EU Council adopts compromise position on pharma reforms

The European Council has taken its position on a package to reform the EU’s pharmaceutical sector, teeing up negotiations with the European Parliament on a final package. The Council’s amendments to the package include providing eight years of regulatory data protection for new drugs and up to two years of additional market exclusivity.

The pharmaceutical package would be the most significant overhaul of the regulatory landscape for drugs in the EU in more than twenty years. The Council stated that the goal of the proposal is to enhance competitiveness while ensuring that all Europeans have access to safe and effective medicines.

One of the most significant changes in the Council’s position has to do with market protections awarded to drugmakers. In contrast with the Parliament’s package, which would provide seven and a half years of regulatory data protection for newly authorized drugs (with the ability to extend that protection to a maximum of eight and a half years) and an additional two or three years of market protection, the Council’s proposal would provide eight years of regulatory data protection and up to two years of market protection.

Additionally, the Council’s proposal would offer greater market protections for orphan drugs than the Parliaments. Instead of nine years of exclusivity plus an additional year of exclusivity for drugs that address a high unmet medical need, the Council’s position provides ten years of market exclusivity for orphan products that can be extended up to 12 years. (RELATED: European Parliament adopts pharmaceutical reform package, Regulatory Focus 11 April 2024)

Despite the more favorable protections compared to the Parliament’s proposal, the European Federation of Pharmaceutical Industries and Associations (EFPIA) criticized the package, saying it poses a “missed opportunity to position Europe’s life sciences sector at the forefront of global competition.”

Under one amendment, member states would have the power to require the marketing authorization holder of a medicinal product to make that product available in “sufficient quantities” to cover the needs of patients in their jurisdictions under a new article (56a) to the directive.

The Council also introduced a new limitation on the transferrable exclusivity voucher for antimicrobial products. Under the Council’s proposal, a voucher “can only be used in the fifth year of the regulatory data protection period, and only if the marketing authorisation holder demonstrates that the annual gross EU sales of the product have not exceeded €490 million in any of the preceding four years.”

Also, to facilitate the earlier market entry of generic and biosimilar medicinal products, the Council’s mandate further clarifies the scope of the so-called ‘Bolar exemption’ and extends it to include submissions for procurement tenders.

Izabela Leszczyna, Polish Minister for Health, said the proposal represents a “vital step toward ensuring that all Europeans have timely and equitable access to safe, affordable, and effective medicines. At the same time, it strengthens the competitiveness and sustainability of our pharmaceutical sector and supports improved regulatory conditions to boost clinical research and to address public health needs. We are building a healthier, more resilient Europe that leaves no one behind.”

The Council is now prepared to start negotiations with the European Parliament to reach an agreement on the package. Subsequently, the new rules will be adopted after a legal and linguistic revision.

EFPIA lamented the shortening of the intellectual property protections. “The choice to reduce intellectual property protections for pharmaceutical companies makes Europe less attractive, discouraging investment and jeopardising the development of innovative treatments in Europe without addressing the underlying barriers and delays to patient access…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.”

Announcement; Regulation; Directive; EfPIA statement

EU Council adopts compromise position on pharma reforms

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