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COVID-19 Vaccines and Drug Patent Laws

photograph of covid vaccine ampules

One of the problems that Canada has had with the COVID vaccines is a lack of domestic production. We are told that there are plans to construct a new facility for such purposes, but that this will not occur until long after it is needed. In the meantime, it was reported this week that Biolyse, a small pharmaceutical manufacturer in Ontario, has offered to produce millions of doses of vaccine but can’t because patents prevent them from being able to do so. This is just one example of a much larger moral issue regarding potential patent reform.

About three-quarters of the vaccine supply has been secured by 10 countries that account for 60 percent of global economic growth. However, 130 countries haven’t received any doses and they account for over 2 billion people. Companies like Biolyse have offered to produce vaccines for lower-income nations, but they haven’t been able to secure a license from companies like Johnson & Johnson in order to do it. This has led to a growing call for waivers for intellectual property such as patent protections so that more companies can manufacture vaccines to increase the supply.

The move has been led by South Africa and India who are seeking support from to suspend elements of the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement concerning intellectual property rights for the direction of the coronavirus pandemic. So far, however, the United States and several other countries have blocked negotiations, and this has led to direct appeals to President Biden as “the full protection of intellectual property and monopolies will only negatively impact efforts to vaccinate the world and be self-defeating.”

While efforts such as the UN supported Vaccines Global Access Facility have helped with distribution of vaccines in lower-income nations, the greatly unequal distribution suggests how limited these efforts have been. Supporters of waiving IP rights in this case argue that we should be able to take advantage of unused production capacity to maximize the supply of vaccines. This is particularly important because current estimates show that many nations will be waiting until 2024 to achieve mass immunization. This situation represents a significant drain on the global economy and complicates our ability to deal with variants. Experience also teaches that drug manufacturers in developing nations can make large amounts of quality drugs inexpensively.

Supporters of a waiver also point out the massive amount of public funding that pharmaceutical companies have received to develop coronavirus vaccines and that much of the groundwork for those vaccines were discoveries that came from federally-funded research. Thus, they argue that the vaccine should be a “people’s vaccine” that is universally available to all at no cost. They also suggest that such a waiver would send a message of commitment to public health as opposed to prioritizing intellectual property rights.

Opponents of the measure, however, argue that waiving patents would dampen scientific innovation by deterring private investment. They argue that a waiver “creates a dangerous precedent of nullifying IP rights” which “destroys the bedrock of what makes medial innovation possible.” The argument makes the case that vaccine development is expensive and, without a guarantee of success, a patent protection guarantee is necessary for innovators to continue to fund their efforts. They also argue that existing regulations are already flexible to allow vaccine drug manufacturers to voluntarily engage in agreements with generic drug manufacturers.

It is important to note that just because regulations are flexible to allow something doesn’t mean that that thing will happen. Nor does one case of a patent waver constitute a “precedent.” Typically, precedents require context, so outside of a pandemic scenario, it’s difficult to see how this might become a problem. Unless, of course, that larger context concerns how to reform our use of patents in the face of other significant moral problems, in which case such a moral conversation might be more helpful.

To consider how a wider discussion of the morality of drug patents might be helpful to the issue of the COVID vaccine, we can look to moral philosophers who have addressed the issue. In 2009, philosopher Thomas Pogge argued that developing nations’ adoption of global uniform intellectual property rights under the TRIPs agreement is morally problematic. He maintained that the loss of freedom to produce, sell, and buy medicines produced by patents imposes a huge loss in terms of disease and premature death that cannot be justified. The typical alternatives of government initiatives and partnerships (such as the UN-backed COVID-19 Vaccines Global Access Facility or COVAX) to deliver medicines to developing nations “are really doing good by improving the situation relative to what it would be under TRIPs unmitigated. Still, these efforts are not nearly sufficient to protect the poor.” Indeed while COVAX has delivered hundreds of thousands of doses, “the disparity between high- and low-income countries remains vast.”

Pogge explains how corporate interests and public health outcomes are misaligned; if pharmaceutical companies help low-income patients benefit from patented medicine, it will undermine its profitability by losing out on customers, both in terms of less revenue but also because the disease will be eliminated more quickly. He suggests several reforms to the patent system including the development of a guaranteed Health Impact Fund (HIF) created by governments where a vaccine developer (for example) would agree to provide production and distribution of their drug at the lowest feasible cost in return for a share equal to its share of the assessed global impact for all HIF-registered products from the HIF reward pools (which would constitute a multi-billion dollar fund) for ten years. Since such a fund rewards those in relation to their impact on global health, drug companies would become more incentivized to focus on treatments and diseases that aren’t simply a priority for the affluent.

This idea makes clear that drug patents are a moral issue one which is connected to other major problems involving excessive litigation and marketing. So perhaps it is a good thing that the waiver is agreed to if a more substantial and target reform can eventually take place. Pogge suggests that patent reform such as his proposed HIF would be a significant step in also addressing global poverty as a whole. So, while discussion of waiving patent protections in the case of COVID is morally important, it may be more morally important to fit this step into a larger conversation that considers the morality of the drug patent system as a whole.

The Social Justice of Copyrights and “Public Domain Day”

photograph of Duke Ellington record

In addition to starting a new calendar year, January 1st marks “Public Domain Day” when copyright restrictions expire for a new batch of artworks, thereby allowing new audiences to view them more easily and new artists to adapt them without needing special permission from the copyright holder. This year, the United States saw certain works from Buster Keaton, Gertrude ‘Ma’ Rainey, Duke Ellington, Virginia Woolf, Agatha Christie, and more enter the public domain, including the classic jazz song “Sweet Georgia Brown” and F. Scott Fitzgerald’s famous book The Great Gatsby.

On the one hand, it might seem like increasing accessibility to cultural artifacts is simply obviously good; given how many high school English classrooms rely on battered copies of Fitzgerald’s story, for example, we can see immediate benefits (both aesthetic and practical) to making it easier and cheaper to purchase new books. But, taken to its logical conclusion, this kind of argument seems to suggest that it might always be necessary for artworks and artifacts to be so accessible. If Gatsby really is so valuable, and if it is so embedded within American culture that it is often called “the great American novel,” then why should Americans have had to pay to read it in the first place? Put differently: why is The Great Gatsby only just now entering the public domain?

In brief, the concept of a copyright offers two related basic protections:

  1. It ensures that artists are compensated for the work that they perform, in a way that
  2. Ensures that society will continually benefit from the work of new artists (who, following from (1), will feel free to pursue their art).

This is why, for example, the Constitution specifically grants Congress the power to “promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.” Basically, in theory, copyrights work to level the social playing field a bit so that artists can (at least potentially) enjoy sufficient financial security to be able to practice their art. In effect, this makes copyrights a matter of social justice, since the people who benefit from these protections the most are precisely those from less-affluent or otherwise disadvantaged backgrounds. Although F. Scott Fitzgerald was not exactly socially disadvantaged, the person aiming to write the next great American novel could easily be discouraged from doing so without the hope of protected financial recompense for their labor offered by the copyright system. That is to say: aspiring writers might instead spend their energy towards non-artistic ends if their Gatsby was to simply immediately enter the public domain without helping the writer to, say, buy groceries.

To illustrate, imagine two people who both have an interest and talent for music: Thomas is born to a wealthy family in Hollywood, while Susan grows up in a lower-middle-class family in the Ozarks. Even if copyrights don’t exist, Thomas still has the luxury to pursue his art to his heart’s content: his family’s wealth offers him a level of comfort that shields him from the risk of “wasting time” on a hobby with no guarantee of compensation. The same cannot be said of Susan so easily: while she might still have plenty of personal reasons for playing music on her own, if the realities of her social position, say, require her to work a full-time job in order to provide for basic necessities, then she would be taking on considerable risk to herself if she instead chooses to devote her time to her art without any real guarantee that her music could offer her a profitable career. In principle, copyright laws offer Susan the promise of some financial protection such that if her art ends up becoming profitable, then she will be able to uniquely enjoy the monetary fruits of her labor without other artists being allowed to copy her work (at least for a time); it’s true that Thomas gets this benefit too, but notice that it doesn’t really affect him — he already had the financial protection to do as he liked with his art in the first place.

So, philosophically speaking, copyrights serve as a mechanism to help underwrite the kind of equality that John Rawls talks about with his first principle of justice: in explaining his view of a free and fair, egalitarian society in A Theory of Justice, Rawls argues that “each person is to have an equal right to the most extensive total system of equal basic liberties compatible with a similar system of liberty for all.” Insofar as copyrights can serve to more fairly distribute opportunities to develop artistic skill and create artworks, they might be thought of as components of a just society. Without protections like this in place, it would become, in principle, roughly impossible for anyone not born into privilege to pursue a career in the arts.

It’s worth noting that this is also why artists cannot copyright “generic concepts” or natural elements of normal life: a copyright is only valid for unique artistic creations. In mid-2020, the estate of Sir Arthur Conan Doyle sued Netflix over the depiction of Sherlock Holmes in its film Enola Holmes; while many of Doyle’s stories involving the character of Holmes have entered the public domain, they all tend to present Holmes as a generally cold and unemotional person. Because it is Doyle’s later stories (that are still under copyright) that see Holmes display more warmth and kindness, the caring demeanor the detective shows his younger sister in the Netflix film provoked the copyright-holder to sue. However, the generally-ridiculed lawsuit was settled out of court in December, presumably because “warmth and kindness” are hardly unique artistic creations.

But this also evidences the problem with the other side of copyright laws: artworks are importantly different than commodities or other products for sale. Fitzgerald and Doyle weren’t just “doing their jobs,” for example, when they wrote The Great Gatsby and the Sherlock Holmes stories: they were effectively contributing to the cultural fabric of our society and the artworks that we collectively use to texture our social fabric with shared points of understanding and reference. It might be argued that, just as “warmth and kindness” are ubiquitous to the point of being un-copyrightable, the cultural familiarity of a character like “Sherlock Holmes” is (or is becoming) similarly un-copyrightable.

Such is the argument for “Public Domain Day.” Only the most radical defenders of the public domain would argue that copyrights are, in principle, problematic: indeed, artists both need and deserve to be secure to create their art (consider also: how else might audiences expect to come by new art to appreciate?). However, over time, the sedimentation of individual artifacts into the cultural consciousness makes a unique property claim on them less clearly valid — particularly after the original artist’s death. Though details differ by country, it is common now for copyrights to extend (in general) for either fifty or seventy years after the death of the artist, allowing both the original creator and their dependents to uniquely benefit from the artwork for a limited amount of time before legal ownership of the artifact is distributed collectively.

Rawls also carves out a space for thinking about copyrights in this way within his Difference Principle that allows for some individuals to benefit more than others if that inequality also serves to benefit the least advantaged in society: presumably promoting the further and continued creation of new artworks (as copyrights are designed to do) is just such a public benefit. But once the general welfare is no longer upheld by the existence of a copyright, it would be just for the copyright to dissolve — as indeed we see demonstrated and celebrated each year on Public Domain Day.

(A crucial note: you may have noticed my repeated hedging in previous paragraphs as I have defended copyright law “in principle” or “philosophically.” This is because the actual practice of copyright law in the United States is fraught with problematic and unfair issues that Rawlsian principles of justice would struggle to support. Indeed, the extension of copyright terms seen in the last few decades, the corporate interests apparently motivating such legislation, and other threats to a shrinking public domain (as well as unique questions posed by new forms of art and media) are all issues that deserve both philosophical and legislative attention in a way that is far more complicated than the simple picture I’ve sketched in this short article!)

Still, copyrights play an important part for anyone looking to protect the financial interests they have bound up in their art; for the rest of us, Public Domain Day grants us the green light to continue bearing back into the past to bring it forward into today.