Felt in fact
1.– By order of 11 October 2019 (ron 6 of 2020), the Court of Cassation, labor section, raised, with reference to articles 2, 3 and 32 of the Constitution, questions of constitutional legitimacy of art. 1, paragraph 1, of the law of 25 February 1992, n. 210 (Compensation in favor of subjects damaged by irreversible complications due to mandatory vaccinations, transfusions and administration of blood products), in the part in which it does not provide that the right to compensation, established and regulated by the same law, also belongs to the conditions provided therein, to subjects who have suffered injuries or infirmities, from which a permanent impairment of psycho-physical integrity has derived, due to a vaccination that is not mandatory, but recommended, against contagion from hepatitis A virus.
The referring court is called upon to evaluate the appeal brought by the Ministry of Health against a judgment of the Court of Appeal of Lecce, which ordered the payment of the allowance in question in favor of AO which had undergone vaccination against the hepatitis A, and which, as a consequence of this, was found to be suffering from "systemic lupus erythematosus". The trial judge considered the existence of a causal link between administration of the vaccine and subsequent pathology proven. Furthermore, on the basis of the constitutional jurisprudence which extended the right to compensation in case of harmful consequences deriving from specific vaccinations which are not compulsory, but incentivized by the health authority, it considered that this right also exists with reference to the vaccine administered in this case .
The contested judgment specifies how the interested party had adhered to a vaccination campaign started in 1997 and extended against the contagion from hepatitis A, and had been subjected to vaccination, in 2003 and 2004, following her personal convocation at the headquarters of the local health authority (ASL) territorially competent. Therefore, according to the contested judgment of the Lecce Court of Appeal, a constitutionally oriented interpretation of paragraph 1 of art. 1 of the law n. 210 of 1992 would legitimize, in the present case, the recognition of the right to compensation.
The appeal by cassation of the Ministry of Health is based on the defect of violation of the law, being the compensation provided for only mandatory vaccinations. On the other hand, the appellant pointed out that the decisions of the Constitutional Court cited in the contested judgment concerned cases other than those considered in the judgment (in particular, the measles, mumps and rubella vaccine with regard to judgment no.107 of 2012 , the hepatitis C vaccine for sentence No. 423 of 2000 and the polio vaccine for sentence No. 27 of 1998).
1.1.– The Court of Cassation, in raising the indicated questions of constitutional legitimacy, starts from the assumption that there is no margin for the constitutionally oriented interpretation placed at the basis of the appeal sentence. The letter of the law would in fact refer unequivocally to compulsory vaccinations, while the judgments mentioned, declaring the partial constitutional illegitimacy of the contested rule concern vaccines other than that administered in the species. This would mean that a mere extension of the ratio decidendi of those sentences "would result in the substantial non-application of the contested provision ope iudicis".
Given this premise, the referring Court underlines how all the necessary conditions of (admissibility and) relevance of the issues raised are met.
In this regard, it notes that the etiological link between the administration of the vaccine and the onset of the pathology suffered by the party requesting compensation is now definitively established, as well as it is established that the vaccination had been strongly recommended by the health authority.
The Regional Council of the Puglia Region, in 2003, had in fact taken note of how recommended vaccinations, like those required, were included in the essential levels of assistance, guaranteed free of charge by the National Health Service and implemented with previous deliberation of the same Council.
On the other hand, in the period in which the interested party had been vaccinated (years 2003 and 2004), a specific campaign against hepatitis A was underway, also because the use of the combined vaccine against viruses A and B of hepatitis and a vaccination campaign against hepatitis B had already been completed
The person concerned, in the present case, had also been individually summoned to the ASL clinics, by means of a communication presenting the vaccination "not so much as a recommended service, but almost as if it had been compulsory".
In terms of not manifest groundlessness, the referring Court notes that the original indemnity protection concerning compulsory vaccinations has been repeatedly extended by constitutional jurisprudence. The ratio of sentence no. 268 of 2017, which declared the provision still censored constitutionally illegitimate, in the part in which it did not allow the payment of compensation in the case of a flu vaccine (not mandatory). In the light of this ruling, the referring court maintains that the public health objective, through generalized immunization phenomena, can be pursued, both through acts that impose vaccinations, and through acts that make it the subject of a recommendation, which will be effective by virtue of the natural reliance of individuals on the indications of the health authority. The public utility of the recommended vaccinations, in these situations, legitimizes and indeed requires the translation of the risk associated with the vaccination practice on the community, regardless of the particular motivations that move individuals (by virtue of articles 2, 3 and 32 of the Constitution, according to the principles set out in the relevant constitutional jurisprudence).
The Court of Cassation reiterates that in this case an objective of necessary immunization against hepatitis A was pursued, with strong incentive tones for individuals, so that, also for the related vaccine, the reasons for constitutional illegitimacy repeatedly found by the Court would apply constitutional regarding the failure to provide compensation for non-compulsory administration.
2.– The President of the Council of Ministers did not intervene in the trial, nor was the constitution of the parties to the proceedings in quo.
Considered in law
1.– The Court of Cassation, labor section, raised questions of constitutional legitimacy, with reference to art. 2, 3 and 32 of the Constitution, of art. 1, paragraph 1, of the law of 25 February 1992, n. 210 (Compensation in favor of subjects damaged by irreversible complications due to mandatory vaccinations, transfusions and administration of blood products), in the part in which it does not provide that the right to compensation, established and regulated by the same law, also belongs to the conditions provided therein, to subjects who have suffered injuries or infirmities, from which a permanent impairment of psycho-physical integrity has resulted, due to a vaccination that is not mandatory, but recommended, against contagion from hepatitis A virus.
As for the relevance of the issues raised, the referring court specifically accounted for the ascertainment of the causal link which, in the event from which the main trial originates, connects the pathology to the administration of hepatitis A vaccination, in order to demonstrate the existence of the further conditions of applicability of the discipline that the law n. 210 of 1992 bears on the subject of compensation. It thus remains clear, according to the referring court, that only any acceptance of the question raised would legitimize the application of the indemnity discipline in favor of the person concerned.
Regarding the unfounded groundlessness of the same questions, the Court considers that, in the event of irreversible complications following vaccination, it would contrast with the constitutional parameters evoked the different treatment imposed by the disputed provision, as regards the payment of compensation, among those who are affected by injuries or infirmities caused by mandatory vaccinations and those who experience the same diseases following a vaccination, not mandatory but recommended by the health authority, such as that against the hepatitis A virus. This vaccination also aims to protect of collective health, as well as individual health, Articles 2, 3 and 32 of the Constitution would make it necessary, even in this case, to pass on to the community the negative consequences that the vaccine has caused on the individual, as well as what already happens, as a result of various rulings by this Court (the sentences n . 268 of 2017, No. 107 of 2012, No. 423 of 2000 and No. 27 of 1998) referring to pathologies dependent on the administration of non-mandatory, but recommended, vaccinations against infectious diseases other than hepatitis A.
2.– First of all, the referring court observes that a constitutionally compliant interpretation of the disputed provision, aimed at recognizing, in the present case, the right to compensation on the basis of the same principles that, on the aforementioned previous occasions, led this Court, would not be practicable to declare the same provision constitutionally illegitimate, in the part in which it did not provide for compensation, following permanent impairments deriving from other and specific vaccination practices, not mandatory but recommended. This would be prevented, both by the wording of the provision, and - in the case in question - by the impossibility of recognizing, in the regional recommendations in favor of hepatitis A vaccination, "administrative acts of substantial imposition of an obligation". Indeed, the extension to the present case of the principles already enucleated by the constitutional jurisprudence with reference to other vaccine cases would result, in the opinion of the referring party, in a "substantial non-application ope iudicis of the contested provision". Ultimately, only the acceptance of the questions raised by this Court could remedy the constitutional illegitimacy found.
The referring reasoning is correct.
Constitutional jurisprudence has repeatedly stated that the unequivocal tenor of the provision marks the boundary in which the attempt to conform interpretation must give way to the union of constitutional legitimacy (thus, in particular, judgment no.232 of 2013 and, more recently, judgments n.221 of 2019, n.83 and n.82 of 2017). On the other hand, again according to constitutional jurisprudence now constant, when the referring court has consciously considered that the content of the disputed provision imposes a certain interpretation and prevents others, possibly in conformity with the Constitution, the verification of the relative hermeneutic solutions does not concern the eligibility plan, and is rather an assessment that concerns the merit of the matter (thus, ex multis, judgments n.50 of 2020 and n.133 of 2019).
Finally, with more direct reference to today's case, the mere finding of the recommended nature of the vaccination, for which damaging consequences are sought compensation, does not allow the common courts to automatically extend to this case the albeit common ratio based on the previous ones, partial, declarations of constitutional illegitimacy of art. 1, paragraph 1, of law no. 210 of 1992 (similarly, albeit in different matters, sentence no. 110 of 2012). In fact, in the event of complications following vaccination, the right to compensation does not derive from any generic indication of prophylaxis from public authorities, to that relative vaccination, but only from specific information campaigns carried out by health authorities and aimed at health protection, not only individual, but also collective. The ascertainment in fact of the existence of recommendations regarding the use of the vaccination in question, which certainly belongs to the common judges, must therefore necessarily follow - in the context of a judgment of constitutional legitimacy - the verification, by this Court, about the correspondence of these recommendations to the particular characteristics which, according to constant constitutional jurisprudence, finalize the healthcare treatment recommended to the individual to the broadest protection of health as an interest of the community, and therefore impose an extension of the normative scope of the contested provision (sentence n . 268 of 2017).
3.– The verification in question provides a positive result and the questions are therefore well founded.
3.1.– First, the remittance order acknowledges the existence, in the Puglia Region, of an anti-hepatitis A vaccination campaign just at the time when the subject - who claimed the right to compensation - had undergone the administration of that vaccine, following, moreover, a specific convocation by the health authority.
In fact, originating in 1997 from a peculiar regional epidemic situation, the vaccination campaign, which also continued in the following years, appears to have been preceded by detailed indications of the Regional Epidemiological Observatory, and translated, exactly in the periods relevant for the judgment in question, in punctual resolutions of the Council and the Regional Council.
In particular, by resolution of 2 July 1996, the Council of the Puglia Region approved a regional program of compulsory and optional vaccinations, which included the free offer of the hepatitis A vaccine in favor of certain risk categories. In line with this program, the regional council, with resolution no. 4272 of 18 July 1996, had among other things established (on the basis of the studies of the Epidemiological Observatory mentioned) to promote a vaccination campaign against hepatitis. In particular, regarding newborns and young XNUMX-year-olds, establishing that the administration had the characteristics of gratuity and voluntariness and which was preceded and accompanied by an information program for the population.
Following these decisions, in the following years, the vaccination coverage of the population groups concerned had grown exponentially, in parallel with a decrease in the infection. Nonetheless, and always on the basis of data provided by the regional epidemiological observatory, with resolution no. 2087 of December 27, 2001, the Board, in approving the Regional Health Plan 2002-2004, had proposed the objective of "carrying out the hepatitis A vaccination program, confirming the nature of gratuity and voluntary work". At an even later stage, the regional council itself, with resolution no. 1327 of 4 September 2003, had established to provide local health structures with "operational indications" for the ongoing implementation of the vaccination coverage against the hepatitis A virus against adolescent subjects.
This, therefore, reconstructed in its essential features by the referring court, the context in which the private part of the main trial, born in 1990 and vaccinated with dual application in 2003 and 2004, had been requested to lend itself to the administration of the vaccine.
3.2.– In light of the conditions set by the jurisprudence of this Court (judgments n.268 of 2017, n.107 of 2012, n.423 of 2000 and n.27 of 1998), even in the present case there is actually presence a broad and persistent information and recommendation campaign by public health authorities, in this case regional, about the strong opportunity, for some classes of subjects, to undergo vaccination against hepatitis A.
The vaccination campaign in question was based on accurate scientific and epidemiological assumptions, which highlighted the risk of a wide spread of the hepatitis A virus, also through interpersonal infections. It, like the rest of the subsequent campaigns, therefore aimed at the objective of a suitable immune coverage of the population, to protect the health of each individual, of the subjects at risk, of the most fragile, and ultimately of the whole community.
3.3.– As we have seen, the vaccination strategy developed by the Puglia Region made use of the recommendation technique, not the obligation technique (regardless of the modalities that characterize the case in which the interested party was even summoned by the health authority to undergo vaccination). And the recommended nature of the vaccination would exclude, by virtue of the textual content of the censored art. 1, paragraph 1, of law no. 210 of 1992, the right to compensation for subjects who complain, as a consequence of the same, of irreversible injuries or infirmities.
However, as the jurisprudence of this Court has also highlighted (judgment n.268 of 2017), although the technique of the recommendation expresses greater attention to individual self-determination (or, in the case of minors, to parental responsibility) and, therefore , to the subjective profile of the fundamental right to health, protected by the first paragraph of art. 32 of the Constitution, it is always addressed in order to obtain the best protection of health as a (also) collective interest.
Without prejudice to the different approach of the two techniques, what is relevant is the essential objective that they both pursue in the prophylaxis of infectious diseases: that is, the common aim of guaranteeing and protecting collective (also) health, by achieving maximum vaccination coverage. In this perspective, focused on health as an interest (also) objective of the community, there is no qualitative difference between obligation and recommendation: the mandatory treatment of vaccination is simply one of the tools available to public health authorities for the pursuit of health protection collective, like the recommendation.
The close assimilation between compulsory and recommended vaccinations has been confirmed by this Court also in more recent judgments, in the context of judgments of constitutional legitimacy proposed mainly against regional or state laws, therefore concerning profiles partly different from those related to law to compensation, here under discussion. Nevertheless, in these same pronouncements it has been observed that "in the epistemic horizon of medical-health practice the distance between recommendation and obligation is much smaller than that which separates the two concepts in legal relations. In the medical field, recommending and prescribing are actions perceived as equally necessary in view of a specific objective "(sentence no. 5 of 2018; in the same sense, sentence no. 137 of 2019), that is, the protection of (also) collective health.
3.4.– In the presence of an effective campaign in favor of a specific vaccination treatment, it is natural that individuals should rely on what is recommended by the health authorities: and this in itself makes the individual choice to adhere to the objectively voted recommendation also to safeguard the collective interest, beyond the particular motivations that move individuals.
This Court has consequently recognized that, by virtue of Articles 2, 3 and 32 of the Constitution, the transfer to the community, favored by individual choices, of the harmful effects that they may have from them is necessary.
The reason for the individual's right to compensation does not therefore lie in the fact that he has undergone mandatory treatment: it rests, rather, on the necessary fulfillment, which is imposed on the community, of a duty of solidarity, where the negative consequences for psycho-physical integrity derive from a health treatment (mandatory or recommended that it is) carried out in the interest of the community itself, as well as in the individual one.
For this reason, the failure to provide for the right to compensation in the event of irreversible pathologies deriving from certain recommended vaccinations results in an injury to Articles 2, 3 and 32 of the Constitution: because it is the constitutionally required solidarity needs, as well as the protection of the individual's right to health, that requires the community to bear the burden of prejudice suffered by them, while it would be unfair to allow the injured individual bears the cost of the benefit, also collectively (judgments n.268 of 2017 and n.107 of 2012).
It should also be reiterated, as already on other occasions (judgments n.5 of 2018 and, again, n.268 of 2017), that the provision of the right to compensation - as a consequence of pathologies in a causal relationship with a mandatory vaccination or, with the clarifications carried out, recommended - does not derive at all from negative evaluations on the degree of medical-scientific reliability of the administration of vaccines. On the contrary, the provision of compensation completes the "solidarity pact" between the individual and the community in terms of health protection and makes any health program aimed at spreading vaccination treatments more serious and reliable, with a view to wider coverage of the population.
3.5.– Lastly, it is worth noting that, in view of a limitation of the possible recipients of the compensation (through a “targeted” acceptance pronunciation), considerations of relating to the purely regional (and not national) nature of the vaccination campaign examined, or to its being mainly addressed to a specific audience of "at risk" subjects (selected, as far as it is relevant in particular, based on age). Neither could play a role, for the purpose of a hypothetical limitation of the subjects to whom the compensation must be paid, the fact, also highlighted by the referring court, that the recommended vaccination in question, for the classes of subjects considered "at risk" ”Belongs to the free services guaranteed by the National Health Service, as it is included in the essential levels of assistance.
First, the vaccination campaign was essentially regional, but it also found various findings and correspondences in the national vaccination plans (in particular, recently, the 2017-2019 National Vaccination Prevention Plan), as well as in a specific recommendation from the Ministry of health of 26 July 2017 (containing "Update of the recommendations for prevention and immunoprophylaxis in relation to the epidemic of Hepatitis A"), acts which prescind and disregard specific territorial references.
Secondly, the fact that an information and recommendation campaign in favor of a given vaccine addresses directly to subjects considered "at risk" (by age, habits, geographic location) has no consequences, for the purposes relevant here.
On the one hand, in fact, what matters, however, is the trust that the individual, whoever he is (subject to risk or not), places in the recommendation of the health authorities, and it is also from this point of view that they must the fundamentals of indemnity protection be outlined.
On the other hand, this Court (judgment no.268 of 2017) has already observed that, although directly addressed to certain categories of subjects, information and awareness campaigns aimed at vaccination coverage inevitably involve the general population, regardless of a previous and specific individual condition of health, age, work, behavior: since the application of the treatment, even if originally designed above all for certain classes of subjects, always allows to protect both individual and wider health collectivity, hindering the contagion of subjects not included in the risk categories and thus contributing to the protection of all, including those who, although being specifically subject to the risk, cannot resort to vaccination due to their specific health condition . Ultimately, the position of subjects at risk does not in any way invalidate the collective importance that the protection of health - also implemented through the mere recommendation of certain vaccination practices - also assumes towards the general population.
Thirdly, and finally, not even the fact that the recommendation is accompanied by the free of charge administration (as happened in the present case, for the hepatitis A vaccine) could not establish any subjective limitation of the number of recipients of the compensation.
Moreover, the question of whether financial constraints can justify limitations of the number of subjects to whom vaccination, as included in the essential levels of assistance (as is the case for the hepatitis A vaccine), can be administered free of charge, certainly those constraints are not justify any exemption from the indemnity obligation, in the presence of the conditions established by law.
Ultimately, the logic of a "targeted" reception (by category of subjects or by portion of the territory), as well as contrasting with the scientific basis of vaccination (which is found as a tool for health protection in the most widespread immune coverage), would result to conflict with the very logic of indemnity protection, which pays at the expense of "everyone" for damage suffered in the interest of "everyone", falsifying the same premises as the recommendation: to the extent that the vaccine choice of the belonging to a category at risk degrades , or of the resident in a given area of the territory, at the choice of voluntary vaccination (even if in the hypothesis indispensable for his health), without direct social consequences, to whom a constitutionally imposed protection should not then be granted, but, at most, a discretionary subsidy (judgments No. 55 of 2019, No. 293 of 2011, No. 342 of 1996, No. 226 of 2000).
4.– In light of all the considerations made, art. 1, paragraph 1, of law no. 210 of 1992 must be declared constitutionally illegitimate in the part in which it does not provide for the right to compensation, under the conditions and in the ways established by the same law, in favor of anyone who has suffered injuries or infirmities, from which a permanent impairment of psychic integrity is derived -physics, due to vaccination against hepatitis A virus.