Intellectual property rights trump the right to health: Canada’s Access to Medicines Regime and TRIPs flexibilities in the context of Bolivia’s quest for vaccines

ABSTRACT

The failure of the Canadian pharmaceutical company Biolyse Pharma to obtain authorization under Canada’s Access to Medicines Regime (CAMR) to produce 15 million badly needed doses of a generic copy of a vaccine needed by a developing country is the occasion for a reflection on the right to health and the compatibility of this right with the dominant system of intellectual property rights (IPR) under the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the Doha Declaration and subsequent decisions. Global health justice and intellectual property rights are difficult to reconcile because patent-supported pricing limits equitable access to medicines and, in addition, produces distortions in the allocation of resources in health research. A ‘delinkage’ of production and development costs is therefore called for. In spite of this, governments of countries with an important pharmaceutical sector are often hesitant to agree to sharing of information and technologies. The ‘flexibilities’ (mainly ‘waivers’ and ‘compulsory licenses’) provided for under the TRIPS system are not applied in a serious and consistent way in order to allow developing countries to deal with health crises, as is illustrated by extreme variation in rates of vaccination between the developed and the less developed world.

KEYWORDS:

• Right to health
• TRIPS
• delinkage
• Bolivia
• covid-19 vaccines
• compulsory licensing

Patent-supported pricing and the right to health

The following essay can be taken as part of an overall discussion of whether the development of essential medicines and their equitable distribution in the world are best served by patent-supported pricing, and of whether the ‘flexibilities’ provided for under the globally dominant system of intellectual property rights (IPR) can be successful in alleviating problems of access created by the high prices associated with patents. In the lines which follow, we look at an implementation of one of these ‘flexibilities’ under Canada’s Access to Medicines Regime (CAMR) – and Bolivia’s unsuccessful attempt to take advantage of it in the context of the COVID-19 Pandemic.

What is Canada’s Access to Medicines Regime (CAMR)?

Health Canada’s website (2015), consulted in 2021, informs us that Canada’s Access to Medicines Regime ‘provides a way for the world’s developing and least-developed countries to import high-quality drugs and medical devices at a lower cost to treat the diseases that bring suffering to their citizens’. The creation of CAMR, in 2004, involved amendments to the Patent Act, to the Food and Drugs Act and to various regulations such as the Use of Patented Products for International Humanitarian Purposes Regulations. Clicking on the tab ‘Companies’ of the above-mentioned Health Canada page (2015) leads to a further page giving some idea of the process which must be followed by an interested company, including but not limited to ‘a Solemn or Statutory Declaration Under Paragraph 21.04(3)(c) of the Patent Act’.

A failed attempt to obtain 15 million doses of a generic covid vaccine for a low-income country

In April 2021, the Canadian generic pharmaceutical company Biolyse Pharma failed in its attempt to use the procedures specified under CAMR to obtain the authorization (in the form of what is known as a ‘compulsory license’) to produce a generic copy of a patented covid vaccine and to export 15 million much-needed doses of it to a lower medium income country, namely Bolivia. This failure seems both scandalous, in view of the ongoing COVID-19 Pandemic, and surprising, given the ostensible purpose for the creation of CAMR ‘to provide pharmaceutical products to developing nations facing public health crises’ (CIPO 2015).

Biolyse’s failure to obtain the necessary compulsory license provides the occasion for the following reflections on CAMR and on the right to health and on the ‘flexibilities’ included in the current globalized regime of intellectual property rights, including patents and trade secrets. Some brief attention will be paid to certain other attempts to mitigate the problems attributable to patent-supported pricing of health-related products.

The ineffectiveness of the ‘flexibilities’ and the need for ‘delinkage’

In spite of the laudable intention of making the system more compatible with the right to health and the duty of national governments to insure this right, the flexibilities have remained largely ineffective in improving access to medications and in correcting misalignment of the priorities of health-related research. Some form of delinkage is therefore required (CEWG 2012, 37). By ‘delinkage’ is meant the idea that the price paid by the end-users of a medicine (or their insurer) should be limited to the per unit marginal cost of production (plus a small additional percentage) and that the cost of developing future medicines should not be reflected in the price of an already existing medicine.

How then should the development of future medicines be financed?

How can delinkage be achieved? The Consultative Expert Working Group on Research and Development (CEWG) of the World Health Organization (WHO), for its part, proposed the institution of a ‘binding convention’ or ‘binding agreement based on Article 19 of the WHO constitution’ which would aim ‘at providing effective financing and coordination mechanisms to promote R&D’ (CEWG 2012, 14). R&D (research and development) would thus be paid for by the governments of member countries and the resulting agency would determine research priorities.

One of reasons that this proposal was never accepted by the World Health Assembly (the governing body of WHO) is indicated by the statement by the US representative Nils Daulaire to the effect that the United States would not ‘support any proposal that would put in place a new financing mechanism that could be characterized as a 'globally-collected tax’ (Carter 2012; Kiddell-Monroe, Iversen, and Gopinathan 2013). Daulaire is further quoted as saying: ‘We do not support the proposal that would establish a single pooled financing mechanism […]’ (Carter 2012). It is also mentioned that pharmaceutical companies and their allies were concerned that the proposal ‘undermined patents and jeopardized the corporate bottom line’ (Kiddell-Monroe, Iversen, and Gopinathan 2013, 3). The basic idea of the proposal is, in fact, that research would be conducted and coordinated by a centralized organization under WHO which would be financed by the compulsory contributions of member countries. The resulting health-related discoveries would thus not be subject to patent-supported pricing and could be competitively produced as generics. Understandably, this measure is currently in abeyance – having been ‘derailed’ (Kiddell-Monroe, Iversen, and Gopinathan 2013).

A perhaps more attainable but less satisfactory recipe for mitigating the unwanted side-effects of patent-supported pricing is the health impact fund proposed by Thomas Pogge and Aidan Hollis (Hollis 2021). A health impact fund uses public money and/or donations to remunerate the holders of patents who agree to register their patents with the fund and who also agree to market their products at cost in exchange for the promise of further compensation as a function of the measured ‘health impact’ obtained as the result of the use of their product. The measurement of the health impact of a product under this sort of scheme raises questions beyond what can be examined here – and replaces the market competition among generics which would be developed under the CEWG proposal for an R&D convention. The voluntary nature of the project also creates problems of funding, uptake and universality – but its design alleviates problems of access and, considered as a method of funding research, has the potential of incentivizing better alignment of research priorities, as compared with patent-supported pricing.

Another scheme for mitigating the problems associated with patent-supported pricing in low to medium income countries is the Medicines Patent Pool (MPP) created in 2010 by Unitaid and financed by a modest number of countries and other donors (MPP 2021). The Medicines Patent Pool obtains voluntary licenses from patent holders and then farms them out to generic producers for the benefit of low to medium income countries. ‘This has enabled the production of generics that treat tens of millions of people around the world’ (MPP 2021). Until recently, MPP has been concerned with a very limited number of diseases including HIV, tuberculosis and viral hepatitis, but is expanding its list to include cancer, cardiovascular disease, diabetes and covid-19. Beginning in May 2021, MPP has also become active in promoting technological transfer to enable local production (under license) of covid vaccines. In summary, MPP is using voluntary licensing in a way similar to the way that CAMR ought to use compulsory licensing to palliate patent-related problems of access to health-related products and technologies in lower income countries. This is not delinkage, however. The basic model (funding by donors) is humanitarian and philanthropical: a system of exceptions designed to shelter less-well-off countries from the worst consequences of the dominant system of IPR. It remains to be said that MPP is very active, contrary to the disuse into which CAMR has fallen, and contributes positively to the health and well-being of numerous populations. MPP is also a major partner in C-TAP.

C-TAP is the acronym for the COVID-19 Technology Access Pool, one of the initiatives which came into being in the context of the COVID-19 Pandemic. One of the particularities of C-TAP, compared to other initiatives, is the importance given to the sharing of IPR. The arguments advanced in favor of C-TAP emphasize not so much the problem of patent-supported pricing as the fact that patent restrictions leave many production facilities idle at a time when they should be fully enlisted to make ‘therapeutics, diagnostics, vaccines and other health products’ (WHO 2021a). The vaccine production facilities of Biolyse Pharma, for example, are presumably, as these lines are being written, standing idle at a time when they could be producing millions of doses of vaccine for Bolivia – if only Johnson & Johnson would grant a voluntary license or if only the Commissioner of Patents at the Canadian Intellectual Property Office had granted a compulsory license. Bolivia’s access-to-vaccines problem is perhaps first and foremost a problem of price, but it is also a problem of production and delivery, as has been observed for many countries in the lower to middle income category and for various vaccines. (Argentina, for example, has experienced major delays in the delivery of the Russian Sputnik V vaccine (Goñi 2021).) The 15 million doses of a copy of the Johnson & Johnson vaccine which Bolivia hoped to purchase from Biolyse would not have displaced sales or reduced production of vaccine in factories under the direct control of Johnson & Johnson. The 15 million doses, would, rather, have added to the total production of doses of vaccine globally and would have allowed Bolivia to increase the rate of vaccination in its population more rapidly. This being noted, we understand more fully why the COVID-19 Technology Access Pool emphasized the urgency of accelerating production and of not leaving production facilities idle. Quoting the relevant page from the WHO website:

[…] The Government of Costa Rica, in partnership with the World Health Organization, and its co-sponsors are calling to action the global community to voluntarily share knowledge, intellectual property and data necessary for COVID-19. Shared knowledge, intellectual property and data will leverage our collective efforts to advance scientific discovery, technology development and broad sharing of the benefits of scientific advancement and its applications based on the right to health. (WHO 2021a)

Strikingly, only 43 countries (including Bolivia but not Canada) have signed the ‘Solidarity Call to Action’ associated with this initiative. One notes the absence of the US, the UK, France, Germany, Japan, Cuba, Russia and China. Countries with strong pharmaceutical sectors in their economies seem not to have been attracted by the prospect of sharing technology and intellectual property rights – not even in the context of the current global emergency – under C-TAP.

This hesitation is further illustrated by the fact that COVAX, which is the major international initiative for the distribution of vaccines to countries otherwise unable to insure an equitable, adequate and timely supply for their populations, does not have a major component involving intellectual property. COVAX is the acronym for COVID-19 Vaccines Global Access. It is the ‘vaccines pillar’ of the Access to COVID-19 Tools Accelerator or ACT (WHO 2021b). COVAX is ‘co-led by [the Vaccine Alliance,] Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO’ (WHO 2021c). COVAX receives donations (and pledges) from about 50 governments and a series of ‘foundations, corporations and organizations’ including the Bill & Melinda Gates Foundation, Shell and Tik Tok (Gavi 2021). Current implementation is, unfortunately, below what had been hoped for and projected. In the words of the Independent Allocation Vaccine Group (IAVG) established by the WHO in January 2021:

The IAVG is concerned about the 25% reduction in supply forecast for the fourth quarter of 2021. It is also concerned about the prioritization of bilateral deals over international collaboration and solidarity, export restrictions and decisions by some countries to administer booster doses to their adult populations. […]

The IAVG continues to be concerned by the low supply of vaccines to COVAX, and reiterates the need for manufacturers, vaccine producing and high-coverage countries to prioritize vaccine equity and transparency, the sharing of information about manufacturing capacity and supply schedules to COVAX, as well as vaccine access plans. […]

The IAVG notes that so far only three manufacturers have waived indemnification and liability for use in humanitarian settings, and none have been waived for use at country level. This has consequences for vaccines allocated to the humanitarian buffer, as well as potentially setting precedents for future use. (WHO 2021d)

Given the current insufficient supply of vaccines and, presumably, other covid-related products, there exists a moral imperative for Canada and other countries having instituted mechanisms similar to CAMR to streamline the onerous formalities of the sort which resulted in the non-issuance of the compulsory license necessary to allow for the provision of vaccines to a lower-income country like Bolivia.

The goat and the cabbage: intellectual property rights and the right to health

What is in question here is the extent to which global health justice is compatible with the inclusion of medicines and other health-related products as patentable under the currently dominant global regime of intellectual property rights (IPR). We can wonder which of these two ‘rights’ – the right to health and the right to intellectual property – has priority over the other (Crombie 2016). We may also want to ask ourselves whether it is not possible to ‘have it both ways’ or, as in French, ménager la chèvre et le chou – ‘to accommodate the goat and the cabbage’. Proponents of globalized IPR may consciously or unconsciously view the health justice movement as a hungry goat which threatens to consume an overly generous portion of the cabbage, namely the ostensible benefits of the system. Those whose primary concerns are health and the right to health, on the other hand, may consider that the ravenous chèvre (or goat) in this context is the currently dominant global regime of intellectual property rights, including patents, and that the chou (or cabbage) which is in danger of being more than nibbled upon, is the universal right to health.

Developing the political consequences of our metaphor, it is clear that, if a significant portion of public opinion believes that the IPR goat is likely to consume overly generous portions of the health justice and humanitarian cabbage, the proponents of global IPR will be under pressure to at least create the impression that significant means are being deployed to protect the cabbage. It makes for bad press when millions of residents of poorer countries are depicted in the media as dying needlessly because they cannot afford the patent-supported price of a medicine which could have saved their lives, since the additional doses required could have been produced at little cost. In the context of the HIV/AIDS pandemic in Africa, this is the theme of Dylan Mohan Gray’s 2013 documentary Fire in the Blood.

CAMR was initially hailed as a measure to protect health and access to health care from the IPR goat – but without unduly limiting the appetite of the latter. The evolution of the situation since the institution of CAMR, on the other hand, shows that it has been the expression of a pious hope, rather than a practical solution to a pressing problem.

Patents and their application to health-related products

A patent is a privilege granted by a government to an inventor with reference to an invention. The inventor, in applying for a patent, must show compliance with certain criteria such as genuine novelty, non-obviousness and usefulness. The holder or owner of a patent has – for a limited number of years – the exclusive right to make, use or sell the corresponding invention. The owner of a patent may also issue a license authorizing others to make, use or sell the invention in the owner’s place. The license issued is typically ‘voluntary’ – but, as we have just seen, a government may make the issuance of such a license ‘compulsory’. Patents may also be bought and sold. The proponents of the patent system represent patents as having been instituted as a way of rewarding inventors for making useful contributions to society which might otherwise go unrecognized and as a way of stimulating future inventions. Historically, however, pharmaceutical and other health-related products have not always been considered to be patentable – and have been regulated in various ways (Gaudillière and Hess 2013). For example, ‘in 1844 the French parliament, against the government’s advice, prohibited patents on medicines for a century’ (Cassier 2013, 237) and in the early 1990s there was a great deal of resistance in many countries to the idea of considering pharmaceuticals and other health-related products as patentable. Jonas Salk is famous for his refusal to patent the anti-polio vaccine (SIBS 2021). One of the three men who in 1945 received the Nobel Prize for the discovery of penicillin, Howard Florey, refused to allow a patent to be sought ‘on a discovery he presumed would benefit all mankind’ (SHI 2017).

Patent-supported monopoly pricing is not appropriate for health-related products

A patent is a form of monopoly. In a monopolistic market, it is the seller who sets the price per unit. Monopolies tend to maximize total income from sales as determined (roughly) by unit price × number sold (Crombie 2016, 9–12). A monopolistic market does not maximize the number of units sold and tends to produce prices much higher than the marginal unit cost of production. In a genuinely competitive market, on the other hand, the price per unit will gravitate towards the marginal cost of production of the most efficient producers and will result in the sale of a much larger number of units than under a monopoly. If the product in question is health-related and each unit sold produces an incremental improvement in the health of the population, a utilitarian will clearly prefer an arrangement under which a larger number of units are produced and sold over that under which a smaller number would be sold – unless some other arrangement turns out to present utilities which overbalance in some significant way those which would be attendant upon the increased availability of the product. The typical deontologist proponent of the right to health will recognize the corresponding duty to promote health and, in the absence of other duties conflicting with the promotion of health in this way, have the same preference as the utilitarian on this point. The onus is thus on the proponents of healthcare-related patents to justify their existence. The difference between patent-supported monopoly prices on pharmaceuticals and the marginal unit production cost has been characterized by Joseph Stiglitz (2007, 123) as a form of ‘tax’; we are thus entitled to ask what benefit we receive from paying the tax and whether the benefit allegedly received in return for the tax might not better be financed in some alternative way. Recalling what I wrote in 2014, I suggest:

The benefits promised in exchange for payment of this “tax” have not […] been forthcoming. Innovation has on the contrary actually slowed down in the period since 1994, particularly in the areas of essential medicines and the 17 officially recognized neglected tropical diseases or NTDs. […] Lack of progress is noted in combatting Chagas Disease, affecting productivity and lifespan for 8 million or more individuals in the Americas, with a loss of 426 thousand disability-adjusted life years. Meanwhile, the major part of the resources derived from patent-supported pricing of medicines is directed, not towards genuine research and innovation, but to advertising and promotional campaigns of various sorts, to the production of “me-too” drugs, to the “evergreening” of patents[, to litigation] and to the reconfiguration of chronic risk factors such as osteoporosis and hypercholesterolemia – which are of concern to affluent first-world populations – in what has been termed “disease mongering”. The currently dominant system of patent-protection and regulation of medicines is thus not providing appropriate incentives for the development of effective remedies for debilitating diseases affecting large numbers of low-income individuals in developing countries – in addition to making slow progress in providing existing remedies to populations in need. (Crombie 2014, 50)

For further doubts cast on the premise that patent-supported prices promote innovation, particularly in the area of pharmaceuticals, see Ansede (2013), Voelker (2009), Healy (2012), Gøtzsche (2013) and Baker (2016, 86–98), among many others.

The TRIPS agreement and its ‘flexibilities’

The globally dominant system governing intellectual property was reinforced by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), concluded in 1994 as one of the founding instruments of the World Trade Organization (WTO). By this agreement, WTO members are required to institute in their respective national legislations a roughly uniform system of protection for patents and other forms of intellectual property rights (such as copyrights, designs and trade secrets). Low-income countries were given extra time (until 2016) to bring their legislation into line with TRIPS.

Partly because of the historical context relative to the burgeoning HIV/AIDS pandemic and other major health problems in the world, a number of ‘flexibilities’ were built into the system, with the purpose of simultaneously maintaining the system of patent-supported high prices while allowing governments – especially but not exclusively the governments of low-to-middle-income countries – to suspend patent protection for products necessary to deal with health emergencies. These flexibilities are part of the original text of the TRIPS Agreement, the subsequent Doha Declaration (2001) and further documents (WTO 2003, 2009).

The ‘flexibilities’ which are central to the present case study include ‘compulsory licenses’ applied to production of medicines. Originally, the idea was that the compulsory license would be for production for use within the country issuing the license by a company located within the same country. A recent example of such a compulsory license is reported to have been granted by the Russian government for the production of a copy of remdesivir – and to have also been contested in a lawsuit launched before the Supreme Court of Russia by the pharmaceutical company Gilead (MSF 2021, 8). After 2003, perhaps in response to the problem identified by Elliott, Bonin, and Devine (2003, 11), TRIPS clearly included a provision allowing for compulsory licenses to be issued by one country for production within that country but for export to a second country (see HIV Legal Network 2012, 3). Typically, this second country will be a low-income country in the throes of a health emergency but which does not possess its own generic pharmaceutical manufacturing capacities. The CAMR was created, or at least so it seemed on the face of it, to implement this possibility.

Canada’s Access to Medicines Regime

Canada’s Access to Medicines Regime (CAMR) was created in 2004 at a time when a well-known Canadian politician, Stephen Lewis, had just become in 2001 the first United Nations Special Envoy for HIV/AIDS in Africa. Lewis went on to launch various campaigns and movements in support of African victims of AIDS. In 2003, Lewis was named ‘Canadian of the year’ by Maclean’s magazine. In 2005, Lewis gave and published the Massey Lectures under the title Race Against Time: Searching for Hope in AIDS-Ravaged Africa (Lewis 2006). This was a time in which public opinion and Canada’s self-image made it imperative to ‘do something’ to help correct a scandalously unacceptable situation. The fact that the law instituting CAMR was also known as the ‘Jean Chrétien Pledge to Africa Act’ was in recognition of the humanitarian concern for the victims of HIV/AIDS in Africa of the outgoing Canadian prime minister for the period 1993–2003 (Rimmer 2015; Cameron 2018).

CAMR constituted the first implementation by a WTO member government of the TRIPS flexibility allowing for the production in one country under a compulsory license of a low-cost generic copy of a patented medication required by another country in order to deal with a health crisis. In 2007, the CAMR mechanism was actually used by the Canadian pharmaceutical company Apotex to produce a low-cost generic copy of a patented antiretroviral for Rwanda, ‘enough to treat 21,000 AIDS patients for a year’ (WIPO 2007). Initially, Canadians and the WTO could congratulate themselves for this achievement. Embarrassingly, though, in spite of the obvious need, the CAMR mechanism has not been employed again since that first use. This surprising lack of uptake of an attractive idea has been attributed to the numerous bureaucratic hoops which applicants must jump through in order to obtain approval – and the fact that the whole routine has to be repeated every two years.

Pushback against compulsory licenses

Meanwhile, from 2001 on, worries about loss of revenue through the re-export or re-import from low-income countries towards rich countries of generic copies of medicines produced under compulsory licenses had been fueling a movement among certain countries ‘to declare themselves ineligible in some cases or in all cases […] to import medicines manufactured in another country under a compulsory license’ (Love 2020).

In 2017, this decision became a formal amendment to the TRIPS agreement. Today 37 members of the WTO are listed as ineligible to import medicines manufactured in another country under a compulsory license, including the governments of Australia, Canada, Iceland, Japan, New Zealand, Norway, Switzerland, the United Kingdom, United States, and the European Union, including the following member states: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden. (Love 2020)

This development – while providing some protection to patent-holders against cheaters – interferes, for example, with the possibility which a company like Apotex might hypothetically have liked to use, of importing (from a third country such as India) a generic copy of one of the necessary ingredients for a medication made and sold by Apotex under compulsory license to Rwanda. This 2017 amendment to TRIPS has resulted, three years later in the context of the COVID-19 Pandemic, in an open letter addressed to those 37 WTO members inviting them to notify WTO that they have changed their mind and that they no longer wish to be listed as ineligible to import medicines produced under a compulsory license. The letter was signed by ‘more than 30 groups and three dozen experts on health, law and trade’ (Love 2020). The 2017 amendment makes compulsory licenses harder to use – and increases the perception that they are appropriate only as a form of humanitarianism and not as a normal adaptation to frequently occurring problems. Compulsory licenses under CAMR (and, in general, under Article 31bis of TRIPS) should be made easier to use and the application procedures should be streamlined, rather than the contrary.

Hoops jumped through in vain

One of the sticking points of an application for a compulsory license under CAMR is the requirement that the drug or vaccine one wants to copy must first be included in the list in Schedule 1 of the Patent Act. A recent attempt by the author to view this document on the CIPO website generated an error message. Arianna Schouten of KEI International writes:

Schedule 1 is a list of pharmaceutical products that are under patent in Canada. Only the products listed on Schedule 1 are eligible for Health Canada review and export pursuant to CAMR. Schedule 1 can be amended through an order by Governor-in-Council, on the recommendation of the Minister of Industry and of Health. The amendment of Schedule 1 and subsequent Health Canada review can be completed before or after submitting the compulsory license application to the Commissioner. The purpose of Health Canada’s review is to ensure that the quality of the product intended for export is at the same safety, efficacy and quality standards applicable to drugs destined for the Canadian Market. (Schouten 2021, 2)

The following excerpt of a report from Médecins Sans Frontières, published in May 2021, gives some idea of the number of bureaucratic requirements which Biolyse had to satisfy to fill its contract with Bolivia:

On 19 February 2021, Bolivia made a general notification to the WTO TRIPS Council expressing the intention to be an importing country using the Article 31bis procedure. On 12 March 2021, Canadian vaccine producer Biolyse issued a statement revealing that it sought but failed to secure an IP licensing agreement with the vaccine developer Johnson & Johnson to produce the single-dose COVID-19 vaccine for both domestic supply and exportation. Biolyse also states that it has the capacity to produce if patent barriers are removed on the Johnson & Johnson adenovirus vectored vaccine to help meet the growing COVID 19 vaccine needs. Accordingly, the company is seeking compulsory license for export under Canada’s Access to Medicines Regime (CAMR) – a legal mechanism that Canada set up to implement the Paragraph 6 mechanism (now Article 31bis of the TRIPS Agreement). In late April, a group of Canadian experts made a request to the government to add ‘COVID-19 vaccine’ to the list of Schedule 1 of the Patent Act, a step needed to initiate the process necessary to obtain a compulsory license issued under CAMR. On 10 May 2021, Bolivia signed an agreement with Biolyse to produce and supply 15 million doses of vaccine should a voluntary license be obtained, or a compulsory license for exportation be issued by Canada. However nearly two months since Biolyse initiated the process necessary to obtain a compulsory license, and three months after Bolivia made a general notification, there is no progress or decision from the Canadian government. Despite these difficulties and the current and historical evidence that the procedure does not provide an adequate solution in an emergency, Canada has continued to suggest that Article 31bis is sufficient and the country does not support negotiations on the TRIPS waiver.

In a nutshell, Article 31bis of the TRIPS Agreement and Canada’s national law do not appropriately respond to the need for compulsory licenses for export to address healthcare needs, including in an unprecedented emergency pandemic situation. (MSF 2021, 8–9, with omission of reference numbers for endnotes)

This was not the first occasion on which an application on the part of Biolyse for a compulsory license under CAMR had failed. Biolyse abandoned an earlier application to produce and export a generic equivalent of Tamiflu (oseltamivir phosphate) thought to be useful against an impending epidemic of Influenza A. The application was abandoned after the government order-in-council required to amend Schedule 1 took place fully seven months after Biolyse submitted its request, in September 2006 (Schouten 2021, 7).

The enthusiasm for providing and improving legal mechanisms to insure access to medicines and health has thus clearly declined from what it was or could easily be imagined to have been in the early 2000s. The current position among the governments of the richer countries – who are presumably sensitive to pressures brought to bear by their respective pharmaceutical lobbies – seems clearly to favor the globalized IPR goat as applicable to medicines, while maintaining only the appearance of temporizing the rigors of TRIPS and making important structural concessions in favor of global health justice and the right to health. Amir Attaran, Professor of Epidemiology at the University of Ottawa, is of this latter opinion. He writes:

CAMR was created not as a genuine public health effort, but as a Prime Minister’s vanity project. By passing it, Canada sought bragging rights as the world’s first country to legislate the compulsory licensing system envisaged by the World Trade Organization in decisions from 2001 to 2003 (although Norway beat us). (Attaran 2010, 2)

We are tempted to add that if there existed the political will to make CAMR work, a similar result could be obtained ‘at world-beating prices’ in order to provide vaccines for countries like Bolivia and others even in greater need of affordable vaccines. (This observation includes of course not only vaccines, but diagnostics, treatments, protective equipment, various medical devices, etc.)

The vaccine situation and global health justice

Here are some statistics gathered from the vaccine tracker webpage provided by the Canadian Broadcasting Corporation (CBC 2021) consulted on July 13, 2021. They show that the current systems providing research, development and distribution with regard to vaccines in particular are not succeeding in instituting global health justice. On the date the tracker was consulted, 68.9% of the Canada’s total population had already received at least one vaccination and 43.4% were ‘fully vaccinated’ in the sense that they had also received the required second shot, where appropriate. (Three of the four vaccines approved for use in Canada require a second shot, the exception being the vaccine that Biolyse wanted to copy.) This compares to 33.5% of Costa Ricans who were reported to have received one dose, while 16% were reported to have been fully vaccinated. For Nigeria, the figures are astoundingly only 1.2% with one vaccination and 0.7% of the population fully vaccinated! This, at a time when cases were beginning to spike for much of the African continent.

There are no statistics for most other African countries on the CBC vaccine tracker page. Statistics for Haiti, Nicaragua and Cuba are also absent. For Bolivia – since we are particularly interested in Bolivia – the percentages are roughly one half of those for Costa Rica and one quarter of those for Canada, or a bit less, namely 16.5% reported to have had at least one vaccination 6.2% fully vaccinated. This situation explains why the Bolivian authorities were and are still anxious to procure covid vaccines from whatever reliable source could be found. On September 9, 2021, a major Bolivian daily newspaper La Razón reported with some enthusiasm that the country’s president, Luis Arce, had announced that delivery was expected ‘next week’ of 370 thousand ‘second doses’ of the Russian vaccine Sputnik V (Corz 2021). This level of enthusiasm is very telling in a country whose population is over eleven and half million. Bolivia has been more or less forced to use a variety of vaccines from different sources: Russian, Chinese, Indian and American. Meanwhile, countries like Canada and the United States seem to have access to more doses of vaccine than they can administer.¹

Far from global health justice

We are thus far from conformity with the affirmation that every human being has a fundamental right to health, including the promotion, maintenance and restoration of health, as found, for example, in Article 12 of the International Covenant on Economic, Social and Cultural Rights of 1976 (OHCHR 2021). We also remind ourselves here of the ‘basic principles’ enunciated in the preamble to the Constitution of the World Health Organization of 1948, which states that ‘unequal development in different countries in the promotion of health and control of disease, especially communicable disease, is a common danger’ and that ‘the extension to all peoples of the benefits of medical, psychological and related knowledge is essential to the fullest attainment of health’ (WHO 2020).

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Additional information

Notes on contributors

James Crombie

James Crombie teaches globalization ethics, biomedical ethics and philosophy of science, among other subjects, at l’Université Sainte-Anne, a small francophone university situated in Nova Scotia, Canada. He is also an adjunct appointee in the Faculty of Health of Dalhousie University, Halifax, and has worked as a volunteer interpreter for the World Social Forum. James’s interests include philosophical and scientific figures like Thomas Reid, Charles Peirce, Paulo Freire, Lewis Mumford and Clodomiro Picado Twight. He has published on the unethical marketing of breast-milk substitutes in developing countries and on various forms of corruption in the area of pharmaceuticals.

Notes

1 Interestingly, because of the confidentiality attached to the contracts under which these vaccines were purchased, it is also difficult to know what price was paid for them. This is a problem for the democratic right to transparency and accountability – which compounds what is/was already a problem for the right to health and health justice.