May 03, 2021
In July of 2020, Canadian Prime Minister Justin Trudeau was the first of eight national leaders whose names appeared in an op-ed in the Washington Post that closed with the following call to action: "We call on global leaders to commit to contributing to an equitable distribution of the COVID-19 vaccine, based on the spirit of a greater freedom for all."
Nine months on, Canada has secured more than 10 doses of COVID-19 vaccine for every Canadian but, despite vague public announcements, has still not published a concrete plan for sharing any of those doses that will be surplus to demand. As such, the country remains among many that have failed to follow through on promises of equitable access.
Canada has also received considerable criticism for its own domestic response, where doses secured have run into delays getting into people's arms and, despite calls throughout the pandemic to do so, has thus far failed to manufacture any vaccines itself.
That's why we in MSF find it so hard to understand Canada's continued opposition to the proposed World Trade Organization (WTO) waiver for intellectual property (IP) on new COVID-19 medical tools currently under discussion.
It's a measure that could help open up the way to increasing supplies of new medicines, vaccines and other health technologies against the virus and help save millions of lives both in Canada and around the world. This waiver is now supported by more than 100 countries; it is high time Canada joined them.
Canada has so far consistently maintained it has not rejected the waiver proposal. But at the same time, it has not supported any progress towards 'text-based negotiations' -- a necessary step forward for the waiver to be adopted by WTO members -- and instead has played an active role in dragging things out. This has taken the shape of repeated demands for more information about specific, concrete IP challenges to accessing new tools, rather than focusing on the need to act urgently now on implementing solutions as the pandemic rages.
We in MSF have repeatedly witnessed how exclusive rights and monopolies granted to pharmaceutical corporations have had a negative impact on the medical care we can provide in different countries, through monopolies that allow companies to control who receives access to medicines they produce and at what price. This story has been repeated over and over, from HIV to tuberculosis. It is happening again with COVID-19
We have also seen -- as outlined by many of the countries advocating for the waiver -- how existing measures under the TRIPS agreement are insufficient. We do of course support the use of existing measures, such as compulsory licenses, under international trade law, by all governments as a critical public health safeguard for access to medicines, including in this pandemic, but we don't believe that compulsory licensing for domestic use or for export are sufficient or equally effective alternatives to the proposed waiver as a response to the pandemic.
Quick to respond
Despite its insistent requests for evidence of the need for the waiver, Canada itself was quick off the blocks to give itself new legal tools to help domestic compulsory licensing at the start of the COVID-19 pandemic. In March 2020, as part of the COVID-19 Emergency Response Act, Canada amended its Patent Act to make the process of granting a compulsory license simpler and faster.
Considering that Canada had only turned to its existing compulsory licensing powers on one other occasion in the 21st century, and with limited success, this was a major step to take to protect public health, particularly since there was no specific product at that time necessitating a compulsory license. The crucial message here is not merely that Canada was willing to move so rapidly to ensure that this simplified pathway to a compulsory license for government use was in its toolbox in the early days of the pandemic, but that it did so without waiting for any actual patent barriers to arise. This demonstrates that Canada was simply preparing for potential barriers it might face and not addressing an actual concrete IP barrier -- in itself, an implicit recognition that IP rights can be, and often are, a barrier to accessing the medicines, vaccines, and other health technologies that we need.
So why, at the WTO, are Canada and other countries asking for evidence of the same sort of specific barriers that Canada itself never waited for before moving ahead with facilitating legislation? It is surely better to proactively anticipate barriers than to react after the fact when lives are being lost.
Undue pressure and overwhelming complexity
The reasons why existing measures under TRIPS have not been widely used are not difficult to identify. Historically countries have been dissuaded from putting compulsory licensing measures in place by the threat of -- or worse -- retaliatory measures bilaterally by trading partners. Even in the midst of the COVID-19 pandemic, the Office of the United States Trade Representative (USTR) issued its 2020 Special 301 Report criticizing actions of trading partners for using or threatening to use TRIPS flexibilities.
In addition, many countries with national laws that do permit compulsory licensing have never operationalized them simply because of the complexity of the processes involved. This is a particular challenge in overburdened ministries who have little capacity to spare to search the patent status of each medicine or vaccine to request compulsory licenses to be issued for government use, and who face protracted litigation from patent holders.
Furthermore, it is frequently not a question of a single patent. When it comes to something like a vaccine, patents may exist at many stages of the development, production and delivery process. The COVID-19 vaccine portfolio involves numerous novel platforms and technologies, such as mRNA. Patents may cover specific strains, adjuvants, antigen production and other such elements. These background patents are frequently owned by different entities in different countries, adding great complexity, as well as potential legal risks, even where compulsory licensing tools are available.
Finally and perhaps most importantly, the typical domestic compulsory license at national level often only covers patents, while other types of IP, such as undisclosed information concerning test data that are essential for production, may not be covered. All in all, compulsory licenses are not adequate, and additional legal tools, covering a range of IP, are needed for such measures to be effective.
Voluntary sharing by pharma -- it's a 'no'
Another recent move by those who don't support the waiver is to suggest that support should be given to voluntary measures by the pharmaceutical industry in sharing patents and know-how for new technologies. But Canada offers its own clear example of the failure of relying upon voluntary actions by the pharmaceutical industry. As a recent Canadian headline reveals: "Every COVID-19 vaccine maker was asked to make their doses in Canada and all said no." Or, put another way: Canada itself failed to secure voluntary licenses from the pharmaceutical industry, despite seeking them.
The result is that Canada has been reliant on importing vaccines, leaving it vulnerable to export restrictions in the United States, and more recently the European Union and India. Canada's subsequent arrangement with Novavax for potential production to begin late in 2021 does not resolve these underlying concerns.
Compulsory licensing for export -- lessons from past Canadian efforts
Canada's current conservative approach also stands in marked contrast to previous actions it has taken in support of improving global access to novel medicines in the face of a pandemic.
In 2004, at the height of the HIV/AIDS pandemic, Canada passed the Jean Chretien Pledge to Africa Act with the ambition of increasing the supply of lifesaving antiretroviral drugs for people in developing countries. The resulting mechanism, called CAMR (Canada's Access to Medicines Regime), was created to enable a special 'flexibility' in the TRIPS agreement (under what is now Article 31bis) that permits countries with the manufacturing capacity, to issue compulsory licenses on products they can make and then export to countries that do not. CAMR thus permitted compulsory licenses to be issued in Canada for production of medical products for export, without that license being granted for domestic use of the same products.
That's how, in 2008, Canada racked up another global first, when CAMR was used by the generics company Apotex to send two shipments of an antiretroviral triple therapy for HIV to Rwanda. However, this global first has long appeared to be a global last. Apotex, the company that used the mechanism, stated publicly it would never use the process again unless the process were reformed. MSF, who was part of this effort to use CAMR shortly after its creation, also conveyed its concerns about the failings of the regime to Canada. It was made abundantly clear that this was a process unable to deliver in its current form.
Yet Canada has bizarrely suggested CAMR works as intended. Going further, Canada has argued at the WTO that the fact that CAMR, and indeed Article 31bis, have only been used once is evidence of the effectiveness of the existing system; evidently, the state of access to medicines is such that countries have had no need to make more use of these measures!
The absurdity of this response has been heightened recently, following the attempt by a Canadian company to actually make use of CAMR to produce a COVID-19 vaccine. That company found one of two phone numbers for CAMR disconnected, and the other unanswered; their efforts to pursue the mechanism further have thus far been unsuccessful.
As illustrated above, Article 31bis is quite inadequate to address the novel challenge of the global pandemic we all now confront. As such, Canada's focus on whether countries have formally initiated the process of exercising this flexibility under TRIPS misses the mark; there is no value in any country initiating use of the wrong tool for the job. Only expanding the global supply will ensure access. The waiver is one such measure to support this vast scale-up of production that is required.
Proactive solutions with new tools
Both in its domestic response to COVID-19, and its global response to past pandemics, Canada has been quick to pass legislation creating tools to improve access to medicines not after careful, studied examination of evidence that these mechanisms are effective at resolving narrowly defined access problems, but on the premise that these novel tools might be of value in the response going forward.
Its failure to adopt a similar approach to the WTO waiver proposal is not only unfortunate, but undermines Canada's stated goal of ending COVID-19 everywhere. Rather than continuing to insist other countries attempt to apply inadequate and insufficient existing tools to the novel problem of the COVID-19 pandemic, Canada's approach at the WTO should take a page from its domestic strategy of proactively anticipating new problems before they arise and creating new tools to address them.
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