
DSV-opinion on the EU pharmaceutical legislation
Improved availability and supply of medicines for insured persons and ensuring sustainable health systems
CC – 10/2023
With the reform of the European
pharmaceutical legislation, the European Commission wants to secure and
strengthen access, affordability and availability of medicines in the European
Union (EU). All patients in the EU should have equal access to innovative and
safe medicines – regardless of the Member State they live in.
In its opinion,
the German Social Insurance (DSV) welcomes the objectives of the European
Commission pursued with the reform proposals. However, in order to ensure
financially sustainable and resilient healthcare systems, the availability of
medicinal products with a proven high benefit as well as high-quality care for
the insured persons, the DSV believes that improvements to the regulatory
proposals are necessary. Current advances in medicine offer great opportunities
for patients and our society. Nevertheless, it must be ensured at the same time
that novel therapies also prove that they are truly innovative. The solidarity
community must not be burdened by expenses that do not bring any actual benefit
to patients.
Shorten regulatory and patent protection
The Commission proposes a differentiated
incentive system for pharmaceutical companies by attaching conditions to the
regulatory protection periods and also reducing data protection from eight to
six years. This makes sense, but for 61 per cent of new medicinal products, the
longest effective protection against competition is provided by patent law or a
supplementary protection certificate and not by pharmaceutical legislation.
From the DSV's point of view, in order to promote price-reducing competition,
regulatory protection in pharmaceutical legislation should be limited to a
maximum of eleven years and the period of validity of a supplementary
protection certificate (SPC) should be shortened to a maximum of four, instead
of five years. For orphan drugs, in addition to lowering regulatory protection,
the criteria for defining a rare disease must also be narrowed down.
Strengthen collection of evidence for conditional marketing authorisations
Proposals that focus on faster approvals at
the expense of evidence or the reliability of the approval process are not
comprehensible. Faster market access does not represent a healthcare advantage
if risks are shifted to patients by medicinal products that have not been
adequately tested in clinical trials. It should be standard practice that all
data on the efficacy, safety and quality of a medicinal product as well as all
necessary documentation are submitted in a formal application for marketing
authorisation at the beginning of an assessment. This needs to be made more
stringent.
Avoid supply and delivery bottlenecks
The European Commission is making
meaningful proposals to improve availability and security of supply. From the
DSV's point of view, the existing system for monitoring medicinal products must
be used to establish a monitoring system that provides an overview of the
current supply-demand situation of medicinal products at any time. There are
also bottlenecks in the production of antimicrobials. The transferable market
exclusivity vouchers ("vouchers") proposed by the European Commission
are not an appropriate means of promoting production. In addition to a
far-reaching cost impact, neither access nor market launch of effective
medicinal products with new modes of action can be guaranteed. In the view of
the DSV, what is needed instead are targeted measures to promote research; if
necessary, also joint procurement of active ingredients.
Strengthen environmental sustainability
The DSV expressly supports the binding and
comprehensive regulations proposed by the European Commission with regard to
environmental sustainability in view of climate change and the numerous
ecological challenges for society. The risk-benefit assessment of medicinal products for quality, safety and efficacy
in relation to health of the patient or public health should also include
environmental risks.
You can find DSV's position in brief here.
We will be happy to send you a detailed opinion with specific proposals for
amendments if you are interested.