Karl Lauterbach (SPD), Federal Minister of Health/photo alliance, Hannes P Albert
Berlin – The Medical Research Law (MFG) is expected to be approved in the Bundestag next week. Federal Health Minister Karl Lauterbach (SPD) confirmed this today at the capital’s congress.
Lauterbach said the law was “particularly important” to him because Germany has significant shortfalls in medical research in general and in clinical trials in particular.
The gap between innovative basic research and pharmaceutical product development is too wide. Other countries such as Spain or Belgium are surpassing Germany when it comes to carrying out clinical studies. This situation is now being combatted with adjustments that would guarantee a “very rapid but complete review” of clinical trial approval procedures.
In future, the evaluation of corresponding applications must take place within 26 days – Lauterbach spoke of a “moonshot strategy”. The approval process for medicines, medical devices and research-related radiation applications will also be accelerated and reduced in terms of bureaucracy.
The MFG package of measures also represents just one component of a larger package of measures, Lauterbach explained. This also included the pharmaceutical strategy, the Law on the Use of Health Data (GDNG) and the regulations regarding the electronic patient record (ePA).
The combination will allow for “a completely new medicine”. The Federal Minister of Health referred, among other things, to the “first-class conditions” for the use of artificial intelligence. The EPA could be used to generate data that could be usefully combined with cancer registries or genome projects, as well as health insurance company datasets. Overall, Germany will “set new standards” across Europe.
Jens Scholz, President of the German University Hospital Association (DVU), positively evaluated the content of the MFG. The law creates the conditions so that Germany can once again fulfill its claim to be “at the forefront”.
The disadvantages of the previous approach, especially in terms of data protection, became clear in particular during the corona pandemic – other countries could have collected epidemiological data much more quickly and comprehensively.
In this context, Lauterbach expressly emphasized that the new President of the Federal Office for Information Security was “remarkable for the competence and energy” (BSI), Claudia Plattner, addressed this topic.
In the past, the compromise between data protection and the use of data protection was taken so far that approval of the use of data could hardly be expected within an acceptable time frame.
Now you reach “a new balance”. His impression is that when it comes to filling the role of Federal Commissioner for Data Protection and Freedom of Information (BfDI) go in that direction. © aha/aerzteblatt.de