Abstract
The underdeveloped states are facing the bitter health outcomes. The social and economic sytems are at the verge of breaking. Even working at full exhaustion the health care facilities have failed to fulfil the surging demands. The “global” pandemic calls for the “global” action and every passing day is costing precious human lives so the deteriorating situation begs for a humane and selfless action. This study highlights the inadequacies of the present-day intellectual property legal framework that has negated equitable access to vaccines. The public health concern begs the waiver of intellectual property rights as the flexibilities so offered by relevant law are symbolic when it comes to vaccine manufacturing. No one is safe against the deadly virus unless the substantial world population is protected. So, it is high time for world leaders to sit and formulate a viable solution and till that time intellectual property rights should be waived.
Keywords: TRIPS Agreement, Patent, Trade-Secret, Technology Transfer, Inequity, Waiver.
Introduction
The central issue in the fight against covid pandemic is an unrestricted demand for immunisation. Seth Berkley, CEO of Global Vaccine Alliance (Gavi) expressed his concern about the inadequate supply of covid vaccine to underdeveloped world at the time when the outbreak was declared a public health emergency and not global epidemic. In his words:
“The thing we have to think about now that’s different is, how do we produce vaccines specifically for the developing world if this is a truly global epidemic.”
The present study at first explains the internationally accepted innovation protection mechanisms that are relevant to vaccine development i.e. patents and trade secrets. This is followed by the analysis of the shortcomings of the flexibility of compulsory licencing in the vaccine context which is argued by the opponents of waiver as sufficient. The foreseeable practice of the pharmaceuticals accounting for the substantial vaccine development against deadly pandemic if the current protection regime remains intact is discussed.
The present paper analyses the shortcomings of the current innovation protection mechanisms (most specifically patent and trade secret) along with the insufficiency of the compulsory licencing flexibility (that is argued by waiver opponents as a solution) to make a case for tentative waiver of intellectual property protection framework.
The current pattern of vaccine agreements with pharmaceutical giants has ignited the debate over the consequential inequity resulting from the unequal distribution. On one side, giant economies have bound the prominent pharmaceutical companies to supply the vaccine production on a priority basis with some states who have already vaccinated half of their population. On the contrary, there are states which have yet to report a case of vaccine administration. With such unequal distribution, the world will not be free of the pandemic due to the delayed receipt of vaccines in years to come.
The crucial issue attached to it is the mutations in the genetic makeup of the virus responsible for this communicable disease. Mutations makes even those vaccinated for one variant vulnerable to other variants therefore making an end to pandemic unforeseeable. The prevailing situation demands herd immunity at the international level that the researchers believe to be the only viable way to get rid of this pandemic. It is achievable when all the states, from developed economies to underdeveloped states (with or without the capacity to produce the vaccination), have equal access to the vaccines (vaccine-induced herd immunity). Higher demand for vaccines by the world's largest economies has negated the supply to poorer states in practical terms.
These correlated issues stem from the lack of bargaining powers of the poor economies, the vaccine nationalism, and the inability of the rampant vaccine production steered by the World Health Organisation (WHO). The Trade-Related Aspects of Intellectual Property Agreement (TRIPS Agreement) is argued by majority states as a major clog to the equitable and expeditious access to vaccines. The pharmaceutical giants have the patent protection under the said agreement that runs for twenty years, within which they potentially make profits to an exorbitant extent on the actual investments spent on their first-time production. The proponents of patent waiver argue that waiting for twenty years for the production to start at optimal levels engaging all the producers to counter global demands of vaccines is humiliating in the given situation where each passing day is crucial to the precious human lives. One clear manifestation is India, which can provide for the substantial world demands of the vaccine as is called the pharmacy for the developing countries. Nevertheless, India is incapable of playing the role and one factor is the patent restriction (except for some like the SERUM Institute agreement with AstraZeneca but with the licencor controlling the recipients). It is miserably affected by the lack of a sufficient number of vaccines since vaccine centres have to shut their doors for the public after every few days for want of more vaccines.
Thus, the debate is sparked among the World Trade Organisation (WTO) members to waiver the intellectual property (IP) rights during the emergency whereby the developing states would be able to produce the generic version of vaccines in the domestic market without fear of reprisal from the patent owners. Unanimous approval is needed from one hundred and sixty-four WTO members whereby every member state will be allowed to play the role they are capable of but to date are cuffed by the IP system. The waiver demand has the backing of international organisations like Medecins Sans Frontieres that are stressing the need to take steps that allow rapid mass production of covid vaccines for catering to global demand.
“It is about saving lives at the end, not protecting systems.”
Dr. Maria Guevara – Doctors without borders
There are different protective mechanisms for innovations under TRIPS Agreement. The most debatable in terms of covid vaccine manufacturing are the patents, the data exclusivity and the trade secrets. The patent is a monopoly granted to the inventor for the invention for twenty years. The trade secrets are, unlike patents, not made public for their nature and include the know-how of the invention, which the owner intends to keep in secret. Such protection is permanent (unless disclosed) and is carried out usually by non-disclosure agreements. Though the debate mostly surrounds the patent waiver yet the writer believes the disclosure of otherwise protected trade secrets is essential for getting the intended benefits from patent waiver. It is not possible to cook something without knowing the ingredients or recipe. To avoid reverse-engineering which can be done easily to form replicas, patents play a key role, but where the good is manufactured in a way that the reversal is not enough to understand the method of manufacturing, then trade secrets best serve the purpose whereby the essential know-how remains within few hands and is not made public. Confidentiality pledge by key employees is one mode of maintaining such secrets. Trade-secret protection generally lasts longer than patent protection. These protections are obstacles during emergencies, as the world is witnessing today. Solely waiving the patent will not work as is evident from the 2020 Moderna decision not to enforce vaccine patent, as without technological transfer and share of know-how, such non-enforcement of the patent is futile. This exhibit its symbolic and nominal empathy of not enforcing the patent. The need is the waiver of both patent and trade secrets essential for scaling up covid vaccine production.
Waiving Intellectual Property Rights: A Step In A Right Direction
The world is in dire crisis with the current terrible pandemic. Emergencies and unprecedented situations demand innovative solutions as old methods do not suffice. The current IP provisions in the TRIPS agreement have caused an “artificial scarcity” of vaccines for two main reasons: either the states cannot afford the prices at which they are sold (as the charitable initiatives are not sufficient) or the slow production of vaccines compared to the exponential demand. Suspending IP rights is unusual but justified in accounting for the inadequate and inequitable supplies of vaccines to the developing and underdeveloped nations. Waving IP rights would enable countries around the globe to use patented invention in the making of generic bio-products without the fear of being sued by the pharmaceutical companies which own such patents.
Although waiving the patent rights directly benefit the less privileged nations; it has undoubtedly an indirect benefit for even the richer states. This benefit is because when the majority of the world population (eighty percent) is immunised, this will help achieve global herd immunity—the only way out from the novel pandemic situation that knows no boundaries. Besides being the right thing to do so, having vaccines available to poorer countries is in the self-interest of the first-world countries. Furthermore, improving the manufacturing capacity of the developing world is another concern of debate.
Extreme situations require extraordinary measures. It is also the fact that not enough vaccines are manufactured to cope with their surging demand, and to waive vaccine-related IP rights is one facet of numerous steps that shall be taken to bring mankind out of the pandemic. Other measures include rectifying supply chains, establishing complex bio-manufacturing facilities, transferring technology from companies, and so on. All these steps need to be cumulatively taken as a global collaboration to make it possible for all individuals around the world to get vaccinated in the fastest possible time.
There is an obvious tendency that states will firstly look after their own citizens who have elected them. Yet, humanity demands a collective fight against the deadly covid pandemic. Viruses do not respect borders. Man cannot live in isolation in this increasingly interconnected and tightly knitted world. With the contagious viruses, no one is protected unless and until the majority gets vaccinated. The immunisation of the majority should be, in the given time frame, for the mutating virus that potentially escapes the effect of a vaccine manufactured for a particular genetic sequence.
Five major covid vaccine producers account for over ninety per cent of all vaccines produced globally. Waiver proponents assert that production needs to happen faster for tackling mutating viruses. IP rights should never be implemented in emergencies like the covid pandemic, even under the TRIPS Agreement. The demand for waiving IP rights is to make sure that countries around the globe can increase production and manufacture enough supply to meet the ever-increasing demand. Furthermore, more manufacturers in more countries could drive prices down, though some manufacturers like AstraZeneca and Jonson & Johnson have vowed to provide vaccines on a non-profit basis during the pandemic. Up to writing this article, some hundred countries led mainly by India and South Africa, have demanded WTO to suspend certain patent rules contained in the TRIPS Agreement. Legal barriers would be overcame by such waiver which otherwise prevents them from manufacturing the generic versions of vaccines. The waiver can act as a stimulus for making availability of vaccines more equitable. More than eighty percent of vaccines produced go to rich and middle-income countries. This led to the prediction that mass vaccination in underdeveloped countries is possible not before 2024 if the same distribution mechanisms remain intact. The richer countries that have the capacity of bulk buying vaccines and even booking them in advance are the ones opposing the waiver. One of the reasons for the opposition is that these states are housing some giant pharmaceutical companies.
Shortcoming of The Existing Intellectual Property Legal Framework
TRIPS Agreement came into force in 1995 following the coalition of developed countries who bargained with the developing and underdeveloped states to consent to this agreement whereby IP rights could be cashed. Over time, as the provisions become clearer in their application, it faced criticism which it is still facing. Doha Declaration of 2001 was a victory for the developing states and organisations that secured certain flexibilities in the TRIPS Agreement in the public health sector. Utilisation of patent was allowed to the states under certain conditions even where patent holder did not permit its usage - the compulsory licencing. Yet the scope of said mode is limited which will be discussed later in the article. The debate on the incompatibility between the TRIPS Agreement provisions and public health is old. Ban Ki-Moon, General Secretary of the United Nations, highlighted in his report of 2016 the disagreement between the public health policy and the practical application of the innovation protection laws. The debate on the said agreement has once again ignited in the backdrop of a deadly pandemic as a compact IP web protects the vaccine and the vaccine-producing platforms.
I. Limitations Imposed by Patents
The normative construction of the patent protection under the TRIPS Agreement does account for the disclosure of protected innovation, but its mechanism is insufficient and inadequate. The information disclosed in the patent application is, first, not technical enough to provide any assistance. Secondly, such information is placed at the public disposal for “usage” in public health crisis once the patent life expires. The said limitation undermines the essence of the patent protection regime and undermines the intention of the Uruguay Round negotiators.
Moreover, once the patent is granted, no further revelation of adequate knowledge is demanded whereby the manufacture has improved. This inadequacy of the information disclosed is a clog to the covid-19 vaccine production. The problem is further aggravated by the gap between the filing of a patent application and the grant of a patent, during which time the public is unaware even of such inadequate knowledge. The manufacturers further employ different tactics to prolong the patent protection, for instance, modifying the original patent application with slight changes and filing modified applications from time to time and enjoying protection thereunder. This makes the time-duration of patent protection doubtful for the competitors, especially in vaccine development which then becomes less appealable to them (though some other reasons are also responsible for making the vaccine market less attractive for investors). Shortly, the extension of patent protection beyond the fixed timeframe and inadequacy of knowledge shared in patent application clogs the covid vaccine’s swift development. This limits the capacity of capable manufacturers in a time where resources must be employed to their full exhaustion to defeat the pandemic that has miserably affected humanity.
II. Disclosure of Know-How And Trade Secrets Inevitable
Vaccines are unique in comparison to medicines, and mere patent information does not suffice in their production. Undisclosed information includes vaccine know-how, trade secrets, and clinical trial data, which the investor intends to hide from the outside world. It is essentially aimed at avoiding free-riding on to the energy, time, and money invested by the inventor in the research and development of the invention from scratch. If disclosed, this will tend to lower the cost of production for others. Unlike patents, the undisclosed information, as the term indicates, is not opened to the public at all. Such disclosure is the biggest concern in the rapid covid vaccine development. The reports suggest that pharmaceuticals manufacturing vaccines have entered into confidentiality agreements that also halt their participation in global voluntary initiatives of pooling technology and know-how as a collective action (most notably Covid Technology Access Pool and technology transfer hub).
Afore discussed two main IP protections and their vitality in the construction of pharmaceutical companies needs to be brought in conformity with the public health policies. The said highlighting of shortcomings should not be construed to mean that the writer backs the non-waiver of IP rights claim, rather, it should be included as part and parcel of the overall bigger package, including technology share, know-how disclosure, non-exclusionary policies both at the international and domestic level. The said package would allow manufacturers from around the world to freely indulge in vaccine production, especially free from fear of the stoppage of vaccines to their countries as a penalty for infringing IP protections.
The waiver proposal led by South Africa and India is an optimistic sign that even if the result is not the waiver, this will lead to the controlled voluntary licencing by pharmaceuticals. The absence of consensus on waiver within a reasonable time would compel a joint action by WTO and WHO to answer to the problem enhancing in its gravity day by day.
Compulsory Licencing: An Insufficient Flexibility In A Vaccine Context
The capable producers are permitted to manufacture the product patented under the licence issued by the respective government. Compulsory licencing has been crucial in biomedical history when access to life-saving “medicines” came under the limelight. The grounds for issuing such licence are not exhaustively listed in the TRIPS Agreement and are in the logical discretion of the member states. For instance, compulsory licence can be issued for grave emergencies, where protecting the public interest is essential. Besides it, other factors can also trigger the application of compulsory licencing.
TRIPS Agreement provides for resorting to compulsory licencing in situations of a grave emergency, but before that, an attempt to negotiate a voluntary licence agreement is a must. Absence whereof, in the national interest, the government can issue a compulsory licence. But the layer and fragmentations of IP protections render the flexibility of compulsory licencing least suitable to vaccine development. There are other reasons as well that demand more than the mere compulsory licencing as its application limits in the context of rapid vaccine development. The overall procedure of vaccine development is not restricted to a single territory, and it is not possible to issue a blanket or an all-inclusive compulsory licence. Therefore, the said issuance needs to be country by country, and case by case, to be more impactful.
The choice to impose additional requirements and criteria for compulsory licencing in domestic legislation can make the two-fold criteria more cumbersome. The issuance of compulsory licences has been a rare circumstance as states are hesitant for fear of severe trade sanctions being imposed on them, as is done in history. The additional protections at the regional and domestic level of exclusivity, for instance, clinical trial data as regulations further obstruct the development of vaccines. This further prolongs the timeframe of protection.
Where a compulsory licence is issued, the inventor/manufacturer should be reimbursed adequately. But what is adequate compensation in the context of vaccines is obscure. The licenced goods were before the 2001 amendment in pursuance of the Doha Declaration were to be essential for domestic demands, yet, following the addition of Section 31bis in the TRIPS Agreement, the goods produced under compulsory licencing can be exported to member countries of WTO. The said amendment’s reservations can be made but countries, especially the EU family, have opted out of it.
The resort to compulsory licencing has rarely been made, for instance, when Rwanda obtained access to vaccines for AIDS, and Canadian companies exported it. However, it is a burdensome and time-consuming step, and is in no way suited to the present-day crises where each passing day is costing lives. The issue of transparency of patent protections has made it more difficult to assess the scope of applications seeking the issuance of compulsory licences. The one hope the TRIPS Agreement waiver proposal has given is that the states are easing their domestic compulsory licencing regulations to make a case against waiver. Though it will help in the availability of diagnostic and therapeutic products, its role is limited in vaccine development. The present study suggests that compulsory licencing should not be employed as a substitution to TRIPS Agreement waiver in addition to the waiver itself. There cannot be negation to the fact that in the containment of viral speed, sole compulsory licencing is insufficient and that advantage offered by the TRIPS Agreement waiver is multifold as compared to the compulsory licencing, which is limited in the ever-advancing field of technology.
Foreseeable Pharma Giants’ Practices With Intact IP Protections
The goal to diminish the covid pandemic with the least loss of lives is undermined by the monetary benefits yielded from the monopoly market. The issue is not as simple as it might appear. The wait of under-developing countries for mass inoculation might be prolonged even after the richer economies have fully vaccinated their population because there are cases reported around the world where even vaccine administered individuals are ailing. Some are dying due to the transmission of the mutated virus that can suppress the effect of the administered vaccine. Here, the role of boosters comes into play. Some countries have even announced the booster shots administration starting from health care workers (for instance, Thailand).
The foreseeable situation would be that, on the one hand, fully vaccinated will be given dosages of boosters and on the other extreme, the citizen of poorer nations will be dying for want of dosage of the vaccine in the first instance. If the IP waiver does not take place now, the world would probably see a decline in the manufacturing of covid vaccines once their demand by prosperous economies is fulfilled. Waiving IP then would be the denial of equal human rights, especially when each passing day is critical. In the absence of any incentive from the poorer nations, the giant pharmaceutical companies would then turn to the race of booster manufacturing by agreeing with giant bargaining powers.
“To deny people their human rights is to challenge their very humanity.”
- Nelson Mandela
Impact Of Waiver On Future Innovations: A Negation To Claims Of Waiver Opponents
There exists a dichotomy of expert opinions on the impact of the IP waiver. On one side, the opponents of waiver term it as a block to future research and industrial development in vaccine production. Putting the advanced technologies in the public domain will undermine the potential developments. While other groups say that a temporary waiver is an ideal solution to convert pandemic to endemic without having many repercussions for pharmaceuticals.
Arguments on incentive-based innovation find little to no support from the existing literature. Even if one admits that innovation stems from the hope of profit, then the same will not hold for covid vaccines owing to the way they have developed. There is substantial public funding that has gone into the research and development (R&D) of covid vaccines, and breakthroughs have taken place in universities and national health institutes. This makes a weaker case for the patenting of the vaccines and the trade secrets utilisation for vaccines manufactured on public subsidies. The privatisation of covid vaccines is not justified where there are zero risks for incentives and profits are attached to development as the governments have entered into advance agreements. The COVAX initiative further secures the return on investments.
Monopoly is created by patent protection for a specified time that prohibits any competition during such time. This implies the choice as to the fixation of price and the dissipation of the technology shared with the patent owners assuming dominance. Thus, the production of commodified goods can be restricted during the life of a patent. This is troublesome for public health policies. Pharmaceuticals are constructed on this patent protection system, and the outcomes of such basis are evident in the prevailing covid crises. The fact that the majority of the WHO approved vaccines had substantial reliance on public fundraising makes a stronger case for the availability of the vaccine to the world population and that the manufacturers have no right to monopolise over what has not been economically afforded by them. The breakthrough as to the duration in which these vaccines are made available for use is accredited to the integral role played by public sectors. The products are yet monopolised, which has badly impacted the proportionate distribution of vaccines to every corner of the globe.
Therefore, the present time calls for treating the pandemic as exceptional, and its impact should not be underscored. The current pandemic is unique and unprecedented and thus should be handled extraordinarily. TRIPS Agreement failed to acknowledge the varying socio-economic conditions of states in pragmatic terms. This has badly impacted the access of underdeveloped countries to lifesaving drugs and vaccines. Under ordinary circumstances, the vaccine market in comparison to the medicine market is less attractive for their not very high demand in higher-income countries, where they are produced to counter the diseases in lower and middle countries and is often on a non-profit basis. There were instances from the past when there was a sole need to deliver vaccines to poorer economies. The markets have often failed, especially against an effort for containing the Ebola virus. It is the best time to devise a solution to the IP framework to tackle prevailing crises and prepare a plan for future inequity in vaccines and medicines.
Currently very few markets are involved in covid vaccine production, which impedes rapid production, and even the offers made by potential manufacturers for voluntary licencing are rejected. Another step that can help mitigate the scarcity of vaccines is to introduce incentive-based global policies to allow the entry of competitors in the vaccine market, which would reduce the monopoly and will account for the demand of increased production. Price fixation and lack of government seeking shares in private profits from vaccines as public commodities, as discussed before, have aggravated the issue for poorer economies who are reported to have been charged higher than others. Pfizer is charging, as the researchers suggest, six percent of the unit production cost and justifies it by saying that this would have been exponentially high had there not been a pandemic environment. The poor economies do not even have the negotiation power for that. AstraZeneca is selling at the production cost, but again the issue is that the company has contractual obligations towards the richer economies. Then there are reports revealing that despite claiming no profit, Astra Zeneca is selling its vaccines at higher costs to lower and middle-income countries than to the richer due to disparity in demand. All in all, the manufacturers’ powers to decide the production matters, price fixation, endemic declaration for purposes of aggravating prices when deemed suited are less likely to solve the grave concern of vaccine equitable distribution.
It is high time to move on to think about lex feranda instead of continuing and defending the existing legal framework (lex lata) that has always been debated for its inadequacies in a public health crisis. The need of formulating alternative policies as a solution to current public health concerns and as preparedness for future public health crises is inevitable. The argument that the waiver would not be effective for want of capacity requirement is baseless as there are demands for licence by governments that do have manufacturing capacity, but the innovation protection mechanism renders the utilisation of such capacity a failure. The first-world countries are under the obligation to incentivise the technology transfer to developing states. Any reluctance, thereof, is in direct conflict with the very spirit of the TRIPS Agreement.
Burden sharing is the need of the hour, and this is not possible without a TRIPS Agreement waiver. The doubtful quality of prospective generic versions of covid vaccines, if allowed, is falsely debated by waiver opponents to be connected with IP waiver. There is no nexus between the two independent issues, and it is just being employed as a scapegoat from waiver. TRIPS Agreement waiver should also negotiate on waiving protection over raw materials necessary for vaccine production as it will then be a challenge once vaccine patents and trade secrets are removed. There is a dire need to reformulate the IP framework connected with public health emergencies in WTO, but till such time, the waiver is essential.
Resolving the issue of inequitable and inadequate distribution of covid vaccine is essential. Besides being a public health concern, the gap in the supply and demand increases the room for corrupt practices - the crimes committed in the dark - which is another challenge to tackle due to the complex processes involved down till the distribution phase. The secrecy of the terms and conditions of the agreement relevant to the procurement of covid vaccines and conflicting interests are some of the aggravating factors for the risk of corrupt practices that undermine the effective implementation of emergency policies, as is reminded by the United Nations Office on Drugs and Crimes. This includes, but is not limited to, the misuse of public funding that has given in huge amounts to the development of a vaccine, counterfeited vaccines, nepotism, and favouritism. The dismissal of Zimbabwean top governmental medical officials on similar grounds has materialised the risks. While writing this, the news from Pakistan surfaced on the detention of the suspects for allegedly plundering the Pfizer vaccines from the governmental stock with the aid of a vaccine administrator employed by the government and selling it for financial gains. This further aggravates the artificial scarcity of the covid vaccines. There are risks involved in the entire chain from procurement to the distribution of covid vaccines. The time is of much essence where these risks are highest because the supply is substantially low compared to the demand. The alleged corruption undermines the public confidence in the governmental efforts in public health emergencies. Mitigating the corruption risks, both at the international and domestic level, is another challenge in the equitable access to the vaccine. Transparency in the agreements over covid vaccines is achievable through open contracts, which will minimise the corruption risk in the procurement stage. At the domestic level, the viable proposal is that specialised committees should be established for monitoring the entire distribution and deployment process. Several guidelines have already been issued in this regard. To address the scourge of corruption globally, especially during a public health emergency, United Nations Convention Against Corruption (entry into force 2005) demands international cooperation in the fight against corruption. Furthermore, it is high time to strengthen the anti-corruption national legislation and fill in the gaps in the laws to mitigate any chances of manipulating the law for personal gains.
Conclusion
The world is indulged in a race to accumulate as many quantities of covid vaccines as they can. This has led to the inequitable distribution of vaccines with advance purchase agreements. One big reason is the IP protection that disables the capable manufacturers from producing their domestic versions of vaccines which is the need of the hour as depicted by the facts. The relevant stakeholders are not serious in the consensual resolution of the problem. Therefore, mandatory action is a must to address the grave issue of the pandemic. End to covid is not just a public health concern but a socio-economic and moral concern too. Demand for a patent waiver does not tantamount to ask charity, rather it asks for an entitlement to manufacture the local vaccines without being sued by the patent owners. The pledge of the developed countries in Uruguay Round Negotiations of 1994 to ensure the provision of benefits of technology transfer and capacity building at the disposal of developing economies is sabotaged with their hoarding of covid vaccines. The race for buying vaccines and even booking the future production has been termed by WHO director-general Tedros Adhanom Ghebreyesus as “catastrophic moral failure,” which is self-defeating, not just economically but also epidemiologically. The pandemic has unveiled the inadequate provisions of the IP mechanism.
Currently, the capacity of global production of the covid vaccine stands at 3.5 billion doses per annum. But the required capacity is 10 billion doses per annum to immunise seventy percent of the world population. Only radical expansion of the current production capacity can meet the demand. Countries housing pharmaceutical giants are the main opposition to the waiver who have entered into advance purchase agreements with richer economies having the bargaining power. Developing and underdeveloped states are left to wait for the supply of a limited number of vaccines under the COVAX scheme, which is insufficient in terms of roll-out and supply to cater to the surging vaccine demands there. This is a do-or-die situation. As early as the world realises it, it will be better for this planet prone to critical survival challenges. It is high time to find plausible solutions to the clash between private monopolistic gains and the public health interest. The lack of empirical study on the impacts of IP rights on vaccine production is a major clog in reaching a logical and reality-based decision on whether it is essential to waive covid vaccine IP rights or not, which the writer believes will help the countries in substantiating their claims in WTO meetings.
In the event of failure of the agreement on waiver demand, aggrieved states can take collaborative action under Section 73 of the TRIPS Agreement as the last option. The richer economies, most notably the United States, now supporting the waiver should also join in. The exceptional situation of pandemic and the repercussions, thereof, fit into the said section and are equal in effect to waiver. Invoking it will be challenged for the settlement of disputes yet, it is a strategy that merits consideration. Dr Tedros Adhanom Ghebreyesus, DG of WHO, has demanded states to be “on war footing” if they want to defeat this unprecedented pandemic. It is still not too late to take a step in the right direction of bringing global health imperatives within the sphere of international law.