Professioni e Sanità

Professions and Healthcare


The (un)informed consent and the role of the doctors

Il consenso (non) informato e il ruolo dei medici
4 - 7 minuti di lettura

On the autism awareness world day, it is difficult not to take an in-depth look, when world science is still divided about the correlation between vaccinations and what is defined as the specific autism spectrum disorder , characterized by social and emotional deficits, stereotypes and possible intellectual disabilities.

The discussion does not aim to be medical, but rather normative. Dr. Paul Thomas, well-known American pediatrician, took into examination the recent discoveries regarding vaccines and autism link. He is the founder of the Physicians for Informed Consent (Doctors for informed consent) association, and among the various subjects covered there is also the so-called measles epidemics to introduce the vaccination mandate.

The informed consent is the synthesis of three fundamental human rights enshrined in our Constitution: the self-determination provided for in article 2, the inviolability of the human person as "freedom of the person to dispose of his own body" provided for in article 13 and the right to health provided for in article 32.

The right to informed consent is prescribed by the art. 5 of the Oviedo Convention of 4 April 1997 and by art. 3 of the EU Charter of Fundamental Law, proclaimed in Nice on 7 September 2000.

In our legal system the art. 33 of the Code of Medical Ethics regulates the consent, the characteristics of information and communication from the doctor with the person being cared for.

In order for consent to be valid it must meet certain requirements and be:

  1. INFORMED, namely the information must be personalized, understandable, truthful, objective and exhaustive;
  2. AWARE, meaning that it must be expressed by a subject aware of his own decision and therefore capable of understanding and of wanting/willing;
  3. TAILORED for the person;
  4. MANIFEST, namely the manifestation of the will must be provided explicitly and unambiguously, in writing, also for evidentiary purposes;
  5. SPECIFIC, referring to the specific health treatment proposed;
  7. REVOCABLE, even immediately before the health intervention itself.

To better clarify the quality of the information submitted by the doctor to the patient, the Court of Appeal 2177/2016 has stated that informed consent must be based on detailed information, suitable for providing full knowledge of the nature, extent and range of the medical-surgical intervention, its risks , the achievable results and the possible negative consequences, since the patient cannot sign an extremely generic form for this purpose, nor does it detect the quality of the patient, which affects only the modalities of the information, to be adapted to his cultural level through a language he is able to understand.

Therefore, the vaccinator doctor should not only provide all the useful and necessary information for the patient to give his informed consent, but he should also make sure that he has understood the information properly given.

The consent will therefore be given legitimately only when the doctor has guaranteed adequate and complete information.

Keep in mind that there is an obligation for the healthcare professional to adequately inform who receives a medical treatment.
However, medical-patient communication often turns out to be approximate, whereas, instead, it is not entirely missing, despite the omissive conduct of the health care professional configuring a civil, criminal and deontological offense (Article 35 CDM).

In 2017, with Law 219/2017, the so-called Gelli Law (Regulations on informed consent and advance processing provisions), the content of the informed consent and its acquisition procedure were also finally regulated.

Informed consent and vaccination practice

It should now be self-evident that vaccinations, whether mandatory by law or simply recommended, being classified as health treatments, as well as any diagnostic or therapeutic activity, certainly do not derogate from the law.

In fact, even in the "Regional Vaccine Prevention Plan 2017-19 - Lombardy" it is clarified that "the introduction of compulsory vaccination with law 119/17 does not entail any derogation from the medical principle, therefore, after having ruled out that there may be impeding circumstances on vaccination and after having properly informed the parent, he must achieve consent before proceeding to vaccination."

The assumption should constitute the cornerstone on which to set the doctor-vaccinator-patient relationship; however, in August 2017, in a circular issued by the Ministry of Health it was stated that informed consent is limited to the recommended vaccinations only, while for mandatory vaccinations it is sufficient to provide the health service user with only an information form.

Unfortunately, this circular has endorsed illegitimate behaviors in the various centers of the vaccination registers allowing, correctly, some parents lend in writing a true and appropriate informed consent, while others received only the informative forms, in fact violating the law on the informed consent and the right of equality (Article 3 of the Constitution).

An intervention by the WTO President Giuseppe Lavra was necessary on 10/10/2017 to dispel any doubts and to reiterate that the informed consent issued by the parents is to be considered indispensable to proceed with the vaccination, whatever it may be, mandatory or recommended.

The only exception allowed in the medical field for the acquisition of informed consent is the mandatory medical treatment in the psychiatric field , and that is, in fact, the only case of coercive health treatment (Law 833/1978).

And, even more recently, the Brescia TAR (administrative court) 05/04/2018, reiterated that "the therapeutic act of compulsory vaccination must be preceded by the collection of informed consent by the healthcare professional".

The missing information

However, what revolves around the vaccination practice is unacceptably nebulous.

According to Law 238/1997 each vaccination center must expose the ' information about the compensation program ex L. 210/92 in case of injuries or illnesses caused by vaccinations, but this does not happen.

The invitation to vaccination should be evaluated in a clear and precise manner, but in most cases even the explanation of the vaccines to be administered is lacking .
The doctor must take action so that the user of the ASST services receives all the information concerning the vaccination practice, both those concerning the quality of the vaccines and those concerning the possible reactions and / or adverse events which, although it is too often forgotten, exist!!!

According to the AIFA (Italian regulatory body) 2017 report on post-marketing vaccine surveillance, reports of adverse reactions were 6,696.
However, doctors often overlook the explanations of adverse events and reactions, how to deal with them and subsequently report them, as well as the existence of Law 210/92 (on compensation program).
And we are deliberately leaving out, as this is not the right place, how cumbersome the compensation process is.

Although the art. 1, 8 of the Gelli Law reaffirms that the relationship between doctor and patient is based on trust, it is inevitable that, in the light of what has been discussed, the parents, who approach the vaccination procedure in this way, have doubts which are far from being easily removed and removable!

In the opinion of the writer, vaccination hesitancy can only be tackled through a reorganization of the vaccination centers that must adopt a unequivocal modus operandi.
Furthermore, it is at least necessary to enhance the principle of consent, but this is only possible by the elimination of a coercive, stigmatizing and sanctioning apparatus, and by using a persuasive approach within a collaborative context with parents.

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