Dr. Ute Kilger and Dr. Sebastian Engels significantly involved in negotiations on model contract clauses for clinical research

Mandated by Deutsche Hochschulmedizin e. V., the two partners of the law firm have been involved since 2019 in the negotiations for the development of guidelines for the drafting of contracts for clinical trials with medicinal products. The model contract clauses 2.0 have been available since the end of 2023.

In terms of the number of clinical research studies, Germany is currently at risk of losing ground to leading countries such as Spain and France. One of the main reasons identified for this is the comparatively long time it takes to negotiate contracts between study sponsors, usually pharmaceutical companies, and trial centers, e.g. medical practices or clinics. A frequent point of contention in contract negotiations is the assignment of rights to inventions and the question of whether additional remuneration is to be paid for the transfer of inventions. It is not uncommon for such test centers to be university hospitals that are financed by public funds, which means that state aid regulations also play a role.

However, lengthy contract negotiations hamper innovation in Germany, deter study sponsors, cost money and delay the market launch of important drugs.

To avoid these delays, sample contract clauses for drafting contracts for clinical trials with medicinal products were published back in May 2019 – by “Deutsche Hochschulmedizin e. V.”, the “KKS-Netzwerk” (“Koordinierungszentren für klinische Studien KKS and Zentren für klinische Studien ZKS”), the pharmaceutical associations vfa and BPI as well as the BVMA (Bundesverband Medizinischer Auftragsinstitute e. V.).

At the end of 2023, after lengthy negotiations, a further developed version was published, supplemented by the frequently controversial topics of “data protection” and “inventions/property rights in the context of clinical trials”. It is intended to help speed up the drafting of contracts between commercial sponsors, trial centers and any third parties with practical recommendations. Other associations, such as the BPI (Bundesverband der Pharmazeutischen Industrie) and the BVMA (Bundesverband Medizinischer Auftragsinstitute BVMA e. V.) have also signed up to the further developed model contract clauses 2.0.

Translated with DeepL.com (free version)The BOEHMERT & BOEHMERT partners Dr. Ute Kilger, patent attorney, and Dr. Sebastian Engels, attorney at law, have been significantly involved in the negotiations on the drafting of the extended model contract clauses relating to IP rights since 2019. The attorneys were mandated by Deutsche Hochschulmedizin e. V.