Inside EU Health: US tariffs and MFN pricing threaten EU investment and access; EMA and FDA agree good AI; ECDC issues warning on Doxy-PEP
Inside EU Health: US tariffs and MFN pricing threaten EU investment and access; EMA and FDA agree good AI principles; ECDC issues warning on Doxy-PEP
US tariffs and MFN pricing threaten pharma investment and access in Europe
US tariffs and pricing pressure are causing uncertainty for the pharma sector, delaying investment decisions and patient access to new medicines in Europe, according to a new industry survey conducted for the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE).
The survey, carried out by Copenhagen Economics asked companies about the US imposition of 15% tariffs on non-generic medicines and what the Trump administration refers to as “most-favoured nation” (MFN) pricing. The survey responses suggest these policies may prompt companies to reconsider investment and launch strategies, potentially shifting activities away from the EU27.
Catherine Feore
EMA and FDA agree on ten principles for good AI
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle.
The principles are relevant to the development of medicines, as well as for marketing authorisation applicants and holders.
Principles include ensuring that data provenance is traceable and verifiable, protecting privacy, and providing scheduled monitoring and periodic re-evaluation to maintain adequate performance.
"The guiding principles of good AI practice are a good showcase of how we can work together on the two sides of the Atlantic to preserve our leading role in the global innovation race, while ensuring the highest level of patient safety,” said Olivér Várhelyi, European Commissioner for Health and Animal Welfare.
The European Commission’s new pharmaceutical legislation aims to support the broader use of AI in the lifecycle of medicines decision-making and creates additional possibilities for testing innovative AI-driven methods.
ECDC reviews evidence on Doxy-PEP and danger to AMR
The European Centre for Disease Prevention and Control (ECDC) has reviewed evidence and raised public health concerns about the use of doxy-PEP, which could be accelerating antimicrobial resistance not only against bacterial sexually transmitted infections (STI) pathogens, but also against other bacteria, including Staphylococcus aureus.
On this basis, ECDC does not recommend doxy-PEP as a population-level intervention. When used, the agency says it should be targeted at those at highest risk, and focused mainly on syphilis prevention and seen as part of a broader sexual health strategy.
