Slovenian Presidency of the Council of the EU 2021

Joint meeting EU Directors for Pharmaceutical Policy & Pharmaceutical Committee

As part of Slovenian presidency of the EU Council, a joint meeting of Directors for Pharmaceutical Policy of EU Member States and the Pharmaceutical Committee of the European Commission took place on 8 and 9 July 2021. In this form, the meeting was organised for the first time and thus brought together policy makers in the field of medicinal products from the Ministries of Health and experts from national medicines agencies or public health institutions of the EU and EEA member states. The meeting was also attended by representatives of EMA and invited renowned international experts.  

The discussion focused on finding common EU solutions that can improve the accessibility and availability of medicines, while also addressing the issue of medicine shortages, especially where a lack of commercial interest may occur, such as in the case of antimicrobials, or in the case of repurposed generic and older medicines in oncology. This would contribute to the strengthening of the European Health Union and the implementation of the Pharmaceutical Strategy for Europe.

On the first day, topics related to innovation, accessibility and availability of antimicrobials in the EU were discussed. The importance of further comprehensive action in the field of antimicrobials was emphasised. It is important to build on and take advantage of the knowledge and cooperation developed so far. Antimicrobial resistance is a silent pandemic and the EU needs to invest all its efforts into addressing this situation to prevent a future crisis. Member states also discussed the possibility of a voluntary model based on joint tender, deriving from the experience with the supply of covid-19 vaccines, while not encouraging the overuse of antibiotics. The model should be piloted first.

The revision of the EU pharmaceutical legislation is an opportunity to examine various incentives, while addressing all other issues related to the availability, accessibility and use of antimicrobials. The European Commission has announced that discussions on future action at the EU level and on the revision of pharmaceutical legislation will continue during its forthcoming meetings.

On the second day, there was a discussion on possible solutions to support the repurposing of already approved, off-patent medicinal products, particularly in the field of oncology, where a significant unexploited potential exists. Repurposing is an opportunity for more effective and affordable medicines to treat cancer in areas of unmet needs. It has proven effective during the current pandemic. Due to the lack of financial interest from the pharmaceutical industry, the involvement of non-commercial stakeholders, such as academic institutions and not-for-profit organisations, was recognised as necessary to achieve this goal, which poses a number of challenges in approving the changed use of an already authorised medicine. It is therefore essential to create an appropriate environment that will support non-commercial stakeholders in their data acquisition activities for new therapeutic uses. 

The Pharmaceutical Strategy for Europe, the Europe’s Beating Cancer Plan, the announced European Health Emergency Response Authority (HERA) and the European Health Data Space offer an opportunity for joint action at the EU level in response to public health needs.

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