The Global Right to Health and Access to Medicines – Chapter 2

The Right to Health as a Fundamental Human Right

The right to health is universally recognized as a fundamental human right, enshrined in various international legal frameworks, including the Universal Declaration of Human Rights (UDHR) and the International Covenant on Economic, Social, and Cultural Rights (ICESCR). According to Article 25 of the UDHR, “Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family,” including access to medical care. The World Health Organization (WHO) further underscores this principle, affirming that the “enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being.”

While these declarations provide a strong moral and legal foundation for the right to health, in practice, access to life-saving medicines remains deeply unequal across the globe. This inequality is particularly stark between high-income and LMICs. Pharmaceutical patents and the resulting high drug prices are often seen as one of the key barriers to achieving equitable access to medicines, creating a tension between IP protection and public health needs.

Access to Essential Medicines in LMICs

The issue of access to medicines is most acute in LMICs, where the majority of the global population resides, but where healthcare systems are often underfunded and fragmented. In these regions, essential medicines – those that satisfy the priority health needs of the population – are often unavailable or unaffordable. According to WHO estimates, around two billion people globally lack access to essential medicines, resulting in preventable deaths from conditions such as HIV/AIDS, tuberculosis, malaria, and, more recently, Covid-19.

High Prices of Patented Drugs

One of the primary barriers to access is the high price of patented drugs. Pharmaceutical companies, particularly in high-income countries, justify these prices by citing the need to recover the massive costs associated with research and development (R&D), clinical trials, and regulatory approval processes. However, for LMICs, where governments often struggle to provide basic healthcare services, paying the high costs of patented medicines is often impossible. This has been the case with several life-saving treatments:

• HIV/AIDS Antiretrovirals: In the late 1990s, patented antiretroviral drugs to treat HIV/AIDS were priced at over $10,000 per patient per year in high-income countries. This price was well beyond the reach of most LMICs, particularly in sub-Saharan Africa, which bore the brunt of the HIV/AIDS epidemic. It wasn’t until the introduction of generic versions, made possible through compulsory licensing and other TRIPS flexibilities, that the prices of antiretrovirals dropped dramatically, expanding access to millions of patients.
• Cancer Treatments: In the last decade, breakthrough cancer therapies, such as monoclonal antibodies and kinase inhibitors, have shown remarkable efficacy in treating cancers like leukemia and lung cancer. However, these drugs often carry exorbitant price tags, with treatments like Imatinib (Gleevec) initially priced at over $100,000 per year, far beyond the reach of most patients in LMICs. Even though compulsory licensing has been used in certain cases to produce cheaper generic versions, the complexity of patents on biologics makes this more difficult than for traditional small-molecule drugs.
• Covid-19 Vaccines: The Covid-19 pandemic highlighted global disparities in access to vaccines. Despite rapid vaccine development, LMICs faced significant barriers in obtaining doses, as high-income countries secured the majority of early supplies. The high prices set by manufacturers for patented vaccines, combined with complex distribution challenges, further exacerbated the inequity. Although mechanisms like COVAX aimed to facilitate global vaccine distribution, they were insufficient to meet demand in many LMICs.

Barriers Beyond Cost

In addition to high costs, other factors contribute to the lack of access to essential medicines in LMICs:

• Weak healthcare infrastructure: Even when generic drugs are available, weak healthcare systems, lack of healthcare professionals, and poor distribution networks can limit their accessibility.
• Regulatory and intellectual property barriers: Some LMICs lack robust regulatory frameworks for approving new drugs, which delays their availability. Additionally, the complex patent landscapes created by secondary patents (patents filed on new formulations, combinations, or methods of use) can prevent the timely introduction of affordable generic alternatives.

The Public Health vs. IP Protection Debate

The conflict between public health and IP protection is at the heart of global discussions on access to medicines. On the one hand, pharmaceutical companies argue that patents are essential for fostering innovation, particularly in an industry where the development of a new drug can take over a decade and billions of dollars. Without the exclusive rights provided by patents, companies claim they would have little incentive to invest in the development of new treatments, particularly for diseases that affect LMICs.

On the other hand, public health advocates argue that the patent system, as it currently operates, prioritizes profits over people, particularly in times of public health emergencies. They point to instances where patents have been used to restrict access to life-saving medicines, such as during the HIV/AIDS crisis or the Covid-19 pandemic. They argue that public health, particularly in LMICs, should take precedence over corporate profits, especially in the case of global health emergencies.

TRIPS and Public Health Flexibilities

Recognizing the tension between IP protection and public health, the WTO’s TRIPS Agreement includes certain flexibilities that allow countries to take measures to protect public health while complying with international IP obligations. These flexibilities include:

• Compulsory Licensing: Article 31 of the TRIPS Agreement allows governments to issue compulsory licenses, enabling them to authorize the production of a patented product without the consent of the patent holder, usually in exchange for a licensing fee. This measure has been used to expand access to essential medicines in LMICs, such as during the HIV/AIDS crisis.
• Parallel Importation: TRIPS allows countries to import patented drugs from other countries where they are sold at lower prices, thus enabling LMICs to purchase medicines more affordably.
• Bolar Provision: This allows generic manufacturers to begin producing a generic version of a patented drug before the patent expires, so they can enter the market immediately upon patent expiration.
• The most significant articulation of these flexibilities came in the form of the Doha Declaration on the TRIPS Agreement and Public Health (2001), which affirmed that TRIPS should not prevent countries from taking measures to protect public health and promoted the use of compulsory licensing for essential medicines.

The Ethical Dimension: Public Health as a Priority

Beyond the legal frameworks, there is a broader ethical argument that suggests that access to essential medicines should not be restricted by the exclusivity rights granted by patents. Human rights frameworks affirm that health is a basic right that governments have a duty to uphold. This perspective emphasizes that the global community should prioritize the health and well-being of individuals over intellectual property rights, particularly in times of health crises. Proponents of this view argue that the current IP system is failing to live up to its responsibilities to the most vulnerable populations, especially in LMICs, and that reforms are needed to ensure that public health takes precedence over profits.

Global Initiatives to Address Access to Medicines

To address the growing concerns about access to essential medicines, several international initiatives have been established:

• The Medicines Patent Pool (MPP): Founded in 2010, the MPP works to increase access to HIV, hepatitis C, and tuberculosis treatments by negotiating voluntary licensing agreements with pharmaceutical companies. These agreements allow for the production of generic versions of patented medicines, making them more affordable and accessible in LMICs. During the Covid-19 pandemic, the MPP extended its mandate to include Covid-19 treatments and technologies, though participation from large pharmaceutical companies has been limited.
• COVAX and Vaccine Equity: COVAX, co-led by Gavi, the Vaccine Alliance, the WHO, and the Coalition for Epidemic Preparedness Innovations (CEPI), aims to provide equitable access to Covid-19 vaccines. However, COVAX has faced significant challenges, including supply shortages and funding gaps, highlighting the difficulties in ensuring global vaccine equity.
• The WHO’s Prequalification Program: This program helps ensure that medicines, vaccines, and diagnostics meet global standards of quality, safety, and efficacy, particularly for diseases prevalent in LMICs. By facilitating access to high-quality, affordable health products, the program helps to bridge the gap between patented medicines and the needs of LMICs.

This chapter has highlighted the critical challenges associated with access to essential medicines, particularly in LMICs, and the tensions between IP protection and public health. The next chapter will explore the legal frameworks that govern pharmaceutical patents, focusing on the WTO’s TRIPS Agreement and the ongoing discussions around the proposed TRIPS waiver for Covid-19 vaccines and treatments.