Pub Date : 2022-03-04DOI: 10.1163/15718093-bja10063
L. Tonti
Governance is a critical upstream tool in public health emergency preparedness, for it provides structure to emergency response. Pandemics, singular public health emergencies, pose challenges to inherently fragmented federal governance systems. Understanding and utilizing the facilitators of response embedded within the system is critical. In its examination of how contemporary federal systems addressed fragmentation in the face of the Covid-19 pandemic, this article uses two mitigation measures, community masking and vaccination administration to compare elements of federal system mechanics in the United States and Germany's respective pursuits of public health goals. With particular focus on federal-state power-sharing, it analyzes the division and application of federal-state authority, therein examining mechanisms of executive expediency, as well as the cooperation of multilevel actors. Comparing the jurisdictions identifies inter-federal coordination, availability of exigency mechanisms, and federal guidance as facilitators of public health goal achievement.
{"title":"Symphony or Cacophony? Orchestrating Federal Mechanics toward Covid-19 Response in the United States and Germany.","authors":"L. Tonti","doi":"10.1163/15718093-bja10063","DOIUrl":"https://doi.org/10.1163/15718093-bja10063","url":null,"abstract":"Governance is a critical upstream tool in public health emergency preparedness, for it provides structure to emergency response. Pandemics, singular public health emergencies, pose challenges to inherently fragmented federal governance systems. Understanding and utilizing the facilitators of response embedded within the system is critical. In its examination of how contemporary federal systems addressed fragmentation in the face of the Covid-19 pandemic, this article uses two mitigation measures, community masking and vaccination administration to compare elements of federal system mechanics in the United States and Germany's respective pursuits of public health goals. With particular focus on federal-state power-sharing, it analyzes the division and application of federal-state authority, therein examining mechanisms of executive expediency, as well as the cooperation of multilevel actors. Comparing the jurisdictions identifies inter-federal coordination, availability of exigency mechanisms, and federal guidance as facilitators of public health goal achievement.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 1 1","pages":"79-102"},"PeriodicalIF":0.8,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44877163","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-04DOI: 10.1163/15718093-bja10064
M. Tumelty, M. Donnelly, A. Farrell, Clayton Ó Néill
Ireland has been a leader in the COVID-19 vaccine rollout in the EU, with almost 80% of the eligible population (aged over 5 years) fully vaccinated at the time of writing. The success of the vaccine rollout in this jurisdiction notwithstanding, the legal frameworks supporting the rollout had significant lacunas. Two aspects in particular highlighted a lack of legal preparedness: the inadequacy of the legal framework for consent and the absence of a vaccine injury redress scheme. This paper explores these components of the COVID-19 vaccine rollout through the lens of legal preparedness. Whilst most often discussed in the context of command and control measures such as social distancing requirements and regional lockdowns, this paper argues for an expanded understanding of what it means to be legally prepared, highlighting the importance of the preparedness of domestic legal frameworks.
{"title":"COVID-19 Vaccination and Legal Preparedness: Lessons from Ireland.","authors":"M. Tumelty, M. Donnelly, A. Farrell, Clayton Ó Néill","doi":"10.1163/15718093-bja10064","DOIUrl":"https://doi.org/10.1163/15718093-bja10064","url":null,"abstract":"Ireland has been a leader in the COVID-19 vaccine rollout in the EU, with almost 80% of the eligible population (aged over 5 years) fully vaccinated at the time of writing. The success of the vaccine rollout in this jurisdiction notwithstanding, the legal frameworks supporting the rollout had significant lacunas. Two aspects in particular highlighted a lack of legal preparedness: the inadequacy of the legal framework for consent and the absence of a vaccine injury redress scheme. This paper explores these components of the COVID-19 vaccine rollout through the lens of legal preparedness. Whilst most often discussed in the context of command and control measures such as social distancing requirements and regional lockdowns, this paper argues for an expanded understanding of what it means to be legally prepared, highlighting the importance of the preparedness of domestic legal frameworks.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":"1-20"},"PeriodicalIF":0.8,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44040287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-04DOI: 10.1163/15718093-bja10062
Aikaterini Tsampi, Jasper V Been, Michelle Bruijn, Brigit Toebes
The Framework Convention for Tobacco Control (FCTC) is undoubtedly the most efficient international instrument for tobacco control. Article 8 FCTC shapes many smoke-free policies worldwide and in doing so it is usually associated with smoke-free regulation in enclosed public spaces. Our paper highlights that the FCTC contains a sound foundation for smoke-free policies that stretch beyond enclosed public places, such as open public spaces and (quasi-)private spaces. We demonstrate, in particular, that such wide smoke-free regulation, which is gaining momentum around the globe, is versatile and compatible with human rights standards. As such, these expanded smoke-free policies contribute to a wider culture of smoking denormalisation that scales up FCTC's aspiration for tobacco control and subsequently to a smoke-free global society.
{"title":"Expansion of Smoke-Free Policies: Stepping Up FCTC's Game.","authors":"Aikaterini Tsampi, Jasper V Been, Michelle Bruijn, Brigit Toebes","doi":"10.1163/15718093-bja10062","DOIUrl":"10.1163/15718093-bja10062","url":null,"abstract":"<p><p>The Framework Convention for Tobacco Control (FCTC) is undoubtedly the most efficient international instrument for tobacco control. Article 8 FCTC shapes many smoke-free policies worldwide and in doing so it is usually associated with smoke-free regulation in enclosed public spaces. Our paper highlights that the FCTC contains a sound foundation for smoke-free policies that stretch beyond enclosed public places, such as open public spaces and (quasi-)private spaces. We demonstrate, in particular, that such wide smoke-free regulation, which is gaining momentum around the globe, is versatile and compatible with human rights standards. As such, these expanded smoke-free policies contribute to a wider culture of smoking denormalisation that scales up FCTC's aspiration for tobacco control and subsequently to a smoke-free global society.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":"261-274"},"PeriodicalIF":0.6,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42589986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-04DOI: 10.1163/15718093-bja10065
A. Donati
The decision of the EU Commission, based on positive advice from the European Medicines Agency, to grant conditional marketing authorisation to Covid-19 vaccines should be qualified as a precautionary measure. Under the established case law of the CJEU, the conditions for the application of this principle are met. Such conditions are the existence of a risk to the environment and public health and uncertainty. Given this qualification as a precautionary measure, whether the Commission had complied with the procedural obligations that surround the implementation of this principle under EU law was assessed. Some shortcomings are identified concerning the risk assessment conducted by the European Medicines Agency and the risk management carried out by the Commission.
{"title":"The Conditional Marketing Authorisation of Covid-19 Vaccines: A Critical Assessment under EU Law.","authors":"A. Donati","doi":"10.1163/15718093-bja10065","DOIUrl":"https://doi.org/10.1163/15718093-bja10065","url":null,"abstract":"The decision of the EU Commission, based on positive advice from the European Medicines Agency, to grant conditional marketing authorisation to Covid-19 vaccines should be qualified as a precautionary measure. Under the established case law of the CJEU, the conditions for the application of this principle are met. Such conditions are the existence of a risk to the environment and public health and uncertainty. Given this qualification as a precautionary measure, whether the Commission had complied with the procedural obligations that surround the implementation of this principle under EU law was assessed. Some shortcomings are identified concerning the risk assessment conducted by the European Medicines Agency and the risk management carried out by the Commission.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 1 1","pages":"33-52"},"PeriodicalIF":0.8,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44932864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-04DOI: 10.1163/15718093-bja10069
Irene Domenici, Franciska Engeser
This article adopts a comparative approach exploring the reactions to the scarcity of resources resulting from the Covid-19 pandemic in Italy and Germany. Both countries showed a fragmented structure including individual hospitals, medical associations and recommendatory interdisciplinary bodies, such as ethics councils. Against this background, the authors use the different constitutional frameworks in which the healthcare systems are embedded to assess the legitimacy of the intervention by non-legislative bodies. It is demonstrated that, in both jurisdictions, a certain level of parliamentary involvement in establishing triage criteria or procedures is constitutionally required, as in situations of extreme scarcity the prioritisation decision cannot be determined by a mere clinical analysis but rather demands a normative choice.
{"title":"The Institutional Tragedy of Pandemic Triage Regulation in Italy and Germany.","authors":"Irene Domenici, Franciska Engeser","doi":"10.1163/15718093-bja10069","DOIUrl":"https://doi.org/10.1163/15718093-bja10069","url":null,"abstract":"This article adopts a comparative approach exploring the reactions to the scarcity of resources resulting from the Covid-19 pandemic in Italy and Germany. Both countries showed a fragmented structure including individual hospitals, medical associations and recommendatory interdisciplinary bodies, such as ethics councils. Against this background, the authors use the different constitutional frameworks in which the healthcare systems are embedded to assess the legitimacy of the intervention by non-legislative bodies. It is demonstrated that, in both jurisdictions, a certain level of parliamentary involvement in establishing triage criteria or procedures is constitutionally required, as in situations of extreme scarcity the prioritisation decision cannot be determined by a mere clinical analysis but rather demands a normative choice.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 1 1","pages":"103-130"},"PeriodicalIF":0.8,"publicationDate":"2022-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48350808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-01DOI: 10.1163/15718093-bja10067
Sofia Palmieri, T. Goffin
The outbreak of the Covid-19 pandemic has forced States to take restrictive measures to contain the growing number of infections. Among these measures, after the approval of vaccines by the EMA, the possibility of introducing a compulsory vaccination has become a plausible and attractive prospect. In Italy, Covid-19 compulsory vaccination is implemented by a succession of Decrees concerning specific categories of workers and, only recently, a section of the population with the recent Decree of 7 January, 2022, no. 1. However, if we look back at the most critical restrictions implemented in the country, we realise that a de facto obligation was already in place before establishing a de jure obligation. The following article traces the most important profiles of the vaccination obligation implemented de jure and de facto by the Italian government.
{"title":"De Jure and De Facto: An Overview on the Italian Measures on Compulsory Vaccination.","authors":"Sofia Palmieri, T. Goffin","doi":"10.1163/15718093-bja10067","DOIUrl":"https://doi.org/10.1163/15718093-bja10067","url":null,"abstract":"The outbreak of the Covid-19 pandemic has forced States to take restrictive measures to contain the growing number of infections. Among these measures, after the approval of vaccines by the EMA, the possibility of introducing a compulsory vaccination has become a plausible and attractive prospect. In Italy, Covid-19 compulsory vaccination is implemented by a succession of Decrees concerning specific categories of workers and, only recently, a section of the population with the recent Decree of 7 January, 2022, no. 1. However, if we look back at the most critical restrictions implemented in the country, we realise that a de facto obligation was already in place before establishing a de jure obligation. The following article traces the most important profiles of the vaccination obligation implemented de jure and de facto by the Italian government.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 1 1","pages":"151-164"},"PeriodicalIF":0.8,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48789780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-03-01DOI: 10.1163/15718093-bja10066
C. Günther
There is a long-established claim that emergency action through the law is impossible, or bound to be ineffective. This article seeks to challenge this position by reference to the response of many European states to the Coronavirus pandemic and by drawing on Lon Fuller's theory of law. It argues that there are a number of reasons why a fragmentation of governance between ordinary, legal action and emergency, extra-legal action is neither necessary nor desirable in this specific context. In societies that are generally rule of law compliant governance according to formal legal principles is not only constraining, it also possesses the quality of a 'liberating limitation', creating the room for effective, sustainable action. Too little has been made of this positive dimension of the legal form as an instrument for emergency action.
{"title":"Legal vs. Extra-Legal Responses to Public Health Emergencies.","authors":"C. Günther","doi":"10.1163/15718093-bja10066","DOIUrl":"https://doi.org/10.1163/15718093-bja10066","url":null,"abstract":"There is a long-established claim that emergency action through the law is impossible, or bound to be ineffective. This article seeks to challenge this position by reference to the response of many European states to the Coronavirus pandemic and by drawing on Lon Fuller's theory of law. It argues that there are a number of reasons why a fragmentation of governance between ordinary, legal action and emergency, extra-legal action is neither necessary nor desirable in this specific context. In societies that are generally rule of law compliant governance according to formal legal principles is not only constraining, it also possesses the quality of a 'liberating limitation', creating the room for effective, sustainable action. Too little has been made of this positive dimension of the legal form as an instrument for emergency action.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"29 1 1","pages":"131-149"},"PeriodicalIF":0.8,"publicationDate":"2022-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47255421","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-28DOI: 10.1163/15718093-bja10060
Federico Forni
In the Pharma Expressz judgment (case C-178/20) the Court of Justice clarified which conditions a Member State can impose to the import of a medicinal product not having a marketing authorisation in the national territory. The Court pointed out that a medicine not authorised in a Member State can entry in that Member State only in accordance with Article 5(1) of Directive 2001/83/EC on medicinal products for human use. Moreover, according to the Court a national measure requiring a medical prescription and a declaration from the competent national health authority is justified to protect public health although the product can be dispensed in another Member State without a medical prescription. After an overview on the development of pharmaceutical law in the EU, the contribution analyses this judgment in which the Court balanced the Treaty rules on the free movement of goods with the need to protect human health.
{"title":"Free Movement of Medicines and Protection of Public Health.","authors":"Federico Forni","doi":"10.1163/15718093-bja10060","DOIUrl":"https://doi.org/10.1163/15718093-bja10060","url":null,"abstract":"In the Pharma Expressz judgment (case C-178/20) the Court of Justice clarified which conditions a Member State can impose to the import of a medicinal product not having a marketing authorisation in the national territory. The Court pointed out that a medicine not authorised in a Member State can entry in that Member State only in accordance with Article 5(1) of Directive 2001/83/EC on medicinal products for human use. Moreover, according to the Court a national measure requiring a medical prescription and a declaration from the competent national health authority is justified to protect public health although the product can be dispensed in another Member State without a medical prescription. After an overview on the development of pharmaceutical law in the EU, the contribution analyses this judgment in which the Court balanced the Treaty rules on the free movement of goods with the need to protect human health.","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":"1-23"},"PeriodicalIF":0.8,"publicationDate":"2022-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46928534","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-02-22DOI: 10.1163/15718093-bja10068
Markus Frischhut
{"title":"Von der Pflicht: Eine Betrachtung, written by Richard David Precht.","authors":"Markus Frischhut","doi":"10.1163/15718093-bja10068","DOIUrl":"https://doi.org/10.1163/15718093-bja10068","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":"1-5"},"PeriodicalIF":0.8,"publicationDate":"2022-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46163541","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-01-11DOI: 10.1163/15718093-12423546
{"title":"The Legislator Must Take Effective Measures Ensuring that Persons with Disabilities Are Protected in Triage Situations Caused by the Pandemic","authors":"","doi":"10.1163/15718093-12423546","DOIUrl":"https://doi.org/10.1163/15718093-12423546","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"1 1","pages":""},"PeriodicalIF":0.8,"publicationDate":"2022-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41895376","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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