01/30/2026 | Marcos Patullo | Migalhas

https://www.migalhas.com.br/depeso/448888/polilaminina-a-luta-judicial-por-um-tratamento-para-lesao-medular 

The judicialization of access to medication exposes the conflict between the right to health, medical urgency, and regulatory requirements of ANVISA (Brazilian Health Regulatory Agency).

The fundamental right to health and life, enshrined in the Federal Constitution, frequently clashes with the regulatory barriers of the health system. One of the most complex arenas of this dispute involves access to medications that are not yet registered with ANVISA, but currently represent the only hope for patients with serious conditions and no therapeutic alternatives. The legal battles surrounding access to Polilaminina, a promising biopharmaceutical for the treatment of acute spinal cord injuries, illustrate the complex balancing of interests between medical urgency and public health safety.

What is Polilaminina?

Pollilaminina is a biopharmaceutical developed over more than two decades of research by UFRJ - Federal University of Rio de Janeiro, in partnership with the Cristália Produtos Químicos Farmacêuticos laboratory. Derived from laminin, a protein found in human placentas, the substance targets the regeneration of lesions in the nervous system. Administered intramedullary, Polilaminina has demonstrated significant potential in preclinical studies and early phases of clinical trials for improving motor function in patients with acute spinal cord trauma, a devastating condition that frequently results in permanent paralysis.

The main obstacle to its widespread use is the fact that the drug is still in the clinical research phase and does not yet have definitive sanitary registration from ANVISA (Brazilian Health Regulatory Agency), a legal requirement for the commercialization and distribution of any drug in the country.

The scenario of spinal cord injury and the search for alternatives

Acute spinal cord injury (SCI), usually caused by car accidents, falls, or violence, leads to a spinal cord injury that interrupts communication between the brain and the body, resulting in loss of motor, sensory, and autonomic functions below the level of the injury. The prognosis for patients with complete injuries, such as paraplegia or tetraplegia, is extremely poor, and the conventional therapies available focus on rehabilitation and management of complications, without offering a cure or reversal of neurological damage.

In this bleak context, Polilaminin emerges as a beacon of hope. However, its effectiveness depends on administration within a very narrow therapeutic window, soon after the trauma occurs. This urgency is incompatible with the ordinary timeframes of ANVISA's regulatory process for the analysis and authorization of medications, leading patients and their families to seek an exceptional avenue of access through the Judiciary.

Legal foundations and perspectives of this debate

The judicialization of the supply of Polilaminina is directed against both the SUS - Unified Health System - and health insurance plans, and brings to light a robust set of constitutional and legal grounds. Undoubtedly, the crux of the controversy lies precisely in the fact that there is no therapeutic substitute for patients with spinal cord injuries, so denying access to a promising treatment, even without ANVISA registration, would be equivalent to denying them the right to health.

It is true that the jurisprudence of our superior courts, for reasons of sanitary safety, has established the understanding that access to medicines without registration with ANVISA (Brazilian Health Regulatory Agency) should only be granted exceptionally, as per, for example, the decisions in Themes 500 and 1234 of the STF (Supreme Federal Court), as well as Theme 990 of the STJ (Superior Court of Justice). These themes, although limiting the supply of these drugs, do not end the debate and allow for the consideration of exceptional situations in which it is necessary to grant access to healthcare to patients in specific circumstances, such as those with rare and ultra-rare diseases, or when there is no therapeutic substitute incorporated into the SUS (Brazilian Unified Health System).

The Brazilian Supreme Court's own Case 500 addresses this issue and states that "it is possible, exceptionally, for a court to grant access to a drug without sanitary registration, in cases of unreasonable delay by ANVISA (the Brazilian Health Regulatory Agency) in reviewing the registration request (a period exceeding that stipulated in Law 13.411/16), when three requirements are met: (i) the existence of a registration request for the drug in Brazil (except in the case of orphan drugs for rare and ultra-rare diseases); (ii) the existence of registration of the drug with renowned regulatory agencies abroad; and (iii) the absence of a therapeutic substitute registered in Brazil."

The Brazilian Supreme Court's own Ruling 500 addresses this issue and states that "it is possible, exceptionally, for a court to grant access to a medication without sanitary registration, in cases of unreasonable delay by ANVISA (the Brazilian Health Regulatory Agency) in reviewing the registration request (a period exceeding that stipulated in Law 13.411/16), when three requirements are met: (i) the existence of a registration request for the medication in Brazil (except in the case of orphan drugs for rare and ultra-rare diseases); (ii) the existence of registration of the medication with renowned regulatory agencies abroad; and (iii) the absence of a therapeutic substitute registered in Brazil."

The criteria above can be used both to make the supply of medications not yet registered with ANVISA more flexible through the public system, and also in actions against health plans, since the STJ itself already has precedents that apply the criteria of STF Theme 500 as a distinguishing element to exclude the application of STF Theme 990, as decided by the 3rd panel in REsp 1.885.384/TJ, reported by the late Justice Paulo de Tarso Sanseverino.

In addition to the possibility of discussing access to treatment through the courts, other factors have strengthened the arguments of those who defend the need to provide polylaminin. Indeed, on January 5, 2026, ANVISA authorized the start of a phase 1 clinical study to evaluate the safety of using polylaminin for the treatment of acute spinal cord injury, a study that will be sponsored by the company Cristália Produtos Químicos e Farmacêuticos Ltda1.

According to the agency's own website, polylaminin is one of the strategic topics of ANVISA's Innovation Committee, which was created in 2025 and aims to monitor and evaluate innovative products and technologies considered priorities for public health in Brazil.

Furthermore, the possibility of determining compassionate use of the drug, regulated by ANVISA's RDC 38/13, cannot be overlooked. This regulation allows new and promising drugs, still in the research phase, to be made available to patients with serious and debilitating diseases for whom there is no satisfactory treatment. In this sense, the decision of the 2nd Federal Court of Barueri in the preliminary injunction 5000043-83.2026.4.03.6703, ordered Laboratório Cristália to include the patient in the compassionate use program for the drug, and also ordered ANVISA to refrain from applying any administrative sanctions to the laboratory for supplying the drug to the patient.

Final Considerations

The case of Polilaminin highlights a central dilemma in public health: how to reconcile the demands of regulatory safety with the urgency of patients who lack therapeutic alternatives. The absence of effective substitutes for spinal cord injuries underscores the importance of responsibly discussing mechanisms that allow access to innovative treatments without compromising health protection.

It is necessary to rethink not only the limits and possibilities of judicialization, but above all to reinforce the need to ensure that critically ill patients are not deprived of a real chance of treatment. In other words, to weigh the formal requirements of health safety against the need to effectively guarantee the right to health of patients suffering from spinal cord trauma.

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1 https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2026/anvisa-autoriza-pesquisa-clinica-para-avaliar-a-seguranca-do-uso-de-polilaminina-em-humanos