Access to high-cost medications and therapies through the writ of amparo
Considerations on the problem and legal challenges
The healthcare system, under certain circumstances, does not provide the drugs, treatments, or devices prescribed by treating physicians because such benefits fall outside of coverage. In this context, as a last resort, the writ of amparo (acción de amparo) stands as a valid alternative—provided that admissibility requirements are met—to access benefits from which a concrete benefit is expected.
The Writ of Amparo
The writ of amparo is a judicial mechanism for the protection of fundamental rights, regulated in Uruguay by Law No. 16,011. Its objective is to obtain a swift solution when a constitutional right—such as the right to life or health—is flagrantly violated or threatened. In the sanitary field, it is frequently used to claim the provision of high-cost medications, therapies, or devices from the Ministry of Public Health (MSP) or the National Resources Fund (FNR) that are not included in the Therapeutic Drug Formulary (FTM) or the catalog of mandatory benefits.
For a writ of amparo to be admissible, the following requirements must be verified cumulatively:
A violated or threatened constitutional right: The plaintiff must hold a right recognized by the Constitution. In health lawsuits, the rights invoked are the right to life and health (Articles 7 and 44 of the Constitution), as well as rights inherent to human dignity (Article 72).
Manifest illegitimacy: The injury or threat must stem from an act, fact, or omission by the State (or other entities) that is manifestly illegitimate. This means the illegality must be clear, evident, and unequivocal, verifiable immediately without the need for extensive analysis. Case law has specified that the illegality must be "gross" (grosera) and verifiable "in continenti." A debatable discrepancy is not enough; the State's conduct must appear, beyond a doubt, contrary to the law.
Current or imminent nature of the injury: The act or omission injuring the right must be occurring at the time the lawsuit is filed or be imminent, posing a risk of irreparable harm or harm that is very difficult to repair if immediate action is not taken.
Residuality (Lack of other effective remedies): Law 16,011 expressly establishes (Art. 2) that amparo only proceeds when no other judicial or administrative means exist to obtain the same result, or when they do exist but are clearly ineffective under the circumstances to protect the violated right. Regarding access to medicine, the legal deadlines for the Administration to resolve a petition (up to 150 business days) make these administrative mechanisms clearly ineffective when the patient's health and life depend on urgent access to treatment.
Statute of limitations: The action must be filed within thirty days of the act, fact, or omission that originated the injury.
When the MSP or the FNR omits providing or financing the drug or treatment indicated by the treating physician, that omission constitutes—according to repeated jurisprudence from the Courts of Appeals—a manifest illegitimacy that enables the amparo route, provided the other requirements are met.
What must a patient prove to win the lawsuit and access coverage?
Jurisprudential experience indicates that the patient must prove:
Diagnosis and severity of the disease: Through medical records and certificates attesting to the pathology, its nature, and its severity.
Founded medical indication: The prescription must come from the treating physician—ideally a specialist—and, if possible, be backed by more than one professional. The indication must be justified by scientific evidence (clinical trials, international guidelines, etc.).
Scientific endorsement of the indication: Courts value it positively if the drug is approved by international reference agencies (such as the FDA or EMA) and if its use is recommended by prestigious clinical guidelines, including national guidelines from university chairs.
Lack of resources to afford it: Article 44 of the Constitution obliges the State to provide free assistance to those lacking sufficient resources. Therefore, it must be demonstrated that the price of the medication makes its acquisition economically impossible for the patient.
Refusal or inaction of the defendant body: It must be proven that the MSP or FNR were formally requested and that they responded negatively or simply failed to resolve the request in a timely manner.
Urgency and irreparability of harm: It is necessary to show that a delay in receiving treatment seriously compromises the patient's life or health, and that the damages caused by such a delay would be very difficult or impossible to repair later.
Furthermore, courts have considered that when the defendant body does not contest the diagnosis or question the efficacy of the drug, that silence significantly strengthens the patient's position.
What arguments does the State oppose?
In this type of litigation, the Ministry of Public Health systematically raises certain arguments that are useful to know in advance, as they are the same ones that the majority of case law has consistently rejected:
The drug is not in the FTM: The State argues it is only obliged to provide drugs included in the Therapeutic Drug Formulary. Courts have responded that the right to life and health cannot be subordinated to a list, especially when the body does not question the drug's efficacy.
The drug is not registered in Uruguay: The State alleges that marketing drugs without sanitary registration violates current regulations. However, Decree No. 18/2020 expressly allows the National Drug Regulatory Authority to authorize the use of unregistered drugs when there is an urgent medical need with no alternative available in the country, or when a court ruling so orders.
The MSP lacks the authority to dispense drugs: The Ministry argues that since the creation of ASSE as an autonomous state provider, its role is regulatory, not welfare-oriented. This has been dismissed when the patient lacks any other effective route.
Budgetary impact and system sustainability: The State warns that the explosive growth of amparos consumes a growing portion of the MSP budget—reaching 78% of operating expenses in 2021—and jeopardizes the health system's sustainability.
No manifest illegitimacy: The body maintains it acts within a legal framework declared constitutional, which would rule out the manifest illegitimacy required by Law 16,011.
In response to these arguments, the predominant jurisprudence of the Courts of Appeals has established that, when the right to life is at stake and the state body does not disprove the efficacy of the claimed treatment, the patient's fundamental rights prevail over the defendant's formal, budgetary, or administrative arguments.
Closing
In the described context, it is key for patients who need access to benefits not provided by the health system—and who are willing to undergo the judicial process with the expectation of obtaining a ruling ordering their provision—to be able to prove the aforementioned points. In all cases, one must keep in mind that effective access will ultimately depend on the ruling of the competent judicial body.