Introduction

Patenting life-saving drugs has made human life a commodity and has created conflicts and disasters during times of global healthcare urgency. While Intellectual Property Rights (“IPR”) serve as a driving force for innovation and research through the creation of life-saving drugs, it also gives rise to conflicts. The application of IPR within healthcare systems creates tension between the exclusive rights granted by patents and the universal right to health. Human rights guidelines framed concerning the right to health include attainable standards of health concerning high pricing, inappropriate drug promotion, clinical trials, etc. but have not been modified with respect to the growing importance of IPR in the legal field to encourage access to affordable medicines during times of pandemics or epidemics.

The Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) agreement and Public Health, 2001 is enforced to protect accessible healthcare in middle and low-income countries. Concurrently, the Office of the United Nations High Commissioner for Human Rights (OHCHR) has laid down guidelines to assist pharmaceutical companies in recognising the human right to medicine. The Doha Declaration’s impact on global healthcare access is limited by the absence of several key nations that are not parties to the treaty due to its voluntary nature. These key nations consist primarily of developing nations which includes the most socio-economically vulnerable individuals with scarce resources and a lack of access to healthcare. These nations were heavily affected during the COVID-19 pandemic since access to life-saving drugs was at a minimal level due to heavy patenting.

Policy interventions become imperative for economically troubled nations, with insufficient manufacturing capabilities. Healthcare should ensure access not only to the least-developed countries but also to the ‘socio-economically vulnerable individuals’ so that they are not affected negatively by patents that merely promote innovation in big companies. It is paramount to strike an optimal equilibrium between health, trade and IPR policies to encourage innovation while securing widespread access to life-saving technologies. Thus, an ethical analysis is required.

Privileging Patents over Public Healthcare

At the heart of the conflict between IPR and global healthcare lies the ethical quandary of blatant commodification of healthcare and unrealistic profits being driven in this sector. A patent serves a dual purpose of a reward or incentive given by the State to the inventor for their contribution to addressing a technological or industrial problem and the right of third parties to not exploit the invention without the consent of the patent holder. By this duality, the investment is encouraged in innovations, but at the same time, a carve-out for humanitarian grounds is done. The pharmaceutical companies have a substantial budget assigned for the discovery of patented drugs and their research and development (“R&D”) and further expenses are undertaken to obtain exclusive licences for production. The high cost of investment coupled with proprietary rights leads to initial high pricing. This consequent delay in the dissemination of resources that are of value to overall public health leads to a lack of accessibility to medicines, resulting in a ‘double jeopardy’ of rights.

Article 15(1)(c) of the International Covenant on Economic, Social and Cultural Rights recognizes the right of every individual to “benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.” However, current patent systems are territorially bound and often heavily regulated and can exacerbate global inequality. This is particularly evident in the pharmaceutical sector where stringent patent protections can restrict access to essential medicines in developing countries. Pharmaceutical companies wield considerable control over drug prices and distribution which can contribute to the disparity in access to life-saving treatments between affluent and developing regions. Hence, the pharmaceutical giants from developed countries are deemed to be significantly contributing to the economic and medical backwardness of developing countries.

Compulsory Licensing: Addressing the Lacunae

To address these gaps, the 2001 Doha Declaration provides a flexible legal framework in TRIPS, which is called compulsory licensing. Under such licensing rules, the government permits the production of a patented product or process by a third party without the approval of the patent holder or intends to utilise the patented invention without the patent owner’s consent. Conversely, Article 27(2) of TRIPS mentions the requirement of WTO members to grant patents to pharmaceutical products, thereby making compulsory licensing a breach of TRIPS obligations and reducing the trade network between developed countries and LDCs, particularly those which have a deficient manufacturing industry in the pharmaceutical sector.

OHCHR’s guidelines for pharmaceutical companies call for companies to have non-exclusive voluntary licences to increase access in low and middle-income countries. The Doha Declaration, in light of the TRIPS agreement and the rights of the least-developed nations, held that nations should enforce patent rights up till 1 January 2016. However, having compulsory licensing in place seems to be counter-intuitive. The requirement to have nations follow up on patent rights while there is the provision of compulsory licensing “under specific circumstances” is vague. This framing indicates that compulsory licensing is not an arbitrary power, but rather can be invoked only under ‘predefined conditions’.Thus, the major lacuna lies in the lack of clarity that ensues and how the terms have been laid out in a manner subject to interpretation entirely. This can lead to gross inconsistency in the application of patent rights, causing it to become a hindering factor in the seamless application of rights and obligations of patent holders.  

The COVID-19 global health crisis has once again underscored the imperative to confront the inherent conflict between the right to health and intellectual property rights (IPRs). It resulted in the race for technological breakthroughs to develop effective treatments and new vaccines for the virus, which raised concerns about global equity and access to those solutions and the role of IP rights in the R&D, production, and distribution of, and access to, healthcare technology. Due to the prevalent “winner-take-all” principle, there were significant barriers presented by patent law in developing or importing health technologies or vaccines due to the disincentivizing of the sharing of pre-patenting knowledge crucial for drug discovery. The bottom line is that profitable or economic incentives and a market economy of supply and demand should not be the only factors in the patenting of pharmaceutical goods as it is a fundamental public health good and cannot be left merely to be subjected to the market system.

Access to Healthcare vis-à-vis Life-Saving Drugs

Patenting life-saving drugs has invariably created a monopoly in the pharmaceutical sector. It represents two sides of the same coin. In terms of economics, the emergence and encouragement of new industries, innovation, R&D, and patents are seen in a positive sense. However, when discussing human rights, particularly the right to health and access to medicines, patents are viewed as a negative constraint.

As seen during COVID-19, the price for most critical medicines to treat the disease rose unusually high. Some essential medicines saw an increase of as high as 16% in at least 24 countries. Getting treatment due to exorbitantly high prices was difficult and developing countries, mainly, bore the brunt of it.

Moreover, few new drugs for TB have been developed, despite 95% of the cases stemming from developing countries. Pharmaceutical companies prioritise making high profits over investing in R&D for life-saving drugs, which undermines the purpose of patenting to foster innovation. Access to existing life-saving drugs was also lacking in many aspects for developing countries during the HIV/AIDS crisis. Whilst it led to changing rules on IPR, a study of Médecins sans Frontières noted that patent rights are motivated by companies’ profit motives instead of public health regarding life-saving drugs. Companies employ strategies motivated by profit such as ‘evergreening’ which involves making minor changes in a drug to extend patent protection on existing drugs. This not only delays the introduction of alternatives but also exacerbates the problem of reduced access to drugs.

Globally, there exists a lack of stringent legislation to curb ‘evergreening’. The framework either does not exist or is so ambiguous that its application remains uncertain, failing to prevent the unwarranted extension of patents on existing drugs, which can produce negative results. An example of a precedent that other legislations can borrow from is the Novartis AG v. Union of India case, wherein the Supreme Court of India gave precedence to life-saving drugs over patent rights. It was a landmark judgement as it gave the green light for making medicines affordable to all, despite patenting. It also gave precedence to the prevention of ‘evergreening.’ This draws attention to the importance of IPR, that it cannot be denied to promote innovation, but innovation should be done to ensure its access to individuals too for life-saving medical assistance and further prevent unnecessary patenting via ‘evergreening.’ 

The cost of treating bone cancer is £2,375 for one dose, out of 48 doses, which is approximately Rs. 2,50,000 per dose. It needs to be understood by countries across the world and international organisations that the mere monopoly of pharmaceutical companies cannot be accepted by the global public when millions of people get denied basic access to life-saving drugs and die trying to afford them.

Policy Analysis and Recommendations

At its core, the current paradigm lies in addressing the gaps which are produced in balancing protecting IP rights and prioritising public health. 

Temporary Suspension of Patents: Balancing Innovation and Public Health Needs

One notable advantage of compulsory licensing is that it does not have to arise during an emergency, and can be used by countries according to the grounds they determine. However, over the years, in India, only very few compulsory licences have been approved and all others since have been rejected on account of not meeting the government’s criteria. Hence, another way of ensuring access to medicines, in addition, is a “temporary suspension” of all patents during a national emergency. When an epidemic or pandemic has been declared, governments, as per practices, release a list of medicines that are prescribed to be taken and which are normally helpful in curing the disease. The patents on these medicines, special medicines and generic medicines should be suspended during the period, or at least until the epidemic is controlled leading to fewer and fewer fatalities. The loss incurred by drug companies in light of saving human lives should be reasonably compensated by the governments as a consequence. This opposes compulsory licensing as it permits third parties to produce the patented product without the consent of the patent owner and governments decide the threshold for production pharmaceutical companies even contend that compulsory licensing will discourage R&D, but in reality, it curbs the exclusivity of patent protection rights. In this case, the temporary suspension of the patent would lead to the government providing legal sanctity for third parties to produce the patented product, alongside compensating the patent owner.

IP Partnerships: A Collaborative Solution

An integrated holistic framework should be inculcated to impose restrictions on the market exclusivity of patenting of repurposed drugs to accelerate the regulatory approval of life-saving drugs. The Serum Institute of India and Maryland-based firm Novavax produced Covavax, consequently, this IP partnership resulted in the fostering of reliable and affordable COVID-19 vaccines. These effective IPR practices such as voluntary licensing agreements (“VLAs”) are critical to ensure the continuation of delivering innovative goods and services to the global community. VLAs represent private contractual agreements wherein pharmaceutical corporations holding patents (referred to as licensors) delineate the terms governing the entry of generic versions of a patented medicine into the market by alternative suppliers (licensees). These licences facilitate the provision of medicines at reduced costs compared to those offered by the pharmaceuticals hence, enhancing the affordability and accessibility of vaccines and medicines.

Balancing Compensation Rights and Social Responsibility

In IPR contracts involving public funding, the public must be recognized as a party with rights. Accordingly, such contracts must have stipulated obligations to ensure that larger public interests are not jeopardised at the cost of patent rights. The right to be paid compensation is a provision which UNCESCR noted during the COVID-19 insurgency, however, IPR must be seen in the scope of business’ social responsibilities, which includes human rights. This keeps the state in the process and serves as a tool to facilitate encouragement for further R&D. Recent measures such as the ‘Open Covid’ pledge and other such medicine patent pools by invoking the security exceptions of Article 73 of the TRIPS agreement should be implemented in coherence with Article 27, which has extended the patent protection to all fields of technology.

Thus, the primary and dual purpose of IPR, which is to protect and stimulate the development and distribution of medicinal drugs in the market based on innovation is ensured, while simultaneously ensuring the right to health construed by the communities most largely affected during health calamities.

Conclusion

It is indisputable that patents and public health are two sides of the same coin. Epidemics such as COVID-19 do not underscore enough the importance of the availability and cost of life-saving drugs. While IPR does unquestionably promote innovation and without it we would have no drugs, its utility in global healthcare systems often underscores the access to life-saving and affordable medicines during pandemics or epidemics- where there is a huge gap between demand and supply.

It is an evidentiary truth that a pandemic is not limited to a few countries, but is a global challenge, and with a recurring surge in cases, a crucial hand-holding is to be done between patent owners and other players having the capacity to manufacture in volumes to address the needs of the global population and healthcare system and bridge the critical gap between needs and wants. Parochial policy interventions must go beyond territorial considerations and take into cognizance the economic disparities and insufficient manufacturing capabilities of middle and low-income countries.

Essentially, the answer to promoting public health by making pharmaceutical items publicly accessible at affordable rates is to create a balance between the two. Fundamentally, striking a balance between IPR protection and equitable access requires shifting the paradigm from commodification to human well-being, only then can we ensure that the life-saving drugs reach not only the “least-developed countries,” but the most socio-economically vulnerable individuals.

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Amishi Jain and Natasha Mittal are first-year students at Rajiv Gandhi National University of Law, Punjab pursuing BA LLB (Hons.)

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Picture Credit: Katherine Streeter for NPR