Inside EU Health: EMA’s ambitions for women; Pharma Package; EU fertility falls to record low; Novo

EMA chief lays out her ambitions for women’s health

To mark International Women’s Day, EMA Executive Director Emer Cooke outlined her ambitions for addressing women’s health needs during the remaining thirteen months of her mandate, “not as a symbolic gesture, but to improve the quality of care for millions of people across Europe.”

Cooke highlighted a consultation on guidelines for including pregnant and breastfeeding women in clinical trials, but stressed that guidance alone is not enough. “We want to continue supporting developers in designing trials that reflect women’s needs across the life course, from adolescence to menopause and beyond.”

Real-world evidence could also help accelerate progress in areas where women have historically been underserved, such as endometriosis, postpartum depression, and other conditions where treatment options remain limited.

“We have already used the DARWIN EU network to examine the risks of combined hormonal contraceptive pills across Europe, and we are now looking at how hormone replacement therapy is used in real-world settings,” she said.

“When it comes to the development of new medicines, women need to be less of an afterthought,” Cooke said.

Council publishes Pharma Package agreed text

The Council has finally published (6 March) the agreed texts from last year’s pharma package negotiations, which were finalised at around 4:00 a.m. on 11 December.

The documents consolidate the complex agreements reached and cover more than 400 articles across a regulation and a directive.

These are not yet the definitive final texts that will receive formal approval by the Council and at the Parliament’s second reading, as translation and legal revision are still pending.

Adoption is currently expected in the autumn.

EU reaches landmark pharma deal after marathon overnight talks

In the early hours, the Parliament and Council managed to reach a deal on one of the EU’s most complex legislative proposals, the Pharma Package

Vital SignsCatherine Feore

EU fertility rates fall to record low of 1.34

An estimated 3.55 million babies were born in the EU in 2024, 3.3% fewer than in 2023. The total fertility rate fell to 1.34 live births per woman, down from 1.38 a year earlier, marking the lowest level since EU-wide records began in 2001.

The United Nations Population Division considers fertility below about 2.1 births per woman to be sub-replacement level. As populations age there is growing concern about how the social and healthcare systems can continue in their current form.

EU fertility falls to record low as population continues to age

New data released by Eurostat show that fertility across the European Union fell to its lowest level on record in 2024, while the population continued to grow older

Vital SignsCatherine Feore

Novo Nordisk reaches an agreement with Hims &Hers

Today, Novo announced that it has struck a deal with ‘Hims and Hers’. The US telehealth provider will no longer advertise compounded GLP-1 offerings on its platform or in its marketing. Its existing patients will be offered “the opportunity” to transition to the FDA-approved Novo products.

In February, US regulators issued a warning to telehealth company Hims & Hers after it announced plans to sell a compounded version of the Wegovy pill. Hims has long been a thorn in the side of Novo, selling compounded versions of the GLP-1 semaglutide, the active ingredient of Wegovy and Ozempic. This was initially allowed to address shortages, but the sales continued and the Danish giant was engaged in a legal battle.