Germany has taken another step to improve the conditions for pharmaceutical research & development in Germany. Now, the Federal Government has adopted the “Standard Contractual Clauses” for pharmaceutical clinical trial agreements. In this blog, we discuss what the new standard clauses cover and how they will affect clinical trials in Germany.
I. Background
In an earlier blog we had reported on the German Federal Government’s proposal for the “Medical Research Act” that aimed to make Germany more attractive for medical research. A key goal was to reduce regulatory and practical burden for clinical trials. The Medical Research Act was adopted in the fall of 2024 and brought significant changes to various German healthcare laws. Among other things, a new Section 42d AMG empowered the German Federal Government to adopt standard contractual clauses for clinical trials with medicinal products in order to streamline and expedite contract negotiations between sponsors and study sites.
In February 2025, a draft set of standard contractual clauses was published for consultation. Now, the final Standard Contractual Clauses were published as part of the “Ordinance on Standard Contractual Clauses for the Conduct of Clinical Trials” (“StandVKlV”) and came into force on 19 September 2025. They will apply to clinical trial agreements concluded after 17 December 2025.
The new Standard Contractual Clauses apply to commercial clinical trials sponsored by industry companies. The new clauses will not apply to non-commercial clinical trials.
It is also important to note that the use of the Standard Contractual Clauses is not mandatory so that the parties can agree to deviate from them. Nevertheless, we could already see in recent months that German clinical trial sites have been referring to the (draft) standard clauses during CTA negotiations.
II. Scope of the new Standard Contractual Clauses
The new Standard Contractual Clauses encompass 10 template clauses on matters that are routinely addressed in clinical trial agreements (“CTA”). Currently, the Standard Contractual Clauses are only available in German, but it is expected that they will soon also be available in English.
We will now summarize the legal issues addressed by the Standard Contractual Clauses:
- Rights to publish study results
The first Standard Contractual Clauses addresses the parties’ rights to publish the results of the clinical trial. Hereunder, the sponsor has the right to first publish the results of the clinical trial. If the sponsor does not do so within 12 months (in exceptional cases 18 months) after the end of the clinical trial, the trial site has the right to publish the results it has generated for non-commercial scientific purposes. For such publications, the clauses set out a coordination procedure under which the sponsor may review the manuscript and identify any non-publishable information.
- Rights to study results and inventions
Section 2 contains clauses that regulate the rights to the research results and address how inventions should be handled. It sets out that all results obtained by the trial site that are within the scope of the clinical trial conducted in accordance with the CTA and the protocol, and do not qualify as inventions, are immediately assigned to the sponsor upon conclusion of the contract. For copyright protected results, the sponsor receives an unrestricted, irrevocable, exclusive, transferable, and sublicensable license.
Regarding inventions, their transfer and potential compensation, the Standard Contractual Clauses differentiate between the below types of inventions. The template stipulates that the sponsor has an exclusive option to the assignment for both types of inventions, but the payment obligations of the sponsor differ depending on the invention type:
- For inventions that result from the execution of the clinical trial in accordance with the CTA and the trial protocol, the sponsor has no additional payment obligation beyond the compensation paid for conducting the clinical trial.; and
- For inventions that result from the execution of the clinical trial as agreed but are based on an additional inventive contribution from an employee of the trial site, the sponsor has to pay the site a compensation for transferring the invention. For such inventions, the clauses provide two compensation mechanisms among which the parties can choose (either (1) a negotiated “market-standard remuneration” or a (2) lump sum payment per invention).
This new clause offers a reasonable approach for an important but often highly controversial negotiation point for CTAs. The proposal is in fact especially reasonable for sponsors as German study sites were usually making way more far-reaching compensation claims for the transfer of inventions and IP.
- Confidential information
Section 3 of the Standard Contractual Clauses sets forth rather typical stipulations on how the parties shall protect confidential information.
- Name and trademark rights
Pursuant to Section 4 of the Standard Contractual Clauses, the parties agree to recognize each other’s name and trademark rights and will not use each other’s name or trademarks without prior written consent or unless an exception under Section 4 applies.
- Equipment and materials provided
Section 5 of the Standard Contractual Clauses addresses equipment and materials provided for the conduct of the clinical trial. Under the provision, such items must be documented in writing. Furthermore, the clause clarifies that the items are only provided for the purpose and the duration of the trial, and that they do not constitute remuneration. The clause also deals with ownership rights to such equipment and material.
- Inspections and audits
Section 6 of the Standard Contractual Clauses addresses inspections and audits by rather common and reasonable stipulations. This clause shall apply beyond the end of the clinical trial – which obviously make sense.
- Liability limitations
Section 7 sets forth liability provisions.
- First, the parties’ liability shall be limited in certain cases of “slight negligence”.
- If the damage results from the violation of “material contractual obligations”, liability is limited to damages that were foreseeable at the conclusion of the CTA.
- Where no material contractual obligation is violated, liability for damages is limited to the value of the contract.
These proposed liability clauses will probably raise concerns on the part of sponsors as they could significantly limit the liability of trial sites. Therefore, we expect that the liability clauses will remain an important point for negotiation even after the Standard Contractual Clauses become applicable (and again, they are not binding).
- Documentation of the clinical trial and documentation archiving
Section 8 proposes specific provisions for the safe and accessible storage of the clinical trial documentation. Under these clauses, the trial site has to store clinical trial information for the statutorily required minimum storage periods either in analog or digital form. Furthermore, the section clarifies that once the statutory retention periods have expired, the documentation may be destroyed, provided that the sponsor confirms expiry. If the parties disagree, the standard clauses envisage that the parties assess the option of a separate extended retention agreement.
- Data Protection
Data protection is the most comprehensive individual subject addressed in the Standard Contractual Clauses. In fact, since the application of the EU GDPR (Regulation (EU) 2016/679), German clinical trial sites and German ethics committees have become quite focused (some say “obsessive”) on data protection aspects in clinical trials. Accordingly, the sections on data protection in CTAs and informed consent forms (“ICFs”) have become very extensive (in ICFs, these are often lengthier than the sections on the medical benefits and risks of the studies).
Section 9 and the Appendix 2 of the Standard Contractual Clauses address data protection. Section 9 stipulates requirements for compliance with the data protection requirements imposed by the GDPR, the Clinical Trial Regulation (EU) 536/2014 (“CTR”), and the German Medicines Act (AMG). It also addresses data transfers from Germany to non-EU/EEA countries as well as the processing of data of the study staff. Should the parties choose to process personal data as “joint controllers”, they may use Appendix 2 of the Standard Contractual Clauses. Appendix 2 is quite extensive and aims to establish a joint-controller-relationship.
- Termination and cancellation of the CTA
The Standard Contractual Clauses concludes with Section 10 that addresses the termination of the CTA. This clause also has rather common and reasonable stipulations.
III. Practical and legal implications for Pharmaceutical Companies
In practice, the Standard Contractual Clauses will become quickly relevant for all parties that conduct clinical trials in Germany. Pharmaceutical companies should therefore ensure that their own teams as well as the teams of their CROs are familiar with the new clauses.
In fact, the new clauses will also be relevant for the CROs as they often negotiate the CTAs with the trial sites on behalf of the sponsor companies.
As already noted, we have seen German clinical trial sites in Germany in the recent months that had already started referring to the new Standard Contractual Clauses in CTA negotiations. Where the new clauses are in their favor, they will push for their use in the respective CTA.
Pharmaceutical companies and CROs should review their existing templates for CTAs and data processing agreements for clinical trials as they may need to make adjustments to these. Insofar, we also outline that some of the new Standard Contractual Clauses appear actually positive for sponsor companies compared to the respective clauses that trial sites were typically requesting in the past (e.g., clauses on transfer of inventions).
As the Standard Contractual Clauses do not provide parties with a complete CTA template but only certain (core) clauses, sponsor companies and CROs will need to implement them into practicable contracts. This will often require the involvement of a variety of company departments whose work is affected by the template changes.
From a practical perspective, we expect that the use of the new Standard Contractual Clauses will indeed accelerate and streamline the CTA negotiations.
At the same time, from a practical and legal perspective, sponsor companies will need to consider the effects of the new Standard Contractual Clauses on their internationally used (master) CTA templates. The implementation of the new German standard clauses will probably lead to specific national provision in the German CTA that will deviate from the CTA template for other countries.
Finally, we again note that the use of the Standard Contractual Clauses is not mandatory. Hence, the parties can agree to deviate from them and execute specific provisions for a particular study. Accordingly, sponsor companies and their CROs should consider implementing processes for deviations from the standard clauses. Deviations may also be requested by trial sites. The need for such deviations will also depend on the specific situation of the respective clinical trial. Insofar, we expect that deviations from the Standard Contractual Clauses will not be unusual.
IV. Standard Contractual Clauses also on the horizon for MedTech companies
While the new Standard Contractual Clauses currently only apply to clinical trials with pharmaceuticals, the German Ministry of Health has already indicated that a second set of clauses is being developed for clinical trials with medical devices. The core provisions are likely to be widely similar to the ones discussed above. Therefore, medical device companies should also analyze the new clauses and be prepared to soon welcoming new Standard Contractual Clauses for medical device studies. There will probably be a respective consultation process, but this may be significantly shorter than the recent consultation.
V. Outlook
The introduction of the new Standard Contractual Clauses represents a significant shift in how clinical trial agreements are negotiated in Germany. The new clauses aim to streamline negotiations and reduce delays. While it remains to be seen whether the new clauses will meet these expectations, the need for the complete CTAs to comply with the underlying (national and international) regulatory and legal requirements as well as with existing internal processes will continue to require careful legal assessments for all parties.
The Life Sciences Team of Covington & Burling LLP in Frankfurt (Germany) will keep you posted about the next developments and stands ready should you have questions on the impact of the new German rules for your clinical trials and contracts.
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