Exploration of pathways for ethical governance of pharmaceutical patents under the perspective of responsible innovation
10.12026/j.issn.1001-8565.2025.08.02
- VernacularTitle:负责任创新视域下药品专利伦理治理路径探索
- Author:
Shuxian GAO
1
;
Guangxing MENG
Author Information
1. 广东药科大学医药商学院,广东 中山 528400
- Publication Type:Journal Article
- Keywords:
responsible innovation;
pharmaceutical patent;
ethical governance;
four-dimensional action framework
- From:
Chinese Medical Ethics
2025;38(8):965-973
- CountryChina
- Language:Chinese
-
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 between rights to life and health and patent rights,the imbalance in drug accessibility 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 for implementing 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 presetting 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.
