INTRODUCTION

India's strong, egalitarian, and dynamic IPR system, in compliance with the TRIPS Agreement, is crucial in expanding and developing its knowledge economy. To maximize the benefits of intellectual property to India's economy and culture while safeguarding the public interest, a comprehensive IPR Policy is needed.[1] IPRs are crucial for innovation and protecting health rights globally, regionally, and nationally. Human rights institutions promote IPR models, fostering a conducive environment for innovation. IPR impacts the pharmaceutical sector by influencing treatment pricing, distribution, and pharmacological discoveries.[2] Over 100 nations have urged the WTO to waive COVID-related patents to boost vaccine manufacturing temporarily, but developed nations have opposed this, leading to the Doha Declaration. This study examines the economics of IPR and vaccines during pandemics.[3]

REVIEW OF LITERATURE

·       Basant R, Srinivasan S.,[4] The study explores the impact of intellectual property protection on India's healthcare innovation growth, highlighting the interconnected processes of improved healthcare access innovation, particularly in the pharmaceuticals sector.

·       Brigitte Tenni,[5] The study explores the impact of intellectual property laws on patients' access to prescribed medications, suggesting that this data could guide the development of trade and intellectual property legislation.

·       Motari, M., Nikiema, JB., Kasilo, O.M.J. et al., [6] The authors discuss the WHO's efforts to bridge the gap between intellectual property, innovation, and medicine access by assisting countries in implementing TRIPS flexibilities.

·       Mohamad AyubDar and Tran Vang-Phu discuss the potential benefits of enhanced IPR legislation, including the Doha declaration, TRIPS, and initiatives by WIPO, WTO, and WHO, in addressing the global health crisis.

·       T G Agitha,[7] The author, discusses the impact of patents and data exclusivity on healthcare costs, emphasizing the need for governments to ensure robust intellectual property protection.

ISSUES

·       Examining how IP influences pricing, distribution, and innovation in the pharmaceutical sector.

·       Investigating how IP protection influences the advancement and distribution of new drugs and medical technologies.

OBJECTIVES OF THE RESEARCH

1.     To study the protection of IP influence on the advancement and distribution of new drugs and medical technologies.

2.     Evaluate the challenges and obstacles to accessing essential medicines and medical technologies in countries with weak IP protection systems.

METHODOLOGY

The research methodology is Doctrinal, using the inductive method to identify trends and establish general conclusions. References include JSTOR, Westlaw PubMed, SCOPUS, Lexis Nexis, e-Newspapers, statutes, and judgments. Primary data includes Acts, Rules, Regulations, Judgments, Commentaries, Published Reports from Governmental Bodies/Institutions, WIPO, WHO, WTO, and UN agencies, and secondary data like books and professional journals.

The Right to Health

Article 25 of the UDHR, adopted on December 10, 1948, includes a provision for the right to health care for all people. That Article provides that “Everyone has the right to a standard of living adequate for the health and well-being of himself and his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.”[8] Like other rights, the State cannot guarantee the right to health, as various factors beyond human control influence health. However, it must provide nutritious food, medical care, clean living conditions, and access to diagnostic and therapeutic medications and high-tech equipment for illness detection, prevention, and treatment to help people live healthier lives.

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PATENT

The patent system is crucial for promoting innovation and healthcare access, but it struggles to tackle major public health issues like HIV/AIDS, malaria, TB, and avian flu. It provides exclusive rights and voluntary licensing channels for pharmaceutical creation, but some argue it lacks financial incentives for researchers to address underserved markets. Patent rights may limit patient access or increase medication costs. The broad scope of patents in early research raises concerns about patent thickets and royalty stacking, which could stifle future innovation.[9]

COPYRIGHTS

The healthcare industry heavily relies on informatics, making copyrights crucial for intellectual property protection. Protecting databases and software can prevent major violations, emphasizing the importance of safeguarding these fields through copyright laws. The healthcare industry recognises databases' growing significance as the "informatics" impacts corporate technology. These databases, including patient data, chemical structure and gene sequencing, and medical treatment efficacy studies, require significant annual capital outlays. They often qualify for copyright protection under copyright laws.[10]

TRADEMARKS

The healthcare industry uses trademarks for intellectual property protection, including names of pharmaceutical medications, medical equipment, and branding campaigns. However, consumers' confusion about product sources could harm healthcare and related businesses, as consumers lack clarity about product sources.[11] Business owners should create distinctive brands to set their products apart from competitors. Conducting a trademark search before launching a new healthcare product or service can help determine potential infringement and mark availability. Trademark law protects labels, logos, and other indicators but does not protect underlying commodities or ideas.[12]

TRIPS Agreement and access to medicine

The TRIPS Agreement, a treaty governed by the WTO, protects the production, development, and preservation of works of art, particularly pharmaceuticals, which require substantial initial investment in R&D. However, monopoly rights granted to investors lead to high prices for new drugs creating a monopoly market protected by intellectual property laws. This creates a monopoly market, limiting access to these services.[13] For example, insulin, a diabetes medication, is difficult to obtain due to a monopoly of three global corporations. Patenting life-saving treatments undermines patients' access. A global campaign against abuses is needed, using TRIPS' national-level flexibilities and limiting state discretion. Pharmaceutical companies should focus on problem-solving in R&D. TRIPS allows member nations to enact public health protection and pharmaceutical accessibility policies.

IPr as a Barrier to Access to Essential Medicines

IP-related factors, such as patents, data exclusivity, and trade secret protection, hinder access to vital drugs. Pharmaceutical corporations use patents to protect competition from generic treatments. However, defining "patentable subject matter" is a challenge.[14] The pharmaceutical industry primarily consists of small-molecule drugs and biosimilars, with biosimilars incurring higher costs due to their inability to be synthesized. Clinical trials and data exclusivity, a regulatory provision, hinder the development of life-saving drugs.[15] The EU pharmaceutical industry demands data exclusivity, preventing generic medication development without clinical studies. India must maintain generic pharmaceutical manufacturing as the developing world's pharmacy, managing trade secret usage and dissemination through Technology Transfer Centres and Patent Materials Disclosure.[16]

CONCLUSION

The healthcare access crisis threatens the world's poorest nations, and despite progress, barriers to quality healthcare must be eliminated. Public health concerns must be prioritized, and the IPR regime should be used to protect people's fundamental freedoms. The WHO should work with other organizations to improve healthcare for all people. Member states should devise a coherent framework with IPR; the enforcement mechanism in the least developed and developing nations is a significant problem. Human rights scholars should investigate the uncharted territory of IPR, and local policies should be based on societal analysis and issues consistent with the international IPR system. The WHO should guide member nations on IPR advancements and adjust medication regimes to lessen the adverse effects on human progress. The current COVID-19 epidemic is a cautionary tale for the world, urging research-oriented inventions and universal health programs. A forward-thinking strategy is needed to educate and improve future standards in the IPR field.

BIBLIOGRAPHY

Ø  ONLINE JOURNAL ARTICLES

·       “Report of the United Nations secretary-general’s high-level panel on access to medicines,” (2016).

·       Basant R, Srinivasan S., “Intellectual property protection in India and implications for health innovation: emerging perspectives,” Innovation and Entrepreneurship in Health, 3:57-68, (2016).

·       John, “Global Surgery 2030: Evidence and Solutions for Achieving Health, Welfare, And Economic Development.” The Lancet, 574. (2015).

·       Motari, M., Nikiema, JB., Kasilo, O.M.J. et al., “The role of intellectual property rights on access to medicines in the WHO African region: 25 years after the TRIPS agreement,” BMC Public Health 21, 490 (2021).

·       T.G, Agitha, “Impact of IP on public health: The developed country scenario,” Journal of Intellectual Property Rights. 18. 382-389. (2013).

·       Tenni, B., “What is the impact of intellectual property rules on access to medicines? A systematic review.” Global Health 18, 40 (2022).

Ø  ONLINE ARTICLES/BLOGS

·       “Improving Access to Health: Activating in the Intellectual Property and Health Nexus | New Tactics in Human Rights” (January 26, 2011) https://www.newtactics.org/conversation/improving-access-health-activating-intellectual-property-and-health-nexus accessed October 16, 2023

·       “Improving Access to Health: Activating in the Intellectual Property and Health Nexus | New Tactics in Human Rights” https://www.newtactics.org/ accessed October 21, 2023.

·       “Intellectual Property Rights and Access to Medicines: International Trade Issues” (CRS Reports, June 14, 2010) https://www.everycrsreport.com/reports/R40607.html accessed October 25, 2023

·       “Significance of Indian Pharmaceutical Patent Laws” (Lexology) https://www.lexology.com/library/detail.aspx?g=1b13bcbb-27b9-4e51-a152-6abc53eb6f18 accessed October 16, 2023

·       “WTO | Intellectual Property (TRIPS) - Council, on Access to Medicines - Developing Countries Paper” https://www.wto.org/english/tratop_e/trips_e/paper_develop_w296_e.htm accessed October 25, 2023

·       Drishty MA, “The Effects of Intellectual Property Rights on Access to Medicines” (Legal Desire Media and Insights, October 24, 2020) https://legaldesire.com/the-effects-of-intellectual-property-rights-on-access-to-medicines/  accessed October 20, 2023.