2016: Decision making and legal capacity in dementia
Consent to medical treatment
Article 11 (1) states, “A prerequisite for the provision of healthcare is the patient’s con- sent given after complete medical information, which is provided by the healthcare services provider to the patient, in due time, and in a manner that is comprehensible to the patient, so that the latter may understand the information provided and make a free and independent choice.”
If the patient has chosen someone else to receive information on his/her behalf (please see relevant section), this person has the right to decide on his/her behalf. Such consent can be given in writing or orally, provided that it is put in writing as soon as possible.
In article 21 (4) of this Law, it is stated that in the case of patients who do not have the capacity to exercise their rights (which includes consent), such rights shall be exercised by a legal representative or a person whom the patient has appointed to that effect. If a representative is not available, reasonable measures must be taken in order to ensure the effective exercise of the patient’s rights.
A person who has been appointed by law to consent on behalf of a patient must involve the latter in the decision-making process to the extent that his/her capacity and circum- stances allow this.
Refusal of consent (by proxy decision maker)
If the person appointed to consent on behalf of the patient refuses to give such consent and the healthcare provider believes that the treatment is in the patient’s best interests, he/she can, time permitting, refer to a court or other body prescribed by law. In the case of a medical emergency, the healthcare provider must act in the patient’s best interests (article 13, § 4).
The right to refuse treatment
There does not seem to be any explicit reference to the refusal of consent in Law No. 1 (I) 2005 although the possibility of refusing treatment can be detected in a few articles. For example, article 11 (§ 1) states that consent is a prerequisite for the provision of health- care so presumably healthcare cannot be provided if such consent is not given (i.e. if it is refused). Similarly, the obligation on the part of doctors to inform patients about the likelihood of success and the possible risks of various forms of treatment but also of non- treatment suggests the possibility of refusing consent (article 12, d). Finally, article 13 (1) makes a reference to the refusal of consent in previously expressed wishes.
Consent to research and participation in clinical trials
According to the provisions of article 14, § 1, people may take part in scientific research and experimental treatment if the following conditions are met:
• there is no alternative solution of comparable effectiveness;
• the risks which may be incurred by that patient are not disproportionate to the poten- tial benefits of the research;
• the research project has been approved by the competent body after independent examination of its scientific merit, including assessment of the importance of the aim of the research and multi-disciplinary review of its ethical acceptability;
• the patient has been informed of his/her rights prescribed by this law.
The following additional conditions (article 14, § 2) apply just to people who are unable to consent:
• the results of the research have the potential to produce real and direct benefit to his/
• research of comparable efficiency cannot be carried out on individuals capable of giv- ing consent;
• the necessary authorization provided for in article 13 (covering healthcare without the
consent of the patient) has been given specifically and in writing, and
• the person concerned does not object.
It is not clear whether the above conditions also apply to participation in clinical trials.
Information is missing about advance directives. However, there are two references in article 13 to previously expressed wishes:
13, § 1 Where the patient is in no position, due to his/her mental or physical state, to express his/her will and the provision of medical care is urgently needed, the consent of the patient may be presumed, unless it is obvious, from previously expressed wishes that he/she would have refused.
13, § 5 In any case where proper consent is impossible to be obtained
a) any healthcare imposed as urgent may only be provided if the healthcare services provider deems it to be of benefit to the patient’s health or in the patient’s best interests;
b) any previously expressed wishes of the patient concerning healthcare shall be taken into consideration.
Whenever healthcare is provided without the prior consent of the patient, any previously expressed wishes concerning healthcare must be taken into consideration. How- ever, there are no guidelines as to how previously expressed wishes should be recorded, the extent to which they are binding or just advisory and whether they must be made in writing.
Last Updated: Wednesday 08 February 2017