Regulation by design is an increasingly common approach in the governance of digital technologies. Under this approach, the developers of digital systems must adopt technical measures that implement the specific requirements mandated by law in their software. Some jurisdictions, notably the European Union (EU), have turned to regulation by design as a mechanism to automatically enforce legal requirements, but this article argues that such an approach can have important implications for long-term governance. Drawing from examples of regulation by design in EU law, it shows that by-design provisions delegate rule-making power to software designers, whose interpretations of the law become entrenched in digital systems. This delegation process suffers from legitimacy deficits, which are compounded whenever digital systems continue to enforce the designer-made rules as they operate for years and, sometimes, decades. Yet, these legitimacy deficits are not unavoidable, as regulation by design can be used to force designers to adopt technical and organisational practices that mitigate the risks of rule entrenchment to future generations. By mapping the long-term risks of regulation by design and potential solutions to them, this article provides a first step towards approaches to regulation by design that do not sacrifice the future for present interests.
{"title":"Regulation by Design and the Governance of Technological Futures","authors":"Marco Almada","doi":"10.1017/err.2023.37","DOIUrl":"https://doi.org/10.1017/err.2023.37","url":null,"abstract":"\u0000 Regulation by design is an increasingly common approach in the governance of digital technologies. Under this approach, the developers of digital systems must adopt technical measures that implement the specific requirements mandated by law in their software. Some jurisdictions, notably the European Union (EU), have turned to regulation by design as a mechanism to automatically enforce legal requirements, but this article argues that such an approach can have important implications for long-term governance. Drawing from examples of regulation by design in EU law, it shows that by-design provisions delegate rule-making power to software designers, whose interpretations of the law become entrenched in digital systems. This delegation process suffers from legitimacy deficits, which are compounded whenever digital systems continue to enforce the designer-made rules as they operate for years and, sometimes, decades. Yet, these legitimacy deficits are not unavoidable, as regulation by design can be used to force designers to adopt technical and organisational practices that mitigate the risks of rule entrenchment to future generations. By mapping the long-term risks of regulation by design and potential solutions to them, this article provides a first step towards approaches to regulation by design that do not sacrifice the future for present interests.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-05-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46477522","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 article provides information on the importance of transparency in decision-making processes, particularly in relation to scientific advice and the COVID-19 pandemic. It highlights the need for clear communication and proactive publication of information, as well as the disclosure of changes in advice based on new scientific evidence, in order to maintain public trust and counter disinformation.
{"title":"Preface of the European Ombudsman: Transparency and Participation in the Face of Scientific Uncertainty","authors":"Emily O’Reilly","doi":"10.1017/err.2023.35","DOIUrl":"https://doi.org/10.1017/err.2023.35","url":null,"abstract":"The article provides information on the importance of transparency in decision-making processes, particularly in relation to scientific advice and the COVID-19 pandemic. It highlights the need for clear communication and proactive publication of information, as well as the disclosure of changes in advice based on new scientific evidence, in order to maintain public trust and counter disinformation.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48852473","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}
In its evaluation cycle, the European Commission emphasises the importance of good data and the systematic involvement of a plurality of policy stakeholders, including citizens. Findings from European Union policy evaluation should inform further law-making, encourage learning and provide accountability. Transparent and inclusive formal procedures and tools are seen as essential for securing citizen participation in risk regulation; however, the Commission faces numerous challenges in securing engagement, particularly concerning the complexity of policy issues and the formal procedures for institutionalised consultations. Considering the Commission’s work from a proceduralist perspective, the article engages with Vivien Schmidt’s notion of “throughput legitimacy” to explore recent procedural innovations emerging since the Better Regulation agenda that have sought to enhance accountability, transparency, inclusiveness and openness, ensuring fairer and more balanced input on EU policy performance. The article argues in favour of greater throughput legitimacy in ex post policy evaluation but recognises challenges to the promotion of evaluation tools and their use by citizens.
{"title":"Exploring the Throughput Legitimacy of European Union Policy Evaluation: Challenges to Transparency and Inclusiveness in the European Commission’s Consultation Procedures and the Implications for Risk Regulation","authors":"Paul Stephenson","doi":"10.1017/err.2023.33","DOIUrl":"https://doi.org/10.1017/err.2023.33","url":null,"abstract":"\u0000 In its evaluation cycle, the European Commission emphasises the importance of good data and the systematic involvement of a plurality of policy stakeholders, including citizens. Findings from European Union policy evaluation should inform further law-making, encourage learning and provide accountability. Transparent and inclusive formal procedures and tools are seen as essential for securing citizen participation in risk regulation; however, the Commission faces numerous challenges in securing engagement, particularly concerning the complexity of policy issues and the formal procedures for institutionalised consultations. Considering the Commission’s work from a proceduralist perspective, the article engages with Vivien Schmidt’s notion of “throughput legitimacy” to explore recent procedural innovations emerging since the Better Regulation agenda that have sought to enhance accountability, transparency, inclusiveness and openness, ensuring fairer and more balanced input on EU policy performance. The article argues in favour of greater throughput legitimacy in ex post policy evaluation but recognises challenges to the promotion of evaluation tools and their use by citizens.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47618868","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}
In a world of rising long-term risks and their ensuing syndromes, the mitigation and financing of long-term risks are therefore arguably some of the most critical issues facing society. However, long-term thinking involving future generations draws limited attention in current political and social systems. Private insurance has received increased attention due to its expert role in risk management and its risk transfer mechanisms, and it has played an important role in dealing with some types of long-term risk, such as floods and earthquakes. Increasingly, insurance also contributes to disaster mitigation through regulating the conduct of policyholders by creating incentives for policyholders to counter short-termism and invest in reduction measures regarding long-term risks. In addition, it has been shown that supply-side problems and behavioural anomalies make it difficult to insure against long-term risks. Innovative long-term insurance solutions and a combination of public and private partnerships are proposed to overcome these restrictions.
{"title":"Mitigation of Long-Term Risks and the Role of Insurance: A Behavioural Law and Economics Perspective","authors":"Qihao He, M. Faure","doi":"10.1017/err.2023.13","DOIUrl":"https://doi.org/10.1017/err.2023.13","url":null,"abstract":"\u0000 In a world of rising long-term risks and their ensuing syndromes, the mitigation and financing of long-term risks are therefore arguably some of the most critical issues facing society. However, long-term thinking involving future generations draws limited attention in current political and social systems. Private insurance has received increased attention due to its expert role in risk management and its risk transfer mechanisms, and it has played an important role in dealing with some types of long-term risk, such as floods and earthquakes. Increasingly, insurance also contributes to disaster mitigation through regulating the conduct of policyholders by creating incentives for policyholders to counter short-termism and invest in reduction measures regarding long-term risks. In addition, it has been shown that supply-side problems and behavioural anomalies make it difficult to insure against long-term risks. Innovative long-term insurance solutions and a combination of public and private partnerships are proposed to overcome these restrictions.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47594985","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 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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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":null,"pages":null},"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}
{"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":null,"pages":null},"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}
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":null,"pages":null},"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}
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