Old medicines for new purposes
The European Commission wants to systematically promote the use of tried and tested medicines for new indications.
UM – 11/2021
On 28 October, the European Medicines
Agency (EMA) and the heads of the competent national medicines authorities
launched a pilot project to support the reuse of medicines. A suitable
framework is being sought for the search for new fields of indication for
existing active pharmaceutical ingredients, so-called "drug
repurposing". The pilot project is based on a June 2019 proposal by an expert group of the European Commission on
safe and timely access of patients to medicines (STAMP) and was announced in
the Commission's Pharmaceutical Strategy Notification of 25
November 2020. A working group ("RepOG") has been set up for
implementation.
No COVID-19 therapies sought
Drug repurposing has become a major issue
in the context of the COVID-19 pandemic. Since the beginning of the pandemic,
researchers the world over have been screening substance databases for their
antiviral potential. However, the framework in which data is to be generated
via the launched pilot project explicitly excludes COVID-19. Instead, the
initiative addresses non-profit organisations (NPOs), having an interest in
ensuring approval of a medicine, which is on the market and no longer protected
by patent or other protection, for a new indication and thus, if necessary,
also prescribed and reimbursed. The non-profit organisations can come from the
scientific community, but they can also be patient organisations.
Target: supply at favourable prices
According to the STAMP expert group, it is
important to provide interested and suitable organisations - so-called
"champions" - with the necessary knowledge of regulatory requirements
and processes, existing data and, where appropriate, data still to be
collected, as well as access to information from clinical trials. In addition,
help will be provided to find cooperation partners in the pharmaceutical
industry who can ultimately market the product with a new indication. In brief:
A systematic approach is needed to find new indications and to bring together
suitable partners so that medicines that become cheaper after patent expiry
remain available for a broader supply – just with a different indication.
Not every NPO is eligible
High expectations are placed on non-profit
organisations. They must be able to shoulder a programme of research into the
suitability of an active pharmaceutical ingredient for a new indication in
order to generate new scientific knowledge. They must also be able to coordinate
cooperation between medicines regulators, the industry and patient groups and
provide them with new information on a regular basis. This is not an easy task
and certainly not for small self-help organisations.
Not to be confused: Off-label use
The
repurposing of active pharmaceutical ingredients is, in principle, nothing
unusual, but common practice. One well-known variation is off-label use, but
this is quite different from "drug repurposing". On the one hand, in
the case of off-label use, medicines that are still patent-protected can be
used beyond the scope of the marketing authorisation. Examples are often found
in paediatrics or oncology. On the other hand, other liability regulations
apply for the prescribing physician and additional requirements for patient
information. In addition, the criteria for eligibility