Federal Medical Association refuses planned Federal Ethics Commission for Medical Research

Federal Medical Association refuses planned Federal Ethics Commission for Medical Research

It is an important signal that the federal government wants to make Germany more attractive for medical research. The security and protection of study participants must always have the top priority. The establishment of a so-called Federal Ethics Commission planned by the Federal Government with the Medical Research Act unfortunately does not do justice to this provision. In the current form, the law undermines the independence of the assessment of clinical studies and thus harms people's trust in medical research as a whole. The settlement of the Federal Ethics Commission at the Federal Institute for Medicines and Medical Devices, which is subordinate to the BMG depending on the issue, mountains the great risk of political-administrative influence. If, in addition to the drug approval and monitoring, the assessment of clinical studies by a Federal Supreme Authority in the future, possible conflicts of interest could not be safely excluded.

The Federal Medical Association (BÄK) expresses its concerns about the current draft of the Medical Research Act. The President of the Federal Medical Association, Dr. Klaus Reinhardt, comments on the draft and indicates the undermining of the independence of the ethical assessment of clinical studies. A Federal Ethics Commission that is located at the Federal Institute for Medicines and Medical Devices and is subject to instructions could be exposed to political influence.

The Bäk emphasizes the importance of an independent ethical assessment and indicates the experiences from the Nazi era, which is a significant cornerstone of the patient and subject protection. A softening of this ethical basic principles would significantly impair trust in medical research.

The draft lecturer also provides for commission members to be appointed by the Federal Ministry of Health and requires its approval for the rules of procedure. The BÄK warns of possible conflicts of interest and demands that the proven system of the ethics commissions set up under state law are retained. According to the BÄK, the optimization potential in the existing system has not yet been exhausted.

The Federal Medical Association is not solely criticized in its criticism of the Federal Ethics Commission. Together with science institutions, industry and the ethics commissions set up according to state law, it is involved in the "Initiative Study Location Germany (ISD)", which rejects the establishment of such a commission and instead demands improvements in the existing system.

The concerns of the Federal Medical Association with regard to possible political-administrative influence and the undermining of the independence of the ethical assessment in clinical studies are shared by other participants in the “Initiative Study Location Germany”. In view of the risks that could arise from the planned structural changes to the draft mechanism, the Federal Medical Association appeals to those responsible to proceed with care and to pursue alternative approaches to the further development of the existing system.

Table:
| Consideration of the Federal Medical Association |
| ——————————– |
| Undermining of the independence of the ethical assessment of clinical studies |
| Danger of politically and administrative influence when the Commission is located at the Federal Institute for Medicines and Medical Devices |
| Possible conflicts of interest in the centralized jurisdiction of the assessment of clinical studies by a Federal Supreme Office |
| Saving the ethical basic principles for patient and subject protection |

Source: Press release of the Federal Medical Association

Source: Federal Medical Association/OTS