How the Medical Research Act strengthens clinical research in Germany

^{Published: 05.27.2024}

 

The Medical Research Act is intended to improve the framework conditions for the development, approval and manufacture of medicinal products and medical devices in Germany. Find out here how it does this and what Sascha Herzer, Alcedis' Head of Regulatory Affairs, thinks of it.

 

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 medicinal products, medical devices and research-related radiation applications, while maintaining high standards for patient safety.

Although the law is still before the Bundesrat and Bundestag for approval and no exact implementation date has been set, it is expected to come into force from 2025. It is considered unlikely that the law will fail.
The draft was presented by the Federal Government as part of a comprehensive strategy to strengthen Germany as a research location. It is part of a series of new laws designed to facilitate access to clinical data and innovative therapies.

 

 

The most important measures at a glance¹

Federal Ministry of Health (BMG)

• Cooperation between different regulatory authorities is being optimized to make processes more efficient.

• The review of mononational clinical trials, i.e. those only to be carried out in Germany, will be accelerated.

• The conduct of decentralized clinical trials will be facilitated.

• The requirements for the labeling of investigational and auxiliary medicinal products will be simplified.

• Standard contractual clauses for clinical trials will be drawn up and published on the websites of the competent federal authorities.

• An independent ethics committee will be set up for complex or urgent procedures, and the state ethics committees will specialize in certain types of procedures.

• Federal recommendations are intended to promote uniform practice in the federal states with regard to manufacturing authorization and testing of certain medicinal products.

• Pharmaceutical companies can agree confidential reimbursement amounts for new drugs.

• Further measures are aimed at accelerating market access for innovative medicinal products in Germany.

• It is also examining how existing laws can be adapted to better integrate modern digital solutions.

 

Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMUV)

• Procedures under radiation protection law are being harmonized with procedures under pharmaceutical and medical device law.

• By implementing a single-gate approach, applications and notifications under radiation protection law can be submitted via the same portals.

• The deadlines for the examination of applications under radiation protection law will be shortened.

• Nuclear medicine facilities will be exempt from the licensing requirement for the manufacture of radioactive diagnostic investigational medicinal products.

• In particular, the BMUV's measures are intended to make the interfaces to procedures relating to clinical trials with radioactive medicinal products more efficient.

 

Assessment

The Medical Research Act offers enormous opportunities for clinical research in Germany. Sascha Herzer, Head of Regulatory Affairs at Alcedis, sees the law as an opportunity to simplify regulatory affairs work and make it more efficient. Identical, parallel and shortened timelines will make the planning and implementation of clinical trials considerably easier.

He is also positive about the Federal Ethics Commission taking over the notification procedures instead of the Federal Office for Radiation Protection (BfS). The BfS currently works very slowly and conservatively, which is why the transfer of responsibilities to the Federal Ethics Commission would make the processes more efficient and modern. However, the BfS will remain responsible for approval procedures.

The introduction of standard and model contracts for clinical trials, which can be enshrined in the Medicinal Products Act and published on the websites of the competent federal authorities, is also to be viewed positively. However, this could conflict with the freedom of contract enshrined in the German Basic Law.

It is also pleasing that the Bundestag is increasingly advocating innovation-friendly framework conditions in clinical research. The Federal Government is thus also signaling at an international level that Germany should be further developed as a research location.

 

Future developments of the Medical Research Act

Despite the numerous advantages, there are also points of criticism. The pharmaceutical companies' new pricing freedom in negotiations with the health insurance funds could lead to a considerable increase in bureaucracy, as complex reimbursement procedures will become necessary. In addition, the pharmaceutical expenditure of the statutory health insurance funds could increase considerably.

Careful consideration of the measures will be necessary in order to maintain the balance between promoting innovation and cost-effectiveness in the German healthcare system.

It remains to be seen when the law will finally be passed and whether there will be any adjustments before then. It will probably be years before it is fully implemented and proves itself in practice. Nevertheless, we are optimistic about future developments and are confident that the law will sustainably improve medical research in Germany.

 

1 https://www.bmuv.de/pressemitteilung/bundesregierung-beschliesst-medizinforschungsgesetz