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Professor Ning Lizhi attended the BRICS Working Group meeting for the Research of Competition Issues in Pharmaceutical Markets

On September 9, the BRICS Working Group meeting for the Research of Competition Issues in Pharmaceutical Markets was held in Wuhan, Hubei Province. The meeting was jointly organized by the Competition Policy and Evaluation Center of the State Administration for Market Regulation (SAMR) and the BRICS International Competition Law and Policy Center under the framework of the 2024 National Fair Competition Conference. Xu Xinjian, Director of the Antimonopoly Bureau of the SAMR, and Andrei Tsyganov, Deputy Director of the Federal Antimonopoly Service of the Russian Federation, delivered speeches successively. Representatives from antitrust enforcement agencies, experts and scholars, and pharmaceutical industry representatives from BRICS countries including China, Russia, India, Brazil, South Africa, and Egypt participated in the meeting through both online and offline channels. Professor Ning Lizhi, Director of the Institute of Intellectual Property and Competition Law at Wuhan University, was invited to attend the meeting. The meeting focused on market access and price competition for biosimilar drugs, exploring how BRICS countries can achieve fair pricing in the pharmaceutical sector by improving competition regulation and intellectual property protection in the pharmaceutical market.

Ning Lizhi delivered a keynote speech titled "The 'Bolar Exception' from the Perspective of Competition Law," exploring the value trade-offs and institutional improvement of China's "Bolar Exception" against the backdrop of the current era encouraging drug innovation. He first interpreted China's "Bolar Exception" based on Article 75(5) of the Patent Law. Through a comparison with extraterritorial "Bolar Exceptions," he pointed out the deficiencies in China's current rules on defenses against pharmaceutical patent infringement. Ning Lizhi also emphasized that while protecting the intellectual property rights of originators under the law, a balance of interests among pharmaceutical patentees, generic drug manufacturers, and patients should be achieved through reasonable restrictions on pharmaceutical patents, thereby maintaining healthy and effective competition in the pharmaceutical sector and actively promoting the prosperity of China's generic drug industry. Ning Lizhi also called on BRICS countries to pay attention to and prioritize public health safety and social public interests, especially as developing countries still lag behind developed countries in terms of original drug research and development capabilities, the development level of the pharmaceutical industry, and the soundness of the patent system. When facing more pressing public health issues, a well-established "Bolar Exception" can significantly alleviate the pressure on access to medicines faced by developing countries. This viewpoint received active discussion and widespread recognition from the experts attending the meeting.

During the meeting, participants also engaged in in-depth exchanges on topics such as "Pricing of Medicines and Biosimilars in BRICS Markets," "Market Access for Biosimilars," "The Role of Patent Law and Competition Law in the Pharmaceutical and Biosimilar Markets," and "Cooperation among BRICS Countries in the Pharmaceutical Market." The successful convening of the meeting and its outcomes will undoubtedly provide valuable experience for the healthy development of the pharmaceutical markets of BRICS countries.