Brussels: EU pharmaceutical reform cleared its last Council hurdle on 28 September 2026, when ministers adopted the new pharma package, which the Council calls the most comprehensive overhaul of EU pharmaceutical legislation in over 20 years. The package consists of a new directive and a new regulation that replace the core medicines rules. The European Parliament must still adopt both texts before they can enter into force.
The heart of the EU pharmaceutical reform is a rebalanced system of protection for new medicines. A new product receives eight years of regulatory data protection, during which competitors cannot rely on the company’s pre-clinical and clinical trial data. It then gets one year of market protection, and a further year can follow for certain innovative medicines or for products that meet an unmet medical need.
Orphan medicines for rare diseases receive nine years of market exclusivity, which rises to eleven for breakthrough products. Orphan medicines authorised under a well-established-use pathway get four years. These periods in the EU pharmaceutical reform give developers of rare-disease treatments a clear horizon, although generic and biosimilar makers will argue that they still delay cheaper competition.
The package also tackles antimicrobial resistance with a transferable exclusivity voucher. A developer of a priority antimicrobial can use the voucher to add one year of data protection to a product of its choice. A blockbuster clause bars the use of the voucher on products whose annual gross sales in the EU exceeded €490 million over the preceding four years. Law firm Matheson summarises the periods in its analysis of the adopted rules.
Medicine shortages receive attention too. Member states may require companies that hold market protection to supply enough medicine to meet patient needs. The text adds safeguards to stop that duty from fuelling parallel trade, in which products move to higher-priced markets. The EU pharmaceutical reform thus links commercial exclusivity to security of supply, a trade-off that patients and health ministers pressed for.
The institutions reached their provisional deal on 11 December 2025, and the Council has now confirmed it. The Council press release and the Council’s policy page on the pharma package set out the adopted texts. Once Parliament votes and the acts appear in the Official Journal, member states will have two years to transpose the directive into national law, subject to some provisions with different timing.
Industry and public health groups will now turn to the details of implementation. Companies must decide how the new exclusivity periods affect their launch plans in 2027 and 2028, while national agencies prepare for changes in authorisation procedures. Governments will also watch how the EU pharmaceutical reform handles shortage obligations in practice during winter, when demand for some medicines rises.
The coming Parliament vote is the next test. If MEPs approve the agreed texts without change, the EU pharmaceutical reform will move straight to publication and a two-year transposition clock. Patients, manufacturers and health ministries will then judge whether the new balance between innovation incentives and access delivers what the Council promised.
