New development for clinical trial agreements in Germany: Proposal of standard contractual clauses from 11.02.2025

Introduction of standard contractual clauses 

One of the key provisions of the Medical Research Act is the introduction of standard contractual clauses (SCs) for Clinical Trial Agreements (CTAs) with trial sites in Germany. These SCs are, however, not part of the Medical Research Act but are to be issued separately in an Ordinance by Germany’s Federal Government. The German Federal Ministry of Health published its proposal for such Ordinance and the SCs on 11 February 2025. 

The German legislator’s driving rationale for introducing the concept of SCs was the fact that CTA negotiations in Germany to date have been significantly more time consuming than in other European jurisdictions. According to the legislator, negotiations in Germany have in average taken more than four times as long as in France, where template agreements for clinical trials already exist. 

This new development will certainly bring opportunities for trial sponsors in Germany, especially in so far as much quicker contract review cycles and negotiations are to be expected. At the same time, the framework provided by the SCs will make it even more challenging to negotiate certain CTA terms as often required by sponsors than it has been to date. 

Scope of standard contractual clauses 

It should be noted, however, that – other than in France – the SCs are not a comprehensive template CTA but are only provided for certain CTA terms that are typically heavily negotiated; this includes, for instance, ownership in study results, publications rights, limitations of liability and termination. 

The Medical Research Act and accompanying Ordinance stipulate that, within their respective scope, the SCs generally have to be used by the Parties. However, there are still several options to deviate from the SCs, completely or in part, as follows: 

• The Parties can mutually agree to completely waive the use of certain or all of the SCs; i.e., the parties would then be entirely free to negotiate the CTA terms without being bound by the SCs in any way; • Specifically with respect to rights in study results, the draft Ordinance currently provides for two alternative SCs, i.e. already under the SCs the parties are free to chose one or the other (whereby one SC provides for an option right of the sponsor to acquire ownership rights while the other merely provides for a license to sponsor);
• Even when the Parties use the SCs, they are still free to include additional or complementary terms into the CTA for aspects not covered by the standards contractual clauses as well as for aspects covered by them (e.g. the parties could include additional limitations of liability beyond those already provided for in the respective SC). 

Based on our experience with clinical trial sites in Germany, we anticipate that sites will generally be reluctant to completely waive the application of all SCs. In doing so, they may argue that the German Government, as a third party not acting in either party’s interests, has issued these SCs as a common ground and compromise which should generally be acceptable to sponsors. At the same time, it is certainly also in the interest of sponsors to accept the SCs to the extent possible in order to actually benefit from the simplified and accelerated negotiations intended by the SCs. 

Challenges posed by standard clauses and mitigation strategies 

However, in the current draft SCs published by the Federal Ministry of Health, we see several provisions which will not be easy to accept for sponsors; this concerns in particular the crucial provisions concerning rights in study results, limitation of liability and indemnification. 

• Therefore, we highly recommend to prepare for future CTA negotiations in Germany by conducting a comprehensive analysis of the SCs as soon as they are ultimately available and prepare a negotiation strategy. In particular, this should include:
  Considering which of the SCs can be accepted without any changes;
• Considering which SCs cannot be accepted as provided by the Ordinance;
• Developing alternative or complementary clauses to the SCs that are not acceptable; and 
• Developing compelling arguments why certain of the SCs are not acceptable and alternative or complementary language is needed.

The last point will likely be a crucial point in future negotiations with German sites. As said above, clinical trial sites will be reluctant to accept deviations from the SCs. Hence, convincing them to negotiate aspects covered by SCs at all will likely become a major challenge once the SCs become applicable. 

Next steps 

With the publication of the draft Ordinance on 11 February 2025 the associations of the pharmaceutical industry now have the opportunity to comment on the draft SCs. After this hearing of the concerned interest groups and potential revisions of the proposed clauses, the Ordinance will also have to pass the German Federal Council (consisting of the German Federal States). Hence, it is currently not foreseeable when the Ordinance and SCs will be finally passed. However, it is proposed that the SCs will become applicable three months after the date of publication of the final Ordinance. Due to this relatively short transitional period, it seems likely that the final SCs might even affect current CTA negotiations. This underlines the need to prepare for the new SCs as soon as their final version will be published. 

Authored by Arne Thiermann, Dr. Tina Welter-Birk and Dr. Benjamin Goehl.