The Council of the European Union has introduced sweeping amendments to its pharmaceutical regulatory framework, marking what it describes as “the biggest reform to EU’s laws on medicines in over two decades.” The revised “pharma package,” presented on June 4, is positioned as a move to expand access to safe, effective, and affordable medicines while simultaneously enhancing the competitiveness of the European pharmaceutical sector.
According to the Council’s official press release, the package seeks to “reduce the regulatory burden and simplify the regulatory framework.” The legislative proposal includes both a directive and a regulation, targeting a more robust and agile pharmaceutical landscape across the EU.
One of the core changes involves modifications to data and market exclusivity timelines. Under the new plan, data generated during drug development would be protected for eight years, preventing competitors from referencing that data in their own applications. Additionally, new medicines would receive one year of regulatory market protection, extendable by an additional year if “certain pre-defined key objectives” are met.
The current EU framework grants eight years of data exclusivity and two years of market protection, with an additional year available for new therapeutic indications. Orphan drugs, however, enjoy up to 10 years of market exclusivity. The proposed changes would realign these timelines, potentially altering the commercial strategy for pharmaceutical companies operating in Europe.
Another provision empowers EU member states to require pharmaceutical companies to supply their medicines in “sufficient quantities” to meet the needs of their populations. This could play a key role in mitigating drug shortages and ensuring more equitable access across the Union.
Polish Minister for Health, Izabela Leszczyna, emphasized the importance of the reforms, stating, “The mandate agreed today is a vital step toward ensuring that all Europeans have timely and equitable access to safe, affordable, and effective medicines.” She added that the package also “strengthens the competitiveness and sustainability of our pharmaceutical sector.”
Despite the Council’s optimistic framing, the European Federation of Pharmaceutical Industries and Associations (EFPIA) voiced strong concerns about the reforms. In a statement, EFPIA described the updated proposals as a “missed opportunity” to elevate Europe’s life sciences industry amid what it called an “unpredictable” global landscape.
EFPIA took particular issue with the shortened exclusivity timelines, arguing that the move could deter investment and hinder innovation. “If Europe is to remain competitive and continue to deliver cutting-edge healthcare solutions, it must provide a predictable and globally competitive environment for research, development and manufacturing,” the group stated.
The backlash comes at a time of heightened concern over Europe’s pharmaceutical competitiveness. In April, EFPIA had already called for “rapid, radical” policy reform to respond to possible U.S. pharmaceutical import tariffs. Industry leaders warned of a potential investment flight if the EU fails to strengthen its support for innovation.
The Council’s proposals now move into the negotiation phase with the European Parliament. Should an agreement be reached, the revised rules will be formally adopted into law, following up on the European Commission’s 2023 proposals to reduce market exclusivity for new drugs from ten years to eight.
