• TIPLPR

IP WAIVERS: NOT A SOLUTION FOR THE IMPENDING VACCINE DOOM

Updated: Jun 17

Introduction

Pharmaceutical giants, in the international vaccination race, have been prompt to voice their objections to the proposed Covid-19 waiver of IP rights for the course of the pandemic. Companies have cautioned that enabling their Covid-19 vaccines to be reproduced without their approval through compulsory licensing will stifle innovation and put people at peril of contracting severe infections. What is really missing from the waiver argument is a coherent justification from waiver supporters as to why they presume their existing right to compulsory licensing will be inadequate to provide access to Covid-19 vaccinations.

The waiver, according to critics, is a misleading cloud that will do minimal to boost global vaccination circulation while eroding opportunities for innovation. Pharmaceutical companies, medical professionals and some nations claim that IP laws and the revenues they provide encourage the production of technological breakthrough in the case of Covid-19 vaccines. The most significant hurdle to global immunization initiatives is a lack of production capabilities, rather than patents. Several nations would be incapable of developing the vaccines lacking the technological competence of the innovators or access to essential components which are presently in high demand, skeptics contend even though the patents were lifted.

Conversely, some legislators and scholars in the US are wary about inviting Chinese government and other competing nations to get valuable intellectual property. Developed nations should discontinue stockpiling vaccines and expand their exports rather than requesting an IP concession. In this article, the authors aim to present the view- that a patent reservation would not serve as a solution, and developed nations ought to be pushed to build a "globally diverse vaccine production chain" to generate simulation model vaccines for the Covid-19 outbreak and forthcoming disease outbreaks.

International Covenants binding the IPR & Vaccination

As the globe dodges with Covid-19, the controversy of IP constraints steals the show. According the TRIPS agreement, vaccinations and other therapeutics devised to counteract Covid-19 are protected from patent infringement.

In November 2001, the Doha Declaration on the TRIPS Agreement and Public Health clarified a crucial leverage granted to governments under Article 31 of the TRIPS Agreement. The ones who criticize the approval process for a TRIPS concession claim that the desire to freeze IP obligations is counterproductive because the TRIPS Agreement has an additional leeway which can be deployed to solve global healthcare emergencies. The authority of a country to grant a license enabling utilization of a patent within the contract period sans the patent owner's approval, which is controlled by Article 31 of the TRIPS Agreement, is one such essential leeway. The European Union advocates for alternatives such as using TRIPS flexibilities and voluntary licenses.

Voluntary licensing and tech transfer from innovator companies can immensely boost perennial production capabilities, particularly when combined with public investment. Their involvement is fundamental for both performance and accuracy. One cannot argue that IP safeguards always benefit the public, nor can one preclude the possibility that IP will become a major barrier to worldwide access in the future. However, overwhelming data insinuates that the infrastructure and production capacity, rather than the legal restrictions, are the primary barriers to worldwide accessibility.

Global Access and Equity: Still a far-fetched dream for vaccines?

The Biden administration recently announced its support for the patent waiver proposal advanced jointly by India and South Africa at the World Trade Organization, however, experts argue that these negotiations may have catastrophic ramifications for the pharmaceutical sector.

One of the prominent issues that the world is currently facing is vaccine scarcity and its inequitable access, and therefore, it is pertinent to understand that these issues are not caused by or related to patent rights; instead, they are merely allocation and contractual problems. Developed and affluent nations have struck pre-order deals to acquire vaccines which are resulting in limited supply and mismanaged distribution for the low and middle-income countries. This leads us to our second imperative issue- Presently there is no established legal framework that would intercept a country and a vaccine manufacturer to enter into the same contractual negotiations for the sparse vaccines that likewise administer the mass production and allocation of other commodifiable goods. Thirdly, there are no compelling legal requirements for the higher-income nations to re-direct the large number of vaccines acquired and share them with the developing nations.

The issues discussed above clearly warrant lawmakers in the low and middle-income countries to take the requisite policy actions and focus their efforts on alleviating the irrepressible repercussions of the contractual mechanisms existing in countries like the U.S. and encourage them to adopt more equitable practices.

Resistance to Waivers

IP waivers are being depicted as a mechanism that will overcome the acute vaccine shortage and increase the supply. These proposals seem precise if the companies will be able to 1) exactly replicate the existing vaccines and 2) produce and distribute to an extent that it reaches the inaccessible regions. However this is not the case here.

a. First step, not a panacea

A temporary waiver may eliminate exclusionary rights but we are still posed with an imperative informational problem. Experts contend that the information disclosed through patents alone is deficient for a third party to exactly replicate a vaccine unless the patent holders themselves cooperate. The disclosure of implicit information and the technical know- how still remains a challenge and bolsters the prevailing competition in vaccine manufacturing. Thus, a waiver may serve as a first step in solving the exclusivity problem, however, it doesn’t serve as an elixir by providing all the knowledge required to produce the desired vaccine.

b. Infrastructural limitations

We have been facing global vaccine manufacturing problem since a long time and the current waiver proposals that are predicted to resolve them may actually intensify the present problems. Even if the legal restrictions are lifted there is simply an inadequacy of infrastructure facilities as well as raw materials to actually manufacture and distribute the vaccines effectually. Additionally, even after addressing the informational gaps there are still concerns as to whether the beneficiaries through the availability of qualified personnel will be able to administer the technology transfer and implement the required knowledge in making the vaccines of required quality.

c. Danger to innovation

Many critics, along with Germany and other European countries, argue that a patent waiver would pose a risk to the future vaccine innovation endeavors and discourage the skilled technicians and manufacturers to produce the vaccines in the first place. Corporate Pharmaceutical Research giants believe that the waiver could result in the disruption of existing supply chains or raw materials and result in substandard use of scarce resources at a critical time. The problems that will ensue because of trade barriers and supply-chain restrictions will have far more troublesome implications than the issue of patent rights.

Conclusion

The IP moratorium is a positive move, but it will likely be insufficient without additional backing in the form of technology transfer and assistance to help establish the necessary infrastructure for high-quality vaccine production. Export prohibitions, distribution network and production capacity bottlenecks are the issues that need to be addressed. Even if the WTO provisionally grants IP & patent rights on some of the world's premier Covid-19 vaccines, the developing countries will have to queue up for a prolonged time to begin producing prototype equivalents. While the waiver resolves the obstacle of getting the legal authorization to produce other companies' vaccines, many analysts maintain that releasing the blueprint and surrendering patents are entirely distinct issues.

IP rights, in no case, should become a legal impediment to facilitating timely accessibility to reasonably priced medications for everybody around the globe during a pandemic. In this regard, WTO members should not respond in a manner which eliminates the incentive schemes that are necessary to stimulate the breakthroughs that allow new medications to be developed.

The Way Forward

‘Transnational cooperation’ in international organizations and ‘international effort’ beyond the WTO, are the answers to the protracted global dispute within the WTO. Suspending IP rights will not benefit any government in the foreseeable future since it will undermine the spirit of invention that spawned these vaccines in the very first instance. The goal of every effort of international institution as well as of the WTO, in the battle to prevent this pandemic, must be to retain harmony.

The ideal equilibrium in WTO trade rules on IP is one that gives all nations enough discretion to maintain IP rights while also pumping up supply to resuscitative medications. There is no confirmation that this equilibrium does not serve a purpose for Covid-19 medications, at this juncture. Therefore, instead of clutching for a needless WTO waiver, the developing nations should concentrate their actions on finding rejoinders to the issues they’re confronting.


Title Image : MSF


This article has been written by Isha Lodha and Prapti Kothari. Isha and Prapti. They are both second year law students from GNLU Gandhinagar and ILNU Ahmedabad.