Standard contractual clauses for clinical trials: Paving the way for Germany to study more efficiently

Regulatory background

The introduction of binding standard contract clauses for clinical trials marks a significant paradigm shift in contract drafting between sponsors and trial centers. This measure results from the provisions of the Medical Research Act (MFG) of October 23, 2024, which empowers the Federal Government to adopt appropriate legal regulations.

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Fundamental issues of contract negotiations

The regulatory approach addresses the documented inefficiency of German contract negotiations, which are exceptionally lengthy compared to other European countries. According to surveys by the pharmaceutical industry, contract negotiations in Germany between 2021 and 2023 lasted more than four times longer than in France. These delays significantly affected Germany's attractiveness as a location for industrially initiated clinical trials.

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Regulatory framework and implementation

The Standard Contractual Clause Ordinance (StandVKLV) was adopted by the Federal Cabinet on May 28, 2025 and received approval from the Federal Council on July 11, 2025. The regulation is based on Section 42d paragraph 1 of the Medicines Act and defines binding contractual clauses for the conduct of clinical trials in accordance with Article 2 paragraph 2 number 2 of EU Regulation 536/2014 (clinical trials involving medicinal products for human use).

The standard contractual clauses apply exclusively to industry-initiated clinical trials and include non-academic, non-commercial studies. Deviations from the standard clauses are only consensual possible between sponsor and test centre, with the exceptions being interpreted restrictively.

Scope and limitations

The regulation primarily concerns drug studies and regulates the rights and obligations between pharmaceutical sponsors and medical institutions. However, the standard contractual clauses provide no comprehensive model contract represent, but only define standardizable contract components.

Key areas of standardization include:

• Distribution of liability between sponsor and test centre
• Compensation modalities for test centres
• Documentation requirements and data transfer
• Sponsor monitoring rights
• Procedure for cancelling or modifying studies.

Effects on study implementation

The implementation of the standard contractual clauses is aimed at significantly reducing contract negotiation times. In future, contract negotiations will only be required in areas where the parties explicitly want to deviate from the standard clauses or need to regulate additional contractual items.

The measure is intended to competitiveness Strengthen the German study location and prevent a further exodus of pharmaceutical research. Between 2018 and 2023, Germany saw a decline in commercial phase I-IV clinical trials from 618 to 417 studies.

Association platform and cooperation framework

The standard contract clause initiative is supported by an association platform that includes the KKS Network, German University Medicine, VFA, BPI, BVMA and BV Med. This platform has been around for years Model contract clauses developed, which, however, were only indicative.

The association platform has also developed “Joint recommendations for the preparation of a comprehensive performance statement for remuneration when carrying out a clinical trial by a trial centre”, which remain applicable even after the standard contractual clauses come into force.

Test centres and implementation structures

The term “trial centres” or “testing centre” is understood to mean all clinics and medical practices in which clinical trials are carried out. These institutions are responsible for carrying out educational discussions with those interested in participating, the planned examinations and treatments, and documenting the treatment procedures. The standardization of contract terms should significantly reduce the administrative burden on these test centres and enable a more efficient allocation of resources.

International contextualisation

The implementation of the standard contractual clauses is based on successful models from other EU countries, which have already demonstrated that standardized contract structures can speed up the conduct of clinical trials. Germany is thus closing a regulatory gap and is once again positioning itself more competitively in the international research environment.

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From MEDIACC's point of view, the introduction of standard contractual clauses for pharmaceutical clinical trials represents an important step towards optimising contract negotiations. As a specialized research institute for clinical trials of medical devices. We are watching this development with particular interest, as it could set a precedent for the future regulation of medical device research. This current regulatory asymmetry could lead to a further disadvantage of medical device studies in Germany and Europe, which could make clinical trials and the supply of innovative medical devices in Europe less interesting for manufacturers. Development is desirable to separateseparate standard contractual clauses for medical device studies, which take into account the specific requirements of MDR and the special characteristics of medical devices, in order to strengthen competitiveness for European and German medical devices.

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Sources: https://www.bundesgesund heitsministerium.de/serv ice/gesetze-und-verordnu ngen/detail/medizinforschungsgesetz.html, https://ww w.bfarm.de/de/medi zinforsch ungsgesetz/_node.html, https://dserver.b undesta g.de/brd/2025/ 0225-25.pdf, https://www.kks-netzwerk.de/studiensu pport/nation aler-studiens upport/sample contract clauses/, (remove space for link)