A vision for changing the wellbeing of future generations by tackling the longstanding shortcomings in maternal healthcare
The development of new medicines for pregnant women has stood still for the last 40 years. Here’s what we need to do to change this.
Did you know that the health of your grandmother during the conception and birth of your mother still plays a significant role in your health today? So, should she have needed medications while pregnant, what was available for her and the following generations over the last 100 years in the UK?
Surprisingly, not too different from today. In the last few decades, only 2 medicines have been licensed for the treatment of pregnancy-specific conditions such as pre-eclampsia (early signs include high blood pressure and protein in urine) and pre-term labour. If you’re surprised by this, you wouldn’t be alone. When you or someone you know goes through a pregnancy with no complications and with no need for medications, it is easy to be oblivious to the fact that this is not the norm — indeed, three out of four women take some form of medication during pregnancy.
However, a lack of data on the safety of many medicines in pregnancy means that GPs and patients are faced with very little information to make decisions on how to best manage taking medications during pregnancy. This includes many medications taken in the management of mental health conditions, where we know that the risk of developing a condition or relapsing during pregnancy and after birth is high. Without sufficient knowledge of the impacts of taking medicines to manage these conditions during pregnancy, women are faced with a difficult choice about whether to start or even continue with treatment. Tackling this problem could make a big difference for these women and their children, with maternal mental health being a key factor in a child’s mental and physical health as they grow up.
This was one of the important issues explored in detail in 2021 by the Birmingham Health Partners Commission for Safer Medicines in Pregnancy and Breastfeeding, led by Baroness Manningham-Buller, currently a member of the House of Lords Science and Technology Committee, and Professor Peter Brocklehurst of the University of Birmingham. Their goal was to gather evidence from key opinion leaders in pregnancy and baby charities, the NHS, universities, industry, and government regulators to help set out a clear agenda for what needs to be done to improve the lives of women whilst they are pregnant, and the health of future generations.
The findings spoke for themselves: if we do not develop new treatments for pregnancy-specific conditions and assess the safety of already available medications, pregnant women and babies throughout the world will continue to get sick and die from largely preventable or treatable causes.
As heard by the Commission, the challenges around developing and testing medicines for pregnant women are complex. Not least the lack of understanding of basic human reproductive biology from the early embryo to the physiology of the mother. But, a collaborative effort across all parties involved in medicines research & development and healthcare delivery, combined with political will, could greatly change the outlook for mothers-to-be in the UK.
The UK government has recently taken a step forward in this space, publishing its first Women’s Health Strategy on Wednesday 20th July 2022. Healthcare during pregnancy was highlighted as a priority area for change by the nearly 100,000 individuals who responded during the strategy’s call for evidence. Charged with bringing about the system-level changes required to close the gender health gap is Dame Lesley Regan, Professor of Obstetrics and Gynaecology at Imperial College London, who has been appointed as the government’s first-ever Women’s Health Ambassador.
So how can the UK deliver on its commitments around women’s health set out in the recently published strategy and keep up the momentum on addressing the reality faced by the women and girls who make up 51% of our population?
In May 2022, the Birmingham Health Partners Commission launched Healthy Mum, Healthy Baby, Healthy Future: The Case for UK Leadership in the Development of Safe Medicines for use in Pregnancy. It lays out 8 recommendations for bringing safe medicines to pregnant women, including the need to incentivise all parts of the system to develop pregnancy-specific treatments, as well as to increase the safety data and information on existing medicines.
The report calls for the creation of a shared vision for safe medicines evaluation and development by reducing barriers to the inclusion of pregnant and breastfeeding women in clinical trials and setting up research centres that invest in pregnancy research. The pharmaceutical industry also has a critical role in finding solutions. Currently, companies are part of international projects like IMI ConcEPTION and TransCelerate to improve the data available for the regulators and researchers doing this work. The Association of the British Pharmaceutical Industry (ABPI) supports the aims of the Women’s Health Strategy, and as an industry, we co-proposed the development of new guidelines on the inclusion of pregnant and breastfeeding individuals in clinical trials at the top table of international regulation.
To truly maximise the impact that we can have on the care of pregnant women and their babies, there is a need for collaborative action on a national and international scale. In the UK, the Women’s Health Strategy is an opportunity for change, with maternal health a key priority. We must bring together the public, scientific, clinical, industry, regulatory and government sectors to address the recommendations of the Commission’s report and make maternal healthcare the best it can be. Health in pregnancy reverberates down through the generations, and by addressing this, we can save lives and boost the wellbeing of mothers and babies in the UK and across the world.
About the authors:
Steve Hoare is a Policy Director for Quality, Regulatory Science and Safety at the Association of British Pharmaceutical Industry (ABPI), sat on the Commission and co-authored the report.
Hannah Chance is a Research Policy Executive at ABPI, sits on the Maternal Health Group that provided some of the Commissioners and expert witnesses, and leads on policies to support Equality, Diversity and Inclusion (EDI) in medicines research.