The Impact of ‘TRIPS-Plus’ Rules on the Use of TRIPS Flexibilities: Dealing with the Implementation Challenges

Abstract

Improving the health and well-being of society is a priority to many governments. One essential element within this debate focuses on the accessibility and affordability of medicines for patients. Although interest in this area has persisted for decades, the recent shift in this field is manifested by this now being treated as a global concern, rather than as a regional or a national one. Patients in both developed and developing countries alike are facing the same challenges and are under an increased pressure to access and afford treatment. The recently published UN High Level Panel for Access to Medicines Report explicitly stated its view of ‘access to medicines, vaccines, diagnostics and related health technologies as a serious, multidimensional global problem, with challenges that affect all people and all countries.…the High-Level Panel recognizes that the costs of health technologies are rising globally and are being felt by individuals and by public and private insurance schemes in both wealthy and resource-constrained countries alike’ (UN Secretary General High Level Panel, ‘The United Nations Secretary-General High-Level Panel on Access to Medicines Report: Promoting Innovation and Access to Health Technologies’, (September 2016), 12. https://apps.who.int/medicinedocs/documents/s23068en/s23068en.pdf.). This thinking represents a fundamental departure from the previous approach which classified the problem related to access to medicines as one mainly attributed to developing and least developed nations. It is within this debate that the role of intellectual property protection in general and by way of the rise of TRIPS-Plus agreements and their impact on accessibility and affordability of medicines takes centre stage.

Trade‐Related Aspects of Intellectual Property Rights Flexibilities and Public Health: Implementation of Compulsory Licensing Provisions into National Patent Legislation

“…6 This included providing legal protection for inventions in all technological fields, including pharmaceutical products. 6 The impact of the introduction of global regulation of IP rights varied by country; although most developed countries already had advanced IP regimes, requiring only minor revisions to domestic IP laws to implement the TRIPS Agreement, most developing countries required a complex set of reforms to update existing laws or adopted new ones in order to meet the minimum standards set by the TRIPS Agreement. 2 The Commission on IP Rights, established by the United Kingdom (UK)'s Department for International Development in May 2001, published a number of reports studying how "national IPR regimes could best be designed to benefit developing countries within the context of international agreements, including TRIPS."…”

“…For example, LDCs are given a transitional period to apply certain TRIPS provisions. 6 Article 66.1 of the TRIPS Agreement states that LDC members "shall not be required to apply the provisions of this Agreement, other than Articles 3, 4 and 5, for a period of 10 years" (Articles 3, 4, and 5 relate to National Treatment, Most-Favored-Nation Treatment, and WIPO multilateral agreements). 18 This was extended several times, most recently in June 2021 when a decision of the TRIPS Council further extended the general transition period for LDCs until July 1, 2034, or until they cease to be an LDC, whichever comes first.…”

“…By allowing alternative production or importation of a generic form of a product without consent of the patent holder-for example, when the price of a pharmaceutical product makes it inaccessible to patients-compulsory licensing is an instrument to overcome patent abuse and curtail anticompetitive behavior. 4,6,31 Although the TRIPS Agreement provides conditions to be respected for issuing such licenses (see Box 1), it does not restrict the freedom of countries to determine the grounds on which they are granted under respective national laws. 29 Indeed, the Doha Declaration explicitly recognizes the right of each member to grant compulsory licenses and the freedom to determine grounds on which a compulsory license may be granted.…”

“…34 There is substantial evidence that the availability of generic drugs (i.e., off-patent medicines) considerably reduces prices of medicines; indeed, prices can drop from 30% to 90% when generic medicines enter the market once a patent expires. 6,32 It is important to note that patent barriers and access to medicines are not just a problem in developing countries; they also present a problem for low-income populations in developed countries such as the United States. 6,31 Furthermore, although the pharmaceutical industry has argued that compulsory licensing reduces innovation and investment in research and development (R&D), research shows that the economic losses from the licensing of these products in developing countries are minimal compared with overall pharmaceutical industry profits and would therefore have little impact on innovation.…”

“…2,6 Proactive implementation of these flexibilities into domestic patent legislation allows nations to act efficiently in the public health sector. 6,7 They also allow countries to tailor TRIPS implementation to address their national priorities. 2 This will be explained in more detail in Background.…”