On 25th November 2020, the European
Commission published its pharmaceutical strategy, which added another building block
to the basic framework of a European Health Union (see also DSV paper "Towards a Health Union", November 2020).
The wide bundle of proposals should:
1. ensure access to essential, innovative
and affordable medicines is promoted
2. strengthen the competitiveness of the
European pharmaceutical industry
3. further develop the EU’s strategic
4. work towards more uniform standards and
a level global playing field.
European pharmaceutical legislation is to
be fundamentally revised and adapted for this purpose by the end of 2022.
The European Commission notes that industry
today does not always invest in developing drugs that are urgently needed.
There are still open requirements, especially in the field of orphan diseases
and children's therapy as well as antimicrobial drugs. The demand for certain
medicaments would sometimes not be met, but this would also be due to strategic
corporate decisions made by the pharmaceutical industry. Moreover, the prices
are too high for the healthcare systems in some countries.
Improving the innovation climate
The bureaucratic procedures surrounding
drug approvals and product and patent protection will also be studied.
Competition could be improved for generics or bio-similars. Industry would need
a "stable and flexible regulatory environment" as well as improved
access to health data, as will be provided in the future in the European Health
One of the lessons of the COVID-19 pandemic
is that Europe needs to become more crisis-proof. This objective is at the
heart of the first European Health Union package and it is also reflected in
the pharmaceutical strategy. More obligations should be imposed on
manufacturers with regard to their supply and transparency obligations in order
to prevent bottlenecks and a "structured dialogue" should be
initiated. One of its first tasks for the planned new authority for crisis
preparedness and response (HERA) will be the field of antimicrobial resistance.
The pharmaceutical industry is globally
intertwined. It is only logical to work on the global stage to ensure that the
product qualities are right, the production conditions are acceptable,
undistorted competition is possible and the exchange of goods remains
unhindered. The international cooperation between European Medicines Agency
(EMA) and the network of national regulatory authorities has already begun. The
aim here is to promote regulatory convergence.
The German Social Insurance ...
... welcomes the fact that the European
Commission is focusing on the availability and affordability of medicines. It
is right to want manufacturers to be more rigorous with regard to their
reporting and delivery obligations. It is good that transparency on the
research and development costs of pharmaceuticals is to be created - this can
support price and reimbursement negotiations at national level. The bottom line
is that the pharmaceutical strategy contains many positive aspects.
Along with the pharmaceutical strategy, the
European Commission has also published other initiatives:
3. the proposal for a data governance law, which will prepare the
framework for sector-specific data governance such as the European Health Data