Medical Research Act: Criticism from the Industry

^{Published: 06.25.2024}

 

The German government's recently drafted Medical Research Act (MFG) is a significant 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 exploit 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 Federal Government sees this as a key measure to revitalize scientific progress in the pharmaceutical sector. The draft is based on the aim of efficiently implementing European standards and simplifying national procedures at the same time.

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 will be published on the websites of the responsible federal authorities. Further measures include the establishment of central points of contact at federal level and the creation of clear responsibilities for complex trial procedures.

In addition, a standardized digital procedure for the submission and processing of trial applications is to be introduced in order to avoid time losses in the approval process. These measures could not only bring benefits for German companies, but could also attract more foreign investors.

 
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 German 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 back to the international forefront. 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.

Another point of criticism concerns the complexity of the existing laws, which many companies feel have not been sufficiently streamlined. The different responsibilities of the authorities at state and federal level also frequently lead to delays in clinical trials.

 

Demands of the German Pharmaceutical Industry Association (BPI)

In a press release, the BPI has called for further adjustments to the MFG³. 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.

The BPI also points out that German regulations on the reimbursement of medicines often do not keep pace with the innovative nature of new therapies. This represents a central obstacle to the modern supply of medicines.

Regular evaluation of the law: The BPI is calling for the MFG to be reviewed every two years to ensure that the intended goals are actually being achieved and to make any necessary adjustments in good time. According to the BPI, the federal government should also involve independent scientific institutes in this process.

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 law be made binding in the Medicinal Products Act. This could significantly increase Germany's attractiveness as a location for clinical trials.

In addition, the BPI is calling for a stronger role for the Bundestag in monitoring and supervising the implementation of the law. Close parliamentary scrutiny is the only way to ensure that procedures are carried out swiftly, transparently and in a targeted manner.

 

Conclusion

The Medical Research Act is an important step towards strengthening Germany as a location 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 exploit the full potential of this law and enable Germany to catch up in the medical research market.

For this to succeed, existing procedures must be consistently simplified, clinical trials must be better supported and gaps in the law must be closed - a challenge that both the Federal Government and the Bundestag must face up to.

 

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