The informed approval of the patient: the doctor’s obligations

L ‘ art. 32 of our Constitution provides in paragraph 1, that ” the Republic protects health as a fundamental right and the public interest “, but also prescribes the 2nd paragraph that ” nobody can be forced to a specific medical treatment unless required by law . “

The Constitution, therefore, operates a balance between two inviolable principles of our legal system, the right to health and the right to personal liberty (art. 13 et seq.), Assuring citizens the right to choose whether to undergo or not to medical care ( except that the same are not required by law: eg .: vaccination), especially when these are prescribed by a doctor.

In this case the manifestation of the patient’s will, that is legally valid, it must be expressed by the awareness of the characteristics, methods, risks, the purposes and effects of the medical treatment he will receive, as well as:

the possible treatment options for intervention;
of instrumental deficiencies of the health care facility;
the consequences that may result from the conscious refusal to care.

This requirement, in accordance with Law n ° 145/2001, it is the physician who will perform the treatment or intervention, which must also obtain the necessary consent / dissent ( informed , in fact) by the patient before the start of the same treatment.

The content and form of informed consent

The law has repeatedly stated that the consent given by the patient, so that it is legally valid, must be:

Personal : manifest to the addressee of the treatment, as owner of the availability of legally protected interest;
Legal : not contrary to public order and morality;
current : simultaneous treatment to be practiced;
poster : expressed a clear and unequivocal manner;
free and conscious : he must come from someone legally able, capable of discernment and having the appropriate age to have that right.

With regard to the form of consent, however, there is no requirement to acquire it in writing, being valid and effective even if paid by the patient verbally, except in certain cases expressly provided by law, such as:

kidney transplant between living persons;
clinical trials of medicines for human use;
medically assisted procreation;
voluntary interruption of pregnancy;
correction concerning the attribution of sex;
transfusion activities;
levy blood donation.

Generally, therefore, the form of the acquisition of consent is free . However, the practice now adopted by physicians and / or health facilities is to get the patient to sign a form containing all the important information about the medical treatment that he is about to receive, in order to avoid legal repercussions.

The exceptions to informed consent

The obligation of the physician to obtain the patient’s informed consent often clashes with reality, particularly with the cases:

which require urgent and timely intervention , in which the time used to obtain informed consent would risk irreparably jeopardize the patient’s health;
in which the patient is a minor .

Cases of urgency

In the first case, a doctor should always assess whether the patient is lucid and conscious: in this case the consent must always be obtained.
In the case in which the patient is unconscious, instead, resulting impossible to obtain from the same a clear manifestation of will, the doctor’s inertia would prove fatal.

This issue has been resolved by the doctrine, which considers applicable to the above case, the rule laid down by. 54 of the Criminal Code ( ” can not be punished those who committed the act to be forced by necessity to save themselves or others from danger present serious harm to the person … as long as the fact is proportionate to the danger “).

This exonerating thus “legalize” medical intervention performed without obtaining informed consent, provided it is proved that the only objective pursued was to safeguard the patient from the danger of serious harm to health (it comes in this case presumed consent ).

The informed consent of the child

If the patient is less of age, informed consent must be provided by the latter or by the parents (or guardian) who exercise responsibility?According to our ordering the acquisition of the necessary consensus is informed by the parents, as the child is considered to be partially unable to understand the consequences resulting from a therapeutic treatment.However, Article 38 of the code of medical ethics states that ” the physician, consistent with age, with understanding and with the maturity of the subject, is obliged to give adequate information to the child and to take account of his will “, especially in cases where the patient proves able to understand the scope of the therapeutic process that is proposed and the consequences of his assent / dissent to treatment.

The additional exceptions

The law, in addition to the just examined this case, predicted further exceptions to the obligation of the physician to obtain the informed consent:

when the sick person has explicitly expressed a desire not to be informed;
in cases of ” implicit consent ” (eg in the treatment routine ), in which it is assumed that the information and the relative consensus are now consolidated;
in cases of atypical consequences, exceptional and unforeseeable surgery, which can cause unnecessary anxiety and fears (unless the patient requests the necessary information to the physician spontaneously);
the Obligatory Sanitary Treatments (TSO) in cases of particular mental disorders;
mandatory vaccinations, agreed in the national public health programs.

Damages

What are the effects of the failure to comply with the disclosure requirements by the doctor? E ‘responsibility towards the patient although the medical treatment has been successful?

The law has long debated on the issue, making it clear recently that the patient owns the right to receive correct and complete information on medical treatment that is going to receive , which is the foundation in the constitutional principles mentioned above. With the result that the damage to that law causes damage independently compensable in his favor , even in cases where treatment or medical intervention has been successful or is not precisely performed.

IN SUMMARY

The consensus (or dissent) informed is the manifestation of the patient’s will, for the implementation of a medical treatment, the doctor expressed only after receiving from the latter complete disclosure on the characteristics, the manner, the risks, the purposes and the effects of this treatment.

Informed consent in order to be valid, must be personal, legal, present, poster, free and conscious and requires no written form, except for certain cases provided by law.

The requirement to obtain it, however, there is in certain cases:

if via both urgency and the patient is unconscious;
when the sick person has explicitly expressed a desire not to be informed;
when it is assumed that the information and the relative consensus are now consolidated;
the Obligatory Sanitary Treatments (TSO) in cases of particular mental disorders; etc.

When the patient is a minor , this consent must be paid by the person exercising parental responsibility, but the lesser must always be involved in the discussion on the manifestation of consent.

Case law has made it clear that the patient is the holder of a right, whose damage causes damage independently compensable in his favor , even in cases where treatment or medical intervention has been successful or has failed to run .

If you have suffered a medical treatment or surgery without the physician will have requested the necessary consent or you have a full briefing on the characteristics and effects of the same treatment, you may be entitled to a reasonable compensation for damages, regardless of the outcome of ‘ intervention.

Contact the law firm Att. Marco Coscia to get a comprehensive legal advice and assistance and find out if you are entitled to compensation for damages