Minutes - TRIPS Council - View details of the intervention/statement

H.E. Ambassador Xolelwa Mlumbi-Peter
12 PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19

278.   We would like to commend you for your stewardship of this very important matter. As indicated in previous meetings, discussions cannot continue to be mired in the evidentiary loop that we have been engaged in over the last few months, co-sponsors have also made it clear that we want to move to text-based discussions, we stand ready to discussion the scope and duration of our proposal in light of comments and observations that Members have made. Co-sponsors executed an intensive schedule of bilateral meetings with various Members during the last two weeks. These meetings included not only Members that support the Waiver Proposal but also those that have raised concerns. We would like to thank Members for the positive spirit in which these discussions took place and we hope that this will spill over into broader discussions under the auspices of this Council. We therefor endorse your call to shift gears and to move to a more solution-oriented approach. 279.   In respect of the arrangements going forward, the practice of convening both formal and informal meetings, both in small and big group format has worked well. Thank you for confirming 15 and 22 April as possible dates for further meetings, my delegation feels that we may have to resume some meetings sooner than the dates indicated. Co-sponsors will reach out in this regard. 280.   In a global pandemic, lifting IP monopolies will give governments and manufacturers full freedom to operate and allow collaboration for the development, production and supply of COVID19 medical products including therapeutics and vaccines, without being restricted by big corporation's "voluntary" willingness. The current ad-hoc, secretive and restrictive business as usual voluntary licensing practices is limiting production and artificially constraining supply with detrimental consequences for public health, society, livelihoods and the economy globally. It is an abuse of the intellectual property system for it has in the past one year failed to leverage global production capacity. Passing this waiver makes ethical, epidemiological, and economic sense. 281.   Dr Tedros Adhanom Ghebreyesus Director-General of the World Health Organization proclaimed that A me-first approach might serve short-term political interests, but it is self-defeating and will lead to a protracted recovery, with trade and travel continuing to suffer (Op-ed Guardian, 5 March 2021). Flexibilities in trade regulations exist for emergencies, and surely a global pandemic, which has forced many societies to shut down and caused so much harm to business – both large and small – qualifies. We need to be on a war footing, and it's important to be clear about what is needed. 282.   We have on several occasions raised concerns about relying on VLs as the main tool for expanding supply for timely access. As with every effort to contribute to dealing with COVID-19, all contributions are welcome. Our experience with VLs is however less than positive. Some key concerns with VLs are first the lack of transparency as the terms of the license are usually confidential; second is the limited geographic scope that even excludes many developing countries from being supplied under the license agreement or allows for manufacturing only for purposes of export; third is that the license is only offered to very specific manufacturers presumably aiming to limit supply; fourth are the restrictive terms on the source and production of active pharmaceutical ingredients (APIs). These and other problematic terms and conditions that restrict production were a commonplace even before the pandemic. They have been a challenge for access prior to the pandemic and such approaches will not deliver to address the access needs of this devastating pandemic. Disparity in access is certain unless concrete steps are taken to address intellectual property barriers. 283.   We have to learn from past mistakes and ensure that the experience of ad hoc, secretive, limited and restrictive VLs does not repeat itself. The pandemic has shone a harsh light on the skewed and unsustainable business models with which the pharmaceutical industry maximises its profits at expense of legitimate public interests. Despite generous contributions from tax-payer money and pre-order purchases, companies are still allowed to decide on critical elements such as the scale of production (and now conveniently complain that demand outstrips supply) while setting ever higher prices that cannot be justified on any rational basis. 284.   It is well reported that South Africa has paid USD 5.25 a dose5 for a version of the vaccine manufactured in India while it seems that the European Commission paying only USD 3.50 per shot. Uganda seems to have paid USD 8.50 a dose. Some of the explanations given for such price differentials include arguments that high-income countries have a lower price because they have invested in the research and development. However, none of these explanations adequately explain why such large price differentials can be justified. There are already suggestions by pharmaceutical companies of post-pandemic hyper pricing strategies. 285.   Prime Minister Rowley of Trinidad and Tobago6 said the following: "History is littered with instances of destructive behaviour, disrespectful dominance, imbalances and other forms of man's inhumanity to man. But on this rare occasion, when we are all yoked to an invisible destroyer, it is my hope and plea that when the journal of this experience is written, it would deviate from what is mostly the norm and record that on this occasion, the rich took care of the poor. And the small and impecunious were not trampled with disdain by those who could have done so simply because they had the wherewithal to do it." 286.   He called for global vaccine distribution based on models of "sharing and caring" that provide equitable access to small countries like his and "benefit of all humankind and not just the privileged, well-heeled few." We would do well to heed this call. 287.   We keep on hearing the refrain from various Members that TRIPS flexibilities are available and should be use. The Vice President of the European Commission, Mr. Dombrovskis stated in a reply to a question from the European Parliament7 that "[If] voluntary solutions fail and IP becomes a barrier to access to treatments or vaccines, the TRIPS Agreement provides for a possibility to grant compulsory licences." However, this is not a reality for many developing countries, whenever such flexibilities are invoked, political and other sanctions are used to counter such efforts. 288.   So far, we have had an extensive exchange in this Council on the importance of TRIPS flexibilities for safeguarding public health and the challenges of solely relying on mechanisms such as compulsory license for government use to manage IP challenges in this pandemic which is a multifaceted issue as we elaborated under document IP/C/W/673. 289.   In the recent USTR Special 301 review process in late January, multinational pharmaceutical industry associations PhRMA8 and BIO9 have both submitted their comments on IP issues in other countries including those in the COVID-19 pandemic. In these submissions, countries have been criticized simply because they have either used TRIPS flexibilities, or adapted emergency rules to facilitate the use of TRIPS flexibilities in the pandemic: a. Russia10 and Hungary11 are criticised for their legitimate use of compulsory licences on COVID-19 medicine in a pandemic; b. Hungary, Colombia and Indonesia12, are criticised for their emergency regulations to ease the procedure of using compulsory license for government use in the pandemic; c. Netherlands13 is criticised for some legislative discussions on using compulsory license in the pandemic; d. European Commission/European Union14 is criticised for its consideration to improve effective use of compulsory license for access to medicines in its IP action plan; e. Chile15 is criticised for the Chilean Chamber of Dispute's calling for the use of compulsory license in the pandemic; and f. South Africa and India for our legitimate use of WTO law to submit the current Waiver Proposal16. 290.   We recall our questions under document IP/C/W/674 and would appreciate delegates of the US and the EU to shed a light on whether the final report of Special 301 review in 2021 and the upcoming EC report on IP enforcement in third countries will both refrain from criticising countries legitimate actions of using and discussing TRIPS flexibilities for public health safeguarding. 291.   In closing, we would once again call that we move to a text-based discussion. We have come a long way since October, we all agree that COVID-19 is an exceptional circumstance that requires common and inclusive actions. As you indicated Chair, there are common understandings that are emerging, which could be captured in documentary form. We all realize that our destinies are intertwined and that we have to find better ways to collaborate, though we continue to disagree on how this can be done in the best way. 292.   Based on past practice of convening meetings in various formats and configurations, we expect that this practice will continue. Co-sponsors will soon start a process to discuss possible approaches to the draft Waiver text which may lead to an amendment of the current text. We look forward to continuing this engagement with all Members as a priority, we need to pass this Waiver as soon as possible. Let's get it done and save lives.

52. The Chair recalled that the "Proposal for A Waiver from Certain Provisions of The TRIPS Agreement for the Prevention, Containment and Treatment of Covid-19" had been circulated by India and South Africa on 2 October 2020. It had since been co-sponsored by the delegations of Kenya, Eswatini, Mozambique, Pakistan, the Plurinational State of Bolivia, the Bolivarian Republic of Venezuela, Mongolia, Zimbabwe, Egypt and, most recently, by the African Group and the LDC Group.
53. At its previous meeting in February 2021, the Council had agreed to once again provide a "Status Report on the consideration by the TRIPS Council of the waiver proposal" to the General Council meeting of 1-2 March 2021. That Status Report had provided a factual overview of the waiver discussions in the Council and highlighted Members' common goal of providing timely and secure access to high-quality, safe, efficacious and affordable vaccines and medicines for all. It had reported that Members had exchanged views, asked questions, sought clarifications and provided replies, clarifications, and information, including through new documents, but had not been able to reach consensus, including on whether it was appropriate to move to text-based negotiations. Delegations had indicated a need for further discussions on the waiver request and views exchanged by delegations. The report had concluded that "[t]he TRIPS Council will therefore continue its consideration of the waiver request and report back to the General Council as stipulated in Article IX:3 of the Marrakesh Agreement."
54. The co-sponsors had signalled their openness to discuss the scope and duration of the waiver, as well as other questions delegations might have, in the context of text-based negotiations. Other delegations had emphasised a need for more discussions and were not ready to move towards textbased discussions. Members had also recognized the challenge arising from limited manufacturing capacity of vaccines and the inability of existing manufacturers to meet global demand. Members needed to engage in a candid and good-faith and evidence-based discussion on what was required to scale up global production in these unprecedented times of a public health crisis. She encouraged Members to engage in a result-oriented process that would contribute to an effective solution to boosting productive capacity for products that were essential to deal with COVID19 across the world. Swift action was required urgently to help scale up COVID-19 vaccine production and distribution. The Council needed to shift gears and move towards a solution-oriented discussion. The world was in desperate need for solutions. She urged delegations to work together and engage with this purpose in mind.
55. At the General Council meeting of 1 March 2021, the Director-General had said we need to do things differently. She had said "it cannot be business as usual. We have to change our approach from debate and rounds of questions to delivering results". She noted that she was not sensationalizing when she reminded delegations that it was a literally a life and death issue. People were dying at that very moment. She urged delegations to demonstrate their commitment to the overarching goals of universal and equitable access to COVID-19 medical products, not only in words, but through action. She wanted to remind Members of the heightened public interest and concern in this regard, that the world was watching, and that the Council should not fail.
56. There were a number of declarations and letters from civil society regarding the WTO's role in the COVID-19 pandemic, which had been made available on the WTO COVID-19 website under the section "Business/Society response". The previous day, she had received a letter from 'Global Nurses United', which would also be made available on that COVID-19 webpage.
57. She encouraged delegations to also address two issues in their interventions:
a. First, the practical question on how the Council should organize the consideration of this matter going forward. The next regular meeting of the TRIPS Council was scheduled for 89 June 2021. She encouraged delegations to share their views on how to consider the matter in the meantime, so that the Secretariat and the Chair can make any appropriate arrangements so that the Council can move swiftly to a balanced outcome and a landing zone on this urgent matter. The Secretariat had identified dates for possible additional meetings, which the incoming chair could use, depending on delegations' views; and
b. Secondly, whether and how to capture a number of shared understandings with respect to TRIPS flexibilities that had been highlighted. While Members were still discussing the waiver request, Members might wish to capture and communicate such shared understandings on the role of IP in the context of a pandemic, which could provide valuable elements for the broader understanding of the TRIPS Agreement; and might also provide positive guidance to prepare for future pandemics.
58. The representatives of India; Maldives; Zimbabwe; Qatar; Pakistan; Egypt; Nepal; Bangladesh; Vanuatu; Cuba; South Africa; Brazil; Ukraine; China; Nigeria; Mozambique; Jamaica; Tanzania, on behalf of the African Group; Chile; El Salvador; Cameroon, on behalf of the ACP Group; Colombia; New Zealand; Mongolia; Namibia; Canada; the United Kingdom; Switzerland; Japan; the European Union; Chinese Taipei; Indonesia; Singapore; Australia; the United States of America; and the World Health Organization took the floor.
59. The Council took note of the statements made and agreed to revert to the matter at its next meeting.
IP/C/M/98, IP/C/M/98/Add.1

5 https://healthpolicy-watch.news/uganda-defends-astrazeneca-price-says-its-not-higher-than-other-countries/

6 https://www.opm.gov.tt/prime-minister-rowleys-statement-at-who-media-conference-18-february-2021/

7 https://www.europarl.europa.eu/doceo/document/E-9-2020-005595-ASW_EN.html

8 https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA_2021-Special-301_Review_Comment-1.pdf

9 https://www.bio.org/letters-testimony-comments/bios-2021-special-301-submission

10 Page 131 of PhRMA submission; Page 10 of BIO submission

11 Page 24, PhRMA submission;

12 Page 24 of PhRMA submission: https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA_2021-Special-301_Review_Comment-1.pdf

13 Page 252 of PhRMA submission

14 Page 9, BIO submission; Page 241, PhRMA submission

15 Page 169, PhRMA submission; Page 12, BIO submission

16 Page 14, PhRMA submission