The Product Liability Directive,1 which was adopted more than thirty-five years ago, deals with liability for defective products and is one of the most important European Union (EU) legal acts in the field of consumer protection law. Similarly, it is one of the rare EU legal acts that deals with fundamental issues of civil law such as liability for the damage caused.2 Despite the fact that the Directive has been in in force for almost four decades, it has been subject only to one amendment in 1994. This amendment dealt with the legal definition of the term “product”, which led to revised wording of Article 2 in addition to the amendment of Article 15.3 The Directive has been interpreted several times by the Court of Justice of the European Union (CJEU), especially based on preliminary rulings commencing with the CJEU’s judgment in Veedfald of 10 May 2001.4 One of the most significant aspects for the application of the Directive concerns the differentiation between a service and the medium (being a movable) through which that service is provided.5 Resolution of this issue determines whether damage caused by that service is also covered by the Directive (there is a common ground that the damage caused by the medium itself falls within the scope of the Directive). This issue recently came before the CJEU in Case C-65/20 Krone – advice published in a newspaper was followed by a consumer, who suffered harm as a result. The question referred to the CJEU by the national court concerned whether this claim for damages arising from “defective” newspaper advice (ie a health service provided
{"title":"Newspaper Advice That Causes Damage Is Not Covered by the Product Liability Directive: The Court of Justice of the European Union’s Clarification in Krone","authors":"V. Mantrov","doi":"10.1017/err.2023.11","DOIUrl":"https://doi.org/10.1017/err.2023.11","url":null,"abstract":"The Product Liability Directive,1 which was adopted more than thirty-five years ago, deals with liability for defective products and is one of the most important European Union (EU) legal acts in the field of consumer protection law. Similarly, it is one of the rare EU legal acts that deals with fundamental issues of civil law such as liability for the damage caused.2 Despite the fact that the Directive has been in in force for almost four decades, it has been subject only to one amendment in 1994. This amendment dealt with the legal definition of the term “product”, which led to revised wording of Article 2 in addition to the amendment of Article 15.3 The Directive has been interpreted several times by the Court of Justice of the European Union (CJEU), especially based on preliminary rulings commencing with the CJEU’s judgment in Veedfald of 10 May 2001.4 One of the most significant aspects for the application of the Directive concerns the differentiation between a service and the medium (being a movable) through which that service is provided.5 Resolution of this issue determines whether damage caused by that service is also covered by the Directive (there is a common ground that the damage caused by the medium itself falls within the scope of the Directive). This issue recently came before the CJEU in Case C-65/20 Krone – advice published in a newspaper was followed by a consumer, who suffered harm as a result. The question referred to the CJEU by the national court concerned whether this claim for damages arising from “defective” newspaper advice (ie a health service provided","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":"14 1","pages":"416 - 421"},"PeriodicalIF":2.9,"publicationDate":"2023-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47470188","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}
Abstract What is the value of including vulnerable people in risk regulation decision-making in the European Union (EU)? This article examines a distinctive approach employed by the European Medicines Agency (EMA): public hearings integrated within safety reviews of medicinal products. The article presents findings from a case study of the EMA’s public hearing on Quinolone antibiotics, which was included by the EMA as part of a review process that led to significant tightening of regulatory restrictions on the prescribing of this class of antibiotics. The article argues that the public hearing enabled a group of patients who had been victims of a debilitating toxicity syndrome associated with Quinolone antibiotics to criticise the existing scientific evidence base around the safety of Quinolone. Deploying the quantitative Discourse Quality Index and an interpretive analytical approach, the article shows how patients challenged the evidence base in a manner that was efficacious in advancing knowledge in this area of risk regulation. When physically staged alongside interventions by professional experts, the article argues that patients facilitated a process of “negotiation” of expertise, leading professional representatives to propose methods of coordination in order to integrate the patients’ qualitative evidence of their suffering with the toxicity syndrome. Ultimately, this process led to the EMA proposing more stringent future guidelines for the prescription of Quinolone antibiotics in the EU.
{"title":"Enhancing Vulnerable Groups’ Participation in Medicines Risk Regulation: The Case of the European Medicines Agency’s Public Hearing on Quinolone Antibiotics","authors":"Matthew Wood","doi":"10.1017/err.2023.10","DOIUrl":"https://doi.org/10.1017/err.2023.10","url":null,"abstract":"Abstract What is the value of including vulnerable people in risk regulation decision-making in the European Union (EU)? This article examines a distinctive approach employed by the European Medicines Agency (EMA): public hearings integrated within safety reviews of medicinal products. The article presents findings from a case study of the EMA’s public hearing on Quinolone antibiotics, which was included by the EMA as part of a review process that led to significant tightening of regulatory restrictions on the prescribing of this class of antibiotics. The article argues that the public hearing enabled a group of patients who had been victims of a debilitating toxicity syndrome associated with Quinolone antibiotics to criticise the existing scientific evidence base around the safety of Quinolone. Deploying the quantitative Discourse Quality Index and an interpretive analytical approach, the article shows how patients challenged the evidence base in a manner that was efficacious in advancing knowledge in this area of risk regulation. When physically staged alongside interventions by professional experts, the article argues that patients facilitated a process of “negotiation” of expertise, leading professional representatives to propose methods of coordination in order to integrate the patients’ qualitative evidence of their suffering with the toxicity syndrome. Ultimately, this process led to the EMA proposing more stringent future guidelines for the prescription of Quinolone antibiotics in the EU.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":"14 1","pages":"332 - 350"},"PeriodicalIF":2.9,"publicationDate":"2023-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48776595","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}
Abstract Stakeholder participation is an important tenet for European Union (EU) policymaking and it can be approached from different disciplinary angles. The legal literature tends to refer to participation as a formal consultative opportunity in regulatory processes, resulting in rather homogeneous institutional arrangements for participation across policy fields and different sets of problems. Sustainability science, on the other hand, starts from the understanding of a problem in its complexity and peculiarities as a driving force determining both the rationale behind and the design of each participatory process. In this paper, we explore lessons regarding participation that could be derived from adopting an approach in which we combine insights from law and sustainability science. Along four principles, we explore potential leverage points for improving the sustainability of EU decision-making processes and their outcomes.
{"title":"Lessons for Participation from an Interdisciplinary Law and Sustainability Science Approach: The Reform of the Sustainable Use of Pesticides Directive","authors":"Annalisa Volpato, A. Offermans","doi":"10.1017/err.2023.9","DOIUrl":"https://doi.org/10.1017/err.2023.9","url":null,"abstract":"Abstract Stakeholder participation is an important tenet for European Union (EU) policymaking and it can be approached from different disciplinary angles. The legal literature tends to refer to participation as a formal consultative opportunity in regulatory processes, resulting in rather homogeneous institutional arrangements for participation across policy fields and different sets of problems. Sustainability science, on the other hand, starts from the understanding of a problem in its complexity and peculiarities as a driving force determining both the rationale behind and the design of each participatory process. In this paper, we explore lessons regarding participation that could be derived from adopting an approach in which we combine insights from law and sustainability science. Along four principles, we explore potential leverage points for improving the sustainability of EU decision-making processes and their outcomes.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":"14 1","pages":"253 - 270"},"PeriodicalIF":2.9,"publicationDate":"2023-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46361523","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}
Due to its severity, the COVID-19 pandemic is one of the greatest crises to have tested the European Union’s (EU) ability to take effective action. The restrictive measures adopted by the Member States to curb its spread affected in particular the free movement of people and partly of goods. This prompted the EU to take action inter alia to maintain essential travel, protect supply chains, enhance contact tracing and facilitate the coordinated resumption of travel. Building on the notion of “output legitimacy”, this paper assesses the EU’s success in responding to the COVID-19 pandemic in transport by looking at the four main initiatives between the end of 2020 and June 2022, namely: (1) the EU Digital COVID Certificates; (2) cross-border contact tracing through Passenger Locator Forms; (3) the “Green Lanes” for freight transport; and (4) the coordinated approach to facilitating safe and free movement. These initiatives are measured against the EU’s legal competence, economic interests, political pressure and the added value of EU action. While recognising the small set of cases, the results show that, although legal competence is a decisive factor for success, EU initiatives can achieve equivalent effect even in its absence, provided other conditions are met.
{"title":"The Good, the Bad and the Rest: How the European Union Responded to the COVID-19 Pandemic in the Transport Sector","authors":"P. Settembri, R. Kumar","doi":"10.1017/err.2023.7","DOIUrl":"https://doi.org/10.1017/err.2023.7","url":null,"abstract":"\u0000 Due to its severity, the COVID-19 pandemic is one of the greatest crises to have tested the European Union’s (EU) ability to take effective action. The restrictive measures adopted by the Member States to curb its spread affected in particular the free movement of people and partly of goods. This prompted the EU to take action inter alia to maintain essential travel, protect supply chains, enhance contact tracing and facilitate the coordinated resumption of travel. Building on the notion of “output legitimacy”, this paper assesses the EU’s success in responding to the COVID-19 pandemic in transport by looking at the four main initiatives between the end of 2020 and June 2022, namely: (1) the EU Digital COVID Certificates; (2) cross-border contact tracing through Passenger Locator Forms; (3) the “Green Lanes” for freight transport; and (4) the coordinated approach to facilitating safe and free movement. These initiatives are measured against the EU’s legal competence, economic interests, political pressure and the added value of EU action. While recognising the small set of cases, the results show that, although legal competence is a decisive factor for success, EU initiatives can achieve equivalent effect even in its absence, provided other conditions are met.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44691588","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}
No matter how good a smart device may be, it remains useless outside the context of a digital ecosystem. Internet of Things (IoT) environments are possible as long as services and products can interconnect smoothly and exchange data in real time. Therefore, interoperability ranks high in global policy agendas, with the promise of bringing an end to network effects slanted in favour of ecosystem orchestrators. However, recent regulatory initiatives introducing interoperability obligations risk falling short of their intent or even risk generating unintended consequences in the absence of a coherent approach to standardisation. Against this backdrop, focusing on the UK Open Banking experience, this article makes a proposal for workable interoperability in IoT ecosystems aimed at ensuring market contestability without undermining incentives to innovate.
{"title":"Shaping Interoperability for the Internet of Things: The Case for Ecosystem-Tailored Standardisation","authors":"G. Colangelo, O. Borgogno","doi":"10.1017/err.2023.8","DOIUrl":"https://doi.org/10.1017/err.2023.8","url":null,"abstract":"\u0000 No matter how good a smart device may be, it remains useless outside the context of a digital ecosystem. Internet of Things (IoT) environments are possible as long as services and products can interconnect smoothly and exchange data in real time. Therefore, interoperability ranks high in global policy agendas, with the promise of bringing an end to network effects slanted in favour of ecosystem orchestrators. However, recent regulatory initiatives introducing interoperability obligations risk falling short of their intent or even risk generating unintended consequences in the absence of a coherent approach to standardisation. Against this backdrop, focusing on the UK Open Banking experience, this article makes a proposal for workable interoperability in IoT ecosystems aimed at ensuring market contestability without undermining incentives to innovate.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46121527","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}
{"title":"Breaking Away: How to Regain Control Over Our Data, Privacy, and Autonomy by Maurice E. Stucke, Oxford, Oxford University Press, 2022, 275 pp.","authors":"Shania Ann Kirk","doi":"10.1017/err.2023.6","DOIUrl":"https://doi.org/10.1017/err.2023.6","url":null,"abstract":"","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41498054","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}
The precautionary principle is a cornerstone of environmental regulation, which has taken full effect at the European level. It is a pillar of European Union (EU) actions in environmental affairs, as described in Article 191(2) and (3) TFEU, and it forms the very fabric of environmental law and governance. In this context, Donati ’ s book is a deep dive into the structure and operationalisation of the precautionary principle in EU law. Her excellent contribution to the field of EU environmental law, especially regarding the relationship between law and science in the design and application of the precautionary principle by EU institutions, is needed and timely. Her analysis is sharp, exhaustive and well-written. In this book review, I explain the arguments that underpin the book, as well as its structure and theoretical framework, before concluding on the merits of the work as a whole. Firstly, Donati specifically dissects the role and use of “ experts ” in the assessment of uncertain risks contained in specific behaviours (Chapters 3 and 4). She strongly argues that the strict separation between decision-makers and scientists that was once thought of as the better model did not survive the test of time. In relation to the mad cow disease crisis in the 1990s, she notes that “ all barriers between science and politics seem to have been blurred ” (p. 143). She then shows the ways in which such barriers have been blurred in a very compelling manner. Indeed, the assumption that science can provide certain and neutral answers causes a range of problems, as it is an incorrect conception of how scientific development actually occurs (p. 150). However, such an erroneous conception then allowed for a lack of regulation of the relationships between experts and policy- and decision-makers and a lack of rules concerning the independence of experts and of their financing. Thisdiscussion is crucial to understanding environmental decision-making, as it is
{"title":"Le principe de précaution en droit de l’Union Européene by Alessandra Donati, Brussels, Bruylant, 2021, 396 pp.","authors":"Justine Bendel","doi":"10.1017/err.2023.5","DOIUrl":"https://doi.org/10.1017/err.2023.5","url":null,"abstract":"The precautionary principle is a cornerstone of environmental regulation, which has taken full effect at the European level. It is a pillar of European Union (EU) actions in environmental affairs, as described in Article 191(2) and (3) TFEU, and it forms the very fabric of environmental law and governance. In this context, Donati ’ s book is a deep dive into the structure and operationalisation of the precautionary principle in EU law. Her excellent contribution to the field of EU environmental law, especially regarding the relationship between law and science in the design and application of the precautionary principle by EU institutions, is needed and timely. Her analysis is sharp, exhaustive and well-written. In this book review, I explain the arguments that underpin the book, as well as its structure and theoretical framework, before concluding on the merits of the work as a whole. Firstly, Donati specifically dissects the role and use of “ experts ” in the assessment of uncertain risks contained in specific behaviours (Chapters 3 and 4). She strongly argues that the strict separation between decision-makers and scientists that was once thought of as the better model did not survive the test of time. In relation to the mad cow disease crisis in the 1990s, she notes that “ all barriers between science and politics seem to have been blurred ” (p. 143). She then shows the ways in which such barriers have been blurred in a very compelling manner. Indeed, the assumption that science can provide certain and neutral answers causes a range of problems, as it is an incorrect conception of how scientific development actually occurs (p. 150). However, such an erroneous conception then allowed for a lack of regulation of the relationships between experts and policy- and decision-makers and a lack of rules concerning the independence of experts and of their financing. Thisdiscussion is crucial to understanding environmental decision-making, as it is","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":"14 1","pages":"422 - 424"},"PeriodicalIF":2.9,"publicationDate":"2023-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47968756","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}
Abstract Climate change emergency requires rapide and determined action. The procrastination of the French state is not without consequences. One of them is that the High Administrative Court (Conseil d'Etat) found that climate risk is not taken seriously enough and is insufficiently addressed. In two decisions ruled in 2020 and 2021, the Conseil d'Etat in France had the opportunity to express itself on these issues. This is the case known as “Grande Synthe”, referring to the city that filed the petition before the High Court, in an appeal for “exces de pouvoir” –exces of power -, asking the administration to take further action in the fight against climate change. Civil society in France is indeed becoming impatient and taking legal action challenging the lack of ambition of the State in climate matters. The decision commented here will no doubt serve as a model for other similar decisions and for other European countries. It will lead to an increase of climate litigation in France and abroad.
{"title":"Climate Change Risk and Climate Justice in France: The High Administrative Court as Janus or Prometheus?","authors":"Marta Torre-Schaub","doi":"10.1017/err.2023.2","DOIUrl":"https://doi.org/10.1017/err.2023.2","url":null,"abstract":"Abstract Climate change emergency requires rapide and determined action. The procrastination of the French state is not without consequences. One of them is that the High Administrative Court (Conseil d'Etat) found that climate risk is not taken seriously enough and is insufficiently addressed. In two decisions ruled in 2020 and 2021, the Conseil d'Etat in France had the opportunity to express itself on these issues. This is the case known as “Grande Synthe”, referring to the city that filed the petition before the High Court, in an appeal for “exces de pouvoir” –exces of power -, asking the administration to take further action in the fight against climate change. Civil society in France is indeed becoming impatient and taking legal action challenging the lack of ambition of the State in climate matters. The decision commented here will no doubt serve as a model for other similar decisions and for other European countries. It will lead to an increase of climate litigation in France and abroad.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":"14 1","pages":"213 - 227"},"PeriodicalIF":2.9,"publicationDate":"2023-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45310727","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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