European Council approves new EU pharmaceutical legislation

The European Council has approved a comprehensive legislative package to reform the European Union’s pharmaceutical regulations. The new rules aim to improve patient access to safe, effective, and affordable medicines while strengthening supply security.

Under the new framework, pharmaceutical companies will receive eight years of data protection for clinical research and testing. This prevents generic or biosimilar competitors from using that data for licensing during this period. Additionally, a one-year market protection period will be granted against generic and biosimilar rivals. This can be extended by one year for drugs meeting specific innovation criteria, and an additional year for medicines addressing unmet medical needs, allowing for a maximum total protection period of 11 years.

Special incentives are included for companies developing priority antibiotics to combat antimicrobial resistance. If these incentives are utilized, the total protection period can be extended to 12 years. The regulation also facilitates faster market entry for generic drugs by allowing manufacturers to conduct necessary tests and studies before the original drug’s intellectual property protection expires. Furthermore, member states will have the authority to require companies to supply sufficient quantities of protected medicines to meet patient needs.