WTO TRIPS Council

February 23, 2021

Summary

In its intervention, Canada reiterated that it has not rejected the waiver proposal, and remains fully committed to identifying consensus-based solutions to any specific issues arising from the TRIPS Agreement in relation to COVID-19 diagnostics, therapeutics, vaccines, devices and equipment.

Canada invites Members to identify unused or underutilized COVID-19 vaccine-production capacity and to have more detailed discussions in this area, including to outline any potential linkages to IP, such as patent licensing considerations, and to the TRIPS Agreement more specifically, such that concrete, consensus-based solutions can be found.

Statement by Canada

Madam Chair,

Canada is pleased that Members were able to agree on a way ahead for this important discussion, to which we remain fully committed with a view to identifying consensus-based solutions to any specific issues arising from the TRIPS Agreement in relation to COVID-19 diagnostics, therapeutics, vaccines, devices and equipment.

Madam Chair, Canada would like to reiterate that it has not rejected the waiver proposal, and remains interested in understanding the specific nature and scope of any concrete IP challenges experienced by Members, related to or arising from the TRIPS Agreement, in their responses to COVID-19, such that concrete, consensus-based solutions can be found. Canada also acknowledges that the procurement of COVID-19 diagnostics, therapeutics, vaccines, devices and equipment has been and remains extremely challenging, including in view of limited production capacity, among other logistical challenges.

Canada therefore takes note with great interest the indications by some Members that there currently exists unused or underutilized COVID-19 vaccine-production capacity.

We must go deeper, and indeed identify the location, readiness status and technical features of all unused or underutilized facilities with capacity to produce safe and effective COVID-19 vaccines, and where production of COVID-19 vaccines would not be to the detriment of the production of other essential vaccines, as well as to understand why this capacity is thus far unused or underutilized.

This is important not only to support our discussions here in the TRIPS Council, including to reach common understanding as to how a waiver could operate in practice, in relation to unused or underutilized production capacity, but also insofar as the identification of unused or underutilized COVID-19 vaccine production capacity and the scaling up of such capacity is, generally, key to a global response to the pandemic.

At our February 4 informal meeting, Canada invited Members to identify unused or underutilized facilities that can produce COVID-19 vaccines, and particularly those that are available and actively looking for in-licensing opportunities and we would continue to welcome any such indications.

Canada fully acknowledges that this issue connects to a broader set of supply and distribution issues, and may involve engagement and discussion with international bodies outside this Council; Canada looks forward to such a coordinated, cross-cutting discussion.

Canada also calls on Members with unused or underutilized COVID-19 vaccine production capacity to concretely identify whether and/or why licencing efforts have so far proven unsuccessful, outline the nature of any TRIPS or otherwise IP-related challenges that Members faced in discussions with potential vaccine licensors, and that Members could not address through the existing TRIPS Agreement flexibilities, or otherwise, and that have thus led to these facilities being unused or underutilized.

As our contribution to the discussion on this question, Canada can note at this point that the Government of Canada has reached out to and has had discussions with seven vaccine developers regarding the possibility of production in Canada.

Until very recently, the conclusion of these discussions was that production capacity in Canada was “too limited to justify the investment of capital and expertise to start manufacturing in Canada”. It is thus Canada’s considered view that a waiver would not address and would not have addressed these circumstances.

Nonetheless, with further investment in production capacity, Canada has now been able to reach a memorandum of understanding with the U.S.-based company Novavax to pursue the production of its COVID-19 vaccine at the National Research Council of Canada’s Biologics Manufacturing Centre in Montréal. Such production is expected to begin later this year once construction at the Manufacturing Centre and regulatory approval from Canada’s health ministry are completed. In this instance, IP rights have not emerged among the key challenges to building our capacity to produce COVID-19 vaccines in Canada.

Madam Chair, vaccines can be produced more or less independently depending on the technology. For certain vaccines, production and scaling up may be contingent not only upon some form of patent freedom to operate, such as through licensing, but also on close cooperation between licensees and licensors to allow full practice of the invention and of the associated art, with a view to producing consistently safe and efficacious products. Canada is thus interested in better understanding how a waiver would incentivize these requisite collaborative relationships; and, where full practice of the art is not possible without the participation of the licensor, we are interested in better understanding the safety, efficacy and regulatory implications of the production of vaccines independently from the licensor.

In other cases, a vaccine technology may be such that production and scaling up is contingent only upon some form of patent freedom to operate. Canada would thus be interested in better understanding how, in situations where holders of patents for such COVID-19 vaccines refused requests for voluntary licences, Members attempted but were unable to apply Article 31 of the TRIPS Agreement.

Having shared some of our experiences in this area, Canada looks forward to hearing about the experiences of other Members in their discussions with vaccine developers and licensors, and indeed to fruitful discussion at the March 10-11 meeting of the TRIPS Council.

Madam Chair, Canada thanks Chile for their innovative proposal about how to further enhance the WTO’s role toward addressing COVID-19. Canada certainly shares this objective and looks forward to engaging on this proposal in the near term.

Thank you.