The environment and amyotrophic lateral sclerosis: converging clues from epidemiologic studies worldwide

The etiology of one of the most severe human neurological diseases, amyotrophic lateral sclerosis (ALS), remains obscure nearly 150 years after its original description by Charcot, despite substantial advancements in the biomedical research on this disease. The possibility that one or more environmental risk factors may trigger or contribute to the degenerative process of motor neurons characterizing this devastating disease remains appealing, and it is supported by a number of epidemiologic studies, though specific causative factors are yet to be confirmed. Among these, pesticides, the metalloid selenium and heavy metals, trauma, electrical shocks, magnetic fields and several other environmental factors, including infectious agents, have been associated with an excess risk of the disease, and geographical analyses appear to add support for an environmental etiology of the disease.Converging indications from different epidemiologic studies and contexts represent an important clue to the validity of etiological hypotheses. Therefore, the results of the study by Das et al. published in this issue of the Journal appear to be particularly interesting as they add further indications of an etiologic role in ALS of some putative environmental risk factors from a setting entirely different from those subject of epidemiologic studies in Western countries, and apparently never previously investigated with regard to the study hypotheses. In particular, this study, carried out in eastern India using a sound methodological approach, provides evidence of an etiologic role of pesticides (not farming per se), smoking, and electrical shock, though these results must be weighed against studies that have reported conflicting results, duly mentioned by the authors. This discrepancy underscores the need to address these etiological hypotheses in large epidemiologic studies in different geographic areas, seeking better concordance. Such effort would greatly help to confirm or refute previously identified risk factors and make them more specific, e.g., to identify the specific toxin in tobacco smoke, or single drinking water chemicals and neurotoxic pesticides to which the neurodegenerative process may be at least in part ascribed. Furthermore, this evidence should be further investigated in light of the results of genetic studies, whose contribution may be to identify factors that make some people more susceptible to environmental factors, in line with the environment-gene interplay that is currently considered to underlie most chronic disease. Although researchers have so far been unable to confirm in an unequivocal manner an environmental etiology of ALS or to identify any of its singular causes, valuable contributions, studies such as the present one by Das et al. are important to elucidate this still elusive and disturbing issue, which should be considered a primary research priority in biomedical research

Frutalose®, a mixture of fructans obtained from enzymatic hydrolysis of chicory inulin, and normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

Following an application from Sensus B.V. (Royal Cosun), submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to Frutalose® and maintenance of normal defecation. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The Panel considers that Frutalose®, a mixture of fructans obtained from enzymatic hydrolysis of chicory inulin, is sufficiently characterised. The claimed effect proposed by the applicant is ‘contributes to regular bowel function by increasing stool frequency’. The proposed target population is ‘the general healthy adult population’. Maintenance of normal defecation is a beneficial physiological effect provided that it does not result in diarrhoea. One human intervention study showed an effect of Frutalose® on the maintenance of normal defecation by increasing stool frequency and improving stool consistency (softer stools) when consumed daily at a dose of 15 g for 8 weeks. The results have not been replicated in other studies. There is a plausible mechanism by which Frutalose® could exert the claimed effect. The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of Frutalose® and maintenance of normal defecation under the proposed conditions of use

The Legal Status of General Practitioners at the dawn of the New Primary Care in Italy

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.Nella sanità italiana è in atto un vivace dibattito sulla possibile revisione dello status giuridico dei medici di medicina generale. La discussione è occasionata dagli eccezionali fondi che l’Unione europea ha attribuito all’Italia a condizione di riforme strutturali tra cui, appunto, il rinnovamento del sistema di assistenza primaria. Una delle questioni più dibattute concerne la trasformazione dei medici di medicina generale in dipendenti pubblici, ovvero la conservazione dello status di lavoratori autonomi, sebbene “parasubordinati.” Tale circostanza non è rilevante soltanto per la qualità e l’efficienza dell’assistenza primaria ma può rappresentare anche un momento per dare maggiore certezza giuridica ad una figura “ibrida” del diritto sanitario italiano. Nel contributo si conclude che, da un punto di vista giuspubblicistico e costituzionale, il rapporto di lavoro dipendente è quello che meglio si attaglia alle verosimili condizioni lavorative dei medici di medicina generale nelle Case della comunità. A livello generale, in ogni caso, è opportuno che legislatore nazionale e regionale tengano in adeguata considerazione i possibili riflessi legali e giudiziali della ridefinizione giuridica dei medici di medicina generale nel nuovo sistema di assistenza primaria italiana

Reshaping EU Legislation for Air Pollution Control: Main Features of the Proposed Directive in Comparison with the US Legislation

Nell’ottobre 2022, la Commissione Europea ha pubblicato la bozza di una nuova Direttiva volta a portare ad un processo di più efficace controllo e prevenzione dell’inquinamento atmosferico in Europa, attraverso la sintesi e l’aggiornamento della normativa precedente. Tale proposta intende ridisegnare l’attuale assetto normativo in Europa e la sua implementazione al livello degli Stati Membri, al fine di conseguire un minore inquinamento dell’area alla luce di recenti scoperte nel campo della salute ambientale e di nuove indicazioni provenienti dall’Organizzazione Mondiale della Salute. In aggiunta, la proposta di Direttiva istituisce un sistema giuridico per il controllo dell’inquinamento dell’aria che ben si integra nel più ampio contesto normativo delle iniziative del Green Deal europeo e del NextGenerationEU. Le nuove norme appaiono peraltro simili alle corrispondenti disposizioni regolamentari statunitensi nel campo del controllo dell’inquinamento atmosferico, pur essendo più rigide in termini di controllo della qualità dell’aria e più aperte ad una logica di integrazione con le autorità locali. In conclusione, la nuova proposta di Direttiva europea sembra prendere in più attenta considerazione le recenti evidenze scientifiche sugli effetti avversi dell’inquinamento dell’aria, e può costituire un efficace strumento giuridico per un’adeguata salvaguardia della salute pubblica.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

COVID-19 Compulsory Vaccination of Healthcare Workers and the Italian Constitution

In data 1° aprile 2021 il Governo italiano ha adottato il decreto-legge n. 44 con cui è stato disposto l’obbligo vaccinale anti COVID-19 per gli operatori sanitari. Nel darne notizia, i commentatori nazionali e internazionali hanno adombrato possibili controversie sulla costituzionalità del decreto. Ci si è infatti domandato se la vaccinazione obbligatoria sia compatibile con il diritto all’autodeterminazione sanitaria previsto dalla Costituzione italiana e se obblighi vaccinali che si applicano ad una sola parte della popolazione rispettino il principio di eguaglianza sancito dalla Carta. Ad entrambi i quesiti è possibile dare risposta positiva. La Costituzione italiana, pur riconoscendo l’autodeterminazione sanitaria, ammette che la legge possa prevedere misure coercitive di sanità pubblica, come si evince dal testo della Costituzione e dal suo significato originario. Inoltre, in riferimento al principio di eguaglianza, la letteratura scientifica ha da tempo dimostrato i particolari benefici derivanti dalla vaccinazione dei sanitari, che appaiono ancor più rilevanti durante una pandemia. Inoltre, la scelta governativa di sanzioni moderate per il rifiuto alla vaccinazione e la natura temporanea del regime obbligatorio appaiono conformi con l’interpretazione data al principio di eguaglianza dalla Corte costituzionale−il cosiddetto “criterio di ragionevolezza.” Ci si aspetta dunque che il decreto-legge−nel frattempo convertito con minori modifiche nella L 76 del 28 Maggio 2021−superi un possibile scrutinio di costituzionalità. Ciononostante, sarebbe utile se il governo italiano argomentasse in modo più esplicito la costituzionalità delle sue politiche in materia di vaccinazione, anche al fine di contrastare l’esitazione vaccinale.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

COVID-19 Compulsory Vaccination and the European Court of Human Rights

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

Standardisation and Authority in Judicial Discipline: a Comment on Italy and Ireland’s Experiences

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