ESIP-MEDEV views on the revision of the EU general pharma legislation

The upcoming proposal by the European Commission on the revision of the EU general pharmaceuticals legislation, expected by the end of 2022, intends to address shortcomings in terms of access to and availability of new treatments. Safety, quality and affordability are crucial elements for bringing effective medicines to the market with
significant benefits for patients and healthcare systems’ sustainability.

The European Social Insurance Platform (ESIP) and the Medicine Evaluation Committee (MEDEV) – the leading voice of statutory healthcare payers across Europe – present a list of detailed amendments to the legal texts - Regulation 726/2004 and Directive 2003/81/EU. Based on our members’ hands-on experience and expertise, two main streams of actions are prioritised: a) ensure robust and timely evidence generation combined with increased transparency and b) improve access by strengthening competition.

Shifting the assessment of safety, quality and efficacy from pre- to post-marketing authorisation should be avoided. Randomised controlled trials (RCTs) are the gold standard and conditional approval pathways should be limited to specific conditions and criteria. Stricter requirements should also be introduced in terms of the obligations and timeframes to perform post-launch studies.

The COVID-19 pandemic has given new impetus to fast-track approval pathways. Yet, their use should not be mainstreamed but rather limited to centralised procedures and to products addressing unmet medical needs, in duly justified circumstances. For this purpose, harmonising the definition of unmet therapeutic needs is crucial. It is equally important to make these products available across all Member States, by introducing an obligation on manufacturers to submit a timely P&R application, failing which marketing authorisation should be revoked.

As representatives of healthcare payers, our goal is to reward meaningful innovation that brings significant benefit to the patients and society as a whole, at a reasonable price. Several measures at the EU level can foster treatment affordability: bringing competitor products to the market as early as possible is one of them. To this end, we recommend shortening the regulatory protection periods as well as allowing competitors to move forward with all the necessary regulatory steps before patents expire.

Transparency is a cross-cutting element across the amendments proposed, both in terms of data to be shared by pharmaceutical manufacturers and publication of relevant information via existing and new EMA databases and registries.

The EU pharma revision offers an unprecedented opportunity to effectively mitigate the negative consequences of the growing weak evidence-high prices conundrum. Stronger evidence will lead to informed, timely decisions, better deals, better priority-setting, better chances for the renegotiation of contracts, healthier competition, and better targeted incentives. HTA, payers’ needs, and concerns should therefore be taken on board early in the regulatory approval process. This is yet another crucial point in the revision that the European Commission needs to prioritise and enable.

Download the ESIP-MEDEV amendments and key messages.

To learn more about our proposals from our experts, make sure to join the ESIP-MEDEV webinar on Wednesday 13 July at 1pm CET. Register today!

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