Experts warn: Federal Ethics Commission creates more bureaucracy and jeopardizes the independence of ethics commissions in Germany
08.02.2024 12:20
Statement by the AKEK (Working Group of Ethics Commissions) on the establishment of a central federal ethics commission at the federal higher authorities. The ethics commissions established under state law in Germany are originally independent institutions initiated by scientists, which since their founding over 40 years ago have pursued essentially the following goals:
1. To protect the rights, safety, dignity and well-being of study participants from risks,
2. to ensure that studies involving humans meet the highest scientific standards and thus generate reliable data, and
3. To minimize the delay of meaningful studies caused by unnecessary bureaucracy.
The Working Group of Medical Ethics Committees in Germany (AKEK) is intensively engaged with the latter issue. We share the view that the federal structure in Germany must not lead to overlapping responsibilities or wasted time. Clear rules of jurisdiction, such as those now being introduced for data protection oversight, are helpful in this regard. These have long been implemented for ethics committees in the pharmaceutical sector: In Germany, only one ethics committee, together with the relevant federal authority, is responsible for the evaluation of a clinical trial. Binding deadlines ensure that this does not result in any wasted time to the detriment of the sponsor – contrary to what is suggested, for example, in the recent report by vfa and Kearney. To facilitate harmonized processing, ethics committees have developed a substantial number of working aids, model formulations, recommendations, and similar resources, particularly in recent years.
However, the evaluation of drug trials presents other difficulties. These stem primarily from the complexity of Regulation (EU) No. 536/2014 (Clinical Trial Regulation, hereinafter CTR) and the malfunctioning IT platform CTIS, for which the European Medicines Agency (EMA) is responsible. The flawed procedural management by CTIS demonstrably leads to a significant increase in workload for all parties involved. Further problems, such as the difficulties in contract drafting, are rightly identified in the strategy paper and the explanatory memorandum accompanying the draft bill for the Medical Research Act. The AKEK (Committee on Ethics in the Pharmaceutical Industry) publicly highlighted the CTR/CTIS problems at an early stage and proposed solutions. This was done in close cooperation with the German Medical Association, the research-based pharmaceutical industry, and scientific societies. This was followed by personal discussions with the European Commission and its Director-General for Health and Food Safety, Ms. Sandra Gallina, the Federal Minister of Health, Prof. Karl Lauterbach, the President of the Federal Institute for Drugs and Medical Devices (BfArM), Prof. Karl Broich, as well as representatives of industry associations and other important stakeholders.
From our perspective, it is therefore very regrettable that the demand for a federal ethics commission, which is not shared by the pharmaceutical associations, is being made in the "Strategy Paper 4.0," the BMG's key points paper, and now also in the draft bill for the Medical Research Act. Neither the bodies responsible for the ethics commissions nor their umbrella organization AKEK were involved in the discussions.
In this context, it is interesting to note that the statistical analysis by the EMA (Monitoring the European clinical trials environment; A deliverable of the ACT EU Priority Action 2 – December 2023) shows that Germany continues to hold a leading position in Europe in all aspects of clinical trial statistics. The ethics committees established under state law undeniably fulfill their tasks. Efforts to abolish the system of decentralized ethics committees in Germany and instead establish a federal ethics committee at the Federal Institute for Drugs and Medical Devices (BfArM) are not justifiable from a political, legal, or economic perspective.
The specific arguments against establishing a federal ethics commission can be found [here/in the following]. here.