3 June, 10:00–11:30
Congress Centre, zone B, 2nd floor, conference hall B2
The pharmaceutical industry traditionally operates in an environment that features strict government regulation, major social obligations, and capital-intensive processes for developing innovative drugs. Ensuring the market is supplied with high-quality innovations is essential to achieving a nation’s pharmaceutical security and technological sovereignty. Accomplishing this goal requires the establishment of a stable operating environment for the industry in which one of the key components is an effective mechanism for enforcing patent rights regarding innovative drugs. At the same time, the government, as the guardian of public interests, is duty-bound to introduce legal instruments that are designed to safeguard such interests in situations where risks of drug shortages arise. One such tool is compulsory licensing – a mechanism that grants the government the power to authorize domestic entities to manufacture or import pharmaceutical products prior to the expiration of their patent, subject to the fulfilment of certain obligations to the patent holder. It is crucial for the sector to strike a balance in which the interests of the industry and society do not come into conflict, and market participants can achieve harmonization through systematic dialogue. How can we reconcile the reliable protection of patent holders’ intellectual property with the state’s right to safeguard public interests in situations involving drug shortages? How can the compulsory licensing mechanism be applied in a manner that eliminates any risks of unfair competition, while ensuring a balance in terms of improving the investment climate? What alternative mechanisms could serve as measures to protect national interests? What measures for protecting intellectual property rights could simultaneously take into account the interests of both manufacturers of innovative drugs and the state? What solutions can Russian and foreign companies propose to balance these interests?
Speakers
Dmitry Galkin
Director of Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation
Vladislav Golubev
Director of Legal Affairs, Ethics and Business Standards, AKRIKHIN
Ivan Guzenko
Chairman, "Andreev, Kagansky, Guzenko" Moscow Bar Association
Valeria Gulshina
Acting Director of the Department for Regulation of Circulation of Medicines and Medical Devices, Ministry of Health of the Russian Federation
Alisa Dzhangiryants
Deputy General Director for Ensuring Access of Drugs to the Market and Oncology, Swix Healthcare
Anatoliy Klimenkov
Deputy General Director for Strategic Interaction with Government Authorities and Healthcare Development, Roche Moscow JSC
Valentina Kosenko
Acting General Director, Scientific Centre for Expert Evaluation of Medicinal Products of the Ministry of Health of the Russian Federation
Aleksandr Petrov
Deputy, Member of the State Duma Committee on Health Protection of the Federal Assembly of the Russian Federation
Broadcast
