EU committee considers antimicrobial incentives, repurposing oncology drugs

Regulatory NewsRegulatory News | 08 September 2021 |  By 

During a recent joint meeting of the European Union (EU) Directors for Pharmaceutical Policy and the Pharmaceutical Committee, members debated potential ways to combat antibiotic resistance and improve access to oncology medicines through the repurposing of older or generic medications.
The meeting, held via video conference on 08-09 July 2021, was co-organized and co-chaired by the Slovenian Presidency of the Council of the EU and the European Commission, with attendance by more than 110 representatives from the European Commission. The meeting takeaways will be presented to EU health ministers during their meeting in October.
Antimicrobial access
On the first day, Christine Årdal, senior researcher for antibiotic resistance and infection prevention at the Norwegian Institute of Public Health, presented a policy brief on improving access to essential antibiotics. She outlined the problem – multi-drug resistant bacterial infections accounted for more than 33,000 European deaths in 2015 and access to both old and new antibiotics has been unpredictable – as well as potential solutions.
The policy brief includes a three-pronged approach to stimulate innovation and improve access to antibiotics by:
  • Improving the supply of existing antibiotics through a medicine tendering process that awards contracts to multiple providers with incentives for the development of independent supply chains.  
  • Ensuring a steady supply of new antibiotics through support for research and development funding that targets the World Health Organization’s Priority Pathogen List.
  • Ensuring access to small market antibiotics through implementation of “pull” incentives that increase revenues for essential marketed antibiotics. Both Sweden and the UK are currently testing “delinked” pull incentives in which the reward value is not connected to the units sold.
During the discussion period, participants focused on the importance of access to antimicrobial drugs and noted that action in this area is overdue. Member states who attended the meeting were mostly supportive of a common action or pilot on antimicrobial procurement that has de-linkage characteristics. Attendees suggested that this type of project could be led by the European Commission with voluntary involvement from industry and EU Member States.
Attendees also discussed the potential for incentives for the development of new essential antimicrobials, such as a program similar to the privileged treatment given to orphan drugs at the EU level. Some member states suggested possible countermeasures such as EU stockpiling of antimicrobials and efforts to shore up production. The discussion also touched on the need to examine bacteriophage therapies and formulations specific to children.
Repurposing oncology drugs
On the second day of the meeting, attendees heard a policy report on the strategy of repurposing of drugs in oncology, which identifies new uses for approved or investigational medicines outside of the original clinical indication.
Sarah Garner, acting regional advisor for Access to Medicines and Health Products at the World Health Organiation’s European Office, reviewed costs and barriers for the use of repurposed drugs in oncology, along with the need for Phase 2 studies on repurposed uses. She also presented potential solutions, such as the use of real-world evidence and earlier involvement of payers and health technology assessment authorities, regulatory simplification, and even using artificial intelligence to improve drug candidate selection.
Garner suggested that the EU consider establishing a list of “priority indications” in oncology that represent unmet medical needs. That list could then be used to drive funding, public-private partnerships, and regulatory assistance around the repurposing of oncology drugs.
During the discussion, some participants supported the idea of establishing a priority list, but others pointed out that it could potentially draw research funding exclusively to the listed areas, according to the meeting summary.
Summary Record: Joint Meeting of EU Directors for Pharmaceutical Policy & Pharmaceutical Committee


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