European Union Advances New Pharmaceutical Regulatory Framework
Legislators reach a provisional agreement on enhanced data and market protection periods intended to boost competitiveness, despite a muted reception from the industry.
Negotiators from the European Parliament (EP) and the EU Council have reached a provisional agreement on a new regulatory framework for the pharmaceutical sector. The framework’s stated goal is to enhance the region’s competitiveness and maintain the flow of capital into innovation. This agreement, termed the “pharma package,” is described as the biggest reform of EU medicines laws in over two decades.
The deal proposes introducing periods of regulatory data protection and market protection for certain new medicines:
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Regulatory Data Protection: Eight (8) years, during which other companies cannot access product data.
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Market Protection: An additional one (1) year to shield against competition from biosimilar or generic drugs.
Companies may qualify for extra years of market protection if they develop drugs that address unmet clinical needs, contain a new active substance, or demonstrate a significant improvement over existing therapies. The combined regulatory protection period is capped at 11 years.
For orphan medicinal products—those addressing diseases with no available treatments—market exclusivity will be up to 11 years.
The European pharmaceutical industry has expressed disappointment with the terms. The European Federation of Pharmaceutical Industries and Associations (EFPIA) acknowledged some benefits but found the overall outlook “underwhelming” and stated the policies are “not strong enough” to significantly move the needle on European competitiveness, especially when competing with the U.S. and China.
Concerns about the competitiveness of Europe’s pharma landscape have intensified, particularly as U.S. companies expand their global dominance. CEOs of 32 major pharmaceutical companies previously wrote a letter to the European Commission President, calling for rapid policy change to maintain capital flow into the continent.
The provisional agreement now awaits formal adoption by the EU Council and subsequent endorsement by the European Parliament in a second reading.
