EU Commission publishes proposal to adapt EU pharma legislation

Largest reform in over 20 years

Thu, 2023 / 04 / 27

On April 26, 2023, the EU Commission's proposal to adapt the EU pharmaceutical legislation has now been published after some delays. Key adjustments include the timeline of centralized marketing authorization, the framework of dossier protection and market exclusivity, as well as a specification of the category "high unmet medical need" - with mixed response from industry and national politics.

The proposed reform covers the EU regulatory framework for all medicines, especially those for rare diseases and for children. The EU Commission's objectives are understandable per se, such as faster and equal access to medicines, an innovation-friendly framework for R&D in Europe, shortening approval times for medicines, and combating the threatening spread of antibiotic-resistant germs. According to the EU Commission, the legislation will be adapted with the reform to the requirements of the 21^st century.

What's new?

Key contents include:

Faster approvals for new drugs: EMA with 180 instead of 210 days, EU Commission with 46 instead of 67 days
Adaptation of protection & exclusivity rights: at least 8 years (6 years of document protection (RDP) +2 years of market exclusivity (ME)) + additional protection periods due to launch in all EU member states (+2 years), unmet therapeutic need (+6 months), data from a comparative study (+6 months) or indication extension (+1 year)
Adaptation of protection & exclusivity for orphan drugs: standard duration of ME is 9 years + additional protection periods for "high" unmet need (+1 year), launch in all EU member states (+1 year) or new orphan indications (max. +2 years)
Creation of transferable, marketable "data exclusivity vouchers" for developers of novel antimicrobial drugs.

The response of the various stakeholders is divided. Major criticism concerns the additional definition of "high unmet medical need" as not only too vague, but also potentially jeopardizing the consequently only "moderate", or at least not "high" unmet need of other (rare) diseases. A further differentiation by unmet need within the orphan drugs is per se not appropriate. Furthermore, an extension of the ME or RDP by only +1 or +2 years is too short to sufficiently incentivize the goals of a Europe-wide marketing. The basic idea explicitly does not work for small and medium-sized pharmaceutical companies without sufficient capacities, so that the system tends to prevent innovation and access. Instead, the system should be harmonized with the current development of the EU HTA system in order to achieve broad availability of drugs for patients throughout Europe. In addition, the overall system could be detrimental to innovation: At the press conference of the EU Commission, Vice President Margaritis Schinas made it clear that the EU Commission would like to see a drop in prices.

According to the EU Commission, the further timeline of this proposal is unclear. However, due to the many delays, it seems unlikely that the proposal will be adopted in the current legislative period until the European Parliament election in May 2024.

SKC is actively contributing to the legislative process on the national and international stage together with various associations, and is closely following the political developments at all levels. We incorporate these developments and the respective implications directly into the consulting of our clients.

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