FIND position statement: TRIPS waivers

Following the waiver of certain patent-related Articles of the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccines, there have been ongoing discussions around a potential extension of this waiver to cover the production and supply of COVID-19 therapeutics and diagnostics. This statement summarizes FIND’s position on these discussions.

First, most COVID-19 diagnostics are composed of biomarkers (which are not patentable), capture agents (which can be proprietary or non-proprietary), detection reagents (which are mostly generic commodities), and sensing technologies (the basis for most diagnostics patents). Many COVID-19 diagnostic tests were based on PCR and lateral flow, for which key patents are expired. As a result, access to COVID-19 diagnostics has not been limited by enforceable patents. Neither compulsory nor voluntary licenses on diagnostic technologies would have been likely to stimulate innovation or sufficient to enable local manufacturing of COVID-19 tests in middle-income countries. Nonetheless, patent-related waivers under the TRIPS Articles may one day be applicable to essential diagnostics or diagnostics for future pandemics, such as emerging sensing technologies.

Second, unlike therapeutics, competitive advantages in the diagnostics industry are often linked to engineering know-how, manufacturing technologies, and production costs. For low- and middle-income countries (LMICs), the lack of manufacturing ‘know how’ and the dearth of technology transfer programmes to support local manufacturing are one of the largest trade-related barriers to global access to diagnostics.

Consequently, TRIPS Articles concerning trade secrets and technology transfer are more relevant to equitable global diagnostics access than those relating to patents and waivers. Trade secrets are addressed in Article 7, Section 39 of the TRIPS Articles; technology transfer is addressed in Article 66, Section 66.2, which states: “Developed country members shall provide incentives to enterprises and institutions in their territories for the purpose of promoting and encouraging technology transfer to least developed country members in order to enable them to create a sound and viable technological base”.2 This statement has been reaffirmed in paragraph 7 of the Doha Declaration.3

Third, given the importance of manufacturing technology and manufacturing know-how to equitable global diagnostics access, we believe that full application of the principles in Section 66.2 could have an important impact. We are therefore calling for Article 66 to be brought to the forefront of ongoing WTO discussions around equitable global access to healthcare products, to remind members of their commitments to technology transfer, and to advocate for the establishment and use of meaningful incentive programmes to transfer diagnostic manufacturing know-how and technology to LMICs.

Fourth, we are calling for further WTO engagement beyond the scope of the TRIPS agreement to address other trade-related barriers that adversely affect the availability of diagnostics in LMICs. These include barriers relating to import duties, product registration, and regulatory harmonization.

In summary, leveraging Article 66 of the TRIPS Agreement has the potential to yield a significant impact on access to diagnostics, even more so than an extended waiver of patent-related TRIPS Articles. We believe that this, along with initiatives to address other trade-related barriers, could represent an effective strategy to improve equitable global access to diagnostics.

Policy brief on diagnostics & intellectual property

The pharmaceutical and vaccines industries both make regular use of patents to protect their innovative products. However, patents are less consequential for diagnostics. This document explains how intellectual property rights are protected in the diagnostics industry.