My professor at Leiden University College recently asked us as a class about the recent suggestion of French doctors to test a possible COVID-19 vaccine on vulnerable populations in the African continent (read more here). Apart from the fact that this case is absolutely appalling, especially to us as a class studying public health ethics, we were asked to write about whether pharmaceutical companies are bound to respect the ethical guidelines – that is: Even though we agree that it’s an absolutely stupid idea, could it still be done? Is there anything stopping pharma companies from doing it? And if there isn’t anything stopping them, would they do it?
This was my answer.
How is international collaboration for the COVID-19 vaccine organized? Does the WHO coordinate the efforts and decide which vaccine is used globally? I have not been able to fully understand the answer to this question, but from what I gather, the WHO is not as important as it may initially seem. Even if the WHO states that it will not allow “Africa” to be a testing ground for the COVID-19 vaccine, it is ultimately up to individual countries and their legal systems. The statement by the Secretary General to not allow such racism may not mean much in practice, but the WHO has issued a lot of documents that can provide information about whether such trials would nonetheless happen. For example, in 1982, the WHO and CIOMS created the International Ethical Guidelines for Research Involving Human Subjects. While these are very elaborate, they are not binding, which – again – means that it will be up to any country’s individual legal system to regulate trials.
What is interesting to look at is under which country’s legal system a trial would take place. Trials are generally conducted by multiple actors, and pharmaceutical companies are usually the “sponsors” in the relationship. That means that they are help a team of researchers and physicians in testing a vaccine, and then usually receive a patent for their involvement. Researchers from universities conducting the trials, importantly, need to obtain ethics approval from their institutional review board (Lee, 2010). Additionally, researchers as well as pharma companies are usually based (at least tax-wise) in more economically developed countries, which usually have legal regulatory procedures that require them to submit to ethics review before being allowed to market a drug or vaccine that they tested abroad. Even the United States, through its FDA, mandates such an ethics view, and for example does not provide patents if informed consent was not met (Lee, 2010). So even if the researchers of the COVID-19 vaccine were Sudanese doctors from a Sudanese university, the pharma company supporting them would have to abide by US ethics requirements if it is US-based.
Another interesting existing mechanism is the “Agreement on Trade-Related Aspects of International Property Rights”, which is rarely used, but can theoretically deny a pharma company the patent for a drug they developed if they violated the rights of the trial participants (Lee, 2010). Of course, this is quite a narrow view of the power dynamics at play if trials are done in LIMCs, but this still shows that pharma companies are not completely unregulated. Also, the fact that property rights can be denied doesn’t necessarily mean that pharma companies won’t develop the drug – after all, in the current pandemic, the vaccine is urgently needed, and pharma companies might think that even if they don’t reap profit, their reputation will go up, and therefore it is worth doing the trials even without the prospect of a patent. This argument would require that even if government deny a patent, they would still use the vaccine, in an effort not to let the “sacrifice” go to waste.
I want to briefly look at why it may make sense to do the COVID-19 vaccine trial in “Africa”. In this context, I found a super interesting article by a Dr Petryna (2005). She explains that clinical trials have many stages, and each stage requires test subjects – these can be hard to come by. She brings up the example that although many people want to voluntarily be involved in clinical trials, there just aren’t enough people in one country – so it is inevitable to expand to other countries. She explains that “many of these new trials are being performed in geographical areas of political and economic instability and unprecedented health care crises” because subjects are readily accessible there (Petryna, 2005, p.183). With the COVID-19 vaccine, there is so much competition ongoing that not every researcher time can likely find sufficient subjects. Petryna refers to the this as a “turf war” that is “raging among pharmaceutical sponsors for human subjects” (p.186).
I read about recent trends in so-called “corporate social responsibility” – the definitions of this term vary, but they all have to do with companies making efforts to do good and going beyond what is legally required of them. For pharma companies, this provides for an especially interesting case – pharma companies are literally there to create life-saving drugs, but have been accused of various wrong-doings, ranging from driving costs of life-saving drugs up, to doing drug trials of vulnerable populations that cannot give true informed consent, and possibly die from the non-yet-perfect drug (Nussbaum, 2009). Therefore, corporate social responsibility (CSR) for pharma companies means that they shouldn’t just abide by the minimum legally required standards, but also actively contemplate whether what they are doing truly maximizes “good”. CSR has developed quite a bit – in early years (a few decades ago), CSR mainly involved companies doing charity drives, donating to charity, or donating money. The concept of social responsibility was therefore not truly mainstreamed into the company’s doings. I can imagine these early charity-based forms of CSR may have entrenched in pharma companies a belief that they have to help the poor – in the context of clinical trials in LIMCs, this may mean that they may think that a country such as Sudan won’t be able to finance vaccines itself. Petryna, who I mentioned above, also argues that many pharmaceutical companies believe they are doing good when they do the trials in LIMCs, as they are “providing health care where there is none” (p.187). However, she nuances that this is a paternalistic judgment, as this means Western pharma companies can determine whether the existing healthcare system in a country like my example Sudan is “good” or not. To test this, empirical research would be needed to see how many lives would be lost through the testing process, vs. how many lives would be lost without any vaccine by corona, and then measure how many lives would be saved relatively.
I took a closer look at the concept of “corporate social responsibility” and found an interesting paper by Daniel Ostas (2004). He highlights that generally, companies are required to comply with the laws of the country they are based in. This term “compliance” means in practice that companies try to find existing loopholes – they comply with the law, but nothing more. Ostas therefore draws on “social responsibilities”, and argues that when a law is based on actual moral imperatives and is not just bureaucratic, companies should consider themselves as having not just a duty to “comply”, but a duty to “cooperate”. He argues that while companies can be absolutely justified in exploiting the loopholes of laws for economic gains in cases where the law is not based on strong moral foundations, companies should do more than just the bare minimum when there is such a moral foundation. He draws on the examples of health, and argues that when people’s health is at stake, companies should cooperate and not just comply. This would mean that even if the WHO’s Guidelines on ethics in clinical trials are not binding, pharma companies should still consider themselves as having a duty to cooperate and not look for loopholes. This also means that pharma companies should consider the obligation to undergo an ethics review before launching clinical trials as something to cooperate with. Ostas also touches upon why cooperation may be beneficial to the company: “The subordinate (businessperson) complies with the demands of his or her superiors (government regulators). The word ‘‘cooperation,’’ by contrast, suggests a relationship between equals. To ‘‘cooperate’’ means to ‘‘work together with another or others for a common purpose.’” (p.566). So even if it does not reap immediate economic benefits to cooperate willingly with a requirement not to rush to “Africa” for clinical trials, cooperating with the WHO’s request not to do so may be better in the long run.
Now of course, the burning question for a pharma company thinking about how to be “socially responsible” is which is more important – creating that vaccine? Or not being racist and exploitative? One could argue that the direct responsibility of the pharma company is to create a vaccine. The argument that a company ought to engage in CSR is inherently deontological, at least at first glance. The argument is that the pharma company is in the field of health, and that it should therefore make the field of health prosper in general, rather than only focussing on individual profits (Ostas, 2004). The idea that a pharma company ought to mainstream CSR and not do its trials in “Africa” therefore mainly appears deontological. Even if the CEO of the pharma company agrees that pharma companies ought to be doing good in the wider context, he likely thinks in a more consequentialist manner. He might therefore dismiss this argument and think: “CSR? Nah, not today.” However, the concept of CSR helps place the individuals acts of pharma companies into context, and that CEO could realize that it’s not just wrong to do the trials in “Africa” just because deontology says so, but for actual medical reasons. Giving untested vaccines to people may not only reduce their quality of life directly, but also harm the health system of the country they are located in. As a lower standard of health is provided to the people in that testing-country than to other countries, this can seriously impede the development of that country, and cause long-term irreversible harm. This means that overall, the population health of the country can decrease because of the way that health is provided, valued, and measured.
References:
Lee, S. B. (2010). Informed consent: Enforcing pharmaceutical companies’ obligations abroad. health and human rights, 12(1), 15-28.
Nussbaum, A. S. K. (2009). Ethical corporate social responsibility (CSR) and the pharmaceutical industry: A happy couple?. Journal of Medical Marketing, 9(1), 67-76.
Ostas, Daniel. (2004). Cooperate, Comply, or Evade? A Corporate Executive’s Social Responsibilities with Regard to Law. American Business Law Journal 41(1), 559-594.
Petryna, A. (2005). Ethical variability: drug development and globalizing clinical trials. American Ethnologist, 32(2), 183-197.
An (Un?)Educated Guess 