TRIPS AGREEMENT – Waiving Off: An Explicit Example.
The COVID-19 pandemic has had an effect on people and organizations all around the world. The pandemic is also having an effect on the security of established intellectual property rights (‘IPRs’) as well as IPRs that are being contemplated for protection. Although IPR holders are normally given immunity from third-party use of their intellectual property (‘IP’), the pandemic has created an extraordinary condition in which IPR holders could be compelled, even temporarily, to allow third-parties to use their IPRs, such as patents or designs, for the public good.
Medical instruments and pharmaceuticals are commonly covered by patents, which give businesses the legal right to prevent third-party access. After investing time and resources into the development of the IP, patent protection helps developers to secure a quasi-monopoly, at least for a few years, on their own unique creations.
On the other hand, the COVID-19 crisis created the need to produce essential equipment and medical supplies regardless of any possible backstop. Indeed, there is a growing need to be able to manufacture essential medical devices such as masks, ventilators and other personal protective equipment.
However, in the current times, it can be seen that there is turf war for either the waiver of IP rights or the seeking of the rights between various corporations and governments across the globe. In this research paper, the author seeks to find out whether or not the IPR should over public welfare.
It is an undisputed fact that the world has come together to curb the spread of COVID-19 by manufacturing effective vaccines in short span. The arrival of vaccines against COVID-19 gives hope in ending the pandemic that has claimed numerous lives so far. Inoculating millions of people around the world, on the other hand, will necessitate substantial vaccine manufacturing and equal distribution. The intellectual property (IP) rights that vaccine developers have are a barrier to vaccine production and distribution. To understand this, one needs to know about TRIPS.
The 1995 Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS) is a key legal mechanism that harmonises intellectual property (IP) protection by implementing binding obligations on member countries to guarantee a certain level of protection and regulation of IP rights in their territories. The TRIPS agreement, which is part of the World Trade Organization’s (WTO) legal framework, regulates the enforcement of intellectual property rights through settlement mechanism.
As the world grapples with COVID-19 today, the controversy takes centre stage. The vaccines and other therapies introduced to tackle COVID-19, which have provided a distinctive silver lining to the epidemic, are covered by the TRIPS agreement. For the duration of the patent, the patent holders retain the sole right to produce, distribute, and use the vaccine or medicine for 20 years from the date of filling for the patent.
The controversy about TRIPS’ effect on people’s right to health has continued since then. IP protection, according to proponents, encourages innovation and, as a result, should be reinforced through a network of national and international legislation. Meanwhile, opponents contend that intellectual property rights, including those related to patents, obstruct the implementation of affordable vaccines and medicines in developing countries and deprive people their right to health. This type of protection could prevent vaccines from being more widely available, prolonging the pandemic. The pandemic will be ended by the whole vaccination process, not by the vaccinations themselves, and the challenge is to ensure that it is universalized.
In this sense, it’s important to understand India and South Africa’s joint WTO proposal for a temporary waiver of IP rights on COVID-19 vaccines and drugs. IP rights, according to the plan, could stymie the affordable delivery of vaccines and medicines.
India and South Africa have proposed that the WTO’s TRIPS Council recommend to the General Council “a waiver from the implementation, application, and compliance of” some provisions of the TRIPS Agreement (waiving IP rights such as patents, copyright, and trademarks) for the prevention, control, or treatment of COVID-19.
“If we fail in the next one or two quarters by not delivering on the TRIPS waiver, let me tell you we will not just fail on the question of equity, we are coming in the way of global growth and livelihoods. It is not only that we are coming in the way of life,” asserted India’s ambassador to the WTO Brajendra Navnit.
If the waiver is approved, WTO member countries may be relieved of their duty to grant or enforce patents and other IP-related rights for COVID-19 drugs, vaccines, and other therapies for a limited time. This would protect countries’ efforts to immunise their citizens against claims of illegality under WTO rules. Thus, to find out find out whether the obligation needs to be waived off or not, one needs to look into the legal angle of the same.
- The Legal Aspect Involved
The Ministerial Conference may waive an obligation imposed on a WTO member country by the WTO Agreement or any other multilateral trade agreement under “exceptional circumstances,” according to Article IX.3 of the WTO Agreement. The terms “exceptional circumstances” as used in Articles IX.3 and IX.4 of the WTO Agreement are not specified. However, the terms “exceptional circumstances” suggest that the right to waive such obligations is intended to legalise actions taken by a government in extreme cases that would otherwise violate WTO rules.
It is quitter evident that COVID -19 that has devastated millions of lives around the world and has caused various economic and social destitutions undoubtedly falls under the bracket of “exceptional circumstances” as mentioned under the above-stated articles.
As the pandemic continues to spread, governments must come up with new approaches to not only boost vaccine production but also ensure prompt distribution at affordable rates. The waiver would lift countries’ IP obligations, allowing those with manufacturing capabilities to manufacture COVID-19 vaccines and send them to countries without manufacturing corporations. The waiver could be issued for a year at first. At the end of the year, it could be reconsidered.
- Are the TRIPS’ Flexibilities really sufficient?
Many who condemn India and South Africa’s proposal for a TRIPS waiver claim that the appeal to terminate IP obligations is unnecessary since the TRIPS Agreement includes many flexibilities that can be used to resolve public health emergencies.
The right of a government to grant a licence to make use of a patent during the patent term without the patent holder’s consent, which is covered by Article 31 of the TRIPS Agreement, is one such significant versatility. Article 31 allows for public non-commercial use, which means that a government may authorise the use of a patent for its own purposes. However, it would be incorrect to assume that this flexibility would be sufficient to address all public health problems, particularly one as large as the current pandemic. For all countries, the utility of the same TRIPS flexibility, such as compulsory licencing, is not the same. Compulsory licencing can be used extensively in countries with pharmaceutical manufacturing infrastructure.
Other flexibilities include voluntary licences, which are licences granted by patent holders to generic firms under mutually agreed-upon terms. A voluntary licence, for example, is the AstraZeneca COVID-19 vaccine, which has been licenced to India’s Serum Institute. The voluntary licences, on the other hand, are mostly concealed in anonymity, with the patent holder regulating key decisions such as who will be the sole beneficiaries of the drug and how third-party sellers will be chosen.
This year, the global community started out with the single goal of putting an end to the COVID-19 pandemic. This would only be likely if a large share of people around the world were vaccinated. Given the overwhelming demand, vaccine supply must be greatly expanded, followed by a more widespread and equal distribution. Such a mission cannot be accomplished only by an IP waiver. Increasing vaccine production and maintaining equitable access will also necessitate strengthening institutional capability in many countries, solving structural bottlenecks, and pursuing the necessary research and development. Nonetheless, a TRIPS waiver may be a critical move toward increasing vaccine production.
The point that suspending IP rights would be a deterrent to the pharmaceutical industry is unpersuasive: with the enormous demand, these corporations are guaranteed to make a profit. Furthermore, pharmaceutical companies also at profit from government grants and funds, such as in the production of the COVID-19 vaccine. As a result, it is reasonable to expect the gains to be shared with the rest of society. Therefore, the global community must use its available resources, including a temporary TRIPS waiver.
Research Paper By – Pragati Gilda
 Walsh, Wallace. et al. “Intellectual Property Rights and Access in Crisis”. (Springer, 2021). https://doi.org/10.1007/s40319-021-01041-1
 Article 28 of the TRIPS Agreement.
 Article 33 of TRIPS Agreement.
 Sunil Kanwar and Robert Evenson, “Does Intellectual Property Protection Spur Technological Change”, (Oxford Economic Papers,2003).
 Chris Kay and Haslinda Amin, “Vaccine Nationalism Threatens WHO’s 2021 Goal of 2 Billion Doses”, (Bloomberg Quint, 2021).
 TRIPS Waiver Proposal, para 12.
 For a detailed discussion on WTO’s Waiver power, See Isabel Feichtner, “The Waiver Power of the WTO: Opening the WTO for Political Debate on the Reconciliation of Competing Interests”, (European Journal of International Law, 2009).
 Ana Santos Rutschman, “The Intellectual Property of Covid-19” (Saint Louis University School of Law, 2021) https://scholarship.law.slu.edu/cgi/viewcontent.cgi?article=1537&context=faculty
 Prashant Reddy, “In India, Covid-19 Vaccines Face A More Urgent Problem Than IPR” (Bloomberg Quint, 2021) https://www.bloombergquint.com/coronavirus-outbreak/in-india-covid-19-vaccines-face-a-more-urgent-problem-than-ipr
Prabhash Ranjan, The Case for Waiving Intellectual Property Protection for Covid-19 Vaccines, (Observer Researcher Foundation, 2021) https://www.orfonline.org/research/the-case-for-waiving-intellectual-property-protection-for-covid-19-vaccines/
#waive #trips #agreement #licensing #aklegalassociates #criminallawyer #lawyer