Accelerating contract negotiations for clinical trials in Germany through new model contract clauses?
On average, contract negotiations for conducting a clinical trial take significantly longer in Germany than in many other EU countries. In order to help speed the process up and make Germany more attractive as a research location, several associations and networks representing university hospitals, medical faculties, coordination centers for clinical studies, pharmaceutical companies and contract research organizations published updated model contractual clauses for clinical trials in November 2023.
In addition to the clauses first published in 2019 (publications, confidential information, trademark clauses/use of name, liability, audits/inspections, archiving, equipment or materials provided and termination/cancellation), the model contract clauses updated at the end of 2023 now also contain provisions on rights to results (including remuneration for inventions) and data protection.
No binding effect of the model contract clauses for clinical trials
The use of these clauses is at the discretion of the contracting parties. Unlike in some European countries (e.g. Great Britain, Spain and France), in Germany there are no model contracts or model contract clauses for clinical trials that are fully or partially binding for those involved. According to the German federal government's draft Medical Research Law of March 27, 2024, the insertion of Section 42d AMG is intended to create a legal basis for the publication of standard contractual clauses for the conduct of clinical trials by the Federal Ministry of Health. However, there are no provisions in this draft law that recommend the use of the model contract clauses to those involved or make their use binding.
Use of the model contract clauses for clinical trials in contract negotiations
Surveys conducted by the associations involved in the development of the model contract clauses for clinical trials among their members in 2023 show that the individual provisions of the model contract clauses met with varying levels of acceptance in practice among representatives of the clients and the study sites. Some clauses (e.g. publications and confidential information) were used more frequently on both sides, while other clauses (particularly liability) were used more in individual cases as a fallback position or as a basis for compromise solutions. It will be interesting to see to what extent the new provisions on the often controversial topics of inventor remuneration and data protection can in practice contribute to speeding up contract negotiations for clinical trials in Germany.
Other important factors for the duration of contract negotiations for clinical trials
The data collected by these surveys shows that the duration of such negotiations in Germany fluctuates greatly: from a few weeks to over 20 months. This indicates that other factors also have a significant influence on the duration of contract negotiations for clinical trials in Germany. In practice, it has been shown that, above all, the quality of the contract templates used, the preparation of alternative and fallback clauses and of model contracts tailored to individual contractual partners, the experience and continuity of the people involved in the contract negotiations for clinical trials and the direct conversation between the lawyers involved on both sides can make it much easier to conclude a contract more quickly.