What is Germany’s new Medical Research Act?
Learn about the act and its potential influence on the global clinical trial market
What is Germany’s new Medical Research Act?
Learn about the act and its potential influence on the global clinical trial market
Exploring the new Medical Research Act
In our video series, we explore how the Medical Research Act is reshaping Germany’s clinical trial landscape, aligning with EU regulations while addressing inefficiencies in the authorization process. We discuss its potential to strengthen Germany’s position in key therapeutic areas like oncology and cardiovascular research, its influence on broader EU policies, and how streamlined contracting could accelerate patient recruitment.
In partnership with the vfa the Association of Research-Based Pharmaceutical Companies, we examine whether this act is a game-changer or just the first step toward making Germany a leader in clinical research once again, joined by guest speaker Thorsten Ruppert, Senior Manager Research, Development and Innovation from the vfa.
About the Medical Research Act
The Medical Research Act (Medizinforschungsgesetz, MFG), which came into force on 30 October 2024, is designed to enhance Germany’s appeal as a hub for pharmaceutical research and production. The Act seeks to achieve this by streamlining and expediting the evaluation process for clinical trials, offering incentives for medical research conducted within the country, and establishing a framework for promoting clinical trials, ensuring ethical standards, and improving data management and patient protection. These measures aim to foster innovation, attract investment, and strengthen Germany’s position as a leading player in the global pharmaceutical industry.
For more information, see the official overview here: BfArM – Medical Research Act
1. How the Medical Research Act and the EU-CTR fit together
The Medica Research Act is aligning the authorization process of trials to the EU-CTR, but if we talk about the broader picture of the EU-CTR, it has so far failed in terms of making the EU as a whole, more attractive for clinical trials, as the number of trials coming to Europe is dropping, the process is quite stiff, so Germany could overtake the wider EU market with this act.
2. The indications that will profit most from the Medical Research Act
The act addresses the authorization of trials, so in theory all indications should benefit from the MRA, however Germany has historic strengths in oncology, cardiovascular conditions, diabetes, and respiratory, which we imagine will be further accelerated. That said, what we hope for, is that the biggest benefitors of this act, will be patients in Germany.
3. Will other EU countries adopt something similar to the MRA?
We think some countries will adopt parts of the Medical Research Act, for example the standard contracting clauses, which Austria and Belgium have already been discussing, however it’s very tailored to the German market. What we could imagine is others adopting a minimum patient threshold for the market access scheme, that said, this could also be a problem, it would not be feasible for every EU country to contribute 5% of patients, that’s why we need an EU-wide approach.
4. How the Medical Research Act influences timelines and efficiencies in Germany
Standard contract clauses should be live from summer 2025, which is needed as prior, it took 156 days to close a contract with sites as a median in Germany, and in France the worst case is 75 days, so we hope the update to the authorization of trials and standard contracting, will not only improve contracting timelines, but provide more time to recruit patients, meaning a higher contribution from Germany.
5. Our future predictions for the Medical Research Act
Thorsten would like to see Germany as a European leader of clinical trials once again, and for Moritz, he wishes to see more sponsors and sites using a platform like ClinLife to conduct trials more easily in Germany.
6. The reception of the Medical Research Act at the vfa
The Medical Research Act is a great first step, but just a first step. While it aims to increase patient counts in Germany, we will see how the act plays out, and watch how sponsors aim to meet the 5% ‘hurdle’ to claim pricing benefits.
Need help with patient recruitment? We’re here to support you!
Schedule a call today with one of our patient recruitment experts to learn how we can support your study.