Service on Health Issues (Oct20/11)
Washington DC, 19 Oct (D. Ravi Kanth) – In the global battle for putting people’s lives before patents and the profits of big pharmaceutical companies, South Africa, India, Kenya, and Eswatini have issued a clarion call for a waiver from certain provisions of the WTO’s TRIPS Agreement for combating the worsening COVID-19 pandemic, participants told the SUNS.
The proposal for a TRIPS waiver by India, South Africa, Kenya and Eswatini (formerly called Swaziland) secured strong support from developing countries, while the United States and the European Union among others rejected it, said participants, who asked not to be identified.
At a meeting of the WTO’s TRIPS Council on 16 October, South Africa, India, Kenya and Eswatini made a comprehensive case as to why provisions governing “certain obligations related to COVID-19 products and technologies” under Sections 1 (copyrights and related rights), 4 (industrial designs), 5 (patents), and 7 (protection of undisclosed information) of Part II of the TRIPS Agreement need to be waived off, said a participant, who asked not to be quoted.
In a Tweet posted on 17 October, the director-general of the World Health Organization (WHO), Dr Tedros Adhanom Ghebreyesus, welcomed the proposal tabled by South Africa and India “to ease international and intellectual property agreement on COVID-19 vaccines, treatments & tests in order to make the tools available to all who need them at an affordable cost.”
“Ending the pandemic starts with collaboration,” he said, suggesting that the WHO had launched the “COVID-19 Technology Access Pool in May, inviting countries to share data, knowledge and intellectual property on vital, life-saving health products in the fight against the coronavirus.”
The Joint United Nations Programme on HIV/AIDS (UNAIDS), Unitaid, the Drugs for Neglected Diseases initiative (DNDi), the Geneva-based South Centre, Medecins Sans Frontieres (MSF) and other international civil society organizations including Third World Network strongly supported the TRIPS waiver proposal on grounds that it would accelerate efforts by developing countries to collectively fight the COVID-19 through creating requisite capacities for manufacturing the vital PPEs (personal protectI’ve equipment) including face masks, therapeutics, and vaccines.
[Meanwhile, a post on the IELP blog citing an op-ed by Public Citizen on the TRIPS waiver published in The Guardian, as well as a comment by Prof. Simon Lester, a US trade law academic, can be found at https://ielp.worldtradelaw.net/2020/10/who-will-get-the-coronavirus-vaccines-and-when-.html – SUNS]
“We are not seeking a donation and we are not confident about the market-based instruments such as COVAX,” said another participant, suggesting that “the developing countries want to create manufacturing and industrial capacities so as to ensure that we are in a position to fight the current COVID-19 as well as future pandemics.”
“In actual fact what we are questioning is the structure of the IP [intellectual property] system and the organizations that depend on the funding,” said a South American participant, who asked not to be quoted.
More than 30 developing countries supported the joint proposal by South Africa and India at the TRIPS Council meeting, while several other countries conveyed their willingness to support the proposal, the participant said.
Some developing countries like Ecuador and Chile sought more clarifications from the proponents on various aspects, including the costs involved, suggesting that they are open to the proposal, the participant said.
However, the United States, the European Union, Japan, Norway, and Brazil among others refused to give up their brutal grip on the international patent system that continues to hinder attempts to fight the COVID-19 pandemic, the participant added.
Despite concerted attempts to close the debate once and for all at the WTO, South Africa and India managed to ensure that the issue remained open for further discussions at the TRIPS Council before the final WTO General Council meeting sometime in December, the participant said.
Furthermore, during the heated debate, the US, the EU, Japan, Norway, and Brazil failed to offer substantive reasons for rejecting the waiver and chose to turn it into a political issue, said another participant.
However, they were unable to provide convincing answers based on the facts, the participant added.
The US, for example, stressed the importance of innovation during the COVID-19 pandemic for safe, effective and affordable medical solutions.
The US argued that IPRs are only one part of the puzzle, since existing health infrastructure and supply chain constraints may have a substantial impact on access.
The US said that it does not support the waiver since it does not address the challenges faced, according to the participants, who spoke to the SUNS after the meeting.
The US also argued that the perspective that IP is a barrier to access to medicines is often forced by governments that have significant barriers like taxes and tariffs in place that affect access, said a participant, who asked not to be quoted.
The European Union, which intervened in the discussion several times, argued that it doesn’t see IP as a barrier, and that other factors such as health infrastructure and lack of materials are more relevant. It admitted, somewhat unwittingly, that the development of a vaccine will take a decade, said a participant who asked not to be quoted.
Yet, the EU stressed on its trade and medicines initiative for liberalization of medical products and other trade facilitation measures. Brussels also spoke about the importance of global cooperation and the EU’s support for the Access to COVID-19 Tools (ACT) Accelerator/COVAX facility, suggesting that the TRIPS Agreement is fit for purpose and hence a waiver is not needed.
Ironically, Brazil, which started the global movement against patents in the late 1990s under the leadership of former Brazilian foreign minister Celso Amorim, is today the new member of an initiative (Quire) for supporting the structure of the international patent system that appears to operate on “coercion” and “arm-twisting” developing countries whenever they seek to invoke a compulsory licence, said a South American participant, who asked not to be quoted.
At the TRIPS Council meeting, Brazil flatly rejected the waiver to the TRIPS Agreement, saying that it is not needed for guaranteeing access, and that it might give the wrong signals to innovators and potentially hinder efforts to produce the solutions needed.
Brazil said WTO members must be honest in recognizing that not all difficulties encountered are attributable to the TRIPS Agreement, the participant said.
However, none of the countries supporting the international IP system spoke about the tens of billions of dollars of public funds provided to pharmaceutical companies that continue to sell medicines and vaccines at un-affordable prices, which are beyond the reach of people in the developing countries, the participant said.
China said it would support the proposal for the waiver, adding that it has some clarifications from South Africa and India, the participant said.
Ahead of the discussion on the waiver, the WTO Secretariat presented a report justifying the paragraph six mechanism for issuing an emergency compulsory licence to countries facing an epidemic but lacking requisite domestic drug manufacturing facilities.
But, so far, only Rwanda has sought a CL (compulsory licence) under the paragraph six mechanism.
However, Rwanda faced considerable difficulties and burdensome requirements to avail of it, the participant said.
Whenever a country sought to use the paragraph six mechanism at the World Trade Organization, that country was subjected to considerable political intimidation as well as “naming and shaming” in the annual US Special 301 reports, as well as in the EU reports, said an analyst, who asked not to be quoted.
The WTO Secretariat also presented a report on the measures taken so far in the context of the COVID-19.
“However, in our view, the measures listed in the report are not sufficient for an effective Covid-19 response, which necessitates the need for our waiver proposal,” India said at the meeting.
STATEMENTS BY SOUTH AFRICA AND INDIA
Introducing the joint proposal on the TRIPS waiver at the TRIPS Council meeting, South Africa said that “the COVID-19 pandemic is a clarion call for us to answer to the better angels of our nature.”
“The high-minded language on solidarity and global public goods, however, has not been matched by tangible steps to share know-how and intellectual property rights to facilitate deep technology transfer in the COVID-19 response,” a South African delegate said.
Business-as-usual approaches, said the South African official, “will not bring back the countless lives that were lost, neither will it ensure that IP barriers to the prevention, containment and treatment of COVID-19 will be addressed effectively.”
Referring to the earlier HIV/AIDS crisis, the South African delegate said that the ARV (antiretroviral) medicines were unavailable to patients at affordable prices and out of reach for many developing countries and ultimately resulting in huge death rates. The delegate vowed that it would never happen again.
Despite the Doha Declaration on TRIPS and Public Health (in 2001), which reaffirmed flexibilities to accommodate access to medicines, including the paragraph six mechanism, prices of many life-saving diagnostics, therapeutics, vaccines and other medical products continue to remain out of reach of most governments and its people, the South African official argued.
Even during the highly pathogenic avian influenza (H5N1) outbreak in 2004, the developed countries had priority access to vaccines, while affected developing countries did not, the South African official pointed out.
“Within 5 years, another pandemic flu (H1N1) emerged and once again rich countries placed large pre-orders of a vaccine, buying almost all doses that could possibly be manufactured,” South Africa said, arguing that “many countries promised to donate vaccines, most of them reneged and moved to secure their own countries’ supply and with COVID-19, history is repeating itself”.
Sadly, after several months of the COVID-19 pandemic, there are no meaningful global policy solutions to ensure access.
Against this backdrop of global emergence of COVID-19, South Africa said that “it is important for WTO Members to work together to ensure that intellectual property rights such as patents, industrial designs, copyright and protection of undisclosed information do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19.”
With the extraordinary measures, including lockdown conditions, put in place, “an effective response to the COVID-19 pandemic requires rapid access to 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,” South Africa argued.
Moreover, “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,” South Africa said.
Further, 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 price to meet global demand,” it argued.
It is obvious that critical shortages in medical products have also put at grave risk patients suffering from other communicable and non-communicable diseases, South Africa said.
Therefore, “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,” the South African delegate emphasized.
Moreover, the emerging second wave of the disease underscores the importance of finding global solutions that ensure equitable access, South Africa argued.
Referring “to the findings in several reports about intellectual property rights hindering or potentially hindering timely provisioning of affordable medical products to the patients,” South Africa said “some WTO Members have carried out urgent legal amendments to their national patent laws to expedite the process of issuing compulsory/government use licenses, as evidenced by the updated Secretariat report on national measures taken by WTO Members.”
Given the changing dynamics of the international IP structures, South Africa said that “beyond patents, other intellectual property rights may also pose a barrier, with limited options to overcome those barriers.”
“In addition, many countries especially 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),” South Africa said, arguing that “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.”
Internationally, said South Africa, “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.”
“Our joint proposal,” said South Africa, calls for “a waiver to be granted to all WTO Members so that they do not have to implement, apply or enforce certain obligations related to COVID-19 products and technologies under Sections 1 (copyrights and related rights), 4 (industrial design), 5 (patents) and 7 (protection of undisclosed information) of Part II of the TRIPS Agreement. Let me stress that the proposed waiver would be applicable only to COVID-19.”
“The waiver is limited and does not suggest a waiver from all possible TRIPS obligations, nor does it suggest a waiver beyond what is needed for COVID-19 prevention, containment and treatment,” South Africa said, adding that 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.”
In its intervention, India emphasized that the joint proposal with South Africa and Kenya among others caters for those who have insufficient or no manufacturing capacity in the health products required to combat the COVID- 19 crisis.
India said it has supplied medical products and equipment required for fighting the pandemic to 150 countries and has resisted attempts by a few countries to corner the supplies.
“We would like to remind members that in a global pandemic where every country is affected, we need a global solution, and our waiver proposal represents an open and expedited global solution to allow uninterrupted collaboration in development, production and supply of health products and technologies required for an effective COVID-19 response,” India argued.