the setting up of families and the valuing of human life, would be a society without moral scruples, and this nobody wants.”
So where is the fertility sector in 2018 in terms of scientific research, patient treatment and the market, for it is controversially now a global market and a global scientific race to bring new fertility developments to patients.
In science, the UK was the first country to license genome editing in research and mitochondrial donation in treatment, there are calls from some quarters to relax the 14-day rule contained in the HFE Act, scientists are working on artificially derived gametes and we may be called on to consider whether entities with embryo-like features should be regulated as embryos.
In treatment, IVF developments have arguably separated biological and social parenthood and the positive definition of family has now become “one or two loving adults of either sex bringing up a child that they greatly want.” In the fertility sector we continue to try to improve outcomes in a wider sense than just live birth rates but there is no explicit mention in the Act of the important and current themes of quality of care, patient experience, emotional support or the use of data.
Against the background of these development we are reluctantly watching a market develop in the UK for a medical treatment provided (unusually) 60% by the private sector. That market is now estimated to be around £320m per annum. The Science Museum exhibition I opened in July this year to celebrate the 40th anniversary of Louise Brown’s birth was called 6 million babies later and, with some estimating that by the end of this century, 400 million babies or 3% of the global population could exist by virtue of IVF babies and their descendants, we live in a world which the HFE Act could never have predicted.
From the regulators’ perspective, of course, the law is never perfect, it begins to age from the moment of Royal Assent. We must work within the Act, even as scientific knowledge, medical possibilities, the fertility sector and broader society move on around us. First and foremost, in spite of any shortcomings in the Act, we need to provide a regulatory regime that is ‘business as usual’ for patients, who need to approach their treatment with confidence in the regime and for all those who work in clinics or research centres, who must be able to undertake that work with clarity about their regulatory obligations at any given time. So the HFE Act is our constant touchstone, it gives legal force to our Code of Practice produced for clinics, it underpins our inspection regime, and helps us to ensure patient’s interests are protected.
Our latest fertility trends report from 2016 shows 68,000 cycles of treatment taking place in 116 clinics across the UK and we expect that number to grow steadily each year. We now license more than 400 conditions for PGD (pre-implantation genetic diagnosis), license mitochondrial donation in treatment on a case by case basis and oversee the import and export of gametes to and from the UK.
So, if we consider both business as usual and the future, as we must, is the Act broken?
The slippery slope envisaged by critics of the original and amended HFE Act, hasn’t happened. We still fulfil all the statutory requirements laid out for us in the Act; we license, inspect and keep a register of licensed clinics and treatments, and we hold the biggest database of fertility treatment in the world offering vital information to donor conceived individuals at 16 or 18. The 14 day rule, despite calls for it to be extended, is still in place, and I, like Ruth Deech, a former HFEA Chair, and Mary Warnock, am not yet convinced it needs to change. We are starting to see the potential for embryos to be kept longer than the point at which the primitive streak occurs but much remains to be learnt about embryonic development before 14 days. The amended Act of 2008 introduced some important issues of the time including legal parenthood, hybrid embryo research, surrogacy and a ban on sex selection. We have been able to introduce new scientific developments which benefit patients, like mitochondrial donation, after rigorous public consultation and parliamentary debate and approval. And we can use our directions and guidance in the Code of Practice more freely than amending primary legislation to adapt to changing society, to further our aims and ambitions with respect to high quality patient care and to consider how that bargain between science and society can best be delivered.
The HFEA is not a campaigning or representative organisation, a political party or activist group. We were set up by Parliament, and like all regulators, we need to ‘make do’ without amending- often for several years or even decades. Some of our notable successes in recent years have occurred without being able to amend the Act so if you would allow me a moment to mention some of those before I come on to what we might like to change.
A reduction in multiple births
Through an ethical, responsive and collegiate approach, we have seen a reduction in multiple births (the biggest risk of IVF) from about a quarter to an average of around 11% across the UK. ‘One at a Time’ - a consensus campaign by the HFEA, professional bodies and other partners has created a huge shift through ethical power and collaborative energy.
Treatment add ons
Our latest work, on similar lines, will be on treatment add-ons where we believe the market has become corrupted and we are concerned that too many patients are being offered unproven treatment add-ons. While we do not want to put up unreasonable barriers to clinical innovation, we believe such add-ons should be available only where there is proof they work. We’ve been working with professional groups to agree a statement about how treatment add-ons should be offered ethically in clinical practice in the UK and we hope it will lead to a step change in this area.
So does the Act need to be fixed and what would I like to see changed?
This is largely a theoretical debate as the current legislative demands on Parliament mean that it is highly unlikely that the Act will be reopened in the near to mid-term future. However, as change is the theme of the conference today, I thought it was worth delving into the realms of future possibility and setting the scene for what, no doubt, will be a heated exchange of views during today.
Baroness Thornton said in the House of Lords debate celebrating 40 years since Louise Brown’s birth that the UK fertility system was “reaching middle age in good shape” but there are clearly areas where the Act has not kept up with either scientific advances or changing society and is starting to show its age. Let me set out three connected but distinct sets of changes – social, scientific and regulatory framework changes.
New areas of scientific research will reach a point where they show real promise for patients, meaning that, ethically, a treatment should be able to be offered to patients without unnecessary further delays. In the week it was revealed a Chinese scientist may (or may not) have genetically modified a human embryo to make it HIV-resistant, germline genome editing, the 14-day rule, the use of in vitro derived eggs and sperm in treatment or bringing embryo-like entities into regulation will all be challenges in the years to come and I hope we will manage robust debate and consultation on these issues before any legislative changes are potentially made.
In the meantime, we can improve the quality and impact of the research we license and could, for example, consider measures to encourage egg and embryo banking arrangements for research, offering more choices for patients who want to donate to research and reducing the wastage of eggs and embryos.
Socially, there are clearer and more immediate changes which could be brought in - increasing the 10-year limit on social egg freezing for example; or where the Act is silent, as I said, on an express duty of care. The Law Commission is currently looking into surrogacy which seems likely to and build on the 2018 guidance.
In terms of regulatory powers, despite the progress made in some key areas, we are out of line with most modern regulatory regimes and our current powers are few and far between: close a clinic; change the length of a licence; have more frequent or unannounced inspections. These sanctions are hardly proportionate in 2018 and we have no economic powers to regulate the price of IVF including add-on treatments across the NHS and private sectors. To be clear, I would welcome giving the HFEA powers of economic regulation, because in a niche sector we can make a real difference for patients.
In conclusion, it’s important to remember that whilst we are talking about the rather dry subject of an Act of Parliament, fertility treatment and research highlights some of humanity’s most sensitive areas- sex and gender, birth and parenthood, science and medicine, human genetics and modern families. Our debates and policy decisions hold up a mirror to some of our deepest social values around genetic, biological legal and social relationships; between children, parents and the altruistic third parties willing to assist by donating gametes or embryos. The often disruptive - but often life-affirming intervention of new technologies upon all of those relationships tests the nature and limits of what the state’s role should be in relation to parenthood in all its wonderful forms.
The ability to retain public trust and confidence via regulation is still key today and has been ever since Mary Warnock and her Committee laid out the ethical framework. I believe it has stood the test of time and provided a safe haven for progress. My contention is that it isn’t broken but would benefit from a few enhancements.
We at the HFEA will work with what we have and as we set out our refreshed strategy to 2023, our aims remain absolutely central to the HFEA’s ambition - high quality care and research; consistent outcomes and support for all patients; and improved standards through using the huge amount of intelligence we hold. I would like to end by paying tribute to the wisdom of Baroness Warnock, the legislators, parliamentarians, policy makers and the public who have made it work so far. We can’t legislate for the rest of the world, but we can be proud of the UK’s bargain between science and society.
I hope you enjoy the rest of the conference and debates today. Thank you.
Publication date: 20 December 2018
Review date: 20 December 2020