Lessons from India and Thailand for Cambodia's future implementation of the TRIPS Agreement for pharmaceutical patents

Abstract

Cambodia is expected to graduate from least developed country (LDC) status in the near future, at which time it will be required to make patents available for pharmaceutical products and processes to meet its obligations under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Given its impending transition from LDC status, there is a need to balance Cambodia's intellectual property (IP) policies and regulations with public health priorities to ensure access to affordable life-saving medicines. This will be critical to achieving universal health coverage, one of the United Nations' Sustainable Development Goals. This paper examines Cambodia's IP laws and regulations to identify provisions which could reduce access to affordable generic medicines when it starts to grant patents for pharmaceuticals. It systematically compares Cambodia's IP laws and regulations applicable to patents with those of Thailand and India-two developing countries which have had some successes in preserving access to medicines despite the introduction of pharmaceutical patents. It identifies lessons for Cambodia from the experiences of Thailand and India in implementing TRIPS and using TRIPS flexibilities such as compulsory licensing to

Cambodia's Imminent Graduation from Least Developed Country Status: What Will be the Impact of the TRIPS Agreement on Access to HIV and Hepatitis C Medicines in Cambodia?

“…16 Some other flexibilities available to all WTO Member States include the freedom to set patentability criteria domestically (e.g., to not make patents available for new use of known substances, methods and processes, and to use strict patentability criteria for examination of pharmaceutical patents to mitigate frivolous patents and "evergreening" opportunities); to enable pre-and postgrant opposition of patents; to use compulsory licensing and parallel importation; 4 and to provide a Bolar (early working) exception for research and experimental use. 17,18 Cambodia met all three criteria for LDC graduation at the most recent review in 2021 19 and is expected to graduate from LDC status 5 in the coming years and, subsequently, will be required to grant product and process patents for pharmaceuticals. Cambodia already has some of the highest out-of-pocket expenditure on healthcare in Southeast Asia.…”

“…They include allowing the accession to multiple patent agreements designed to expedite the granting of patents, 41 such as the Joint Statement of Intent with Japan, 42 the Memorandum of Understanding (MoU) on Intellectual Property Cooperation with China, 43 the MoU with Singapore, 44 the Patent Cooperation Treaty, 45 the MoU with South Korea, 46 a Worksharing Arrangement with the United States, 47 Cambodian patent law contains other TRIPS-plus provisions including a mailbox system. 18 This system allows for the filing of patent product applications during the LDC transition period-despite no TRIPS requirement to do so. 35 In accordance with Cambodia's Rule 45 of the Prakas on the Procedure for Granting Patents and Utility Model Certificates, mailbox applications will not be examined as to their patentability until 2033, or when Cambodia ceases to be a LDC.…”

India’s Distinct but Opposing Patent Model Is Under Pressure: Prospects and Challenges in the Global Arena

“…India's process patent regime created a feasible arrangement for the growth of its robust generic drug industry. By adopting this approach, India not only provided cheaper drugs to its own population but also took pride in being 'the pharmacy of the developing world' because of its role as a major supplier of generic medicines (Tenni et al, 2023). Excluding pharmaceutical drugs from product patent protection was no longer an option after signing up to TRIPS.…”

“…India, having a well-established generic drug industry, faced opposition by many interest groups and stakeholders to the implementation of TRIPS (Tenni et al, 2023). India’s obligations under TRIPS also conflicted with the constitutional obligation under Article 47 of the Constitution of India to provide the right to health to citizens.…”

“…In March 2012, India, at the request of Natco, issued a compulsory license for Sorafenib Tosylate (Nexavar), Bayer's cancer drug. This was the first and only compulsory license issued by India (Tenni et al, 2023).…”