EU regulator steps up efforts on women’s health

The European Medicines Agency (EMA) has unveiled a series of initiatives designed to address low representation of women in clinical trials and gaps in understanding sex-based differences in the effect of treatments.

The move is an attempt to rebalance historic and ongoing issues in women’s health. Although there are differences in how men and women experience illness, and in the response to treatment, clinical trials recruit disproportionate numbers of men. As a result, some treatments do not fully meet women’s specific needs. Certain conditions, such as preeclampsia, menopausal symptoms, and endometriosis, remain insufficiently recognised or addressed.

Women live longer than men on average but spend more of their lives in poorer health. This disparity is due, in part, to gaps in disease prevention, diagnosis, and treatments, which do not always fully address the specific health needs of women. Now the EMA says it will proactively embed women’s health considerations in medicines development and regulation.

The regulator will broadcast a women’s health workshop on 28-29 September, examining gaps in women’s health needs and identifying priorities for more inclusive clinical research.

The workshop is part of a wider effort to address sex-specific differences in care. The European Clinical Trials Regulation now requires that people enrolled in trials reflect the populations likely to use the medicine; manufacturers are required to list sex-specific differences, such as differences in dosage requirements, on medicine labels; the EMA is seeking to strengthen the evidence on the use of medicines in pregnancy and while breastfeeding; and real-world evidence will have a greater role in reducing regulatory uncertainty regarding the effect of medicines on women.

‘Advancing developments in women’s health is one of my personal priorities,’ said EMA Executive Director, Emer Cooke. ‘This is an area where we are seeing strong momentum at EU and global level, and where EMA is well placed to drive meaningful progress and help shape a clear path ahead. As medicines regulators, we have a role to play to enable the development of products that are better tailored to women’s needs.’