The National Research University Higher School of Economics has held the annual forum “Legal challenges of the healthcare industry in 2020”, organised jointly with Pepeliaev Group

On 7 February the National Research University Higher School of Economics (NRU HSE) held the forum “Legal challenges of the healthcare industry in 2020”, which has become an annual event. The forum was organised jointly by Pepeliaev Group and NRU HSE’s department of biological law. The speakers and guests of the forum discussed the most topical legal issues for and development prospects of the pharmaceuticals industry and social healthcare.

The opening address was, by tradition, delivered by Alexander Panov, Head of Commercial Practice, Life Sciences at Pepeliaev Group, and Head of the Master’s Programme “Legal regulation in the pharmaceutical industry and biotechnology” at NRU HSE, and by Darya Chernyaeva, the Academic Head of the Master’s Programme “Legal regulation in the pharmaceutical industry and biotechnology” and the head of the NRU HSE’s department of biological law. Alexander and Darya pointed out that businessmen and public authorities as well as representatives of the academic community are demonstrating an ever increasing interest in the legal issues in the life sciences industry.

The first panel discussion was dedicated to the issues of the circulation of medicines. Ivan Glushkov, Director of the External Relationships Department of Nizhpharm (the Stada Group of Companies) opened the discussion with a report on the reimbursement pilot project. The speaker pointed out that if the project was a success in Russia, this will radically change the procedure for providing people with medicines and would require the market to adapt quickly.

Speeches relating to IP issues provoked much response from the participants of the forum. In particular, Irina Sheykha, the Legal and IP Director of the Association of International Pharmaceutical Manufacturers, spoke about the existing issues concerning the institution of data exclusivity in Russia.

Vladislav Shiyanov, Senior Legal Counsel at the Astrazeneca pharmaceutical company, supported the discussion and highlighted the difficulties that companies are facing when reregistering the prices for medicines.

Alexander Panov and Elena Buran, Legal Counsel at Sanofi Russia, discussed during a Q&A session the latest administrative and judicial decisions concerning the advertising of prescription and over-the-counter medicines. Elena reported that the latest trends show that Russia's antitrust regulator, the FAS of Russia, has taken a stricter approach to the advertising of prescription medicines and companies should do their best to comply with the legislation on advertising and prevent disclosure of information intended for healthcare specialists.

The second panel discussion at the forum was dedicated to the new developments in the area of the circulation of medical devices. Ekaterina Tretyakova, an associate at Pepeliaev Group’s Life Sciences practice, spoke about the draft Law “On mandatory requirements for medical products” which is being prepared with the active involvement of the practice's lawyers.

Andrey Stolbov, professor at I.M. Sechenov First Moscow State Medical University, spoke on behalf of the medical community at the second session. He described his point of view regarding the prospects of using artificial intelligence in healthcare, creating genome data registers and cyber-security in the era of healthcare digitalization.

Mikhail Potapov, Legal Director at IMEDA, described the main topical issues the medical devices industry is facing or will face owing to the EAEU's common market being formed.

Within the framework of the discussion, businessmen also had a unique opportunity to ask Elena Astapenko, Head of the Department of the State Control and Registration of Medical Devices of Federal Service for Surveillance in Healthcare (Roszdravnadzor), questions relating to the circulation of medical devices that are causing their concern.

At the third panel discussion the participants of the forum discussed compliance in healthcare. Julia Fedorova, Senior Legal Counsel at GE Healthcare, opened the session. As a compliance pioneer in Russia, Julia spoke about the way the attitude to compliance in our country has changed, as well as about the main methods to prevent violations of anticorruption legislation and the possible implications of such violations.

Maria Nikonova, a partner at Pepeliaev Group, delivered a presentation dedicated to tax compliance. Maria advised that all pharmaceutical companies should perform an assessment of tax risks and select the method to prevent such risks which would be most convenient for them. She also pointed out that the latest practice shows that the Russian Federal Tax Service is becoming increasingly interested in the activity of players on the pharmaceuticals market, and therefore the latter should do their utmost to address their tax risks and deal with them correctly. Elena Rybalchenko, compliance manager at Chiesi Pharmaceuticals, also took an active part in the discussion.

The last panel discussion of the forum was dedicated to the legal issues of E-Health. Dmitry Minkin, manager of Sberbank PJSC’s Centre of Medical Products and Services, spoke about the development prospects of telehealth in Russia, the success of foreign colleagues in the this sphere and about the predicted decrease of pressure on the primary care segment if the telehealth technologies are implemented.

Maria Krasner, an associate in Pepeliaev Group’s Life Sciences practice, highlighted the main issues of implementing electronic medical cards and shared her perception of the legal nature of such cards and their place in the system of legal regulation.

Boris Zingerman, head of the Digital Medicine department at INVITRO, took part in a discussion on whether medical services can be classified as Big Data, what the prospects are of medical services being used in compliance with ethical standards and what the options for commercialisation are.

The forum was attended by over 100 people and is receiving the highest praise from its participants.