Diya Uberoi
Around the world, research to find a possible vaccine or treatment for the novel coronavirus has begun. The magnitude of the pandemic and its impact on the global economy makes the need for affordable medicines and treatment a pressing issue. But if we are to win the battle to contain COVID-19, then states must prioritize equitable access to affordable prevention, treatment, and care, and to do that, there are lessons to learn from the HIV/AIDS movement.
Today, access to medicines, including essential medicines, is a core component of the right to health. States must ensure that medicines are affordable and accessible, of good quality, and available without discrimination. While the fulfilment of the right to health is subject to progressive realization and requires states to take gradual steps based on available resources, access to medicines is an obligation that must be fulfilled immediately. At the very least, states must ensure (1) non-discriminatory access to health services; (2) provision of essential drugs, as defined by the World Health Organization; (3) equitable distribution of all health facilities, goods, and services; and (4) that their national public health strategy addresses the health concerns of the whole population, with particular attention to vulnerable or marginalized groups.[1] Yet, a human rights-based approach centering affordable access to care is largely missing from government responses.[2] If low- and middle-income countries (LMICs) are to contain the impact of the current crisis, they must prioritize access to prevention and treatment.
One of the ways in which countries may control the spread of COVID-19 is through the development of a vaccine. As a means of encouraging the pharmaceutical industry, states have begun to increase their average investment in research and design (R&D). Studies suggest that developing a vaccine from the preclinical phase to registration requires an investment of approximately US$200 million to US$900 million.[3] The United States in particular, has become a forerunner. The US Government released a US$8.3 billion emergency spending package that sets aside nearly US$3 billion for vaccine production, most of which will go to the the private sector.[4]
As the search for the vaccine continues, despite the economic hardships being experienced globally, it is vital that investment in the private sector does not undermine health. Most LMICs are dependent on high-income countries’ provision of medical technology, products, and services. In many instances, especially where trade incentives are in play, LMICs lack leverage to ensure the affordability of those goods and services. As a consequence, high costs of treatment drive thousands of people into poverty each year.[5] While a return on investment is necessary for manufacturers, states have a human rights imperative to ensure treatment is affordable for those whose lives depend on it. Access to existing medicines should be improved, and research and development for a new vaccine should focus on improving health outcomes, not just on returns on investment. As history has shown, especially the early days of the HIV crisis when treatment costs left millions of people without access to lifesaving medicines, states must intervene in private efforts to ensure population health, and to respect health rights.
Access to treatment and lessons from the HIV epidemic
When the HIV/AIDS pandemic was at its height and high costs kept millions of people from accessing essential antiretrovirals (ARVs), it was governments’ ability to use exceptions under the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) that made the breakthrough. In the late 1990s, the pharmaceutical industry was forced to negotiate and reduce prices for ARVs in South Africa, for example, when 39 of the world’s leading pharmaceutical companies dropped their lawsuit against the South African government for attempting to legalize the importation of cheaper, generic versions of these drugs.[6]
Today, India is the largest provider of affordable medicines to LMICs because of its generic pharmaceutical industry. Prior to 2005, India’s patent law prohibited product patents, which made it difficult for pharmaceutical companies to charge exorbitant prices and hold a monopoly position in the country. In 2001, when the HIV crisis was at its peak and the need for ARVs particularly acute, it was the availability of cheaper generic ARVs from LMICs such as India that led to a reduction in price from over US$10,000 per patient per year to less than US$350 per patient per year for first-line combination therapy.[7]
Even though India had to amend its patent law in 2005 to include patenting of medicines to comply with its obligations under TRIPS and WTO law, the government ensured the inclusion of safeguards to prevent companies from abusing the patent system through “evergreening” – claiming patents on existing drugs by making only minor modifications.[8]
Learning from the lessons of the HIV response, it is crucial that states prioritize access to treatment when so much remains uncertain around the pandemic. LMICs should use TRIPS flexibilities to help them fulfill their obligations to protect public health and prioritize their people’s access to treatment by promoting generic competition, local production, and voluntary licensing by innovators to generic companies.
Although a vaccine for the coronavirus is still under development, it may not be long before pharmaceutical companies and other private actors will apply for patents for their “new, useful, and nonobvious inventions.”[9] A monopoly over the distribution, use, and price of a coronavirus vaccine could keep future treatment costs exorbitantly high. LMICs will remain ahead of the curve if they balance their trade obligations with their obligations to protect health rights.
The challenge remains, however, to ensure that once products are deemed safe and effective, they become accessible to the billions of people in the world who need them. Collaborative efforts must be made to ensure that the resulting benefits “are physically available and economically affordable on a basis of non-discrimination.”[10] As everyone is entitled to enjoy the benefits of scientific progress, states must ensure the pharmaceutical industry acts in accordance with human rights standards.
The right to health places a duty on the pharmaceutical industry to take all reasonable steps to make a medicine “as accessible as possible” after it has been marketed, including to those who cannot afford (high) prices.[11] Pharmaceutical companies should be encouraged to work towards disassociating R&D costs from product prices so that prices can be reduced and access to treatment enhanced. Where a patent is awarded, industry should authorize the state to use the invention for the benefit of the larger population. Any approved COVID-19 drug should be included in the WHO Essential Medicine List and made directly available to states.[12]
States must prioritize strategies to gain access to vaccines and potential treatments once they are available as part of their human rights obligation to ensure access to medicines and treatment. They must also take steps to ensure access for populations that routinely face barriers, such as women, children, and people living in poverty. Laws should prioritize budgetary allocations to ensure public financing for future prevention and treatment of COVID-19.
The true impact of the current pandemic is still unknown. But with so much uncertainty around the future of people’s health and well-being, countries must prioritize access to affordable prevention and treatment.
Diya Uberoi is a postdoctoral research fellow at the Dalla Lana School of Public Health, University of Toronto, Canada.
References
[1] UN Committee on Economic, Social and Cultural Rights (CESCR), General Comment No. 14: The Right to the Highest Attainable Standard of Health (Art. 12 of the Covenant), 11 August 2000, E/C.12/2000/4, para. 43; UN Committee on Economic, Social and Cultural Rights, Statement on the coronavirus disease (COVID-19) pandemic and economic, social and cultural rights, 6 April 2020, UN. Doc. E/C.12/2020/1, para. 12.
[2] See, for example, Guidelines from India, where need for protective equipment and protection of health workers are called for, but no mention of access to testing, sharing of knowledge etc. is made. Ministry of Health & Family Welfare, Gov’t of India. “National Guidelines for Infection Prevention & Control in Health Care Facilities.” (Jan. 2020). Available at https://www.mohfw.gov.in/pdf/National%20Guidelines%20for%20IPC%20in%20HCF%20-%20final%281%29.pdf (last accessed 13 June, 2020).
[3] F. Andre, “How the Research-based Industry Approaches Vaccine Development and Establishes Priorities.” Developments in Biology 110:25-29 (2002).
[4] L. Hirsch, and K. Breuninger, “Trump signs $8.3 Billion Emergency Coronavirus Spending Package,” CNBC.com (March 6, 2020), https://www.cnbc.com/2020/03/06/trump-signs-8point3-billion-emergency-coronavirusspending-package.html; S. Simmons-Duffin, “Where That $8.3 Billion in U.S. Coronavirus Funding Will and Won’t Go,” NPR, (March 6, 2020), https://www.npr.org/sections/health-shots/2020/03/06/812964894/where-that-8-3-billion-in-u-s-coronavirusfunding-will-and-wont-go (last accessed June 7, 2020).
[5] WHO and The World Bank, Tracking Universal Health Coverage: 2017 Global Monitoring Report (2017).
[6] D. J. Ncajyana, “Antiretroviral therapy cannot be South Africa’s first priority,” DJ CMAJ. 164(13):1857–1858.(2001).
[7] See, Médecins Sans Frontières, “Untangling the Web of ARV Price Reductions”, (11th edition, 2008).
[8] Ministry of Law & Justice, The Patents Amendment Act, 2005, No. 15 of 2005 (Govt of India) Sec. 3d.
[9] See, TRIPS Article 27: “[P]atents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”
[10] UN Human Rights Council, Report of the Special Rapporteur in the field of cultural rights, The Right to Enjoy the Benefits of Scientific Progress and its applications. A/HRC/20/26 (2012) at para. 30.
[11] P. Hunt and R. Khosla, “Are Drug Companies Living Up to Their Human Rights Responsibilities? The Perspective of the Former United Nations Special Rapporteur (2002-2008),” PLoS Medicine 7/9 (2010).
[12] Knowledge Ecology International, “Israel issues compulsory license to allow the government to import generic versions of Kaletra,” KEIonline (March 23, 2020), available at: https://www.keionline.org/32503.