Vaccine Nationalism, the TRIPS Waiver Proposal and Public International Law

[Avani Laad is a penultimate year law student at Symbiosis Law School Pune, India, and represented her college in the 19th John H. Jackson Moot Court Competition 2021]

Introduction

In the wake of the world’s response to Covid-19, an emergence of the phenomenon of vaccine nationalism has taken place. Vaccine nationalism refers to the prioritization of a State’s own domestic needs for vaccine supply, at the expense of other States. This results in developed countries purchasing and hoarding vaccine supplies for their own population, by entering into agreements with pharmaceutical companies well in advance of them becoming publicly available.

Intellectual property rights of vaccine manufacturers are yet another impediment to achieving equitable distribution of vaccines across the world. The thicketof intellectual property that surrounds a vaccine causes major encumbrances for manufacturers in developing countries. This is because manufacturers are required to obtain licenses from such patent‑holding pharmaceutical companies before they can produce their own vaccine, which is difficult to afford for low and middle income countries. Sometimes, the patent holders may also not grant licenses to such smaller manufacturers in hopes of supplying vaccine to other countries. However, in a situation where the demand is high and the provision of supply is concentrated in a limited number of distributors – that have reserved them for a limited number of countries – equitable access to vaccines is denied.

In light of this encumbrance faced by developing countries, India and South Africa have proposed for a waiver of the Trade in Intellectual Property Rights (TRIPS) Agreement, a multilateral agreement of the World Trade Organization for governing intellectual property (IP).

WTO and the TRIPS Agreement – State Response in the Form of Waiver Proposal

Under the TRIPS Agreement, Member States of the WTO are required to abide by certain minimum standards of intellectual property protection and enforcement. The proposal by India and South Africa essentially vouches for a temporary waiver of such provisions on IP protection with respect to the materials needed for Covid-19 prevention and treatment. By grant of such waiver, WTO Member States would not be obligated to enforce and protect patents and other IP pertaining to Covid-19 medicines, vaccines, and equipment.

The legal basis for the TRIPS waiver is found under the Marrakesh Agreement establishing the WTO, Article IX.3 of which stipulates that the Ministerial Conference, which is the decision making body of the WTO, may waive obligations imposed by any Agreement of the WTO in ‘exceptional circumstances’. Where the waiver concerns a multilateral trading agreement like TRIPS Agreement, its consideration would lie with the TRIPS Council.

Several provisions of the TRIPS Agreement recognize public health as an important consideration. Article 7 of the agreement provides for the objective of promotion of technical innovation and transfer of technology that balances rights and obligations and is in consonance with economic and social welfare. Article 8 expressly recognizes the right of Member States to adopt measures necessary for public health, so long as they are consistent with the Agreement.

Moreover, the TRIPS Agreement also provides for certain flexibilities that can be resorted to in case of public health emergencies. Under Article 31, the provision for compulsory licensing of patented materials is enshrined, wherein Member States may compulsorily provide for the licensing of patents without the authorization of the patent holder, if a situation of national emergency or extreme urgency arises. The Doha Declaration on TRIPS and Public Health also furthered the interpretation of Article 31 to allow for epidemics and pandemics to be included in the meaning of a “national emergency”. Further, Article 31bis was added to the TRIPS agreement, allowing for exportation of products manufactured through compulsory licensing to States having “insufficient or no manufacturing capacities”. This addition waived the obligations of exporting Members under Article 31(f), which had otherwise allowed them to use such products only domestically. Article 27(2) further allows for members to exclude patentability of inventions which are necessary for protecting human health.

Voluntary licensing is another option for States to encourage patent holders to enter into agreements with third parties to manufacture affordable vaccines, such as the agreement between the Serum Institute of India and AstraZeneca. Thus, one can argue that by virtue of such flexibilities, the IP encumbrance to vaccine access should not arise. This has also been the stance of the countries opposing the waiver.

It is indeed true that many countries invoked compulsory licensing in response to Covid-19 for manufacturing vaccines domestically, such as Canada and Germany. However, these flexibilities are not mutually exclusive from the waiver, and should instead complement them. This is because the existing flexibilities suffer from their own limitations, being case-by-case and product-by-product. Compulsory licensing would require the patent manufacturers to be provided ‘adequate remuneration’ by such low and middle income countries (Article 31(h) TRIPS Agreement), and with every license issued separate negotiations would have to take place as to the terms of the license. This is exacerbated by the fact that every vaccine would involve a number of patents as well as other IP rights, requiring separate licenses at each step. Thus, from a practical point of view, the current flexibilities under the TRIPS Agreement are insufficient, and there is a consequent need for a waiver.

From the Lens of Public International Law Principles

The debate surrounding equitable access can also be analyzed through the lens of public international law principles, as WTO members may also have obligations thereunder which can inform and complement the TRIPS waiver proposal.

On the one hand, the principle of non-intervention prevents other countries from intervening with the internal affairs of any other country. It may be said that since every State will have sovereignty over the vaccines manufactured in their territory, by virtue of this principle, they cannot be coerced out of vaccine nationalism. Furthermore, even under the right to health enshrined in Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR), State parties are obliged to take “necessary” steps for the “prevention, treatment and control of epidemics.” The General Comment 14 on the right to health provides that immunization is included within the right to health. The natural interpretation of this right usually involves the obligation of a State towards its own population as opposed to others, thus inclining towards vaccine nationalism. On the other hand, even under Article 12(2) of the ICESCR, the use of the term “necessary” brings into question the issue of whether having inordinate supplies of a vaccine kept in reserve is “necessary” to protect the health of the population.

In any case, the right to health also has international elements, as enshrined under the no-harm principle and the obligation of international cooperation and assistance. The no-harm principle under customary international law obliges States to not conduct activities that may cause transboundary harm to other States. From the right to health perspective, this arguably means that a State has the right to protect the health of its citizens, but not where doing so harms the health of people in other States, such as through vaccine hoarding. Moreover, the obligation of international assistance and cooperation as embodied under Article 2(1) of the ICESCR extends to the achievement of the right to health, and thus calls for such cooperation between States to ensure access to vaccines.

Conclusion

It would be in the self-interest of States to support equitable access to vaccines, since Covid-19 is a global problem and the world today is increasingly globalized. Vaccine nationalism may lead to damaging the global supply chain of pharmaceutical products. Perhaps the biggest global disadvantage of vaccine nationalism would be the mutation of the virus in countries lacking in vaccines, which might lead to the current vaccines becoming ineffective against those mutations. The controversy surrounding the TRIPS waiver also brings into light the practical and procedural problems associated with the IP regime today, despite the flexibilities in place. It highlights the importance of reflecting on the system and revising it in order to ensure that it is resilient towards future pandemics. Indeed, as the saying goes, ‘no one is safe until everyone is safe’; thus, measures should be taken to prevent vaccine nationalism and IP encumbrances which impede equitable access.