Intellectual Property And Global Public Health - Balancing Innovation And Access To Medicines

Author: LawSphereX

Category: General Law

Published: 2026-08-23T20:21:32.388983+00:00

Updated: 2026-08-30T07:12:16.274Z

INTELLECTUAL PROPERTY AND GLOBAL PUBLIC

HEALTH: BALANCING INNOVATION AND ACCESS TO MEDICINES

Juhi Joshi, Manav Rachna University Yashwin Ohri, Manav Rachna University

ABSTRACT

The role of international organizations like WHO in protecting global public health in times of emergency, as well as to protect the IP rights related to critical technologies, and the equipment are important. The TRIPS agreement helps in broadening access to necessary resources like medicines and others by the public health authorities in accord with the manufacturers and researchers. The report highlights the Evaluation of the Global Public Policies addressing Intellectual Property and Medicine Access. Major discussion is undertaken on the identified strategies for impartial access to medicines. The report also highlights Major legal frameworks for the Patient’s Rights. The report also undertakes a brief discussion examining the role of global organizations in mediating intellectual property rights and public health.

The report also helps in analysing the major challenges in global public health facilities. The recommendation is also presented due to challenges faced in public health. Intellectual property (IP) rights are a critical part of global healthcare development, especially in the novel development of medicines and vaccines among others.

Introduction

The protection of intellectual property (IP) rights is a critical part of global healthcare development, especially in the novel development of medicines and vaccines among others. The importance of IP rights was clearly visible during the recent COVID-19 pandemic. The laws to protect IP rights should not hinder access to critical medicines, justice and equity for the general public. This is especially true in the case of low and middle-income countries. The available global health IP rights protection rules should not be in the way of sharing the technology, equipment of manufacturing and others used for the manufacturing of vaccines and medicines around the globe.

Global governance on healthcare products related to the manufacturing and equitable distribution of these products could be achieved through the “World Health Organisation (WHO)” mechanisms like “EUL (Emergency Use Listing)” and WHO PQ (prequalification). 1 These mechanisms would help to improve the confidence level of pharmaceutical giants in sharing some components of their technology and also improve access to critical medicines for patients around the world. The creation of global coalitions that protect the IP rights of pharmaceutical companies and the patients like the “Coalition for Epidemic Preparedness Innovations (CEPI)” formulated by the WHO during the COVID-19 pandemic was another example of ensuring the right balance between protecting patient’s rights, as well as the IP rights of the manufacturers, and scientists.

Discussion Evaluation of the Global Public Policies addressing Intellectual Property and Medicine Access The healthcare organization in the current generation has been evolving with inducing several policies and strategies that are relevant for the development of the firms in order to provide medicine and treatments to the patients. In contrast to the public policies that are being consumed by the global organizations such as World Health Organization (WHO) have been instigated with initiatives that can help the firms to provide better services to the patients respectively. There are various diseases that have been spreading all over the world and with concerns to the respective countries that are prone to get infected are also being detected for 1 Hotez, P. J. , Batista, C. , Amor, Y. B. , Ergonul, O. , Figueroa, J. P. , Gilbert, S. , Gursel, M. , Hassanain, M. , Kang, G. , Kaslow, D.

C. and Kim, J. H. Global public health security and justice for vaccines and therapeutics in the COVID-19 pandemic. EClinicalMedicine, 39. (2021). further prevention. Moreover, the post-COVID instances have also affected the organizations as well as the global public policies which have been hindered with the passage of time and the authorities are working to bring everything back into the original places. Furthermore, the Intellectual Property (IP) have been creating measures and other related strategies which can be utilized to access the medicines that are for high-end cases. According to the “TRIPS Agreement”, a “detailed preamble” is constituted which involves the parties that are willing to negotiate with the objectives of the World Trade Organization (WTO) system.

This also contains various ideologies that have been adapted from the people in and around the organizations as well as the industries and have been enhanced with the passage of time. 2 The World Health Organization (WHO) on the other hand have been measuring the consequences and other variables such as the regulatory systems, marketing authorizations and many more which can be used for considering the medical products to be entrusted to a responsible regulatory body. It can also be said that the benchmarks of the respective regulatory bodies and systems can imply a “structured and documented process”. This can further assist the “Member States (MSs)” to address and identify gaps for reaching a goal related to the “level of regulatory oversight” with respect to “stability, well-functioning and integrated regulatory systems” respectively.

3 Identification of the strategies for impartial access to medicines The global pharmaceutical organizations have been flourishing with the emerging technologies as well as strategies that can enhance the Intellectual Property (IP) with the specific access to medicines. Although the pharmaceutical giants in the global healthcare sector have been inducing several brands of medicines in their respective firms, the World Health Organization (WHO) has also been regulating technicalities for conducting better procedures. In contrast to this, several other drugs have also been induced within the pharmaceutical firms which have been hindering the access of medicines by less educated people. This has become a major factor for the common people in the local areas as the cost of these medicines have also increased with the induction of the specific drugs.

The delivery of latest drugs for clinical utilizations in 2 Correa, C. Trade related aspects of intellectual property rights: a commentary on the TRIPS agreement. Oxford University Press, (2020). 3 World Health Organization. WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems of medical products: revision VI. (2021) the last three decades have also increased the investments in “research infrastructure” by the companies of pharmacy and advances in the technological sectors respectively. 4 Simultaneously, the subconscious viewpoints and probabilities are further reduced by the application of relevant strategies in the pharmaceutical companies. These strategies include, “patent pooling, public-private partnerships and tiered pricing models” respectively, ensuring a better access to the reviving treatments during the maintenance of “innovation incentives”.

In contrast to this the procedure of patent pooling involves providing an agreement among two parties which includes the patient and the party licensing them to the third party respectively. It can also be said that patent pooling is connected with the complicated technologies which require patents to supply “efficient technical solutions” respectively. On the other hand, public private partnerships also termed as P3 refer to the “long-term arrangement” among the private sector institutions and the government. This particularly involves the projects of the government that are related to “private capital financing and upfront services” which are assisting to draw more revenue from the users as well as the taxpayers regarding the contract of P3.

5 Exploration of the impact of Intellectual Property (IP) rights on access to medicines The protection of IP rights for the global pharmaceutical giants is critical for continuous innovation and the development of new medicines to mitigate the challenge of emerging diseases or faster and more successful treatment mechanisms for patients. However, the intellectual property rights regulatory laws and rules can have a serious impact on the access to medicines by patients. The “Trade-Related Aspects of Intellectual Property Right (TRIPS)” agreement between the manufacturers and public health bodies in Doha in 2001 was a major event. This agreement between the “World Trade Organisation (WTO)” members helps in widening access to necessary resources like medicines and others.

The decision at the 2022 meeting of the ministerial conference (MC12) at the WTO helped achieve a major goal to improve access to vaccines and other healthcare products for patients. The MC12 meeting allowed the public healthcare authorities of countries around the world to access critical and emergency healthcare equipment medicines and vaccines. They amended Article 31B of the 4 Verbaanderd, C. , Rooman, I. and Huys, I. Exploring new uses for existing drugs: innovative mechanisms to fund independent clinical research. Trials, 22(1), p. 322, (2021). 5 Kiriiri, G. K. , Njogu, P. M. and Mwangi, A. N. Exploring different approaches to improve the success of drug discovery and development projects: a review. Future Journal of Pharmaceutical Sciences, 6, pp. 1-12, (2020).

TRIPS agreement which pushed the medicine and vaccine manufacturing companies to override patent rights in a situation of health emergency. 6 The impact of protection of IP rights has a serious impact on the right of access to medicine among the patients. The laws and agreements are designed in such a fashion that they protect the rights of the companies to protect their technologies. This helps them to constantly innovate and design new medical products. The portable devices that are been used by the general public to monitor their health are another important aspect of the protection of human rights as per the regulations available. An example was the formulation of the “Coalition for Epidemic Preparedness Innovations (CEPI)” by the WHO.

Also, potential solutions like the creation of a “voluntary licensing agreement (VLA)” between the pharmaceutical products manufacturers and the public health bodies like WHO would play an important role in ensuring patient’s right to access medicines. 7 Examining the role of global organization in mediating intellectual property rights and public health The role of global health bodies like the WHO has been critical to improving access to medicine and vaccines at times of medical emergencies. The fundamental contradiction in this regard is about the access of medicines to the people, especially in low and middle-income countries, while not harming the IP rights of the pharmaceutical companies. International organisations like WHO could play a significant role by keeping in mind the public interest and plurality.

The principal barrier to global access to the technologies and medicine primarily designed and produced by some Western pharmaceutical giants is the Doha 2001 TRIPS agreement. Article 31B of the deal significantly restricted the sharing of novel technologies and products for the global public good. Also, in the UK and Europe, the patents could be refused by the companies for inventions by giving some vague reasons like if their commercial exploitation would be against to public morality. The presence of copyright laws like the “Copyright, Designs and Patents Act (CDPA)” in the UK prevents any sharing of technology or other innovations by pharmaceutical companies to the public. 8

6 wto.org. TRIPS and public health, (2024).

7 jindalforinteconlaws.in. From Patents to Patients: Exploring the Nexus of Intellectual Property Rights and Human Rights in Global Healthcare, (2023). 8 Walsh, K., Wallace, A., Pavis, M., Olszowy, N., Griffin, J. and Hawkins, N. Intellectual property rights and access in crisis. IIC-International Review of Intellectual Property and Competition Law, 52, pp.379-416, (2021).

Organisations like the WHO have a significant role in mitigating the challenge of creating the right balance between the protection of public health, as well as the protection of the rights of the companies. Agreements like “The General Agreement on Tariffs and Trade (GATT), 1994”, “TRIPS Agreement” and others with the attachment of parties like WHO, the local health bodies and the management of these pharmaceutical companies are some of the most important ones. For example, in Africa, the exemptions that were achieved as a result of the TRIPS agreement helped WHO to play a major role in eradicating the Ebola Virus Disease (EVD) after receiving the necessary medicines approved by the “United States Food and Drugs Administration (USFDA)” for the treatment of children and adults. 9 Furthermore, as a result of a resolution WHA56.

27 by the WHO member states in 2003, a “Commission of Intellectual Property Rights, Innovation, and Public Health” was founded, which assists WHO in developing global healthcare action plans. Major legal Frameworks for Patient’s Rights The legal framework involved in patient rights is a subset of human rights that forms the framework of Global Health for protecting public health. The World Health Organisation (WHO) has developed a framework for patient safety that outlines the creation of cultures and purposes to reduce harm in patient care. Patients for Patient Safety (PFPS) are an initiative that helps in improving patient safety and enhancing healthcare quality. The initiative helps promote systematic engagement between patients and medical professionals.

Patient safety rights chartered by the World Health Organization (WHO) help in protecting patients’ right to live, health and strengthen personal safety. The International Covenant on Economic, Social and Cultural Rights (ICESCR) is a legal framework that helps protect individual rights to health. The highest standards need to be maintained in raising the standards of both physical and mental health. The framework also helps in upgrading both environmental and industrial hygiene by ensuring access to proper medical care. Article 11 of the framework highlights States Parties to identify the right of individuals to raise the standard of living through adequate food, clothing and housing. 10 The Universal Declaration of Human Rights underlines that health as a part of human rights and adequate living needs to be raised to the highest standard.

Basic freedom needs to be given to all individuals as everyone has the right to life, liberty and 9 Motari, M. , Nikiema, J. B. , Kasilo, O. M. , Kniazkov, S. , Loua, A. , Sougou, A. and Tumusiime, P. 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, pp. 1-19, (2021).

10 ohchr.org, 2024. “International Covenant on Economic, Social and Cultural Rights”

security of person. The international legal framework Patient safety rights are the major elements that help to enhance healthcare preventing harm to patients during their treatment. The dignity and self-worth of the patient are protected by ensuring the right medical care is received that helps to protect physical and mental health without discrimination (Kiani et al. 2020). 11 Patient’s health is improved by the proper care of nurses, doctors, and other health professionals in the healthcare sector. Challenges and Issues High cost of medicines due to patent monopolies The rise of the technologies in the recurrent generation has been evolving with relevant strategies that can enhance the procedures of public health organizations such as WHO and other similar ones.

Due to the rise of technologies, patent monopolies and high-end treatments, the cost of medicines has also increased as the more cost issues the more revenue is to be collected by the company respectively. Countries all around the world are further developing legislative measures as well as policies that can address the major issues that are related to access to medicines. It has been stated in the previous estimations that the “global pharmaceuticals” had spent around “1. 2 trillion USD” in 2018 and “1. 5 trillion USD” by the year 2023. 12 Tension between innovation and public health needs The various innovations that have been inaugurated in the sector of public health organizations have also been issuing various challenges that are hindering the procedures of access to medicines.

In contrast to this, the public health sectors are also inducing several strategies related to “Health Information Technology (HIT)” which provides a “timely, accessible and up-to-date summary” of the developments of policies. Moreover, the major priorities as well as the opportunities that are emerging by the HIT systems are also supposed to offer more 11 Kiani, M. A. , Maamouri, G. , Noori, M. , Roudi, E. , Jarahi, L. , Kianifar, H. and Zakerian, M. ,. Evaluating the Awareness of Patients’ Rights Based on the Charter of Patients' Rights in Medical Staff of Mashhad University of Medical Sciences in Mashhad, Iran. Medical Education Bulletin, 1(1), pp. 11-23. (2020). 12 Kakkar, A. K. Pharmaceutical price regulation and its impact on drug innovation: mitigating the trade-offs. Expert Opinion on Therapeutic Patents, 31(3), pp. 189-192, (2021).

infrastructures that are necessary for the health and care systems. 13 Critical care facility Global Public Health helps in addressing major health issues affecting public health in the global environment. Certain challenges have stalled the Progress of global healthcareSince covid 19 there has been a massive change in the medical system all around the world. Overcrowding in the emergency room results in delays, poor care and adverse health outcomes among the patients in the hospital. Major challenges in the emergency department of the hospital include a lack of adequate staff, financial pressure, and work-related stress. Disparities in health accessibility There is a major concern about social inequality within the health care system all around the world. Discrepancy in health status and access is a major challenge that global healthcare is facing.

Health disparities globally include differences in health outcomes all around the world. Inequalities in healthcare are the differences in the distribution of medical resources among different population-based social conditions. 14 Inequalities in healthcare practice based on social conditions include unfair and avoidable differences in medical facilities. Individuals with low income suffer from Rising Costs of Healthcare Services. Families with low income are drained to poverty because all the household resources are drained due high cost in medical facilities. Recommendations Implementation of Tiered Pricing Models The pharmaceutical companies in the current generation have been evolving with general strategies that can exhibit better outcomes and reach out to more specific consumers all around the world.

In contrast to this, they can also adapt the models related to tiered pricing which implements that the respective drugs and their prices have been adjusted with regards to the 13 Sheikh, A. , Anderson, M. , Albala, S. , Casadei, B. , Franklin, B. D. , Richards, M. , Taylor, D. , Tibble, H. and Mossialos, E. Health information technology and digital innovation for national learning health and care systems. The Lancet Digital Health, 3(6), pp. e383-e396, (2021). 14 Yao, R. , Zhang, W. , Evans, R. , Cao, G. , Rui, T. and Shen, L. Inequities in health care services caused by the adoption of digital health technologies: scoping review. Journal of medical Internet research, 24(3), p. e34144, (2022). economic status of the respective country. This can particularly permit the “low and middle class” income regions to access the medicines at a lower rate.

Furthermore, this can also ensure that the significant treatments are affordable by the common people in spite of undermining incentives that are utilized for “innovation in wealthier markets” respectively. 15 Encouraging the utilization of Compulsory Licensing The government authorities in the countries that are enhancing with respect to the aspects of technologies as well as strategies can utilize the procedure of compulsory licensing which can further provision the agreements issued by the international markets respectively. International agreements such as “Trade Related aspects of Intellectual Property Rights (TRIPS)” allow the consumers as well as the industrial members to authorize and produce versions of “patented drugs” that are generally cheaper.

Therefore, the cases related to public health emergencies also ensure a better and broader access confrontation for the particular medicines that are related to the rights of Intellectual Property (IP). Conclusion The protection of IP rights and also public health around the globe is a major challenge. The right balance between the protection of IP rights and providing access to critical medicines, technologies and medical equipment to the healthcare workers, as well as the patients is a serious challenge. Global organisations like the WHO have a critical role to play in this regard. International agreements like the TRIPS Agreement, which protects companies from sharing critical technologies, or formulas to make novel medicines with healthcare organisations have a critical role to play in this juncture.

The “Patient Safety Rights Charter” outlined by the WHO needs to be critically looked into regarding access to medicines and vaccines at the time of global medical emergencies like the COVID-19 pandemic. The provision of a voluntary licensing agreement (VLA) between the scientists, and those who can produce medicines at a mass scale is also an important feature which should be further analysed. Public health bodies like WHO therefore should consult with the member states, the WTO and pharmaceutical companies to develop a comprehensive plan to formulate new policies which would balance the IP rights and patient care concerns.

15 Pogge, T. Just rules for innovative pharmaceuticals. Philosophies, 7(4), p.79, (2022).

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