Health Technology Assessment, Courts and the Right to Healthcare

Daniel Wang

• Publisher: Routledge
• Year: 2021
• ISBN:
  9781351371315
• Edition: 1
• Topic: Volkswirtschaftslehre
• Subtopic: Öffentliche Finanzen

Both developing and developed countries face an increasing mismatch between what patients expect to receive from healthcare and what the public healthcare systems can afford to provide. Where there has been a growing recognition of the entitlement to receive healthcare, the frustrated expectations with regards to the level of provision has led to lawsuits challenging the denial of funding for health treatments by public health systems.

This book analyses the impact of courts and litigation on the way health systems set priorities and make rationing decisions. In particular, it focuses on how the judicial protection of the right to healthcare can impact the institutionalization, functioning and centrality of Health Technology Assessment (HTA) for decisions about the funding of treatment. Based on the case study of three jurisdictions – Brazil, Colombia, and England – it shows that courts can be a key driver for the institutionalization of HTA. These case studies show the paradoxes of judicial control, which can promote accountability and impair it, demand administrative competence and undermine bureaucratic capacities. The case studies offer a nuanced and evidence-informed understanding of these paradoxes in the context of health care by showing how the judicial control of priority-setting decisions in health care can be used to require and control an explicit scheme for health technology assessment, but can also limit and circumvent it.

It will be essential for those researching Medical Law and Healthcare Policy, Human Rights Law, and Social Rights.

1 Introduction

DOI: 10.4324/9781315149165-1

Patients all over the world face the agonizing mismatch between the optimal level of care they expect to receive and what their health systems provide. One of the main reasons for this imbalance is the scarcity of resources, which forces even well-functioning and best-funded health systems to limit or deny funding for treatments that can potentially prolong and/or improve lives. This is a phenomenon known in the literature as healthcare rationing.

The fact that healthcare demand increasingly outstrips health systems’ supply capacity is in part the result of important advances in health and healthcare in recent years. Poverty reduction, access to primary care, and the efforts to control transmissible diseases globally have increased life expectancy, which means people now need care for longer and for conditions that are more expensive to treat. Healthcare coverage has expanded significantly (albeit unevenly) all over the world and promoting access to the formerly unprotected, especially if the principles of equity and equality in healthcare are taken seriously, requires substantial subsidies and public spending that are not always sufficient. Knowledge and information spread fast, and patients and professionals have more access to information. They also have more channels where they can make their needs, preferences, and demands known (e.g., social media, lobbying/advocacy, and litigation), particularly when they have the support of the medical industry. Investment and progress in science have enabled the development of new health technologies at a breakneck pace, expanding the possibilities for patients – including for those with very rare conditions – while significantly increasing the costs for health systems.

Therefore, if all goes well, the demand–supply imbalance in healthcare will likely continue and be aggravated as living conditions, health coverage, access to information, public involvement, and scientific knowledge improve. Ironically, the “burden of triumph”¹ will also mean a continuous dissatisfaction with health systems even when their performance and results improve.

1 Andrew Dilnot, “The Burden of Triumph: Meeting Health and Social Care Needs,” The Lancet 390, no. 10103 (October 2017).

Scarcity of resources and unmet health demands are a constant source of conflict between and among patients, health professionals, the healthcare industry, and health authorities. These conflicts play out in different institutional arenas and this book will focus on two of them that have been gaining increasing attention from policymakers and scholars: courts and health technology assessment (HTA) bodies. More importantly, it aims to offer an evidence-informed analysis of the relationship between courts and HTA bodies.

The involvement of courts in decisions about the funding of health treatments in several jurisdictions, which includes reviewing and making allocative decisions, has caught the attention of the literature in law, ethics, and health. The court cases against health systems that challenge healthcare rationing decisions will be called in this book the “right to healthcare litigation”. In many countries, particularly in the global south, this phenomenon can be attributed to what Gauri and Brinks call social rights constitutionalism, that is, “the increasing inclusion of social and economic rights language in constitutions, the increasing use of that language by social actors to pursue their goals, and the increasing judicialization of political disputes under the social rights rubric”.² The right to healthcare litigation can also be found in countries with very different legal and constitutional traditions such as Canada, Germany, the Netherlands, Switzerland, and Thailand.³

2 Daniel M. Brinks, Varun Gauri, and Kyle Shen, “Social Rights Constitutionalism: Negotiating the Tension between the Universal and the Particular,” Annual Review Law and Social Science 11 (November 2015): 290. 3 Colleen M. Flood, “Just Medicare: The Role of Canadian Courts in Determining Health Care Rights and Access,” Journal of Law, Medicine & Ethics 33, no. 4 (Winter 2005); Stefanie Ettelt, “Access to Treatment and the Constitutional Right to Health in Germany: A Triumph of Hope Over Evidence?” Health Economics, Policy and Law 15, no. 1 (January 2020); Floortje Moes et al., “Contested Evidence: A Dutch Reimbursement Decision Taken to Court,” Health Economics, Policy and Law 12, no. 3 (July 2017); Felix Kesselring, “First Fundamental Decision of the Federal Supreme Court of Switzerland on Cost-Effectiveness in the Area of Human Healthcare,” European Journal of Risk Regulation 2, no. 3 (September 2011); Sripen Tantivess and Viroj Tangcharoensathien, “Coverage Decisions and the Court: A Public Health Perspective on Glucosamine Reimbursement in Thailand,” Health Systems & Reform 2, no. 2 (2016).

The impact of courts on access to healthcare, the distributive effects of judicial decisions on health systems, and the proper role of courts in issues of social policy have been widely debated and researched.⁴ This book will build upon this relevant body of literature. However, if, why, and how courts and litigation affect the way health systems set priorities and make rationing decisions has been mostly neglected. Not much is known about changes in the processes of health systems for making funding decisions when policymakers are aware that courts may review their decisions and even oblige them to fund treatment. Yet, it is plausible to hypothesize that such changes occur as litigation and judicial rulings are potentially disruptive for policymakers working with the courts looking over their shoulders.

4 See, e.g., Andre den Exter and Martin Buijsen, eds., Rationing Health Care: Hard Choices and Unavoidable Trade-offs (Antwerp: Maklu, 2012); Colleen Flood and Aeyal Gross, eds., The Right to Health at the Public/Private Divide: A Global Comparative Study (New York: Cambridge University Press, 2014); Alicia Ely Yamin and Siri Gloppen, eds., Litigating Health Rights: Can Courts Bring More Justice to Health? (Harvard University Press, 2011); Jeff King, Judging Social Rights (Cambridge: Cambridge University Press, 2012).

The specialist literature has not given much attention to the impact of litigation and courts on HTA either. This book will argue that it should. HTA is the systematic evaluation of health technologies to inform decision-making by health systems. In many countries, HTA has been institutionalized, that is, carried out by dedicated specialist bodies and through formal processes aimed at guaranteeing high scientific standards, transparency, and impartiality. Health systems adopt HTA to avoid funding technologies that will not produce significant health gains or whose cost may jeopardize their financial sustainability and negatively affect the provision of other services. HTA bodies are also institutional mechanisms to resolve disputes about the funding of treatment and thus legitimize rationing decisions that will often be contested by stakeholders and seen as controversial by the general public.

Legal issues related to HTA have been very rarely discussed in the specialist literature.⁵ This is surprising given that the institutionalization of HTA is made through the law. The foundation of HTA bodies, the key details about their functioning (e.g., scope, members, procedures, and level of autonomy), and the nature of their outputs (e.g., whether mere recommendations or binding decisions) are all determined in legal norms. Moreover, HTA recommendations/decisions can be scrutinized by courts. They can also be presented in legal disputes as evidence to justify or challenge a priority-setting decision.

5 See, however, Daniel Widrig and Brigitte Tag, “HTA and Its Legal Issues: A Framework for Identifying Legal Issues in Health Technology Assessment,” International Journal of Technology Assessment in Health Care 30, no. 6 (December 2014).

This book will fill these gaps in the scholarship on courts and HTA through an in-depth analysis and comparison of three jurisdictions – Brazil, Colombia, and England. In these jurisdictions, there is evidence that courts, by challenging the denial of funding for health treatments, have contributed to the institutionalization of HTA in their respective health systems.

Comparing Brazil, Colombia, and England may seem odd at first sight given the significant differences in their healthcare and legal systems. England has a long-established and world-renowned national health system (the National Health Service – NHS) founded in 1948, funded by general taxation, and generally free at the point of use. The NHS is responsible for most of the healthcare expenditure in the country. Brazil also has a national health system (the Sistema Único de Saúde – SUS) idealized in the 1988 Constitution and effectively created in 1990. Inspired by the NHS, it is funded by general taxation...