Today’s report led by the University of Birmingham ‘Healthy Mum, Healthy Baby, Healthy Future: The Case for UK Leadership in the Development of Safe Medicines for Use in Pregnancy’ is a thoughtful look at how to improve the number of medicines available to pregnant women.
Just two medicines for pregnant women have been approved in the last forty years. The ABPI and our members are working to improve this and addressing some of the key challenges identified in the report.
The EU Innovative Medicines Initiative (IMI) ConcePTION project for example, is a pan-European public-private initiative involving more than 15 industry partners. It aims to establish a trusted ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate and disseminate reliable evidence-based information on the effects of medications used during pregnancy and breastfeeding to women and their healthcare providers.
Another pan-industry initiative is the TransCelerate Interpretation of Pharmacovigilance Guidances & Regulations Initiative, which aims to analyse the current regulatory guidelines for addressing pregnancy and breastfeeding from early clinical development to post-marketing settings and propose solutions to help pharmaceutical companies better understand and comply with these regulatory requirements.
But there’s a lot more to do. Today’s report rightly highlights that the whole health system must work together to address this issue.
There are constructive solutions in the report that will help. Unblocking insurance as a barrier to involving pregnant women in clinical trial research would be a major step forward. Data-poor risk assessment and resulting high premiums deter much research, which in turn could improve the data used for such assessments. Breaking this vicious circle could increase the confidence to carry out trials including pregnant women.
It will also be important to incentivise and drive research and development to improve our ability to generate safety and efficacy evidence. Improved research models that generate safety information before human trials can better inform the treatment decisions. With true collaborative working (industry, academia, charities, regulators, patients and clinicians), clinical trials can be a more inclusive activity and yield safer medicines for all.
To maximise the impact of the recommendations, there is a need for national and international national action. In the UK, the Women’s Health Strategy is an opportunity for change, with maternal health a key priority for the strategy.
Industry is committed to working with Government, regulators and the wider life sciences sector to put the constructive solutions of this report into practice, to benefit pregnant women, their families and everyone else in society.
- Clinical research