The architecture of responsibility in biotechnology was discussed at the SPIEF: The PROMOMED expert suggested using mutual horizontal control of market participants

At the St. Petersburg International Law Forum (SPIEF), as part of the session "Law and Biotechnology: from Prohibitions to the Architecture of Responsibility", Maria Porokhnya, Director of Intellectual Property at PROMOMED, proposed expanding the use of mutual horizontal control in the field of biotechnology. Such a solution, along with traditional prohibitive legal instruments, will allow the most competent market participants to independently adjust each other's behavior, providing soft regulation and real access to innovations in an area where changes occur extremely quickly.

The discussion was moderated by Oleg Grin, Head of the Department of Medical Law and Biotechnology Law at Kutafin University (MGUA). Among the participants were leading experts from the country: Natalia Bodunova, Head of the Center for Personalized Medicine at the Moscow Clinical Research Center named after A. S. Loginov of the Moscow Department of Health; Dmitry Butusov, Chairman of the Federal State Budgetary Institution Gosortkommission; Sergey Vasenin, Head of Legal Affairs at the Kurchatov Institute National Research Center; Andrey Vasiliev, Director of the Institute of Developmental Biology N. K. Koltsov, Russian Academy of Sciences; Andrey Glotov, Head of the V. S. Baranov Department of Genomic Medicine at the D. O. Ott Research Institute of Obstetrics, Gynecology and Reproductology; Vera Izhevskaya, Deputy Director for Scientific Work at the N. P. Bochkov Medical and Genetic Research Center; Sergey Kabyshev, Chairman of the State Duma Committee on Science and Higher Education; Olga Ruzakova, Deputy Chief of Staff of the State Duma Committee on State Construction and Legislation.

Experts unanimously noted that the world is on the verge of transition to the era of engineering biology. In the legal regulation of new technologies in general and engineering biology in particular, a balance must be found between justified regulatory restrictions and fostering development.

In her speech, Maria Porokhnya stressed that intellectual property issues deserve special attention as part of efforts to improve legislation on genetic technologies. The speaker recalled that intellectual property is not only an engine of progress and contributes to the development of biotechnology, but is also designed to ensure the accessibility of technology to society.

Maria Porokhnya noted that the existing prohibitive norms excluding from patent protection methods of human cloning, the use of embryos for commercial and industrial purposes, as well as modification of the genetic integrity of the human germ line, do not prevent the patenting of genetic technologies. Rospatent interprets these prohibitions based on the purpose of their introduction — to avoid inherited modification of the human genome and the unethical use of human embryos. This gentle approach to interpretation allows for the patenting of a wide range of genetic technologies, including in vitro fertilization, genetically modified animals, and genome editing unrelated to the germline.

Speaking about the regulation of genetic technologies directly, the speaker suggested using the experience of related industries in the search for legislative solutions. Maria Porokhnya cited as an example the institution of compulsory licensing (Article 1362 of the Civil Code of the Russian Federation), which is a form of protection of public interest through horizontal control by market participants: insufficient use of patented technology by some market participants is compensated by the willingness of others to provide access to this technology.

Maria Porokhnya proposed using the concept of horizontal control in the regulation of genetic technologies. Mutual audit will allow market participants to adjust each other's behavior and ensure a balance between restrictions and facilitating progress through soft regulation. This requires a legal environment in which market participants have the tools and additional incentives to exercise such mutual control. The choice of specific mechanisms remains to be discussed. This is an independent task for the professional community and the legislator.

The participants of the discussion highly appreciated the proposed approach, calling it a new round of development of legal regulation in this area.