Medical Research Act - New rules bolster Germany as a research location
The Medical Research Act, which was adopted by the Bundesrat [upper house of German parliament] on 27.9.2024, has set the course for modernised and more competitive medical research in Germany. The aim of the new rules is to accelerate the development, approval and manufacture of medicinal products and medical devices and to dismantle bureaucratic hurdles.
The new legislation includes, in particular, three regulatory areas by means of which Germany as a research location is intended to be bolstered so that innovations can secure its international competitiveness. These are: more efficient clinical trials for studies, new rules regarding drug pricing and additional reporting obligations for hospitals.
1. One of the key elements of the legislation is the simplification and acceleration of clinical trials.
In order to be able to evaluate complex studies more rapidly a specialised ethics committee will be established. The intention behind this is for decisions to be taken in a more efficient way and, thus, to help treatment options reach patients more quickly. Moreover, standard contractual clauses for studies will considerably reduce the administrative red tape for research projects.
2. Another area of emphasis is drug pricing.
In the future, pharmaceutical companies that carry out research in Germany will be able to agree confidential reimbursement prices with the health insurers for innovative active substances. The intention is to evaluate this arrangement, which will initially be in place until 30.6.2028, at the end of 2026. While the German Federal Government views this measure as an incentive for innovation, nevertheless, critics have expressed concern that keeping reimbursement prices confidential could lead to rising prices in the healthcare system.
3. A controversial aspect of the legislation are the new reporting obligations for hospitals.
In the future, hospitals will be obliged to transmit quarterly data on the allocation of medical staff to the service groups. However, in an accompanying resolution, the Bundesrat called for the withdrawal of this provision because the benefits are questionable and the administrative red tape for the hospitals seems to be considerable.
