On June 15th 2021, the 27 EU Health Ministers adopted the Council Conclusions on Access to Medicines and Medical Devices for a stronger and resilient EU, during a dedicated meeting that took place in Luxembourg.
Though Council Conclusions are not legally binding, they highlight the views of Member States on specific topics and call on the European Commission to work on these aspects, which can lead to actions being undertaken at EU level.
The conclusions tackle several important elements related to current discussions at EU-level surrounding the 3As (Access, Availability and Affordability of medicines).
Under the Accessibility chapter, the Council Conclusions invite the Commission and Member States to agree on a common set of criteria to identify unmet medical needs and it recognizes the importance of having tailored incentives to develop medicinal products answering those needs.
Regarding Availability, the importance of understanding the reason behind access delays is highlighted and the text references the pilot project on market launches of centrally approved products as a way to increase understanding of these delays. It also mentions the regulatory flexibilities taken on the approval of vaccines as a way to facilitate the availability of medicines, while emphasizing the need to remain cautious and focused on needs. Additionally, to enhance the resilience of the pharmaceutical sector, the text calls to diversify and secure supply chains.
Finally, under the Affordability chapter, the Conclusions also recognize the value of real-world evidence as a way to “complement regulatory knowledge, reduce evidence gaps in HTA and payer decisions, and support medical decisions on best treatment options”.
Overall, these Council Conclusions refer back to many topics addressed as well in the Pharmaceutical Strategy published by the European Commission in November 2020. Following their publication, the European Federation EFPIA has issued a press release, which you can find here , whereas if you would like to read the Council Conclusions you can find them here.