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Berlin – With confidential reimbursement prices and the creation of a Federal Ethics Commission, two of the central projects of the Federal Ministry of Health (BMG) on the Medical Research Bill (MFG) continues to face strong resistance. Shortly before the hearing on the project at the Federal Health Committee, a clear atmosphere emerged between associations and experts.
The plan to give pharmaceutical companies the option of confidential reimbursement pricing when introducing new drugs was rejected almost unanimously. Only the Association of Research-Based Pharmaceutical Companies (vfa) is in favor of this, without any restrictions.
This would simply be an additional contractual option for special constellations where international reference pricing would greatly compromise the availability of innovative medicines in Germany, he writes. vfa in its statement about the project: “A change from the public to confidential processing system for all refund amounts will not be implemented nor induced by the new requirements.”
Due to the small number of expected use cases, such regulation would not cause any significant bureaucratic costs for the entire system. Furthermore, the principle of subsequent reimbursement is not fundamentally new, after all, this is already the case with the retroactive validity of the reimbursement amount in the procedure under the Medicines Market Reorganization Act (AMNOG).
The regulation is therefore fundamentally appropriate in individual cases to achieve the aim of improving care. The vfa even advocates not unnecessarily restricting the scope of the option.
The Pharma Germany Association (formerly BAH) already sees things a little differently. Although the association welcomes the plans in principle, the proposed implementation rules would contain a large number of procedural measures and participants, “which not only require an immense implementation effort, but also put at risk the secure and consistent protection of confidentiality”, it says. the statement.
The health economist Jürgen Wasem, who was questioned as an expert, believes that the idea is fundamentally understandable, as it could, at least in individual cases, help to ensure that medicines for which this would not be possible without this regulation. However, the regulation “would lead to friction with existing control mechanisms in several places”, for example, in the context of performance audits.
On the other hand, there is a broad front of associations and institutions, some of which firmly reject the plans. Includes the German Medical Association (BAK), O National Association of Statutory Health Insurance Fundsthe Federal Joint Committee (G-BA), the Private Health Insurance Association, the Institute for Quality and Efficiency in Health Care (IQWiG), the Federal Association of Pharmaceutical Wholesalers (Phagro), the Association of Pharmaceutical Importers, the Evidence-Based Medicine Network, BAG Self-Help, and several health insurance associations.
Most of them point out that there is no evidence to support BMG’s idea that companies would actually give bigger discounts under the premise of confidentiality. The opposite is likely to happen: a lack of price transparency would endanger existing instruments to regulate the economic supply of medicines and lead to disproportionate additional bureaucratic effort, writes G-BA, for example.
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Furthermore, such regulations would have negative effects on the benefits evaluation process. The annual costs of appropriate comparative therapies would then have to be calculated on the basis of publicly available list prices, which would have little in common with the costs actually incurred by statutory health insurance and are generally considered too high in the resolutions.
“For the outside world – doctors and patients in Germany, but also within the European Union (EU) – it would no longer be understandable to what extent the additional benefit determined in the benefit assessment decision still has any influence on drug prices if the value of the negotiated reimbursement is not made public”, writes G-BA.
The National Association of Statutory Health Insurance Funds also warns of considerable additional financial burdens, which could also arise from weakening the cost-effectiveness requirement. “Without knowledge of the confidential reimbursement amount, the contracting physician cannot identify and select the drug that is truly cheapest for the legal health insurer – especially when deciding between the different AMNOG drugs,” he writes in his statement. Any discounts granted in favor of GKV would then not be realized.
A similar feeling arises when it comes to the issue of creating a Federal Ethics Commission, which is officially called the “Specialized Ethics Commission on Special Procedures”. For Pharma Germany, this step appears to be convenient, at least for certain procedures. However, this would result in some ambiguities regarding the requirements and internationally required independence of this ethics committee.
Furthermore, the current process of assigning ethics committees to carrying out clinical trials would be, “contrary to the propagated approach of reducing bureaucracy, more complicated and less transparent”, writes the association. “It is doubtful that this measure will increase Germany’s attractiveness for applying for and carrying out clinical trials.”
When it comes to the issue of the Federal Ethics Commission, a broad group of associations and institutions expresses their rejection, without there being explicit supporters of the project. The Working Group of Medical Ethics Committees (AKEK), vfa, Leopoldina, BÄK, IQWiG, but also BPI and BAG Self-Help clearly criticize the project in some cases.
A Federal Ethics Commission would be under the aegis of the same institution – the Federal Institute of Medicines and Medical Devices (BfArM) approval, ethical assessment and, if necessary, evaluation are carried out after the end of the study, for example, criticizes IQWiG.
AKEK warns that a parallel bureaucracy would be created alongside the tried and tested state ethics committees. “This would subsequently lead to a waste of time, loss of knowledge, additional friction and a weakening of existing ethics committees, which would also have an impact on Germany as a study location,” he writes in his statement.
Furthermore, the creation of a specialized ethics committee at the BfArM and the appointment of its members by the BMG are not compatible with the independence of ethics committees within the meaning of the Declaration of Helsinki: “All functions and decision-making powers would therefore be concentrate on the area of the highest federal state body and the Division of the Ministry of Health.” © lau/aerzteblatt.de