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TWN Info Service
on Health Issues (Oct20/03) On 2 October 2020, two very important submissions were made to the WTO TRIPS Council that will meet on 15-16 October. The first is from India
and South Africa that calls for a waiver of several provisions in
the TRIPS agreement as a necessary response to the worsening COVID-19
pandemic The second is from the Least Developed Countries group requesting for an extension to the transition period for implementing the core provisions of the TRIPS Agreement by 12 years, from 1 July 2021 to 2033 when the current transition period ends (https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W668.pdf&Open=True) With best wishes, India, South Africa
seek TRIPS waiver to combat COVID-19 Washington DC, 5 Oct (D. Ravi Kanth) – India and South Africa have called for the waiving off the provisions in the WTO’s TRIPS Agreement concerning copyrights, industrial designs, patents and protection of undisclosed information, in an attempt to combat the worsening COVID-19 pandemic that has already claimed more than one million lives around the world. The two countries circulated a four-page proposal (IP/C/W/669) on 2 October stating that members of the global community are facing “exceptional circumstances” due to the rapidly spreading SARS-CoV-2 virus which causes the COVID-19 disease. So far, more than 35 million people have been infected with the COVID-19 all over the world, with more than one million people having lost their lives due to the pandemic. India and South Africa have requested the TRIPS Council to recommend, “as early as possible, to the General Council, a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.” The request made by India and South Africa seeks to drop the “standards concerning the availability, scope, and use of intellectual property rights” concerning “copyright and related rights”, industrial designs”, “patents,” and “protection of undisclosed information”- which is increasingly becoming the major route for not disclosing information concerning novel therapeutics and medicines. “The waiver should continue until widespread vaccination is in place globally, and the majority of the world population has developed immunity, hence we propose an initial duration of [x] years from the date of the adoption of the waiver,” India and South Africa said. The joint request is expected to be discussed at the next TRIPS Council meeting later this month. It remains to be seen whether the request from India and South Africa will make its way to the General Council which is meeting in mid-October, said a TRIPS trade official, who asked not to be quoted. Against this backdrop, “all WTO Members are struggling to contain the spread of the pandemic and provide health care services to those affected” due to lack of therapeutics and vaccines, India and South Africa argued. “Many developed, developing and least developed countries have declared a national emergency with the aim to curb the growing outbreak, and as advised by the WHO implemented social distancing measures with significant consequences for society and the economy,” India and South Africa said. The COVID-19 pandemic has affected “developing countries and least developed countries” more disproportionately than the developed countries, according to the World Health Organization. Given the urgent need “for affordable medical products including diagnostic kits, medical masks, other personal protective equipment and ventilators, as well as vaccines and medicines for the prevention and treatment of patients in dire need,” India and South Africa argued that the outbreak has increased the demand for these vital items for combating the COVID-19 pandemic. The two countries cautioned that “the longer the current global crisis persists, the greater the socio-economic fallout, making it imperative and urgent to collaborate internationally to rapidly contain the outbreak.” Further, developing and least-developed countries have raised concerns about the prompt supply of therapeutics and vaccines at affordable prices. Moreover, “as new diagnostics, therapeutics and vaccines for COVID-19 are developed, there are significant concerns, how these will be made available promptly, in sufficient quantities and at affordable prices to meet global demand,” India and South Africa said. The two countries emphasized that “critical shortages in medical products have also put at grave risk patients suffering from other communicable and non-communicable diseases.” In the face of growing “supply-demand gap” and rising fears of “vaccine nationalism,”, several countries have initiated domestic production of medical products and/or are modifying existing medical products for the treatment of COVID-19 patients. “The rapid scaling up of manufacturing globally is an obvious crucial solution to address the timely availability and affordability of medical products to all countries in need,” India and South Africa argued. However, there are growing complaints and reports about intellectual property rights (IPRs) “hindering or potentially hindering timely provisioning of affordable medical products to the patients.” According to news reports, “some WTO members have carried out urgent legal amendments to their national patent laws to expedite the process of issuing compulsory/government use licenses,” India and South Africa said. In addition to patents, “other intellectual property rights may also pose a barrier, with limited options to overcome these barriers,” India and South Africa argued. The two countries said “developing countries may face institutional and legal difficulties when using flexibilities available in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).” “A particular concern for countries with insufficient or no manufacturing capacity are the requirements of Article 31bis and consequently the cumbersome and lengthy process for the import and export of pharmaceutical products,” the two countries emphasized. More importantly, “there is an urgent call for global solidarity, and the unhindered global sharing of technology and know-how in order that rapid responses for the handling of COVID-19 can be put in place on a real time basis,” India and South Africa said. “In these exceptional circumstances,” the two countries requested that “the Council for TRIPS recommends, as early as possible, to the General Council a waiver from the implementation, application and enforcement of Sections 1, 4, 5, and 7 of Part II of the TRIPS Agreement in relation to prevention, containment or treatment of COVID-19.” According to India and South Africa, “the waiver should continue until widespread vaccination is in place globally, and the majority of the world’s population has developed immunity, hence we propose an initial duration of [x] years from the date of the adoption of the waiver.” According to the draft decision text annexed to their proposal, on copyright and related rights, India and South Africa are seeking to suspend the implementation, application, and enforcement of key provisions in the TRIPS Agreement such as those in “relation to the Berne Convention”, “computer programs and compilation of data”, “rental rights,” “term of protection,” “limitations and exceptions,” and “protection of performers, producers of phonograms (sound recordings) and broadcasting organizations.” As regards industrial designs, India and South Africa are seeking the waiver for “requirements for protection,” and “protection.” In the most important section of the TRIPS Agreement on patents, India and South Africa would like the TRIPS Council to recommend a waiver for “patentable subject matter,” “rights conferred”, “conditions on patent applicants,” “exceptions to rights conferred,” “other use without authorization of right holder,” “Article 31bis”, which is an amendment to Article 31(f) that was included following the Doha public health agreement of 2003, “revocation/forteiture,” “term of protection,” and “process patents, burden of proof.” On the “protection of undisclosed information,” India and South Africa requested the waiving off Article 39 on protection of undisclosed information. LDC PROPOSAL ON TRIPS In a separate proposal submitted to the TRIPS Council on 2 October, Chad, on behalf of the least-developed countries (LDCs), has called for extending the transition period for implementing the core provisions of the TRIPS Agreement by 12 years, from 1 July 2021 to 2033. The LDC proposal (IP/C/W/668) says categorically that “the COVID-19 pandemic has further exacerbated the challenges that the LDCs continue to face.” Citing the United Nations Department of Economic and Social Affairs (DESA) report, Chad argued that “COVID-19 threatens to have devastating consequences in LDCs.” The LDC group argued that “health systems may be unable to cope with a precipitous increase in infections and these countries lack the resources to cope with the socio-economic consequences of lockdowns around the world.” “Unless bold policy actions are taken by the international community, achieving the Sustainable Development Goals (SDGs) by the 2030 deadline will likely slip out of reach,” the LDC group warned. Moreover, “the lockdown and slump in global demand has particularly impacted LDCs that are dependent on exports of finished products.” Given the disastrous economic impacts due to the COVID-19 pandemic on the LDCs, including those on the path to graduation, Chad said that “the exports of LDCs are anticipated to be severely affected, primary commodities prices are in decline, supply chains disrupted, and the tourism industry largely at a standstill. There is also a strong likelihood of a balance of payments crisis in LDCs.” The LDCs need a viable technology base for which they require “new technologies, and building domestic capacity and a knowledge base to be able to fully utilize acquired technologies and promote indigenous capacity on a sustainable basis for research and development are needed to enhance productive capacities in least developed countries.” Chad argued that “Article 66.1 of the TRIPS Agreement accorded least developed country Members a ten-year exemption from most obligations under the TRIPS Agreement in view of the special needs and requirements of the least developed country Members, their economic, financial and administrative constraints and their need for flexibility to create a viable technological base. Since then this exemption has been renewed on two occasions.” On 29 November 2005, a TRIPS Council decision (IP/C/40) extended this general transition period until 1 July 2013. Subsequently, on 11 June 2013, TRIPS Council decision (IP/C/64) renewed the transition period until 1 July 2021. The least developed countries, according to Chad, “continue to face serious economic, financial and administrative constraints and are still struggling with various challenges to uplift the socio-economic conditions with very limited capacities.” “Such a situation is restricting them to divert resources from other areas, where there is utmost necessity to improve the socio-economic condition of their people. The COVID-19 pandemic has further exacerbated the situation in those countries,” the LDC group argued. As the TRIPS Agreement may not be conducive to pursue its goals relating to developing a strong technology base, the LDCs called for a further extension of the current waiver from implementing TRIPS commitments by another 12 years. Against this backdrop, the LDC group said that “a least developed country Member shall not be required to apply the provisions of the Agreement, other than Articles 3, 4 and 5, as long as the Member remains in the category of least developed country and for a period of twelve years from the date of entry into force of a decision by the UN General Assembly to exclude the Member from the least developed country category.” Further, the LDCs said that “this Decision is without prejudice to the right of least developed countries to seek further extensions of the period provided for in paragraph 1 of Article 66 of the Agreement.”
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