The COVID-19 pandemic has urgently underlined the need for global solidarity, particularly with regard to access to various health technologies including vaccines, medical equipment and diagnostics.
However, the phenomenon of vaccine nationalism has pushed forth a new debate over the capitalistic viewpoint through which international intellectual property (IP) laws were originally drafted.
Keeping in mind the unprecedented threat to human health in October 2020, India and South Africa put forth a proposal to waive certain provisions of TRIPS for the prevention, containment, and treatment of COVID-19. It was proposed to waive the implementation, application, and enforcement of sections 1, 4, 5 and 7 of part II of the TRIPS agreement, which are provisions relating to copyright, industrial design, patents, and undisclosed information (trade secrets). The proposal mentioned that in the light of exceptional circumstances, waivers from the obligation of the TRIPS agreement is justified.
While this proposal has deep altruistic undertones, there were several real problems attached to it. Accordingly, the proposal has met with some fierce criticism and apprehension around the world.
Many countries and international organisations have proposed allegedly “better” alternatives to tackle the vaccine shortage issue during the pandemic keeping in mind the logistical and financial issues that may be caused by the proposal.
Different countries, different opinions
The India-South Africa proposal gained support from the US, albeit in a limited sense. The United States has proposed to temporarily suspend intellectual property protection for the duration of the pandemic. However, such suspension will be limited to vaccines only. While vaccination is one (and most stable) way to control the pandemic, a broader inspection would require addressing the limited supply of coronavirus medicines, testing kits etc, as well.
The World Bank on the other hand has opposed the proposal on the ground that it would hamper innovation in the pharmaceutical industry. The global financial institution’s stance has found support from many vaccine manufacturers as well, who have voiced a similar concern.
The European Union’s (EU) proposal regarding COVID-19 vaccine access focuses on three major elements.
The first aspect focuses on fixing global supply chain issues. The second part requests that governments support vaccine manufacturers and developers to ensure affordable vaccine supplies. The final element focuses on intellectual property and affirms that voluntary licenses are the most effective method of facilitating increased production and sharing of expertise. Even G20 has endorsed voluntary measures to transfer IP to enhance access to COVID-19 countermeasures.
The noble intentions behind these recommendations are apparent. However, there are problems with all three elements. The EU recommends the countries producing the vaccines increase their vaccine exports to fix the supply chain issues. It has been seen in the past that having a broken supply chain during any disease outbreak can be catastrophic, the recent example being the US itself. However, given the ongoing “country first” stance most of the countries have been taking to secure vaccines for their citizens first, it is unlikely that global exports will see growth anytime soon. Similarly, many countries do not have direct access to vaccine manufacturers which is hampering their vaccine rollout programme. South Africa’s vaccine rollout programme was obstructed because the Serum Institute of India was not able to fulfil the demand owing to the surge in COVID-19 cases in India. In such a situation, the question of the government supporting vaccine manufacturers goes out of the window.
The EU and G20’s recommendation to encourage voluntary licensing sounds encouraging as it involves giving licenses to other companies, preferably local companies in places facing a vaccine shortage. This will give the local companies the know-how to produce vaccines or other countermeasures locally. Though given the vaccine manufacturers’ opposition to IP waivers, voluntary licenses seem unlikely. As an alternative, these companies can be forced to dole out compulsory licenses. As a matter of fact, the EU advocates for using the existing mechanism under the TRIPS agreement to solve this. This step is also not likely to be very fruitful given the limitation of the TRIPS provisions themselves.
Article 31, along with additional provisions of the TRIPS agreement deal with compulsory licensing. Over the years, various shortcomings of the articles came into light which led to the amendment of these provisions during the Doha Declaration. Two such problematic provisions were articles 31(f) and 31(h). According to article 31(f), the compulsory license could only be given for supply to a domestic market. Article 31(h) contained a problem regarding the ability to pay for developing or least developed countries. It is possible that low-income nations could not afford the appropriate “economic value of the authorisation”.
These shortcomings led to the development introduction and adoption of article 31bis. Post the amendment, it could be expected that it would be met with open arms by the members of the WTO. However, it has not been so. The flexibilities around compulsory licensing have been incapable of addressing the emergencies such as national emergencies or pandemics adequately both in terms of procedure and legal substance. Maybe this is the reason this provision has been used only once (Canada vs Rwanda). During the proceedings of the 2010 review, many member states were concerned about the effectiveness of the provision given the fact that the one time this provision was used, it took nearly three years to reach fruition. Such timing would be unacceptable and unworkable under any conceived definition of national emergencies. Such emergencies tend not to wait for cumbersome bureaucracies.
As of April 2021, low-income countries have received only 0.3% of the global vaccine supply, while some high-income countries have received up to 81%. This disparity is not only alarming but also a giant hindrance in the fight against this pandemic. The global IP waiver as proposed by India and South Africa is a promising step. This will allow the free flow of information between the concerned parties. However, this does not address the issue of supply chains or that the manufacturing capabilities of a country might not be up to the mark to act on such information. Moreover, getting all the countries to agree to give up their IP rights even for a limited period is easier said than done. On the other hand, recommendations by the EU poke at other persistent problems associated with the disparity in vaccine distribution and they have their problems as well.
A holistic approach should be taken, considering both the options of global IP waiver as well promoting vaccine exports to the nations suffering from its shortage. In any way, global IP waiver offers an efficient weapon against the fight against the pandemic, and it should be encouraged as much as possible. Recently, the WTO decided to hold ‘text-based negotiations’ about India’s proposal opening up for further talks. India has proposed a deadline of July to complete the negotiations. If these negotiations come through, they will open a new door to combat the problem at hand.
Kavita Chawla is an assistant professor at the School of Law, BML Munjal University, Gurugram. Priyamvada Singh is an advocate practicing in Delhi courts.