Italy, Administrative Justice Council for the Region of Sicily, 16 March 2022, Order no. 351/2022
Case overview
Country
Case ID
Decision date
Deciding body (English)
Deciding body (Original)
Type of body
Type of Court (material scope)
Type of jurisdiction
Type of Court (territorial scope)
- Local Court
- State Court
Instance
Area
Further areas addressed
- Education
- Vaccination
- Sanctions and remedies
- Scope of powers of public authorities (legislative, executive etc.)
- Pharmacovigilance
Link to the full text of the decision
General Summary
Art. 4 of the decree-law n. 44/2021, in force in Italy, imposes a vaccination requirement for certain categories of workers, especially in the medical and health field.
In a case concerning a nursing student, subject to the requirement of vaccination against COVID-19 in accordance with the law, the Court considers the question of constitutionality relating to the vaccination requirement to be relevant and not manifestly unfounded.
The Court reaches this conclusion after having carried out an extensive investigation on the efficacy and effects of the vaccine and after having verified the persistent uncertainty about the side effects of the vaccine, statistically more frequent than in other cases of mandatory vaccination and after having questioned the correct and complete information of the obliged subjects.
The question arose as a precautionary measure, when the Applicant asked to be able to carry out an internship without undergoing the compulsory vaccination.
Since the judge has remitted the documents to the Constitutional Court doubting the illegality of the provision that imposes the vaccination requirement, the trial was suspended until the Court’s decision.
Facts of the case
The Applicant is a student in nursing sciences at the University of Palermo and was prevented from participating in the training internship as he was not vaccinated against COVID-19.
The Applicant argued:
a) The experimental nature of the vaccine;
b) That he had already had COVID-19 and therefore enjoyed perennial immunity;
c) That he would have risked dying from a severe immune system reaction (A.D.E. - Antibody Dependent Enhancement).
The judge ordered an investigation by asking a college (made up of technicians from the Ministry of Health, the Superior Health Council and the General Direction of Healthcare) for various information and clarifications.
Type of measure challenged
Measures, actions, remedies claimed
Individual / collective enforcement
Nature of the parties
Claimant(s)
Private individualDefendant(s)
Public
Type of procedure
Conclusions of the deciding body
The Court doubts the constitutionality of the vaccination requirement on the ground of proportionality and compatibility with some constitutional provisions as follow:
- Principle of substantial equality and proportionality (art. 3, Italian Constitution)
- Right to health (art. 32, Italian Constitution)
- Right to work (art. 4 and 35, Italian Constitution)
- Right to good administration (art. 97, Italian Constitution)
- Right to education (art. 33 and 34, Italian Constitution)
- Freedom of thought (art. 21, Italian Constitution)
The decision is therefore left to the Constitutional Court.
Reasoning of the deciding body
First of all, the Court established that under the law the Applicant is subject to the vaccination requirement, which applies to medical and health care personnel, including trainees, for the protection of personnel in the workplace and of the patients and healthcare end users. There is no subjective exemption from the statutory health obligation, since there is no ascertained danger to health; moreover, the immunization resulting from the previous illness determines only the postponement of vaccination and leaves the obligation firm.
Hereinafter, the referring court states that based on art. 32 of the Italian Constitution, compulsory health treatments, such as vaccination, are allowed provided that:
a) The individual right to health of the obliged subject and the concurrent collective right to health are balanced;
b) Treatments do not negatively affect the state of health of the obliged subject except for the normal and tolerable consequences;
c) In case of further damage to the person subject to the treatment, provision prescribes the payment of a fair indemnity in favor of the injured party;
d) Moreover, the measures to implement the vaccination requirement must include precautions and must be conducted according to the modalities that the state of scientific knowledge and art prescribes, including a complete and adequate communication and information on the risk of injury both to the person who is subjected to them and to the people who must make decisions in this regard.
According to the referring court, in the application of the precautionary and the solidarity principles, the use of therapies is allowed even on the basis of incomplete data as long as they ensure more benefits than risks; as for the vaccine against COVID-19, in particular, vaccines are surely effective in preventing hospitalization, admission to intensive care and death, affecting the individual vaccinated and the health care system as a whole; so that the first condition imposed by the Constitution (above sub a) is respected.
Nevertheless, regarding the condition-imposed sub b) (as above), critical issues relating to possible adverse events affecting the judgment of proportionality are not completely refuted. In fact, recent additional information, in particular, the AIFA annual report on the safety of vaccines against COVID-19, have highlighted a number of adverse events significantly higher than that found for other mandatory vaccines.
In this regard, it is clear the role played by the collection and analysis of data at a European level, though the appropriate EudraVigilance database, and shared worldwide, as reported in VigiBase (Pharmacovigilance database of the WHO Uppsala International Medicines Monitoring Counter), as related to the adverse event reports; among these ones, in addition to modest and transient effects, qualifiable as to be negligible effects and within the normal tolerability. There are disorders and pathologies affecting the cardiocirculatory (thrombosis, ischemias, immune thrombocytopenias), lymphatic, cardiovascular (including myocarditis), endocrine, immune systems, connective and musculoskeletal tissues, nervous, renal, respiratory systems, neoplasm. There are very serious events whose statistical frequency can question the constitutionality balance represented by the overall tolerability for the obliged subject of the possible side effects. According to the referring court, whilst it is true that serious reactions constitute a minimal part of the events having been considered, the adequacy of a mere quantitative or statistic evaluation according to the criterion of normal tolerability, rather the adoption of an individual evaluation is questionable. Moreover, the statistical data collected also seem to exclude the fortuitous event and the unpredictability of the individual reaction, which seems to accept the adverse effect being even less tolerable according to the principle of proportionality.
The referring court does not overlook the risk of non-complete reliability of the data collected. For example, regarding the attribution to the vaccine of consequences not dependent on it, or, on the contrary, the underestimation of events not collected because they are outside the time window as fixed by a particular algorithm set by the WHO.
The Court finds, however, that, according to the challenged law and to the administrative practices by health institutions, no specific surveys were carried out on individual vaccinated subjects, nor in relation to any COVID-19 in progress, which raises additional doubts of the absolute necessity of the measure evaluated in light of the proportionality principle.
The Court holds in this respect that, in consideration of the general uncertainty about the side-effects, an appropriate monitoring regime should be required of the administration to ensure that collateral negative effects related to vaccination are promptly and effectively detected. The lack of such collection leads to an autonomous profile of unreasonableness and makes one doubt good and correct administration.
According to the referring court the legislative choice of mandatory vaccination should be subject to continuous review in light of the evolution of medical and scientific knowledge and legislation should require precautionary and mitigation measures related to the effects of the vaccine. Finally, it does not seem reasonable to require informed consent with respect to mandatory vaccination.
Fundamental Right(s) involved
- Right to education
- Right to health (inc. right to vaccination, right to access to reproductive health)
- Right to work, freedom of thought
Fundamental Right(s) instruments (constitutional provisions, international conventions and treaties)
- Right to health, art. 32, Italian Constitution
- Right to work, art. 4, Italian Constitution
- Right to education, art. 34, Italian Constitution
- Freedom of thought, art. 21, Italian Constitution
Rights and freedoms specifically identified as (possibly) conflicting with the right to health
- Health (public) v. access to health services
- Health v. right to education
General principle applied
- Proportionality
- Reasonableness
Balancing techniques and principles (proportionality, reasonableness, others)
The balancing technique related to the constitutionality refers to the previous rulings of the Constitutional Court in relation to vaccination. It is remarkable to note that an in-depth investigation was carried out and the Court acquired lots of relevant data, also factual ones, to reach the judgment of not manifest groundlessness of the question. The procedure followed is quite similar to that one used by the CJEU (compare the “Vavricka case”; Great Chamber, April 8, 2021). The question submitted to the Constitutional Court is whether the equilibrium among conflicting interests related to vaccination based on the proportionality principle can be shifted in the face of a world health emergency such as the COVID-19 pandemic.
Judicial dialogue
- Constitutional Court of Austria, January 26, 2022 (Vaccination against COVID-19).
- Conseil Costitutional France, August 2021.
Impact on Legislation/Policy
The Italian government, after the ordinary vaccination cycle, 2 doses plus the so-called booster dose, is currently considering introducing an additional mandatory booster against COVID-19 reserved for particular categories of frail subjects such the elderly, and those suffering from certain illnesses.
Other notes
Instance: appellate on fact and law; interim procedure.
Outcome of the decision: suspension of the trial and referral to the Constitutional Court.
National precedents as follows:
- Constitutional Court, June 22, 1990, n. 307 and January 18, 2018, n. 5 (about vaccination requirement and its legal limitation)
- Council of State, III, n. 7045, October 20, 2021 (validation of vaccination requirement)
- Administrative Court of Lombardia, Milan, I (remission to the Constitutional Court of some provisions relating to vaccination requirement)
- Court of Labor of Padua, December 7, 2021 (remission to the EU Court of Justice of some questions relating to the vaccination requirement imposed to the healthcare workers)
