Region: Americas
Year: 1997
Court: Constitutional Court
Health Topics: Health care and health services, Health systems and financing, HIV/AIDS, Informed consent, Medicines
Human Rights: Freedom of association, Right to health, Right to life, Right to social security
Tags: Access to drugs, Access to health care, Access to medicines, Access to treatment, AIDS, Antiretrovirals, ARVs, Budget, Generic drugs, Health care professionals, Health care workers, Health expenditures, Health funding, Health insurance, HIV, Informed choice, Out-of-pocket expenditures, Patient choice, People living with HIV/AIDS, PLHIV, Reimbursement, Social security, Subsidies
The case combined six writs of tutela that were filed against the Institute of Social Security (ISS) into one record.
The Plaintiffs were persons living with HIV who had not been able to obtain protease inhibitors to treat their HIV. The protease inhibitors sought by the Plaintiffs were antiretrovirals used in the treatment of HIV and AIDS. They were not listed on the Ministry of Health’s manual of essential medicines at the time of the complained conduct, although by the time of the appeal they had been added. The antiretrovirals were prescribed to some of the Plaintiffs, but not to others. However, the Plaintiffs did not receive the drugs in any of these cases, because there was no obligation for a health service company (HSC) to provide drugs that were not on the list of essential medicines unless the life of the patient was threatened by not doing so. The Plaintiffs brought tutelas seeking to have the protease inhibitors provided by the ISS.
A further writ of tutela was filed against the Health Promoter Entity (HPE) Health Colmena. The Plaintiff in this case had been prescribed an antiretroviral (zidovudina and zalcitavina) by his doctor, but Health Colmena did not reimburse the medicines because they did not appear in the manual authorized by the Ministry of Health. The Plaintiff alleged that his rights to life, equality and dignity had been violated, whereas the Respondent alleged that the action lay against the state, not a private provider.
The Plaintiffs also complained that a support group (the Club of Happiness) for them and their families had been disbanded as a result of not being allowed to hold its meetings at the Pedro Claver Clinic. The Plaintiffs alleged that their right to the freedom of association had been breached by the disbanding of the Club of Happiness.
The six tutelas were appealed to the Constitutional Court after dissimilar outcomes at first and second instance.
The Court considered that the rights to health and social security were fundamental rights when they were necessary to protect the right to life. These created obligations on the state, which were then delegated to HPEs through the Colombian social security laws. One of the primary obligations under this health care system was to provide basic treatment.
As such, if the patient’s life was at stake, prescribed treatments and medicines needed to be provided in their totality. These included AIDS treatments and antiretrovirals. Importantly, the Court noted that these rights extended to treatments that prolonged life expectancies or relieved symptoms for patients with incurable diseases that would regardless face certainty of death. However, prescribed medicines would only be funded if they were essential, the prescription was for the generic form, and the prescription came from the patient’s treating physician.
The Court thus held that even if the medicine was not on the list, if the life of the patient was at stake and the other criteria were met, the HPE had an obligation to provide it. Although HPEs were contractually obliged only to provide medicines authorised by the Ministry of Health, it would be too burdensome to require patients to launch administrative actions against the State to modify the list of medicines before going to the HPE. It was therefore up to the HPE to provide medicines to the patient and then reclaim the cost from the State. The State could then fund these medicines from the health promotion sub-account of its Solidarity and Guarantee Fund. In reaching these conclusions with regard to protease inhibitors, the Court emphasised the fact that AIDS was a disease covered by the national health plan at the time, and that the inhibitors had later been added to the list.
The Court also held that doctors were free to prescribe drugs not on the official list of essential medicines for catastrophic diseases, as long as the patient had given their informed consent to take the drug after being explained of its benefits and side effects.
Finally, the Court held that the Club of Happiness should be permitted to continue. Although judges could not order treatments not prescribed by the treating physician, they could determine whether the guarantee of “access to the services of promotion, protection and recovery” in Article 49 of the National Constitution was met. In this case, because Decree 1543 of 1997 established a right to counselling, and the Club of Happiness could be considered as such, the meetings could not be blocked by the hospital authorities.
“If the medicine is part of the official list, is essential, and is generic, unless only registered brands exist, the date of issue of the decree or agreement that sets forth the list of medicines is irrelevant, and, if the life of the patient is at stake, the HSE has the obligation to provide the indicated medicine, even if it is not on the list. It is not possible to act contrary to the preservation of the patient’s life and justify this action under the argument that it is an obligation of the State due to its omission in including the required medicine. To oblige the patient to initiate an administrative procedure against entities of the State, in order to have access to a prescribed medicine, is to place in peril the life of the ill person. The State may not be ordered to the provide medicine when the patient is affiliated to a HSC that, it is repeated, has the duty to provide the medicine when the life of the person is at stake. This celerity for the provision of health service, in the case of AIDS, is due to the fact that it appears in the basic health plan.” Translation, pages 39-40.
“Accordingly, this conclusion emerges: after the informed consent is given, for a catastrophic diseases such as AIDS, or other diseases where life is at stake, essential medicines are prescribed in the form of generics, unless only registered-brand medicine exists, the patient is free to accept them or not, and if they accept those medicines, they have the right to receive that drug on the part of the HPE, under the condition that it is prescribed by the treating doctor.” Translation, page 47.
“Since the Club of Friendship is a self-help support group that allows a life in conditions less tough for AIDS carriers, and the ISS disrupted the schedule of the meetings that were being held in the San Pedro Claver Clinic, it should be concluded that since the entry into force of Decree 1543 of 12 June of 1997, those meetings must be permitted to continue. And it should be added that doctors are the ones who give their advice on whether self-help support group contribute to the therapy of the patients that presented the writ of tutela.” Translation, page 48.