The Council of the EU adopted the pharma package on 2026-09-28. The reform comprises a regulation and a directive and still requires European Parliament adoption, followed by publication in the Official Journal. The announcement should therefore not be read as a rule already applicable everywhere.
Innovation alongside competition. The Council's background note describes eight years of data protection and one year of market protection for new medicines. The former concerns trial data; the latter delays competition from generics and biosimilars. These are different concepts, and extensions are conditional.
On supply, Article 121 of the regulation text requires an up-to-date shortage prevention plan for prescription medicines and additional designated products. Its annex details mapping supply-chain vulnerabilities and reviewing preventive measures. This goes beyond reporting a shortage after it occurs.
What could it mean in Hungary? In our editorial assessment, patients and purchasers ultimately need actual access: whether a medicine is available, on what terms and how reliably. Manufacturer protection and shortage prevention could influence that through different channels. Adopting legislation alone does not establish an immediate price reduction or the disappearance of every shortage.
The next checkpoints are parliamentary adoption, the final published text and application deadlines. Businesses need those details when preparing. Political agreement, legislative adoption and practical transition are distinct stages.
Original editorial content. Read our editorial standards.
Budapest Global Review: Council adopts the EU pharma package; Parliament is next. Budapest Global Review, 28 September 2026. https://globalreview.hu/en/cikk/eu-gyogyszercsomag-tanacsi-elfogadas-2026-szeptember-28