In less than 3 months, COVID-19 has become a global pandemic of proportions we have not experienced this century. This has led to some of the largest economies in the world racing to develop a vaccine to combat the disease. However, in this time of urgency, patent laws may conflict with the equal provision of these future medicines worldwide. International organizations, in particular the World Health Organization (WHO), has a crucial role in fostering an environment of international cooperation and enforcing equitable access to medicines on a global scale, by pressuring powerful and wealthier states to collaborate with poorer countries. Article 25 of the Universal Declaration of Human Rights clearly emphasises the right to adequate medical care, and so the international community is responsible for ensuring that this right is upheld equally amongst the world population. Particularly in times of crisis, health must not be perceived as a privilege for some, but as a human right for all.
The protection of intellectual property rights, especially in the case of pharmaceutical inventions, can be a potential barrier to public health protection. Article thirty-one of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) governs the issuing of compulsory licenses by states, including the licensing of pharmaceutical and medical products. States issue these licenses to develop a bioequivalent, that is a cheaper, synthesized version of the drug called ‘generic medicines’, that can be marketised at an accessible price (TRIPS Agreement, Article 31). For example, the AIDS triple combination HAART therapy costs around 10,000$ per patient per year in the United States. However, the pharmaceutical company Cipla, which manufactures the synthesized or generic version of the drug, costs $200 per patient per year (WHO Bulletin, 2006). In recent months, countries like Ecuador (Ecuador Resolution, 2020) and Chile (Chile Resolution, 2020) have issued compulsory licenses for pharmaceutical products related to Covid-19. This will allow them to develop generic versions of future drugs and vaccines and ensure a more accessible and affordable distribution of these products, thus helping to curb the coronavirus outbreak.
Despite these licenses allowing for accessible medicine, not all countries have the adequate resources and infrastructure for the production of medical and pharmaceutical products. The Doha Declaration, a supplementary legislation to TRIPS (The Agreement on Trade-Related Aspects of Intellectual Property Rights), makes a specific provision for countries that lack such technology and resources, allowing them to import generic forms of medicine from countries with developing capacity (The Doha Declaration on the TRIPS Agreement and Public Health, Paragraph 6). However, the implementation of this provision has proved lacking, as Rwanda is to date the only country to make use of this scheme. In fact, after its export of medicine to Rwanda, the medical supply company reported that it would no longer carry out any such transactions because they did not generate enough profit. Moreover, the need for compliance with specific criteria under this scheme by the countries involved led to significant time delay and financial strain on both parties. These bureaucratic and unprofitable aspects therefore predict a bleak future for the potential of future implementation of the provision (Pogge, Rimmer and Rubenstein, 2010).
In the event of a coronavirus vaccine being introduced, it seems that poorer countries – especially the most densely populated – lacking medical infrastructure and resources will be left vulnerable and at the mercy of wealthier states. And this is not the first time. Access to health facilities is a long-standing battle being fought on the African continent in particular. During the Ebola crisis, health workers in Liberia used plastic bags instead of medical gloves to protect themselves and several deaths were reported among health workers in government-run healthcare centers (Human Rights Watch, 2014). Failures like these during the Ebola response not only violated the health rights of patients, but also put health workers unnecessarily at risk. The right to health goes hand in hand with the right to life, and without access to proper medical equipment to protect workers and patients alike, loss of life becomes an inevitability. Countries with weak state structures and insufficient health infrastructure will therefore need the support of wealthier states and international organizations, both to limit the current spread of the coronavirus and to get much-needed access to a vaccine, once developed.
Another barrier for healthcare provision in poorer countries are the power dynamics played out at global and state levels. States with stronger health infrastructures will undoubtedly first cater to their own citizens’ medical needs before helping other countries to curb the pandemic. Richer countries like the USA, China and European states are the major players in the development of a COVID-19 vaccine and are also currently the most affected by the coronavirus (The New York Times, 2020). It seems unlikely, therefore, that a vaccine would make it beyond their borders shortly after being developed Moreover, poorer countries are easily swayed towards the interests of more powerful states. This was recently demonstrated when India, one of the largest producers of generic medicines, eased export restrictions on hydroxychloroquine, a product that could potentially help thwart the risks of COVID-19. The country had previously ordered a temporary ban on medical exports to meet domestic demand, but the ban was lifted after the USA allegedly threatened India with sanctions if the drug was not made available to them (Reuters, 2020). Individual national interests and the power of some states over others are therefore likely to determine the global distribution of medicines in this pandemic.
Equitable access to health facilities and medicines for states that lack resources thus appears like a herculean task. In times of crisis, these countries have very low bargaining power, and global power dynamics are bound to affect their future. Nevertheless, these states should still have recourse to the WHO to ensure that their medical needs are met by the global community. In this time of pandemic, the WHO has made a global call for sharing resources to combat the deadly virus, through the report they published on COVID-19 (WHO Report, 2020). Despite this, India enforced its temporary ban on the export of 26 pharmaceutical products, though later partially lifted it. The EU has also passed a resolution to limit the supply of medical equipment and pharmaceuticals outside of EU countries (EU Regulation). If steps to share resources are not currently being implemented by these countries, it is hard to imagine that a future vaccine will be equitably distributed among the world population.
States that lack vaccine developing capacity are heavily reliant on the WHO for medical assistance. However, its failure to encourage states to share resources raises concerns about the WHO’s ability to put pressure on powerful states. In fact, its failures fighting the pandemic can also be understood in relation to its response to the 2009 Influenza A (H1N1) outbreak. Like our current situation, the rapid spread of H1N1 made a vaccine seem like the only practical solution to curb the outbreak. WHO coordination ensured that 78 million vaccine doses were donated to 77 countries, but only long after they were of any help to these populations (Report of WHO meeting, 2010). Initially, the donation of such vaccines was conducted without a fixed delivery date, leading to severe delays in distribution (Fidler, 2010). In Ghana and Malawi, government vaccine distribution lacked guidance for health workers and clarity on how to care for patients. In Malawi, around 75% of the WHO vaccines were used to curb the outbreak, but the rest of the doses remained unaccounted for (Sambala and Manderson, 2017). Another major issue was the absence of public information systems in these countries, which resulted in a large part of local populations being unaware that they could receive a vaccine and access health facilities (Croiser, Mcvey and French, 2014). To overcome these challenges and make global vaccine distribution more effective, donor countries need to be monitored and held accountable, supplies in recipient countries need to be tracked, and real-time charts on roles and responsibilities must be swiftly implemented.
If an equitable distribution of vaccines is to succeed, the response to the crisis must rely on a two-pronged approach that ensures global as well as individual preparedness among states. The 2009 failure should provide us with perspective and an incentive to prevent such a situation from occurring with COVID-19. To reach global preparedness, WHO should urgently enforce its ‘Guidance on Development and Implementation of a National Deployment and Vaccination Plan for Pandemic Influenza Vaccines’. These guidelines were created in light of the failure of vaccine deployments in 2009 and as a direct result of calls for a centralized Management Information System (MIS). The response would consist of a global information database on vaccine use, as well as country profiles detailing national health infrastructures and ability to deploy vaccines (WHO Report, 2012). In the current circumstances, it appears that these guidelines may be key to determining the future of the pandemic, but only if they are implemented at the earliest to ensure state preparedness.
At individual state levels, there is also a need to develop a collaborative atmosphere. States cannot successfully curb the pandemic without systematic communication with the public and must have transparent policies to keep populations informed about their fight against the virus. States with resources and technology should also be encouraged to jointly help developing generic medicines with states without such resources. For example, Uganda-based Cipla Quality Chemicals is a joint venture between Cipla, a large Indian generics manufacturer, and the Ugandan government. It is the only company in Africa that produces an empirical therapy to treat HIV (UNCTAD Report, 2011). This form of cooperation will support the emergence of better health infrastructure and medical supplies in poorer countries and is a step towards making these states less dependent on outside actors.
Under the UDHR, states have a positive obligation to provide necessary medical care and protect the public health of their citizens (UDHR, Article 25). This obligation is also reiterated in the TRIPS agreement (TRIPS Agreement, Article 8). However, many poorer states are not able to deliver on these duties and their populations are thus left unprotected from pandemics like this one. It is therefore imperative for international and national institutions to make public health-related patent regulations a priority concern and to do their utmost to overcome the medical supply shortage faced by states that lack developing capacity. As the global pandemic continues to spread, powerful states must be encouraged to provide assistance and resources to states in dire need, in order to protect public health worldwide. International institutions protecting health rights must therefore develop a more interventionalist approach to ensure equal access to medicines, encouraging universal guidelines and global cooperation mechanisms. Instead of using the interdependency of nations as a bargaining tool, states should recognize a larger cause and work towards the common goal of ending the pandemic globally. This pandemic could provide the opportunity to create a more cooperative global health system among states and prevent unnecessary loss of life in poorer states in the future.
Adam Croiser, Dominic Mcvey, Jeff French. (2014) By failing to prepare you are preparing to fail’: lessons from the 2009 H1N1 ‘swine flu’ pandemic, European Journal of Public and Health, Volume 25, Issue 1, February 2015, Pages 135–139.
Chile Resolution. (2020) ” Resolution for the Granting of Non-voluntary licenses referred to in Article 51º Nº 2 of Industrial Property Law Nº 19.030 to facilitate access and availability of medicines and technologies for the prevention, treatment and cure of Coronavirus Covid-19”, Knowledge Ecology International, [online]. Available at: https://www.keionline.org/chilean-covid-resolution
David E. Sanger, David D. Kirkpatrick, Sui-Lee Wee, Katrin Bennhold. (2020) Search for Coronavirus Vaccine Becomes a Global Competition. The New York Times [online]. Available at: https://www.nytimes.com/2020/03/19/us/politics/coronavirus-vaccine-competition.html
Doha Declaration on the TRIPS Agreement and Public Health. (2003), Paragraph 6, [online]. Available at: https://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm
Ecuador Resolution. (2020), “Resolution of granting Covid-19 products compulsory licenses”, Knowledge Ecology International, [online]. Available at: https: //www.keionline.org/wp-content/uploads/ES-Ecuador-CL-resolution.pdf.
EU Regulation, Commission Implementing Regulation (EU) 2020/402 of 14 March 2020 making the exportation of certain products subject to the production of an export authorization, [online]. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:077I:TOC
Fidler DP. (2010), Negotiating Equitable Access to Influenza Vaccines: Global Health Diplomacy and the Controversies Surrounding Avian Influenza H5N1 and Pandemic Influenza H1N1, PLoS Med, 7(5), [online]. Available at: https://doi.org/10.1371/journal.pmed.1000247
Neha Dasgupta. (2020), India likely to soon ease some drug export curbs after U.S. pressure – sources, Reuters, [online]. Available at: https://www.reuters.com/article/us-health-coronavirus-india-pharmaceutic/india-likely-to-soon-ease-some-drug-export-curbs-after-us-pressure-sources-idUSKBN21J4YN
Report of WHO Meeting. (2010), Main operational lessons learnt from the WHO Pandemic Influenza A (H1N1) Vaccine Deployment Initiative, [online]. Available at: https://www.who.int/influenza_vaccines_plan/resources/h1n1_vaccine_deployment_initiaitve_moll.pdf
Sambala, E.Z., Manderson. (2017), L. Policy perspectives on post pandemic influenza vaccination in Ghana and Malawi, BMC Public Health, 17, 227.
Thomas Pogge, Matthew Rimmer, Kim Rubenstein. (2010),Incentives for Global Public Health: Patent Law and Access to Essential Medicines, Cambridge University Press, [online]. Available at: https://ssrn.com/abstract=1427521
TRIPS Agreement, Article 8, [online]. Available at: https://www.wto.org/english/docs_e/legal_e/27-trips.pdf
TRIPS Agreement, Article 31, [online]. Available at: https://www.wto.org/english/docs_e/legal_e/27-trips.pdf.
UNCTAD Report. (2011), Investment in Pharmaceutical Production in the Least Developed Countries, [online]. Available at: https://unctad.org/en/Docs/diaepcb2011d5_en.pdf
Universal Declaration of Human Rights, Article 25, [online]. Available at: https://www.un.org/en/universal-declaration-human-rights/
West Africa: Respect Rights in Ebola Response. (2014), Human Rights Watch, [online]. Available at: https://www.hrw.org/news/2014/09/15/west-africa-respect-rights-ebola-response
WHO Bulletin. 2006, Access to AIDS medicines stumbles on trade rules, [online]. Available at: https://www.who.int/bulletin/volumes/84/5/news10506/en/
WHO Report. (2020), A Co-ordinated Global Research Roadmap: 2019 Novel Coronavirus, [online]. Available at: https://www.who.int/blueprint/priority-diseases/key-action/Coronavirus_Roadmap_V9.pdf ? ua=1
WHO Report. (2012), Guidance on Development and Implementation of a National Deployment and Vaccination Plan for Pandemic Influenza Vaccines, [online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/75246/9789241503990_eng.pdf
This is informative and helpful. Well written !
Very informative article, the need of the hour.
This is a brilliant read Kashvi.. Iits so well thought, well-informed and superbly written. It portrays the dark and bitter truth of a world divided by power and influential economies. The pandemic has affected the rich-poor alike and on grounds of humanity, each and every human being is entitled to a vaccine. Very thought-provoking article and shows your profound knowledge of the law and your genuine concern for humanity….
thank you for sharing this article post.