By Catherine Paley-Vincent, Associate lawyer and Nathalie Boudet-Gizardin, Lawyer counsel

Vaccinating adolescents against COVID-19

Since June 15, 2021, vaccination against COVID-19 has been open to adolescents aged 12 to 17 years.

Based on the recommendations issued by the National Consultative Ethics Committee1 (CCNE), the General Directorate of Health (DGS) published on June 13 a note, addressed to health professionals, specifying the conditions to be fulfilled for a minor over 12 years of age to be administered the vaccine against COVID-19.

The unresolved question, the answer to which was long awaited by practitioners, remained whether the vaccine against COVID-19 could be administered to an adolescent patient, without his agreement, despite that given by his two parents, co-owners of the parental authority.

Remember that for the care usually given to minor children, Article L. 1111-4 paragraph 7 of the Public Health Code provides that " The consent of the minor […] must be systematically sought if he is able to express his will and participate in the decision. ».

Thus, article L. 1111-4 of the CSP, which lays down the principles applicable to the consent of minors to decisions concerning their health, proposes a system of " systematic research »The consent of the minor, when the latter is able to express it, for the taking of a care decision concerning him. If a " Participation Challenge »Of the minor to the decision is therefore required, his agreement is not, ultimately, not required to perform an act of personal care. 

However, three types of medical acts benefit from a derogatory regime, for which the refusal expressed by the minor cannot be overridden:

  • Acts not necessary for the health of the minor, such as biomedical research (article L. 1122-2 of the CSP) or the removal of bone marrow (article L. 1241-3 of the CSP), cannot be imposed on the minor who benefits a right of veto;
  • The collection and conservation of the minor's gametes or germinal tissues, "in for the subsequent realization, for his benefit, of medically assisted procreation, or for the preservation and restoration of his fertility »Are subject to his consent, to which is added that of one of the holders of parental authority (article L. 2114-11 of the CSP);
  • Medical acts related to the sexual life of the minor such as voluntary termination of pregnancy or contraception and those requested by the minor in the exercise of his right to secrecy, if they are necessary to safeguard of his health, can be carried out without the agreement of the holders of parental authority, in the event of express opposition to the consultation of the latter (article L. 1111-5 of the CSP).

To date, the compulsory vaccination of a minor is subject to the common law regime provided for by article L. 1111-4 of the CSP.

But what about vaccinating a minor against COVID-19?

For a minor to be vaccinated against COVID-19, the DGS specifies that:

  1. The two legal representatives of the minor patient must each give their consent to the vaccination by completing a certificate. which will be kept by the healthcare professional. If the presence of at least one of the parents at the time of the injection was until June 21, 2021 mandatory according to the recommendations of the DGS, Social Security has just removed this condition by specifying on its Ameli site that " This is a recommendation and not an obligation » 2. So, the minor who goes alone for the vaccination must present the parental authorization completed and signed by both parents. 

    On the other hand, if only one of the parents accompanies the minor, the latter must certify on the honor of the agreement of the absent parent, co-holder of parental authority.

  2. The practitioner must obtain the free and informed consent of the adolescent concerned.

More precisely, the practitioner must, during the preparatory interview for the vaccination, give the minor patient “ clear information adapted to his age on the uncertainties related to the disease, on the vaccine itself and its effectiveness in the medium and long term, as well as on the additional means of preventing the disease (in particular the imperative respect of the barriers) ». 

The administration of this vaccine can therefore only be done if the minor patient has expressly given his consent, since the performance of this act is " conditioned the free and informed consent of the minor concerned ».

Also, it is no longer a simple " research "The consent of the minor to the decision, but indeed a" collection With his consent.

However, curiously, only oral consent from the minor patient is required by the DGS, even though it is likely to prevent vaccination against COVID-19.

This oral consent of the minor patient undoubtedly raises the question of proof of the latter. 

How can a doctor prove the refusal or, on the contrary, the consent given by a minor patient in the event of a later dispute by the latter or by his parents, in the absence of any written record? 

Would it not have been preferable to provide for this decision to be transcribed on a certificate / questionnaire, or minima appears in the patient's health record?

In the current context, we invite health professionals to exercise great caution in the event of refusal of consent from a minor patient to vaccination against COVID-19, by keeping by all means a traceability of this one.

 

1 CCNE opinion: Ethical issues relating to the vaccination against Covid-19 of children and adolescents, June 9, 2021

2 https://www.ameli.fr/paris/assure/actualites/covid-19-tout-savoir-sur-la-vaccination-des-adolescents-de-12-17-ans

Catherine Paley-Vincent

Catherine Paley-Vincent

Partner

Recognized expert in health law, she intervenes in particular for the constitution and monitoring of structures between hospital and / or liberal health professionals, for the management of possible conflicts and their transactional, judicial or disciplinary consequences. The field of medical imaging is particularly familiar to him.

She advises pharmaceutical companies on medical devices, labeling and clinical trials.

She is regularly consulted on the application of ethics, in particular with regard to the regulation of professional orders of networks, advertising and the Internet used in the medical and veterinary world.

Portraits GINESTIÉ MAGELLAN PALEY-VINCENT 2021

Nathalie Boudet-Gizardin

Counsel

She joined the firm the same year in the Civil and Health team of Catherine Paley-Vincent. She advises health professionals particularly in terms of:

Civil, disciplinary and criminal defense of health professionals, professional orders and medical and veterinary biology laboratories

Advice and assistance to health professionals to structure their activities, including within the framework of public / private cooperation, particularly in medical imaging

Support for healthcare professionals and innovative companies in the development of their e-health projects.