Case 393/2011

This case was an appeal brought by the National Monetary Fund (“FNR”, for its initials in Spanish) in a protection action before the Second Chamber of the Court of Civil Appeals. The action was brought against Resolution No. 67, which had found for the claimant, determining that coverage for the drug “NEXAVAR-DROGA SORAFENIB”, should be provided to the patient until a decision was reached in respect of its inclusion on the Therapeutic Drug Roster for his case. The appellee argued that its decision to deny coverage for the drug was not manifestly unlawful, given that, although the medication was included in the Therapeutic Drug Roster, it was not included for the purposes for which the patient had requested it (the patient had liver cancer, and the drug was indicated for the treatment of renal cancer). Therefore there had been no unlawful action or omission by the FNR, which followed procedure.

The Court agreed with the lower court, which found that the FNR’s decision not to cover a drug that was on the roster of medications but approved to treat renal, rather than liver, cancer, was "manifestly unlawful". It considered that the drug was approved to treat cancer and that all patients had the right, at the discretion of their doctors' technical and scientific judgment, to the treatment and medication that best benefited them.

Separately, the Court noted that the lower court's procedure for giving notice in this case had not followed the applicable law.

The Court therefore confirmed the lower court's decision to grant the protection action.

“It is indisputable that we must begin from a place of recognition of the fundamental right to the protection of human health; this protection must be put in place by the State, making use of all methods at its disposition and to the benefit of all persons; equal access for all persons to the necessary care in accordance with the health of each person, and particularly, the right to have access to necessary medicines, which form an essential part of the right to health.” (Translation page 2)

“Es indiscutiblepartir del reconocimiento de la existencia del derecho fundamental a la protección de la salud de las personas; que éste debe ser puesto en práctica por el Estado a través de todos los medios disponibles y en beneficio de todas las personas; que se debe garantir el igual acceso de cada persona a los cuidados necesarios de acuerdo con suestado de salud y, particularmente, el derecho de acceso a los medicamentos necesarios forma parte esencial del derecho a la salud.” (Original page 4)

“…administrative authorities’ actions can be regulated in these cases [through the protection action]. If this were not the case, we would have to ask ourselves what is the judiciary’s role, if we are unable to regulate administrative actions that affect the fundamental rights of citizens.” (Translation page 2)

“…es controlable el actuar de la administración en estos casos, sino fuera así cabría preguntar separa qué estaríamos los jueces si no pudiéramos controlar actuaciones administrativas que afectan derechos fundamentales de los ciudadanos.” (Original, page 4)

“In the case at hand, the respondent timely rejected the claimant’s petition, despite the fact that the drug in question was listed in the FTM, because the drug was not specifically included as a treatment for liver cancer. In fact, Sorafenib is included in the list as an oncological medication, but as a treatment for renal cancer. Therefore, there is no argument whatsoever, as the respondent would have, that there is no manifest illegality, given that we are dealing with a medication that is covered by the FNR for the treatment of cancer, and which was rejected for a technicality.” (Translation, page 3)

“Ahora bien en la especie la demandada rechazo la petición oportunamente presentada por el reclamante ,pese a estar en el FTM ,por no estar incluido específicamente para el tratamiento para heparcinoma . En efecto en el listado de medicamentos surge que el Sorafenib esta incluido como medicamento oncológico pero indicado para el tratamiento del cáncer de riñón. Por consiguiente no puede hablarse en grado alguno como pretende la recurrente de la inexistencia de ilegitimidad manifiesta ya que se trata de un medicamento que se encuentra cubiertopor el FNR para enfermedad esoncológicas que es rechazado por motives formales .” (Original, page 5)

“When the treating physician, as in the case at hand, is of the opinion that the medicine that he or she prescribes is the best treatment and medicine for the patient, we are dealing with a technical and scientific decision that must be respected, and particularly in the case of a prescription for a medication authorized by the MSP (and included in the FTM), and which is also covered by the FNR.” (Translation, page 5)

“Si el médico tratante como sucede en autos, entiende que el mejor tratamiento y medicamento que debe tomar su paciente es el solicitado, se trata de una decisión técnica y científica que debe respetarse máxime cuando se trata de un medicamento que se encuentran autorizado por el MSP ( incluido en el FTM ) y que por cierto es cubierto por el FNR.” (Original, page 7)