Overview of Access, Judicialization and the Provision of Medicines: The Importance of the Pharmaceutical Industry Analyzing and Monitoring Qualified Data on Judicial Claims
In an increasingly complex regulatory environment, the ability to transform judicial data into actionable intelligence has become a competitive advantage and a central element of governance.
Judicialization of access to medicines is a reality that continues to advance as a structural phenomenon. The latest survey conducted by the National Council of Justice (“CNJ”), published in 2025, revealed relevant data: between August 2024 and July 2025, favorable preliminary decisions were issued in 73% of cases involving public healthcare and 69.5% of cases involving private healthcare, while final decisions were favorable in 84% and 87% of cases, respectively.
There is also a growing number of new lawsuits being filed each year.
This issue, which is structural to the Brazilian system, brings together different stakeholders, including patients, public healthcare policy, the operation of public and private entities connected to healthcare, budgets, oversight and inspection activities involving the Ministry of Health, the National Health Surveillance Agency (“Anvisa”), the Medicines Market Regulation Chamber (“CMED”), and the Judiciary itself. More recently, it has increasingly attracted the attention of the pharmaceutical industry to the strategic data that can be obtained from this context.
Monitoring judicial proceedings is no longer merely a reactive activity. It has become an important tool for obtaining qualified data, managing risks within the pharmaceutical industry, understanding the regulatory environment, and anticipating trends or discussions that may affect the sector.
The collection and analysis of qualified data generated from judicial proceedings have allowed companies in the sector to understand how their products appear in litigation, which legal arguments are being used in claims, and how the Judiciary has been deciding sensitive issues involving healthcare and medicines within their portfolios.
Structured monitoring of data obtained from the analysis of judicialization provides a comprehensive view of court behavior, making it possible to identify patterns in the granting of medicines, recurring legal grounds, and potential changes in judicial interpretations.
Our experience in this area has already revealed a number of concerning circumstances: the provision of medicines pursuant to judicial orders involving parallel imports of medicines from other countries, with package leaflets in foreign languages; medical opinions recommending specific brands or containing information that was outdated in relation to the treatment of certain diseases; outdated judicial databases, particularly those maintained by the Judiciary Technical Support Centers (“NAT-Jus”); concentration of claims in certain regions; clinical protocols and therapeutic guidelines that were not properly assessed in certain cases; discussions regarding prices and a tendency to reduce product costs in connection with court-ordered supply; among several other circumstances.
It is possible to map which products are most frequently requested, in which regions lawsuits are most concentrated, and which factors influence the likelihood of preliminary relief being granted.
Another relevant aspect is the identification of legal issues emerging from judicial proceedings that are directly related to the pharmaceutical industry’s activities. Issues such as health registration, incorporation of technologies, clinical protocols, exceptional provision, and claims of medical urgency frequently appear in these lawsuits and, above all, may signal regulatory or institutional communication challenges.
Monitoring also makes it possible to understand the profile of claimants and the requests made in judicial proceedings. Information such as the type of prescription, medical justifications, therapeutic alternatives, and amounts involved helps companies understand the clinical and social context of judicial claims, extracting from this data important elements for a range of internal analyses that may ultimately affect the company’s activities.
Monitoring also contributes to the assessment of reputational risks. Judicialization, particularly when it involves high-cost medicines or innovative treatments, often attracts the attention of the media and oversight bodies, including the Public Prosecutor’s Office. A company that monitors these matters in a structured manner is able to anticipate potential crises, prepare positions, and align its internal teams to provide consistent and coordinated responses.
This integrated approach strengthens governance and reduces vulnerabilities. Our experience shows that the companies that have been most successful in this area are those that, over the past two or three years, have strategically prepared themselves to monitor and act in a specialized manner across all fronts arising from these judicial cases.
In addition, continuous monitoring of judicial proceedings provides qualified information that reaches several areas of the company, including market access, government relations, compliance, and regulatory affairs. These insights can guide institutional dialogue strategies and support health education initiatives.
Another important benefit is the ability to anticipate demands and adjust internal policies. By identifying growth trends in certain therapeutic classes or changes in the profile of claimants, companies can review processes, improve technical materials, and strengthen patient support initiatives, also improving the operational efficiency of the teams involved in these matters.
Judicial proceedings involving specific products of a given pharmaceutical company also deserve particular attention, especially due to the numerous official requests that companies receive on a daily basis to comply with supply orders, whether judicial or administrative, through state and/or municipal Health Departments. By way of example, we highlight several cases in which appropriate monitoring made it possible to mitigate reputational risks and other more serious consequences.
There have been situations in which:
- a judicial request for the supply of a medicine was accompanied by an order to reduce the supply price, based on previous contracts with healthcare authorities in which prices had been negotiated according to significantly different parameters;
- the medical prescription was not accompanied by the complete information required for the company to safely supply the medicine, as companies often need a series of preliminary details in order to properly comply with an order issued in a judicial decision;
- cases were identified that had the potential to result in communications to the Public Prosecutor’s Office or CMED, involving allegations that a medicine had been offered above the maximum price established and regulated by CMED;
- allegations were made of acts detrimental to the administration of justice against the company, or even fines were imposed for alleged non-compliance with judicial decisions;
- “administrative requests” for the supply of medicines were issued by state and/or municipal Health Departments, among many other examples.
What we have observed is that monitoring judicial proceedings has increasingly become a legal and business intelligence tool. It enhances a company’s ability to understand the environment in which it operates, strengthens decision-making, and contributes to a more responsible, transparent approach aligned with the requirements of the healthcare sector.
In a scenario of increasing judicialization, structured monitoring of this issue is not merely a good practice, but also a strategic necessity capable of differentiating market players.
This material is for informational purposes only and should not be used independently as a basis for decision-making. Specific legal advice may be provided by one of our attorneys. All copyrights are reserved by KESTENER VIEIRA TORRONTEGUY SPEGIORIN ADVOGADOS.
