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29.06.2022
14:30–16:00
Regulation of the Pharmaceutical Market: Law in Search of a Balance
Congress Centre, conference hall D4
Broadcast
Access to medication is a crucial aspect of public health, maintaining quality of life for patients, etc. And it is essential to ensure both availability and affordability. A range of legal tools have been employed to these ends. These include protecting intellectual property rights, price regulation for certain items, incentives for participating in government procurement schemes, and so on. The key legal issue in this regard is striking the right balance between the interests of various players in the market, while doing everything possible to meet societal needs.
• Ensuring access to medication: striking a balance between protecting intellectual property rights and meeting societal needs.
• Employing antimonopoly regulation as part of efforts to ensure availability of medication (registration of prices for vital and essential medicines, unscheduled inspections of business entities, amendments to rules underpinning government procurement procedures).
• Ensuring access to medication: striking a balance between protecting intellectual property rights and meeting societal needs.
• Employing antimonopoly regulation as part of efforts to ensure availability of medication (registration of prices for vital and essential medicines, unscheduled inspections of business entities, amendments to rules underpinning government procurement procedures).
Moderator
Konstantin Sharlovsky
Head of Pharmaceuticals and Healthcare Practice, Pepeliaev Group
Panellists
Sergey Glagolev
Deputy Minister of Health of the Russian Federation (online)
Ivan Glushkov
Chief Executive Officer, PharmCapital
Timofey Nizhegorodtsev
Deputy Head, Federal Antimonopoly Service of the Russian Federation
Ajay Manikrao Khanwilkar
Judge, Supreme Court of the Republic of India
Fatima Tsomartova
Senior Researcher, Institute of Legislation and Comparative Law under the Government of the Russian Federation
Tadzio Schilling
Chief Executive Officer, Association of European Businesses (АЕВ)
Broadcast
Konstantin Sharlovsky
Head of Pharmaceuticals and Healthcare Practice, Pepeliaev Group
Sergey Glagolev
Deputy Minister of Health of the Russian Federation
Ivan Glushkov
Chief Executive Officer, PharmCapital
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.
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.
Ajay Manikrao Khanwilkar
Judge, Supreme Court of the Republic of India
Justice Ajay Manikrao Khanwilkar was born on 30th July 1957 at Pune (Maharashtra), India.
He did B.Com from Mulund College of Commerce, Mumbai and L.L.B. from K.C. Law College, Mumbai.
Enrolled as Advocate on 10th February, 1982 and appeared before various Subordinate Courts and Tribunals and the High Court of Judicature at Bombay on the Appellate and Original Side.
Practiced exclusively in the Supreme Court of India from July, 1984 onwards.
Appointed as the standing counsel for the State of Maharashtra for Supreme Court matters in October, 1985, in which position he worked till December, 1989. He was also Panel Counsel for the Union of India; and standing counsel for the Election Commission of India for Supreme Court matters.
Appointed as Additional Judge of the Bombay High Court on 29th March, 2000 and confirmed as permanent Judge on 8th April, 2002.
Appointed as Chief Justice of the High Court of Himachal Pradesh on 4th April, 2013. Thereafter, as Chief Justice of Madhya Pradesh High Court on 24th November, 2013.
Elevated as Judge of Supreme Court of India and assumed charge on May 13, 2016.
He is also the Chairperson of the Mahanadi Water Disputes Tribunal, constituted by the Government of India.
He is Chancellor of Maharashtra National Law University, Aurangabad and nominated in other National Law Schools and Institutes in different capacities.
He is also nominated on various Judges Committees in the Supreme Court of India.
He did B.Com from Mulund College of Commerce, Mumbai and L.L.B. from K.C. Law College, Mumbai.
Enrolled as Advocate on 10th February, 1982 and appeared before various Subordinate Courts and Tribunals and the High Court of Judicature at Bombay on the Appellate and Original Side.
Practiced exclusively in the Supreme Court of India from July, 1984 onwards.
Appointed as the standing counsel for the State of Maharashtra for Supreme Court matters in October, 1985, in which position he worked till December, 1989. He was also Panel Counsel for the Union of India; and standing counsel for the Election Commission of India for Supreme Court matters.
Appointed as Additional Judge of the Bombay High Court on 29th March, 2000 and confirmed as permanent Judge on 8th April, 2002.
Appointed as Chief Justice of the High Court of Himachal Pradesh on 4th April, 2013. Thereafter, as Chief Justice of Madhya Pradesh High Court on 24th November, 2013.
Elevated as Judge of Supreme Court of India and assumed charge on May 13, 2016.
He is also the Chairperson of the Mahanadi Water Disputes Tribunal, constituted by the Government of India.
He is Chancellor of Maharashtra National Law University, Aurangabad and nominated in other National Law Schools and Institutes in different capacities.
He is also nominated on various Judges Committees in the Supreme Court of India.
Fatima Tsomartova
Senior Researcher, Institute of Legislation and Comparative Law under the Government of the Russian Federation
Graduated from the Faculty of Law of Khetagurov North Ossetian State University and postgraduate studies at the Institute of Legislation and Comparative Law under the Government of the Russian Federation. Candidate of Legal Sciences.
The sphere of scientific interests consists of general theoretical and special problems of legal regulation of relations in the social sphere, legislation on the protection of the health of citizens, on the circulation of medicines, etc. Author of more than 60 publications on relevant topics.
From 2008 to the present - Senior Researcher at the Department of Social Legislation at the Institute of Legislation and Comparative Law under the Government of the Russian Federation. As part of the Institute's activities, she carries out scientific expertise of draft legal acts in the field of healthcare.
She was awarded a diploma of the Ministry of Health of the Russian Federation.
The sphere of scientific interests consists of general theoretical and special problems of legal regulation of relations in the social sphere, legislation on the protection of the health of citizens, on the circulation of medicines, etc. Author of more than 60 publications on relevant topics.
From 2008 to the present - Senior Researcher at the Department of Social Legislation at the Institute of Legislation and Comparative Law under the Government of the Russian Federation. As part of the Institute's activities, she carries out scientific expertise of draft legal acts in the field of healthcare.
She was awarded a diploma of the Ministry of Health of the Russian Federation.
Tadzio Schilling
Chief Executive Officer, Association of European Businesses (АЕВ)
On May 1, 2020, Tadzio Schilling took office as the CEO of the Association of European Businesses (AEB).
Mr. Schilling was elected by representatives of the AEB’s member companies at the Annual General Meeting on March 17, 2020. He replaces Dr. Frank Schauff, who had headed the AEB since 2007 and was re-elected to a fourth term in 2016.
Tadzio Schilling holds an MA in International Relations and an advanced MA in International History and Politics from the Graduate Institute Geneva, as well as an Executive MPA from the Hertie School of Governance in Berlin.
In his professional career, he has worked in various finance, HR, and sales functions for companies such as Zurich Cantonal Bank, Dell Inc., Wesser & Partner, and FirstClimate. He has also worked as a researcher and lecturer in Russian Studies at the Humboldt University of Berlin.
Before joining the AEB, he served as Deputy Head of Economic Affairs, Finance, and Science at the Swiss Embassy, then as Inbound Business Development Leader and Head of the German Business Center at EY.
He has also served as Chairman of the AEB SME Committee and a Board Member of the Joint Chambers of Commerce Switzerland-CIS.
Tadzio speaks German, English, French, Italian, Russian, Polish, and some Chinese.
Mr. Schilling was elected by representatives of the AEB’s member companies at the Annual General Meeting on March 17, 2020. He replaces Dr. Frank Schauff, who had headed the AEB since 2007 and was re-elected to a fourth term in 2016.
Tadzio Schilling holds an MA in International Relations and an advanced MA in International History and Politics from the Graduate Institute Geneva, as well as an Executive MPA from the Hertie School of Governance in Berlin.
In his professional career, he has worked in various finance, HR, and sales functions for companies such as Zurich Cantonal Bank, Dell Inc., Wesser & Partner, and FirstClimate. He has also worked as a researcher and lecturer in Russian Studies at the Humboldt University of Berlin.
Before joining the AEB, he served as Deputy Head of Economic Affairs, Finance, and Science at the Swiss Embassy, then as Inbound Business Development Leader and Head of the German Business Center at EY.
He has also served as Chairman of the AEB SME Committee and a Board Member of the Joint Chambers of Commerce Switzerland-CIS.
Tadzio speaks German, English, French, Italian, Russian, Polish, and some Chinese.