Improved availability and supply of medicines for insured persons and ensuring sustainable health systems

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.