Euro­pean Commis­sion plans incen­tive system for Antibi­otics

The European Commission´s official proposal of the amend­ment to the phar­ma­ceut­ical leg­is­la­tion is eagerly awaited. It was supposed to have been published at the end of March, but the European Commission postponed the date. Initial working drafts regarding the amend­ment made it clear that the European Commission also wants to address the development of new antibiotics needed to treat infections caused by multi-resistant bacterial pathogens (see news 2/2023).

What are vouchers?

In order to provide incentives to develop new antibiotics, the European Commission plans to introduce transferable exclusivity extension vouchers (also called vouchers or TEEV). The developer or marketing authorisation holder of the new antibiotic can apply it once to a pharmaceutical product of his choice that holds a central marketing authorisation. The voucher will then extend its data protection period by one year under certain conditions. It can also be sold on to another pharmaceutical company. At least that's how it looks in theory.

Vouchers are costly and inef­fi­cient

Despite the intended supposedly restrictive usage framework, German Social Insurance European Representation (DSV) has rejected the new voucher system in its statement. If, as the European Commission intends, a system is to be created that keeps pharmaceutical products affordable to health systems and simultaneously rewards innovation, then a voucher system is counterproductive. There are three reasons for this:

High costs

Vouchers are disproportionately expensive because, under the current European Commission plans, manufacturers could apply them to any pharmaceutical product of their choice that fulfils the stipulated conditions and has the highest possible sales potential. This would also include profitable blockbusters with annual sales of more than one billion euros. Extended protection periods will hamper the development of more affordable competitive products and delay their market access as generic pharmaceutical products.

No guar­antee of access to antibi­otics

An antibiotic will still not be available on the market if it only holds a marketing authorisation. The European Commission´s plan does not guarantee that patients will actually have access to the newly developed antibiotic if the voucher is used. It must be ensured that urgently needed new antibiotics are available in all member states and that all patients can benefit from them.

Alter­na­tive incen­tive mech­a­nisms

Alternative incentive scheme proposals exist that would better resolve the problem of a lack of investment in developing new antibiotics. Examples of market launch bonuses are those that are paid independently from the ordered quantities and where the income or payment is decoupled from sales. There is also the possibility of direct development funding in the form of milestone bonuses or the establishing of research-funding funds through so-called play-or-pay mechanisms. Also under discussion are a European-wide annual revenue guarantee, purchasing patents or production licences or compensation for incurred R&D expenses.

Focus on preven­tion

In addition to all the incentives to be discussed, developing new antibiotics must never lose sight of the need for preventive measures, which will particularly ensure that antibiotics and especially reserve antibiotics are used with restraint and according to indication.