China's Spokes WTO Quad Waiver Text, Offers to Sidestep if Conditions Met; India & WHO: An Uneasy Equation
Newsletter Edition #136 [The Curated Primer]
These are busy times, so we will cut to the chase.
In today’s edition we have two stories for you.
One takes a look at the discussions at the WTO General Council this week on the TRIPS waiver, as text-based negotiations finally get underway on the so-called Quad text.
We also have an update for you that tries to understand the tightrope WHO has had to walk with member states such as India.
Thank you for you reading.
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Watch out for our primers on the World Health Assembly coming soon. Our regular publications schedule may likely get wonky in the coming weeks in view of consultations at WHO and WTO around the Assembly and the Ministerial. Keep an eye out for our analyses.
Until next week!
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I. POLICY UPDATES
China's Spokes WTO Quad Waiver Text, Offers to Sidestep if Conditions Met
China, one of the biggest exporters of COVID-19 vaccines, told WTO members this week that it has concerns on an exports-based eligibility criterion that seeks to exclude developing countries that export more than 10% of the world’s vaccines – a condition that has been proposed as a part of the “Quad waiver text”, now being negotiated at the WTO. China said that “using the criterion of export share to define eligible members will send a wrong signal to the outside world and also have systemic implications to the future negotiations”.
China also offered that if its concerns on such a criteria are addressed, it will not avail the flexibility in a potential waiver proposal. This was reportedly welcomed by the DG Ngozi Okonjo-Iweala and some members.
These discussions were a part of the General Council (GC) meeting earlier this week where the TRIPS Waiver was on the agenda among other matters. The Quad text is based on the discussions brokered by the DG, between 4 keys members – the US, the EU, India and South Africa.
HOW A FOOTNOTE CAME TO THE FORE
According to the Quad text (IP/C/W/688), presented by the DG to WTO members, a footnote specifies eligibility criteria for a potential waiver proposal. It says:
“Footnote 1: [For the purpose of this Decision, all developing country Members are eligible Members. Developing country Members with capacity to export vaccines are encouraged to opt out of this Decision.] [For the purpose of this Decision, developing country Members who exported more than 10 percent of world exports of COVID-19 vaccine doses in 2021 are not eligible Members.]”
China has expressed serious concern on this second square bracket in the above footnote.
After all, China has sent more than 2.2 billion doses of vaccines to over 120 countries and international organizations, a recent statement said.
In a statement made at the WTO TRIPS Council a week ago (May 6), China said:
“…For China, we can’t accept the second brackets of footnote 1 which uses the criterion export share to define eligible members. Such an unreasonable and arbitrary criterion will send a wrong signal to the outside and also have systemic implication to the future negotiations. On one hand, this implies punishment to those who supplied a large amount of vaccines to others even when they themselves were suffering from shortages. On the other hand, this constitutes a tolerance or even an incentive for members to adopt inward-looking policies and apply export restrictions in difficult times when we should resist such temptations. So, my question to everyone in this room is: is it a right signal that the WTO, a long-time advocate of free trade and multilateral cooperation, should be sending to the world? Should the contributions made by members during the pandemic be encouraged or discarded?
Compared with this second brackets language, the first brackets adopt a more positive approach, i.e. to encourage developing members who have capability to opt out from this decision. This is the right direction we should work to. However, as to what I just said on export criterion, we believe a more general language to encourage developing members who are in the position to opt out can be a solution.”
At the GC meeting this week, China offered to not avail flexibilities as described in the Quad waiver text if its concerns on the export criterion is addressed.
“To further demonstrate our pragmatism and constructiveness and to better facilitate the negotiation (on the draft document circulated by the DG), China hereby announces that if our concern on the footnote is properly addressed, we will not seek to use the flexibility provided for by this decision.”
The country was joined by other members in rejecting the proposed restriction on waiver eligibility to those developing countries that exported more than 10 per cent of the world’s vaccine doses in 2021.
Here is why.
According to a policy brief by South Centre that has systematically analysed the proposal by the DG, such a criterion could set a precedent for other COVID-19 medical products. “This restriction creates a precedent of particular concern if the same criteria were to be applied to diagnostics and therapeutics in the future (in accordance with para. 8 of the draft) since developing country members with large potential to supply the world demand for those products would become automatically excluded as well,” authors Carlos Correa and Nirmalya Syam argue.
But the fight to keep therapeutics and diagnostics out of the scope of the waiver is expected to be intense. Recall that it was the US that has been keen on limiting any waiver only to vaccines. It remains to be seen whether the EU and other WTO members will be amenable for such an inclusion to expand the application of any waiver to therapeutics and diagnostics. After all, the EU was reportedly open to considering a wider product scope in a potential waiver proposal.
This week, WHO DG Tedros Adhanom Ghebreyesus, asked Pfizer to improve access to its antiviral drug for COVID-19. He suggested that Pfizer must increase the geographical scope on the licensing it has signed with Medicines Patent Pool, keep drug prices affordable and transparent, have no additional contractual requirements that hamper or delay access, and support generic manufacturing for increased supply.
(See our exclusives: Efforts to limit the implementation of the TRIPS Waiver, proposals to exclude India & China. Also, Pfizer Allegedly Pressured UNICEF to Keep Secret, Pricing for Anti-Viral Treatment Paxlovid. UNICEF Yielded.)
THE GENERAL COUNCIL MEETING: 9-10 MAY 2022
In a statement on the General Council meeting this week, WTO noted, “….WTO members agreed that the outcome document emerging from the informal process conducted with the Quad (European Union, India, South Africa and the United States) opens the prospect for text-based negotiations on an intellectual property response to COVID-19.” (See Members welcome Quad document as basis for text-based negotiations on pandemic IP response.)
Giving an update on the waiver discussions at the TRIPS Council, Chair Ambassador Lansana Gberie (Sierra Leone), reportedly said that it is not very helpful to speculate about the ownership of this document. He said the focus should be on the substance. He urged members to focus on this particular document because it is the only product, and the only game in town, given that the WTO ministerial conference is only a month away, WTO officials said at a press briefing this week.
"I think we should look at the document on its merits and see whether this is something that we can take forward to the stage of negotiation," he said. "I think it is important that we reflect on this because it is, frankly, the only product we have, the only game in town. We don't have a lot of time,” Ambassador Gberie is learned to have said.
However, the ownership of the Quad text continues to raise questions among members. As we reported last week, there has been confusion on whether the Quad members have agreed on the text. Many media outlets have reported about the discussions as a compromise or an agreement, when in fact it is not. Apart from the EU, none of other members of the Quad group have supported it pending conclusive internal consultations.
This is important because at this critical stage of the negotiations, perceptions and numbers matter. WTO decision-making is ruled by consensus. So, although 64 members of the WTO have co-sponsored the original waiver proposal, it will remain to be seen if and how the quad text will unite or splinter this group of co-sponsors.
It is also learned that one of the existing co-sponsors could take a lead role in strengthening the quad text in the coming weeks, Geneva-based sources indicated.
Hectic negotiations will resume in Geneva with a small group of countries reportedly meeting today, May 13, to kickstart discussions on the quad text. We unable to get more details by the time this story was published.
In a blogpost this week, Deputy Director General Anabel Gonzales described the Quad text as follows:
At its core, the outcome document would confirm the right of developing country governments to issue executive decrees, emergency orders and other legal instruments, in addition to conventional compulsory licenses, to authorize a company to use the patents underlying the COVID-19 vaccines without the consent of the patent right holder, subject to a delicate balance of flexibilities and clarifications crafted within the general equitable principles set out in the framework of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Vaccines produced under these conditions may be exported, not only used to service domestic markets, and adequate remuneration to the patent right holder may take into consideration the humanitarian and not-for-profit purposes of these programs to support manufacturers to produce and supply vaccines at affordable prices. WHO guidelines also provide a helpful reference, given the lack of domestic experience in many countries. In addition, protection of clinical trial data would not prevent a government from effectively implementing these flexibilities. These provisions are to be applied for a period to be determined of between 3 to 5 years, and any measure taken in conformity with them would not be subject to the WTO’s dispute settlement mechanism. Six months from now, WTO members would decide whether to extend this treatment to COVID-19-related therapeutics and diagnostics.
For more, see: Moving towards a WTO deal on COVID-19 vaccines? A Blogpost by WTO Deputy Director General Anabel Gonzales.
Intellectual Property, Transfer Of Technology And Capacity Building For Covid-19 And Beyond: A proposal from Brazil
On the WTO Response to The Pandemic, read an update from Third World Network.
India & WHO: An Uneasy Equation
By Priti Patnaik & Megha Kaveri
Global health governance scholars have often described India as a middle power in the changing configurations in geopolitics. Its recent role in deploying vaccine diplomacy during the COVID-19 pandemic as a strategy in foreign relations has also attracted attention and envy. This is even as it has been criticised, perhaps somewhat unfairly, for holding back supplies to the COVAX Facility at the peak of the Delta wave that ripped through the country in the summer of 2021 claiming millions of lives.
India’s support for the TRIPS waiver proposal at the WTO, have also, firmly put the country as a fairly serious player in how the developing world will negotiate equity into new rules in the governance of health emergencies. (Not unlike some other developing countries, its position on the Ukrainian crisis given its traditional relationship with Russia has also complicated this picture.)
For a country that could potentially, decisively shape health diplomacy in a post-pandemic world, its actions are far from inspiring. We look at some recent events.
Last week, WHO released data on excess mortality that showed, India, more than any other country had registered the highest number of deaths related to COVID-19 at more than 4.5 million. These numbers have been disputed by the Indian government.
According to WHO, the global excess mortality associated with COVID-19 was 14.91 million in the 24 months between 1 January 2020 and 31 December 2021, representing 9.49 million more deaths than those globally reported as directly attributable to COVID-19.
Even before these estimates were released, India had made public its unhappiness with these figures. Devex first reported in March 2022, that India was one of the countries stalling WHO’s report on COVID-19 excess deaths. (See Indiaspend: India's Objections To WHO COVID-19 Mortality Estimates Are Misleading, Experts Say)
The New York Times appeared to have followed up in April 2022 on Devex’s story published earlier: India Is Stalling the W.H.O.’s Efforts to Make Global Covid Death Toll Public.
India’s ministry of health and family welfare released a statement on April 16, 2022, contesting this story, objecting the methodology of the report. “The model gives two highly different sets of excess mortality estimates of when using the data from Tier I countries and when using unverified data from 18 Indian States. Such wide variation in estimates raises concerns about validity and accuracy of such a modelling exercise. India has asserted that if the model accurate and reliable, it should be authenticated by running it for all Tier I countries and if result of such exercise may be shared with all Member States,” the statement said.
This is not the first time India has pushed back against studies on its COVID-19 death toll. Two studies (published in Science.org and Lancet) were dismissed by the Indian government as ‘speculative’, ‘misinformed’ and of having a ‘non-validated methodology’.
(See Deccan Herald: Covid-19 excess mortality: India's data 'imagocracy': “India is pulling down the quality of science, statistics and evidence-based public policymaking standards globally”)
On WHO’s part, in February 2021, it created the Technical Advisory Group on COVID-19 Mortality Assessment to estimate the global death toll, caused directly and indirectly due to COVID-19. This included 33 members with expertise in epidemiology, demography and statistics from across the world. The WHO had also invited all member states to nominate a point of contact to coordinate the exercise and encouraged the countries to share any data that they felt was relevant to the exercise.
(See Global technical consultation on ‘excess mortality estimates associated with the COVID-19 pandemic’ and WHO Member States information session on excess deaths associated with the COVID-19 pandemic)
WHO says it has provided a completely transparent audit trail for every estimate that is put out. “We provide all the input data that we have used, we provide a detailed description of the methods that have been used to generate these estimates. The underlying statistical code that is used to generate these estimates and then provide the final numbers,” a WHO technical official explained to reporters recently.
The pressure faced by WHO is hardly limited to that from India. In 2020, WHO suppressed a report “An unprecedented challenge – Italy’s first response to COVID-19”. (See Health Policy Watch from December 2020: World Health Organization’s Censorship Of Report On Italy’s Pandemic Response Sets Dangerous International Precedent – Critics Say)
We asked WHO, how it would future proof the institution from political backlash in future health emergencies. Officials said that WHO and the UN are working towards policies in data governance that would make data as accessible public goods.
Dr Samira Asma, Assistant Director-General, for Data, Analytics and Delivery said at a recent briefing, “Data sharing is an important area during peace time and during health emergencies. Data is important to save lives and to promote health. We are very clear about that. We as WHO are committed to support countries so that every country has the capability to generate timely, reliable, disaggregated and actionable data. There are variabilities in capacities across the countries. So, there are reasons why we don't have the ideal data and health information systems that we need. We also recognize data sharing policies need to be very clear and they need to be operationalized.”
(WHO’s disclaimer associated with the COVID-19 excess mortality data says: “The estimates of excess mortality associated with COVID-19 pandemic have undergone a country consultation process. The estimates presented here may differ from, and should not be regarded as, the official national statistics of individual WHO Member States”)
The vulnerability of data and production of information is not limited to the pandemic alone.
In yet another instance, it was reported that data pertaining to India’s air pollution was not included in the WHO’s new air quality database. According to a report by Health Policy Watch, the country’s data was deleted from WHO’s database “just before the health agency published its new Air Quality Database on April 4, 2022”. The deleted data consisted of 1139 data points from 2010 to 2019, most of which were collected from published government sources. Despite being overtaken by newer open-source data, WHO’s Air Quality Database has been the benchmark for assessing and comparing air quality data between countries.
India, among the world’s most polluted countries, has always viewed the WHO data with skepticism. It has repeatedly refused to accept WHO’s assessment on the grounds that it provided a ‘distorted view’ of the findings. However, over the years, the basis of India’s objections has become shaky since results from several other research reports on air quality also were similar. (Also see: ‘Missing’ India Air Pollution Data Restored to WHO Air Quality Database)
This is as much about India, as it is about WHO and the significance of its determination to publish this data.
India must stand up to the expectations as a leader of the developing world. As negotiations for new rules on health emergencies are being forged, it has a critical role to play, from proposing how countries of the south can access benefits from sharing information, to restoring an overall balance to discussions on intellectual property, not only at WHO. It behooves a country of more than a billion people, with major burdens of diseases, to treat the sanctity of data with responsibility.
Queries sent to Indian authorities for this story were not answered.
II. PODCAST CORNER
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III. WHAT WE FOUND INTERESTING
WHO and MPP announce agreement with NIH for COVID-19 health technologies: Medicines Patent Pool
Moderna Claims Compulsory License from U.S. Government to Use Third Party Patents in its Covid-19 Vaccine - Knowledge Ecology International
Atul Gawande on why we still need covid funding - Washington Post
Hunt begins for the cause of acute hepatitis cases - The Lancet
‘Our Loss is World’s Gain’; African Leaders on Nkengasong’s Confirmation to Head PEPFAR - Health Policy Watch
WTO Covid patent waiver that no one wants to own - Financial Times
As Poor Nations Seek Covid Pills, Officials Fear Repeat of AIDS Crisis - The New York Times
What Would the End of Roe Mean? Key Questions and Answers.- The New York Times
Bill Gates on the pandemic: a misplaced faith in innovation - The New Statesman
Establishing a Financing Mechanism for Global Health Security and Pandemic Preparedness: Where Are We Now and What Comes Next? - Center for Global Development
The Domestic Sources of U.S. Foreign Policy on Global Health - Think Global Health
The legality of a TRIPS Waiver for COVID-19 vaccines under international investment law: Cambridge University Press
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