Medical Research Act: Criticism from the Industry
Published: 06.25.2024
The German government's recently drafted Medical Research Act (in German Medizinforschungsgesetz, MFG) is an important step towards strengthening Germany as a research location. However, as with many reforms, it is clear that the devil is in the detail. Despite good approaches, there is justified criticism and demands for improvements in order to realize the full potential of the law.
What is the Medical Research Act?
The Medical Research Act is a draft law that aims to speed up and reduce bureaucracy in approval procedures for clinical trials as well as approval procedures for drugs, medical devices and research-related radiation applications, while maintaining high standards of patient safety.
In his speech to the Bundestag1, Federal Minister of Health Prof. Karl Lauterbach emphasized the three main objectives of the law: strengthening Germany as a research and production location for pharmaceuticals, improving care through more research and removing bureaucratic hurdles. He emphasized that Germany has fallen behind considerably in the field of pharmaceutical research in recent years, which has meant that innovative medicines are often only available to German patients at a late stage.
The most important measures include, for example, optimizing cooperation between the various regulatory authorities, facilitating the implementation of decentralized clinical trials or standard contractual clauses for clinical trials, which are published on the websites of the responsible federal authorities.
Criticism and suggestions for improvement from the industry
Despite the positive aspects, there are points of criticism that have been voiced by various players in the pharmaceutical industry and research. The Association of Research-Based Pharmaceutical Companies (vfa)2 and the Initiative Studienstandort Deutschland (ISD) praise the approach of the law, but emphasize that it does not go far enough to bring Germany to the forefront internationally. In particular, they point out that the number of industry-initiated drug trials in Germany continues to decline and that urgent measures are needed to reverse this trend.
Demands of the German Pharmaceutical Industry Association (BPI)
In a press release, the BPI has called for further amendments to the Medical Research Act3. Dr. Kai Joachimsen, Managing Director of the BPI, highlights three core demands:
- Appropriate remuneration for research: Joachimsen criticizes the fact that innovative therapies are not sufficiently remunerated in Germany. In particular, the pricing of new drugs must be reformed in order to adequately recognize small but important advances in drug development. The current price constraints in the AMNOG system make Germany unattractive for pharmaceutical companies, which also has a negative impact on the international price structure.
- Regular evaluation of the law: The BPI calls for the Medical Research Act to be reviewed every two years to ensure that the intended objectives are actually being achieved and to make any necessary adjustments in good time.
- Binding standard contractual clauses: In order to shorten contract negotiation times prior to clinical trials, the BPI proposes that the standard contractual clauses provided for in the Act be made binding in the Medicinal Products Act. This could significantly increase Germany's attractiveness as a location for clinical trials.
Conclusion
The Medical Research Act is an important step towards strengthening Germany for pharmaceutical research and development. It addresses many of the existing problems and creates a basis for future improvements. However, as the reactions from the industry show, further adjustments are necessary in order to realize the full potential of this law and enable Germany to catch up in the medical research market.
References
1 Speech by Federal Minister of Health Prof. Karl Lauterbach on the Medical Research Act
2 vfa statement on the Medical Research Act
3 BPI press release on the Medical Research Act