What is Germany’s New Medical Research Act?

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.

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.

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.

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.

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.

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.