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Berlin – The planned Medical Research Act is a first step towards improving the framework conditions for biomedical research and innovations in Germany – but from the point of view of the National Academy of Sciences Leopoldina, an overall strategy with further comprehensive measures is necessary.

This is the result of a new so-called ad hoc statement by the Academy on the draft law. It is entitled “From the Medical Research Act to the overall strategy: strengthening biomedical research in Germany in the long term.” According to the Leopoldina, such an overall strategy should encompass all political levels and relevant departments.

This includes rules for therapeutic and diagnostic studies, including those involving the use of artificial intelligence or robotics. Sustainable funding for basic research should also be guaranteed in the long term. The scientists emphasize that the translation of basic research results into the clinic should be faster. But the flow of findings from clinical trials and routine care into basic research must also be improved.

The ad hoc statement also recommends measures to adapt animal protection regulations in the research sector. The current provisions of the German Animal Protection Act and the different interpretations of EU regulations have led to uncertainty and excessive bureaucracy in research. The Leopoldina recommends that the protection of animals used for scientific purposes be anchored in a separate animal testing law and transferred to the area of ​​responsibility of the Federal Ministry of Education and Research (BMBF).

The statement advocates that all clinical trials be registered before they start and their results be published, but without creating additional bureaucratic burdens for researchers. The experts also see a need for action in data protection: Since many patients want to make their data available for medical research purposes, politicians should further expand the possibility of so-called secondary use of patient data for research purposes.

The Federal Cabinet approved the draft Medical Research Act at the end of March. The aim of the reform is to improve the framework conditions for the development, approval and manufacture of pharmaceuticals and medical products in Germany. The first reading in the Bundestag is scheduled to take place this week. © hil/aerzteblatt.de