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
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
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.
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).