The forum: “Legal challenges of the healthcare industry” organised by Pepeliaev Group and the Faculty of Law of the NRU Higher School of Economics was held on 6 February 2019. Alexander Panov, Head of the Life Sciences Practice of Pepeliaev Group, moderated the event.
Daria Chernova, the academic head of NRU HSE's educational programme: “Legal regulation in the pharmaceutical industry and biotechnologies” welcomed the forum's participants. Daria spoke about the main trends in training in the programme, as well as plans and events that have taken place within the framework of the programme.
The first panel session was devoted to IP issues in healthcare industry. The panelists highlighted the process for transferring a registration dossier and registration certificate in the context of transferring technologies in the pharmaceuticals industry. They discussed recent trends in patent disputes, key issues of mandatory licensing and future scenarios of generic products. The patent linkage mechanism was discussed during the session. This mechanism permits a generic product not to be launched until the patent to the original medical product has expired.
The second panel session was devoted to legal issues of the circulation of medicines, medical devices and biologically active supplements. Anna Shibanova, a senior associate at Pepeliaev Group, addressed the matter of software in healthcare industry, while Ekaterina Tretyakova, an associate at Pepeliaev Group, considered the specific aspects of PPP in healthcare, specifically, the practice of PET-centres. In his report Oleg Slavyanov-Dolin, an expert in interactions with competent public authorities, talked about the problems of legal regulation of medicines, medical devices and biologically active supplements by focusing on the balance between values that are protected by the Constitution and public and private interests. Alexander Panov spoke about Big Data in the pharmaceuticals industry, and when it is used in operations with medical devices and when first aid is delivered.
The third panel session was devoted to the issues of antitrust regulation in the healthcare industry. During the discussion, the boundaries were outlined within which Russia's Federal Antimonopoly Service is permitted to gather information about pharmaceutical markets, and the relevant case law was presented. Alexey Ivanov, director of the BRICS Antimonopoly Centre and director and head of the group of the HSE-Skolkovo Institute for Law and Development, spoke about mandatory licensing. He cast light on this matter from the perspectives of both economics and history. Daria Kotova of the HSE-Skolkovo Institute for Law touched on the topic of social aspects of antitrust regulation in the healthcare industry by making the attendees think about the ethical aspects of business.
At the fourth panel session, Boris Zingerman, the head of digital medicine at INVITRO, and Anzhelika Sakhipgareeva, postgraduate student at Kutafin Moscow State Law University (MSAL), discussed legal issues in medicine and bioethics. Anzhelika spoke about control and supervision in the healthcare industry by analysing the approaches of Russia and the USA, while Boris highlighted the main legal uncertainties in the digitalisation of healthcare.
Over 100 audience members attended the forum; they took an active role in the discussion and raised challenging and controversial questions for the speakers.