Bundestag/Maybaum Health Committee Meeting
Berlin – The federal government’s plans to allow confidential reimbursement prices today encountered widespread resistance at the Federal Health Committee. Only pharmaceutical associations spoke in favor, while statutory health insurance foresees additional costs worth billions.
With the Medical Research Act (MFG), the Federal Ministry of Health (BMG) strengthen pharmaceutical research and development in Germany, among other things, by accelerating and simplifying the approval process. However, today’s hearing at the Federal Health Commission was characterized by an aspect of the bill that was actually not central: the option for pharmaceutical companies to agree confidential reimbursement prices for new active ingredients.
Although the law itself was widely approved – especially plans such as the introduction of model contractual clauses in clinical studies and simplifications in radiation protection requirements – most associations and experts criticized the planned introduction of a Federal Ethics Commission that was redeclared as “Ethics Committee Specialized in Special Procedures” and the aforementioned reimbursement pricing modalities.
If 25 percent of all reimbursement price negotiations were subject to confidentiality, this would, according to calculations by the National Association of Statutory Health Insurance Funds, cause up to €8.5 billion in additional burdens for taxpayers in next ten years, explained his head of the AMNOG reimbursement negotiation department, Anja Tebinka.
If all negotiations were conducted confidentially, up to €36 billion could be expected during the same period. These are orders of magnitude that can lead to premium increases.
According to Kerstin Noëlle Vokinger, professor of Regulation in Law, Medicine and Technology at the University of Zurich, these are not unrealistic scenarios. “Secret pricing is an industry initiative and brings no benefit to supply,” she criticized.
Studies of other health systems show that companies often begin confidential reimbursement negotiations with higher prices and that negotiations take longer. The World Health Organization (WHO) also speaks out against them.
The advocates’ claim that other healthcare systems also work with confidential reimbursement prices and that Germany is alone in Europe with its full price transparency is also not valid, emphasized the CEO of the Federal Association AOK, Carola Reimann.
Because the MFG’s plans 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 make health insurance companies overburdened,” he warned.
Furthermore, the project is “profoundly un-European” because its logic is to undermine the benchmark effect of the German market. This would inevitably lead to higher prices in other European countries and, in turn, less availability of new medicines in those countries’ healthcare systems. In this country, the regulation would lead to a considerable amount of additional bureaucracy, as there would normally be an overpayment which would then have to be compensated.
Furthermore, it is doubtful whether the confidentiality of reimbursement prices can be guaranteed, explained the CEO of the umbrella organization BKK, Franz Knieps.
During his time as head of the department for healthcare, statutory health insurance and nursing care insurance at the Federal Ministry of Health, he was also responsible for pharmaceutical products and in this context he was often confronted with the situation of other countries working with prices confidential.
“One or two calls to the right people in foreign health systems” were usually enough to find out the actual reimbursement amount for a drug, he explained. He also stressed that he considers the plans “very questionable from a European point of view” given the reference effect of the German market.
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 purchase prices, explained board member Thomas Porstner.
However, wholesalers cannot simply transfer these additional costs to other trading levels due to price fixing. “We are therefore demanding compensation for these additional costs. We cannot pass these increases on to our customers,” he said.
Allessandro di Lorenzo, from the expanded board of the Pharmaceutical Importers Association, was also clearly critical of the plans. The import system serves to reduce costs by reinforcing price competition – if real domestic prices are not known, the system is undermined. “The envisaged regulation would mean that in the future the manufacturer would have the power 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 that might not even be introduced onto the German market under transparent conditions is also inadequate, explained the head of the Institute for Quality and Efficiency in Healthcare (IQWiG), Tomás Kaiser.
There is absolutely no evidence that this is the case. Quite the opposite: Germany is the only country in Europe with complete price transparency and, at the same time, has the largest and fastest availability of new active ingredients.
The Federal Joint Committee (G-BA) joined the project’s opponents. The cost-effectiveness requirement will be impossible to apply to outpatient care “if the Lauer tax contains fantasy prices”, explained the impartial chairman, Josef Hecken. This would mean that a central control instrument would be a waste of money.
Proponents only found confidential reimbursement prices at the Association of Research-Based Medicines Companies (vfa) and Pharma Germany. VFA President Han Steutel explained that his association viewed the bill very positively: “This is a very important step for the investigation industry in Germany. Confidentiality can help prevent products from leaving the market.”
Furthermore, it is necessary to make adjustments to the regulations of the GKV Financial Stabilization Act. The introduced guidelines, which, among other things, meant that in certain cases a new medicine should not cost more than the comparative therapy despite proven additional benefits, had already led to the unavailability of new products.
Five new medicines – three oncology and one against HIV and one against psoriasis – were not introduced in Germany due to protection barriers. “That worries me,” she emphasized. Pharma Germany has joined the calls to abolish guardrails and combined discounts. Only medicines that can be sold would be researched.
Plans to establish a Federal Ethics Commission have also met with widespread resistance. It is intended that BMG approves its statutes and appoints its members, in addition to entering into an agreement with the Federal Institute of Medicines and Medical Devices (BfArM) is linked to a higher federal authority, bound by instructions and also subordinate to the BMG, criticized the chairman of the Working Group of Medical Ethics Commissions (AKEK), Georg Schmidt.
“In my opinion, this is not justifiable,” he said, highlighting that the Declaration of Helsinki requires the independence of ethics committees. A special German route is not a good idea. The managing director of policy at the German Medical Association (BAK), Ulrich Langenberg, emphasized that he firmly rejects a Federal Ethics Commission: Independence is a valuable asset that must not be sacrificed for the desire for harmonization and acceleration. © lau/aerzteblatt.de