The European Commission has begun a public consultation on potential reforms to EU general pharmaceutical law. According to an Out-Law.com report, 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 was 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 anti-microbial 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, or introducing new types of incentives in these areas. The commission has also asked for feedback on potential measures that could be introduced to improve access to, and affordability of, medicines. It acknowledged the role that generic and biosimilar medicines have in this regard.
The commission’s consultation runs until 21 December. The commission aims to adopt a proposal for a regulation by the end of 2022.
Out-Law article – EU considers reform of general pharma law (Open access)
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