The rise of globalization has precipitated vast amounts of growth worldwide. However, it has also brought about the rise of multinational corporations as powerful non-state actors that have the capacity to affect human rights on a large scale. While international law and codes of ethics pertaining to human rights were initially developed to hold states accountable for human rights abuses, globalization has “forced international law and institutions to reckon with the emergence of multinational corporations as major actors in human rights violations” (Ferreira, 2002). Upon analyzing the human rights implications surrounding multinational pharmaceutical corporations, it is easy to recognize a systemic abuse of human rights that takes the form of many different activities including excessively high drug pricing, inadequate development of treatments for illnesses that predominantly inflict poor nations, illegitimate drug “donations,” and unethical clinical trials. While pharmaceutical corporations can play a key role in providing necessary benefits that aid in the development of global public health measures, they can also resort to “unscrupulous business, abuse and crime” for the sake of profit (Negri, 2017).
In order to provide a thorough depiction of the extent of human rights abuses committed by multinational corporations on a systemic level, this paper begins with a brief overview of the complexities of the human right to health as it pertains to state and non-state accountability under international law. This analysis is then followed with detailed accounts of different realms within the pharmaceutical industry in which extensive human rights abuses are being committed, starting with the impediment to access to healthcare and medicine as well as exorbitant drug pricing that is supported by strong patent protections. Within this section, the issue of insufficient attention to illnesses that are more common in developing countries as well as drug “donations” are also identified and discussed in detail. These accounts are then followed by a look into the problematic nature of clinical trials in regards to the right to informed consent as well the lack of efficient oversight mechanisms. The paper then ends with a conclusion that includes proposed solutions that attempt to effectively address the issue of human rights abuses within this industry and enact measures to put an end to and prevent further violations.
Health as a Human Right
The rise of the pharmaceutical industry as a profitable network of multinational corporations has been no different from other industries at this level in regards to the serious implications of human rights abuses involved in its activities. The human rights violations of this multinational industry mostly pertain to violations to the fundamental human rights to health and life. Although upon initial consideration this seems to be a simple right to protect, the ability to sufficiently protect the right to health is much more complex as it “encompasses medical care and the underlying determinants of health, such as water, sanitation, non-discrimination, and equality” while also being subject to the availability or resources to do so, which varies from country to country and becomes problematic when trying to promote this right in developing nations, where resources are already extremely limited (Hunt, 2008). With that being said, the human right to health is still guaranteed under various international agreements including the Helsinki Declaration, the International Covenant of Economic, Social, and Cultural Rights, the Universal Declaration of Human Rights, the Nuremberg Code, the Council for International Organizations of Medical Sciences Guidelines, and many more. However, when violations to this human right are perpetrated by entities in the private sector, the issue becomes more complex as there is a lack of mechanisms that are able to hold these corporations accountable for their abuses. Furthermore, the human rights violations of non-state actors is a matter of contentious debate in terms of international law requirements.
Access to Medicine and Exorbitant Drug Pricing
Based on estimates from the World Health Organization, roughly one third of all health related deaths are caused by treatable medical conditions while roughly 100 million people on a global scale are pushed below the poverty line due to excessive healthcare expenses (Vieira, 2016). At the other end of this spectrum, the pharmaceutical industry remains as the most profitable industry in the world, operating with a profit margin of roughly 18.5%, as compared to other industrial sectors that operate with a profit margin of 3.3% (Vieira, 2016). In other words, millions of people are unnecessarily dying on a global scale while multinational pharmaceutical companies reap the financial benefits of being the business of “saving lives.” Due to strong patent protections under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), pharmaceutical corporations are often given the authority to set the price of their drug during the period in which it is under patent protection, which results in the exorbitant pricing that is seen today. Pharmaceutical corporations justify these excessively high costs with the claim that their research and development incurs high costs that can only be recovered by setting these prices as well as maintaining a monopoly over the drug, which is ensured via the protection of intellectual property in the form of these patents, which keep these drugs out of the public sector for an established period of time before a more affordable generic form is able to be formulated. However, despite these justifications, studies have found that there is very little evidence that can support this claim (Nwobike, 2006). While it can be acknowledged that pharmaceutical companies do have a responsibility to benefit their shareholders, they also have an immense obligation to the millions of people in need of their life-saving drugs. In fact, countries such as South Africa have attempted to introduce legislation aimed to reduce prices of life-saving drugs in order to ensure broader access to medicine for their citizens but have been faced with severe pushback from multinational pharmaceutical corporations that argue that this type of legislation would be an infringement on their intellectual property rights. However, as this issue progresses, unfair and outrageous pricing of integral medicines has been interpreted as a violation of universal human rights including the right to health, life and development.
The issue of exorbitant drug pricing as it pertains to an infringement on access to medicine and the right to health is particularly apparent when analyzing it in the context of the global issue of HIV/AIDS. Despite the fact that recent developments in the pharmaceutical industry have made this illness more manageable, people in developing countries, which accounts for roughly 90% of those infected globally, cannot afford these life-saving drugs (Ferreira, 2002). For example, in South Africa, where the average daily income amounts to a mere $7, a one year supply of the most common HIV treatment from major pharmaceutical companies costs roughly $1,200, whereas the generic equivalent would only cost $350 for the same supply (Ferreira, 2002). Despite any justifications for the unfair pricing of these drugs that may be provided from these corporations, there is an emerging consensus among the international community that the right to affordable HIV/AIDS drugs is part of the fundamental right to health and that states have an obligation to ensure this right. However, higher priced drugs protected under patents take up an unreasonable portion of the public health budget of developing countries, which in turn forces them to ration the medicine and thus restrict necessary access to healthcare from much of the population. Thus, in fighting for their ability to maintain these unreasonably high drug prices for the sake of exponential profit, pharmaceutical corporations are in turn violating fundamental human rights by infringing on the ability of developing nations to provide their citizens with access to affordable and life-saving drugs, and thus their rights to health and life. The issue of excessive drug prices further implicates developing nations as they are inundated with a “shrinking domestic policy space hemmed by a thicket of overlapping treaty commitments, diminishing health budgets, and national court judgments ordering the provision of essential medicines to the patients who demand them” (Helfer, 2016).
One issue that further elucidates the shortcomings of pharmaceutical corporations in regards to human rights would be the extent of the Hepatitis C epidemic, which inflicts roughly 185 million people, or 3% of the global population (Vieira, 2016). Recently, a pharmaceutical corporation known as Gilead has released a drug known as sofosbuvir that is known to effectively treat this condition. Due to patent protections that have allowed the corporation to set their own price, this drug quickly became known as the “$1,000 pill” as the 3 month course of treatment was priced at $84,000, a price that would exclude the vast majority of those infected with Hepatitis C from accessing it (Vieira, 2016). Despite the incredibly high price of this treatment, the University of Liverpool has estimated that the production cost of the drug had only cost between $68 and $136 (Vieira, 2016). When considering the immense discrepancies between production costs and marketing pricing, the justifications for these prices provided by the pharmaceutical industry become unfounded as it becomes apparent that there is plenty of room to accommodate for a more reasonable and fair pricing structure.
Among other activities of multinational pharmaceutical corporations that violate the right to health, pharmaceutical corporations fail to prioritize the health needs that predominantly affect low income countries. This can be seen with the issues of both dengue fever and the zika virus, in which both almost solely inflict those in developing nations and thus have “never been considered a priority in the development of drugs and vaccines not because they did not affect a large number of people but because they did not affect people in rich countries” (Vieira, 2016). The profit-driven model of pharmaceutical companies also impedes on the development of the best possible treatments in a more time sensitive manner, which in turn threatens thousands of lives. This can be seen in the case of HIV treatment programs, in which Gilead waited to clinically develop a drug known as TAF, which had been known to have potential benefits over the currently-used drug, TDF, for almost 12 years until the patent protection of TDF (their own drug) ended in order to further maximize their profits. There were also concerns of liver and kidney toxicity surrounding the conventional TDF drug, which could prove to be lethal for patients who were also infected with Hepatitis C (which Gilead had also ironically released an extremely expensive treatment for); however, these concerns were not enough to push Gilead to invest more in the development of the potentially safer TAF drug as profit took precedent over human health and even survival and thus “endangered the lives and health of millions” of people infected with HIV (Vieira, 2016).
Another troubling issue regarding access to healthcare is the public announcements of drug “donations” to developing countries, in which pharmaceutical corporations hide behind a false sense of altruism that masks ulterior motives of cutting costs. In fact, a study conducted by the World Health Organization found that only 56% of drug “donations” from pharmaceutical corporations were sufficient in regards to what was actually needed, and only 12.5% of drugs requested by these countries in need were actually received. Among the rest of the donations, 57% were found to have erroneous labels and 40% would reach their expiration date in less than one year (Brown, 2016). It is the unfortunate fact that the “donation” of drugs that are close to or past their expiration dates is a relatively common activity of pharmaceutical corporations as it is often less expensive to “donate” these drugs rather than dispose of them, which in turn imposes more costs on the receiving countries rather than legitimately helping them in any way.
Right to Informed Consent and Clinical Trials
Over the past two decades, profit driven pharmaceutical corporations have increasingly outsourced their sponsored drug trials to developing countries, “turning into a widespread phenomenon imbued with ethical challenges and dilemmas” (Negri, 2017). The outsourcing of clinical trials is largely motivated by cutting costs, through which the pharmaceutical corporations are able to take advantage of the lenient regulations and vulnerable populations of developing countries. Upon analyzing various cases of unethical clinical trials that involve human rights abuses, the right to informed consent appears to be of primary concern.
Among the most notorious examples of unethical clinical trials remains the 1996 trials of an experimental drug known as Trovan, in which a pharmaceutical corporation known as Pfizer responded to a meningitis outbreak in Nigeria as an opportunity to test its experimental drug on infected children. By the end of the trial, a total of 11 children died while a multitude of others suffered from various and adverse side effects including “blindness, deafness, and paralysis” (Lee, 2010). Standard obligations required Pfizer to monitor the children's health throughout the trial via the analysis of blood samples in order to determine their response (or lack thereof) to the drug. In the event that a child wasn't responding to the trial drug, the corporation was then required to administer the conventional, FDA-approved treatment. However, this protocol was often ignored as many of the blood samples went unanalyzed, which led to the deterioration of numerous subjects. In the instances in which Pfizer researchers actually switched to the standard drug (which had already been proven to be effective at treating meningitis) upon a lack of response to the trial drug, they often administered a reduced dose that was one third of the recommended amount, which “could have lowered the drug's efficacy and skewed any comparison to Trovan” (Lee, 2010). There was also insufficient evidence to prove that Pfizer had informed the children's parents that “the proposed treatment was experimental, that they could refuse it, that serious risks were involved, or that other organizations at the same site offered more conventional treatments for free” (Lee, 2010). In fact, many of the subjects along with their parents claimed that they were unaware of the fact that they were even participating in a clinical trial upon the end of the experiment. This severely unethical clinical trial is important to recognize when analyzing the extent of human rights abuses within this realm of pharmaceutical activities as it was one of the initial cases that shed a light on human rights violations perpetrated by these corporations.
Another poignant case study regarding clinical trials involves the testing a drug known as Nevirapine in Uganda from 1997 to 2003. Sponsored by the pharmaceutical corporation Boehringer Ingelheim, this trial was intended to test the efficacy of a drug formulated to prevent the transmission of HIV from mother to child. From the beginning of the trial, there had been serious discrepancies in record keeping as well as numerous failures to disclose thousands of side effects and serious reactions to the drug, including a misstep that led to fourteen deaths going unreported. Issues surrounding the integrity of informed consent also arose after researchers failed to obtain consent from the subjects after changes were implemented in the experiment. There were also numerous instances in which the research staff issued incorrect doses that also led to adverse side effects among the patients. Upon rising unease that the ethical concerns surrounding this trial would necessitate an audit by the U.S. Food and Drug Administration (whom would be receiving an application for the approval of this drug), Boehringer Ingelheim requested the US National Institutes of Health (NIH), which was also involved in the study, to discard the initial copy of the research report in a potential attempt to destroy any evidence of human rights violations. However, Boehringer Ingelheim (BI) later released a statement that attempted to absolve them of any responsibility as they claimed that “the trial was conducted under the sole responsibility of the NIH. BI at no point covered up any information or destroyed any documents” (Weyzig, 2008).
Despite the fact that there have been numerous cases of problematic clinical trials throughout the years, these human rights violations still continue to this day. A more recent case of human rights abuses involving clinical trials would be those surrounding the vast amount of trials that are being conducted in Egypt, which is ranked second in regards to the country that hosts the most multinational corporation-sponsored clinical trials in Africa (Dursich, 2016). One common ethical issue of these clinical trials is that the consent forms are often not provided to the patients in their own language, which thus delegitimizes any sense or presence of informed consent within these trials. The poor economic situation of the vast majority of these patients also becomes problematic as the transnational pharmaceutical corporations are able to exploit the immense need for healthcare in order to recruit test subjects and thus blur the line between “voluntary participation” and “free treatment opportunity” (Dursich, 2016). This desperation for access to any form of treatment, no matter how risky it may be, creates unsuitable conditions for any legitimate presence of informed consent.
Yet another problematic element surrounding these clinical trials is the difficulty of understanding the actual extent in which abuses are occurring as oversight is a particular issue, with the U.S. Food and Drug Administration investigating the conduct of less than 1% of foreign sites that are testing drugs that are submitted for approval in the United States (Levinson, 2010). The lack of transparency and effective oversight further implicate the ability to understand the extent of human rights abuses within clinical trials occurring around the world that are sponsored by pharmaceutical corporations as it “cannot be estimated how many unethical clinical trials escape public attention and therefore remained unnoticed” (Weyzig, 2008). Due to the fact that roughly 40 to 65% of clinical trials that are testing drugs that are in the process of receiving US FDA approval are conducted in regions outside the borders of the United States, it is concerning to see the potential scale, though impossible to specifically determine, of which human rights abuses within clinical trials are possibly taking place (Levinson, 2010). Another point of concern is the fact that the early phase of clinical trials, which is the most dangerous phase as these new drugs have yet to be adequately tested on human subjects in order to understand their potential side effects, are increasingly being conducted in developing countries, where the populations are already vulnerable due to various underlying socioeconomic issues.
Conclusion: Proposed Solutions and Preventative Measures
Upon reaching the end of this analysis of the various human rights abuses that are perpetrated by multinational corporations within the pharmaceutical industry, it is important to note that these abuses are by no means the full extent of what is occurring on a global scale. While only a few corporations have been mentioned in this article, these abuses are more indicative of a systemic issue that involves a multitude of multinational corporations within the industry. While states have the primary obligation to protect and ensure the human rights of their citizens, including the rights to health and life, their ability to do so is encroached upon by unethical practices of multinational pharmaceutical corporations, including excessively high prices, inadequate attention to research and development concerning diseases that disproportionately impact people in low income countries, as well as problematic clinical trials (Hunt, 2008). Certain international legal perspectives have determined that the widespread experiments in particular that disregard human rights are commensurate to crimes against humanity under international law as they amount to what is considered to be inhumane treatment, which is criminalized in all four Geneva Conventions (Negri, 2017).
Due to the fact that the standard operations of pharmaceutical corporations have proven to directly obstruct the ability of states to protect fundamental human rights of their citizens, it is absolutely integral to aid in strengthening the ability of developing nations to protect the human rights of their citizens in order to prevent these abuses from continuing. However, due to that fact that focusing too much attention on the human rights obligations of pharmaceutical corporations creates the risk of “detracting attention away from state obligations, making it easier for governments to shirk their own obligations,” it is still important to place pressure on these nations to ensure that they are fulfilling their responsibilities as well (Moon, 2013). There is also an inherent need to establish an international legal framework that holds transnational corporations, including those in the pharmaceutical industry, accountable for their numerous violations of human rights as “human rights scholars believe that a strong legal system is crucial to regulate multinational corporation operations in host countries and to inhibit human rights abuses” (Giuliani, 2014). In order to account for the changing nature of the pharmaceutical industry, it will also be important for international law to be developed in a manner that coincides with both bioethics and scientific advancements in order to more effectively address and protect the interests of all involved parties. In order to address the issue of exorbitant drug pricing and its infringement on the right to health and access to medicine, exemptions should be granted in regards to sacrificing patent protections under the TRIPS agreement in order to aid in making life-saving drugs more affordable and thus accessible in low income countries. Non-governmental organizations and public advocacy groups can also play a key role in shining a light on these issues in order to raise public awareness while placing pressure on these corporations to adopt measures of conduct that are more closely aligned with international agreements surrounding human rights, as this will be integral in holding these multinational corporations accountable for upholding their obligations to the international community as a whole. In advocating for a necessary reform of the conduct of these multinational corporations, the efforts to promote public health and human rights can become more compatible in a more equitable manner that respects and protects the rights of every global citizen.
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