[CTC] As civil society, biotech groups lobby on waiver, USTR stays the course

[Arthur Stamoulis]

Several articles on the TRIPS waiver below...

South Africa presses Biden to bridge gaps in Covid-19 vaccine waiver debate
By Doug Palmer, Politico Pro 
9/14/2021
 
President Joe Biden on Tuesday was urged by a South African official and members of Congress to use a Covid-19 vaccine summit next week to break a WTO deadlock over whether to waive intellectual property rights for the life-saving drugs.

Zane Dangor, a special adviser to South Africa’s foreign minister, called on the U.S. to come up with the text of a proposed agreement that could be further negotiated and ultimately agreed to at the World Trade Organization.

That would allow countries to “get to the business of actually ensuring that we get jabs in arms of those who need it most, and that we have equitable access,” Dangor said during a discussion hosted by Public Citizen <https://www.youtube.com/watch?v=GMD04U3RffQ&t=4s>, a policy advocacy group.

Vaccine summit: The U.S. is hosting the virtual global summit on Sept. 22  <https://subscriber.politicopro.com/article/2021/09/biden-wants-leaders-to-commit-to-global-vaccination-at-covid-summit-3991024>during the annual meeting of the United Nations General Assembly.

“What we are doing is asking President Biden to close the deal,” Rep. Jan Schakowsky <https://cd.politicopro.com/member/51607> (D-Ill.) said during the Public Citizen event. “The time has come. Time is absolutely of the essence because we know that no one in the world is safe until everyone is safe.”

Backstory: South Africa and India requested a broad waiver of intellectual property rights on Covid-19 vaccines, therapeutics and diagnostics nearly one year ago at the WTO. The issue gained little traction while former President Donald Trump was in office.

Change came in May, when Biden threw his support behind a narrower waiver that just covered Covid-19 vaccines, over the objections of the U.S. pharmaceutical industry and many Republican members of Congress.

Many progressive Democrats supported the move and have expressed disappointment that no agreement has been reached at the WTO. That’s due mainly to the opposition of the European Union, and Germany in particular.

They argue that IP protections are necessary to encourage innovation and that waiving the rights would not vastly increase production because many developing countries that want to manufacture the vaccines lack the technological know-how to produce them.

Latest discussions: The issue was discussed again on Tuesday at an informal meeting of the WTO’s intellectual property committee, without any change in positions, a Geneva trade official said.

The U.S. delegate told the group that the Biden administration has been discussing the issue internally and with other trading partners over the past several weeks to find a way forward that contributes to increasing production and equitable distribution of vaccines, the Geneva trade official said.

Next steps: WTO Director General Ngozi Okonjo-Iweala has been trying to coax members to reach some agreement on actions to help fight the pandemic that the organization could take at its upcoming ministerial meeting on Nov. 30-Dec 3.

WTO members are expected to continue to discuss the issues in small groups to produce a status report on the talks for the WTO TRIPS Council meeting on Oct. 4. That report is to be formally transmitted to the WTO General Council on Oct. 7-8.

There has been some discussion of approving a narrower waiver covering just vaccines, but South Africa and other proponents of a broad waiver do not believe that would be effective, Dangor said.

“The vaccines are important, and we need to focus on them, but you have all sorts of other medicines and therapeutics ... that are required that have huge IP barriers to them,” Dangor said. “Narrowing the scope of the waiver in a way that doesn't deal with what is actually needed, may just result in a waiver that does more of the same, which is nothing.”

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TWN Info Service on Trade, IP and Health
16 September 2021
Third World Network
www.twn.my <https://wp.twnnews.net/sendpress/eyJpZCI6IjYwNjYwIiwicmVwb3J0IjoiMzc2OCIsInZpZXciOiJ0cmFja2VyIiwidXJsIjoiaHR0cDpcL1wvd3d3LnR3bi5teSJ9/>
EU, Switzerland, UK continue opposition, amid support for TRIPS waiver
Published in SUNS #9418 dated 16 September 2021

Washington DC, 15 Sep (D. Ravi Kanth) – Amid the groundswell of international support for the TRIPS waiver at the WTO coupled with more countries, including Malaysia, joining as co-sponsors of the waiver, three members – the European Union led by Germany, Switzerland, and the United Kingdom – seem determined to undermine an expeditious decision on the temporary waiver for combating the COVID-19 pandemic, said people familiar with the development.

The intransigent positions adopted by these three members against the waiver appears more like an attempt to protect the monopolies and massive profits of Big Pharma over the enormous loss of lives globally due to the ravaging COVID-19 pandemic and the denial of vaccines to the global South, said people familiar with the discussions.

The much-delayed temporary TRIPS waiver seeks to suspend certain provisions in the TRIPS Agreement relating to copyrights, industrial designs, patents, and protection of undisclosed information for ramping-up the production of diagnostics, therapeutics, and vaccines across countries on an expeditious basis.

The EU, Switzerland and the United Kingdom escalated their opposition to the waiver on “ideological” grounds that could create a permanent state of “vaccine apartheid” as well as loss of millions of lives due to Covid-19, said people, who asked not to be quoted.

Launching its flagship Trade and Development Report (TDR) 2021, the new Secretary-General of the UN Conference on Trade and Development (UNCTAD), Ms Rebeca Grynspan, said her organization would support the waiver to accelerate production of vaccines across countries in the Global South.

The TDR 2021 said that “the reluctance of other advanced economies to follow the lead of the United States on (supporting) the vaccine waiver is a worrying sign and a costly one; on one recent estimate, the cumulative cost (in terms of lost income) of delayed vaccination will, by 2025, amount to $2.3 trillion with the developing world shouldering the bulk of that cost.”

Meanwhile, in a separate development on 13 September, 140 former Heads of State and Nobel Laureates called on candidates for German Chancellor to support a wide and comprehensive waiver of intellectual property rules on all COVID-19-related technologies at the WTO if elected and chosen to lead the next German Government.

The letter argued that “German publicly-funded science developed the world-class mRNA BioNTech-Pfizer vaccine … Yet vaccines are zero per cent effective for those who cannot access them. The fact that a few vaccine producers hold monopoly control over how much vaccine is made and where it is made has resulted in a serious shortage of doses. […] The artificial restriction on manufacturing and supply is leading to thousands of unnecessary deaths from COVID-19 each day, and countless thousands of cases – a proportion of which will suffer long term, adverse health impacts.”

TRIPS CHAIR’S AMBIGUOUS POSITIONS

At an informal WTO TRIPS Council meeting on 14 September, the 64 co-sponsors of the TRIPS waiver proposal, with Malaysia being the latest co-sponsor, expressed grave concerns over the continued non-engagement by the opponents to the waiver.

The three opponents – the EU, Switzerland and the United Kingdom – repeatedly raised the same questions without showing any willingness to seriously engage in the negotiations to find a solution, said people familiar with the development.

The three opponents to the waiver continued to adopt “diversionary” tactics in raising the same issues while claiming that they want more discussions in the small group meetings, said people familiar with the discussions.

The chair of the TRIPS Council, Ambassador Dagfinn Sorli from Norway, said that it is his assessment from the small group meetings that there is little change in the members’ positions (only three members are blocking the waiver).

Ambassador Sorli suggested that members are ready for more meetings in his so-called “text process” without getting into actual text-based negotiations.

He indicated that members (in reference to the three countries) still want to delve into the issues of “scope” and “implementation.”

Incidentally, the three opponents to the waiver, who are members of the plurilateral Joint Statement Initiative group on electronic commerce, apparently remained silent about the scope and definition of electronic transmissions, said a JSI participant, who is a co-sponsor of the waiver.

It appears that the text-based process adopted so far seems to be dragging the discussions on the same old issues in an attempt to deny the waiver, said a co-sponsor, who asked not to be quoted.

Apparently, another issue that was raised during the small group consultations is the relationship between the TRIPS Council process and the other ongoing General Council-appointed facilitator process.

The facilitator, Ambassador David Walker from New Zealand, is expected to hold his second meeting on Wednesday to discuss the collaboration between the WTO and other international organizations and preparations for future pandemics.

Even though the co-sponsors want intense negotiations, the chair has suggested that the next General Council meeting is scheduled for 7-8 October, and that he would prepare a neutral and factual draft report towards the end of September.

Ambassador Sorli said unless there are any major changes in members’ positions until then, that draft report will be very closely based on the previous status report submitted to the General Council in July.

The chair’s last report suggested that the TRIPS Council had “… not yet completed its consideration of the revised waiver request” and “therefore continue its consideration of the revised waiver request, including through small-group consultations and informal open-ended meetings, and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement.”

The chair intends to convene a formal meeting of the TRIPS Council on 4 October to discuss/agree on his draft status report. Members agreed to hold small group meetings on 23 and 29 September.

CO-SPONSORS CALL FOR URGENT OUTCOME

South Africa, the leading co-sponsor of the TRIPS waiver proposal, highlighted the grave situation of the worsening Covid-19 pandemic with the death toll at around 10 million.

Despite the World Bank’s assessment of global economic growth of around 5.6% during 2021, the global economic recovery appears “highly asymmetrical, however, with only two countries accounting for a quarter of the said growth,” South Africa said.

The economic crisis in developing and least developed countries is forecast at 2.9%, South Africa said, adding that “vaccine inequity” is a major contributory factor.

With 75% of vaccines going to 10 countries, according to a World Health Organization estimate, South Africa suggested that the European Union is able to vaccinate 60.1% of the adult population; the UK 64.4%; Switzerland 51.9%; and Africa only 3.3%.

Despite having spent months answering questions from various Members and submitting a revised proposal (IP/C/W/669) to address the various concerns raised, South Africa said the co-sponsors regret that rather than getting into a “genuine text-based negotiation process, the meetings were used to ask and often repeat questions which had already been dealt with.”

The co-sponsors, said South Africa, remain frustrated and disappointed as their continued efforts to engage in good faith seem to have not yielded the anticipated results.

Even though the co-sponsors of the TRIPS waiver proposal showed flexibility and good faith in agreeing to the consideration of the EU’s proposal, South Africa told the chair that “you will recall that at the time of its introduction, the proposal’s legal basis was not certain and the co-sponsors had serious reservations about its efficacy.”

South Africa reckons that members should avoid “a binary between the TRIPS Waiver proposal and the EU’s proposal on compulsory licensing,” suggesting that it is prepared to engage constructively on all proposed solutions.

Such engagement, said South Africa, would be consistent with a recently approved Resolution of the European Parliament “calling for support for proactive, constructive, and text-based negotiations for a temporary waiver of the WTO TRIPS Agreement, aiming to enhance global access to affordable COVID-19-related medical products and to address global production constraints and supply shortages”.

South Africa said the “TRIPS Waiver is a credible response and Members should engage in good faith discussion as the overall objective for all of us should be to save lives.”

Moreover, it is a necessary, targeted, time-bound and proportionate legal measure directed at addressing intellectual property (IP) barriers in a direct, transparent and efficient fashion, which is consistent with the WTO legal framework, South Africa argued, suggesting that an expeditious agreement would vindicate global solidarity.

South Africa suggested the following immediate actions in the following weeks.

They include:

1. Members being encouraged to engage constructively with the text of all proposals on the table. This entails focusing on the topics at hand in each meeting of the TRIPS Council.

2. Aligning the discussion of the TRIPS Council to the Walker-led process. The TRIPS Waiver is a critical part of the WTO response to the pandemic and is crucial to a credible outcome at MC12. It is important that we work with speed to deliver an outcome before MC12. This necessitates that we engage differently and in a solution-based process. The outcome will be possible if we sit around the negotiations table with the sole objective of saving people’s lives. People are watching and history will judge us harshly if we fail.

3. We hope to get a schedule of meetings that will assist to structure our discussions. We believe on the need to come back to the scope of the waiver, including picking up the discussion on undisclosed information and sharing of regulatory data. The duration and implementation of the Waiver are also issues that seemed to be of interest to Members. We assure Members that we remain flexible and are committed to successful negotiations of the Waiver proposal.

4. We will continue our outreach and are willing to engage substantively with Members both within and outside the TRIPS Council setting with the view to reaching solutions.

India, another leading co-sponsor of the TRIPS waiver, said it did not want to waste more time in countering the arguments presented by a few members at the TRIPS Council who argued that the waiver is not the response to enhancing supplies and production and combating COVID-19.

Expressing concern over the loss of time in discussing the same issues repeatedly, it is time for members to fulfil their commitments, either through consensus or by starting substantive text-based negotiations, India said.

New Delhi regretted that some members only accepted engaging in a text-based process to evade or delay any constructive engagement on the waiver text and finalize it.

India welcomed Malaysia as the new co-sponsor of the waiver proposal, emphasizing that the majority of WTO members – except a handful – see the waiver as the best response to the current health crisis.

It reiterated that the waiver for temporary suspension of relevant TRIPS rules would provide manufacturers around the world the freedom to operate and scale up production of vaccines. Further, the temporary waiver would lead to more accessibility and affordability through such a process.

India argued that even if production is ramped up to reach a target of 11/12 billion doses by the end of the year, serious problems surrounding equitable access and affordability of these vaccines would continue to persist.

Many other developing and least-developed countries including Cuba, Bangladesh, Bolivia, Tanzania (on behalf of the African Group), Malaysia and Indonesia made strong interventions in support of the waiver proposal.

Australia, which announced its support for the TRIPS waiver last week, said they back it as a way to send the world a powerful message of solidarity through a positive, meaningful and consensus-driven outcome at MC12. Also, the decision on the waiver would send a strong signal that the WTO has the ability to respond to a major global crisis.

Australia expressed concern that some of the entrenched views repeatedly expressed in the TRIPS Council are putting at risk the WTO’s ability to achieve consensus. It urged members to find common ground.

Australia said it looks forward to progressing the Trade and Health Initiative, which includes provisions on export restrictions, customs, services, technical regulations, tariffs, transparency, and the expansion of voluntary licensing arrangements.

China, which supports the waiver, suggested that over the past couple of weeks the momentum on vaccine-related discussions has been especially notable in various fora, including APEC, the G-20 and BRICS.

China emphasized that the WTO has the responsibility to provide a response and a solution to the pandemic, in particular from the perspective of IP (intellectual property). It called for intensifying the work, suggesting that upcoming discussions must build upon the previous discussions so as to arrive at a tangible outcome.

US CALLS FOR INCREASING VACCINE MANUFACTURING CAPACITY

Without mentioning the words “temporary waiver”, the US stressed that the most important part of global efforts in fighting COVID-19 is increasing vaccine manufacturing capacity domestically and in other countries around the world.

It welcomed the clarifications provided before the summer break with regards to the revised or new proposals and said that moving towards text-based negotiations was a move in the right direction.

The US delegate maintained that efforts by WTO members have lost momentum and forward progress has stalled in recent weeks, despite the fact that the urgency of the pandemic continues.

The US said the WTO needs to up its game to demonstrate its relevance in a time of global humanitarian and economic needs, suggesting that a way forward can and should be achieved through moving this effort beyond form and going into substance.

Washington spoke about its consultations as well as bilateral meetings with other members to listen to views, and to explore ways forward. The goal has been to encourage members to weigh in with approaches to moving forward with steps that contribute to increasing production and equitable distribution of vaccines, the US said.

It called for moving beyond entrenched policy positions and make a meaningful contribution to addressing the pandemic crisis. The US delegate said the current crisis is a collective one, adding that members’ solution through the WTO requires a collective sense of purpose and collective responsibility.

New Zealand, Korea, and Brazil also underscored the need to think out of the box to find a solution.

New Zealand reiterated its support for a TRIPS waiver outcome which covers vaccines. It urged members to move away from the repetition of entrenched positions in order to facilitate the emergence of an outcome and show the world that IP is a key tool as part of the WTO’s efforts to contribute to the global response to the pandemic.

Korea said while the protection of the IP system is an important principle in international trade, members should examine if exceptional measures can be taken to cope with the grave health crisis the world is facing.

The Korean delegate said a broadly based and holistic approach should be taken in order to effectively respond to this and future pandemics, including by encouraging technology transfer, facilitating the supply of raw materials and strengthening the COVAX operation.

Brazil called for openness and flexibility with regard to the different avenues of negotiations which are underway in the TRIPS Council, including the waiver proposal. Brazil stressed the need to engage with all members with a view to exploring different tools that contribute to tackling the challenges countries are facing to ramp up production of life-saving drugs and vaccines.

More importantly, Brazil suggested that it is ready to discuss targeted reforms of the TRIPS Agreement in order to improve the compulsory licensing system, based on the EU proposal.

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As civil society, biotech groups lobby on waiver, USTR stays the course
By Hannah Monicken, Inside US Trade 
9/15/2021
 
Despite widespread lobbying from civil society groups, lawmakers and industry groups over a proposed waiver of some World Trade Organization intellectual property obligations to fight the pandemic, the Office of the U.S. Trade Representative has largely not strayed from the terms of its initial announcement, leaving stakeholders in the dark about the U.S.' agenda.

The talks over the waiver have largely stalled amid ongoing opposition from the European Union and others as well as disagreements among supporters over the scope and implementation of the proposal. But as WTO members look to deliver outcomes at the upcoming 12th ministerial conference, many countries will push for a result on IP as a part of a larger pandemic package.

While the Biden administration earlier this year came out in support of a waiver limited to vaccines, the administration has not said much since then, even to those stakeholders pressing for such information. The Biotechnology Innovation Organization, which represents the biotechnology industry, including pharmaceutical companies, is among those industry groups opposing the waiver. The group sent a letter to USTR in June and has since put out other statements and open letters outlining its arguments that the waiver will do more harm than good in the push for vaccines.

But BIO has yet to hear from the agency since USTR Katherine Tai first met with pharmaceutical company and other industry officials shortly before announcing the administration’s support, according to BIO Executive Vice President for International Affairs Joseph Damond. Damond on Wednesday told Inside U.S. Trade industry groups would like to know USTR’s negotiating position given it’s their member companies whose IP is being negotiated.

BIO is not alone in this. Civil society groups and progressive lawmakers have been pressing President Biden to “follow through <https://insidetrade.com/node/172190>” on his administration's pledge of support. And a South African official this week urged the administration to commit to a waiver text.

Damond noted that USTR could even brief industry and civil society groups together.

The U.S., though, has largely laid low in the waiver negotiations, as Inside U.S. Trade reported in July <https://insidetrade.com/node/171692>. Most recently, the U.S. on Tuesday in Geneva urged WTO members to think creatively to come to a solution so the WTO can deliver at MC12. In previous meetings, the U.S. has raised questions and noted its support for a waiver related to vaccines only.

The U.S. isn’t the only major power from which civil society groups are demanding answers. In particular, waiver advocates are pushing Germany – a waiver opponent – to reverse course. Eyeing Germany’s election later this month, a swath of former global heads of state as well as a several Nobel laureates urged the new German leader to support the waiver.

“We do not advocate a suspension of intellectual property rules lightly, but we believe that it is essential in the fight against the pandemic,” they wrote <https://progressive.international/wire/2021-09-14-germany-can-and-must-lead-the-charge-to-vaccinate-the-world/en>. “Moreover, a waiver would still allow for vaccine originators to be fairly compensated whilst vaccines truly become a public good.”

Damond also pointed to the global campaign against the waiver. BIO and a broad selection of biotechnology and pharmaceutical companies and industry associations across the country and the world wrote an open letter in June <https://www.bio.org/letters-testimony-comments/declaration-members-worlds-biotechnology-sector-global-access-covid> outlining their opposition. The companies and groups largely hail from more developed countries with robust biotechnology sectors.

“The proposed ‘waiver’ of intellectual property rights proposed in the World Trade Organization (WTO) will be ineffective and counterproductive in addressing this crisis,” the letter says. “Intellectual property rights are not responsible for the imbalance in COVID vaccine supplies between higher and lower income countries.”

Specifically, Damond argued that the wavier would make vaccine supply chain constraints worse and could exacerbate distribution difficulties. “We agree with [civil society groups] on the end goal” of improving manufacturing capacity in developing countries and delivering vaccines worldwide, Damond said. “We just don’t agree on the way to do that.”





Arthur Stamoulis
Citizens Trade Campaign
(202) 494-8826



Arthur Stamoulis
Citizens Trade Campaign
(202) 494-8826




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