[This post has been authored by SpicyIP intern Rohan Srivastava. Rohan is a Second Year student at National Law School Of India University and has a keen interest in IPR and Technology Law.]
The recent increase in COVID-19 cases in India comes as a Deja Vu, reminiscent of the predicament India and the world were in 2 years ago. While the spike should not be a cause of concern owing to a proper vaccination run (also see here for the number of doses administered), elsewhere, experts and delegates are still engaged in negotiations over a possible extension of the TRIPS waiver to medical supplies and pharmaceuticals products. The TRIPS waiver, which became a hot topic for debates around multilateralism from October 2020, brought to the forefront the international community’s inaction and paralysis in the face of a global crisis of unprecedented scale. The fact that the negotiations recently extended the deadline for deciding on the waiver, almost a year after the medical emergency was subdued, is itself a testament to how time taking and inefficient the waiver fiasco has ended up being.
This post will seek to look back at the controversy surrounding the waiver and reflect on it with the benefit of hindsight. In doing so, this post shall uncover the handicaps in seeking the TRIPS waiver, both internally in the WTO decision-making process and problems with the idea of a waiver as a way out of the crisis. This piece will then conclude with certain considerations that must be kept in mind for the future.
The Pandemic was not the first time that the WTO’s inefficient decision-making process came to the forefront. (For example- Trade Law enthusiasts will recall the painstakingly long Doha Round of Negotiations, which were the 9th round of negotiations and the first since the WTO was established.) Part of the reason behind the WTO’s inefficient decision-making is its consensus-based model. Consensus, at WTO, means the lack of sustained opposition i.e. a decision is made when no member formally objects to it. (In the context of the TRIPS waiver, the consensus-based decision-making model can be seen in Article IX: 3 (1) of the Marrakesh agreement r/w Footnote 1.)
Thus, decision-making at the WTO requires lobbying each and every member of the Organization in support, which often ends up being a zero-sum game for the members. While there is certainly merit in having this consensus-based approach, insofar as it is more democratic and allows due consideration to be given to all viewpoints, the pandemic has clearly exposed that the same rationale may be turned on its head during a medical health emergency. Already, there has been a lot of global north and global south contention over the availability of essential medicines at the time of crisis. For instance, the HIV/AIDS crisis and the surrounding access to medicines issue that started off in 2001 and fructified into an amendment only in 2017 (see here). The same was reflected in the context of TRIPS COVID-19 Vaccine waiver as well, where first a broad waiver was proposed by the member countries (see here and here) and after the subsequently revised proposals (see here), the existing waiver, which applies only on vaccines, was accepted. These instances show how the consensus-based approach at the WTO, which can be argued to protect the interests of the less influential countries, can also work against them when decision-making is required to be made in emergencies where time is of the essence. This is especially significant since the developing countries have for long been in majority in the WTO but still have not had their say, for the self-interests of a handful of developed nations (read here and here). What is even more ironic is that despite the strong resistance by the developed nations in the negotiation process which led to further delays in reaching a conclusive and timely waiver, the ministerial council’s final decision did not even concern the developed nations as they were not eligible members as per the document. What is to be kept in mind is that it was ultimately the developing countries that had to face the brunt of being deprived of their IP Protection. (Find more on this here.)
Looking at the October 2020 draft, proponents claimed that a waiver is necessary to ensure proper access because the existing flexibilities in the TRIPS such as compulsory licensing etc. are not feasible in an emergency such as the pandemic. However, proponent countries themselves actively refused from utilising already existing flexibilities first to reach the above assertion. For instance, the Indian Supreme Court even questioned the Indian government’s reluctance to utilise compulsory licensing provisions in domestic law on precisely this point, and yet there was no action on this front. (Read more on this here)
The lack of an efficient internal decision-making process at the WTO and wide disagreements over the desirability of a waiver raises the question of whether it is the appropriate recourse at times of crisis or if the global community would do better to envisage alternative mechanisms in the future.
The opponents of the waiver, who were mostly the developed nations housing the major pharmaceutical manufacturers, argued that the October 2020 waiver will take away the incentive to innovate the cure for the pandemic. They instead argued that the members should utilize the flexibilities incorporated within the TRIPS in order to cater to the rising need for essential commodities.
Even the final ministerial decision was an iteration of the opponent’s sentiment only, in so far as it did not technically waive off any IPR protections under the TRIPS but instead clarified the existing flexibilities. Looking at the TRIPS agreement, one can see that it is cognizant of the need to balance such social imperatives with the protection of IPR, and has incorporated relevant structural features. For instance, Article 7 provides that the ‘protection and enforcement of intellectual property rights shall be in a manner conducive to social and economic welfare’ while Article 8 states that Members ‘may, in formulating or amending their laws and regulations, adopt measures necessary to protect public health … provided that such measures are consistent with the provisions of the Agreement’. The TRIPS agreement makes it clear that Members are free to pursue legitimate public policy objectives. Furthermore, despite claims to the contrary, TRIPS flexibilities, including mandatory licensure, pharmaceutical transition measures, parallel importation, and research exceptions, have all been used and successfully demonstrated. For instance, a study by Ellen t’Hoen et al on the use of TRIPS flexibilities found that 89 countries used TRIPS flexibilities 176 times between 2001 and 2016, with over half of those uses (79.5%) involving Compulsory license, public noncommercial use, and LDC pharmaceutical transition measure. Thus, one would not be wrong to think that a lot of crucial time wasted in the negotiations at the time of the crisis could have been saved, had the proponents focussed more on aggressively pursuing the existing options or seeking clarification regarding the same for greater certainty, especially given that this was what was eventually agreed to instead of having a blanket waiver.
It is undoubtedly true that a global crisis of such a magnitude would require multilateral cooperation and collective initiatives, the question however is what could be achieved by a patent waiver when most LDC countries lack the required infrastructure capabilities to actually engage in vaccine manufacture. Looking at a chart of key vaccine developing countries (here) one can see that there are only a handful of developing countries with vaccine manufacturing prowess. Assuming the broader waiver proposal was accepted, the opponents (housing the majority of vaccine developers) could still have refused to apply the same in their countries, (this intent is evident from the outcome waiver document that expressly exempts the developed countries from the ambit of its application). And thus, the only benefit that would have occurred out of the broad waiver would have been the flexibility to not be sued for non-consensual use of the IP involved in the production of the vaccines, by the manufacturers located in these developing- broad waiver proponent countries. However, it is pertinent to note, that if the ultimate benefit of the waiver would have been the freedom from being sued for non-consensual use of the underlying IP, then as argued above, TRIPS already caters to it under Article 73 (b)(iii), and thus making the whole exercise largely a rut.
It is also interesting to note that the developed countries which came to the table in favour of the TRIPS waiver in the name of multilateral cooperation for assuring equitable access to vaccines, were at the same time also doing lip service to their commitments by signing bulky procurement orders with multiple vaccine manufacturers to keep their eggs in several baskets. These orders were also often in excess of the vaccine requirement of the particular country, at a time when vaccine availability across the world was uncertain. The TRIPS negotiation allowed vaccine nationalism to maintain face at the international fora as is also evident from the final ministerial decision which limited the applicability to the developing countries and LDCs. (Refer here)
The Way Forward
It thus becomes evident that a TRIPS waiver cannot be seen as a ready response that will act as a panacea to the woes of vaccine availability during times of crisis. With regards to the internal process in the WTO, the pandemic has made it clear that WTO cannot be expected to make ad-hoc decisions due to the consensus requirements given that differing considerations, such as the impact on innovation etc. are involved in such a decision. The only hope on the IPR front would be for the WTO to create structural safeguards that can aid in times of such crisis and clarify such flexibilities. Given that the utility of a waiver itself is also under question, the WTO also needs to focus more on ensuring the availability of vaccines, pharmaceuticals, and treatment options by continuing its efforts to identify and reduce barriers to trade, to ensure that states which do not have the institutional capacity to make use of the waiver are not left out. One instance of such a barrier is regulatory bottlenecks which impeded the speedy dispersal of vaccines globally. (Read more on this here and here) In addition to this, there have also been criticisms against the TRIPS framework for being unable to protect the interest of developing nations and encouraging the growth of technology in the LDCs. So far, TRIPS has only ensured greater IP protection to technology-generating countries and there has been no trickle-down or transfer of technology from the higher-income countries to the LDCs, despite having provisions urging the same.
It is imperative that WHO, which is better suited for responding to a global health crisis, steps up to the game for ensuring equitable access to vaccines, pharmaceuticals, and other medical aid through multilateral cooperation. Much of the international cooperation in such efforts will also depend upon the fate of the global treaty for future pandemic emergencies under the WHO which is currently under negotiations. The main purpose of the initiative is to ensure early detection and prevention of future pandemics, including a stronger international health framework within the WHO that would attempt to ensure universal and equitable access to medical solutions. It is also pertinent to note that the treaty includes provisions for timely waiver of IP protection so that there is no tussle at the time of crisis and valuable time and lives are not wasted (Article 7.4). However, as if the international community refuses to learn, the negotiations are again facing institutional concerns and are being done in a non-transparent manner (See Talha Burki’s statement on this media coverage here). This can potentially undermine trust in the process and history might again repeat itself with another deadlock over the differences between the developed and developing nations and over the fate of countless lives.
Multilateral cooperation at times of global emergencies like the pandemic is understandably hard to come by given the pressing needs each member state has internally. The COVID-19 pandemic cannot be seen as a one-off event and it is widely predicted that as man taps more with nature it is likely that there may be a rise in the frequency of pandemics. Thus, it would do well if the international community sees the entire TRIPS waiver fiasco as a lesson on how things pan out practically in times of crisis and is able to come up with more practical and efficient mechanisms which would allow all states to acquire an equitable supply of vaccines despite the socio-economic inequalities across the borders.