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Right to Informed Consent| SPAIN
| GENERAL OVERVIEW | BIOMEDICINE CONVENTION | EU MEMBER STATES | TYPES OF PATIENT RIGHTS LEGISLATION |
| 1. The right of a patient to informed consent is one of the basic patient rights in Spain. The Patient Rights Law defines an informed consent as the free, voluntary and conscious decision of a patient, stated in the full use of his faculties after receiving proper information, so that an action concerning his health can be undertaken. 2. The consent must be obtained once the patient has received prior information. This information has to be truthful, has to be communicated to the patient in a manner that is comprehensible and suited to his needs and has to help him take decisions in accordance with his own free will. The law stipulates in broad terms that patients have the right, by virtue of any intervention in the scope of their health, to learn any information available on their health, with the exception provided for by law. Such information includes at least the purpose and nature of each intervention, its risks and consequences. 3. The Patient Rights Law establishes as a general rule that the informed consent must be given orally, unless otherwise stipulated by law. 4. The Patient Rights Law establishes two exceptions to the requirement of informed consent. The physician shall in the first place be able to conduct clinical interventions which are essential for the health of the patient without the informed consent of the patient in case there exists a risk for public health. In the second place the informed consent does not have to be obtained when there is an immediate serious risk for the physical or mental integrity of the patient and it is not possible to obtain his consent, consent of the family or the consent of persons tied to the patient for de facto reasons. 5. The Spanish Patient Rights Law acknowledges the right of patients to refuse a medical treatment. The patient can also freely revoke his consent in writing at any moment. 6. The introduction at state level of a regulation concerning previously expressed wishes in article 11 was one of the most important innovations of the Patient Rights Law. A capable and free person of age (18 years) can declare his will in advance as regards the care and treatment of his health or the destination of his organs or his body in case of death by means of the document of prior instructions, so that his wishes are complied with at the moment he is not capable of expressing his will personally. 7. A minor who is emancipated or has reached the age of 16 has attained the age of medical majority. The Patient Rights Law stipulates that consent by representation cannot be granted in case of minors who are neither incapable nor incapacitated but who are emancipated or who are more than 16 years of age. Nevertheless, in case of interventions that involve serious risks -according to the judgment of the physician- the parents must be informed and their opinion must be taken into account. When the minor patient is under age and is neither intellectually nor emotionally capable of understanding the scope of the suggested intervention, the informed consent must be given by the patient’s legal representative. The minor must be heard if he is more than 12 years old. 8. When the attending physician is of the opinion that the patient is not capable of taking a decision or his physical or mental state does not allow the patient to appreciate his situation, the consent must be granted by a legal representative. A person who is of age, capable and free can designate a representative to act as an intermediary with the physician or the medical team in order to fulfill the patient’s will. If the patient has no legal representative, the consent shall be granted by a member of his family or by a person tied to the patient for de facto reasons. The patient is the one who has the right to information. A member of his family or persons tied to the patient for de facto reasons may also be informed to the degree that the patient gives his permission in an explicit or tacit manner. The patient has to be informed, even in cases of incapacity, in a manner that is adjusted to his possibilities of comprehension. Moreover, the legal representative must also be informed. When the attending physician is of the opinion that the patient lacks the capacity for understanding the information due to his physical of mental state, the information must be made available to family or persons tied to him for de facto reasons. |