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Judgment No. 438 of 2008

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Court/Judicial body:  Constitutional Court
Date: 23 December 2008 CRC
Provisions:  Article 24: Health and health services Article 33: Drug abuse
Domestic provisions: Article 2 of the Constitution: inviolable rights of the person to express and develop human personality Article 32 of the Constitution: right to healthcare and no forced treatment unless provided by law Article 117(2)(m) of the Constitution: the state has exclusive legislative powers in matters of healthcare Article 3 of Piedmont Region law No. 21 of 6 November 2007 (Provisions governing the use of psychotropic substances on children and adolescents): (1) children up to the age of 18 years may only be treated with psychotropic substances in the region when parents or guardians express their written, free, informed, current and manifest consent; (2) the Regional Council is responsible for drawing up a form for informed consent, by which the practitioner provides information regarding the treatment, the side effects, alternative treatments and the procedures for administration; and (3) the Regional Council is responsible for the identification of means and procedures for promoting the access to alternative or supplementary therapies to the treatments mentioned. International
Provisions: Convention on Human Rights and Biomedicine, Article 5: Informed consent to medical treatment Charter of Fundamental Rights of the European Union, Article 3: Right to physical and mental integrity and informed consent to treatment

Case summary

Background: The Court considered a direct application by the office of the Prime Minister against Article 3 of the Piedmont Region law setting out requirements relating to informed consent from a parent or guardian for the administration of psychoactive drugs to minors, as well as the provision of information regarding possible alternative treatment (the contested provision). The applicant argued that the contested provision exceeded the legislative competence of the Piedmont Region on healthcare as the requirement for informed consent is a fundamental principle in the area of healthcare and is a matter reserved exclusively to the state. Since informed consent is not required under national law except in certain exceptional cases in respect of clinical trials and biological donations, it was argued that by imposing such requirements, the Piedmont Region is in effect limiting the right and access to and the full provision of healthcare. The Region argued that the national law regarding informed consent were of limited scope and ambiguous and cannot therefore be elevated to the status of fundamental principles prohibiting all other contrary regulations. As regards the alleged violation of the right and access to healthcare, the Region noted that the full knowledge and provision of information concerning the most appropriate treatment is intended precisely to protect this right. Finally, there was no violation of the state’s exclusive legislative powers since the provisions governing informed consent do not relate to medical assistance to be provided on a uniform basis throughout the country. Finally, the Region argued that the system of informed consent operates in accordance with Article 5 of the United Nations Universal Declaration of Human Rights of 1948 and Article 33 of the United Nations Convention on the Rights of the Child, ratified and implemented in Italy by law No. 176 of 27 May 1991.

Issue and resolution: Parental consent to administering psychotropic substances to children. The Court struck down the contested provision on the grounds that they purported to regulate matters directly touching on a fundamental principle in the area of healthcare, over which the state had exclusive legislative powers.

Court reasoning: The Court decided that informed consent, understood as an expression of the informed acceptance of the medical treatment proposed by the doctor, has the status of a full-scale right of the person and is grounded in the principles expressed in Article 2 of the Constitution, which protects and promotes fundamental rights, and Articles 13 and 32 of the Constitution which provide, respectively, that “personal freedom is inviolable” and that “nobody may be forcefully submitted to medical treatment except as provided by law”. Moreover, numerous international law provisions such as Article 24 of the CRC, Article 5 of the Convention on Human Rights and Biomedicine and Article 3 of the Charter of Fundamental Rights of the European Union stipulate and/or infer the requirement for the informed consent of the patient to medical treatment. The need for the patient to be put in a position to gain knowledge of his course of therapy can also be inferred from various national laws governing specific medical activities. The fact that informed consent is grounded in Articles 2, 13 and 32 of the Constitution gives prominence to its role as a synthesis of two fundamental rights of the person – the right to self-determination and the right to healthcare – since, whilst it is the case that every person has the right to receive medical treatment, all persons also have the right to receive appropriate information regarding the nature and possible developments of the course of therapy to which they may be subject, as well as any alternative therapies; this information must be as comprehensive as possible, precisely in order to guarantee a free and informed choice by the patient and, therefore, his very personal freedom, in accordance with Article 32(2) of the Constitution. It follows therefore that informed consent must be regarded as a fundamental principle in the area of healthcare, the substantive regulation of which is reserved to the state. The Court declared the contested provisions unconstitutional, since Piedmont Region is in effect regulating in an area reserved exclusively to the state and which it has no authority to do so.
Excerpt citing CRC and other relevant human rights In particular, Article 24 of the Convention on the Rights of the Child, signed in New York on 20 November 1989, ratified and implemented by law No. 176 of 27 May 1991, stipulates that the states “recognize the right of the child to the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health”, going on to provide that “all segments of society, in particular parents and children, are informed… of child health and nutrition”. Article 5 of the Convention on Human Rights and Biomedicine signed in Oviedo on 4 April 1997, ratified by Italy by law No. 145 of 28 March 2001 (although the instrument of ratification has not yet been deposited), provides that “an intervention in the health field may only be carried out after the person concerned has given free and informed consent to it”; Article 3 of the Charter of Fundamental Rights of the European Union, proclaimed in Nice on December 2000, provides moreover that “everyone has the right to respect for his or her physical and mental integrity” and that in the fields of medicine and biology, amongst other things, in particular “the free and informed consent of the person concerned, according to the procedures laid down by law” must be respected.

CRIN comments:  CRIN believes children are end to be actively involved in their own health care from the earliest possible age. The CRC recognises the value of a child’s views and the need to give them weight in accordance with the age and maturity of the child.

Citation:  Judgment No. 438 of 2008

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