As the European Commission prepares to publish its proposals for overhauling the EU pharmaceutical legislation at the end of the year, member states have been discussing a range of technical and legal issues such as the scope of the centralized approval procedure, the use of electronic product information and the shortage of inspection capacities.

EU member state authorities have been told they can use Jynneos, the US version of Bavarian Nordic’s smallpox vaccine, for the prevention of monkeypox. The bloc is also buying some 110,000 doses of the vaccine, with deliveries expected to begin shortly.

The new regulation on cross-border threats to health is the final part of the European Health Union, along with strengthened roles for the European Medicines Agency and the European Centre for Disease Prevention and Control. Its aim is to ensure collective EU action on preparedness, surveillance, risk assessment, and early warning and response in the event of health emergencies.

Experiences during the COVID-19 pandemic are expected to help identify future opportunities for regulatory cooperation on real-world evidence and avoid divergent decision-making for products including advanced therapies and personalized medicines.

A rolling review of an adapted version of Moderna’s COVID-19 vaccine Spikevax aimed at variants of SARS-CoV-2 has begun at the European Medicines Agency. The EMA has also given an update on its latest vaccine safety reviews, including reports of heavy menstrual bleeding with Spikevax and Comirnaty.

R&D-based companies have denounced what they see as a dangerous and unjustified attack on intellectual property after the World Trade Organization’s ministerial conference finally adopted a decision on an IP waiver for COVID-19 vaccines. NGOs, by contrast, say the decision amounts to little more than a limited exception to existing rules on the compulsory licensing of medicines.