The Supreme Court will soon decide whether the government will subsidise high-cost drugs, including where the Health Surveillance Agency (ANVISA) has not approved their use in Brazil. This issue is sensitive and has attracted widespread attention from stakeholders in the Brazilian healthcare system, as it relates to the health, wellbeing and constitutional rights of citizens, as well as the responsible use of public resources, which come solely from taxpayer contributions.
Under the Constitution, healthcare is enshrined as a right and the government must provide universal and equal access to health services. The Unified System of Health (SUS) was established in the 1990s to address the government's actions and services for the protection of health at the federal, state and municipal levels, in order to ensure physical, mental and social welfare and free access to, among other things:
- medical treatments;
- drugs; and
- medical devices.
The SUS is a well-structured and inclusive system that provides healthcare to millions of citizens who cannot afford the above services and treatments. However, the SUS has several problems and limitations, such as long wait times for scheduling medical appointments, examinations and surgeries. The SUS's main issue is its limited budget; states must limit their expenditure according to a percentage of the revenues received from taxes.
The argument that the government should bear health costs for citizens is based on the constitutional principle of access to health services. Under this principle, thousands of citizens have requested judicial authorisation from the courts forcing the government to support their high-cost medical treatments and drugs. In the past five years, the number of judicial claims has skyrocketed, increasing from approximately 9,400 claims in 2010 to 18,045 in 2015.
In most cases, the lower courts have ruled in favour of citizens and the government has borne the cost of the required medical treatment. Public attorneys at the federal, municipal and state levels have argued that:
- the public resources available for healthcare are limited; and
- the judicial decisions forcing the government to support high-cost medical treatments deviate resources from basic treatments, which are offered to thousands of citizens.
Thus, the public healthcare system has not been able to achieve one of its fundamental principles: universality.
Offering drugs that are yet to be approved by ANVISA is another main issue regarding the claims under review by the Supreme Court. Citizens have argued that ANVISA takes years to approve a new drug, in which time an ill person may die. Conversely, ANVISA's president has said that using non-approved drugs could cause significant public health problems, as there will be no surveillance or certainty as to their safety and efficiency. As such, ANVISA's president has said that the registration process for new drugs could be expedited.
How can Brazil sustain its healthcare system with a limited budget? In this regard, some nations, such as the United Kingdom, rely on the quality-adjusted life year (QALY) methodology. This system quantifies a specified amount to be spent based on the number of years in a healthy person's life, taking into account new technology. For example, between £20 and £30,000 can be borne by the state for the QALY of each individual. A similar parameter could help the courts when reviewing cases in Brazil.
The Supreme Court is set to announce its decision shortly. Three justices have already announced their decisions, two of whom did not agree with providing non-approved drugs, except in cases of delay by ANVISA. As regards high-cost drugs, all three justices have agreed that the state must provide the drugs listed in the SUS drug list. Until a final decision has been made, the general expectation is that the ruling may bring an intermediary solution that has a smaller effect on public resources than the existing system. However, it may also abridge the rights of citizens who have no other option available to fund their medical treatments.
For further information on this topic please contact Elysangela de Oliveira Rabelo at TozziniFreire Advogados by telephone (+55 11 50 86 50 00) or email ([email protected]). The TozziniFreire Advogados website can be accessed at www.tozzinifreire.com.br.
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