On the afternoon of December 1^st, 2024, during the 2024 China BioMed Innovation and Investment Conference (CBIIC), the Pharmaceutical Policy Sharing Forum was held. The forum invited distinguished guests including Lin Jianning, Former Party Secretary of the National Medical Products Administration Institute of Medical Economics; Chan Sze Tao, Chief Pharmacist of the Department of Health, Hong Kong SAR Government; Luo Yubing, Director of Administrative Licensing Division of the Guangdong Provincial Drug Administration; Song Ruilin, Executive President of China Pharmaceutical Innovation and Research Development Association (PhIRDA);Liu Junshuai, Vice-Chairman of Medicinal Policy Specialty Committee of PhIRDA and Member of Specialty Committee on Diagnosis of Treatment and Protection of Rare Diseases;Shao Rong, Vice-Chairman of Medicinal Policy Specialty Committee of PhIRDA and Executive Dean of Institute of Regulatory Science of China Pharmaceutical University; Jin Chunlin, Director of Shanghai Health Development

Research Center; Hu Yuanjia, Director of the Scientific Research Center for Drug Regulation at the 

University of Macau; and Kang Wei, Executive Advisor at RDPAC, along with industry representatives including Samuel Han, Managing Director & Global Partner of Boston Consulting Group,and Feng Hao,Chief Innovation Officer of MgX Health Technology. The discussions focused on two main themes: “Commercial Insurance Promoting Pharmaceutical Innovation” and “Based in the Greater Bay Area, Facing the World.” The forum deeply explored the possibilities of policies such as the Hong Kong-Macao Medical Products Connect, Hong Kong’s “1+” mechanism, and Macao’s medical product registration in supporting Chinese innovative medical products going global. It also analyzed current obstacles in commercial health insurance development and solutions, which will promote domestic and international dual circulation and accelerate the construction of a Chinese-style modern biopharmaceutical innovation industry.

Lo Yuk Lam, President of HK Bio-Med Innotech Association, delivered a welcome speech, stating that Hong Kong will fully commit to building an international medical innovation hub, aligning with internationally recognized standards, and accelerating mainland innovative achievements going global.The forum was moderated by Hu Xin,Chairman of Medicinal Policy Specialty Committee of PhIRDA and Chief Expert of the Department of Pharmacy of Beijing Hospital.

Lo Yuk Lam

Hu Xin

Lin Jianning delivered the opening report on “Several Thoughts on the Current Trend of the Development of Pharmaceutical Economy.” He first reviewed the recent pharmaceutical economic situation, pointing out that slower growth, investment decline, high costs, low profits, and export decline remain the main characteristics of the adjustment period. He attributed these to four major factors: global political and economic turbulence, strict anti-corruption measures and medical insurance cost control, excessive duplication of same targets, and high market share of generic drugs. However, he noted that future central government economic stimulus policies will benefit industrial economic recovery, and the pharmaceutical industry will not forever be overshadowed by darkness.

Based on the Greater Bay Area, Facing the World

The Guangdong-Hong Kong-Macao Greater Bay Area is one of China’s most open and economically vibrant regions. Through the implementation of policies such as the Hong Kong-Macao Medical Products Connect, Hong Kong’s “1+ New Drug Review Mechanism”, and Macao’s medical product registration, the Greater Bay Area is playing an increasingly important role in facilitating both “bringing in”  and  “going out” of innovative products.

Chan Sze Tao shared insights on “Reform and Prospects of Hong Kong’s Medical Products Regulation” based on Hong Kong’s regulatory reform practices. He highlighted that with strong support from the NMPA, Hong Kong continues to deepen reforms in medical product regulatory systems and actively participates in international organizations such as PIC/S and ICH. Building on internationally recognized regulatory capabilities, Hong Kong launched the “1+ New Drug Review Mechanism”, significantly improving the efficiency of innovative product review and approval. Leveraging mature clinical data platforms and high-level clinical trial centers, Hong Kong utilizes the Greater Bay Area’s resource integration advantages to promote deep cooperation and build a favorable clinical trial ecosystem. In the future, Hong Kong will establish its characteristic Center for Medical Products Regulation (CMPR), implement regulatory center operations and move towards first-tier approval, promote medical device legislation, coordinate comprehensive reforms in clinical trial regulation, testing and inspection, and drug inspection, advancing towards becoming an internationally authoritative medical products regulatory agency, promoting the innovation and internationalization of China’s pharmaceutical industry, and better entering the world stage.

Luo Yubing presented a report on “Introduction to the Latest Progress of the ‘Hong Kong and Macao Medicine and Equipment Connect’ Policy.” Director Luo noted that under the guidance of the Work Plan for Innovative Development of Medical Products Regulation in the Greater Bay Area, regulatory reform continues to advance, with all six tasks in the first phase of the Bay Area Six Measures fully implemented. At the government level, systematic planning for high-quality development of the biomedical industry has been established, using the “Hong Kong-Macao Medical Products Connect” policy as a key driver for promoting high-quality development of healthcare in the Greater Bay Area. Supported by specialist expertise, real-world studies, world-class information, rich clinical resources, and a complete medical device industry chain, legal measures are being used to address challenges such as slow market entry and hospital access difficulties, making the Greater Bay Area an innovation hub for multinational pharmaceutical companies.

The panel discussion, entitled “Based on Guangdong-Hong Kong-Macao Greater Bay Area to Embrace the World” was moderated by Kang Wei with participation from Chan Sze Tao, Shao Rong, and Hu Yuanjia. The experts highlighted that the Greater Bay Area encompasses two systems, encompasses two systems, three customs territories, three currencies, and three medical product regulatory systems. Integrating these regional resources and advantages will promote coordinated development within the region and global innovation cooperation. Hong Kong ranks among the global leaders in basic research, with regulatory systems highly aligned with international standards. It is preparing an independent review and registration mechanism, where mainland product clinical data can meet Hong Kong’s localization requirements. As a PIC/S member, Hong Kong’s GMP inspection results are internationally recognized. Macao, as a Portuguese-speaking region, has influence over other Portuguese-speaking economies and is actively advancing its clinical research capabilities and promoting relevant regulatory standards.

Commercial Insurance Promoting Pharmaceutical Innovation

Healthcare and social security constitute a vast and complex system that should not be constrained by single elements. Medical insurance should not be limited to basic medical insurance, as commercial health insurance plays an equally crucial role. In the future, commercial medical insurance is expected to become the mainstream payment method for innovative drugs, as no country’s social security system alone can support rapidly developing pharmaceutical innovations.

Samuel Han delivered an insightful report on “Commercial Health Insurance Supporting Medical Innovation Practices and Challenges.” He highlighted that while commercial health insurance payments for innovative drugs have grown from RMB 3.4 billion in 2019 to RMB 7.0 billion in 2023, showing diversification in payment patterns - particularly with oncology drug coverage increasing from 6% to 9% - this proportion remains relatively small compared to the RMB 140 billion innovative drug market. Moreover, within overall insurance premium products, both the final payment ratio and net premium scale for innovative drug coverage remain at relatively low levels. Han emphasized that addressing the coordination between commercial and basic medical insurance, as well as overcoming barriers to cooperation between pharmaceutical companies and insurance providers, will be crucial factors in driving the future development of commercial health insurance.

Addressing the challenges in commercial health insurance development, the forum organized a panel discussion on “Commercial Insurance Promoting Pharmaceutical Innovation.” The discussion was moderated by Liu Junshuai, with panelists including Jin Chunlin, Samuel Han, and Feng Hao. The experts noted that the National Healthcare Security Administration and insurance regulatory authorities have explicitly committed to improving the “1+3+N” multi-level medical security system and supporting commercial health insurance development. The experts emphasized that discussions on commercial insurance should extend beyond inclusive insurance products. They stressed that commercial insurance development must return to its business fundamentals, clearly define its role within the social medical security system, formulate attractive policies, develop diversified products, enhance data capabilities, encourage enterprises and high-income groups to purchase commercial insurance, strengthen fundraising capacity, and promote win-win cooperation with medical institutions and pharmaceutical companies.

Group Photo