Why we need Siobhain McDonagh's bill to amend the HFE Act

'It is...time that the law ensures the welfare of women is at the heart of IVF law so that IVF enables the celebration of new life, whilst protecting those women undergoing it.' Siobhain McDonagh, Labour MP for Mitcham and Morden

For the last few months I have been involved with Siobhain's parliamentary push to protect the welfare of women in IVF law.

My background is in the voluntary sector rather than politics or reproductive medicine. And since early November, I have been engaged with the #SaferIVF campaign; working with Siobhain and her office to proactively listen to the IVF sector.

The core objectives of the 'Safer and Better IVF Campaign' are:

• To get an explicit added commitment to safeguard the welfare of women preparing for and undergoing IVF treatment into the Human Fertilisation and Embryology Act
• For the Human Fertilisation and Embryology Authority (HFEA) to collect information about drugs and dosages administered to women during IVF and early pregnancy
• To ask the government to investigate amending disclosure rules, specific to fertility treatment. We anticipate that linking the HFEA registry with hospital, cancer, birth and death registers would enable accurate recording and publication of the links between IVF and severe ovarian hyperstimulation syndrome (OHSS), cancer and mortality among women

The working assumptions are:

• That women undergoing IVF treatment are subject to emotional and financial pressures that put them in an acutely vulnerable position when making decisions about treatment
• That better data collection and monitoring should improve the evidence base for IVF treatments; ultimately leading to more effective treatment (more successful pregnancies). It should also, in theory, reduce the likelihood of women suffering negative health effects, for example OHSS.
• There is no centralised monitoring of drugs and dosages prescribed to women during IVF in the UK presently
• That amending disclosure rules specific to fertility treatment would enable routine data linkages between the HFEA registry and hospital, cancer, birth and death registries
• That permanently linking these registries should help accelerate evidence on the short and long-term impact of IVF on the growing number of women undergoing treatment

During the campaign we proactively sought conversations with the HFEA, the British Fertility Society, diverse academics and clinicians, and patient support groups, such as IVF Babble, Donor Conception Network and Fertility Network.

Key concerns raised included an insufficient understanding of the emotional impacts on women undergoing or recovering from IVF treatment, as well as understanding successful interventions. The acute vulnerability of women undergoing treatment can put them in a precarious position when trying to make informed decisions - safeguards are needed.

OHSS, and the need to reduce its incidence was another issue. OHSS can occur in some women who take fertility medication to stimulate egg maturation. OHSS symptoms range from bloating and nausea through to hospitalisation and, in its most severe form, it can be fatal. The Office for National Statistics notes two known deaths registered in the UK as a result of OHSS, while a Confidential Inquiry into Maternal Death in the UK noted at least four deaths.

Peer-reviewed papers suggest that one third of women undergoing IVF at present suffer from mild OHSS, with 3-8 percent of cases being moderate or severe, according to HFEA data. It is clear from the differences in data recorded by clinics, the HFEA and NHS that processes and systems for identifying, reporting and preventing OHSS can be better.

Unproven 'add-ons' are another area where we need to continue to push for an evidence-based approach. The documented widespread use of these treatments was flagged frequently, with continued concern about the lack of evidence of their efficacy and the potential for adverse health impacts.

We also need increased access to relevant data for quality research. We heard that it is often time-consuming for researchers to undertake data-linking studies (for example between the HFEA registry and cancer registry) due to different confidentiality rules for fertility treatment. This is an important deterrent to research to understand the health implications of IVF treatment on women. With over 75,000 cycles of IVF being conducted annually we heard compelling arguments that this treatment is at a scale where linking databases is essential.

We heard from the HFEA about its concerns that additional regulation could stifle innovation; and that the data currently collected is sufficient for research purposes. Yet, we heard from others convincing arguments about the potential benefits of big data and examples of retrospective raw data analysis exposing unexpected correlations and links. Ultimately, we felt that the benefits of improved transparency outweighed the potential pitfalls.

Experts such as Professor Rene Frydman, the 'father' of France's first test tube baby stressed the need to link data registries. 'Without this data it is impossible to build accurate understanding of any short or long-term impact of IVF on women undergoing treatment… [this] is already happening in other countries. It is time for the UK law to catch up,' he said.

Marina, an IVF patient and chemist in her professional life stated: 'The lack of regulation is especially worrying as women going through IVF are in an incredibly vulnerable position and will often accept any level of risk if it might increase their chances of success. It should be the responsibility of the government to make sure that they are not forced into making this decision.'

The internet and social media channels are awash with open and closed forums where patients discuss every aspect of IVF. We were concerned to find so many women with their own personal experiences of moderate and severe OHSS. A couple of the most powerful stories included Sara Marshall-Page's (co-founder of IVF Babble) blog, and that of Kathryn, writing in First Hand Experience.

I think that Jessica Hepburn, author, patient advocate and fertility campaigner articulates our conclusions best: 'In an environment where individual anguish meets an emerging area of medical science, society has a duty to ensure it does its utmost to protect the welfare of patients - women, men and the children who are born as a result… Better collection of data relating to the drugs and treatments prescribed during IVF treatment has got to be a no-brainer.'

Siobhain's bill will be read for the second time on 5 April 2019. In the next parliament the intention is to continue to push for legislative change and a national debate on fertility. We welcome you to get in touch with your suggestions for improving the welfare of women undergoing treatment.