The TRIPS Agreement, adopted in 1994 by WTO Member States, marked a watershed moment, ushering in a new global regime for intellectual property protection that significantly impacted access to medicines. Effects included higher prices for medicinal products, barriers to local production of generics through reverse engineering of patented items, importation of cheaper medicines from countries without patents or under licensing agreements, and delays in the market entry of generic products. Three decades have passed since the TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights was adopted. Concerns initially raised during its negotiations—such as expensive medicines, market exclusivity, and delayed entry of generic alternatives—have resurfaced prominently during the recent COVID-19 pandemic, underscoring their enduring relevance.[1] India serves as a crucial supplier of cost-effective generic medicines to developing and least-developed countries (LDCs). Approximately 80 per cent of the AIDS medications utilized by Medecins Sans Frontieres (MSF), an international medical humanitarian organization aiding over 60,000 patients across more than 30 nations, originate from generic drugs produced in India.[2] India is widely recognized as a global hub for affordable medicines due to its diverse range of pharmaceuticals available at lower costs. Through the practice of reverse engineering, Indian manufacturers have successfully created economical versions of drugs originally developed in other countries. One notable achievement is India’s pivotal role in combating HIV/AIDS in Africa. Recognized by the WHO as a major health threat in Africa, HIV/AIDS was effectively addressed by India through the provision of antiretrovirals at significantly reduced prices compared to those charged by major pharmaceutical companies. Costs plummeted from $10,000 per patient to less than $1, making treatment accessible to a broader population. Today, India remains a key global supplier of affordable HIV medications, leveraging its capability to swiftly produce newer HIV drugs as generics. Another example of India’s success lies in the production of the recombinant Hepatitis B vaccine. India’s stance against the practice of evergreening patents—a strategy that extends patent protection through minor modifications, thereby keeping drug prices high and inaccessible—further underscores its commitment to affordable healthcare solutions.[3] This article aims to undertake the legal framework that governs the intersection between IP Laws and public health. It will also shed light on the TRIPS agreement and Doha declaration that is in essence to the debate.
TRIPS Agreement and Doha declaration
TRIPS, as part of the WTO’s Agreement Establishing the World Trade Organization, stands as the most extensive international agreement safeguarding intellectual property. Its provisions from Articles 27 to 34 specifically shield patent rights, granting patent holders the legal authority to prohibit others from manufacturing, using, or selling their inventions for a designated period, typically lasting at least 20 years from the patent application date. Exceptions under Article 27 of TRIPS allow governments to deny patents under certain circumstances related to public health concerns. These exceptions include cases where preventing commercial exploitation of an invention is necessary to protect human, animal, or plant life or health, as well as for new diagnostic, therapeutic, and surgical methods for humans or animals, and specific plant and animal inventions. Under Article 30 of TRIPS, governments are permitted to create limited exceptions to patent rights, provided these exceptions do not unreasonably conflict with the normal exercise of the patent. This may include using a patented invention for research purposes or obtaining regulatory approval from public health authorities. Compulsory licensing, defined in Article 31 of TRIPS, allows governments to grant licenses to produce patented products or processes without the patent owner’s consent, particularly in emergencies or other unusual circumstances where normal licensing requirements may be waived.Parallel importation, also known as participation in the gray market, involves purchasing goods in a foreign country at a lower cost and reselling them domestically at a price equal to or lower than the local market price. For instance, medicine X purchased at a lower price in Thailand may be imported back into Australia and sold at a competitive rate compared to locally offered prices.[4]
Before the Doha Round (1995-2001), when TRIPS came into effect in 1995, Least Developed Countries (LDCs) were initially exempted from its patent rules. However, many of these countries lacked the ability to produce their own medicines and relied heavily on importing affordable generics from countries like India. This reliance meant that when other developing nations, often their sources for generics, became subject to TRIPS patent rules, both these developing countries and LDCs faced the daunting prospect of medicines becoming too expensive for their populations. Despite TRIPS offering some flexibility, such as compulsory licensing, poorer countries faced strong pressures against using these options from more powerful interests. This lack of access to affordable medicines led to the Doha Round of trade negotiations, which culminated in the Doha Declaration on Public Health in November 2001. The Declaration, updated in 2002, recognized the serious public health challenges affecting poorer nations, including epidemics like HIV/AIDS, tuberculosis, and malaria. It affirmed that TRIPS should not hinder member countries from taking necessary measures to protect public health, highlighting important flexibilities such as parallel imports and compulsory licenses.
However, challenges remained, especially with Article 31 of TRIPS imposing conditions on compulsory licenses that made it difficult for developing countries and LDCs to access affordable imported medicines. A breakthrough came with the 2003 Implementation of Paragraph 6 of the Doha Declaration, which introduced a temporary waiver later converted into a permanent amendment to the TRIPS Agreement in December 2005. This amendment allowed WTO member countries to adjust their domestic patent laws, permitting exports under compulsory licenses to support countries lacking manufacturing capabilities. Under this amendment, an exporting country could export its entire production to meet the needs of an importing nation. Post-2005, despite these flexibilities, WTO member countries are obligated to uphold patent protections as outlined in TRIPS. The transitional period for developing countries like India to achieve full compliance with TRIPS concluded in 2005.[5] The LDC Transition period is the transition period for Least Developed Countries (LDCs) exempts them from TRIPS requirements regarding pharmaceutical patents until 2033 or until they cease to be classified as LDCs. This exemption enables LDCs to procure and/or manufacture more affordable generic medicines.[6]
Patent Regime and the Pandemic: Impacts and Considerations
The global COVID-19 pandemic has starkly highlighted challenges in ensuring access to essential medicines. It has disrupted normal operations across various industries worldwide, particularly impacting the pharmaceutical sector. This new reality necessitates innovative approaches and technologies to combat the pandemic and develop effective treatments. Research and development efforts in pharmaceuticals are crucial for innovation and addressing disease outbreaks. The pandemic has also posed significant challenges to patent laws and regulations. Fundamental principles and standards governing patent law are being tested, especially concerning issues like compulsory licensing aimed at improving access to essential medicines during crises. Efforts to achieve equitable distribution of vaccines have encountered numerous hurdles within national and international patent systems, revealing inconsistencies and lack of coherence. There remains an inherent tension between patent law, which supports compulsory licensing to enhance access to medicines through generic production, and pharmaceutical principles advocating for data protection and exclusivity. This conflict is evident in provisions such as data exclusivity laws in various countries, which restrict generic manufacturers’ access to trial and research data. In order to improve access to medicines, there is a pressing need to reform patent laws to adapt to current realities, including pandemics like COVID-19. The pandemic should serve as a catalyst for modernizing legal frameworks to achieve equitable access to medicines while balancing the public interest and patent holders’ exclusive rights. Clear and defined exemptions within patent laws for situations like pandemics are essential to ensure timely and effective responses to global health crises.[7]
Politics of Patents and Access to Medicines
Intellectual property rights (IPRs) pertain to ownership and control of wealth and knowledge. They fundamentally shape how knowledge, often referred to as ‘the new capital,’ is generated, owned, controlled, and spread, both within countries and worldwide. However, knowledge is also inherently a public good, influencing the availability of other public goods like healthcare and education. This dual nature of knowledge—as both a form of capital and a public good—is central to any intellectual property regime and the debates surrounding it.[8]
The US trade agreement, having skirted and weakened the principles of the Doha Declaration and the TRIPS-plus ethos for quite some time, saw a breakthrough with the May 10 Agreement. This landmark event severed the link by reducing intellectual property (IP) constraints in FTAs with Peru, Panama, and Colombia, marking a positive stride towards increasing generic medicine production and accessibility in developing nations. However, a flaw in the US stance remained evident: this agreement introduced three provisions to neutralise its beneficial impact. These included Patent Linkage, which bars national drug regulatory authorities from granting usage permissions in the presence of an active patent; Patent Extension provisions allowing patent lengthening due to administrative delays; and Data exclusivity, granting patent holders sole rights over medicine data. While these provisions aim to preserve incentives for innovation and research and development (R&D), their efficacy in developing countries remains unproven.[9]
A pivotal moment in Indian legal history occurred with the ruling of the two-judge bench of the Supreme Court of India in Novartis AG v. Union of India (2013). This landmark case saw pharmaceutical giant Novartis challenging the rejection of their patent application for the leukaemia drug Gleevec, marking a significant legal challenge under India’s recently revised patent laws. The court’s decision was hailed globally for its potential to maintain access to affordable medicines for millions, effectively curbing practices that could extend patent monopolies. The judgement is widely regarded as a safeguard ensuring accessibility to life-saving medications at reasonable costs for people in India and beyond.[10] It was a step against the unethical practice of evergreening patents which led to the discouragement of generic medicine production and gave companies the right to extend patents after minuscule change in the formula of the drug. The judgement comes as a saviour for common people and shows India’s commitment to equitable access to life-saving drugs.
Human Rights Paradigm – The Ethical Dilemma
Despite the COVID-19 pandemic no longer being classified as a global health emergency, it has raised significant global concerns regarding the availability and accessibility of COVID-19 vaccines, treatments, and related medical advancements. There has been a stark contrast in vaccine access between high-income countries (HICs) and Low and Middle-Income Countries (LMICs). The distribution of vaccines and pharmaceuticals globally has been uneven, leading to terms like “vaccine apartheid,” “vaccine hoarding,” or “vaccine nationalism” becoming critical warnings in global public health discourse. The vaccines with high efficacy have predominantly been developed in wealthy nations, highlighting a modern form of colonialism present in various sectors, including global public health, through the commercialization of essential medicines. Strict enforcement of intellectual property rights (IPRs) in cases involving COVID-19 vaccines and essential pharmaceuticals has commodified life-saving treatments, prioritizing financial gain over human life. International human rights law aims to transform moral and ethical responsibilities into legal obligations, providing a universal framework for sustainable health and global health equity. The preamble to the 1946 World Health Organization (WHO) constitution asserts the fundamental right of every human being to the highest attainable standard of health, regardless of background. International organizations such as the United Nations (UN), World Trade Organization (WTO), and WHO recognize health as a fundamental human right. A human-rights based approach emphasizes governments, pharmaceutical companies, and stakeholders’ duty to ensure medicines are accessible and affordable for all individuals, regardless of socio-economic status or location. However, the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement often prioritizes IPRs over human rights, particularly in Articles 7 and 8, which compel WTO members to resolve conflicts within the framework of intellectual property law, subordinating human rights to innovators’ interests. A decolonized approach to human rights in public health calls for a shift away from market-driven paradigms towards models grounded in the experiences of those affected by current systems. To achieve a decolonized human rights approach in public health, it is crucial to ensure universal access to life-saving medications, dismantling barriers created by IPRs and market access regulations. The dichotomy between IPRs and human rights presents a significant obstacle to decolonizing human rights in public health. True decolonization will require TRIPS and existing IPR regimes to explicitly recognize the human right to health as central to the enforcement of intellectual property rights.[11]
Conclusion
Health is a fundamental right that everyone should have, essential for enjoying other rights like the opportunity to grow and live with dignity. Governments need to make health a priority in their policies and programs, regardless of people’s economic, social, cultural, religious, or political backgrounds. However, many people around the world still struggle to fully access this right, mainly because it’s hard to get affordable, high-quality medicines quickly, especially in the Least Developed Countries (LDCs). This challenge hurts people’s dignity, which is the basis for all human rights, including the rights to life, health, and development.
From a human perspective, being able to get medicines when needed is tied to important values like fairness, treating everyone equally, being open about decisions, including everyone in decisions, and making sure people are held responsible for their actions. It’s really important to keep making progress like the Doha Declaration did to make sure everyone who needs medicine can get it. This means making the TRIPS Agreement stronger to stop people from using its rules in ways that hurt others. The World Health Organization (WHO) should also take a more active role by making a treaty for LDCs to help them research and develop treatments for tropical diseases that get overlooked. This would balance making sure everyone can afford medicines with learning more about diseases that mostly affect LDCs, making sure everyone has a fair chance to get the medicine they need.[12]
[1] Tara Leevy, “Intellectual Property and Access to Medicine for the Poor” 8 AMA Journal of Ethics 838 (2006).
[2] Id.
[3] The Better India, Médecins Sans Frontières, et.al., “5 Reasons Why India is the ‘Pharmacy’ of the Developing World” (June 24 2016).
[4] Id at 1.
[5] Id at 1.
[6] Brigitte Tenni, Hazel V. J. Moir, et.al., “What is the Impact of Intellectual Property Rules on Access to Medicines? A Systematic Review” National Library of Medicine (15 April 2022).
[7] Ms. Sri Bhavanisha K S, “Issues Related to Equitable Access to Medicines: A Patent Law Perspective” 1 Alliance Journal of Intellectual Property Law 10-11 (2023).
[8] Muzaka and Valbona, “The Politics of Intellectual Property Rights and Access to Medicines” Research Gate (2011).
[9] “Intellectual Property and Access to Medicine” Oxfam America.
[10] Novartis A.G. v. Union of India, (2013) 6 SCC 1.
[11] ZAMAN K. Decolonizing Human Rights Law in Global Health – the Impacts of Intellectual Property Law on Access to Essential Medicines: A Perspective from the COVID-19 Pandemic. Asian Journal of International Law. Published online 2024:1-18. doi:10.1017/S2044251323000747.
[12] Maria Jurua, “Access to Drugs at Risk: Securing Access to Medicines for Least Developed Countries” 42 JSTOR 101-120 (2017).
Author: Harshita
Juris Centre 