Review article
Compulsory or recommended vaccination: Dimensions from the legal perspective
Vacunación obligatoria o recomendada: acotaciones desde el Derecho
C. Cierco Seira
Área de Derecho Administrativo, Universidad de Lleida, Lleida, Spain
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Cierco Seira" "autores" => array:1 [ 0 => array:3 [ "nombre" => "C." "apellidos" => "Cierco Seira" "email" => array:1 [ 0 => "cesar.cierco@udl.cat" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Área de Derecho Administrativo, Universidad de Lleida, Lleida, Spain" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Vacunación obligatoria o recomendada: acotaciones desde el Derecho" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">The importance of regulating vaccination without succumbing to simple disjunctives</span><p id="par0005" class="elsevierStylePara elsevierViewall">Vaccination is suffering the consequences of three aberrations that, unfortunately, have taken over thought and analysis about more than a few matters in our time: over-simplification, disinformation and Manichaeism. If we refer specifically to Spain, it is true that questioning vaccination is neither a major tendency here nor one that has much impact. This does not mean that it can be ignored or even less that we can lower our guard against what is occurring abroad. The World Health Organisation has expressed serious concern about the backward step in vaccination in many parts of the world, including developed countries which until recently enjoyed optimum vaccination rates. Some countries as close to Spain as France and Italy have also experienced serious difficulties in this field, and these problems are more than sufficient reasons for thought. On the other hand, it is also a fact that signs of the influence of certain anti-vaccination currents of thought and positions have emerged here. It is even more worrying that signs of weakness in the social image of vaccines and in citizen trust of systematic vaccination programs are emerging. Anti-vaccine phenomena and above all vaccine-hesitance are not therefore new to us.</p><p id="par0010" class="elsevierStylePara elsevierViewall">The real influence <span class="elsevierStyleItalic">hic et nunc</span> of anti-vaccination currents cannot therefore be ignored. It is also necessary to pay attention to certain social indicators which emerge from sociological studies on citizens’ opinions of vaccination. For example, the European Commission report in the <span class="elsevierStyleItalic">Special Eurobarometer 488 on Europeans’ attitudes towards vaccination</span> (March–April 2019)<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">1</span></a> found that although the vast majority of Spaniards vaccinate, we feel a certain degree of insecurity about the meaning and efficacy of vaccination. A surprising finding here is that only 8 per cent of those surveyed believe the health authorities are the most reliable source of information about vaccination. Although findings like this are striking, they do not show anything that is really new. Other previous studies had already indicated the presence of a certain distrust and feeling of a lack of information among citizens. The <span class="elsevierStyleItalic">Medical Barometer</span> (2016) of the Sociological Research Centre or the <span class="elsevierStyleItalic">Survey of Social Perception of Science</span> (2018) by the Spanish Foundation for Science and Technology contain relevant findings here.<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">2,3</span></a> Among other specific points about how our vaccination system is perceived, these documents warn that even though vaccination rates in Spain are within an optimum band, a significant percentage of the vaccinated population visited the doctor because of advice by their paediatrician or other medical professional rather than any deep conviction. This, <span class="elsevierStyleItalic">grosso modo</span>, could be described as “inertia”, and it largely depends on the trustworthy image of medical services and professionals regarding their quality and competence, respectively. Thus even though the current model is not in danger of losing momentum, there are clouds on the horizon. This is why it is highly important to deliberate and try to detect the inputs about vaccination citizens receive, together with their resulting patterns of behaviour. We also have to accept that the success of our model is currently based on the strength of the public health service and the commitment and work of medical professionals. That is the positive side; the negative side is that these professionals are heavily burdened with work and generally have very little time to spend on persuasion and finding new ways of combating disinformation.</p><p id="par0015" class="elsevierStylePara elsevierViewall">It would be very hard to regulate vaccinations by simply drawing a line. The search for answers to the challenges arising from planning and implementing a modern vaccination program demands subtle solutions and a complex mechanism with many parts. These have to be arranged precisely, so that it balance the interests involved. Likewise, it is fundamental that the legal debate about the role of the law and how it will function in this unique context takes place without artificial distractions, distortions and even disinformation arising from over simplification, falsehoods and Manichaeism above all.</p><p id="par0020" class="elsevierStylePara elsevierViewall">I believe that one of these distortions may arise when selecting a vaccination model is presented as the choice between two opposing possibilities: obligatory vaccination <span class="elsevierStyleItalic">versus</span> recommended vaccination. I will try to refute this disjunctive argument by defending two ideas:</p><p id="par0025" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Firstly</span>: that substantially less separates obligatory and recommended vaccination systems than is usually supposed or assumed. However, to see this it will be necessary to go into the details of the regulation, placing it in context and comparing it with practice.</p><p id="par0030" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">Secondly</span>: the legal coverage of vaccination, <span class="elsevierStyleItalic">i.e.</span>, its regulation, which aims to be complete, is necessary in both models, even though the system is based on the voluntary adherence of citizens.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">The obligatory and recommended vaccination systems have the same purpose, and there is a risk of rushed evaluation of the harshness and clarity of these strategies</span><p id="par0035" class="elsevierStylePara elsevierViewall">The first idea leads us to consider the existence of a substantial similarity between obligatory and recommended vaccination systems. This similarity is based on their purpose, which in both cases is fight disease by creating widespread individual immunity and the resulting herd immunity. There is therefore no essential difference between the obligatory and recommended vaccination systems in terms of their aim.</p><p id="par0040" class="elsevierStylePara elsevierViewall">The difference between obligation and recommendation therefore consists, and this should be underlined as many times as may be necessary, of an <span class="elsevierStyleItalic">instrumental choice</span> of how best to achieve a single aim. It is the strategy that changes: some people may believe it is better to ensure widespread vaccination by establishing a legal duty which applies equally to all citizens; nevertheless, other may consider it preferable to trust their voluntary actions, based on their good educational level and the convincing information they have received on the individual, social and mutual benefits of vaccination. It is true that from a theoretical viewpoint and thinking of the public health ideal and deepest sense of human rights, achievements attained by voluntary collaboration are better. That is so. However, it is important to remember that this premise does not invalidate the legitimacy of the obligatory alternative. The latter fits equally well within the parameters of public health science and respect for human rights.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Obligatory vaccination is based on a long and solid legal history. The duty to vaccinate has been accepted by many constitutional guarantees, and it is still accepted as valid. There is therefore a solid jurisprudential <span class="elsevierStyleItalic">corpus</span> which supports the restriction of individual rights in favour of systematic vaccination programs. This jurisprudential corpus has deep roots. The historical United States’ Supreme Court cases of <span class="elsevierStyleItalic">Jacobson vs. Massachusetts</span> (1905) and <span class="elsevierStyleItalic">Zucht vs. King</span> (1922) are usually mentioned here. Nevertheless, I insist, that the constitutional validity of the duty to vaccinate has been supported in many states and not only in the past, but also in recent times.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">4</span></a> Thus to return to the European continent and our own times, decisions by the Constitutional Court of the Czech Republic (27 January 2015) can be cited, together with others by France (20 March 2015); Serbia (26 October 2017); Italy (18 January 2018); or Moldavia (30 October 2018).<span class="elsevierStyleSup">a</span></p><p id="par0050" class="elsevierStylePara elsevierViewall">These systems basically consist of a selection of strategy, so it is clear that they will depend on the circumstances of each time and place. This means that although one system or the other may be defended more strongly in conceptual terms, both should be taken into account given that one of them will eventually be used.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">5</span></a> Discourse that is hostile to obligatory vaccination usually refers to the experience of countries which achieve excellent rates of coverage without needing to create a duty. Spain is usually included among these countries. The aim of this is to question whether obligation is excessive, given that gentler means are equally effective and proven in preserving herd immunity. Although this argument is solid in theory, it is less consistent in practice. And practical circumstances are, as has been underlined here, extremely important in vaccination. Thus obligatory vaccination has to be judged in the light of the policy of each country, in the light of its own circumstances. This requires knowledge of the current epidemiological situation as well as the social image of vaccination, together with the capacity of the public health service. The same requirements apply when evaluating the success of a system based on recommendation. Not everything can be attributed to the supposedly ideal adhesion of citizens to the cause of collective immunisation. Perhaps everything can be explained by the quality and trustworthiness of the medical system and the training of the medical professionals who work in it.</p><p id="par0055" class="elsevierStylePara elsevierViewall">I therefore do not agree that either model should be categorically rejected. Rather than this, I believe that rather than seeing them as antagonists, pragmatism should lead to their being considered complementary, thereby leaving the door open to gradual approaches and hybrid formulas.</p><p id="par0060" class="elsevierStylePara elsevierViewall">The option of recommended vaccination cannot radically annul the need to use obligatory vaccination. This is because a health emergency may occur which requires a forceful response – vaccination <span class="elsevierStyleItalic">extra ordinem</span>, and it is also advisable to have a “plan B” in case recommendation proves unable to maintain optimum vaccination rates—<span class="elsevierStyleItalic">ratione temporis</span>—or has to be reinforced—<span class="elsevierStyleItalic">ratione materiae</span> for certain diseases, or—<span class="elsevierStyleItalic">ratione personae</span> for certain groups or professionals. The history of vaccination policy in France has left us the following valuable reflections on this point. In January 2016 the French Minister of Health implemented an action plan to renew vaccination policy. One of the core requirements of this plan was the identification of why the social image of vaccination had deteriorated in France. To this end the <span class="elsevierStyleItalic">Comité d’orientation de la concertation citoyenne sur la vaccination</span> was created, resulting in the <span class="elsevierStyleItalic">Rapport sur la vaccination</span>, of 30 November 2016.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">5</span></a> This report concluded that it was advisable to emphasise obligatory vaccination for a certain time, supported by a highly ambitious vaccination plan and with an exemption clause due to personal convictions; this would be an intermediate step before reaching the ideal vaccination scenario, based on voluntary social compliance.</p><p id="par0065" class="elsevierStylePara elsevierViewall">In the same way, the option of obligatory vaccination cannot stand alone, without education and information to stimulate voluntary compliance with the duty of vaccination. The reaction to incompliance will not be simple to manage, so that simply invoking a legal mandate for a goal which requires the mass obedience of citizens will not ensure a serene and clear outcome. Italy is like France a European country that is important in this field. The difficulties that it has undergone in recent years perfectly illustrate the above point. In 2017 these difficulties led to the adoption of an obligatory vaccination system, even though it came with a multitude of conditions to make it less harsh and reduce conflict. Thus for example, if incompliance were detected then the first response was to call the parents or tutors for a “colloquio al fine di fornire ulteriori informazioni sulle vaccinazioni e di sollecitarne l’effettuazione”; the desire to persuade was therefore not completely eliminated by the fact of obligation<span class="elsevierStyleSup">b</span>.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">6</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">It must not therefore be forgotten that between these two hypothetical poles there is a rich range of intermediate colours and eclectic options, <span class="elsevierStyleItalic">i.e.</span>, that it is possible to simultaneously combine obligation and recommendation, most of all while taking into account the fact that the current catalogue of vaccines is plural and heterogeneous.</p><p id="par0075" class="elsevierStylePara elsevierViewall">On the other hand, the strategies of obligation or recommendation do not always take the same form. There is no single model of obligatory vaccination in the world, and nor is there one for recommended vaccination. There are no predefined patterns to be selected for use as if they books in a library. A simple glance at Comparative Law is enough to see that the labels of obligatory or recommended vaccination each cover a very wide range of options.</p><p id="par0080" class="elsevierStylePara elsevierViewall">The specific nature of the strategy in each case therefore has to be examined without preconceptions. I will start by looking at one of the most widespread of the latter: the one that takes it for granted that obligation is a <span class="elsevierStyleItalic">harsher</span> option than recommendation.</p><p id="par0085" class="elsevierStylePara elsevierViewall">The fact is that it isn’t always so. Depending on the form it takes, obligation may in fact be a milder option than recommendation. I shall try to explain this.</p><p id="par0090" class="elsevierStylePara elsevierViewall">The legal duty to vaccinate yourself represents, <span class="elsevierStyleItalic">in abstracto</span>, a harsher option because it imposes a restriction on the exercise of basic rights – and this connects with the ethical viewpoint, too.<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">7</span></a> What happens is that, depending on the specific form that it takes, its degree of rigour may be wide ranging and therefore condition each individual's freedom in a very different way. This may be seen in two aspects.</p><p id="par0095" class="elsevierStylePara elsevierViewall">Firstly: the consequences of incompliance. The response to a personal failure to obey the duty to vaccinate often involves punishment rather than compulsion. The harshness of the system will therefore ultimately depend on the nature and configuration of the said penal or administrative punishment and its content. If it consists of the payment of a small fine, for example, it is clear that freedom may be affected, <span class="elsevierStyleItalic">in concreto</span>, very slightly, given that its impact will depend on the economic capacity of the individual in question. We can add a second aspect to this: the legal duty to vaccinate yourself is sometimes accompanied by a series of exception or exemptions that may take many forms. When this occurs, the harshness of the duty will also depend on the breadth of the exempting condition: if, for example, it is possible to object to vaccination due to personal convictions, this largely overcomes the initial severity. The actual degree of interest in persecuting incompliance should therefore not be forgotten. The degree of leniency demanded in compliance with the duty to vaccinate has to be taken into account, given that there may be a gap between what the regulations state and the tolerance displayed by the authorities respecting incompliance, especially when community coverage rates are not at stake. Due to all of these considerations, the comparative study of obligatory vaccination systems around the world has shown that there is no single universal model. Rather than this, there are major differences in their design, which in turn lead to the appearance of a “harshness scale”. An interesting essay which attempts to isolate elements or signs of harshness and thereby classify obligatory systems may be seen in MacDonald et al.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">8</span></a></p><p id="par0100" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleItalic">A priori</span>, on the other hand, recommended vaccination systems are considered to be softer options. Nevertheless, it may happen that recommendation is incentivised by stimuli such as family aid, and that access to this aid is an economically important reason that determines the behaviour of the whole population or those with fewer resources. Could it be said that the impossibility of accessing aid amounting to <span class="elsevierStyleItalic">x</span> Euros is a softer option than having to pay a penalty of <span class="elsevierStyleItalic">y</span> Euros? It is evident that the answer will depend on the amounts involved in <span class="elsevierStyleItalic">x</span> and <span class="elsevierStyleItalic">y</span>.</p><p id="par0105" class="elsevierStylePara elsevierViewall">The severity of the obligation is not the only preconception. Another common assumption refers to <span class="elsevierStyleItalic">clarity</span>. It is taken for granted that the obligatory model will offer a board showing beforehand how all of the different pieces can move; this makes it easy for everyone to behave as they wish because the rules of the game are clear. This is not the case with the recommendation model, as it inherently permits a wide range of citizen reactions, hindering the offer of uniform responses and guidelines.</p><p id="par0110" class="elsevierStylePara elsevierViewall">I agree that lack of definition is the Achilles heel of recommendation.<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">8</span></a> The fact is that we lack a doctrinal definition of this figure and how it fits in the different ways the administration can act: what does it mean to “recommend”? How is recommendation applicable? Are all recommendations the same, or can they be classified according to their intensity? What responsibilities would derive from making an incorrect recommendation? Or responsibilities due to not obeying a recommendation when it leads to preventable harm? There are many questions such as these, with no clear answer in legal terms. Due to all of these considerations, it seems to me that the legal duty of vaccination is, in itself, a synonym of <span class="elsevierStyleItalic">lex certa</span>.</p><p id="par0115" class="elsevierStylePara elsevierViewall">It should therefore be pointed out that countries which we often include in the obligatory model lack a clause of direct obligation; this is deduced indirectly from the prerequisites which make vaccination a condition <span class="elsevierStyleItalic">sine qua non</span> for access to public or community services. And not only this. It has already been said that the legal duty to vaccinate may be accompanied by some type of exception that moderates or curbs the obligation. This may be based on ideological or religious reasons: I leave exception for medical reasons to one side, as these connect <span class="elsevierStyleItalic">in via recta</span> with human dignity and are therefore indispensible. These exceptions involve the need to adjust the scope of obligation and adjust the seriousness of the purpose to how it is put into practice, which, it has to be said, may cause friction and eventually become a source of uncertainties.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">The juridification of vaccination as a complex and multiple act, over and above obligation and/or recommendation</span><p id="par0120" class="elsevierStylePara elsevierViewall">The second idea which supports my opinion is that the difference between obligatory and recommended vaccination systems does not consist of the advisable “amount” of law.</p><p id="par0125" class="elsevierStylePara elsevierViewall">There is a quite widespread idea that the obligatory system will by definition be one that is severely and deeply governed by law. Contrasting with this, the recommendation system will be less formally controlled and will be less legal. I disagree, as I pointed out above, with this formulation.</p><p id="par0130" class="elsevierStylePara elsevierViewall">It is true that acceptance of the advisability of the law is simpler to assimilate when it is obligatory. When a legal duty to vaccinate is established this constitutes a restriction on freedom, and this may only occur due to a law, according to the classical doctrine of fundamental rights. As this is so, and given the need for legislators to act, it is naturally accepted that the corresponding legal text, as well as establishing the duty to vaccinate, also regulates other types of associated questions. These questions may include the preparation of the vaccination calendar or compensation for vaccination prejudice. Due to this, countries with an obligatory vaccination system usually have more detailed regulations governing the same. We could say that the hypothesis of freedom as an area protected from the law may tend to facilitate the juridification of vaccination through the inertia of the need to compose a legal text.</p><p id="par0135" class="elsevierStylePara elsevierViewall">Things are different, however, where recommendation rules. The tendency here is, on the contrary, to consider that vaccination does not need a detailed legal channel because it rests, basically, on voluntary adhesion by citizens. Juridification may even be thought to be counterproductive because it is usually considered to have a dissuasive effect, even if <span class="elsevierStyleItalic">sottovoce</span>—or because the law interferes with other non-juridical disciplines.</p><p id="par0140" class="elsevierStylePara elsevierViewall">It should be explained that, wearing jurist glasses, this discourse is based on what is unfortunately a very common distorted and stereotyped view of the law. But that is not all. Stating that recommended vaccination requires no legal attention may lead to serious dysfunctions. I will restrict myself to the five conflicts which seem to me to be the most strident.</p><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Lack of definition of the roles of the different agents in vaccination and, decidedly, of the promoter function of the health authorities</span><p id="par0145" class="elsevierStylePara elsevierViewall">Relegating the law to a secondary level hinders clarification of the roles of the different agents who intervene in vaccination. These include Civil Servants, sometimes giving rise to the impression that the state of the system should simply be looked at from outside, without interfering. In other words, that voluntary vaccination necessitates a sort of neutrality on the part of public authorities, and this is clearly and flatly false. Acceptance of the social function of community immunisation involves the public authorities adopting a position in favour of vaccination. Firstly, because vaccination requires the organisation of a public service to provide access to vaccines. This access should ideally be universal, equal and free, so that the administration should ensure that this is so in a way that defines all public services, with regularity and adaptation, removing any obstacles to equal access. Without a strong vaccination service, without free public vaccines or a body of medical professionals committed to immunisation, it would be hard for a vaccination system that was not obligatory to be successful. But that is not all. Given the social function of vaccination in preserving the general interest by preventing the spread of infectious diseases, the authorities have to promote it. Thus the authorities cannot play a passive role in recommended vaccination systems; their role is to promote and encourage public vaccination.<span class="elsevierStyleSup">c</span></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Gaps in the regulation of significant aspects of vaccination</span><p id="par0150" class="elsevierStylePara elsevierViewall">It tends to be forgotten that vaccination regulations are not solely about establishing a clause making it obligatory, or not. Many questions other than the legal obligation to vaccinate have to be answered. The risk is precisely that these other questions will be left to one side, without a clear legal framework and at the mercy of <span class="elsevierStyleItalic">Soft Law</span>, jurisprudence or, in other words, improvisation. As no formal law has to be passed to create the duty to vaccinate, there is no need to legislate for this. This opinion explains why it is that in Spain, without looking farther afield, we lack a basic legal regulation of the nature, contents and preparatory procedure for a vaccination calendar. These questions, among others, as it is easy to imagine, are not minor ones and even less so are they restricted to the obligatory system. At the end of the day, whether by obligation or agreement, it is necessary to have a vaccination calendar. It is therefore also necessary to take decisions in this respect, some as important as deciding which vaccines are to be made available,<span class="elsevierStyleSup">d</span> and, as a result of this, have to be included in the corresponding healthcare portfolio. Only if we accept the depth of vaccination in our time as a public service will we be able to gain an idea of the number of questions which will arise about its design: Which vaccines will be acquired? What procedure will be used? Who will pay for them? Which professionals will be able to administer them? Where and how? Who will record the data? And so on.</p><p id="par0155" class="elsevierStylePara elsevierViewall">Some important aspects are not expressly regulated and create vacuums that are not always filled with the help of <span class="elsevierStyleItalic">Soft Law</span> or jurisprudence. This creates areas of uncertainty and feeds certain attitudes that take advantage of disorder to attack vaccination as a whole. These attitudes centre on lack of transparency and eventual contradictions in the heart of the legal system. It is of interest to note that the de facto regulation of vaccination, if properly done, may bring about a strengthening of the institution through the effect of the principles of good government demanded now by Law when approving norms. This applies not only to those that connect with the background of the regulation – as is the case with proportionality – but also with those aspects connected with the preparatory procedure, including participation and transparency. Transparency is, simply, crucial in the management of vaccination policies. Often, countries which have experienced a crisis in the latter had suffered an episode of lesions or adverse effects, and informing the public of this had not been managed properly.<a class="elsevierStyleCrossRefs" href="#bib0120"><span class="elsevierStyleSup">9,10</span></a></p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Lack of attention to counterweights and, decidedly, the introduction of an objective system of liability for severe vaccination accidents</span><p id="par0160" class="elsevierStylePara elsevierViewall">Although positive factors are undoubtedly more important, it is indisputable that vaccination programs in general have a negative side, and this brings together a range of interests. The most visible negative side is composed of severe vaccination accidents; even though this phenomenon is extremely rare, it could hardly be eliminated from the equation: like any other medications, vaccines are not innocuous, and nor is it possible to demand that vaccination services be infallible. The fact is that when vaccination is obligatory, it is easier to understand the need to compensate for lesions of this type based on an objective sum calculated according to the redistribution of social costs. It is true that the actual form this postulate takes may admit many versions, each one with its pros and its contras. Nevertheless, objective compensation is desired in all cases as a <span class="elsevierStyleItalic">correlato naturaliter</span> for the obligation to vaccinate. Although this is so theoretically, in practice, as was shown by the recent study by Attwell et al.,<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">11</span></a> not all countries with an obligatory vaccination system have a legal regime that meets their objective responsibility.</p><p id="par0165" class="elsevierStylePara elsevierViewall">Unfortunately, the same is not true of recommendation. This is unfortunate because the reasons justifying the application of objective compensation are exactly the same: the social utility of the individual act of vaccinating is not reduced by the fact that it was voluntary. Few doubts arise in theoretical terms about whether compensation for injuries caused in the context of a systematic vaccination program should apply an objective canon of responsibility.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">12</span></a> All of the presuppositions demanded by the theory of equitable redistribution for public costs are applicable. It is also no coincidence that this situation is used as the perfect example of a situation in which the Administration is objectively liable. The work by Rodríguez Fernández is very graphic in this respect.<a class="elsevierStyleCrossRefs" href="#bib0140"><span class="elsevierStyleSup">13,14</span></a> The question is that this doctrinal agreement lacks any specific regulatory expression in Spain, so that it is currently based on jurisprudence. The leading case here is the STS of 9 October 2012 (appeal 6878/2010). As I have said in another place, this is not just any loose end; determining the compensatory regime for vaccination accidents must, in my opinion, be one of the bases of the vaccination system. It must also, due to its importance and the need for clarity (which is so important in this context) be supplied with a legal space.<a class="elsevierStyleCrossRefs" href="#bib0145"><span class="elsevierStyleSup">14,15</span></a></p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Lack of connection between the different sectors involved in vaccination</span><p id="par0170" class="elsevierStylePara elsevierViewall">The lack of a legal text which has the core purpose of regulating vaccination leads to different treatment of different aspects of the same in sectors where the vaccination variable has sufficient intrinsic weight: medication, medical professions, international health, <span class="elsevierStyleItalic">etc.</span> The risks of this dispersion may be intuited easily, although the most worrying of all lies, I believe, in the absence of a single shared concept of vaccination, the general interest they serve and the basic principles that lead to comprehension of it. However, it is possible to offer an image of vaccination that does not completely coincide in the different branches of juridical classification.</p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Slipping towards a purely regulatory approach to vaccination</span><p id="par0175" class="elsevierStylePara elsevierViewall">Given its technical and everyday nature, vaccination in Spain and many other countries has historically been considered suitable for regulation in a way that is both convenient and adaptable. This is so the degree that, in my opinion, an idea has entered that is both slippery and still present, and which does not correspond to the importance of vaccination: that it is something to be dealt with in the context of administrative regulations in the strict sense, regulations that we identify with bureaucratic matters without sufficient substance to be covered by law. The risk of this tendency is clear, and it consists of ignoring that, even in systems governed by recommendation, there are elements and processes able to cause severe disruptions and frictions with individual freedoms; all of these contingencies may only be clarified without leaving the regulatory framework in a very artificial way, and which would be improved, for this reason alone, by the presence of express legal constraints.</p><p id="par0180" class="elsevierStylePara elsevierViewall">Proof of the above is shown by what is happening with kindergartens in Spain, where children have to be certified as vaccinated to enrol. This instrumentalisation of vaccination is not being applied by means of formal legislation. At the most it is established as a regulation and, in any case, very discretely as it is not considered to be a qualified requisite that requires particular conditions, but rather just one more demand to be satisfied for enrolment. The situation in Galicia is an example. Making access to infant schools conditional on previous accreditation of being up-to-date with paediatric vaccination is based on an Order<span class="elsevierStyleSup">e</span> (which uses the following terms:</p><p id="par0185" class="elsevierStylePara elsevierViewall">“Compliance with the Galician Program of Vaccination Calendar as well as the formalisation of enrolment is indispensible for confirmation of a place. If this is not fulfilled then the application by the interested party will be rejected” (art. 12.2 <span class="elsevierStyleItalic">in fine</span>).</p><p id="par0190" class="elsevierStylePara elsevierViewall">Then it can be seen that the matter is dealt with in terms of purely procedural regulations.</p><p id="par0195" class="elsevierStylePara elsevierViewall">The result of this is that the relationship between vaccination and pre-school education – even though this is of maximum importance – is resolved in Spain in a commonplace way.</p><p id="par0200" class="elsevierStylePara elsevierViewall">I am not criticising the basis of demanding vaccination in this context. The courts, in fact, have supported this conditionality on the basis of considering that it seeks to preserve a legitimate end, which is herd immunity, together with the health of those children who are the most exposed to the risk of infection. Lastly, and without going any further, there is the sentence of the case brought against the State in Court No. 16, Barcelona, 445/2018, of 28 December, confirming the legality of the resolution of a Town Hall that had rejected the inscription of an unvaccinated child in a municipal kindergarten. It is of interest, and that is why it is described here, to check that the requisite of vaccination had been established by a Regulation of the internal Regime. The sentence does not question the range that would be necessary to set a limitation of this type.</p><p id="par0205" class="elsevierStylePara elsevierViewall">Nevertheless, I do wish to call attention to the formal side of this. It seems to me that a measure of this type is sufficiently relevant to demand a certain degree of cohesion at a national level, given that it affects the bases of vaccination and may conflict with the exercise of parental responsibilities. These arguments advise <span class="elsevierStyleItalic">interpositio legislatoris</span> without an offence.</p></span></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Conclusion</span><p id="par0210" class="elsevierStylePara elsevierViewall">After all of the above, it is not my intention to advocate the need for regulation for regulation's sake, and far less to suggest that the quality of a vaccination system is measured by the weight of its norms. However, it seems to me to be indisputable that vaccination, due to its intrinsic importance and dimensions, requires a legislative body of sufficient density to offer predictability, at the least, in cardinal questions. It is therefore advisable, I believe, to have a vaccination law that, emphasising the positive points of our recommended model and its strengths, is able to compensate for the deficits which I have just described to bolster our system against current and future threats.</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Conflict of interests</span><p id="par0215" class="elsevierStylePara elsevierViewall">The author has no conflict of interests to declare.</p><p id="par0220" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleSup">a</span> In locating the statements mentioned below I found it highly useful to consult the constitutional jurisprudence data base of the Venice Commission of the European Council.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">2</span></a></p><p id="par0225" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleSup">b</span> See art. 1.4 of the <span class="elsevierStyleItalic">Decreto-legge</span>, of 7 June 2017, n. 73, and its conversion into law, with modifications, by the Recante disposizioni urgenti in materia di prevenzione vaccinale. Legge of 31 July 2017, n. 119. A measure which, moreover, was considered positive as it justifies the rationality of the reform of the vaccination system undertaken (8.2.4 of the Sentenza Corte Costituzionale 5/2018, of 18 January).</p><p id="par0230" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleSup">c</span> Thus instead of the syntagm “voluntary vaccination”, it would be preferable to use “recommended vaccination”, which I believe is semantically more inclusive.</p><p id="par0235" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleSup">d</span> “Publificar”: in law this means having some public responsibility.</p><p id="par0240" class="elsevierStylePara elsevierViewall"><span class="elsevierStyleSup">e</span> Order of the Conselleria de Política Social of 8 March 2019, convoking and establishing the procedure for awarding places in the children's education service for boys and girls aged from 0 to 3 years old in privately owned 0–3 kindergartens for the 2019/20 school year.</p><p id="par0245" class="elsevierStylePara elsevierViewall"><a href="https://www.xunta.gal/dog/Publicados/2019/20190315/AnuncioG0425-080319-0002_es.pdf">https://www.xunta.gal/dog/Publicados/2019/20190315/AnuncioG0425-080319-0002_es.pdf</a></p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:10 [ 0 => array:3 [ "identificador" => "xres1510437" "titulo" => "Abstract" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0005" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1370090" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres1510436" "titulo" => "Resumen" "secciones" => array:1 [ 0 => array:1 [ "identificador" => "abst0010" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1370091" "titulo" => "Palabras clave" ] 4 => array:2 [ "identificador" => "sec0005" "titulo" => "The importance of regulating vaccination without succumbing to simple disjunctives" ] 5 => array:2 [ "identificador" => "sec0010" "titulo" => "The obligatory and recommended vaccination systems have the same purpose, and there is a risk of rushed evaluation of the harshness and clarity of these strategies" ] 6 => array:3 [ "identificador" => "sec0015" "titulo" => "The juridification of vaccination as a complex and multiple act, over and above obligation and/or recommendation" "secciones" => array:5 [ 0 => array:2 [ "identificador" => "sec0020" "titulo" => "Lack of definition of the roles of the different agents in vaccination and, decidedly, of the promoter function of the health authorities" ] 1 => array:2 [ "identificador" => "sec0025" "titulo" => "Gaps in the regulation of significant aspects of vaccination" ] 2 => array:2 [ "identificador" => "sec0030" "titulo" => "Lack of attention to counterweights and, decidedly, the introduction of an objective system of liability for severe vaccination accidents" ] 3 => array:2 [ "identificador" => "sec0035" "titulo" => "Lack of connection between the different sectors involved in vaccination" ] 4 => array:2 [ "identificador" => "sec0040" "titulo" => "Slipping towards a purely regulatory approach to vaccination" ] ] ] 7 => array:2 [ "identificador" => "sec0045" "titulo" => "Conclusion" ] 8 => array:2 [ "identificador" => "sec0050" "titulo" => "Conflict of interests" ] 9 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2020-02-18" "fechaAceptado" => "2020-03-19" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1370090" "palabras" => array:5 [ 0 => "Vaccination" 1 => "Mandatory vaccination" 2 => "Recommended vaccination" 3 => "Individual freedoms" 4 => "Public health" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1370091" "palabras" => array:5 [ 0 => "Vacunación" 1 => "Vacunación obligatoria" 2 => "Vacunación recomendada" 3 => "Libertades individuales" 4 => "Salud pública" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:2 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Law is intended to play a relevant role concerning vaccination. This paper defends the importance of taking into consideration the advantages of increasing the regulation of this matter. The increase in regulation, ideally through the approval of a specific vaccination act, should be made avoiding the superficiality of the treatment, going in depth of the keys, strengths and weaknesses of the different regulatory options.</p></span>" ] "es" => array:2 [ "titulo" => "Resumen" "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">El Derecho debe desempeñar un papel relevante en el hecho de la vacunación. En este trabajo se defiende la importancia de interiorizar las ventajas de densificar la juridificación de esta materia. Eso sí, dicha juridificación, idealmente mediante la aprobación de una ley de vacunación, debe llevarse a término huyendo de simplismos y apriorismos, profundizando en las claves y sopesando las fortalezas y debilidades de las distintas opciones regulatorias.</p></span>" ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Cierco Seira C. Vacunación obligatoria o recomendada: acotaciones desde el Derecho. Vacunas. 2020;21:53–59.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:15 [ 0 => array:3 [ "identificador" => "bib0080" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "European attitudes towards vaccination [Internet]" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "European Commission" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:1 [ "fecha" => "2019" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0085" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "BARÓMETRO SANITARIO (Total Oleadas) Estudio no 8816 [Internet]" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "Ministerio de Sanidad SS e ID general de SP" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:1 [ "fecha" => "2016" ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0090" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Percepción social de la Ciencia y la Tecnología 2018 [Internet]. 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