The European Union has started pharmaceutical reform, aiming to modernize outdated regulations and improve access to medicines, particularly in response to rising antimicrobial resistance (AMR). The European Parliament and Council have proposed different approaches, especially on regulatory data protection and innovation incentives. The Parliament supports shorter exclusivity periods with targeted extensions to promote equitable access, while the Council favours longer base protections to support industry investment. Both institutions back the use of transferable exclusivity vouchers to encourage development of new antibiotics, but experts warn these alone may be insufficient. Critics, including patient groups and public health advocates, argue that the Council’s proposals risk limiting generic drug availability and underrepresent patient voices. The outcome of the negotiations will determine how effectively Europe balances public health priorities, innovation incentives, and equitable access to essential medicines in the years ahead.
Information and links used: EU pharmaceutical reform negotiations to kick off, but concerns remain | Science|Business
