This piece has been authored by Rinsha Narayanan, Law student, 5th Year BBA LLB (H.), Christ (Deemed to be University), Delhi NCR
“Balancing intellectual property protection with the right to health is crucial. While it’s important to reward innovation, it must ensure that patent protection doesn’t hinder access to life-saving medicines, especially in low-income countries.”
Gro Harlem Brundtland, Former Prime Minister of Norway
Gro Harlem Brundtland, a prominent figure in global health and sustainable development, reflected on improving access to vital medicines for poor people in developing and low-income countries in her closing remarks at the WTO Workshop on Differential Pricing and Financing of Essential Drugs. She acknowledged the importance of drug pricing, the need for robust healthcare systems, and the role of intellectual property protection in driving innovation. Brundtland noted that current international trade agreements, including the TRIPS Agreement, aim to balance the rights of patent holders with those of patients, though the effectiveness of these agreements is still under evaluation. She highlighted the need for increased international financial assistance and suggested establishing a new international health fund to mobilize resources and support countries lacking a strong donor presence.
Pharmaceutical Industry and Patent Protection in India
Patent protection plays a pivotal role in fostering a robust and dynamic research environment within any nation. Within the realm of patents, two key types are product patents, which safeguard newly developed products from unauthorized exploitation, and process patents, which protect the methods used to produce a product. Such protection serves as an encouragement, motivating inventors and research-focused companies to engage in innovative research and development endeavours, which is achieved by granting them exclusive rights and shielding their innovations from competitive pressures.
India has long been a leader among developing nations in adapting its pharmaceutical patent laws to meet the healthcare needs of its population. It places a strong emphasis on addressing the needs of the common man, aligning with the country’s expansion goals. In India, a significant portion of the people lives below the poverty line, and health care expenses are often paid out of pocket. This condition highlights a significant healthcare crisis, characterized by inadequate access to and affordability of medicines in the country.
One distinctive provision in Indian patent Act, 1970, i.e, Section 3(d), plays a crucial role in achieving a delicate balance between adhering to the requirements of international agreements, such as TRIPS, and safeguarding access to medicines for the underprivileged. This unique provision has positioned India as a leader in the pharmaceutical industry, particularly in the production of cost-effective generic drugs. Section 3(d) addresses evergreening, preventing the grant of patents for minor modifications of existing drugs without significant improvements in efficacy. To obtain a patent, a modified version must demonstrate a substantial increase in therapeutic efficacy compared to the original substance. This provision aims to balance innovation incentives with ensuring timely access to affordable generic medicines. It discourages extending patent monopolies on existing drugs without meaningful advancements.
TRIPS Agreement and Public Health
The landscape has significantly changed since the implementation of the TRIPS Agreement. In the context of pharmaceutical patenting in India, there is significant importance, particularly concerning contemporary public health issues. Indian pharmaceutical companies and the market itself play a crucial role as providers of cost-effective pharmaceutical products, predominantly in the form of generic medications. The issue of obtaining access to medicines has garnered worldwide attention, primarily stemming from India’s active participation in the Doha Declaration on the TRIPS Agreement and Public Health in 2001. Key articles within the agreement, such as Article 7, which emphasizes the need to promote both access to medicines and technological innovation; Article 8, which encourages members to consider the social and economic welfare of the population when implementing intellectual property rights; and notably Article 31, which allows governments to issue compulsory licenses to ensure affordable access to essential medicines during public health emergencies, aim to make life-saving medicines more accessible and affordable.
The Doha Declaration on TRIPS and Public Health emphasized that adherence to the TRIPS Agreement should not prevent nations from implementing measures to safeguard public health and ensure universal access to medications. It allowed for flexibility in implementing intellectual property rules, including issuing compulsory licenses to produce generic versions of patented medicines and other mechanisms to ensure access to essential medicines.
Pharmaceutical Industry Post – TRIPS
The country’s ingrained and progressively export-oriented pharmaceutical industry has been complemented by growing awareness within civil society about healthcare needs. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement has spurred a notable surge in patent-related activities within India This increase is primarily driven by both domestic and international pharmaceutical giants focusing on patent applications for new or enhanced processes rather than the products themselves. Research and development, henceforth referred to as R&D, serves as the anchor for success in the pharmaceutical sector. However, prior to 1995, India witnessed limited innovative R&D activity, primarily due to the absence of a product patent regime. The post-1995 era marked a transformative period, witnessing comprehensive growth among the leading players in the Indian pharmaceutical landscape. Acknowledging the necessity to compete globally, major pharmaceutical companies in India initiated a strategic transformation. They realized that achieving a significant global presence required substantial R&D capabilities. Consequently, a distinct increase in research investments within the pharmaceutical industry has been observed following the implementation of TRIPS. This heightened commitment to research has ushered in a new era of progress and innovation within India’s pharmaceutical sector.
India has emerged as a central figure in the international campaign to improve access to medicines. The Indian pharmaceutical industry has provided crucial economic support to this campaign by demonstrating the viability of an alternative pharmaceutical model. Recent patent law judgments, such as the Supreme Court’s decision in the Novartis case, underscore India’s continued commitment to prioritizing public health concerns through its pharmaceutical patent laws.
It is clear that the presence of patents in the pharmaceutical industry can hinder competition from manufacturers of generic drugs, resulting in higher drug costs. As a result, these patents are widely recognized as a substantial obstacle to the accessibility of medicines in developing nations.
International Human Rights Framework
A key goal outlined in Sustainable Development Goal 3 (SDG 3) is to guarantee universal access to cost-effective medications. In 2017, a significant modification to the World Trade Organization’s TRIPS Agreement was implemented, specifically aiming to provide developing nations with a reliable legal framework to obtain affordable medicines.
The right to health is a fundamental human right recognized by international human rights treaties and declarations, such as the Universal Declaration of Human Rights, Article 25 (1), which states: “Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing, medical care, and necessary social services.”and This is further supported by the International Covenant on Economic, Social, and Cultural Rights, such as Article 12(1), which recognizes the right of everyone to the highest attainable standard of physical and mental health, and Article 12(2), which outlines the steps States Parties should take to fully realize this right.” Likewise, the Indian Constitution underscores the right to health as a fundamental right, Article 21, emphasizing the state’s responsibility to ensure affordable healthcare for all. Moreover, it promotes accessibility to medicines by encouraging equitable distribution and affordable pricing, as stated in the Directive Principles of State Policy. Key issues in this context include access to medicines, compulsory licensing, patent opposition and challenges, innovation in health, and public health policy.
TRIPS – PLUS
In recent times, several developing nations, under the influence of trade agreements with states like the United States or the European Union, are facing heightened pressure to adopt more stringent patent laws, surpassing the requirements stipulated by the TRIPS Agreement. These additional conditions, commonly known as ‘TRIPS-Plus’ provisions, are not obligatory under international law, yet countries such as Brazil, China, and several Central American states find themselves compelled to integrate these provisions into their legislation.
TRIPS-Plus provisions encompass a range of measures, such as extending patent terms beyond the mandated twenty years and implementing limitations on the usage of compulsory licenses, which are crucial for ensuring affordable generic alternatives. A significant example of these provisions is ‘data exclusivity’.
The expansion of TRIPS-Plus provisions highlights the ongoing struggle between global trade dynamics and the imperative of providing affordable and accessible medicines, posing a challenge to the steadiness between IP rights and public health.
India, being a major player in the pharmaceutical industry and a country with a large population, has traditionally been concerned about the impact of strong IP protection on the availability and affordability of essential medicines. India has implemented TRIPS in its domestic laws but has also used flexibilities allowed by TRIPS.
India has been cautious in entering bilateral and regional trade agreements that include TRIPS-Plus provisions. The country has, at times, faced pressure to adopt stricter intellectual property standards, especially in negotiations with trading partners like the US and the EU. However, India has sought to safeguard its policy space to address public health concerns.
Conclusion
The complex relationship between IPR and right to health, particularly within the framework of the TRIPS Agreement, demands an equilibrium. The author delves into India’s pharmaceutical landscape, highlighting the evolution spurred by TRIPS, the pivotal role of patents, and the country’s commitment to public health through landmark legal judgments. Section 3(d) of the Indian Patent Act, 1970, underscores India’s leadership in producing cost-effective generic drugs while adhering to international agreements. The Doha Declaration has further empowered countries to take measures to protect public health, fostering flexibility in implementing intellectual property regulations and ensuring access to essential medicines. Internationally recognized and enshrined in India’s Constitution, the fundamental right to health emphasizes the state’s responsibility to ensure affordable healthcare, underscoring the need for a balanced approach between IPR and public health.
Key words: Patents, Pharmaceutical, TRIPS, IP Rights, Health