Friday, December 1, 2023, 3:51 p.m
“It is a positive signal to patients that the government wants to strengthen research and development in Germany as a pharmaceutical location,” says BPI Managing Director Dr. Kai Joachimsen on the strategy paper on the Medical Research Act presented today by Federal Health Minister Karl Lauterbach. “At the same time, this is just the beginning of an urgently needed, comprehensive pharmaceutical strategy. This must provide pharmaceutical companies with predictable and economically viable framework conditions for research, development and production and create an administration that supports and does not slow it down through excessive, inefficient bureaucracy. It is also important to correct the undesirable developments in the so-called AMNOG guard rails.”
“One goal must be for Germany to quickly become one of the most attractive countries for clinical trials again. And for this we need accelerated and simplified approval and notification procedures for safe clinical trials. Patients don’t have time to wait for the innovations they urgently need. Politicians have obviously understood this and want to make some changes here. For example, it makes sense that processing times for mononational studies should be shortened. And progress should also be made when it comes to the use of health data; the data basis for research in the industrial health sector should be improved and bureaucratic hurdles reduced. However, many other points remain in need of improvement, including the collection of and access to structured data.
The fact that a federal ethics commission should be created at the BfArM for special types of study is not necessary in view of the urgently needed reform of the ethics commissions in the sense of a harmonization of their assessment behavior, which has been requested for years. However, we expressly welcome the fact that the radiation protection procedure should be integrated into the approval process for clinical trials and that notification procedures for accompanying diagnostics will be taken over by the ethics committees in the future. This is a real relief for the sponsors, who were previously faced with two separate proceedings. It should also be easier for auxiliary and investigational products, which, according to the draft, can now only be labeled in English. And finally, the BMG should publish an announcement on practical model contract clauses for contracts between sponsors, test centers and, if necessary, third parties. That is correct in principle, but a legal regulation would be more binding. In addition, it should result in the use of model contracts, the contents of which are checked and updated annually by a commission of experts.”
“Overall, the regulations provided for in the draft bill for the Medical Research Act are not a revolution, but are nevertheless steps to strengthen the research and development location. As part of the Federal Government’s outstanding comprehensive pharmaceutical strategy, security of supply and the strengthening of local production for broad patient care must definitely be on the agenda, as this is essential to the success of the industry on the one hand and the location on the other.”
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