Medical Research Act passed

The Medical Research Act, long awaited by the pharmaceutical industry, can now come into force. The law is a central component of the Federal Ministry of Health's pharmaceutical strategy and is intended to strengthen Germany's attractiveness as a location for medical research. Federal Health Minister Prof. Karl Lauterbach sees the law as an important step towards implementing the federal government's pharmaceutical strategy.

"We are giving researchers and companies the necessary planning security, reducing bureaucracy and speeding up procedures and strengthening patient care, especially with innovative medicines. This will strengthen Germany as a research location," said Lauterbach. Both research and production should take place in Germany.

"The Medical Research Act makes progress in reducing bureaucracy and speeding up administrative procedures. In the area of radiation protection, we are ensuring a consistently high level of protection for people from ionizing radiation and at the same time reducing unnecessary bureaucracy in a targeted manner," said Steffi Lemke from the Federal Ministry for the Environment, Nature Conservation, Nuclear Safety and Consumer Protection. Among other things, a specialized ethics committee is to decide on "particularly complex or urgent procedures" – such as the clinical testing of drugs for advanced therapies. There had been a lot of criticism of this in the run-up, for example in connection with the commission's lack of independence.

Lower drug prices planned

In addition, the scope for negotiating pharmaceuticals is to be increased. Accordingly, pharmaceutical companies should be able to "agree confidential reimbursement amounts for drugs with new active ingredients". There had been much criticism of the proposal in advance. "Pharmaceutical companies will be given the opportunity to agree confidential reimbursement amounts for new medicinal products for a limited period until June 30, 2028. This can only be chosen following the reimbursement amount agreement or determination. In return, companies must grant a price reduction of 9%,"[link to https://www.bundesgesundheitsministerium.de/presse/pressemitteilungen/medizinforschungsgesetz-brat-27-09-24.html] according to the Federal Ministry of Health. However, the research must take place in Germany.

Removing the "bureaucratic horcrux"

There had been criticism of the obligation for hospitals that was added in the course of the legislative process. Every three months, they must report "detailed data on the allocation of medical staff to the service groups that are to be decisive in the hospital reform", as stated by the Bundesrat (PDF). The Federal Council criticized the fact that even the Hospital Care Improvement Act does not provide for a quarterly review. If the figures were not reported or reported incorrectly, the hospitals would be obliged to pay €50,000.

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Hospitals demand less bureaucracy

Dr. Andreas Philippi (SPD) criticized the controversial point, saying that this was "no mean feat". For hospitals, the obligation was a "bureaucratic horcrux", with already three hours of bureaucratic work every day. He argued that excessive control bureaucracy, from which patients do not benefit, must be urgently reduced. The Federal Council is therefore calling for this point to be removed from the draft bill.

(mack)