In the trade journal Pharma Recht (46th year, 15 March 2024), Dr. Marco Stief deals with the competition law assessment of research, cooperation and development agreements, with special consideration of the Research and Development Block Exemption Regulation.
Both in the EU and across the globe, the pharmaceutical industry is one of the most R&D-intensive sectors of the economy. The importance of research and development cooperation agreements between start-ups, pharmaceutical companies and public institutions has increased significantly in recent years. In the pharmaceutical sector in particular, close attention needs to be paid to ensuring compliance with competition law regulations when drafting such agreements. A breach of the highly complex regulations can easily result in the offending clause or even the entire agreement becoming null and void. Especially for projects in the pharmaceutical and life sciences sector, which are typically particularly long-term and investment-intensive, this often has serious consequences and can result in the foundering of a previously successful research project. Even if a renegotiation of one or more invalid provisions can be successfully concluded, it frequently comes at the cost of a significant delay, which in itself often jeopardises the success of the project. Furthermore, breaches of antitrust law can lead to investigations by competition authorities, impositions or even fines. The article provides an overview of the relevant and particularly critical regulations. Its aim is to help companies to appraise their research and development agreements and also to shed light on the sometimes convoluted system of European competition rules and the R&D Block Exemption Regulation.
