Drug Security Forum

The economic approach to the drug supply system means choosing from a set of alternative management decisions that can achieve the maximum result given limited resources while simultaneously increasing demand for modern drugs. The proper choice of the right alternative, in turn, depends on the ability to select and analyse the primary factors of influence to achieve a balance of demand for drugs and supply. The institutional environment of the modern pharmaceutical market in Russia has an impact on both the state and its commercial segment. One of the key aspects of achieving a balance and optimizing the economics of drug supply is an effective public drug procurement system that is built both taking into account the current market realities and all the innovative models that exist in world practice. How flexible should the legal regulation of the pharmaceutical industry be? How should pricing be managed when people’s personal funds account for 64% of the demand for drugs? What economic factors dictate the choice of a procurement system? What are the economic consequences of changing drug therapy and should this be taken into account when choosing treatment tactics? How should preferences work for the domestic pharmaceutical industry?

Moderator
Elena Maksimkina, Director, "Federal Center for Planning and Regulation Of Medical Supply Circulation" of the Ministry of Health of the Russian Federation

Elena Maksimkina

Director, "Federal Center for Planning and Regulation Of Medical Supply Circulation" of the Ministry of Health of the Russian Federation

She was born in Moscow in 1961.

In 1984, she graduated from the Faculty of Pharmacy of the First Moscow Medical Institute (First Moscow State Medical University named after I.M. Sechenov). Since 1984, she graduated from the Faculty of Pharmacy at the I.M. Sechenov First Moscow State Medical University, where she subsequently held the positions of senior laboratory assistant (1984-1986), assistant (1986-1989), senior lecturer (1989-1993), associate professor (1993-2005), professor of the Department of Pharmacy Management and Economics of the Faculty of Pharmacy (2005-2006), head of the Department of Pharmacy Management and Economics (since 2007), dean of the Faculty of Postgraduate Professional Education for pharmacists (since 2005).
Expert in the field of management and economics of pharmacy, Doctor of Pharmacy, Professor.
She is the author of the first dissertation in marketing research on the pharmaceutical market in Russia, one of the founders and chief editors of a professional pharmaceutical magazine "LadyVita" (2003-2004).
Since 2005 she has been the editor-in-chief of the professional pharmaceutical magazine Pervy Stol.
Since 2007 she has been a member of the international pharmaceutical organization FIP.
By order of the Minister of Health of the Russian Federation, she was appointed Director of the Department of State Regulation of Circulation of Medicines.
In July 2013, she was appointed Assistant Minister of Health of the Russian Federation.
In October 2013, she was appointed Director of the Department of Drug Provision and Regulation of Circulation of Medical Products of the Russian Ministry of Health.
In 2020, she was appointed Head of the Federal State Institution "Federal Center for Planning and Organization of Drug Provision to Citizens".

Panellists
Dmitriy Galkin, Director of Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation
Igor Narkevich, Rector, St. Petersburg State Chemical-Pharmaceutical Academy
Timofey Nizhegorodtsev, Deputy Head, Federal Antimonopoly Service of the Russian Federation
Filipp Romanov, Deputy Chairman of the Board, Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (EAEU)
Victor Fisenko, First Deputy Minister of Health of the Russian Federation

Dmitriy Galkin

Director of Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation

Igor Narkevich

Rector, St. Petersburg State Chemical-Pharmaceutical Academy

Timofey Nizhegorodtsev

Deputy Head, Federal Antimonopoly Service of the Russian Federation

In 1997, Timofey Nizhegorodtsev graduated from the Biology Department of Irkutsk State University. In 2009, he received a Master of Jurisprudence degree from the Russian Academy of State Service under the President of the Russian Federation.
At the Federal Antimonopoly Service of Russia, he is engaged in the development of competition in the social sphere and trade. With his direct involvement, a system of public and expert advisory councils under the FAS Russia was created. A number of action plans and packages of amendments to the regulatory legal acts for the development of competition in such spheres as health care and trade, tourism and education, as well as in the sphere of ritual services have been prepared. These include the Law on Trade (2009) and amendments to it (2016), the Law on Education (2012), the Law on Compulsory Health Insurance (2010), as well as amendments to the Law on Tourist Activities, the Law on Public Health Protection (2010) and the Law on Circulation of Medicines.
Timofey Nizhegorodtsev contributed greatly to the tariff regulation in the field of circulation of medicines. In particular, in 2018, new rules for state registration and re-registration of maximum selling prices for drugs included in the list of VEDs were developed and approved by Government Decree No. 1207, as well as a methodology for calculating such prices. In addition, with his participation legislation on the interchangeability of medicines was prepared (2014, 2019).
He was also actively involved in the development of "antimonopoly packages".
In 2007, Timofey Nizhegorodtsev headed the Department of the social sphere and trade of the Federal Antimonopoly Service of Russia.
In 2018, the work of the Department of Control of the Social Sphere and Trade in the field of competition advocacy was highly appreciated at the international level. The regulatory act developed by the Department, which brought transparency to the specifics of the description of medicines for medical use that are procured by the state, won in the category "Creating Markets for Private Sector Development" and thus for the first time brought FAS Russia 1st place in the World Bank-ICC international competition on competition advocacy.
In 2013, he was awarded the Medal of the Order "For Merit to the Fatherland" II degree, in 2017 - the Medal of the Order "For Merit to the Fatherland" I degree.
In 2011, he was awarded the title "Honorary Worker of the Antimonopoly Agencies of Russia".
In 2015, he was awarded the Badge of Honor of the Federal Antimonopoly Service "For Merits in the Development of Competition in Russia".
In 2019, he was awarded the Medal of the Federal Antimonopoly Service "For Distinction in Service" III degree.
In 2019, he was awarded the medal "For Contribution to the Development of the Eurasian Economic Union".
As Deputy Head of the Federal Antimonopoly Service of Russia, Timofey Nizhegorodtsev supervises health care, social sphere, trade and non-productive services.

Filipp Romanov

Deputy Chairman of the Board, Association of Pharmaceutical Manufacturers of the Eurasian Economic Union (EAEU)

Victor Fisenko

First Deputy Minister of Health of the Russian Federation

Front row participants
Roman Ivanov, Director of the Scientific Center for Translational Medicine, Vice-Rector for Scientific and Technological Development, Sirius University of Science and Technology
Alexey Kolbin, Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, First St. Petersburg State Medical University named after Academician I.P. Pavlova
Vadim Tarasov, Director, Institute of Translational Medicine and Biotechnology Institute of Translational Medicine and Biotechnology, First Moscow State Medical University named after I.M. Sechenov
Galina Shemanaeva, Acting Deputy Head of Administration of the Tambov Region

Roman Ivanov

Director of the Scientific Center for Translational Medicine, Vice-Rector for Scientific and Technological Development, Sirius University of Science and Technology

Alexey Kolbin

Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, First St. Petersburg State Medical University named after Academician I.P. Pavlova

Educational background:
- 1990 – 1996: St. Petersburg State Pediatrics Medical Academy (SPbSPMA). Diploma of paediatrician
- 1996 – 1998: clinical residency at the SPbSPMA Department of Clinical Pharmacology
- 1999 – 2001: Ph.D. studies at the Department of Allergology and Clinical Pharmacology, SPbSPMA Faculty of Professional Development and Postgraduate Education
- Ph.D. of Medical Sciences in the following specialties: 14.00.09 – pediatrics and 14.00.25 – pharmacology, clinical pharmacology
- 2001 – 2006: doctoral studies at the Department of Allergology and Clinical Pharmacology, SPbSPMA Faculty of Professional Development and Postgraduate Education
Doctor of Medical Sciences in the following specialties: 14.00.25 – pharmacology, clinical pharmacology and 03.00.24 – mycology
Specialty:
doctor-pharmacologist, clinical pharmacologist (certificate)
Academic degree:
Doctor of Medical Sciences
Employment:
- 2012 - up to now: Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, The First Pavlov State Medical University of St. Petersburg
- 2012 - up to now: Clinical pharmacologist of the Children’s Hospital 1, St. Petersburg
- 2008 – up to now: Professor at the Department of Pharmacology, Medical Faculty,
St. Petersburg State University.
- 2008 to 2013: Head of the Regional Center for Drug Safety Monitoring, which is a part of the national drug safety monitoring system (pharmacovigilance) in the North-Western Federal District of Russia and in St. Petersburg
- 2007 to 2013: head of the clinical pharmacology laboratory, Medical Faculty,
St. Petersburg State University
- 1998 to 2008: Associate Professor at the Department of Allergology and Clinical Pharmacology, SPbSPMA Faculty of Professional Development and Postgraduate Education.
Medical facilities:
- Children’s Hospital 1, St. Petersburg
- Clinics of the First Pavlov State Medical University of St. Petersburg
Scientific work:
379 scientific works were published
Member of the editorial board of Russian-language periodicals
- Paediatric Pharmacology (approved by the Higher Certification Commission)
- Medical Technologies. Review and selection
- Good clinical practice
Member of international professional societies
- International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
- Since 2012 - President of ISPOR in St. Petersburg
Member of public and expert organizations
- The Working Group of Monitoring Formation of Lists of Drugs, Ministry of Health of the Russian Federation
- Working group of developing of clinical recommendations, Ministry of Health of the Russian Federation
- Russian Association of Clinical Pharmacologists
- Training and Methodological Commission for Clinical Pharmacology, Ministry of Health of the Russian Federation
- President ASSOCIATION OF SPECIALISTS IN THE FIELD OF HEALTH TECHNOLOGY ASSESSMENT (registered in the Ministry of Justice in 2017)

Vadim Tarasov

Director, Institute of Translational Medicine and Biotechnology Institute of Translational Medicine and Biotechnology, First Moscow State Medical University named after I.M. Sechenov

Galina Shemanaeva

Acting Deputy Head of Administration of the Tambov Region