Analysis of Restrictive Clauses on Pharmaceutical Technology Transfer in TRIPS-plus Agreements
akhlāq-i pizishkī i.e., Medical Ethics,
Vol. 18 (1403),
29 July 2024
,
Page 1-18
https://doi.org/10.22037/mej.v18i-.45018
Abstract
Background and Aim: TRIPS-plus agreements establish various terms governing the relationships between originators and recipients of pharmaceutical technology, particularly in the realm of intellectual property rights and pharmaceutical patents. This study aims to introduce and describe these terms, followed by an analysis of their effects on the transfer of pharmaceutical technology.
Methods: This research employs a review methodology, gathering information through a library-based approach utilizing credible English and Persian resources. Articles from the Heinonline, SouthCentre and Noormags databases were consulted, along with agreements related to intellectual property rights and pharmaceutical patents available on the official website of the Office of the United States Trade Representative (USTR). Additionally, relevant regulations from the United States Food and Drug Administration (FDA) were referenced.
Ethical Considerations: Throughout the research and writing process, ethical principles were upheld, ensuring the originality of the text and the reliability of the sources used.
Results: This study analyzes the terms that restrict the transfer of pharmaceutical technology in TRIPS-plus agreements. Given the extensive nature of these regulations, they are categorized into two groups: common terms (data exclusivity, patent term extension, restrictions on parallel imports, protection of new uses of known drugs and limitations on compulsory licensing) and new terms (patent linkage, protection of biologics and grace periods).
Conclusion: TRIPS-plus agreements and their associated regulations for intellectual property rights and pharmaceutical patents create significant barriers to the transfer of pharmaceutical technology to developing countries and restrict access to generic drugs. This situation poses risks to human rights and medical rights, particularly the public’s right to access medicine and ensure public health. Despite these challenges, the acceptance of such agreements remains high, with newer and stricter protective regulations being developed. Developing countries often enter into these agreements due to various economic, commercial and political pressures.
- Developing Countries
- Pharmaceutical Industry
- Intellectual Property Rights
- Pharmaceutical Patents
- Pharmaceutical Technology Transfer
How to Cite
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