“破壁者”宋瑞霖：乐意为医药创新鼓与呼｜我们的四分之一世纪

Core Viewpoint - The article highlights the significant contributions of Song Ruilin to the Chinese pharmaceutical industry over the past 25 years, emphasizing his role as a reformer and advocate for innovation in the sector [3][4][5]. Group 1: Background and Achievements - Song Ruilin, born in 1962, transitioned from a legal background in the State Council to lead the China Pharmaceutical Innovation Promotion Association (CPIA) for 16 years, becoming a key figure in China's pharmaceutical reforms [4][5]. - He played a crucial role in drafting policies that addressed systemic issues in drug approval and patent protection, significantly impacting the pharmaceutical landscape in China [6][19]. - His leadership helped transform the CPIA from a marginal organization into a prominent voice for pharmaceutical innovation, advocating for industry interests and engaging in policy discussions [9][28]. Group 2: Key Events and Contributions - Between 2016 and 2018, Song Ruilin was involved in pivotal reforms, including the issuance of the "Opinions on Deepening the Reform of the Drug Review and Approval System" which aimed to eliminate barriers to pharmaceutical innovation [17][18]. - He identified flaws in the clinical trial system, arguing that the requirement for generic drugs to undergo unnecessary trials delayed innovation by 4 to 5 years compared to international standards [18][20]. - His advocacy for a robust patent protection system was recognized at a high-level meeting, leading to the formal adoption of reforms that aligned with international practices [20][19]. Group 3: International Engagement - The CPIA's membership in the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) marked a significant step in aligning China's drug regulatory standards with international norms [21][22]. - Song Ruilin's efforts facilitated China's entry into the International Council for Harmonisation (ICH), enhancing the credibility of Chinese pharmaceuticals on the global stage [23][22]. Group 4: Industry Representation and Challenges - As a non-pharmaceutical professional, Song Ruilin's leadership style and willingness to engage in controversial discussions set him apart, often leading to debates over drug pricing and industry regulations [27][26]. - His approach to advocacy emphasizes the importance of understanding industry needs and challenges, positioning the CPIA as a genuine representative of the pharmaceutical sector rather than a mere regulatory body [27][30]. Group 5: Legal and Ethical Standards - Song Ruilin's legal background informs his commitment to evidence-based advocacy, insisting on regulatory compliance and ethical standards in industry practices [34][33]. - His tenure at the CPIA reflects a dedication to transparency and accountability, ensuring that the association operates within legal frameworks while advocating for industry interests [35][37].