EU strategy on COVID-19 therapeutics
After the vaccines it is now the turn of medicines to treat COVID-19.
UM – 05/2021
Since the early summer of 2020, no topic
has occupied as much space in the coronavirus pandemic as issues surrounding
vaccine development and manufacturing, reserved vaccine quantities and
supplies, and the provisos surrounding approval by the European Medicines
Agency (EMA). One year later, the EC is now setting out its ideas on how to
advance the development of suitable medicines for treating the
coronavirus.
It's about time
The somewhat one-sided fixation on vaccines
is also being critically commented on in Germany. The Federal Ministry of
Education and Research admits that only about 17.5 million out of about one
billion euros in research funds have been allocated to medicinal research since
the pandemic started in Germany. The remainder is earmarked for vaccine
development against COVID-19 (see here).
However, experts have pointed out that any vaccine campaign must be accompanied
by the development of therapeutics. The EU apparently wants to make up for
this. It presented its strategy on this subject (COM(2021) 355 final) On May 6.
The therapeutic offer is very limited
It frankly admits: to date, Remdesevir is
the only approved drug for treating patients suffering from COVID-19. That is
about to change. Three new therapies are expected to be available by October
2021 and two more by the end of the year. This will be made possible by the
fact that the EMA is already reviewing three medicines as part of its rolling
approval procedure and it is also involved in an advisory capacity in more than
50 relevant development processes. Part of the EU’s strategy is to make full
use of the accelerated approval tools for new potential
“candidates".
The customers are there
It should also be possible to draw on the
flexible capacities of the "EU Fab" project for producing the new
therapeutics. The EU has earmarked 40 million euros for this purpose. EU Fab is
a Europe-wide network of production capacities for vaccines and medicines that
can be used in the event of a crisis. In the long term it will become part of
the future European Health Emergency Preparedness and Response Agency (HERA). Production
is also expected to become attractive because the EC intends to drive up
demands for new COVID-19 medicines as part of the “rescEU” emergency reserve
stock.