[Ip-health] TWN Info: Developed countries continue to block TRIPS waiver proposal
sangeeta at twnetwork.org
Tue Nov 24 09:52:43 PST 2020
TWN Info Service on Intellectual Property Issues (Nov20/08)
24 November 2020
Third World Network
Dear friends and colleagues,
Below is a report of the 20 November TRIPS Council discussion on the Waiver Proposal initiated by India and South Africa. An earlier version was published in SUNS #9239 (24 November).
The TRIPS Council will continue this discussion at its next formal meeting on 10 December.
With best wishes,
Third World Network
Developed countries continue to block TRIPS waiver proposal
(An earlier version was published in SUNS #9239 dated 24 November 2020)
Geneva, 23 Nov (D. Ravi Kanth) — As the global pressure grows by the day for a waiver to suspend various provisions of the WTO’s TRIPS Agreement in combating the COVID-19 pandemic, the United States, the European Union, Japan, and Switzerland among others have apparently adopted “stonewalling” tactics to block progress towards a General Council decision on this issue, negotiators told the SUNS.
Even as there is increasing recognition that there has been little progress in the world’s poorest securing access to COVID-19 vaccines, the US, the EU, Japan,and Switzerland continue to stubbornly oppose the large-scale gains for developing and poorest countries through the waiver, which would result in large-scale manufacture of therapeutics, diagnostic kits and equipment, and vaccines, said a negotiator, who asked not to be quoted.
At a virtual G20 leaders’ meeting on 22 November, German chancellor Angela Merkel warned that “progress was slow”, saying that “she would raise the matter with the global vaccines alliance GAVI),” according to a BBC report late Sunday.
“We will now speak with GAVI about when these negotiations will begin because I am somewhat worried that nothing has been done on that yet,” the German chancellor said, according to the BBC report.
Speaking at the same G20 leaders’ meeting, the French President Emmanuel Macron urged his G20 counterparts to “go further and faster” in supporting poorer nations by donating doses, forging industrial partnerships and even sharing intellectual property, according to the BBC report.
These statements by the G20 leaders precisely reflect the concerns raised by the proponents of the TRIPS waiver – South Africa, India, Kenya, and Eswatini (formerly Swaziland) – in their interventions at the informal TRIPS Council meeting on 20 November, said a negotiator, who asked not to be quoted.
The problem with the TRIPS Agreement is that it is a double-edged sword, the negotiator said, suggesting that it acts on two fronts.
On the legal front, the TRIPS Agreement is burdened with stringent provisions that would make it almost impossible for any developing country to adequately use the flexibilities, including the compulsory license provision, the negotiator said.
And on the second front, the powerful members such as the US and the EU exert enormous pressure, including “arm-twisting” behind the scenes if any developing country wants to avail of the compulsory licensing and other flexibilities, the negotiator said.
Ironically, Brazil, which has now allied itself with the US against the waiver, was the first country to stand up to the US coercive tactics in 2000, when Brasilia launched a global movement against intellectual property rights (see the WTO US-Brazil IPR dispute no. 199). Brazil had passed an industrial law that established a “local working” requirement for the enjoyment of exclusive patent rights.
In the face of the international civil society movement and other pressure groups, the US quietly climbed down and withdrew its dispute panel request at the WTO, the negotiator said.
It is against this backdrop that the proponents have sought a waiver to suspend several TRIPS obligations as long as the ravaging COVID-19 pandemic lasts and until more than 7 billion of the world’s population are all vaccinated, said another negotiator, who asked not to be quoted.
At the informal TRIPS Council meeting held at the WTO on 20 November, the four proponents rebutted the criticisms levelled against their proposal, particularly against the questions raised by the US, the EU, Japan, Switzerland, and Brazil among others to confound the salient features of the proposal for a waiver, said another negotiator, who asked not to be quoted.
In their joint proposal (by South Africa, India, Kenya, and Eswatini) contained in document IP/C/W/669.Add.3 and now joined by Mozambique and Pakistan, the six proponents called for a General Council decision to suspend the implementation of TRIPS provisions concerning copyrights, industrial designs, patents, and protection of undisclosed information in relation “to prevention, containment or treatment of COVID-19” for a temporary period.
Due to the paucity of time following the sudden convening of the Doha Rules negotiating body meeting on 20 November, the participants at the TRIPS Council meeting could not discuss several issues, the negotiator said.
The chair of the TRIPS Council, Ambassador Xolelwa Mlumbi-Peter from South Africa, informed members that a formal TRIPS Council meeting will be convened on 10 December with the aim of adopting a report on this matter that can be submitted to the next General Council meeting, scheduled for 16-17 December.
The chair said that she will get in touch with delegations bilaterally, with group coordinators, and in small groups in the run-up to the 10 December meeting to get a sense of what the Council can likely agree on, said another participant.
During the meeting, the US, the EU, Japan, Switzerland, Brazil, the United Kingdom, and Canada among others raised many questions in an apparent attempt to divert attention away from the core objectives of the proposal.
QUESTIONS BY OPPONENTS OF TRIPS WAIVER
At the meeting, a US delegate said intellectual property rights (IPRs) encourage innovation and R&D, as well as manufacturing and access to medicines around the world, emphasizing that these core features are necessary for the global community to help and develop new medicines.
The US delegate said that IPRs are not an obstacle for addressing the pandemic and, if anything, they motivated countries to find treatment and medicines. The delegate argued that the joint proposal to waive off provisions on patents, copyrights, industrial designs, and undisclosed trade secrets in relation to the prevention, containment, and treatment of COVID-19, would be broad and be an unprecedented step.
The US described the waiver as a departure from the past WTO agreements, suggesting that the proposal “does not identify any specific measures for which it is requesting, instead, it says the waiver is meant for waiving TRIPS provisions for PCT (prevention, containment and treatment)”.
It argued that the waiver appears to be diametrically opposed to the G20 ministerial statement of 20 March, which states that “we agree that the emergency measures designed to tackle COVID-19 must necessarily be targeted, proportionate, transparent and temporary and that they do not create barriers to trade and disruptions to global value chains.”
Based on the G20 ministerial statement, the US posed several questions such as whether the proponents could explain how the waiver is a proportionate response to COVID-19, and whether the proponents could explain how members determine that their measure is related to prevention, containment and treatment of COVID-19, and so on. The US also sought to know from the proponents whether their measure is targeted against the COVID-19 pandemic during the implementation of the waiver.
The US delegate acknowledged government funding running into tens of billions of dollars for the development of therapeutics and vaccines but suggested that the governments do not manufacture the drugs or vaccines. The US said pharmaceutical companies take enormous risks for developing these medicines, arguing that they need to be supported through strong IPR protection.
According to the US, intellectual property has not been an obstacle in addressing the pandemic but rather has motivated global efforts to find treatments and cures. “Given the need to provide access to the entire global population, limits to manufacturing capacities and supply chain issues are currently the most significant concerns especially for vaccines,” the US said.
Japan argued that if “IP (intellectual property) (is) not properly protected, it will reduce investment in the medical field, especially in the Infectious Disease area.”
“It will also introduce a risk factor for the development of medical technology (which) will be hindered and essential products may not be developed in future crises,” Japan said.
Japan said that the proponents did not explain the basis for their proposal and why the current IP framework is not working, noting that companies and researchers are working to ensure access to effective medical products.
The European Union underscored the need for “a coordinated and multilateral public action to focus resources on the development of safe and effective therapeutics and vaccines to ensure rapid expansion of production of such vaccines and therapeutics as well as to ensure growth and equitable distribution including in low- and middle- income countries, safeguarding access for vulnerable populations across the world.”
Given the success stories of Pfizer and Moderna, which have developed vaccines for the COVID-19, the EU said that “these results show that the intellectual property system as a framework that provides incentives and the foundation for stakeholders to invest and innovate has delivered.”
The EU said that “the proposed waiver would put in question the ongoing investments and efforts undertaken by researchers to develop the vaccine at an unprecedented speed.” The waiver “could also undermine the ongoing public-private collaboration on the equitable access to affordable Covid-19 vaccines around the globe,” the EU said, without providing any concrete evidence.
The EU reluctantly agreed that “even though we do not foresee IP becoming a barrier to treatments or vaccines against Covid-19, we agree that members need to prepare for all eventualities in the times of crisis.”
The EU said that “this is why domestic legal frameworks should properly reflect the flexibility provided by the TRIPS agreement such as the possibility of issuing a compulsory license including for production for export to vulnerable countries that lack production capacity or including fast-track procedures that can be used in health emergencies.”
Brazil, which had fought against IPRs in 2000, has now joined forces with the US and chose to raise questions that are almost similar to the ones raised by the US delegate to stall progress on the waiver, said a negotiator, who preferred not to be quoted.
Brazil sought precise responses to its questions, including on issues such as the rationale for including industrial designs in the proposal.
Brazil, which is the second largest country in terms of the number of COVID-19 deaths, sought to know from the proponents the cases in which a waiver on copyright could be pertinent for preventing, containing or treating Covid-19.
Contrary to its earlier industrial law and positions taken at the WTO against IPRs, Brazil sought to know from the proponents how members are facing legal and institutional difficulties when using flexibilities.
Even before finalizing a decision on the waiver, Brazil sought “to hear from the proponents whether a waiver could reveal instead to be cumbersome and difficult to implement considering that most members would have to submit it to their national parliaments and (for) them to delve into the specific rights in each of the IP domains that would fall into the scope of the measure.”
Switzerland, Canada, Mexico, the UK, and Israel among others strongly supported the TRIPS flexibilities, and suggested that there is no need for a TRIPS waiver at this juncture.
Norway, which had opposed the waiver at the last meeting in October, did not join the opponents this time around, said a participant, who asked not to be quoted.
INTERVENTIONS BY THE PROPONENTS
The proponents offered detailed responses to the various issues raised by the US and other opponents.
Kenya, for example, said that “the narrow emphasis on maintaining intellectual property to increase resources for pharmaceutical companies, disregards the fact that rapid development of COVID-19 diagnostics, therapeutics and vaccines is the sum of public funding and global collaboration.”
According to work done by several think tanks, Kenya said that global committed funding was $9.1 billion for COVID-19, while pharmaceutical companies received both funding commitments for research and development totaling more than $3.9 billion (excluding funds identified as purely for manufacturing).
Kenya noted that the affected countries have shared digital sequence information and relevant public health information to enable researchers to track the evolution of this novel coronavirus and support the R&D (research and development).
“The current monopoly-based model of R&D puts the fruits of a collective effort into a single company, allowing it to dominate the market, dictate supply and charge high prices with governments and taxpayers once again footing the costs of the medical product,” Kenya said. “The co-sponsors,” said Kenya, “do not believe that such an outcome is in the interest of a solidarity-based collaborative approach to address COVID-19.”
Kenya said it is wrong to say that there is no evidence that intellectual property is a barrier to accessing vaccines, treatments or technologies for the COVID-19, suggesting that “cases involving potential intellectual property infringements emerged early on in the pandemic revealing the complex legal implications of producing copies of life-saving medical products or parts thereof as well as impact on access.” Kenya cited the example of the Gilead patent for Remdesivir, saying that Gilead has blocked access to generic alternatives until 2031.
SOUTH AFRICA’S INTERVENTION
Arguing that “ad hoc, non-transparent and unaccountable bilateral deals that artificially limit supply and competition cannot reliably deliver access during a global pandemic,” South Africa said “these bilateral deals do not demonstrate global collaboration but rather reinforce “nationalism”, enlarging chasms of inequality.”
It pointed out that, for vaccines, “bilateral deals are being signed by pharmaceutical companies with specific governments but the details of these deals are mostly unknown.”
While these bilateral agreements “are for manufacturing of limited amounts and solely supplying a country’s territory or a limited subset of countries,” many companies have not signed any agreements to expand manufacturing and supply, meaning that during the time of vaccine development when such supply bottlenecks could have been addressed, companies are refusing to share intellectual property in a responsible fashion, South Africa said.
“This (attitude of the pharmaceutical companies) turns countries against each other to compete for supply in lieu of working together to defeat the pandemic,” said South Africa, citing the example of the Pfizer/BioNTech vaccine, which has been “pre-booked by developed countries representing 14% of the global population, and no public commitment has been made in support of sharing its COVID-19 vaccine knowledge, technology and related intellectual property to boost supply, reduce price and enhance equity.”
Citing the pronouncements made by Moderna, which has developed the m-RNA vaccine for tackling the COVID-19, on the premise that it will not enforce its “COVID-19 related patents against those making vaccines intended to combat the pandemic,” South Africa said “the global pandemic response cannot be dependent on the possibility of such ineffectual, ad hoc announcements.”
South Africa said “voluntary licenses offered by patent-holding pharmaceutical corporations also tend to exclude millions of people from access to more affordable treatments.” It cited the example of Medicines Patent Pool licenses that normally exclude many developing countries and high-income countries from being supplied under the licenses.
The South African delegate offered concrete evidence to demonstrate that intellectual property is a barrier to access vaccines, treatments, or technologies in the global response to COVID-19.
South Africa said many of the monoclonal antibody candidate therapeutics such as tocilizumab, bevacizumab, and even the Regeneron’s monoclonal antibody treatment, which has just been granted license for emergency use authorization, pose huge problems due to the disparity in access unless concrete steps are taken to address intellectual property barriers.
With regard to diagnostics for the COVID-19, said South Africa, mass testing for the COVID-19 in Netherlands could not be done because of heavy dependence on Roche equipment and supplies of the liquid buffer to run the tests.
South Africa argued that “emerging intellectual property disputes already threaten the development and supply of COVID-19 medical products.” In one dispute, Regeneron and vaccine developers Pfizer and BioNTech are facing a lawsuit from Allele Biotechnology and Pharmaceuticals alleging that their coronavirus products were developed using Allele’s mNeonGreen fluorescent protein without the company’s permission, South Africa pointed out.
India suggested that while TRIPS flexibilities, including those confirmed in the Doha Declaration on TRIPS and Public Health, played a crucial role in promoting access to medicines, the present COVID-19 global pandemic presents exceptional circumstances.
India said that while “the TRIPS flexibilities do allow limited policy space for public health, they were never designed to address a health crisis of this magnitude (such as the COVID-19 pandemic).”
India explained some of the challenges in using TRIPS flexibilities in this current global crisis:
1. Understanding of TRIPS flexibilities is usually in the context of patents. However, as explained before, various types of intellectual property rights i.e. patents, copyrights, industrial designs and trade secrets pose a barrier towards an effective response to the COVID-19 as the pandemic requires access to various commodities, involving multiple IP rights. Flexibilities in other categories of IPRs than patents, are less understood and implemented before. Therefore, options available to Members through existing TRIPS flexibilities are limited.
2. Many countries lack the institutional capacities to utilize such flexibilities.
3. Moreover, compulsory licenses are issued on a country by country, case by case and product by product basis, where every jurisdiction with IP would have to issue compulsory license, practically making collaboration among countries for the development and manufacturing of medical products (where different components are sourced from different countries) extremely onerous.
4. Further, Article 31bis mechanism established to support countries with insufficient or no pharmaceutical manufacturing capacity has even in normal times been widely criticized for its cumbersome procedures. The mechanism includes procedures such as specific labelling or marking of products; special packaging and/or special colouring/shaping of products, making it practically meaningless. The procedure being used only once, since its inception in 2006, itself testifies to the difficulties associated with its use.
5. Finally, very often the implementation and use of flexibilities is accompanied by pressures from trading partners as well as other stakeholders.
India said countries such as the US, the EU, Japan, Canada, and Brazil – “who think that TRIPS flexibilities are enough for Covid-19 response and they do not need the waiver,” – “can choose to not implement the waiver in their domestic legislation, but they should not come in the way of international collaboration with respect to development, production and supply of needed healthcare products for Covid-19 that we seek to achieve through the TRIPS Waiver.”
“The waiver is more than just a legal mechanism, it is a statement of intent by all countries that they accord highest value to protecting human lives rather than protecting private profits,” India said.
As regards the use of initiatives such as ACT-Accelerator (ACT-A) and Covax Advance Market Commitment (AMC) including donations to these initiatives are sufficient to address the global need for vaccines and therapeutics, India said these initiatives would not be sufficient to ensure timely and equitable access to Covid-19 products and technologies.
The aim of ACT-A including the Covax AMC is to provide 2 billion vaccine doses (for 1 billion people if we consider a two-dose vaccine regimen) to the world by the end of 2021, India said, suggesting that “these initiatives are obviously inadequate to meet the medium- and long-term needs of the 7.8 billion people of this world.”
Given the disparity in access between the developed countries and the rest of the world, India said “developed countries have been able to leverage their financial position” to enter into bilateral deals.
“The global needs are massive and can only be addressed with global sharing of technology, knowledge and related IP, which is what our waiver proposal seeks to achieve,” India argued, pointing out that “it would be naive for any country to think that it can win over a virus, which knows no boundaries, by simply vaccinating their own population.”
Members “need to rise up to the demands of this crisis and show to the world that WTO is still relevant and very much capable of responding to the global need of saving lives and livelihoods, at least during a health crisis like COVID,” India said.
Pakistan, said “as custodians of the world trading order, I believe no one would like to be known for saving fish, but not human lives.”
On behalf of the ACP (Africa, Caribbean, and Pacific) group, Jamaica said there is agreement that “Covid-19 presents severe challenges to our health systems, our development, our individual lives and to global quick response in that regard.”
Jamaica said members “need equitable access to safe and effective vaccines” urgently, suggesting that “is why I can make or remain sympathetic with the proposal as it is seeking to respond to a pressing urgent international problem that confronts us all.”
Jamaica said “we believe the impact of the Covid-19 pandemic is unprecedented and requires extraordinary efforts.”
Moreover, the “WTO has a critical role to play in this process [and] saving human lives should always be our priority,” Jamaica said, suggesting that “the general objective of the proposal is in line with the urgency adopted by all our governments bilaterally and in other international fora including in the WHO and in New York.”
Therefore, said Jamaica, “we (the ACP group members) believe that there’s hope for WTO members to engage constructively on this initiative including suggesting any necessary amendments to the proposal to bring its provisions in line with what is mutually acceptable to the WTO membership.”
Nigeria said “the current TRIPS flexibilities, including compulsory licenses while they are good reference point, they are at most times difficult to implement especially in this emergency situation caused by the pandemic.”
Nigeria said the proponents for the waiver made it clear that the intention is for the waiver to apply temporarily and in relation to COVID-19 related materials and also based on the unique needs of different countries.
Tunisia urged members to “focus on the solidarity required to address this exceptional situation, and supports any initiative that can provide a rapid and effective and equitable response in order to contain this pandemic.”
Cuba, supporting the proposal, urged WTO members “to work together and to guarantee that intellectual property rights and patents, industrial designs, copyrights, and protection of undisclosed information do not create obstacles to access to affordable medical products, including vaccines and medicines to treat COVID-19.”
Ecuador adopted a somewhat ambiguous position by supporting the TRIPS flexibilities and the initiative taken by the six countries (South Africa, India, Kenya, Eswatini, Mozambique, and Pakistan) in addressing the COVID-19 pandemic.
Chile said it is important that the proponents clarify not just the technical aspects of their proposal but also “if it is the most adequate and relevant to address the concerns of the proponents given the comments that we have heard today.”
Singapore favoured the voluntary public-private partnerships and collaborations such as the COVAX facility to promote access to the diagnostics, vaccines, and therapeutics.
Bangladesh requested “a favourable consideration of the waiver proposal,” saying public health should not be seen from a narrow perspective. “Trade will fail to bring prosperity if we fail to save human beings from this global disaster,” Bangladesh warned.
Turkey said further consultations are needed on the waiver because of its “comprehensive nature”, emphasizing that “it is beneficial to have constructive discussions on this issue and we remain committed to work with all members to avoid further damage to human life.”
Ukraine thanked the proponents for their initiative and the information provided “for joint actions for global solidarity and putting in place collective response to COVID-19.”
In crux, the proponents took the battle for the waiver proposal to a global stage where it is increasingly becoming clear that the developing and least-developed countries are unlikely to get easy and affordable access for the new therapeutics and vaccines for COVID-19, as the US, the EU, Japan, Switzerland, and Brazil want to ensure that the profits of the big pharmaceutical companies take precedence over human lives, said several negotiators. +
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