Antimicrobial Incentives and Oncology Drug Repurposing being considered by EU

During a recent joint meeting of the European Union (EU) Directors for Pharmaceutical Policy and the Pharmaceutical Committee, members discussed how repurposing older or generic medications could help tackle antibiotic resistance and enhance access to oncology medicines. 

The meeting, which took place via video conference on the 08th and 09th of July 2021, was co-organized and co-chaired by the Slovenian Presidency of the EU Council and the European Commission, with more than 110 European Commission representatives in attendance. The summit’s outcomes will be submitted to EU health ministers at their October meeting. 

Christine rdal, a senior researcher at the Norwegian Institute of Public Health who specializes in antibiotic resistance and infection prevention, delivered a policy brief on enhancing access to important antibiotics on the first day. She described the problem – multidrug-resistant bacterial infections killed over 33,000 people in Europe in 2015, and access to both old and new antibiotics has been sporadic – as well as potential solutions. 

Participants focused on the issue of antimicrobial medicine availability during the discussion time, noting that action in this area is long needed. The majority of the member states in attendance were in favor of common action or pilot on antimicrobial procurement with de-linkage characteristics. Attendees urged that the European Commission lead such a project with voluntary participation from business and EU Member States. 

Attendees also addressed the possibility of providing incentives for the development of new important antimicrobials, such as a programme comparable to the EU’s orphan drug treatment programme. Some member states suggested responses such as antimicrobial stockpiling in the EU and initiatives to boost output. The necessity to investigate bacteriophage therapy and formulations tailored to children was also discussed. 

Attendees heard a policy report on the approach of repurposing pharmaceuticals in oncology on the second day of the meeting, which identifies novel uses for approved or investigational medicines outside of their original clinical indication. 

Sarah Garner, the World Health Organization’s European Office’s acting regional advisor for Access to Medicines and Health Products, discussed the costs and challenges of using repurposed medications in oncology, as well as the necessity for Phase 2 research on repurposed usage. She also discussed possible remedies, such as the use of real-world evidence and earlier payer and health technology assessment authority involvement, regulatory simplification, and even the use of artificial intelligence to improve medication candidate selection. 

Garner urged that the EU consider creating a list of unmet medical needs in oncology called “priority indications.” This list might then be used to spur funding, public-private collaborations, and regulatory support for oncology drug repurposing. 

According to the meeting report, some attendees supported the notion of creating a priority list, while others pointed out that it may potentially pull research funding exclusively to the topics specified.