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Berlin – Despite criticism from the Bundesrat, the federal government is sticking to its plans to create a Federal Ethics Commission and introduce confidential reimbursement prices. This is clear from the draft counter-declaration to the Federal Council’s statement on the planned Medical Research Act (MFG).
Last week, the Federal Council expressed its dissatisfaction with the federal government’s plans and, in particular, expressed its opposition to two central projects.
The creation of a specialized at the Federal Institute of Medicines and Medical Devices (BfArM) the ethics committee questions the tried and tested system of ethics committees created in the states, without any gain in reliability and speed, explained Brandenburg Health Minister Ursula Nonnemacher (Greens), after the Federal Council accepted a proposal for your health committee in this regard.
The federal government now contradicts this. The suppression of the creation of the Specialized Ethics Committee for Special Procedures (SEKbV) is officially out of the question, as it is intended to implement the main objective of the MFG, namely to specialize Germany as an internationally leading location for research and development in the field of clinical studies to strengthen.
“Criticism of the research-based pharmaceutical industry and scientific research regarding inconsistent requirements and the resulting effort, waste of time and lack of planning in the approval process should not go unnoticed,” the counter-statement says.
With SEKbV, we opted for a proportional means that creates the necessary improvements and still maintains the system of registered ethics committees in the states. SEKbV creates specialization and expertise for the evaluation of particularly demanding procedures and innovative new therapies, which impose high technical demands and require in-depth knowledge.
The same legal requirements regarding member independence would apply to the SEKbV and the registered ethics committees of the federal states. These must guarantee their independence in writing through declarations of independence and, therefore, like the members of a country’s ethics committee or other institutions, they are not bound by instructions.
“No compromises will be made here – in the interests of patients,” the federal government emphasized. On the contrary, the creation of the SEKbV ensures that the background knowledge required for special procedures is available and that unnecessary effort and wasted time are eliminated.
Furthermore, the ethics committees of the federal states have repeatedly referred to the complex requirements of the relevant EU and European regulations. Clinical Trial Information System brought to attention. They would also be replaced by the SEKbV.
The German Medical Association and state medical associations have also criticized plans for a federal ethics commission. An “independent specialized ethics committee” should deal with particularly complex and urgent procedures. It must be located in the BfArM and its members must be appointed directly by the Federal Ministry of Health. According to the BÄK, this calls into question the independence of the ethical evaluation of study projects.
Referring to arguments from the pharmaceutical industry, the federal government also refuses to renounce the introduction of confidential reimbursement prices. Due to the so-called external reference price effect, the German reimbursement amount has an economic impact that goes far beyond the German market.
“According to statements from the pharmaceutical industry, this limits companies’ scope for reimbursement negotiations,” he continues. This could lead to pharmaceutical companies deciding to withdraw from the German market, which in turn could endanger German patients’ access to innovative medicines.
Germany is the only EU Member State with comparable transparency in medicine prices. Even in the context of an “international trend towards confidential pricing”, it is therefore necessary to extend the flexibility of negotiating partners and their negotiating scope in order to avoid the negative effects associated with the external reference price effect of the German reimbursement amount .
“By allowing confidentiality, Germany is compensating for a competitive disadvantage in competition with virtually all comparable countries that have always agreed confidential prices for new medicines,” explains the Federal Government.
At the same time, however, it can be assumed that pharmaceutical companies will only resort to the manufacturer’s option of confidential reimbursement prices “in individual cases”, as the procedure will entail additional costs for them.
As the federal government writes, other proposed changes should be rejected “for technical reasons”. The state chamber’s submissions “would partially contradict the objective of the Medical Research Law to reduce bureaucracy and simplify medical research.”
This includes, among other things, requests from the Federal Council for changes with regard to the obligations of sponsors of clinical trials, additional training for trial participants and obligations for researchers or monitoring, as well as further changes to the distribution channel of clinical trials. medicines in the context of decentralized clinical trials.
The federal government also rejects proposed changes to expand the possibility of exemption from the price moratorium, which exists under strict conditions, for medicines with a previously fixed price, as well as requests for changes to the subject of the radiological protection law. © lau/may/aerzteblatt.de