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

H.E. Ambassador Xolelwa Mlumbi-Peter

420.   As we now hear, various delegations consider voluntary license agreements the preferred option to leverage production and supply capacity globally. We would like to unpack the issues of voluntary license once again, and recall document IP/C/W/674 regarding the key questions on voluntary license raised by the co-sponsors. 421.   We thank Canada and various other Members for various views offered. Once again, we hear Members calling for evidence! This is a classic tactic to stall matters; we have answered all questions posed to us. Canada was very quick to give itself new legal tools to ease the issuance of domestic compulsory licensing at the start of the COVID-19 pandemic. In March 2020, as part of the COVID19 Emergency Response Act, Canada amended its Patent Act to make this process simpler and faster. In a MSF briefing note17 the following observation was made: Canada was willing to quickly ensure that this simplified pathway to a compulsory license for government use was in its toolbox very early in the pandemic, but that it did so without waiting for patent barriers to arise. This demonstrates that Canada was not responding to a specific, concrete IP barrier that required this intervention, but was instead preparing for potential barriers it might face. As such, at the WTO, other countries are being asked to supply evidence of specific barriers that Canada itself never waited for. Furthermore, the expiry date included in its compulsory licensing measure further demonstrates Canada was willing to enact measures to respond to emergency situations that were temporary, rather than permanent, in nature. Such is the case with the proposed waiver. Canada should permit a similarly temporary measure intended to proactively overcome potential barriers at the international level via the waiver. 422.   Some opponents of the Waiver Proposal suggest that even if the waiver is passed tomorrow, there are no companies in the developing world that can produce any number of products relevant to COVID-19, including mRNA vaccines. This is a gross misrepresentation of reality, in fact developing countries have advanced scientific and technical capabilities as would be demonstrated by the licensing agreements entered into by various pharmaceutical companies with producers in the developing world. The shortage of production and supply caused by the inappropriate use of intellectual property rights by right holders themselves, who enter into restrictive agreements that serve their own narrow monopolistic purposes putting profits above life. The situation in the developing world is not characterised by a lack of capacity, but a lack of opportunity and incentive since most companies will not produce if they are face with the risk of legal claims. We can unlock this potential by enabling these companies to produce to scale, the more manufacturers we have, the quicker we will reach our goal to vaccinate everyone in the shortest possible time. 423.   Countries opposing the waiver stress on voluntary licensing as the main tool to collaborate for scaling up manufacturing, to transfer technology and know-how. But these same countries have very limited or no information on the terms and conditions of the current licensing arrangements and so we find little basis for their arguments. In all the years that I have covered the TRIPS Council no developed country Member has been enthusiastic about technology transfer and then only to LDCs. We note the intervention by the EU that voluntary licenses should be allocated. Does the EU guarantee that their private companies will partner with companies in the developing world to transfer technology? 424.   We have already explained that bilaterally signed voluntary license agreements between companies are often kept confidential and come with restrictive terms and conditions. Restrictive licensing terms can limit the sourcing, production and supply of raw materials, limiting the geographic coverage for supply, unilaterally ask for grant-back of improvement made by the licensees without equivalent obligation to the licensors, using technology transfer or know-how sharing terms as a way to reduce territory coverage for supply, restricting the licensee's statutory right to challenge the validity of the licensor's IP.18 425.   These kind of terms and conditions, if used in a pandemic as we are experiencing, will lead us to nowhere near mobilizing and leveraging the full global capacity and maximizing the freedom to operate worldwide. 426.   Bilateral confidential licensing agreements also often come without adequate public scrutiny and regulations. Although some countries have anti-trust regulations to deal with harmful voluntary license practices, those only come as an aftermath remedy for competitors and are not established with public health underpinning. 427.   In the current pandemic, we have so far not seen one single example led by multinational vaccine and therapeutic companies that has used a different approach to voluntary license by keeping the license terms and conditions fully transparent, opening up worldwide coverage for production and supply of both raw materials and finished products, unconditional transfer of knowhow and technologies and coming with no other restrictive conditions. All these elements could have been beneficial and helpful, but unfortunately have not been the choice of the industry. This should teach us a critical enough lesson that while governments can continue to appeal and encourage voluntary actions, it is a matter of decision making and accountability for governments to intervene and use other measures to tackle the inherent limitations of voluntary license.

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

17 https://www.doctorswithoutborders.ca/sites/default/files/msf_canada_briefer_on_trips_waiver.pdf

18 https://msfaccess.org/sites/default/files/2020-10/IP_VoluntaryLicenses_full-brief_Oct2020_ENG.pdf