On September 9, a meeting of the BRICS Working Group for the Research of Competition Issues in Pharmaceutical Markets was held in Wuhan, China. FAS of Russia is a co-chair of the Working Group along with the State Administration for Market Regulation (SAMR) of the People's Republic of China.
The issues of developing competition and fair pricing in pharmaceutical markets are a key issues and always on the agenda of competition authorities, including BRICS countries. Increasing access to the market for biosimilars of a medicine, so-called generic, contributes to the efficient functioning of the market and stimulates price reductions.
The development and production of biosimilars helps to increase the availability of medicines for citizens. At the same time, this process is multi-stage and complex and requires significant healthcare costs. Currently, there is a tendency in the world to simplify regulatory requirements for the development of biosimilars, including with the aim of increasing the competitiveness of medicines.
During this meeting, participants discussув issues of fair pricing in pharmaceutical markets, in particular the relationship between the production of biosimilars and the price level, with an emphasis on specific examples of medicines price reductions in BRICS countries. Particular attention was paid to the protection of intellectual property rights in pharmaceutical markets.
The market of biological medicines and their analogues in turn is one of the most promising in the pharmaceutical industry. BRICS countries have a great opportunity to develop this segment of the industry by producing their own medicines at lower and fair prices. Due to the complexity of the molecular structure of biological medicines, their development and production are very expensive, which leads to high prices for end clients - patients - and also increases barriers to entry on the market. In this regard fair regulation is strongly needed.
Biological medicines are protected usually by several patents at once. Generic biologics, so-called biosimilars, enter the market with additional challenges, including regulatory hurdles and inadequate intellectual property and competition laws that limit patient access to these medicines.
In addition, patents on biological medicines are typically held by large international manufacturers who, to the detriment of consumers, use various anti-competitive practices to protect their position in the relevant product market. In turn, large pharmaceutical manufacturers create barriers to entry for local manufacturers to enter the BRICS market. As a result, a significant part of patients are unable to purchase biological medicines and their analogs or have to buy them at monopolistically high prices.
Biosimilars could increase the availability of biological medicines for consumers around BRICS countries and support and develop competition on this market.Therefore, by bringing together their industrial leverage and expertise and empowering their respective regulatory frameworks, the BRICS countries are capable of building their independent market for biosimilar medicines that will be driven by fairness and universal access to healthcare.
Currently, within the framework of the BRICS Working Group on the for the Research of Competition Issues in Pharmaceutical Markets, with the support of the BRICS Competition Law and Policy Centre, a corresponding study of competition issues in the biosimilars market is being conducted. As part of the research that brings together policy researchers and pharmaceutical experts from several developing countries, it is planned to summarize the experience of BRICS countries and prepare a report on the results.
The questions for discussion included the following:
- Pricing for medicines and biosimilars in the BRICS market
- How the increasing and simplifying market access for biosimilars affect price reduction?
- Strategies for reducing the price of medicines, examples, cases, etc.
- The role of patent law and competition law in the medicines and biosimilars market
- Market access for biosimilars (domestic regulatory frameworks)
- Interchangeability of medicines and biosimilars
- BRICS cooperation in pharmaceutical markets
Moderator:
- Alexey Ivanov, Director, BRICS Competition Law and Policy Centre
14:00 – 14:10 Welcome Speeches
- Xu Xinjian, Director-General of Antimonopoly, State Administration for Market Regulation;
- Andrey Tsyganov, Deputy Head, FAS Russia.
14:10 – 15:50 Report sharing
- Andrey Tsyganov, Deputy Head, FAS Russia
Development of Competition and Fair Pricing in the Market of Medicines in Russia. The Role of Patent Law in Medicines Market
- Liu Jian, Director, Anti-monopoly division of State Administration for Market Regulation (SAMR);
- Chen Zhijiang, Head of the Department in Charge of Price Supervision and Cracking Down on Unfair Competition, SAMR;
- Ms Raksha Darji, Principal Economist, Competition Commission South Africa (virtually);
Mr Tlabo Mabye, Principal Analyst, Competition Commission South Africa (virtually).
Report sharing: Strategies for reducing the price of medicines, examples of cases from South Africa & Market access for biosimilars (regulatory framework of South Africa)
- Ms. Ghada Elwakeel, Head of the Investigations Team, Egyptian Competition Authority (virtually)
Report sharing: Enhancing Competition in Egypt's Regulated Pharmaceutical Sector
- Samir Kulkarni, Professor, Institute of Chemical Technology, Mumbai, India
Report sharing: Business of Biosimilars: Development Path to enable affordable access in BRICS
- Mrudula Bele, Associate Professor, MVP Samaj's College Of Pharmacy, India (virtually);
- Song Xiaoting, Professor, Shanghai International College of Intellectual Property, Tongji University; Director, Center for Pharmaceutical Law and Intellectual Property Studies; Chair, Pharmaceutical Intellectual Property Professional Committee of the China Health Law Society;
- Ning Lizhi, Professor, Law School of Wuhan University; Director, Institute of Intellectual Property and Competition Law; Member, Expert Advisory Group of the State Council Antimonopoly and Anti-Unfair Competition Committee;
- Roman Ivanov, Vice Rector, Sirius University of Science and Technology, Russia;
- Ujjwal Kumar, Associate Director & Deputy Head, CUTS International, India.
Report sharing: Biosimilar regulation and competition
- Vitor Henrique Pinto Ido, Programme Officer, Health, Intellectual Property and Biodiversity Programme, South Centre, Brazil;
- Andrey Ivaschenko, Head of Board of Directors, Chemrar Group of Companies, Russia (TBC);
- Shanghai Pharmaceuticals Holding Co., Ltd.
15:50 – 16:50 Discussion
All attendees and discussants:
- Jia Kai, Tenured Associate Professor, School of International and Public Affairs, Shanghai Jiao Tong University;
- Yuhan Bao, the Liaison Officer and the Human Practices Program Coordinator of iGEM Foundation, the vice director of the Youth Working Group of Synthetic Biology Branch under Chinese Society of Biotechnology.
16:50 – 17:00 Concluding remarks
- Fu Hongwei, Director, Competition Policy and Assessment Center, SAMR;
- Alexey Ivanov, Director, BRICS Competition Law and Policy Centre.