INTRODUCTION
This paper examining analysing TRIPS provisions and legal framework of Article 30 in an attempt to realise SDG 3 in terms of access to lifesaving medicines in the context of developing nations. The author argues on the basis of the TRIPS agreement, which restricts the access to medicine in the developing countries and seeks for the patent exclusions as a way out. It brings a change in perception of Article 30 with reference to the provision of balance between patent owner's right and the global interest in the availability of the life-saving drugs. It is worth stating that failures in its implementation are caused by learners and tutors' lack of knowledge about Article 30. In this regard, it is necessary to reveal how Article 30 has been and will be applied with reference to the TRIPS agreement's Articles 7 and 8, VCLT and the Doha Declaration. It pointed towards a deeper understanding of article 30, contestation, bias, and rationale of the exemptions contained therein. The paper has three research findings First, through the analysis of the Article 30 of the TRIPS agreement, the author is able to give a new meaning to it which would enable poor countries create exemptions for a number of development-related objectives that include public health and drug availability. Second, it advances the utilization of patent exemptions in the developmental discourses as a tool towards the realization of the third of the seventeen sustainable development goals. Last of all, it hints at an exception for emergencies such as preparing for a pandemic or an epidemic, so long as such urging a developing country to store copyrighted medication. It is argued that patent exceptions are a useful strategy in IP policy that should be boldly stated and used by countries, especially where aimed at enhancing access to essential medicines and to realise SDG 3. While proposing the interpretation of Article 30, the phrase 'unreasonably' has been introduced here as part of a balanced fair and equitable review process to favour both the proprietors of patent and the public in general. The paper provides a comprehensive analysis of Article 30 and its potential to address the challenges faced by developing countries in accessing essential medicines. It emphasizes the importance of balancing patent rights with societal interests. The proposed stockpiling exception presents a practical solution to enhance access to essential medicines and contribute to SDG 3.
BALANCING IP AND ACCESS
Developed countries desire to maintain their intellectual property rights (IPRs), while developing countries must balance this with public interest considerations. The World Trade Organization's Agreement on TRIPS1 has been chastised for failing to achieve this balance. Many claim that exclusive patent rights stifle social progress in poorer countries by restricting access to critical medications.2 All United Nations states have agreed that access to essential medicines is through Sustainable Development Goal 3, is essential for social development, which strives to "ensure good health and foster welfare for all people of all ages." SDG 3 is regarded as "a critical step towards achieving the right to health protected by Article 12 of the International Covenant on Economic, Social, and Cultural Rights, including nations' primary dedication to providing access to essential medicines." Three major contributions are made by this article. It first suggests a fresh reading of Article 30 based on these interpretive sources and precedents. Second, it pursues SDG 3 by employing an innovative strategy to support patent exceptions with development justifications. Third, it proposes a fictitious exemption to stockpiling for epidemic and pandemic preparation, enabling developing nations to get patented critical medications in order to meet SDG 3. This article suggests that governments should use patent exceptions as a useful IP policy tool with more trust in their domestic legal systems, especially when those exceptions are meant to increase access to critical pharmaceuticals in order to accomplish SDG 3.3
TRIPS PATENT REGIME
Most of the members in the World Trade Organization are considered developing nations,4 typically characterized by their low-income levels and standards of living. These developing nations can be divided into a subgroup known as least-developed countries5 (LDCs), which are among the world's poorest nations with the highest levels of poverty.6 It's important to note that in this article, LDCs are not classified as "developing" states because they have extended transition period until 2034 for implementing the TRIPS patent provisions. The agreement requires patents to cover all innovations, including medicines, and to guarantee holders exclusive rights for at least 20 years, has significantly improved patent safeguards and enforcement in poor countries. These patents can pose obstacles to the social development and accessibility of affordable medicines in these nations, as they create monopolies that drive up drug costs by eliminating competition from generic alternatives and hindering subsequent innovation. Previous study findings support the idea that implementing patent systems in low and middle-income developing countries may result in price hikes ranging from 15% to 200%, possibly restricting effective access to medications in these regions.7 Patent monopolies are typically defended through the use of incentive theory, which contends that patents are the most effective method to drive creativity and innovation, both of which are critical for progress.8 Patents, according to proponents, can assist to social progress by providing the appropriate incentives to stimulate the manufacture of socially useful items like medicines. However, the WTO acknowledges that research have demonstrated that patents have both beneficial and negative effects on innovation. Furthermore, it recognises that patents are ineffective in providing incentives for the discovery of novel treatments for "neglected diseases" or "diseases of the poor" due to their low commercial possibilities. As a result, the legitimacy of incentive theory as a rationale for pharmaceutical patents in poor nations is being called into doubt.9 According to General Comment No., "parties must ensure that intellectual property rights do not result in the restriction of access to necessary medicines required for the realisation of everyone's right to health."10 When states implement domestic intellectual property policies that effect patent rights in order to achieve their commitments under the right to health, it may represent a permissible approach under the TRIPS agreement for public health goals. Nevertheless, since TRIPS doesn't explicitly acknowledge human rights, and the World Trade Organization Dispute Settlement Body (DSB) primarily functions as a specialized trade institution that has historically been cautious about incorporating external norms, states might encounter challenges in WTO DSB proceedings, while depending on the right to health. This assertion is supported by the absence of human rights discussions in the Australia-Trans Pacific Partnership agreements. The long-term objective of the strategy is "to accomplish the goal of access to secure, efficient, quality, and economical essential medicines and vaccines for all" and at the same time "to ensure access to economical essential medicines and vaccines, reflecting the Doha Declaration." For three reasons, a development-oriented strategy is chosen over a human rights-based. Firstly, the preamble of the TRIPS agreement explicitly acknowledges the use of intellectual property policies to pursue "development objectives," Furthermore, the preamble to the General Agreement for Tariffs and Trade of 1994 expressly discusses the establishment of trade policies in order that encourage "sustainable development." Utilizing development arguments to justify intellectual property policies has the advantage of aligning with the internal norms of the WTO system, supporting current human rights disputes without depending on external rules. Second, it is acknowledged that national development goals and programmes should incorporate intellectual property laws in order for these laws to promote development in underdeveloped countries. Although developing nations may have varied approaches to development, all developing nations may benefit from the 2030 Sustainable Development Agenda of the United Nations. Thirdly, SDG 3.b explicitly recognizes the Doha Declaration and endorses Making advantage of TRIPS "flexibility to safeguard public health, as well as, in specific, ensure access to medicines for everyone." According to the World Trade Organisation, "SDG 3 itself recognises the international patenting framework as an efficient means of public policy, highlights the need for policy flexibility, and specifically allows for distinct regulatory approaches at the national level."11 SDG 3 thus encourages the use of TRIPS flexibilities, such as patent exclusions, to make vital medications more accessible.
Footnotes
1. Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 UNTS 3 (entered into force 1 January 1995).
2. Johan Rochel, 'Intellectual Property and Its Foundations: Using Art. 7 and 8 to Address the Legitimacy of the TRIPS' (2020) 23(1–2) JWIP 21, 22.
3. Supra note 01.
4. WTO, Who Are the Developing Countries in the WTO? (Web Page, 2021) https://www.wto.org/english/tratop_e/devel_e/d1who_e.htm.
5. R. Olwan, Intellectual Property and Development Theory and Practice, (Springer, 1st ed, 2013).
6. Id.
7. UNCTAD, Using Intellectual Property Rights to Stimulate Pharmaceutical Production in Developing Countries (United Nations, 2011).
8. P. Adusei, 'The Myth of Patent Justifications: Triumph and Failure Dichotomy in the North and South' in Patenting of Pharmaceuticals and Development in Sub-Saharan Africa, (Springer-Verlag, 1st ed., 2013) 111 & 121.
9. C. Garrison, 'Exceptions to Patent Rights in Developing Countries', Issue Paper No. 17, UNCTAD-ICTSD, 2006) 40.
10. Committee on Economic, Social and Cultural Rights, General Comment No 24: State Obligations under the International Covenant on Economic, Social and Cultural Rights in the Context of Business Activities, UN ESCOR, UN Doc E/C12/GC/24.
11. WTO, WTO Contribution to the 2021 High Level Political Forum.
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