Healthy Mum, Healthy Baby, Healthy Future: The case for UK leadership in the development of safe medicines for use in pregnancy (Birmingham Health Partners, May 2022)

Summary

In a UK-first report launched in the House of Commons, leading figures from charity, healthcare, industry, law and academia have outlined a collaborative vision for UK leadership to improve maternal health. The Healthy Mum, Healthy Baby, Healthy Future: The Case for UK Leadership in the Development of Safe, Effective and Accessible Medicines for Use in Pregnancy report proposes a clear roadmap to improve the lives of millions of people, not just for women while they are pregnant, but for future generations.

Over the past year, a Birmingham Health Partners led Policy Commission – co-chaired by Baroness Manningham-Buller, Co-president of Chatham House and Professor Peter Brocklehurst, University of Birmingham – has heard from key stakeholders on how best to develop safe, effective and accessible medicines for use in pregnancy. Compelling evidence gathered throughout the process has informed eight critical recommendations which, if implemented by government, will successfully prevent needless deaths and find new therapeutics to treat life-threatening conditions affecting mothers and their babies.

Content

Recommendations

1. Deliver effective advocacy for medicines in pregnancy through a coalition of pregnancy and baby charities, working together with the public, researchers from academia and industry as well as Government to create a shared vision for safe medicines evaluation and development in pregnancy. This will allow for clear and consistent messages to the public and clinicians.
2. Pregnant women should be offered the opportunity to take part in all clinical trials of medicines that could be used in pregnancy, unless there are specific safety concerns.
3. Prioritise updates for existing medicines with the potential to be used in pregnancy, with regulators and industry working towards pregnancy-specific information on safety, dosing and effectiveness. Resources should be put in place to maintain this activity, particularly for generic medicines.
4. De-risk insurance processes for early and late phase clinical trials of new and existing medicines for use in pregnancy, using lessons and successes from other challenges.
5. Incentivise industry to develop pregnancy-specific medicines, utilising cross-stakeholder working to ensure that the UK is in a globally-competitive – and globally-collaborative – position to drive drug development for pregnancy-specific conditions.
6. Establish a UK-wide national network of research centres encouraging major public and private investment and collaboration in pregnancy research expertise and infrastructure. This will ensure sustainable drug development from discovery science through to pre-clinical screening tools and clinical evaluation.
7. Improve use of routine clinical care maternity data to help assess the safety and effectiveness of new and existing medicines used in pregnancy. Establish a designated maternity ‘Health Data Research Hub’ through Health Data Research UK with a focus on medicines evaluation in pregnancy.
8. Appoint a UK Steering Committee aligned to the Government’s Women’s Health Strategy to deliver the above recommendations, with oversight of implementation, ensuring milestones are set and monitored.