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Silvio Roberto VINCETI

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Dipartimento di Giurisprudenza
CULTORE DELLA MATERIA
Dipartimento di Giurisprudenza

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Pubblicazioni

2024 - Fluoride and caries prevention: a scoping review of public health policies [Articolo su rivista]
Veneri, Federica; Vinceti, Silvio Roberto; Filippini, Tommaso
abstract

Background: Dental caries is the most common infectious disease, affecting approximately 60 to 90% of the world population, especially young children, and disadvantaged communities. Due to the extremely high prevalence and the significant negative impact on general health, well-being, and quality of life it is considered a global public health problem. Despite the improvement of policies to promote oral health care in the past decades, dental caries is still a healthcare challenge, characterized by increasing disparities among different social groups between and within countries. Fluoride-based prevention of dental caries is a cost-effective approach, that has been implemented since 1940's. It includes systemic and topical administrations, through community-based or individual programs. Preventive interventions should be tailored to individual and community caries risk assessment and estimate of cumulative fluoride intake, in order to maximize the preventive effect and avoid the risk of potential adverse effects associated with excessive fluoride exposure. Regulation of public health policies plays a major role in this context. Study design: Scoping review. Methods: The aim of this scoping review was to report an overview of current guidelines regarding fluoride-based preventive strategies for dental caries and relevant policies on the matter, as well as to address current issues related to public health aspects of dental caries prevention. We searched for the relevant literature on the matter, focusing on policy documents, such as recommendations, position papers and guidelines, issued from the major scientific and regulatory institutions involved in oral health promotion and on publications concerning relevant aspects of public health law. Results: Prevention of dental caries through fluoride can rely on topical fluorides for home-use (toothpastes and mouthrinses), professionally applied topical fluorides (gels, varnishes, silver diamine fluoride, fluoride-releasing restorative materials and sealants), fluoride supplements (tablets and drops), and community-based strategies (community water fluoridation, fluoridated salt and milk). Current relevant guidelines for all these preventive aids are outlined in the paper. A significantly greater preventive effect of topical fluorides has been widely established in the recent past, as compared to systemic effects. Furthermore, increasing concerns have emerged on potential adverse effects on general health associated with early and excessive systemic exposure to fluoride, especially for children, supported by recent meta-analyses. Also, community water fluoridation has raised significant aspects of relevance for health law and policies. In a public health perspective, healthcare policymakers should tackle social iniquities by promoting information and oral health literacy, through community and school-based programs, ensuring access to early dental visits and basic dental care and improving availability and affordability of fluoride topical products. Conclusions: Fluoride-based prevention can provide a simple and cost-effective approach to reduce the incidence of dental caries and the associated social burden. Among fluoride-based preventive strategies, systemic community-based administration of fluoride should be considered with great caution, due to the unfavorable risk-benefit ratio currently established. Topical fluoridated products are generally preferred, given the optimal risk-benefit ratio. Further efforts must be made to identify and tackle the barriers to dental caries prevention and related social iniquities from a public health perspective. Policies and laws on oral health should promote access to caries prevention with targeted comprehensive strategies.

2024 - Il pubblico ministero negli Stati Uniti: Una figura ancora in cerca di identità [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

With its almost unfettered discretion and different legal regimesbetween state and federal levels, the American prosecutor strikes as a peculiar institution in the realm of comparative public law. While discretion in charging is regarded as the main source for the prosecutor’s enormous power, other legal dimensions, such as the disciplinary regime, play a significant role: comparative inquiries should thus acknowledge the broader legal framework when contrasting foreign prosecutors with American ones. Moreover, the uncertainty as to the constitutional identity of the American prosecutor and the role it is supposed to fulfill points to a question of great comparative interest: the nature of the prosecutorial function and its place in the separation of powers.

2024 - Water fluoridation between public health and public law: an assessment of regulations across countries and their preventive medicine implications [Articolo su rivista]
Vinceti, Silvio Roberto; Veneri, Federica; Filippini, Tommaso
abstract

Background: Among health professionals and health policymakers concern is growing as to the difficulty of balancing the prevention of dental caries through cost-effective interventions and the need to limit unnecessary exposure of the population, and especially children, to environmental chemicals. In this respect, the use of water fluoridation to prevent tooth decay epitomizes the dilemma by raising questions relevant to both public health and public law, ranging from the balance of public health and medical selfdetermination, the division of powers between local or national authorities over water fluoridation, and the need to avoid the adverse effects of socioeconomic inequalities as well as both under- and over-exposure. Study design: We carried out a narrative review by searching the relevant literature about the laws and rules related to drinking water fluoridation at the community level in the US, UK, and Europe, in order to discuss how the issue is handled from both a public health and public law perspective. Methods: Sources of data for this review were the biomedical and legal literature retrieved by searching online databases, and websites of public health and legal institutions. Results and conclusions: We found that water fluoridation is still largely adopted throughout the US, while in the UK and particularly in the European Union only a minor part of the population is subject to it. In addition, the recommended and maximum allowed amounts of fluoride in drinking water are being adapted to the public health recommendations and the new regulations, within an evolving evaluation of the epidemiologic evidence and the risk assessment currently in progress by two major regulatory agencies, the US National Toxicology Program - NTP and the European Food Safety Authority - EFSA. Under a comparative public law perspective, the three investigated legislations are facing a reassessment of their policies and regulations, to allow for effective and safe public health measures in the field of water fluoridation and more generally for a preferred use of topical fluoride for caries.

2023 - Cronaca ragionata del convegno “La Missione Salute del PNRR: Idee ed esperienze per la riforma” (Università degli Studi di Roma “La Sapienza”, Facoltà di Economia, 5 maggio 2023) e stato delle questioni [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

2023 - Gli incerti confini della materia “tutela della salute” [Nota a Sentenza]
Vinceti, Silvio Roberto
abstract

The Italian Constitutional Court upheld the constitutionality of a statute providing aid measures for oncologic patients adopted by a region subjected to a repayment plan, by claiming that the measures pertained “to the social sector and the social life of individuals”, rather than to healthcare. By doing so, however, the Court problematically shrank the conceptual magnitude of the right to health.

2023 - L’applicazione della condizionalità europea agli ordinamenti giudiziari: Un formante efficace per la definizione di un modello unitario di magistratura? [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

The application of conditionality schemes to the organization of national judiciaries of Member States marks a momentous step in the process of European judicial integration. While still fraught with potential issues, the conditionality mechanism seems to avoid some of the limitations afflicting the legal formant that to this day brought the most changes to Europe’s very different judiciaries: the European Courtof Justice’s case law. Using the ordinary treaty revision procedure as a benchmark for European integration, the Essay argues that the use of conditional funding outweighs case law both in harmonizing ability and political legitimation

2023 - Magistrati e social media: una riflessione alla luce dell’esperienza statunitense [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

With converging indications portending a policy intervention on the use of social media by judges in Italy, a review of foreign experiences appears of evident importance to the enactment of an overall convincing regulation on the subject. By distinguishing between the more restrictive and liberal approaches adopted in the United States — which, for different reasons, constitute the prime regulatory framework in the comparative landscape — the study outlines the key legal issues in the judges’ use of social media. Furthermore, the essay articulates a reflection on two competing accounts of the constitutional interests bearing on the policy question, which in turn foreshadow contrasting understandings of the role of judges in contemporary constitutional democracies.

2023 - Nella salvaguardia costituzionale dell’autorizzazione alla realizzazione di strutture sociosanitarie un’occasione di riconciliazione tra tutela della salute e concorrenza [Nota a Sentenza]
Vinceti, Silvio Roberto
abstract

Although the rationale may have been better grounded in article 117, § 3, of the Italian Constitution and the referral order’s limitations thwarted the scrutiny of possible inconsistencies of Italian health law with European regulations, the Constitutional Court decision no. 74/2023 vividly proves that healthcare provision and competition policy can indeed be reconciled

2023 - Reorganizing Italy’s Territorial Healthcare: the Ministerial Decree No. 77/2022 and its Comparative Significance [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

As approved by the European Commission in 2021, Italy’s National Recovery and Resilience Plan encompasses a far-reaching reform in the governance and structure of the national health service (NHS) that should shift the focus of assistance from large, centralized hospitals to a tight network of numerous smaller health centers dislocated in the country. In this respect, the adoption of the Ministerial Decree no. 77 on May 23, 2022, represented a key step in the execution of the intended reform, to the extent that the Decree set forth the main terms of the primary care reorganization process. This review summarizes the key elements of the Decree, foreshadows its legal and public health implications, acknowledges the uncertainties about the economic feasibility of the reform, and highlights its possible comparative significance for health systems facing similar challenges, especially those — such as the UK NHS — that share a comparable type of funding system and organizational framework.

2023 - Reshaping EU Legislation for Air Pollution Control: Main Features of the Proposed Directive in Comparison with the US Legislation [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

In October 2022, the European Commission released a draft of a new Directive aimed at securing more effective control and prevention of outdoor air pollution in Europe through the recasting and update of previous European legislation. The proposal is intended to reshape the current regulations in the field within the EU and its implementation at the Member State level and achieve lower air pollution in light of the recent advancements in environmental health and novel indications in the field from the World Health Organization. In addition, the proposed Directive provides a legal framework for air pollution control that falls within the wider legal context of the EU Green Deal and NextGenerationEU initiatives. The new rules are also remarkably consistent with corresponding and updated US regulations, though stricter in terms of air pollution control and more open to interactions with local authorities. In sum, the proposed EU Directive appears to take better stock of the emerging scientific evidence on the adverse effects of air pollution and may provide an effective legal instrument for adequate public health protection.

2023 - Sciopero dei magistrati e costituzioni: L’esperienza italiana in prospettiva comparata [Monografia/Trattato scientifico]
Vinceti, Silvio Roberto
abstract

The lawfulness of judicial strikes represents a “vexata quaestio” of Italian public law that has increasingly come into focus also within comparative public scholarship. The present study offers for the first time a comparison between the discussion over the constitutionality of judicial strikes in Italy— from the dispute in the Constituent Assembly to the ensuing heated controversy — and corresponding debates in other legal systems, thus highlighting the striking convergence in some argumentative lines while reaffirming the conspicuous uniqueness of the Italian experience.

2022 - COVID-19 Compulsory Vaccination of Healthcare Workers and the Italian Constitution [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

On April 1, 2021, the Italian Government issued the Decree Law no. 44 establishing COVID-19 compulsory vaccination for healthcare workers. In covering the news, national and international commentators have foreshadowed controversy over its constitutional status. In fact, it seems sensible to wonder if mandatory vaccination is consistent with the right to medical self-determination in the Italian Constitution, and if vaccine mandates that exclusively apply to a specific part of the population can be squared with its Equality Principle. As it happens, both answers are in the affirmative. On the one hand, the Italian Constitution acknowledges medical self-determination, but it explicitly admits of public health coercive measures, as both the text of the Constitution and its original understanding make abundantly clear. On the other, as to the Equality Principle, the scientific literature has long attested to the unique benefits of vaccinating healthcare workers, which seem all the more appropriate amidst a pandemic. Moreover, the government’s choice of moderate penalties for vaccine refusal and the temporary nature of the mandatory regime further agree with the Italian Constitutional Court’s interpretation of the Equality Principle - the so-called “Reasonableness Criterion.” The Decree Law – meanwhile become, with minor modifications, Law 76 of May 28 2021 - is thus expected to pass foreseeable judicial review. However, it would be beneficial if the Italian government more vocally advocated the constitutionality of its vaccination policies in a general effort to contrast vaccine hesitancy.

2022 - La mobilità sanitaria interregionale in Italia alla luce della teoria federalista e delle esperienze comparate [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

Patient mobility between Italian regions appears a clear instance of “foot voting”, as the phenomenon has been recently recast and discussed within the legal strand of the theory of federalism. When interpreted in this way, however, the Italian legal framework for patient mobility is not only instrumental to already well-known constitutional functions but also conducive to the oft-neglected principle of democratic accountability of the national health system. Moreover, from a comparative standpoint, the Italian experience of patient mobility emerges as a quite unique phenomenon: this circumstance thus calls for a strong engagement of Italian public law scholarship in shaping a new European common framework. For different reasons, in fact, the desirable establishment of a European Health Union will likely lead to a surge in interstate health mobility.

2022 - La responsabilità disciplinare del magistrato in Irlanda. Spunti sul dibattito italiano a margine dell’istituzione del Consiglio di giustizia irlandese [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

With the adoption of the Guidelines concerning Judicial Conduct and Ethics in February of 2022, the new system of judicial discipline established by the 2019 Judicial Council Act came into full force in Ireland. The establishment of a Judicial Conduct Committee and the new procedure for disciplining judges mark a shift from a rather informal system where the most salient provision was the constitutional procedure for the parliamentary removal of a judge. At the same time, the new framework contains elements of continuity with Ireland’s informal tradition in judicial discipline, since the definition of judicial standards of conduct does not seem to amount to an instance of genuine standardization. By comparing Ireland and Italy’s systems for judicial discipline, the Essay aims at demonstrating that standardization is a less momentous policy in combating judicial misconduct than the fine-tuned allocation of authority over judicial discipline. Moreover, it is further contended that, while a parliamentary power to remove misbehaving judges seems at variance with Italy’s constitutional tradition and recent political developments, the complaints procedure of the Judicial Council Act could beneficially be transplanted into the Italian legal framework.

2022 - Leveraging artificial intelligence to advance the understanding of chemical neurotoxicity [Articolo su rivista]
Aschner, M.; Mesnage, R.; Docea, A. O.; Paoliello, M. M. B.; Tsatsakis, A.; Giannakakis, G.; Papadakis, G. Z.; Vinceti, S. R.; Santamaria, A.; Skalny, A. V.; Tinkov, A. A.
abstract

Neurotoxicology is a specialty that aims to understand and explain the impact of chemicals, xenobiotics and physical conditions on nervous system function throughout the life span. Herein, we point to the need for integration of novel translational bioinformatics and chemo-informatics approaches, such as machine learning (ML) and artificial intelligence (AI) to the discipline. Specifically, we advance the notion that AI and ML will be helpful in identifying neurotoxic signatures, provide reliable data in predicting neurotoxicity in the context of genetic variability, and improve the understanding of neurotoxic outcomes associated with exposures to mixtures, to name a few.

2022 - L’accreditamento istituzionale tra vincoli costituzionali e integrazione europea [Nota a Sentenza]
Vinceti, Silvio Roberto
abstract

In framing the context of the Italian Constitutional Court’s decision to strike down a clause limiting the autonomy of the private provider of health services on behalf of the public health system, the Note outlines two alternative argumentations that would have allowed a stricter interpretation of the division of powers and enhanced the role of competition in healthcare.

2022 - Revising the legislation of Ethics Committees to ease biomedical research in humans across the world: lessons from the COVID-19 emergency [Articolo su rivista]
Vinceti, Silvio Roberto; Filippini, Tommaso
abstract

: As a legislative domain that considerably influences implementation of biomedical research, the need to improve the legal rules surrounding the organization and functioning of Ethics Committees in public health, toxicology, and clinical medicine is widely recognized within and outside the European Union. Given the often-heard complaints by researchers about the complexity and length of both the application and the review process by Ethics Committees in the authorization of new studies, adjustments to their legislation appears to be warranted. Within the European Union this seems also all the timelier, given the upcoming new regulation of clinical trials to become effective in early 2022. For this process, valuable lessons can be gleaned from the COVID-19 pandemic and the changes in the functioning of Ethics Committees that were adopted to cope with the exceptional circumstances imposed by the health emergency. The pandemic experience clearly indicates that a more responsive and practical system of applications' review by the Ethics Committees can be squared with acceptable levels of transparency and reliability in ethical accountability. For this reason, countries like Italy should consider undertaking a significant revision of the public law rules that govern the review processes of Ethics Committees in light of the pandemic experience. (www.actabiomedica.it).

2022 - Standardisation and Authority in Judicial Discipline: a Comment on Italy and Ireland’s Experiences [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

The legislative description of types of judicial misbehaviour and the allocation of authority over cases of alleged misconduct are two of the main features characterizing systems of judicial discipline. While sometimes judicial misbehaviour is only very vaguely defined in the law, in ‘standardised’ systems specific and concrete disciplinary offences are listed by statute. At the same time, legal systems diverge also in allocating authority over judicial discipline, as different constitutional arrangements of the power to remove judges demonstrate. By comparing Ireland’s and Italy’s experiences, the Comment argues that standardisation plays a comparatively less important role in contrasting judicial misconduct than the fine-tuned allocation of authority and, particularly, of the power of judicial removal.

2022 - The role of statistical significance testing in public law and health risk assessment [Articolo su rivista]
Filippini, Tommaso; Vinceti, Silvio Roberto
abstract

Following a fundamental statement made in 2016 by the American Statistical Associations and broad and consistent changes in data analysis and interpretation methodology in public health and other sciences, statistical significance/null hypothesis testing is being increasingly criticized and abandoned in the reporting and interpretation of the results of biomedical research. This shift in favor of a more comprehensive and non-dichotomous approach in the assessment of causal relationships may have a major impact on human health risk assessment. It is interesting to see, however, that authoritative opinions by the Supreme Court of the United States and European regulatory agencies have somehow anticipated this tide of criticism of statistical significance testing, thus providing additional support to its demise. Current methodological evidence further warrants abandonment of this approach in both the biomedical and public law contexts, in favor of a more comprehensive and flexible method of assessing exposures of toxicological interest to human and environmental health.

2021 - Abstract Clauses and the Descriptive Limits of Originalism: Embracing Legal Realism [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

There seems to be an intuitive distinction between the concrete and abstract clauses of the U.S. Constitution: If concrete clauses–such as Article II’s requirement that the U.S. President be at least thirty-five years of age–appear fairly uncontroversial as to their meaning and reference, abstract clauses–such as the Eighth Amendment’s prohibition of “cruel and unusual punishments”–show a more vague and debatable content. In the Article, I argue that the peculiar modality of legal change abstract clauses undergo thwarts a complete understanding of the U.S. Constitution in originalist terms. I take up Dworkin’s “moral reading” originalism and Bork’s “orthodox” one as two archetypal reconstructions of the framers’ intent in regard to abstract clauses. Despite substantial differences, both a Borkean and Dworkinian originalism share a commitment to a formal understanding of abstract clauses. For different reasons, however, they both fail in providing a sound account of abstract clauses’ change over time: If Dworkin’s account seems at variance with the rationale of a rigid constitution, a Borkean conception of abstract clauses, although interpretatively sound, appears at odds with reality. From the failure of the two reconstructions, I deduce several conclusions. First, that the best way to make sense of the abstract clauses’ change is to give up any formalist account thereof: Abstract clauses give rise to a plain instance of informal legal change, the reason for that possibly being that formalism is in competition with other human values–namely, the desirability of the outcomes. In that abstract clauses do not comport with formalism, an originalist account thereof is not descriptively accurate. But if abstract clauses do not abide by formal legal reasoning, the lawyer might wonder how to deal with them–especially, when faced in court. I contend that philosophy of language could hardly be of any help, despite the fact that abstract clauses recall the vagaries in reference “indexicals” bring about in analytic philosophy. Conversely, the employment of disciplines that study human behavior in different normative domains might prove decisive. If these reflections wound up agreeable, the validity of the insights of American legal realism would be reaffirmed. On the one hand, constitutional law is, to some extent, “legally indeterminate”; on the other, empirical social sciences–not armchair philosophy–are our best ally in addressing the indeterminacy.

2021 - COVID-19 Compulsory Vaccination and the European Court of Human Rights [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

Between August and September 2021, the European Court of Human Rights rejected three re-quests for interim measures against France and Greece’s compulsory vaccination statutes against COVID-19. Due to the procedural nature of the interim measures, however, the status of vaccine mandates against SARS-CoV-2 under the European Convention of Human Rights has not been addressed. The paper argues that COVID-19 compulsory vaccination is consistent with both the text and the original understanding of Article 8 of the Convention. Moreover, considering pertinent case law on medical mandatory treatments, COVID-19 vaccine mandates should also square with the European Court of Human Right’s “living instrument” doc-trine. For this reason, it is expected that the European Court of Human rights will uphold COVID-19 vacci-nation programs. At the same time, it would be beneficial if more Council of Europe member states triggered Article 15 derogation mechanism in order to make an even stronger case for fast-track developed vaccines and contrast vaccine hesitancy.

2021 - Federalismo e originalismo: Il duplice verso della relazione tra interpretazione costituzionale e riparto di competenze nel diritto statunitense (con una nota sul criterio storico-normativo) [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

There exists a two-way relation between originalism and federalism. While originalism brings renewed objectivity to the interpretation of the division of powers in the American Constitution, the practice of federalism reveals some limitations in the originalist approach. The article examines this two-way relation and eventually emphasizes the interesting similarity between originalism and the «historical-normative criterion» of constitutional interpretation in Italy

2021 - Italian National Recovery and Resilience Plan: a Healthcare Renaissance after the COVID-19 crisis? [Articolo su rivista]
Filippini, Tommaso; Vinceti, Silvio Roberto
abstract

: Proposed for the first time by European Commission in May 2020, the "NextGenerationEU" (NGEU) program is the European Union's most important effort to address key issues relating to public health and healthcare, digital and technological innovation, climate change, sustainable mobility, and key sociocultural aspects. In addition, the NGEU represents a response to the COVID-19 crisis through an extremely powerful financial intervention (over 800 billion euros). Italy is one of the main recipients of the NGEU plan's resources with almost 200 billion euros received in grants and loans. Implementation of the NGEU in Italy will take place through the National Recovery and Resilience Plan (NRRP). The NRRP not only describes how the NGEU resources will be used, but it singles out crucial public law reforms in national legislation and organization. Unsurprisingly, public health intervention represents a major component of the NRRP. Here we summarize and discuss the rules, regulations and perspective envisaged by the NRRP to foster effective healthcare and to reshape the Italian National Health System through the redesigning of primary care, enhanced communication between hospital and community healthcare, and stronger implementation of digital technologies in public health. (www.actabiomedica.it).

2021 - La clausola necessaria e propria: flessibilità e garanzia del federalismo statunitense e ruolo della dottrina [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

In addition to being a cornerstone of American constitutional law, the Necessary and Proper Clause is considered the archetype of modern “flexibilization clauses” in several constitutions’ division of power between the central authority and member units. While they have been historically construed in an extensive and centralizing fashion, flexibilization clauses also display a “safeguarding role” for local governments. Through a review of the Necessary and Proper clause’s interpretation in American constitutional law, the Article emphasizes the role of legal scholarship in protecting the safeguarding role of flexibilization clauses.

2021 - La costituzionalità della psicologia di base: Una pronuncia “regionalista” con interessanti profili di diritto comparato [Nota a Sentenza]
Vinceti, Silvio Roberto
abstract

In upholding the Campania Region’s primary care psychology service, the Italian Constitutional Court avoids the imposition of new limits to the concurrent competence on «health protection». At the same time, the decision validates regional legislation that is set to align Italian health law to comparative experiences on the integration of mental health into primary care.

2021 - Public health and public law issues for the toxicological risk assessment of chemical mixtures [Articolo su rivista]
Vinceti, Silvio Roberto; Filippini, Tommaso
abstract

Humans are simultaneously exposed to a near-infinite number of substances of both nutritional and toxicological interest. While traditional risk assessment has been based on the evaluation of effects of single substances, real-life exposure is characterized by their combination into chemical mixtures. As consequence, the need to focus on substance interactions is of considerable relevance. From the public health point of view, factors able to modulate the kinetic and toxicity of chemicals need to be included in the assessment of health effects. Several European projects including SOLUTIONS, EuroMix, ECD-MixRisk and HBM4EU have been implemented aiming at the characterization of hazardous properties of chemical mixtures and the development of new approaches and tools for their risk assessment, including advanced statistical methodologies. From the public law point of view, the legislative status of mixtures is outlined in a still general way, with a specific focus on a few substances only, e.g. dietary exposure to pesticide residues. Although some advances have been made with the ongoing revision of CLP Regulation specifically focusing also on chemical mixtures, identification of mixtures and the regulation of their use raise relevant and challenging issues to be timely addressed within a collaboration of specialists from toxicology, public health, and public law. Moreover, given the transnational scope of the problem, risk assessment of chemical mixtures presents a valuable occasion for a comparative law approach.

2021 - The Legal Status of General Practitioners at the dawn of the New Primary Care in Italy [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

Abstract: A debate is developing in Italy on the reform of the employment status of general practitioners. The dispute was prompted by the extraordinary resources the European Union has allocated to Italy on the condition of several structural reforms, among which lies the renewal of the primary care system. One of the most debated questions is whether general practitioners should become civil servants or remain autonomous workers. The issue is not only relevant to the quality and efficiency of primary care but is propitious for improving the legal certainty of this "hybrid figure" in Italian health law. The commentary suggests that, from a public law point of view, the employment status of civil servants better agrees with the foreseeable conditions of general practitioners working in Community Houses. In any case, national and regional policymakers must take into consideration possible controversies and litigation arising from an inappropriate qualification of the legal status of general practitioners in building the new system of Italian primary care.

2021 - Towards the dismissal of null hypothesis/statistical significance testing in public health, public law and toxicology [Articolo su rivista]
Vinceti, Silvio Roberto; Filippini, Tommaso
abstract

Null hypothesis significance testing (NHST) text was once widely popular and almost systematically used for the identification of causal relations and for risk assessment in toxicology and medicine. Interestingly, the public law world has been more prudent and more advanced than the biomedical one in the use of this dichotomous approach, based on the conventional p-value cut-points of 0.05/0.001, to assess causality. The recent 2016 statement by the American Statistical Association, the joint action by methodologists in all fields of science, and not least the seminal decisions by the US Supreme Court have highlighted the pitfalls of the dichotomous approach embedded in NHST. Overall, they also indicated the need to entirely dismiss NHST when assessing causal relations, favoring instead a more flexible and adequate approach for data analysis and interpretation. The demise of statistical significance testing would have major beneficial implications for risk assessment in toxicology, public health, and human medicine, alongside important public law implications. It could also lead to a reanalysis and re-interpretation of previous studies and bodies of evidence that may have been inaccurately assessed due to the flaws inherent in NHST.

2021 - Updating the European Union's regulation on classification, labelling and packaging of substances and mixtures (CLP): A key opportunity for consumers, workers and stakeholders with interests in the legislation and toxicology of hazardous chemicals [Articolo su rivista]
Vinceti, S. R.; Docea, A. O.; Tsitsimpikou, C.; Filippini, T.
abstract

Recent advancements in toxicology and the European Union's Green Deal, with its Chemicals Strategy for Sustainability, have paved the way for major changes in EU legislation on the control of environmental chemicals for a cleaner and safer environment. Another substantial legislative advancement underway is the update of the “Regulation on Classification, Labelling and Packaging of Substances and Mixtures (CLP),” an ambitious piece of EU legislation with exceptional scientific toxicological background in identifying a hazard, aiming at better protecting its citizens and the environment from the risk of chemical substances and products, the occupational settings included. Update of CLP legislation additionally aims at facilitating the free exchange of chemicals in the European Internal Market, provided that proper labelling and packaging processes are implemented. Participation in the ongoing online public consultation on these issues, ending on November 15, 2021, is of key relevance to ensure a transparent and effective definition of such an important piece of legislation, fully compliant with current EU priorities in terms of human and environmental protection and animal welfare.

2020 - L’originalista: l’interpretazione costituzionale nel pensiero e nella vita di Robert Bork [Articolo su rivista]
Vinceti, Silvio Roberto
abstract

For the seminal contribution to originalist constitutional interpretation and the controversies surrounding his failed confirmation at the United States Supreme Court, Robert Bork has left a lasting mark on American constitutional history. The purpose of this study is to describe Bork’s career as a public servant, outline the key concepts of his jurisprudence and contribution to originalism, and understand the implications of his legacy on American legal culture.