The supply of medication has recently been repeatedly strained. Now a new law is intended to make Germany more attractive again as a location for research and production of pharmaceuticals. Criticism comes from the medical associations.
The federal government wants to make Germany more attractive again as a location for the development and production of medicines. To this end, the cabinet has introduced a bill from Federal Health Minister Karl Lauterbach (SPD). The Medical Research Act is part of the federal government’s pharmaceutical strategy.
Medicines should be tested and approved more quickly – and thus come onto the market more quickly. This also directly benefits patients in Germany who could benefit from new therapies, said Lauterbach.
Among other things, simplifications in clinical trials are planned. This proves the effectiveness, safety and tolerability of substances before they are approved and come onto the market. Such tests also have ethical and legal requirements to protect participants in studies, as the federally owned Paul Ehrlich Institute explains in principle.
Simplifications at Radiation applications
The Federal Ministry for the Environment, Nuclear Safety and Radiation Protection is also involved in the proposed law. Simplifications in the procedures for research-related radiation applications are also planned. High ethical and scientific standards were maintained and effective radiation protection was maintained, explained Federal Environment Minister Steffi Lemke (Greens).
There should also be unbureaucratic decision-making processes by bringing the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul Ehrlich Institute closer together, with the BfArM having the steering function. The pharmaceutical industry had criticized the application procedures at various authorities as time-consuming and costly.
Procedures for ethical assessment should also be streamlined. In the future, there will be a nationwide ethics commission under the umbrella of the BfArM, which will be responsible for particularly urgent or demanding procedures. Its members should be appointed directly by the Federal Ministry of Health.
Criticism from medical associations
The German Medical Association and several state medical associations had criticized this plan. This puts the federal government in direct competition with the ethics commissions that have been set up in the states for decades, they criticized. This leads to the creation of a parallel bureaucracy and a loss of time.
The government’s plan to allow confidential reimbursement amounts for medicines with new active ingredients is also controversial. Negotiated reimbursement amounts for new medicines have so far been publicly available.
The background: Since Germany is considered a reference country for drug prices in many other countries, manufacturers say they have to keep the costs of new drugs in this country artificially high in order not to get into a downward spiral. If the agreements were secret, the pharmaceutical industry could offer its products in Germany at lower prices.
“Secret regulation only serves pharmaceutical companies”
However, this argument is doubted by the health insurance companies. “Secret prices give pharmaceutical companies scope for non-transparent pricing and will drive up costs. We are not talking about millions, but rather many billions of euros in additional costs for contributors every year without any added value for the care,” explained the board member Central Association of Statutory Health Insurance Funds (GKV), Stefanie Stoff-Ahnis.
Florian Reuther, director of the Association of Private Health Insurance (PKV), criticized that the planned secret regulation only served the interests of pharmaceutical companies in order to get a price advantage outside Germany. “It is precisely those insured people who are cost-conscious who suffer the financial damage.”