When the State is still experimenting, patients already exist

The recent initiative by the National Health Surveillance Agency to create a so-called "regulatory sandbox" for activities related to medicinal cannabis exposes an uncomfortable reality: Brazil has yet to establish a structured regulatory framework for patient associations.

In technical terms, the sandbox is an experimental, temporary, and precarious environment created for the agency itself to test models, produce evidence, and only after that decide whether to issue — or not — a definitive regulation.

In simple terms: the State still does not know how to regulate and decided to experiment.

The problem is that while the Public Administration tests hypotheses, thousands of patients already exist. They are already suffering. They already depend on continuous treatment. They have already found, in associations, the only viable means of access to therapy.

This is the central asymmetry of the debate.

On one side, a regulatory apparatus that moves slowly, trapped in administrative cycles, public consultations, working groups, and experimental environments. On the other, real people with refractory epilepsy, autism spectrum disorders, chronic pain, degenerative diseases, cancer, fibromyalgia, and other conditions that require care now — not after the next resolution.

The regulatory sandbox is not public policy. It is not a definitive framework. It does not create legal stability. It does not ensure therapeutic continuity. It can be terminated at any moment. It does not generate acquired rights. It does not recognize existing organizational models.

It is, legally, a normative laboratory.

This means that associations and patients are invited to step onto unstable, revocable, provisional ground. A soil that can give way at any moment by administrative decision. A true regulatory quicksand.

And this is where the most serious inversion arises: there is an intention to displace people who are already being served by organized associative structures into an uncertain state experiment.

Meanwhile, associations continue to do what the State has yet to structure.

Today, there are associations in Brazil with thousands of active members, maintaining continuous medical follow-up, developing their own clinical protocols, promoting social assistance, generating direct and indirect jobs, and driving scientific research projects.

These entities are not pilot projects. They are not embryonic experiments. They are fully functioning community health structures.

More importantly: they do not operate on the margins of medicine.

The supply is conditioned to individualized medical prescriptions, there is clinical follow-up, a nominal registry of patients, traceability of preparations, and internal production control. There is no free access, no indiscriminate distribution, and no recreational purpose.

This is organized therapeutic care aimed at patients with specific pathologies, many of whom are in situations of extreme vulnerability.

The Judiciary itself has already been recognizing this technical and supervised nature of the associative model, stating that the use of cannabis must necessarily be conditioned to medical prescription. In other words: it is not about unrestricted liberalization, but about controlled, clinical, and responsible therapeutic access.

The paradox is evident: while the State is still trying to understand the phenomenon through a regulatory sandbox, civil society has already built concrete, functional, and socially validated solutions.

The question that needs to be asked is straightforward: does it make sense to remove patients from an existing ground to place them in an experimental environment?

Sanitary regulation should exist to enable fundamental rights, not to suspend them.

When the State delays, society organizes itself. When bureaucracy stalls, care finds alternative paths. This has happened in other moments in the history of public health — and is now repeating itself with medicinal cannabis.

The debate about associations is not just technical. It is constitutional.

We are not talking about abstract regulatory innovation. We are talking about human dignity, continuity of care, and real access to health.

The sandbox may be a useful administrative tool for the State to learn. But it cannot serve as an institutional excuse to delay effective regulation of the associations that already exist, already serve, and already care.

Patients do not live in an experimental environment.

They live in their bodies.

And the body does not wait.

The author's opinion does not necessarily reflect the opinion of Sechat.