Litigating the right to health in court: Best practices regarding high-cost technologies

By María Natalia Echegoyemberry

In Argentina, health-related lawsuits have skyrocketed in recent decades, mainly in relation to very high-cost drugs.

Judicialization of health is not new and is in service of the effective protection of the right to health, and a tool to hold States accountable to human rights standards. However, it is of great concern because of its impact on health systems and resources.

People resort to judicial means when access to rights is hindered by barriers whether economic, administrative and bureaucratic. But not everyone can litigate due to the associated time and costs. Many people with unmet legal health needs will never access justice or be able to achieve the recognition, guarantee, and enforceability of fundamental rights. 

This phenomenon, an “epidemic of judicialization” originates from the expansion of rights and pathways to legal recourse introduced through numerous Constitutional Reforms throughout Latin America during the 1990s. These reforms made it easier to access justice, consequently resulting in a rise in legal cases brought before the courts.

However, judicialization is not always the most effective way to solve complex health problems. Even judicial decisions may give rise to new problems related to inequality and inequity. Some authors argue that litigation over the right to health has little capacity to reduce health inequity.

Recent studies found a temporal relationship between the appearance of high-cost medications in the national press and the increase in lawsuits seeking protections, even in relation to medications without marketing approval in Argentina.

It has been found that the, since the budgetary and operational forecasts of the managers are not part of the judicial decision.

There are at least three large categories of problems regarding judicialization:

• First, an increase in judicialization of the right to health in Argentina, has not generated structural changes in the health system or preventive approaches to judicialization. In effect, individual judicialization  does not generate collective responses or impact on the design and implementation of public policies. The role of the courts in the guarantee and effectiveness of the right to health is unclear as are the effects, consequences, and social, economic, and environmental impacts of litigation in the health field?

• Second, there is a deficit of preventive, comprehensive, and health-promoting judicial approaches or alternative mechanisms for resolution of health conflict and decision-making in complex cases through case management models, case meetings, consultative tables, or social participation.

• Third, scientific evidence usually occupies a marginal place in court decisions. . Lawsuits are initiated without support in clinical guidelines or evidence of efficacy and safety and sentences are also resolved without the use of the best available evidence. 

Judicial rulings are often at the service of the market, which creates and induces new health needs, and medicalizes, pathologizes, and commodifies people's daily lives, while making other forms of care, such as community care, self-care, and ancestral knowledge invisible. Recent studies have found that new medications have failed to demonstrate new therapeutic value and may be less safe than previous therapies. However, people continue to demand access to high-cost products through judicial means.

Justice in the individual case is often in tension with social equity. Decisions may authorize patients to access treatments or benefits in other countries when there are viable therapeutic alternatives in the country of origin; or endorse unnecessary medical interventions, increasing costs and risks for patients; or condemn the coverage of a certain brand of medication; or authorize experimental or high-cost treatments without sufficient evidence of their effectiveness (or even with scientific evidence against them).Courts do not analyze the economic, social, and environmental impacts of their decisions (whether in the short, medium, or long term). They also do not consider equity of access to technology for those who have the same condition or situation.

In many cases, excessive judicialization redirects national and subnational budgets toward high-cost health technology rather than addressing social determinants of health or rights interrelated with health or encouraging preventive health practices. 

Preventing judicialization through public policy

The Argentine Ministry of Health, during 2019-2023, has developed public policies in collaboration with provincial health authorities, civil society organizations, and scientific and academic bodies to address and mitigate the judicialization of health problems. These policies aim to provide clear information on judicialization patterns, identify artificially induced judicial needs, and offer timely, efficient, and equitable responses to the public, while promoting the rational use of medicines and providing support in decision-making.

The National Commission for the Evaluation of Health Technologies and Clinical Excellence (CONETEC,2023) evaluates and recommends health technologies for integration into the Mandatory Medical Plan (PMO). In addition, there is a special procedure that allows for the compassionate use of medical products not approved in Argentina.

The Health Technology Assessment for Rare Diseases and Special Pathologies (CATPROS, 2023) and specific directorates within the Ministry of Health aim to manage special and high-cost medicines. In addition, a national registry will track lawsuits involving high-cost drugs and technologies, with the goal of analyzing and better understanding litigation patterns. These efforts collectively seek to reduce unnecessary litigation and ensure a scientific and equitable approach to health policy and judicial decisions regarding health rights.

The Registry of Protection claims in Argentina provides valuable insights into the extent of claims filed for access to high-cost technologies, including the number of cases, associated expenses, most requested medications, prevalent pathologies, and responsiveness of different sectors. 

However, Argentina's Judicial Information System doesn't centralize this data, highlighting the need for public policies to prevent judicialization and address health issues from a human rights and collective health perspective. 

Evidence-based decision-making within the judicial system is crucial to drive structural changes in the health system and justice administration.

The new Observatory of Health and Climate Justice in Latin America (2023) seeks to make visible and analyze what the Judiciary of Latin American and Caribbean countries decide on the right to health. It shows the patterns of judicialization of the right to health, the criteria on which legal cases are based, the accessibility to health technologies, critical inputs, medicines, treatments and vaccines. The Observatory of Health and Climate Justice in Latin America is an initiative of civil society organizations, academia, public bodies, networks, and social movements.

It is hoped that the aforementioned initiatives, implemented to address the judicialization of the right to health, can become state policies and therefore can be maintained despite recent changes in political management.