Vouchers for medicinal products unsuitable as incentive for development of new antibiotics

UM – 08/2022

As part of the upcoming revision of the pharmaceutical legislation, the European Commission is considering using additional incentives to promote the development and production of new antibiotics. Resistance to available antimicrobial agents is on the rise due to the absence of any significant breakthroughs in this segment for years.

Incentives alone are not enough

It is understandable that the incentives for the development of new antibiotics – especially reserve antibiotics – are now also being reconsidered in the revision of the pharmaceutical legislation. But that alone does not solve the problems.

The European Public Health Alliance (epha) and ReAct Europe, an independent global network addressing antimicrobial resistance, made good use of the early summer. Against the backdrop of the upcoming reforms, a short position paper that addresses so-called vouchers (transferable exclusivity extension - TEE) as a tool to promote the development of new antibiotics has emerged. The principle of TEE works like this: A company that launches a new antimicrobial drug may transfer all or part of the rights to exclusively distribute the pharmaceutical product to another product. Alternatively, the right can be sold to another company.

Vouchers for medicinal products are inefficient

The position paper, which is supported by a number of other non-profit organisations, including the Association of European Cancer Leagues and Health Action International, clearly rejects TEEs. They hold subsidising one area of therapy at the expense of another as being ethically questionable. Patients and payers alike would face excessive social costs, while developers of medicinal products, especially large companies would be disproportionately rewarded. Vouchers would not ensure the production of new antibiotics.

Handling antibiotics responsibly 

The authors maintain that the voucher would set a bad precedent. This is because the voucher does not inherently guarantee a commitment to the responsible handling and appropriate use of antimicrobial drugs. This would require further conditions and requirements. DSV also sees it that way. A whole package of measures would be needed to solve the problem. In particular, those that directly address the use of antibiotics – both in the veterinary sector and in human medicine. The DSV has given feedback on the topic. 

Integrating HERA

The European Commission's proposal for the revision of the pharmaceutical legislation is expected in the fourth quarter of this year at the earliest. Epha and ReAct Europe appeal to the European Commission to refrain from socially costly and inefficient market incentives in the revision of the legislation. There would be more appropriate tools for the development of new antibiotics. A special and coordinating role could be played here by the new Health Emergency Preparedness and Response Agency (HERA).