The European Commission has begun a public consultation on potential reforms to EU general pharmaceutical law.
The review of the EU’s general pharmaceutical legislation is a core plank of the European Commission’s pharmaceutical strategy, published in November 2020. The Commission said the aim of the review is to “ensure a future-proof and crisis-resistant medicines regulatory system”.
In its review, the Commission is considering potential reform in a wide range of areas including in relation to unmet medical needs; improving access to and affordability of medicines; addressing antimicrobial resistance, ensuring security of supply of medicines, adapting the regulatory approach to account for “novel products”; and environmental challenges.
Notably, EU policymakers are considering how to stimulate innovation in areas of unmet medical needs and whether the existing incentives framework is fit for purpose. The consultation seeks views on potential changes to the current regulatory data and market exclusivities which innovators enjoy upon getting regulatory approval for new speciality medicines. The proposed options include introducing 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.
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