Hospital.Help

Berlin – With confidential reimbursement prices and the establishment of a Federal Ethics Commission, two of the key projects of the Federal Ministry of Health (BMG) in the draft Medical Research Act (MFG) continue to face great resistance. Shortly before the hearing on the draft in the Federal Health Committee, a clear mood is emerging among the associations and experts.

The plan to give pharmaceutical companies the option of confidential reimbursement prices when introducing new drugs has been met with almost unanimous rejection. Only the Association of Research-Based Pharmaceutical Companies (vfa) is in favour of this without reservations.

This would merely be an additional contract option for special situations in which international price referencing would massively endanger the availability of innovative medicines in Germany, writes the vfa in its statement on the draft: “A system change from public to confidential processing of all reimbursement amounts is neither implemented nor induced by the new requirements.”

Due to the small number of expected applications, such a regulation would not cause any significant bureaucratic costs for the system as a whole. In addition, the principle of subsequent reimbursement is fundamentally nothing new, as this is already the case with the retroactive application of the reimbursement amount in the procedure under the Pharmaceutical Market Reorganization Act (AMNOG).

The regulation is therefore fundamentally suitable for achieving the objective of improving care in individual cases. The vfa even advocates not unnecessarily restricting the scope of the option.

The German Pharma Association (formerly BAH) sees things somewhat differently. Although the association welcomes the plans in principle, the proposed implementation rules would include a large number of measures and participants in the process, “which not only require an immense amount of implementation effort, but also endanger secure and consistent confidentiality,” the statement says.

Health economist Jürgen Wasem, who was asked to give his opinion as an expert, believes that the idea is fundamentally understandable, as it could at least in individual cases help to ensure that medicines are offered on the German market that would not be possible without this regulation. However, the regulation would lead to “frictions with existing control mechanisms in various places”, for example in the context of cost-effectiveness audits.

In contrast, there is a broad front of associations and institutions, some of which are firmly opposed to the plans. These include the German Medical Association (BÄK), the National Association of Statutory Health Insurance Funds, the Federal Joint Committee (G-BA), the Association of Private Health Insurance, the Institute for Quality and Efficiency in Health Care (IQWiG), the Federal Association of Pharmaceutical Wholesalers (Phagro), the Association of Drug Importers, the Evidence-Based Medicine Network, the BAG Self-Help and several health insurance associations.

The majority of them emphasize that there is no evidence to support the BMG’s idea that companies would actually offer higher discounts under the premise of confidentiality. The opposite is probably the case: a lack of price transparency would endanger the existing instruments for regulating economic drug supply and lead to a disproportionate increase in bureaucracy, writes the G-BA, for example.

In addition, such regulations would have a negative impact on the benefit assessment process. This is because the annual treatment costs of the appropriate comparative therapies would then have to be calculated on the basis of the publicly available list prices, which would then have little in common with the costs actually incurred by the statutory health insurance and would usually be overestimated in the decisions.

“For the outside world – doctors and patients in Germany, but also within the European Union (EU) – it would no longer be comprehensible to what extent the additional benefit identified in the benefit assessment decision still has any influence on the prices of the medicines if the negotiated reimbursement amount is not made public,” writes the G-BA.

The National Association of Statutory Health Insurance Funds also warns of significant additional financial burdens that could also arise from circumventing the principle of cost-effectiveness. “Without knowledge of the confidential reimbursement amount, the contracted doctor cannot identify and select the drug that is actually cheaper for the statutory health insurance fund – especially when deciding between different AMNOG drugs,” it writes in its statement. Any discounts granted to the statutory health insurance fund would then not be realized at all.

A similar mood emerges when it comes to the question of setting up a federal ethics committee, officially called a “specialized ethics committee for special procedures.” Pharma Germany believes that this step would be expedient, at least for certain procedures. However, this would result in some ambiguities regarding the requirements and the internationally required independence of this ethics committee.

In addition, the current procedure for assigning ethics committees to conduct clinical trials would be made “more complicated and opaque, contrary to the propagated approach of reducing bureaucracy,” the association writes. “It is doubtful whether this measure will increase Germany’s attractiveness for applying for and conducting clinical trials.”

When it comes to the Federal Ethics Commission, a broad front of associations and institutions have expressed their opposition, without there being any explicit advocates for the project. The Working Group of Medical Ethics Commissions (AKEK), the vfa, the Leopoldina, the BÄK, the IQWiG, but also the BPI and the BAG Self-Help have criticized the project, in some cases clearly.

With a Federal Ethics Commission, the approval, ethical assessment and, if necessary, post-study evaluation would be carried out under the umbrella of the same institution – the Federal Institute for Drugs and Medical Devices (BfArM), criticizes the IQWiG, for example.

The AKEK warns that a parallel bureaucracy would be created alongside the tried and tested and established ethics committees of the states. “This would lead to a loss of time, a loss of expertise, additional friction and the weakening of the existing ethics committees, which would also have an impact on Germany as a study location,” it writes in its statement.

In addition, the establishment of a Specialized Ethics Committee at the BfArM and the appointment of its members by the BMG is not compatible with the independence of ethics committees in the sense of the Declaration of Helsinki: “All functions and decision-making powers would thus be concentrated in the area of ​​the higher federal authority and in the area of ​​responsibility of the Ministry of Health.” © lau/aerzteblatt.de