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
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:
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
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