Broad front against confidential reimbursement prices in...

Broad front against confidential reimbursement prices in…


Meeting of the Health Committee of the Bundestag /Maybaum

Berlin – The federal government’s plans to allow confidential reimbursement prices met with widespread opposition in the Federal Health Committee today. Only the pharmaceutical associations spoke in favor of them, while the statutory health insurance system expects additional costs amounting to billions.

With the Medical Research Act (MFG), the Federal Ministry of Health (BMG) wants to strengthen pharmaceutical research and development in Germany by, among other things, accelerating and simplifying approval procedures. However, today’s hearing in the Federal Health Committee was dominated by an aspect of the draft law that is actually not a central one: the option for pharmaceutical companies to agree on confidential reimbursement prices for new active ingredients.

While the law itself was largely met with approval – especially plans such as the introduction of model contract clauses for clinical trials and simplifications in radiation protection requirements – most associations and experts criticized the planned introduction of a Federal Ethics Commission renamed the “Specialized Ethics Commission for Special Procedures” as well as the aforementioned reimbursement price regulations.

If 25 percent of all reimbursement price negotiations were subject to confidentiality, this would, according to calculations by the GKV-Spitzenverband, cause up to 8.5 billion euros in additional burdens for contributors over the next ten years, explained its head of the AMNOG reimbursement amount negotiations department, Anja Tebinka-Olrich.

If all negotiations were conducted confidentially, up to 36 billion euros could be expected in the same period. These are orders of magnitude that could lead to increases in contributions.

According to Kerstin Noëlle Vokinger, Professor of Regulation in Law, Medicine and Technology at the University of Zurich, these are not unrealistic scenarios. “The secret prices are an industry initiative and do not bring any benefit in terms of care,” she criticized.

Studies from other health systems show that companies regularly enter confidential reimbursement negotiations with higher prices and that the negotiations take longer. The World Health Organization (WHO) also speaks out against them.

The argument by supporters that other health systems also work with confidential reimbursement prices and that Germany is alone in Europe with its full price transparency is also not valid, stressed the chairwoman of the AOK Federal Association, Carola Reimann.

The plans in the MFG would only change part of the system: unlike other European countries, Germany does not have a fourth hurdle such as cost efficiency when it comes to reimbursement. “Secret prices without any economic control lead to the health insurance companies being overburdened,” she warned.

In addition, the plan is “deeply un-European” because its logic is to undermine the reference effect of the German market. This would inevitably lead to higher prices in other European countries and thus in turn to a poorer availability of new medicines in their health systems. In this country, the regulation would lead to a considerable increase in bureaucracy because there would regularly be overpayments that would then have to be compensated.

In addition, it is doubtful whether the confidentiality of the reimbursement prices could be guaranteed at all, explained the chairman of the BKK umbrella association, Franz Knieps.

During his time as head of the Department of Health Care, Statutory Health Insurance and Long-Term Care Insurance in the Federal Ministry of Health, he was also responsible for pharmaceuticals and in this context was often confronted with the situation that other countries work with confidential prices.

He explained that it was usually enough to make “one or two calls to the right people in foreign health systems” to find out the actual reimbursement level for a drug. He also stressed that he considered the plans “very questionable from a European perspective” given the reference effect of the German market.

The wholesalers also spoke out against the plans. According to calculations by the Federal Association of Pharmaceutical Wholesalers (Phagro), these would lead to additional costs of 3.5 billion euros due to higher purchasing prices, explained board member Thomas Porstner.

However, wholesalers cannot simply pass these additional costs on to other retail levels due to price fixing. “We are therefore demanding that these additional costs be compensated. We cannot pass these increases on to our customers,” he said.

Allessandro di Lorenzo, a member of the extended board of the Association of Pharmaceutical Importers, also strongly criticized the plans. The import system serves to reduce costs by strengthening price competition – if the actual prices in the country are not known, the system will be undermined. “The planned regulation will mean that in future it will be up to the manufacturer to decide whether competition is possible or not,” he emphasized.

The Federal Government’s argument that confidential reimbursement prices could increase the availability of new medicines, which under transparent conditions might not even be introduced onto the German market, is also unsuitable, explained the head of the Institute for Quality and Efficiency in Health Care (IQWiG), Thomas Kaiser.

There is no evidence at all that this is the case. Quite the opposite: Germany is the only country in Europe with full price transparency and at the same time has the highest and fastest availability of new active ingredients.

The Federal Joint Committee (G-BA) also joined the opposition to the plan. The requirement for cost-effectiveness will be impossible to enforce in outpatient care “if the Lauer-Taxe contains fantasy prices,” explained the impartial chairman, Josef Hecken. This would render a central control instrument useless.

Confidential reimbursement prices were only supported by the Association of Research-Based Pharmaceutical Companies (vfa) and Pharma Deutschland. His association viewed the draft law very positively, explained vfa President Han Steutel: “For us in Germany, this is a very important step for the research industry.” Confidentiality can help prevent products from leaving the market.

In addition, it is also necessary to make adjustments to the regulations of the Statutory Health Insurance Financial Stabilization Act. The guard rails introduced by it, which, among other things, meant that in certain cases a new drug could not cost more than the comparative therapy despite proven additional benefits, had already led to the unavailability of new products.

Five new drugs – three oncology drugs and one each for HIV and psoriasis – have already not been introduced in Germany because of the guard rails. “That worries me,” he stressed. Pharma Germany supported the calls to abolish guard rails and combined discounts. Only drugs that can also be sold are being researched.

The plans to establish a Federal Ethics Commission also met with widespread opposition. It is planned that the BMG will both approve its statutes and appoint its members, and that it will be affiliated with the Federal Institute for Drugs and Medical Devices (BfArM), a higher federal authority that is bound by instructions and also reports to the BMG, criticized the chairman of the Working Group of Medical Ethics Commissions (AKEK), Georg Schmidt.

“In my view, that is not acceptable,” he said, pointing out that the Declaration of Helsinki requires the independence of ethics committees. A special German approach is not a good idea. Ulrich Langenberg, the director of politics at the German Medical Association (BÄK), also stressed that he is firmly opposed to a federal ethics committee: independence is a valuable asset that cannot be sacrificed to the desire for harmonization and acceleration. © lau/

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