BRUSSELS — EU lawmakers have clinched a long-awaited agreement on the bloc’s overhaul of its two decades-old pharmaceutical rules — one of the EU’s biggest health files. The revamp is designed to restore Europe’s competitive edge and give companies more certainty that the EU remains an attractive market, while also pushing for more equal access to medicines across member countries. The deal between the Parliament and the Council was struck at 5 a.m. on Thursday, more than two years after the Commission tabled the proposal, which consists of directive and regulation, in spring 2023.  It marks a major victory for the Danish presidency, which pledged to wrap up the file before the end of the year, and for Health Commissioner Olivér Várhelyi, who has pushed to seal the reform amid growing geopolitical uncertainty.

Fake weight-loss drugs are increasingly being advertised and sold across the EU, posing a serious public health threat, the bloc’s drugs regulator warned today. The European Medicines Agency said there has been a “sharp rise” in the number of illegal medicines marketed and sold as GLP-1 agonists, such as the popular semaglutide, liraglutide and tirzepatide, in recent months. Authorities have identified hundreds of sham Facebook profiles, advertisements and e-commerce listings promoting the fake drugs. These websites often mislead customers by using official logos and false endorsements, the EMA said. While genuine versions under the brand names Wegovy, Ozempic, Saxenda and Mounjaro are available through legitimate health services and with a prescription, the fake versions are “not authorised and do not meet necessary standards of quality, safety and efficacy,” the agency said. “Such illegal products pose a serious risk to public health. They may not contain the claimed active substance at all and may contain harmful levels of other substances,” the EMA warned. “People who use these products are therefore at a very high risk of treatment failure, unexpected and serious health problems and dangerous interactions with other medicines.”