Drug Security Forum

Three Regulatory Keys to Ensuring Drug Availability: Pricing, Registration, Quality Control

02 Jun , 12:15–13:45
Drug Security Forum
Pavilion G, conference hall G3

Regulatory changes and breakthroughs, for which the pandemic paved the way, are needed for patients to access drug treatment earlier, as well as for eliminating drug supply bottlenecks. The government of the Russian Federation has approved a special procedure for re-registering prices for the most popular medications on the essential drugs list in the event of their shortage. However, the current pricing system remains the key reason behind a number of drugs being withdrawn from the market. Amendments to federal legislation (Russian Government Resolution No. 441 dated 3 April 2020) have paved the way for expedited registration of certain drugs (in cases when quality testing is guaranteed). Nevertheless, the requirement for international manufacturers to conduct local studies when registering new drugs impedes commercialization. Switching to drug registration under general EAEU rules, as well as taking into account global best practices, will allow requirements to be harmonized between countries. In addition, it will bring the system closer to the European standard of registration, control, and circulation of registered drugs, based on principles of public access to expert reports by the regulatory agency. This approach will help improve the quality of state expert analysis, thereby ensuring that effectiveness is monitored and drugs are circulated on the market in a secure way. Ultimately, this will favourably impact clinical practices. What initiatives could help solve the problem of low-margin drug shortages and prevent foreign manufacturers from leaving the market when protectionist measures are taken? Is the external price regulation system sufficient in the Russian Federation? Is there room in Russia for value-based pricing and a system of internal price regulations? What decisions may help expedite registration procedures in the future and help commercialize new drugs which have been guaranteed to be safe? How can regulatory practices be harmonized in the common EAEU pharma market? Will integration into a common pharmaceutical market speed up or hinder the development of the pharma industry and drug supply in the Russian Federation? What regulatory initiatives could address drug quality, effectiveness, and security requirements?

Aleksandr Petrov, Head of the Subcommittee on Circulation of Medicines, Development of the Pharmaceutical and Medical Industry, Committee of the State Duma of the Federal Assembly of the Russian Federation on Health Protection

Ugur Gunaydin, General Director, Russia and CIS, Amgen
Andrey Kolesnikov, Director for Government Affairs and Market Access, Teva
Valentina Kosenko, Acting General Director, Scientific Center for Expertise of Medicinal Products of the Ministry of the Ministry of Health of the Russian Federation
Timofey Nizhegorodtsev, Deputy Head, Federal Antimonopoly Service of the Russian Federation
Filipp Romanov, Director of the Department of State Regulation of Medicines Circulation, Ministry of Health of the Russian Federation (online)
Alla Samoylova, Head, Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Front row participants
Sergey Klimenko, Partner of the Moscow Office, Head of the Russian Practice in the Field of Pharmaceuticals, Medicine and Biotechnology, Dentons
Vadim Kukava, Executive Director, The Association of Pharmaceutical Companies «Innovative Pharma»
Dmitry Rozhdestvensky, Head of the Division for Coordination of Work in the Sphere of Circulation of Medicines and Medical Devices, Department of Technical Regulation and Accreditation, Eurasian Economic Commission (online)