负责任创新视域下药品专利伦理治理路径探索

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[中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）08-0965-09

DOI：10.12026/j.issn.1001-8565.2025.08.02

Exploration of pathways for ethical governance of pharmaceutical patentsunder

theperspectiveof responsible innovation

GAO Shuxian1，MENG Guangxing1.2

（1. School of Pharmaceuticd Business， Guangdong Pharmaceutical University， Zhongshan 52840O，China; 2.National Medical Products Administration Key Laboratory for Pharmacovigilance Technology Research and Evaluation， Zhongshan 52840o，China）

Abstract： Pharmaceutical patents，as a critical mechanism to incentivize medical innovation，carry complex ethical considerations due to their close association with humans‘basic rights to life and health.The conflicts betweenrights to lifeandhealth and patent rights，the imbalance in drugacessibility caused by patent protection，the abuse of the patent system in practice，and the ethical risks of patent information asymmetry together constitute the primary obstacles to the healthy development of pharmaceutical patent ethics. Responsible innovation，as a comprehensive governance strategy，provides theoretical support for the ethical governance of pharmaceutical patents through its framework of anticipation，reflection，deliberation，and responsiveness.Drawing on the practical cases of the Supplementary Protection Certificate system in the European Union and the drug patent linkage system in the United States，this paper explored the methodology forimplementing ethical balance under the framework of responsible innovation.Based on these， recommendations were proposed to improve China's pharmaceutical patent ethical governance system， including improving the pharmaceutical patent linkage system and preseting a new patent licensing framework to enhance the orderliness and predictability of pharmaceutical market access；establishing a social impact assessment system and an ethics review committee to continuously reflect on the effects of the pharmaceutical patent system on price，accessibility，and ethics；creating a multi-party consultation platform to promote information sharing and technical cooperation and ensure a balance of interests among all parties；and establishing an emergency response team and optimizing the compulsory licensing procedures to flexibly respond to changes in public health needs.

Keywords： responsible innovation；pharmaceutical patent；ethical governance； four-dimensional action framework

在全球科技竞争日益激烈的背景下，科技伦理问题，尤其是负责任创新理念，已成为国际社会关注的重要议题。（剩余14497字）