Case 39/2010

The appellant suffers from metastatic kidney cancer and was previously being treated with SORAFENIB. This treatment failed, and his treating physicians requested the National Resource Foundation (Fondo Nacional de Recursos, hereinafter FNR) to provide the patient with the drug SUNITINIB. The treating physician cited that this was the only treatment that had the potential to improve the appellant’s health.

The Ministry of Public Health had conducted technical and political studies on SUNITINIB and included it in the Therapeutic Drug Form, which allows the FNR to supply the drug. However, there had not been sufficient studies to show with a degree of certainty that the drug would benefit patients using it after the failure of SORAFENIB.  Thus, FNR denied the request, however, on the grounds that SUNITINB lacked necessary scientific certainty that it would be a real benefit to the patient.

The appellant submitted a writ of amparo to require the FNR and the Ministry of Public Health to provide the drug SUNITINB but was dismissed. The appellant appealed and that is this case.

The Court held that FNR’s denial to supply SUNITINIB violated the appellant’s constitutional rights to life and health and required FNR to supply the requested medication until the final disposition of the case by the Court of Civil Appeals or until the inefficacy of the treatment is known.

The Court held that the FNR was wrong to require evidence of the efficacy of the drug. The Court noted that the physician’s obligation is one of means and not results. This means that the physician is charged with an obligation to provide the means by which a patient might improve and not an obligation to produce results. However, the Court acknowledged that the prescription of medical must conform to scientific knowledge. As the physician’s request for SUNITINIB was based As such, FNR’s excuse was not viable because FNR wanted to require proof of a high probability of efficacy before supplying SUNITINIB when this is beyond the obligation of the physician.

The Court also noted that the purpose of an amparo is to protect against an actual or imminent threat to a fundamental right. As such, the court held that the right to life of the patient must be prioritized in deciding that a lack of studies demonstrating efficacy of the treatment is insufficient in denying the only drug that may improve the patient’s health.

The Court found that the Ministry of Public Health had properly put the drug on the Therapeutic Drug Form and that it was FNR’s duty to distribute the drug not the Ministry’s and thus dismissed the appeal against the Ministry.

“In medicine, one can never be completely sure nor entirely dismiss that a medication or treatment will work. It is always about chances and never assured results. It is logical that due to intolerance to SORAFENIB one resorts to SUNITINIB. It is not a valid excuse that there are no studies showing evidence of its benefits so as to deny coverage; the right to life of the patient must be prioritized” (p. 1)

“En medicina nunca puede asegurarse ni negarse que una medicación o tratamiento vaya a funcionar, siempre se trata de chances y nunca de resultados asegurados que no los hay. Resulta lógico que frente a la intolerancia al SORAFENIB se acuda al SUNITINIB. No resulta válida la excusa que no existen estudios que demuestren evidencia I de beneficio para negar la cobertura por lo que debe priorizarse el derecho a la vida del paciente.” (p. 1)

“[I]t should be remembered that the physician’s obligation is an obligation to provide means and not one to produce results. And in this case, the Court finds that the FNR manifest illegitimacy lies in the fact that the drug in question was accepted and included in the FTM but the FNR denies its supply or coverage because its efficacy or outcome has not been sufficiently tested. Therefore, it is appropriate to ratify and endorse Dr. Tabaré Sosa’s words in his judgment in the sense that the provision of the drug was denied as if it were an obligation to produce results; the provision of the drug was subjected to proof of a high probability of efficacy. In doing that, an obligation to produce results (in this case to prolong or improve survival) had been mistaken with what is legally understood as the content of the medical service, which is an obligation to provide means, . . .” (pp. 4-5)

“recordarse que la obligación del médico es de medios y no de resultado. Y en el caso, el Tribunal entiende que la  ilegitimidad manifiesta del FNR radica en que encontrándose aceptado e incluido el medicamento en el FTM, niega su empleo o cobertura por no estar suficientemente probada su eficacia o resultado. Por tanto corresponde ratificar y suscribir lo manifestado por el Dr. Tabaré Sosa en su fundamento de voto en el sentido que se rechazó su suministro como si se tratara de una obligación de resultado al supeditar dar el medicamento cuando esté demostrado que es altamente probable su eficacia. Con ello se confunde lo que sería una obligación de resultados (en el caso prolongar o mejorar la sobrevida) con lo que jurídicamente es el contenido de la prestación médica que es una obligación de medios, principio sentado por la jurisprudencia a partir del caso Mercier de 1936 de la Casación francesa que hacía referencia al control jurisdiccional en base a los “datos de experiencia” de la medicina . . . .” (pp. 4-5)

“In cases like this where the fundamental right to life is at stake, as we expressed in the hearing, the only way to know whether the drug works is to give it to the patient” (p. 5)

“... debe tenerse en estos casos en que está en juego el derecho fundamental vida con lo que expresó en audiencia (fojas 329 vuelto) en el sentido que la única forma de saber si funciona el fármaco es dárselo al paciente” (p. 5)