Informed consent and bio-will: legal profiles

The December 14, 2017 the Senate definitively approved the law on informed consent and the “bioassay” with 180 votes in favor, 71 against and 6 abstentions, after a tortuous passage through Parliament and a persistent public pressure.

At 8 years after the bill presented to Parliament urgently to avoid – unnecessarily – assisted death of Eluana Englaro and then covered up, the Lawgiver, with Law No. 219 of December 22, 2017 , legitimized and governs the right of citizens to choose the care and therapeutic treatments to be received, even in case of mental and physical incapacity future (with obvious direct limits to protect other rights guaranteed by the Constitution).

For a country like Italy, characterized by a strong Catholic tradition and culture, this law certainly represents a historical turning point, came following a democratic battle that has pitted two opposite directions: on the one hand the traditionalist Catholic matrix, directed to safeguarding the good life at all costs, what right constitutionally unavailable and inalienable. The other one that puts emphasis on the individual’s right to self-determination and, therefore, the freedom to dispose entirely of their own lives.

The law

The Law n ° 219/2017 – whose entry into force is expected today, January 31, 2018 – two key governing institutions: the informed consent and advance directives provisions (or ” DAT “).

The second, closely related to the first, allow the person of age capable of understanding and willing to express their will on future health and diagnostic treatments (with the methods described below), ” in view of a ‘ possible future inability to self-determination ” (art. 4, paragraph 1).

1) Informed consent

The main purpose of the Act is set out in art. 1: promote and enhance ” the relationship of care and trust between patient and doctor, which is based on informed consent”, in which they meet the decision-making autonomy of the first and competence, professional autonomy and responsibility of the second.

Informed consent – already analyzed in detail in the previous article ( The failed acquisition of informed consent: for damages in favor of the patient ) – is in the patient’s right to:

learn about your medical condition and to be informed in a complete, updated and they understand the diagnosis, prognosis and related benefits and risks, and possible alternatives and the consequences of refusal of medical treatment;
refuse – in whole or in part – to receive the above information, or indicate the family or a person of his confidence in charge to receive them and give consent on their behalf.
refuse to give its consent to the therapeutic treatment or revoke access at any time, if given previously, as well as again will change following the withdrawal or refusal.

The informed consent, its revocation, rejection for the therapeutic treatment and the possible indication of a charge, must be expressed in written form or through video recordings (or, for the person with disabilities, through devices that allow it to communicate) and compulsorily included in the medical record and electronic health records patient.

The patient, however, may not require medical treatment contrary to the law, in professional ethics or good clinical care practices .

Given these requirements, the doctor does not have professional obligations.

What is the duty of the physician in case of withdrawal or refusal of treatment by the patient?

The physician must respect the patient’s will to refuse medical treatment or give up the same and, for this reason, is exempt from civil or criminal liability .

The law, however, provides that the doctor must envisage the patient – and, if they agree, to his family – the consequences of refusal and possible alternatives to it, as well as promoting any support measures for the same patient, making use of the services of psychological assistance.

The treatment of pain and dignity of life

The refusal or withdrawal of consent to medical treatment, especially in cases of terminal illnesses, does not exempt the physician from the obligation to alleviate the suffering of the patient. To this end, it must always guarantee him a proper pain relief to his health, by providing the palliative care provided by law March 15, 2010, n. 38.

However, in the presence of suffering refractory to medical treatment, the ‘ art. 2 provides that the doctor can resort to ” sedation deep palliative continues “, in association with the treatment of pain, the patient agrees.

In the event that the latter’s death is imminent, the physician must refrain ” from any unreasonable obstinacy about the care and the use of unnecessary or disproportionate treatment “.

Minors, interdicted and incapacitated

If the patient is a minor or a subject interdict, informed consent to medical treatment must be expressed or rejected by the parents (or guardian, in the second case), always taking into account the will of the minor (or forbidden) , in relation to its age and degree of maturity, so that it is protected her mental and physical health and dignity.

For this the ‘ art. 3 stipulates that the child shall receive ” information on choices regarding their health so suited to his abilities to be put in a position to express its will” .

In the case where the patient is a subject incapacitated, the informed consent or refusal to it will be expressed by the latter, unless it is not assisted by a support administrator in the health field. In this case the final decision will be up to the administrator, taking into account the patient’s wishes.

What if the parents or legal representatives of the aforementioned persons refuse to give informed consent and the doctor thinks however necessary and appropriate diagnosed treatment ?

In this case the decision should be left to the judge supervising, on appeal from the parents or representative.

2) The DAT (early treatment provisions)

As mentioned above, the Law n ° 219/2017 introduces into our legal advance directives provisions, a “bioassay” that allows any person of age capable of understanding and will, in anticipation of a future event that may make it incapable of to express their will, to decide in advance:

whether to be informed or not on their psycho-physical conditions and therapies that will receive;
to provide the consent or refusal to certain therapeutic or diagnostic treatments (including the practices of nutrition and artificial hydration );
choose medical treatments (which are not contrary to the law) that it will receive in anticipation of a specific disease / disorder.

Where do they draw up and record the DAT? They can be modified?

DAT, within the meaning of ‘ art. 4 , paragraph 6, shall be in:

public act (with a notary or other public official authorized);
private deed (always by a notary or other public official)
or private writing, delivered personally at the office of the registrar of the municipality of residence of the settlor himself, who provides to the record on a register, if established, or in healthcare facilities.

In the case in which the physical condition of the patient does not allow it, the DAT can be expressed by the latter through video- or devices that allow a person with disabilities to communicate.

The DAT may be renewed, modified and revocable at any time as well as exempt from registration, exemption from stamp duty and any other tax, taxes, duties and taxes.

In cases where emergency reasons and prevented urgent need for the withdrawal of DAT with the forms provided by the previous periods, these can be canceled on record collection or videotaped statement by a physician , with the assistance of two witnesses.

The trustee

In DAT the settlor has the right to indicate a person of his
confidence that it takes the place and represent it in relations with the doctor and medical facilities, in case of future incapacity.

The trustee must be a person of age and capable of
discernment and must accept the appointment by the subscription of the DAT (of which receives a copy) or a subsequent act, attached to the same.

The mandate of the Trust may be revoked by the settlor at
any time, with the same procedures for the appointment and
without stating reasons. The same trustee has the right to waive the appointment at any time, by written instrument to be delivered to the settlor.

What happens if the settlor does not indicate any fiduciary or they will have waived, dies or becomes incapable?

In these cases, the DAT still maintain effectiveness with regard to the will of the settlor, but the judge may appoint an administrator of support that takes the place.

The doctor, in case of absence of a trustee, is always obliged to respect the DAT, but can disregard them, in whole or in part, only if:

they appear incongruous clearly or do not correspond to the patient’s current medical condition;
there are no predictable therapies on subscriptions, able to offer real opportunities for improving living conditions.

Regional Register of DAT

Under Article. 4, paragraph 7, ” the regions that use telematics data management mode of the person registered to the National Health Service, can regulate the collection of copies of the DAT, including an indication of the trust, and their inclusion in the database, while leaving the signer the freedom to choose whether to give a copy or indicate where they are available . “

IN SUMMARY

The Law n ° 219/2017 regulates two fundamental institutions: the informed consent and advance directives provisions (or ” DAT “).

The informed consent is to the patient’s right to:

learn about your medical condition and to be informed in a complete, updated and they understand the diagnosis, prognosis and related benefits and risks, and possible alternatives and the consequences of refusal of medical treatment;
refuse to receive such information, or indicate the family or a person of his confidence in charge to receive them and give consent on their behalf.
refuse to give their consent to treatment or revoke it at any time, if previously paid.

The patient, however, may not require medical treatment contrary to the law, in professional ethics or good clinical care practices . Given these requirements, the doctor does not have professional obligations.

The refusal or withdrawal of consent to medical treatment, especially in cases of terminal illnesses, does not exempt the physician from the obligation to alleviate the suffering of the patient.

The DAT , however, allow any person of age capable of understanding and will, in anticipation of a future event that may make it unable to express their will, to decide in advance:

whether to be informed or not on their psycho-physical conditions and therapies that will receive;
to provide the consent or refusal to certain therapeutic or diagnostic treatments (including the practices of nutrition and artificial hydration );
choose medical treatments (which are not contrary to the law) that it will receive in anticipation of a specific disease / disorder.

The DAT must be drawn up by public deed or private deed or delivered to the register office of the municipality of residence of the settlor . In case of failure of the latter, it can also be expressed by means of video recordings or other devices suitable for the purpose.

In DAT the settlor has the right to indicate a fiduciary it takes the place and represent it in relations with the doctor and medical facilities, in case of future incapacity.

The Lawyer. Marco Coscia offers legal advice and assistance in the preparation and registration of advance treatment provisions. Contact now studying for more information.