New Standard Contractual Clauses for Commercial Clinical Trials of Pharmaceutical Products in Germany

In an effort to boost its clinical research industry, Germany has enacted the Medical Research Act or “MRA” (Medizinforschungsgesetz). The MRA introduces significant changes to various German healthcare laws and procedures.

One such change comes in the form of the Standard Contractual Clauses Ordinance (StandVKlV) published by Germany’s federal government in September of 2025. The StandVKIV seeks to shortcut clinical trial agreement (CTA) negotiations by providing pre-established contract terms (the standard clauses or SCs) for ten central — and often heavily negotiated — CTA provisions: (1) Publication Rights; (2) Intellectual Property; (3) Confidential Information; (4) Name and Trademark Rights; (5) Equipment/Material Provision; (6) Inspections and Audits; (7) Liability; (8) Clinical Trial Documentation; (9) Data Protection; and (10) Termination and Cancellation.

The SCs apply to CTAs for industry-initiated clinical trials of pharmaceutical products concluded after December 17, 2025. 

An unofficial English translation of the StandVKIV is available at Ordinance on Standard Contractual Clauses for the Conduct of Clinical Trials (Standard Contractual Clauses Ordinance) (Standardvertragsklauselverordnung – StandVKlV).

Why This Matters:

We expect that sponsors may start to see SCs incorporated into CTAs soon.

The SCs are not mandatory at this time (i.e., parties to a CTA have discretion to apply them, modify them, or omit them). However, clinical trial sites are broadly expected to embrace the SCs, whether in whole or in part, as the "norm." This means that commercial sponsors wanting or needing to deviate from the SCs may face pushback during CTA negotiations.

Additionally, the SCs do not constitute a complete CTA template. Rather, they are sample wording for some (but not all) CTA terms. This means that to the extent SCs are incorporated, attention will be needed to ensure the CTA remains complete and internally consistent.

Spotlight on Selected SCs:

We have highlighted some selected SCs of particular note for sponsors conducting their drug trials in Germany:

• Limitations on liability: This SC outlines certain limits to liability that have not always been present in German CTAs. This includes limiting a clinical site’s responsibility for certain liabilities resulting from “slight negligence” and setting a one-time-the-value-of-the-contract liability cap for certain damages. Sponsors will likely want to continue to negotiate this provision, both for clarity and for substance. Additionally, sponsors may wish to discuss any remaining site liability limits with their insurers to confirm coverage is in place.
• Rights to study results and inventions: Study results that are not inventions or copyright-protected are automatically assigned to the sponsor upon conclusion of the CTA. For copyright protected results, the sponsor is granted an exclusive license. Inventions that result from proper performance of the clinical trial protocol will be owned by sponsor; provided that if an invention depends on the inventive contribution of a trial site employee, additional remuneration is owed in accordance with the German Law on Employee Inventions (Arbeitnehmererfindungsgesetz (ArbnErfG)). This SC offers that a sponsor may pay such remuneration in the form of a lump sum payment or reoccurring payment on revenue. It further provides that the parties may agree on certain details upfront in the CTA (e.g., amount of lump sum payment), or they may defer to a later agreement. Big picture, this SC does not materially shift intellectual property ownership expectations, but it does offer some added clarity around the process of paying invention remuneration pursuant to the German Law on Employee Inventions.
• Personal data protection: This SC together with Annex 2 to the StandVKIV addresses GDPR compliance, both with respect to the parties’ respective employees and subcontractors and with respect to clinical trial subjects. For employee data, the SC requires that each party be able to produce to the other party its GDPR-compliant data protection policy covering employee and subcontractor data. For clinical trial subject data, Annex 2 to the StandVKIV provides a framework for joint controllership, which is commonly required by German sites in connection with the processing of clinical trial subject data. Sponsors should evaluate the proposals under the SCs against existing data protection arrangements, including how these provisions align with sponsor’s wider contracting documents, vendor agreements and informed consent forms.
• Rights to Publish Study Results. This SC provides that if the sponsor does not publish study results within 12 months (18 months in certain cases) after the end of the clinical trial, the trial site may publish its results. As a result, clinical sites may be less willing to discuss longer publication timelines. 

Need guidance?

If you are conducting a study under a US IND and need help drafting or negotiating CTAs for your study in Germany, please contact us. We are here to assist you with assessing and negotiating issues that may impact your CTAs, including those prompted by the new SCs.