Info Service on Health Issues (Jan21/02)
Geneva, 14 Jan (D. Ravi Kanth) – As the COVID-19 pandemic has so far claimed more than 1.9 million lives globally amidst a rising wave of “vaccine apartheid,” the time has come for countries blocking a temporary waiver for suspending several provisions in the WTO’s TRIPS Agreement in combating the worsening pandemic to come clean on the questions raised by the proponents of the waiver, sources told the SUNS.
The proposed temporary waiver calls for suspending the TRIPS obligations concerning copyrights, patents, industrial designs, and protection of undisclosed information so as to ensure that countries are well placed to ramp up production of the requisite therapeutics, vaccines, and other medical products for combating the COVID-19 pandemic.
The proponents of the temporary TRIPS waiver – South Africa, India, Kenya, Eswatini (formerly Swaziland), and Pakistan among others – had challenged the opponents led by the United States, the European Union, Switzerland, Japan, Canada, Brazil, Australia, and Mexico among others with a set of questions at the last TRIPS Council meeting on 10 December last year.
At that meeting, the proponents answered many questions raised by the opponents about the perceived negative effects of the waiver on the WTO’s TRIPS Agreement and the global economy, insisting that the waiver only helps countries to overcome the global shortage of COVID-19 therapeutics and vaccines by ramping up their production in the immediate short-term.
It is against this backdrop that the opponents of the waiver will have an opportunity to answer the questions raised by the proponents for the first time at an informal TRIPS Council meeting to be held on 19 January, said a source familiar with the development.
The opponents’ answers could indicate whether they are on the side of putting profits and patents before the loss of millions of lives due to the COVID-19 pandemic or they are in favour of the waiver for protecting and saving lives, the source said.
The proponents seeking the waiver – South Africa, India, Kenya, Eswatini (formerly Swaziland), Pakistan, Bolivia, and several other countries – have made a strong case as to why the waiver is urgently needed for preventing and containing the deadly COVID-19 pandemic, said another source, who preferred not to be quoted.
The proponents have also consistently answered questions raised by the US, the EU, Switzerland, Japan, Brazil and other members about the need to suspend provisions in the TRIPS Agreement and its flexibilities that provide compulsory licenses and other provisions for countries to avail of during the current COVID-19 pandemic.
With the alarming levels of disparities having cropped up among countries in the distribution of new vaccines for COVID-19 over the past two months, particularly the denial of vaccines to the developing and poorest countries despite the implementation of various schemes such as the COVAX facility being implemented by the World Health Organization in partnership with the Geneva-based GAVI (the Vaccine Alliance), the temporary waiver to ramp up the production of new therapeutics, vaccines, and other health products has assumed global importance, the source suggested.
At the formal TRIPS Council meeting on 10 December, the proponents led by South Africa and India provided concrete answers on a range of questions raised by the opponents about the waiver and its implications for the WTO’s TRIPS Agreement. (See SUNS #9253 dated 14 December 2020).
At that meeting, India posed several questions to the opponents – the US, the EU, Switzerland, Japan, Canada, Brazil, and Australia among others – about the waiver.
The questions include:
1. Do the opponents have any data regarding how the waiver would demonstrably have negative impact on Members’ economies, if any?
2. Public funding has been driving COVID-R&D. In addition, billions of dollars are spent on purchasing the vaccine. Given the demand volumes, pharma companies will anyway make profits. So why is there a need for IP as an incentive, in a global pandemic situation?
3. Can the opponents provide data as to how voluntary licensing approaches and existing global cooperation mechanisms, including ACT Accelerator, the Covax facility and Covax AMC, would be sufficient to address the vaccine requirements of 7.8 billion people in the world?
4. If voluntary mechanisms work, why has the pharmaceutical industry collectively rejected participation in the WHO COVID-19 Technology Access Pool (C-TAP), an initiative that encourages voluntary contribution of IP, technology and data to support global sharing and scale-up of manufacturing and supply of COVID-19 medical and pharmaceutical products?
India said the proponents are ready to engage with the members if they have any further questions, emphasizing that “the objective, as stated earlier, is to reach a common ground as early as possible, so that a large proportion of world population is not left behind in the quest for timely, equitable and affordable access to successful vaccines and therapeutics.”
More importantly, “WTO Membership needs to act now to ensure that the pandemic should not be needlessly prolonged, only because we fail to act collectively at this juncture,” India said at that meeting.
Prior to the formal TRIPS Council meeting on 10 December, the opponents led by the US and Brazil had raised questions such as (i) “could the proponents provide data that establishes that the identified TRIPS obligations have systematically hindered or blocked the prevention, containment or treatment of COVID-19;” (ii) “no explanation why compliance with each of the identified TRIPS obligation creates an identifiable and undue hardship such that waiver is necessary;” (iii) “elaborate the rationale for industrial designs in the proposal (by Brazil);” and (iv) “further specify the cases in which waiver in copyright could be pertinent for preventing, and containing or treating COVID-19.”
In response to these questions from the opponents as to why the scope of the waiver extends to patents, trade secrets, copyrights and industrial designs and what is the evidence that the waiver from these aspects are important to prevent, contain, and treat Covid-19, the South African delegate Mr Mustaqeem Da Gama had said that “in formulating the proposal, the starting point was to consider what products are needed to curb COVID-19 and what are the barriers to diversifying suppliers and scaling up manufacturing.”
Given the need “for N95 masks and other personal protective equipment, diagnostics, therapeutics and vaccines” and that “global shortages of these medical products have been widely reported,” as well as the alarming shortage of vaccines, the South African delegate offered various examples of shortages of therapeutic medicines such as remdesivir developed by Gilead Sciences, a therapeutic drug for COVID-19, or anti-body treatments such as Regeneron among others to show the “disparity in access” which is the ugly reality of the pandemic that members cannot ignore.
“We have provided concrete evidence of the staggering inequality in access to essential products between developed countries and less developed countries,” the South African delegate argued.
He said that a global solution to this challenge is to diversify and increase production and supply processes.
The South African delegate said it “requires addressing the legal barrier of IP that prevents diversification and production.”
He argued that for preventing, containing, and treating Covid-19, and more specifically for the medical technologies required, it is imperative to suspend relevant categories of IPRs such as patents, trade secrets, industrial designs and copyrights.
As to the need to include industrial designs in the waiver, the South African delegate pointed out that industrial designs and copyright protection can become barriers to reproduction of products, as witnessed in Italy, where “two local engineers 3D printed ventilator valves to supply a local hospital as the regular supplier could not supply the valves, [and] had faced IP barriers.”
The fundamental problem with the TRIPS Agreement, according to the South African delegate, is that even though it sets minimum standards for patents, trade secrets, copyrights and industrial designs, such “standards do limit the policy space available for countries to take the measures necessary to collaborate, manufacture and supply, addressing the shortages mentioned.”
Due to the stringent conditionalities attached to implementing the TRIPS provisions since 1995, the “developing countries have faced constant pressures from their trading partners to limit the use of flexibilities, often criticizing actions that may be taken to simplify the use of flexibilities.”
The South African delegate also provided a graphic account of the difficulties faced by developing countries for availing of compulsory licenses (CL) or Article 31bis of the TRIPS Agreement (which are territorial and used on a case-by-case basis), suggesting that the challenges faced by all countries need to be addressed on a global basis.
Meanwhile, in an op-ed article in the Daily News (Egypt) on 27 December 2020, entitled “Science has delivered, but will the WTO deliver?”, India’s trade envoy Ambassador Brajendra Navnit argued that “the adoption of the Waiver will also re-establish WTO’s credibility and show that the multilateral trading system continues to be relevant and can deliver in times of a crisis. Now is the time for WTO members to act and adopt the Waiver, to save lives and help in getting the economy back on the revival path quickly.”