61
197. The Court considers it relevant, from a comparative law perspective of domestic laws and
jurisprudence, to reinforce the interpretation given to the rule of informed consent as a requirement
prior to medical procedures and the specific guarantees, which have also been reflected in the
domestic laws and practice of various Member States of the Organization of American States (OAS),
in particular, most of the State that have ratified the American Convention.
198. The Court has corroborated that, by 2000, when the facts of this case occurred, many of the
States for which information is available253 had different domestic norms concerning informed consent,
such as laws, technical guidelines or resolutions of health institutions, and even relevant
jurisprudence. The vast majority had a general norm for every type of medical procedure, 254 while
The States for which information for the year 2000 is available are: Argentina, Barbados, Bolivia, Brazil, Canada, Chile,
Colombia, Costa Rica, Ecuador, El Salvador, Honduras, Jamaica, Mexico, Panama, Paraguay, Peru, United States, Uruguay
and Venezuela.
253
(i) Argentina: Law on the Exercise of medicine, odontology and ancillary activities, National Law No. 17,132 of 1976,
article 19, paragraph 3 and Basic Health Law of the Autonomous City of Law of Buenos Aires, Law No. 153/99 of 1999, article
4(d) and (h); (ii) Bolivia: Code of Medical Ethics, Law No. 728 of August 4, 1993, articles 19 and 23. Also, the Code of Medical
Ethics and Deontology was adopted in Bolivia, according to information provided to this Court by the parties by Ministerial
Resolution No. 047/04 of July 2004. This code reiterates several provides of the 1993 Ethics Code in its articles 8(6) and (10);
20, 22, 23, 25 and 37. Similarly, see current articles 16, 18 (previously articles 19 and 23) and 22 of the Code of Medical
Ethics provided by the parties (file of the procedure before the Commission, volume II, folios 406 to 408 and 411 and 412);
(iii) Canada: the Supreme Court handed down two important judgments concerning informed consent: Reibl v. Hughes and
Hopp v. Lepp (1980) and Malette v. Shulman (1990). The former established the “reasonable patient test,” also known as the
“subjective-objective test” to determine the information that should be provided to obtain informed consent; to this end, it
was considered that doctors knew or should know what their patient wished to know about the medical procedure. The second
established that the obligation to obtain informed consent resulted from the doctrine of individual autonomy and indicated
that the information should include a description of the treatment, its benefits and risks, the urgency of the treatment and
whether it was necessary or elective, the existing alternatives (their risks and benefits), the consequences of refusing the
treatment, the medical opinion, and any other information that the patient requested. In addition, the provinces have enacted
laws, as in the case of Ontario which enacted the Health Care Consent Act in 1996; (iv) Chile: Ethics Code of the Chilean
Association of Physicians, of 1986, article 15; Supreme Decree No. 42 of 1986 (derogated in 2005), article 105; Charter of
the patient’s rights of the National Health System (FONASA) of 1999, and Decree No. 570 of July 2000, article 20, applicable
for public and private psychiatric in-patient establishments; (v) Colombia: Medical Ethics Act, Law No. 23 of 1981, article 15;
Decree No. 3380 of 1981, regulating Law No. 23; Constitutional Court of Colombia, Judgments Nos. T 401/94, T-477/95, SU337/99, and Resolution No. 13437 on Patient’s rights, adopted by the Ministry of Health in 1991, article 2; (vi) Costa Rica:
General Health Act, No. 5395, articles 10 and 22; (vii) Ecuador: Cf. Code of Medical Ethics of 1992, articles 15 and 16; (viii)
El Salvador: General Regulations for Hospitals of the Ministry of Public Health and Social Assistance of 1996, articles 114 and
115; (ix) United States of America: Consumer Bill of Rights and Responsibilities, also known as the “Patient’s Bill of Rights.”
Adopted by the President’s Advisory Commission on Consumer Protection and Quality in Health Care Industry. Similarly, since
the beginning of the twentieth century, United States case law has referred to the obligatory nature of informed consent, for
example, in the cases: Mohr v. Williams (1905), Pratt v. Davis (1906), Rolater v. Strain (1913), and Schloendorff v. Society
of New York Hospitals (1914); (x) Mexico: General Health Act, articles 51 bis 1 and 2 (introduced by an amendment of April
2009); article 100, paragraph IV (concerning consent in research on human subjects); article 103 (concerning the treatment
of those who are ill); article 77 bis 37, paragraphs V and IX. (introduced by an amendment of May 2003), and Regulations to
the General Health Act on matters of health-related research of December 1981, article 14, paragraph V, among others; (xi)
Paraguay: Criminal Code, Law No. 1160 of 1997, article 123; (xii) Peru: Cf. General Health Act, Law No. 26842 of 1997, which
continues in force, articles 4; 6, 15(h), 27 and 40; (xiii) Uruguay: Bioethical Decree No. 258/92 of 1992, articles 5 and 36 to
39; and Code of Medical Ethics of April 1995, articles 15 and 38. Article 38 indicates that male and female sterilization must
have the free and full consent of the person after they have been duly informed of the consequences of this medical procedure;
(xiv) Venezuela: Medical Deontology Code of 1985, article 69(4).
254