"German health minister Karl Lauterbach wants to facilitate clinical trials and attract pharmaceutical manufacturers to Germany. The health insurance companies criticize this as economic development by the contributors to the health insurance system.
When it comes to science, no image is too strong for the health minister - even if it is wrong. In view of the Medical Research Act, which the Bundestag passed recently, Karl Lauterbach even tried a Christian metaphor. "As a resurrected heavyweight in research, Germany will make important contributions here," he said. The new regulations not only provide research incentives and improve the approval of drugs. They also promote pharmaceutical production in Germany, said the SPD politician.
Even before it was passed, the law had made Germany more attractive as a location, said Lauterbach, alluding to the recent settlement and expansion plans of international corporations such as Sanofi, Eli Lilly, Daiichi-Sankyo, Roche and Merck: "In anticipation of better framework conditions, many companies have already invested." The Passing the law in the Bundestag confirms the commitments and ensures that approvals for clinical trials are accelerated, responsibilities are pooled, testing requirements are standardized and digitization is used more, promised Lauterbach: "This will lead to better research in medicine in Germany, many cancers and dementia are still incurable."
The amendment provides, among other things, for harmonizing the standards and cooperation of the approval authorities and ethics committees and for creating binding standard contractual clauses. If clinical trials take place in Germany, the processing time will be reduced to 26 days. Academic studies can be better funded in the future, and inspections of "good manufacturing" (GMP) in other countries, especially in China, will also be recognized if the certificates come from qualified third countries, for example the USA.
Reduced "secret prices"
The law also aims to help reduce drug prices. In this context, the clause that the reimbursement prices for new preparations negotiated by pharmaceutical manufacturers and health insurance companies should be kept secret in the future was controversial for a long time. The reason for this is that the publicly known, often heavily discounted German prices have previously served as a reference for other countries. From the manufacturers' point of view, this limited their negotiating room in the other countries, which is why they insisted on confidentiality.
After a heated debate, the compromise now stipulates that the amounts do not have to be disclosed until mid-2028. But only if a price reduction of 9 percent is granted and only if the company "can demonstrate a drug research department and relevant projects of its own and cooperation with public institutions in preclinical or clinical drug research in Germany". This rule is to be evaluated in 2026. Many pharmaceutical providers think these requirements go too far. However, they are quite happy with the new regulation that the so-called AMNOG guard rails for the reimbursement of new patented drugs with little or no additional benefit are to be relaxed.
Criticism from doctors and health insurance companies
In future, there may be more money for these products if some of the research was carried out in Germany. Specifically, 5 percent of the test subjects from the approval study must have taken part in the clinical study in Germany. The higher remuneration is then limited to three years, unless the company can prove that it has carried out relevant research of its own in Germany.
Industry associations largely welcomed the amendment. "The Medical Research Act is the most important result of the federal government's pharmaceutical strategy to date," said the President of the Association of Research-Based Pharmaceutical Manufacturers, Han Steutel. "The law will significantly improve the framework conditions for drug development in Germany."
On the other hand, representatives of doctors such as the Marburger Bund and the National Association of Statutory Health Insurance Physicians have voiced criticism because the innovations in clinics and practices have led to more bureaucracy. For example, the prescription software of practicing physicians must be modified in such a way that doctors can ensure that prescriptions are cost-effective despite not knowing the drug prices. Health insurance companies are also dissatisfied. Drug spending would certainly increase, not decrease, as Lauterbach claims. The law primarily serves to promote the economy, complained the umbrella organization of statutory health insurance: "We reject the idea that the federal government should allow this funding to be financed from our contributions."" [1]
1. Anschub für die Pharmaforschung. Frankfurter Allgemeine Zeitung (online) Frankfurter Allgemeine Zeitung GmbH. Jul 4, 2024. Von Christian Geinitz
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