Pharma

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. Learn more about the draft law and find out what Sascha Herzer, Head of Regulatory Affairs at Alcedis, thinks about 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 effect by 2025. A rejection of the law is considered unlikely.

 

Latest Whitepaper

The Medical Research Act promises to simplify and accelerate clinical research in Germany. In this white paper, Sascha Herzer, Head of Regulatory Affairs at Alcedis, discusses the new legal framework, the industry's reactions and the practical implications for contract research organizations.
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The most important measures summarized1

 

Federal Ministry of Health (BMG)

  1. cooperation between different regulatory authorities will be optimized in order to make processes more efficient

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

  3. facilitating the conduct of decentralized clinical trials

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

  5. standard contractual clauses for clinical trials will be drawn up and published on the websites of the responsible authorities

  6. an independent ethics committee is set up for complex or urgent procedures, and the state ethics committees specialize in certain types of procedures.

  7. recommendations from the federal government are to promote uniform practice in the federal states with regard to manufacturing authorization and testing of certain medicinal products.

  8. pharmaceutical companies can agree on confidential reimbursement amounts for new drugs.

 

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

  1. radiation protection procedures are harmonized with procedures under pharmaceutical and medical device law

  2. Applications and notifications under radiation protection law can be submitted via the same portals, following a single-gate approach

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

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

 

Our assessment

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

He also sees the assumption of the notification procedures by the Federal Ethics Commission instead of the Federal Office for Radiation Protection (BfS) as positive. 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 will likely be included in the Medicinal Products Act and published on the websites of the responsible federal authorities, should also be viewed positively. However, this could conflict with the freedom of contract enshrined in the German Basic Law.

 

Outlook

Despite the numerous advantages, there are also points of criticism. The new pricing freedom of pharmaceutical companies in negotiations with health insurance companies 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.

Time will tell 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