On the morning of March 24, 2025, the European Federation of Pharmaceutical Industries and Associations (EFPIA) delegation visited the China Pharmaceutical Innovation and Research Development Association (PhIRDA). The delegation was received by Ms. LU Xiaoti, Deputy Secretary-General of PhIRDA; Mr. ZHU Jian, Partner at JunHe; Ms. REN Wei, Head of Small Molecule IP, China, BeiGene; and Ms. WANG Xinyan, IP Director at Luye Pharma. The two sides held in-depth discussions on key topics including Intellectual Property (IP) protection, data exclusivity for pharmaceutical trials, and enhancing the cooperation between the two associations.

Meeting between PhIRDA and EFPIA

Ms. LU Xiaoti extended a warm welcome to the EFPIA delegation and spoke highly of EFPIA’s significant contributions to advancing global pharmaceutical innovation and the protection of IP rights. She emphasized that IP protection is a cornerstone of pharmaceutical innovation and a shared priority for pharmaceutical enterprises in China, Europe, and around the world. In recent years, under the guidance of China’s innovation-driven development strategy and regulatory reforms, the country has significantly improved its innovation ecosystem. Notable progress has been made in pharmaceutical IP systems, including the implementation of the early dispute resolution mechanism for pharmaceutical patents, the patent term compensation system, and market exclusivity for first generics—bringing China’s pharmaceutical IP protection system more closely with international standards. She further noted that the recent release by China’s National Medical Products Administration (NMPA) of the Draft Measures for the Implementation of Data Exclusivity for Drug Trials (for Trial Implementation) is expected to further promote a fairer innovation environment and robustly safeguard the vitality of pharmaceutical R&D. As a think tank-style association leading pharmaceutical innovation in China, PhIRDA has conducted extensive research on key issues such as patent term restoration and IP protection, and has played a proactive role in driving and contributing to the development of pharmaceutical IP protection.

Mr. Thomas Gelin, Executive Director of International Affairs at EFPIA, expressed his appreciation for PhIRDA’s efforts in advancing pharmaceutical IP protection in China. He stressed that IP protection is a major area of focus for EFPIA and its member companies. In the context of lengthening innovation cycles and rising R&D costs, a stable and predictable IP system has become a top priority for multinational pharmaceutical companies. He acknowledged that China has introduced a series of relevant policies and legal frameworks in the pharmaceutical sector in recent years, offering solid support for global biopharmaceutical R&D. Mr. Gelin expressed EFPIA’s willingness to collaborate with PhIRDA to foster dialogue and cooperation between Chinese and European IP systems, with the shared goal of addressing unmet medical needs.

Mr. Lars Kellberg, orporate Vice President and Global Head of Corporate Intellectual Property, Novo Nordisk, emphasized that due to the lengthy and high-risk nature of pharmaceutical innovation, countries such as the U.S., EU member states, and Japan have established Patent Term Extension (PTE) systems to encourage innovation by offering up to five years of additional patent protection. He acknowledged China’s current PTE framework—limiting extensions to no more than five years and ensuring total patent protection does not exceed 14 years after market approval—as a driver of innovation. However, he pointed out existing gaps in IP protection for multi-indication innovative drugs in China, which may result in a mismatch between R&D investment and returns, potentially discouraging companies from developing additional indications. He expressed hope that China will continue to optimize its IP framework to further enhance the innovation and business environment.

Mr. ZHU Jian, Partner at JunHe, noted that China is taking steady and pragmatic steps in reforming its pharmaceutical IP protection system, which is rapidly aligning with international practices. He highlighted that the recent draft policy on data exclusivity demonstrates a well-designed and rigorous mechanism, laying out a comprehensive framework to encourage the introduction of innovative and high-quality medicines in China and to stimulate innovation among both domestic and multinational pharmaceutical companies.

Ms. REN Wei, Head of Small Molecule IP, China, BeiGene, remarked that China’s innovation environment has significantly improved in recent years. Policies such as the early dispute resolution mechanism for pharmaceutical patents have injected new momentum into the industry’s high-quality development. As a leading domestic innovative pharmaceutical company, BeiGene is both a beneficiary of these institutional improvements and an active contributor to industrial advancement. She affirmed that a continuously improved IP system will provide a solid foundation for pharmaceutical innovation globally.

Strengthening China-Europe collaboration in pharmaceutical IP protection holds great significance for driving global pharmaceutical innovation, advancing new drug development, and ultimately benefiting patients worldwide. As two highly influential associations in their respective regions, PhIRDA and EFPIA will continue to deepen cooperation in the field of IP protection to promote high-quality development in global pharmaceutical R&D. This meeting also marks another important step following the signing of a Memorandum of Understanding (MoU) between PhIRDA and EFPIA in September 2024. Going forward, both parties will further strengthen their collaborative ties, leverage their respective resources, and jointly promote the high-quality development of the pharmaceutical industries in China and Europe. Attendees include Michelle Cabula, Manager of International Affairs at EFPIA, and LIU Xiangxin, Senior Patent Attorney at Novo Nordisk and etc.

Group Photo