On 18 September 2025, the German government enacted standard contractual clauses (SCCs) for Clinical Trial Agreements (CTAs) between sponsors and German trial sites, following the Medical Research Act ("Medizinforschungsgesetz") of October 2024. This marks a step in Germany's strategy to boost pharmaceutical research, in part by streamlining and harmonizing contractual negotiations.

Key features and scope

Since 18 December 2025, the SCCs are in principle compulsory for CTAs between German trial sites and commercial sponsors. Unlike comprehensive template agreements in some other jurisdictions, the German SCCs address only the most contentious CTA terms, including ownership of study results, publication rights, and liability. Hence, the SCCs do not constitute a complete CTAs, and parties need to supplement the SCCs with additional provisions, provided these do not conflict with the mandatory clauses. Notably, the parties to a CTA also remain free to partially or even fully waive the application of the SCCs, and to use terms deviating from the SCCs. However, doing so requires an express agreement.

Opportunities and challenges

The introduction of SCCs is intended to significantly reduce negotiation times, a longstanding issue in Germany compared to other EU countries. Thus, by using the SCCs, sponsors can benefit from faster contract review cycles. However, the generally mandatory nature of the SCCs also means less flexibility to negotiate certain terms, particularly around study results and liability. While agreeing to deviate from the SCCs is possible, as said above, trial sites are generally prone to insist on adherence to the SCCs, citing their government-backed status. Moreover, by entirely or largely waiving the application of the SCCs, the parties lose the benefit of more streamlined and swifter negotiations.

Practical implications for sponsors

Sponsors should review the SCCs against their CTA templates to develop effective negotiation strategies that protect their legal interests while making use of the SCCs where appropriate for more efficient negotiations. Key steps, therefore, include:

• Identifying which SCCs can be accepted.
• Determining which SCCs may require deviation or supplementation.
• Preparing alternative language for SCCs that are problematic.

In addition, compared to proposing to waive them altogether, using SCCs to a certain extent – while proposing deviations only where strictly necessary – is more likely to be accepted by German sites.