EU proposes reforms for general pharma legislation

EUROPE – The EU Commission has proposed reforms to the general pharmaceutical laws that seek to ensure a future-proof and crisis-resistant medicines regulatory system.

The review of the EU’s general pharmaceutical legislation is a key component of the European Commission’s pharmaceutical strategy, released in November 2020.

In its review, the Commission is looking at potential reforms in a variety of areas, including unmet medical needs, improving access to and affordability of medicines, addressing antimicrobial resistance, ensuring the security of medicine supply, adapting the regulatory approach to account for “novel products,” and environmental challenges.

Notably, EU policymakers are debating how to stimulate innovation in areas of unmet medical needs, as well as whether the current incentive framework is adequate.

The consultation seeks feedback on potential changes to current regulatory data as well as market exclusivities granted to innovators upon regulatory approval of new specialty medicines.

The options proposed include adding new conditions to existing incentives, such as a commitment to make the medicine available in all EU member states, granting longer periods of protection in areas of unmet medical needs, or introducing new types of incentives in these areas.

Stella Kyriakides, Commissioner for Health and Food Safety, said: “Today we take an important step for the reform of EU’s pharmaceutical legislation by the end of next year. A regulatory framework for pharmaceuticals, which is modernized and fit for purpose, is a key element of a strong European Health Union and crucial to addressing the many challenges this sector is facing. I call on all interested citizens and stakeholders to help us shape EU rules for the future, responding to patients’ needs and keeping our industry innovative and globally competitive.”

The consultation, which will last until December 21, will solicit feedback from the general public and stakeholders in order to support the evaluation and impact assessment of the EU’s pharmaceutical legislation revision.

The most recent comprehensive review of general pharmaceutical legislation was proposed nearly 20 years ago. Since then, societal and scientific changes have occurred, as have new areas of concern such as antimicrobial resistance, environmental challenges, and medicine shortages.

In this context, the Pharmaceutical Strategy, which was adopted in November 2020, includes an ambitious agenda of legislative and non-legislative actions to be implemented over the next few years, with four main goals:

Providing patients with affordable medicines and addressing unmet medical needs (for example, in the areas of antimicrobial resistance, cancer, and rare diseases);

Supporting the EU pharmaceutical industry’s competitiveness, innovation, and sustainability, as well as the development of high-quality, safe, effective, and environmentally friendly medicines;

Improving crisis preparedness and response mechanisms, as well as addressing supply security; and

Ensuring a strong EU voice in the world by promoting high levels of quality, efficacy, and safety.

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