Common model contract clauses 2.0: Acceleration aid for clinical trials in Germany as a study location
09.11.2023 14:28
As of today, a further developed version of the “Model contractual clauses for clinical trials with drugs under the responsibility of a pharmaceutical company” is available for contract negotiations for drug studies. It was published by German University Medicine, the KKS network, the pharmaceutical associations vfa and BPI and the BVMA (for contract research companies). Those involved would like to help accelerate contract negotiations for conducting a clinical study. This common approach can make Germany more attractive as a research location.
The associations published model contractual clauses for drafting contracts for clinical trials with medicinal products for the first time in May 2019. They serve as orientation and as a starting point between all institutions in Germany involved in conducting a study. Compared to the first version, the topics “data protection” and “inventions/property rights in the context of clinical trials” have been added. They are intended as non-binding but practical recommendations and a starting point for concrete contract negotiations between commercial sponsors, test centers and, if necessary, third parties.
The model contract clauses are a proposal from several stakeholders and associations to improve location conditions in Germany. This means that they can also be used within the framework of the intended Medical Research Act to comprehensively accelerate clinical studies.
Background: Before a clinical trial with drugs can start, the study sponsor (often a pharmaceutical company) and the test centers willing to participate (i.e. clinics or doctor's practices) and, if necessary, other partners must conclude contracts. Everyone involved is interested in concluding a contract quickly, but this can hardly be achieved if the contracting parties are negotiating from completely different starting points. The model contractual clauses provide guidance for both sides, especially for aspects that must be the subject of the contract in almost all clinical trials. The authors have taken great care to take into account the different interests of all those involved in the clauses and to implement them in a balanced manner. The clauses are designed in such a way that they can be easily transferred to similar contractual relationships in other areas of health research.
Study location Germany
Germany is currently still a popular location for clinical trials, but its study activity has already become more intensive. The international location competition between countries for investments in pharmaceutical research and development has increased enormously - fueled again by the Covid-19 pandemic and geostrategic efforts for independence. Pharmaceutical companies, for their part, are in an intense “race” to gain market approval for innovative therapies. This means they are evaluating more critically than ever in which countries they can get studies started sufficiently quickly.
There is currently a worrying trend: Germany risks losing touch with other leading countries when it comes to pharmaceutical innovation. An important factor here is the long duration of contract negotiations between study sponsors and centers. Increasing the number of studies in Germany and accelerating their start is therefore in the interest of everyone responsible in the field of clinical research. It also benefits patients for whom access to clinical trials means additional treatment opportunities.
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The “Model contractual clauses for clinical trials with medicinal products under the responsibility of a pharmaceutical company (industrial sponsor) 2.0” including various sample appendices can be found in the following places (also in English):