Parliament Proposes Extended Regulatory Safeguards for Pharmaceuticals

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The committee on environment and public health has advocated for an extension of regulatory protection for pharmaceutical products, amplifying the European Commission’s proposed new pharmaceutical legislation by one-and-a-half years.

Enhancing Patient Access and Industry Role

In April 2023, the European Commission introduced a new pharmaceutical legislation framework with the aim of ensuring equitable access to medicines for patients and bolstering the industry’s presence throughout the European Union. A central tenet of this proposal involves enhancing the availability, affordability, and accessibility of medicines, thereby prompting the Commission to introduce new incentives to support innovative pharmaceutical companies by bolstering regulatory protection over their products.

Amendments and Compromise

Following a series of compromise amendments supported by a majority of political groups, the primary alteration from the original proposal centers on the regulatory protection period. Parliament has proposed a minimum protection period of seven-and-a-half years, a significant increase from the Commission’s initial stance of six years, albeit a reduction of six months from the current standard. Additionally, companies have the opportunity to secure a maximum of eight-and-a-half years of protection by fulfilling several stipulations.

Conditional Extensions

Pharmaceutical companies stand to gain extensions under certain conditions. Specifically, a one-year extension is granted if a medicine addresses an unmet medical need (UMN) at the time of marketing authorization, a provision that surpasses the Commission’s proposed six-month extension. Moreover, an extra six months may be awarded if the developer conducts comparative clinical trials to support marketing authorization and an additional six months if a significant portion of research and development occurs within the EU, in collaboration with public entities.

Industry Response and Inter-Institutional Process

While the European Federation of Pharmaceutical Industries and Associations (EFPIA) has expressed apprehension regarding the potential impact of the legislation, the generic and biosimilar industries represented by Medicines for Europe call for intensified efforts to ensure equitable access to medicines across the EU. As the European Parliament prepares for a plenary vote on the committee report in April, inter-institutional discussions will ensue, shaping the final contours of the regulatory framework for pharmaceutical products in the EU.


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