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Berlin – The Federal Council addressed the Medical Research Law for the first time today and is not at all satisfied with the law. The State Chamber followed a Submission from the Health Committee of the Federal Council, in which several changes are necessary.
Among other things, the Federal Council rejects the planned creation of a specialized federal ethics commission. Various medical representatives and organizations, such as the German Medical Association, also spoke out against this.
Also criticized: secret drug prices that drug manufacturers are reimbursed by legal health insurance companies. In addition to the great lack of transparency, the process involves a lot of bureaucratic and financial effort with only questionable benefits, it was said today.
Brandenburg’s Health Minister Ursula Nonnemacher (Greens) stressed today that the aim of the law, which aims to reverse the downward trend in clinical trials in Germany, was correct.
But the planned creation of a specialized ethics committee based at the Federal Institute for Medicines and Medical Devices, for example, calls into question the tried and tested system of ethics committees created in the federal states without any increase in reliability and speed, she said. .
“There is an absolute need to maintain an independent ethical assessment of clinical trials in the future. This has been a basic principle of guinea pig protection in Germany for decades,” said Nonnemacher.
However, the creation of a specialized ethics committee at the Federal Institute of Medicines and Medical Devices could compromise this important independence in ethical assessment, since the Federal Ministry of Health should appoint the members of the committee and carry out technical supervision.
The draft Medical Research Act is part of a strategic document “Improvements in framework conditions for the pharmaceutical sector in Germany” approved by the federal government on December 13, 2023, which aims to strengthen the attractiveness of the research and production location.
Specifically, the structural conditions for the development, approval and production of medicines and medical devices must be improved. The content of the bill consists of amendments to the Medicines Law, the Medical Devices Law Implementation Law, the Radiological Protection Law and the Medicines Prescription Ordinance.
The countries today received approval for their positions. “We welcome the fact that federal states are rejecting the opportunity for pharmaceutical companies to agree on secret prices for medicines,” said Stefanie Stoff-Ahnis, board member of the National Association of Statutory Health Insurance Funds.
Secret prices undermined the principle of profitability. If doctors are deprived of price transparency, they will no longer be able to prescribe economically. “If secret pricing prevails, it will significantly increase the already growing expenditure on medicines by many billions of euros.”
Similar sounds come from AOK Federal Association. “The introduction of secret reimbursement amounts would lead to a considerable lack of transparency, as well as a high level of bureaucratic and financial effort that is incompatible with responsible health economic considerations,” said Jens Martin Hoyer, vice-president of AOK.
“In general, almost no one seems to think that secret pricing is a good idea: neither the medical profession, nor private health insurers, and even parts of the pharmaceutical industry are explicitly in favor of them. So you wonder: who really benefits from this in the end?”
The Federal Association of Drug Manufacturers (Bah) expressed concern about some proposed deletions, especially in the areas of clinical trials and the Radiation Protection Act. These proposals did not meet the objectives of the law.
“Uniform guidelines are key to the successful implementation of our national pharmaceutical strategy,” said Dorothee Brakmann, General Director of BAH. Therefore, we strongly advocate maintaining the authority of the Medical Ethics Committees Working Group (AKEK) guidelines. © may/aerzteblatt.de