2009: Healthcare and decision-making in dementia
Consent to treatment
Consent to medical treatment is covered by article 32 (2) of the Italian Constitution, which states,
"No-one may be forced to undergo any particular medical treatment, save under the provisions of the law. In no case shall the law violate the limits imposed by proper respect for the human person."
Article 13 (1) of the Constitution states that personal liberty is inviolable. As a person's moral liberty, the right to self-determination and physical liberty (the right to respect for bodily integrity) are all elements of personal liberty, this article can also be understood to cover the issue of consent. Article 32 of the Constitution further states that nobody may be forcefully submitted to medical treatment except as regulated by law and that such law may in no case violate the limits imposed by respect for the human being.
Consent is also covered by the Italian Code of Medical Ethics of 18.12.2006. Articles 33 to 37 deal specifically with informed consent. The doctor cannot undertake any diagnostic or therapeutic procedure without the informed consent of the patient. The doctor's actions must be guided by the will of the patient which should be freely and explicitly expressed. This should be supplemented by written consent. Diagnostic or therapeutic procedures which could be seriously hazardous to the safety of the patient, can only be undertaken in the case of extreme necessity. The doctor must explain the possible consequences of the proposed procedures and obtain documented and informed consent.
Article 37 provides for the situation where a person may be unable to consent due to infirmity of the mind. In this case, the person's legal representative can consent on his/her behalf.
Consent in case of emergency
If the legal representative opposes treatment which the doctor considers to be essential and urgent, the doctor must inform the judicial authorities. Such opposition is ineffective in cases where the law provides for compulsory medical treatment. If treatment is necessary and urgent and the patient is unable at that particular moment to object to it, the doctor can provide any essential treatment and care (article 37).
The right to refuse treatment
If a patient who is capable of comprehension and intention explicitly refuses treatment, the doctor cannot go ahead with any diagnostic or curative action.
Consent to the donation of organs and/or human tissue
Organ donation from living donors can only be carried out if the both the donor and the person receiving the organ fully understand the risks involved and freely consent to the operation. This is covered by article 41 of the Italian Code of Medical Ethics.
Consent to clinical trials and research
The consent of the patient is obligatory for pharmaceutical experimentation according to the Legislative Decree of 24.6.2003, n. 211, for the implementation of the Direction 2001/20/CE concerning the carrying on of the suitable clinic treatments for clinical experimentation of new medicinal preparations. The patient must also have received the necessary information in order to make a decision, and he/she can withdraw consent at any moment.
A person who is unable to give his/her consent can only participate in research under special conditions including, amongst others:
- That his/her legal representative has given his/her consent after getting the necessary information; the consent must represent the alleged will of the person cared for and it can be withdrawn at any moment; without any prejudice for the incapable person;
- That the incapable person has received all the relevant information necessary to understand either the kind of experimentation which is going to be carried on or the subsequent risks and benefits;
- That the experimentation is essential to validate results already obtained in clinical experimentation on people who are able to give their informed consent or to validate the results of different research methods on the condition that the experimentation is strictly related to a life threatening clinical situation or of a disabling clinical condition that the person who is unable to consent is affected by.
Pharmaceutical experimentation is also covered by articles 48 and 49 of the Italian Code of Medical Ethics.
There is not yet a law about advance directives in Italy. Whilst waiting for a clear and appropriate law, it is nevertheless possible in Italy to have recourse to a rule which allows for the wishes of an incapable person to be respected.
Art. 408 of the civil code as renewed by law n. 6/2004 grants the possibility to incapable people to appoint, directly and prior to their illness, the guardian they would like in the future. This involves planning and preparing for possible future incapacity. The appointing deed must be made by a legal notary or written in private written and then authenticated. The guardian’s duties can be specified in the deed either with regard to the handling of the person’s properties or to matters concerning decisions related to certain treatments or therapies.
The anticipated appointment of one’s guardian can therefore establish choices linked to healthcare (beginning from his/her consent to hospitalization to decisions about the continuation of treatment, medical research and all the other related matters).
Previously expressed wishes are also covered in article 38 of the Italian Code of Medical Ethics which states that the doctor must respect the freely expressed wishes of the patient and act in respect of the patient’s dignity, freedom and autonomy. This, it is stated, includes respecting the previously expressed wishes of the patient who is no longer able to express him/herself, provided that these wishes were clearly expressed and documented.
Access to information/diagnosis
Access to information
The right to be informed of one's diagnosis and state of health is covered by the Italian Code of Medical Ethics. According to article 33, the doctor must provide the patient with clear and appropriate information on the diagnosis, prognosis, prospective treatment and the likely consequences of treatment or non-treatment. If the patient has additional questions, these must also be answered. If the information to be given includes a serious or fatal prognosis or something which is likely to cause anxiety or suffering to the patient, it must be provided with circumspection, using terminology which is unlikely to traumatise the patient, making sure to include any element of optimism.
The doctor must take into account the particularities of each patient to whom he gives information. This includes the patient's level of education, emotionality and reasoning capacity. He/she must further ensure that information about diagnostic and therapeutic procedures is limited to what the patient is capable or receiving and accepting in view of his/her education and psychological condition. Superfluous details associated with scientific aspects should be avoided.
Access to medical records
The doctor must grant access to the patient’s medical records in his/her possession to the patient’s legal representative or to doctors or institutions indicated by the patient in writing (article 25).
The right to appoint another person to be informed on one’s behalf
The documented wish of the patient to delegate another person to be informed on his/her behalf must be respected (article 33).
The doctor’s right to withhold information
As mentioned above (article 33 of the Code of Medical Ethics), the doctor may be justified in withholding certain information.
The procedure for informing the patient is very detailed and could adapt well to a person with dementia, although the valid safeguards against traumatising the patient could also clearly be used to justify a paternalistic attitude.
The patient’s right to refuse information
The documented wish of the patient not to be informed (or, as mentioned above, to delegate another person to be informed on his/her behalf) must be respected (article 33).
Confidentiality/disclosure of information to other people
According to article 34 of the Italian Code of Medical Ethics information can be provided to a spouse provided that the patient consents to this. In the event of grave danger to the health or life of any third party information can be given without consent.
It is not stated that information can be given to guardians. However, article 37 stipulates that where a patient is afflicted by infirmity of mind, informed consent must be given by the legal representative. As informed consent is dependent on the person making the decision being fully aware of all the relevant factors, this article implies that legal guardians have the same right to information as the patient.
End-of-life care and issues
According to art 39 of the Italian Code of Medical Ethics relating to caring for incurable people:
“In the event of a disease with a poor prognosis or which has reached the terminal stage, the physician should behave in such a way as to prevent unnecessary physical and mental suffering to the patient and provide the appropriate treatment to protect, as far as possible, the quality of life and the dignity of the patient. In case of a reduced state of consciousness, the doctor should continue to administer life supporting treatment for as long as he/she deems it worthwhile, avoiding any form of harsh and futile treatment.”
There is at the moment no specific law on palliative care. However, there is an advanced bill currently being debated in Parliament.
Passive euthanasia, which involves the withholding of life-preserving measures, is illegal and could be considered as “incitement or assisted suicide” under article 580 of the Penal Code:
“Whoever leads or incites another person to commit suicide, or assists them in any way, shall be punished, if suicide occurs, by imprisonment of between five and twelve years …..”
According to article 579 of the Penal Code, direct active euthanasia is considered as homicide.
Please see the above section and the one on “murder at the request of the victim.”
Non-assistance to a person in danger
Non-assistance to a person who is or appears to be unconscious, wounded or otherwise in danger, or failure to inform the relevant authorities may be punished by a prison sentence of up to 3 months or a fine. The sentence is increased if the person suffers injury as a result and is doubled in case of death (article 593 of the Penal Code).
Article 575 of the Penal Code states that whoever kills another person will be sentenced to a minimum of 21 years in prison. Articles 576 to 577 mention certain aggravating circumstances which may lead to a more severe sentence such as life imprisonment or even the death penalty. These include, amongst other things, premedication or the fact that the victim is a close relation. Article 584 mentions a lower sentence of 10 to 18 years if someone kills another person but did not intend to do so.
Murder at the request of the victim
Article 579 of the Penal Code states that whoever causes someone’s death, with his/her consent, shall be punished by imprisonment of between six and fifteen years.
Last Updated: Wednesday 27 April 2011