This post is part of a symposium on Amy Kapczynski’s essay “The Right to Medicines in an Age of Neoliberalism.” All contributions to the symposium can be found here.
Amy Kapczynski’s essay “The Right to Medicines in an Age of Neoliberalism” is part of a growing scholarship on the apparently paradoxical situation where human rights are mainstreamed globally as the lingua franca to discuss issues of justice while inequalities increase and the capacity of states to provide social protection and promote redistribution is reduced.
Some attribute this situation to the lack of attention by the human rights movement to socioeconomic rights (i.e., health, housing, education). Philip Alston, for instance, suggests that emphasis on realizing socioeconomic rights through their recognition, institutionalization, and accountability is one of the answers to the increasing inequality that feeds populist movements around the world.[1] Therefore, instead of being overly sceptical of human rights, we should reinforce our commitment to them with special emphasis on socioeconomic rights.
Kapczynski, however, builds on a body of literature that is critical of human rights and sees them as insufficient to address inequality (and possibly reinforce it). According to this literature, mainstream human rights movements fail to see the connection between, on one hand, the inequality and social deprivation they decry and, on the other, the economic system that creates them. Therefore, these movements try to address social injustice leaving untouched the tenets of a fundamentally unjust system that produces the human rights violations they combat.
“The Right to Medicines in an Age of Neoliberalism” contributes to this debate with an analysis of the right to medicines in Brazil and Colombia. In these countries, the right to health and the right to life have been used by thousands of individuals to substantiate legal claims for the public funding of specific health treatments (particularly the high cost drugs). The courts in these two jurisdictions have not hesitated to order the provision of the claimed treatments irrespective of price or the financial and distributive impact on health systems.
According to Kapczynski, this sort of litigation does not address the political economy of medicines and, in particular, it does not challenge the protection of intellectual property (IP) rights that make treatments unaffordable for millions and transfers resources from governments in low- and middle-income countries to patent-owner companies in high-income countries. By forcing health systems to pay high prices for medical treatments, courts and the right to medicines are legitimizing and reinforcing the market mechanisms that create obstacles for the access to drugs and aggravate inequalities locally and globally.
Kapczynski proposes that human rights need to be reframed and used to fight the current political economy of medicines. She mentions court cases in which litigants have challenged monopoly rights that create obstacles for the access to essential drugs as concrete examples of how human rights can have this transformative role. As opposed to individual claims for treatments, these legal actions aim to promote access to medicines by revealing and addressing, rather than ignoring, the connection between human rights violations and the political economy of medicines.
Does the Judicialized Right to Medicine Reinforce the Current Political Economy of Drugs?
Kapczynski is right that court rulings ordering the provision of high cost treatments to individuals contribute to a political economy that disproportionately benefits patent holders’ private interests over public health. She offers a powerful reality check for those expecting litigation to be a driver for equality.
One aspect of this phenomenon that she did not mention, but that vindicates her argument, is the fact that the pharmaceutical industry uses litigation as a strategy to grab a larger share of the public health budget. There is evidence from Brazil that pharmaceutical companies, in partnership with industry sponsored patient NGOs, have been promoting information campaigns to encourage litigation; creating networks of patients, health professionals and lawyers for the purpose of bringing judicial claims; and covering patients’ litigation costs.[2] Some interesting examples are the class actions against multinational pharmaceutical companies accused of sponsoring participants of their own clinical trials to litigate against the public health system for the public funding of the tested treatments after the end of the research. The Brazilian clinical trials regulations state that post-trial access should be guaranteed by trial sponsors but instead of providing the tested drugs companies are apparently using research participants and the courts to sell their products to the government.[3]
In Colombia, pharmaceutical companies have also worked closely with patient associations to encourage and support the use of tutelas against health providers to access high cost treatments.[4] Although this may have promoted access, it has also led to the dissemination of questionable information about the inferiority of generics and to the focus of litigation on patented medicines.[5] Moreover, because private insurers were not obliged by law to cover products not included in the mandatory packages, every treatment provided following a court order would be reimbursed by the government. This created incentives for questionable agreements between private insurers and pharmaceutical companies to encourage the prescription of high cost patented drugs and their claim through courts at the expense of the public health budget.[6]
I am not suggesting that all the right-to-medicines court cases benefit or are supported by pharmaceutical companies. It is clear, though, that this type of judicialization is well suited to monopolists maximizing their profit. It neutralizes the tools available for health systems to select the most important treatments for public health and that prevent expenditure that may threaten the provision of other services. The normal process for the public funding of a treatment involves marketing authorization, price regulation and negotiation, health technology assessment that considers effectiveness and cost-effectiveness, and a policy decision by an authority responsible for managing the budget to provide services for a population. Courts have become a shortcut for the funding of treatments that have not completed this process, which is worrying given the increasing number of expensive new therapies of doubtful quality.
Can Courts and the Right to Medicines Have a Transformative Role?
Kapczynski does not suggest that human rights should be abandoned. Instead, she proposes that human rights can be used to demand that governments make structural changes to the current political economy of drugs. One could think she expects courts to play a central role in this process given her substantial analysis of court cases in which litigants have sought to invalidate IP protections that prevented access to treatment.[7] However, towards the end of the essay, she acknowledges the limits of courts and calls for broader political action to challenge unjust neoliberal policies.[8]
This limited enthusiasm about courts is not fully explained in Kapczynski’s conclusion, but I agree with her for reasons that I suspect she may not endorse. In my view, courts should exercise a significant degree of self-restraint in cases involving human rights challenges to IP protection for the same reasons they should avoid ordering the provision of treatments. In these individual right-to-medicines cases, issues of science, policy, and politics are ignored or oversimplified under the guise of offering a quick solution to what is interpreted as human rights violations. Courts are unlikely to understand the broader context in which their decisions are made and do not have control over the distributive implications of their decisions. The adjudication process seems too limited to deal with the complexity of policymaking while being too vulnerable to capture by economic interests.[9]
The same could be said about courts using human rights as grounds for not upholding drug patents that comply with local IP law requirements or for demanding compulsory licenses to be issued. Can the country cope with trade retaliations that may impact important sectors of the economy? Could this affect existing or future investment, voluntary licenses, or technology transfer agreements between the country and the patent holder? Does the country have the resources and technology to produce generics locally or is there a supplier elsewhere? If the frequent refusal to uphold intellectual property rights reduces private investments in R&D, can public investment or other mechanisms replace IP incentives for medical innovation? Will flexible IP laws affect the development of innovative start-ups in developing countries? Even if countries can withstand the political and economic costs of challenging the IP of a drug, how often can this be done before they run out of political and economic capital?
In many circumstances, some may answer the questions above and conclude that a strong case can be made for using TRIPS flexibilities to break the monopoly on a drug.[10] However, it is very likely that reasonable people will disagree, which raises the question of which institution should decide this matter in a democracy. Courts seem to have neither the institutional capacity nor the democratic legitimacy to deal with these polycentric issues that can have unpredictable consequences for a political community.
To avoid objections about their lack of legitimacy and capacity, courts may opt for dialogical approaches in which they use weaker remedies that allow governments a wider margin of discretion in deciding when and how to address the human rights violations. Yet, the evidence from the socioeconomic rights literature suggests that weak remedies are too limited to promote the results expected by claimants, which makes the transformation of the political economy of medicines through this form of adjudication even more unlikely.[11]
Shall we Talk More about Politics?
Even if courts deliver victories that help break some drug monopolies or lower the price of specific patented products, it is difficult to imagine how instances of sparse litigation can “dislodge the contemporary political economy of medicines.”[12] Kapczynski seems to acknowledge this when she mentions the need for broader politics towards the end of her essay, but the form of this political activism is unclear.
The human rights movement tends to equate political action with controlling and nudging governments through legal constraints, campaigning, advocacy and accountability.[13] Human rights activism in and outside courts has undeniably produced important results in promoting access and in challenging IP protection. The successful policy for antiretrovirals in Brazil is largely due to civil society organizations acting through legal and political accountability mechanisms using the language of human rights.[14] However, even the most successful cases do not come close to dislodging the political economy of medicines. At best, they create islands protected from the economic forces that hinder broader access to drugs, such as resource constraints and patent protection
The transformation of the political economy proposed by Kapczynski would probably require some sort of developmental state with economic policies that allow a degree of independence to make commercial retaliation from multinational companies and developed countries less damaging. This state would also need to have fiscal and governance capacity to promote public investment in R&D, industrial policies to foment the local production of medicines, and healthcare policies that can catalyse local industrial and scientific development.[15] It would also need a robust foreign policy to achieve a high level of cooperation and coordination at international and supranational levels to promote global access to drugs and R&D in the absence of patents and market mechanisms.[16]
Putting aside the challenges of building adequate institutions for these tasks and the possible shortcomings of such a state, changing the political economy of medicines along these lines would require the political mandate and power that can only be achieved through macro level politics. This includes having a comprehensive long-term developmental agenda; winning national elections to implement it; and building broad coalitions in government and between government, capital, and civil society to resist the organized interests that are likely to oppose change. It is unlikely that human rights and its focus on accountability (in or outside a courtroom) can be a protagonist in reforming the political economy of medicines.
In sum, I agree with Kapczynski’s critique of what the judicialization of socioeconomic rights has achieved. However, unless high-level politics emerge to the forefront of the discussion, I cannot share her optimism about the use of human rights to change the political economy of drugs.
NOTES
[1] Philip Alston, “The Populist Challenge to Human Rights,” Journal of Human Rights Practice 9, no. 1 (February 2017): 1–15.
[2] Virgílio Afonso da Silva and Fernanda Vargas Terrazas, “Claiming the Right to Health in Brazilian Courts: The Exclusion of the Already Excluded?” Law & Social Inquiry 36, no 4 (Fall 2011): 825–53; Ana Luiza Chieffi, Rita De Cassia Barata Barradas, and Moisés Golbaum, “Legal Access to Medications: A Threat to Brazil’s Public Health System?,” BMC Health Services Research 17, no. 1 (July, 2017): 499; Marcelo Medeiros, Debora Diniz, and Ida Vanessa Doederlein Schwartz, “The Thesis of Judicialization of Health Care by the Elites: Medication for Mucopolysaccharidosis,” Ciência & Saúde Coletiva 18, no. 4 (April 2013): 1079–88; Claudia Marcela Vargas-Peláez et al., “Right to Health, Essential Medicines, and Lawsuits for Access to Medicines—A Scoping Study,” Social Science & Medicine 121 (November 2014): 48–55.
[3] Daniel Wei L. Wang and Octavio Luiz Motta Ferraz, “Pharmaceutical Companies vs. the State: Who Is Responsible for Post-Trial Provision of Drugs in Brazil?,” The Journal of Law, Medicine & Ethics 40, no. 2 (July 2012): 188–96.
[4] C. Prachniak-Rincón and J. de Onís Villar, “HIV and the Right to Health in Colombia,” Health and Human Rights 18, no. 2 (December 2016): 157–69.
[5] Cesar Rodriguez-Garavito, “Constructing and Contesting the Global Intellectual Property Legal Field: The Struggle over Patent Rights and Access to Medicines in Colombia,” in Balancing Wealth and Health, ed. Rochelle Dreyfuss and Cesar Rodriguez-Garavito (Oxford: Oxford University Press, 2014).
[6] Everaldo Lamprea, “Colombia’s Right-to-Health Litigation in a Context of Health Care Reform,” The Right to Health at the Public/Private Divide: A Global Comparative Study (April 2014); Cesar Rodriguez-Garavito, “Constructing and Contesting the Global Intellectual Property Legal Field.”
[7] Amy Kapczynski, “The Right to Medicines in the Age of Neoliberalism,” Humanity 10, no. 1 (Spring 2019): 79–107, 89–93.
[8] Ibid., 95.
[9] Daniel Wei Liang Wang, “Social Rights and The Nirvana Fallacy,” Public Law (July 2018): 482–99.
[10] Cinthia Leite Frizzera, Borges Bognar, Brittany L. Bychkovsky, and Gilberto de Lima Lopes, “Compulsory Licenses for Cancer Drugs: Does Circumventing Patent Rights Improve Access to Oncology Medications?” Journal of Global Oncology 2, no. 5 (June 2016): 292–301.
[11] Jackie Dugard, “Courts and the Poor in South Africa: A Critique of Systemic Judicial Failures to Advance Transformative Justice,” South African Journal of Human Rights 24 (2008): 214; Landau, “The Reality of Social Rights Enforcement,” Harvard International Law Journal 53 (2012): 402, 406; Anashri Pillay, “Revisiting the Indian Experience of Economic and Social Rights Adjudication: The Need for Principled Approach to Judicial Activism and Restraint,” International & Comparative Law Quarterly 63, no. 2 (2014): 385; Katherine Young, Constituting Economic and Social Rights (Oxford: Oxford University Press, 2012), 182; Rodriguez-Garavito, “Beyond the Courtroom: the Impact of Judicial Activism on Socioeconomic Rights in Latin America,” Texas Law Review 89 (2011): 1669.
[12] Kapczynski, “The Right to Medicines in the Age of Neoliberalism,” 89
[13] Philip Alston, “The Populist Challenge to Human Rights.” Journal of Human Rights Practice 9, no. 1 (February 2017): 1–15; Alicia Ely Yamin and Ariel Frisancho, “Human-Rights-Based Approaches to Health in Latin America,” The Lancet 385, no. 9975 (April 2015): e26–29.
[14] Mary Garcia Castro; Lorena Bernadete da Silva, Responses to AIDS challenges in Brazil: Limits and Possibilities (Brasília: UNESCO, Ministry of Health, 2005); Amy S. Nunn, Elize M. Fonseca, Francisco I. Bastos et al. “Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment,” PLoS Med 4, no. 11 (November 2007): 1804–17; V. Oliveira Cruz, J. Kowalski, B McPake, “Viewpoint: The Brazilian HIV/AIDS ‘Success Story’– Can Others Do It?” Tropical Medicine & International Health 9, no. 2 (February 2004): 292–97.
[15] Kenneth C. Shadlen and Elize Massard “Health Policy as Industrial Policy: Brazil in Comparative Perspective,” Politics & Society 41, no. 4 (November, 2013): 561–87.
[16] Thomas Pogge, “The Health Impact Fund: Enhancing Justice and Efficiency in Global Health,” Journal of Human Development and Capabilities 13, no. 4 (2012): 537-559.
