Law 22 December 2017, n. 219 Rules on informed consent and advance processing provisions

Law 22 December 2017, n. 219 Rules on informed consent and advance processing provisions
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Art. 1 Informed consent

  1. This law, in compliance with the principles set out in articles 2, 13 and 32 of the Constitution and articles 1, 2 and 3 of the Charter of Fundamental Rights of the European Union, protects the right to life, health, dignity and self-determination of the person and establishes that no health treatment can be started or continued without the free and informed consent of the person concerned, except in cases expressly provided for by law.
  2. The relationship of care and trust between patient and doctor is promoted and valued, which is based on informed consent in which the patient's decision-making autonomy and the competence, professional autonomy and responsibility of the doctor meet. The healthcare professionals who make up the healthcare team contribute to the care relationship based on their respective skills. In this relationship, if the patient so wishes, also his family members or the party to the civil union or the cohabitant or a trusted person of the patient are involved.
  3. Everyone has the right to know their health conditions and to be fully informed, updated and understandable to them about the diagnosis, prognosis, benefits and risks of the diagnostic tests and health treatments indicated, as well as about the possible alternatives and the consequences of any refusal of medical treatment and diagnostic assessment or renunciation of the same. You can refuse to receive the information in whole or in part or indicate the family members or a trusted person in charge of receiving it and express consent on your behalf if the patient so wishes. The refusal or renunciation of information and the possible indication of a person in charge are recorded in the medical record and in the electronic health file.
  4. Informed consent, acquired in the ways and with the tools most suited to the patient's condition, is documented in writing or through video recordings or, for the disabled person, through devices that allow them to communicate. Informed consent, in any form expressed, is entered in the medical record and in the electronic health record.
  5. Every person capable of acting has the right to refuse, in whole or in part, with the same forms as referred to in paragraph 4, any diagnostic assessment or medical treatment indicated by the doctor for his / her pathology or individual acts of the treatment itself. Furthermore, he has the right to revoke the consent given at any time, with the same forms referred to in paragraph 4, even when the revocation involves the interruption of the treatment. For the purposes of this law, artificial nutrition and artificial hydration are considered health treatments, as they are the administration, on medical prescription, of nutrients using medical devices. If the patient expresses the renunciation or refusal of health treatments necessary for his survival, the doctor proposes to the patient and, if he agrees, to his family, the consequences of this decision and the possible alternatives and promotes any support action to the patient. , also by making use of psychological assistance services. Without prejudice to the possibility for the patient to change their will, acceptance, revocation and rejection are noted in the medical record and in the electronic health file. 
  6. The doctor is obliged to respect the will expressed by the patient to refuse medical treatment or to renounce the same and, consequently, is exempt from civil or criminal liability. The patient cannot demand health treatments contrary to the law, professional ethics or good clinical-care practices; in the face of such requests, the doctor has no professional obligations.
  7. In emergency or urgent situations, the doctor and the members of the health team ensure the necessary care, respecting the will of the patient where his clinical conditions and circumstances allow it to be implemented.
  8. The time of communication between doctor and patient constitutes treatment time. 
  9. Each public or private health facility guarantees with its own organizational methods the full and correct implementation of the principles referred to in this law, ensuring the necessary information to patients and adequate staff training.
  10. The initial and continuing training of doctors and other health professions includes training in patient relations and communication, pain therapy and palliative care.
  11. The application of the special rules governing the acquisition of informed consent for certain medical acts or treatments is reserved.

Art. 2 Pain therapy, prohibition of unreasonable obstinacy in treatment and dignity in the final phase of life

  1. The doctor, making use of means appropriate to the patient's condition, must make every effort to alleviate the suffering, even in case of refusal or revocation of consent to the medical treatment indicated by the doctor. To this end, an appropriate pain therapy is always guaranteed, with the involvement of the general practitioner and the provision of palliative care as per law March 15, 2010, n. 38. 2. In cases of a patient with a poor short-term prognosis or imminent death, the physician must refrain from any unreasonable obstinacy in administering treatment and from resorting to unnecessary or disproportionate treatments. In the presence of suffering refractory to health treatments, the doctor can resort to continuous deep palliative sedation in association with pain therapy, with the patient's consent. 3. The use of continuous deep palliative sedation or its refusal are motivated and are noted in the medical record and in the electronic health file. Pain therapy, prohibition of unreasonable obstinacy in treatment and dignity in the final phase of life 1. The doctor , making use of means appropriate to the state of the patient, must make every effort to alleviate their suffering, even in the event of refusal or revocation of consent to the medical treatment indicated by the doctor. To this end, an appropriate pain therapy is always guaranteed, with the involvement of the general practitioner and the provision of palliative care as per law March 15, 2010, n. 38.
  2. In cases of a patient with a poor short-term prognosis or imminent death, the physician must refrain from any unreasonable obstinacy in administering treatment and from resorting to unnecessary or disproportionate treatments. In the presence of suffering refractory to health treatments, the doctor can resort to continuous deep palliative sedation in association with pain therapy, with the patient's consent.
  3. The use of continuous deep palliative sedation or its refusal are justified and are noted in the medical record and in the electronic health file.

Art. 3 Minors and incapable

  1. The minor or incapable person has the right to the enhancement of their understanding and decision-making skills, in compliance with the rights referred to in Article 1, paragraph 1. They must receive information on the choices relating to their health in a manner consistent with their own ability to be put in a position to express his will.
  2. The informed consent to the health treatment of the minor is expressed or refused by the exercisers of parental responsibility or by the guardian taking into account the will of the minor person, in relation to his age and degree of maturity, and having as its purpose the protection of the mental and physical health and life of the minor in full respect of his or her dignity.
  3. The informed consent of the person banned pursuant to article 414 of the civil code is expressed or refused by the guardian, having heard the interdict where possible, with the aim of protecting the psychophysical health and life of the person in full respect of his / her dignity. .
  4. The informed consent of the disabled person is expressed by the same disabled person. In the event that a support administrator has been appointed whose appointment provides for the necessary assistance or exclusive representation in the health sector, the informed consent is also expressed or refused by the support administrator or only by the latter, taking into account of the will of the beneficiary, in relation to his degree of ability to understand and want.
  5. In the event that the legal representative of the disabled or incapacitated person or the support administrator, in the absence of the advance treatment provisions (DAT) referred to in Article 4, or the legal representative of the minor person refuses the proposed treatments and the doctor considers instead that these are appropriate and necessary, the decision is remitted to the guardianship judge upon appeal by the legal representative of the person concerned or by the subjects referred to in articles 406 and following of the civil code or by the doctor or by the legal representative of the health facility.

Art. 4 Advance treatment provisions

  1. Every adult person is capable of understanding and willing, in anticipation of a possible future inability to self-determine and after having acquired adequate medical information on the consequences of his choices, can, through the DAT, express his wishes regarding health treatments, as well as consent or refusal with respect to diagnostic assessments or therapeutic choices and to individual health treatments. It also indicates a person of his trust, hereinafter referred to as "trustee", who takes his place and represents him in relations with the doctor and health facilities.
  2. The trustee must be an adult and capable of understanding and willing. The acceptance of the appointment by the trustee takes place through the signing of the DAT or with a subsequent deed, which is attached to the DAT. A copy of the DAT is issued to the trustee. The trustee can renounce the appointment by written deed, which is communicated to the settlor.
  3. The assignment of the trustee can be revoked by the settlor at any time, with the same modalities provided for the appointment and without the obligation to give reasons.
  4. In the event that the DAT does not contain the indication of the trustee or the trustee has renounced it or is deceased or becomes incapable, the DAT remains effective with regard to the wishes of the settlor. In case of need, the tutelary judge appoints a support administrator, pursuant to Chapter I of Title XII of Book I of the Civil Code.
  5. Without prejudice to the provisions of paragraph 6 of article 1, the doctor is required to comply with the DAT, which may be disregarded, in whole or in part, by the doctor himself, in agreement with the trustee, if they appear clearly incongruous or that do not correspond to the current clinical condition of the patient or that there are therapies not foreseeable at the time of subscription, capable of offering concrete possibilities for improving living conditions. In the event of a conflict between the trustee and the doctor, the procedure is pursuant to paragraph 5 of article 3.
  6. The DATs must be drawn up by public deed or by authenticated private deed or by private deed delivered personally by the settlor to the civil status office of the municipality of residence of the settlor, which records them in a special register, where established, or at health structures, if the conditions referred to in paragraph 7 are met. They are exempt from the registration obligation, stamp duty and any other tax, duty, right and tax. In the event that the physical condition of the patient does not allow it, the DAT can be expressed through video recording or devices that allow the person with disabilities to communicate. With the same forms they are renewable, modifiable and revocable at any time. In cases where reasons of emergency and urgency prevent the revocation of the DATs with the forms provided for in the previous periods, these can be revoked with a verbal declaration collected or videotaped by a doctor, with the assistance of two witnesses.
  7. The regions that adopt telematic methods of managing the medical record or the electronic health file or other IT methods of managing the data of the individual registered with the National Health Service may, by their own deed, regulate the collection of copies of the DAT, including the indication of the trustee, and their inclusion in the database, leaving the signatory the freedom to choose whether to give a copy or indicate where they can be found.
  8. Within sixty days from the date of entry into force of this law, the Ministry of Health, the Regions and the health authorities shall inform of the possibility of drawing up the DAT based on this law, also through their respective websites.

Art. 5 Shared planning of care

  1. In the relationship between patient and doctor referred to in article 1, paragraph 2, with respect to the evolution of the consequences of a chronic and disabling pathology or characterized by unstoppable evolution with a poor prognosis, a shared care planning between the patient and the doctor, to whom the doctor and the health team are required to comply if the patient finds himself in the condition of not being able to express his consent or in a condition of incapacity.
  2. The patient and, with his consent, his family members or part of the civil union or cohabitant or a trusted person are adequately informed, pursuant to article 1, paragraph 3, in particular on the possible evolution of the pathology in act, on what the patient can realistically expect in terms of quality of life, on the clinical possibilities of intervention and on palliative care.
  3. The patient expresses his consent with respect to what is proposed by the doctor pursuant to paragraph 2 and his intentions for the future, including the possible indication of a trustee.
  4. The patient's consent and any indication of a trustee, referred to in paragraph 3, are expressed in writing or, in the event that the patient's physical condition does not allow it, through video-recording or devices that allow the person with disability to communicate, and are included in the medical record and in the electronic health record. The care planning can be updated as the disease progresses, at the request of the patient or at the suggestion of the doctor.
  5. As regards the aspects not expressly governed by this article, the provisions of article 4 apply.

Art. 6 Transitional rule

  1. The provisions of the same law apply to documents expressing the wishes of the settlor regarding health treatments, deposited with the municipality of residence or with a notary before the date of entry into force of this law.

Art. 7 Financial invariance clause

  1. The public administrations concerned ensure the implementation of the provisions of this law in the area of ​​human, instrumental and financial resources available under current legislation and, in any case, without new or greater charges for public finance.

Art. 8 Report to the Chambers

  1. 1. The Minister of Health sends to the Chambers, by 30 April of each year, starting from the year following the one in progress at the date of entry into force of this law, a report on the application of the law. The regions are required to provide the necessary information by February of each year, on the basis of questionnaires prepared by the Ministry of Health.

This law, bearing the seal of the State, will be included in the Official Collection of regulatory acts of the Italian Republic. Anyone who is responsible is obliged to observe it and have it observed as state law.


Source: https://www.gazzettaufficiale.it/eli/id/2018/1/16/18G00006/sg