India’s Tryst with The Right to Be Forgotten -Trying to Not Miss the BoatJuly 18, 2021
MARATHA RESERVATION JUDGEMENT: ANALYZING THE “RULE OF 50% CEILING”July 18, 2021
In October 2020, at the WTO’s TRIPS Council, India and South Africa proposed a draft for waiver of certain provisions of the TRIPS Agreement on Intellectual Property protection. The proposal propounds a waiver for all the WTO member countries on the implementation as well as enforcement of provisions in relation to the “prevention, containment or treatment” of COVID-19. It might be a smart move, but entails profound contemplation. The question of whether the flexibilities provided by the TRIPS Agreement are inadequate in dealing with the present pandemic situation has been much debated—substantially, those countries which lack the production capacity in the pharmaceutical industry. Uncertain ownership rights may also result in investment reluctance. The proposers contended this would overcome the barriers regarding the prompt access to affordable medical products encompassing vaccines and medications or manufacturing and supply of indispensable medical products. The article underlines the benefits and potential TRIPS waiver, overview of TRIPS agreement, history and present scenario of TRIPS agreement in India, and finally some suggestive annotations.
II. WTO COVID-19 TRIPS Waiver Proposal
The communication was disseminated pursuant to the request of the delegations belonging to the African Group, the Plurinational State of Bolivia, Egypt, Eswatini, Fiji, India, Indonesia, Kenya, the LDC Group, Maldives, Mozambique, Mongolia, Namibia, Pakistan, South Africa, Vanuatu, the Bolivarian Republic of Venezuela and Zimbabwe. Although, various developing and underdeveloped countries embraced the proposal as a contribution to the deliberation, many were still rectifying it and entreated for elucidation for certain conditions, explicitly concerning its feasible implementation and the probable economic as well as legal impact of the waiver on a domestic level. It is also worth noting that there is no manifestation that Intellectual Property Rights have been an undisputed obstacle for the purpose of obtaining COVID-19 related medicines and technologies. The EU has also proposed that members of the World Trade Organization (WTO) agree on a global trade effort for equal access to COVID-19 vaccinations that includes the following three elements: 1) trade facilitation and export limits discipline; 2) production expansion, including pledges by vaccine producers and developers and; 3) flexibilities relating to compulsory licences. However, EU and some other developed nations are not espousing the move.
Several pharmaceutical industry groups have also proposed a five-step plan to urgently advance COVID-19 equity. In order to scale up worldwide production, manufacturers have continued to collaborate with other businesses. Merck and Gilead have signed into voluntary license agreements with Indian manufacturers to make their respective drugs. Some WTO members have also contemplated extending their vaccine access through existing TRIPS flexibilities. Bolivia, for example, has maintained its efforts to import the Johnson & Johnson COVID-19 vaccine from Biolyse Pharma, a Canadian business, under a compulsory license under TRIPS Article 31bis.
India has recommended text-based negotiations on the interim TRIPs waiver proposal to deal with the COVID-19 pandemic as there is little time to waste and nations should aim to wrap up the talks by the end of July. Furthermore, at the formal TRIPs Council Meeting on June 8-9 in Geneva, India indicated in a statement on TRIPs waiver request that it would like to engage in line-by-line talks on the text and that it is open and flexible to engage in all feasible formats, whether in plenary or small group sessions. The plan has been criticised by major pharmaceutical corporations, who claim that it will stifle innovation.
III. Overview of TRIPS Agreement
The TRIPS (Trade Related Intellectual Property) agreement has developed as a basic framework for security Intellectual Property (IP) rights around the globe. Every member of the WTO is obliged to include TRIPS provisions in their national Intellectual Property legislations. The three core primary features of the Agreement are- Standards, Enforcement and Dispute settlement. Following areas of Intellectual Property are subject to the Agreement: 1) Copyrights and concerning rights; 2) Geographical Indications; 3) Industrial Designs; 4) Patents (including conservation of new breed of plants); 5) Trademarks; 6) Trade Secrets
Developing countries, predominantly the BRIC countries ought to assimilate their domestic systems of transformation to the worldwide IP mechanism increasing after the enactment of the TRIPS Agreement for escalating global economic welfare. Majority of the developed countries demonstrate misconfigured policies which restrict innovation, resulting in economic loss and other drawbacks. Successful implementation of IP regime is significant to safeguard SMEs from exploitative and bigger competitors. The obstacle faced by emerging economies is to procure the advantages of IP policies without addressing the challenges that the developed countries have themselves failed to resolve. Practical approach is requisite which would include research exemption/ experimental use of IP, anti-blocking regulations, doctrine of essential facilities, government prescribed nonexclusive licensing, and compulsory licenses. Besides drafting and attaining parliamentary approval of new legislations, member countries also need to comply with the agreement. It also demands reappraisal of national laws in the matter of administrative, civil and criminal procedures, additionally, reformulating the role of law enforcement agencies. Drafting legislation requires active participation and combined efforts of various state organizations, as well as communication with the private sector and the community.
IV. Indian Context
In 1994, India signed the TRIPS Agreement which promotes trade and technology transfer between countries by laying down minimum standards of Intellectual Property Rights globally. The Agreement manifests a three-phase framework for bolstering the IP regime in developing nations like India. Before the agreement became operational, India did not sanction product patents in the fields of pharmaceuticals and agrochemicals.
The TRIPS Agreement, in India, came into effect on 1 January 1995. Several amendments were made in the Patent Amendment Act, 2005 and the Copyright Amendment Act, 2010. These amendments were brought in order to enhance the legal framework in compliance with the WTO’s TRIPS agreement. There has been a proliferation of R&D investments in India, causing multinational corporations to sub-contract R&D work to India.
The Indian policymakers seem dubious about how they should proceed with IPR regulations for growth and profitability in India. Taking account of the innovations in the technology sector, increased patent filing, projects which demand copyrights, IPR enforcement needs to be reinforced. Effective formulation of laws is necessitated to protect Patent Filing and Trade Secrets.
V. Important Considerations
Intellectual property determines health R&D. While appraising impact, intellectual property should be considered apropos of other
Successfully implemented, a global IP mechanism can be utilized to ameliorate the access to new medicines and public health interventions by poor
Developing countries that intend to use the TRIPS agreement as a national advantage must invigorate systematic IP policies to take part in the global marketplace and reap benefits from emerging technologies.
TRIPS empowers the countries to establish national patent policies that encounter treaty obligations and economic needs. The National Intellectual Property Rights (IPR) Policy 2016 was adopted to manage the future development of IPRs in India (“Creative India; Innovative India”).
This article can be concluded by asserting the fact that apart from the significance of the TRIPS treaty, yet, there are several contentions and loopholes of the Treaty which have been expressed by the developing countries.
The ultimatum with reference to the waiver and its actual execution can call forth several things. Firstly, if implemented, the waiver will make certain that pharmaceutical industries are compensated for their work in developing vaccines while fortifying that they will not intercept large-scale production. Secondly, if the TRIPS waiver is sanctioned, WTO member countries, for instance, India–wherein international treaties predominantly fail to become a part of domestic law. Consequently, these countries would have to make requisite alterations in their domestic IPR regime to implement the waiver. These alteration swill hinge upon the real terms that the waiver would be exposed to, which we are not aware of up to the present moment. By way of an illustration, countries which might be sanctioned to temporarily suspend or relax the Intellectual Property Rights on COVID-19 vaccines, and therapeutics may initiate Bilateral Investment Treaty (BIT) claims against the host country contending that the suspension of the IPR violates the BIT standards such as expropriation, FET, and so forth.
Under such circumstances, BIT claims by foreign pharmaceutical companies against India for the rescission, suspension or failure to comply with IPR could undermine the advantages of a prospective TRIPS waiver. Thus, to uphold its regulatory legitimacy, India should negotiate, bilaterally or multilaterally, with its alliances. Such countries can formulate a binding agreement, which makes IPR affiliated measures unjustified before Investor-state dispute settlement (ISDS) tribunals. This IPR waiver agreement pertaining to BITs might either take the form of a discrete multilateral or a bilateral treaty affirming that it shall nullify all the prevailing BITs in connection with the products to fight COVID-19. The other course of action could be that India and its alliances ratify this IPR waiver bilaterally as a subsequent agreement under Article 31(3)(a) of the Vienna Convention on the Law of Treaties (VCLT). This is a global emergency that demands “extraordinary measures”.
ABOUT THE AUTHOR
Tanisha Sharma is a third year student at Amity Law School, AUUP.
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Kindly note that the views and opinions expressed are of the author and not of the Indian Journal of Law and Public Policy.