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Berlin – The Medical Research Act (MFG) is to be passed in the Bundestag next week. This was confirmed today by Federal Health Minister Karl Lauterbach (SPD) at the Capital Congress.

Lauterbach said that this law was “particularly important” to him, as Germany has significant deficits in medical research in general and in the conduct of clinical trials in particular.

The gap between innovative basic research and the development of drugs is too large. Other countries such as Spain and Belgium are overtaking Germany in the conduct of clinical trials. This is now being addressed with adjustments that will ensure a “very quick and yet thorough review” of approval procedures for clinical trials.

In future, the evaluation of corresponding applications will take place within 26 days – Lauterbach spoke of a “moonshot strategy”. Approval procedures for drugs, medical products and research-related radiation applications will also be accelerated and made less bureaucratic.

The MFG’s package of measures is only one component of a larger package of measures, explained Lauterbach. This also includes the pharmaceutical strategy, the Health Data Use Act (GDNG) and the regulations surrounding the electronic patient record (ePA).

The combination will enable “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 data sets from health insurance companies. Overall, Germany will “set new standards” across Europe.

Jens Scholz, Chairman of the Association of University Hospitals in Germany (VUD), assessed the contents of the MFG positively. The law creates the conditions for Germany to once again be able to fulfill its claim to be “at the forefront”.

Especially during the corona pandemic, the disadvantages of the previous approach, especially in terms of data protection, became clear – other countries could have collected epidemiological data much more quickly and comprehensively.

In this context, Lauterbach expressly emphasized that it was “remarkable with what competence and energy” the new President of the Federal Office for Information Security (BSI), Claudia Plattner, had taken up this issue.

In the past, the balance between data protection and data use was pushed so far that it was hardly possible to expect approval for data use within an acceptable time.

Now we are reaching “a new equilibrium”. His impression is that the new appointment to the post of Federal Commissioner for Data Protection and Freedom of Information (BfDI) is also moving in this direction. © aha/aerzteblatt.de