Abstract This paper focuses on the legal adoption and possible implications of the proposed per- and polyfluoroalkyl substances (PFAS) restriction. In the case of PFAS, this restriction puts value on the regulatory efforts to implement far-reaching and ambitious targets amid a high level of scientific uncertainty. The purpose of this paper is to present a report rather than conducting an in-depth analysis of the mentioned field. Overall, the paper argues that such a daring decision might be justified by the precautionary principle. However, the implementation might raise opposition from the stakeholders’ side and might take longer than initially anticipated, most likely with additional derogations concerning essential goods that do not currently have safe alternatives.
{"title":"One Step Closer to Zero Chemical Pollution: The Legal Adoption and Implications of the Per- and Polyfluoroalkyl Substances Restriction Proposal","authors":"Viktoria Obolevich","doi":"10.1017/err.2023.64","DOIUrl":"https://doi.org/10.1017/err.2023.64","url":null,"abstract":"Abstract This paper focuses on the legal adoption and possible implications of the proposed per- and polyfluoroalkyl substances (PFAS) restriction. In the case of PFAS, this restriction puts value on the regulatory efforts to implement far-reaching and ambitious targets amid a high level of scientific uncertainty. The purpose of this paper is to present a report rather than conducting an in-depth analysis of the mentioned field. Overall, the paper argues that such a daring decision might be justified by the precautionary principle. However, the implementation might raise opposition from the stakeholders’ side and might take longer than initially anticipated, most likely with additional derogations concerning essential goods that do not currently have safe alternatives.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136308274","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}
This symposium sets out to scan the horizon for the foremost dual-use technologies, quantum and artificial intelligence (AI), with transformative and even disruptive potential for social and economic affairs. The symposium intends to encourage a debate regarding possible regulatory and policy responses that might channel development and adoption in a way that responsibly balances benefits and risks. The symposium will also refer to the discussion on how these deep technologies interact with or relate to the climate change challenge currently confronting humanity. Risks and opportunities stemming from the development and deployment of new technologies might be fruitfully analysed and addressed from an anticipatory governance perspective. The aim of this symposium is to shed light on the regulatory horizon, with contributions reflecting the latest transatlantic scholarly and policy debates on the breakthrough technological developments in the climate, AI and quantum technology domains.
{"title":"Climate, AI & Quantum: Europe’s Regulatory Horizon","authors":"Elif Kiesow Cortez","doi":"10.1017/err.2023.74","DOIUrl":"https://doi.org/10.1017/err.2023.74","url":null,"abstract":"This symposium sets out to scan the horizon for the foremost dual-use technologies, quantum and artificial intelligence (AI), with transformative and even disruptive potential for social and economic affairs. The symposium intends to encourage a debate regarding possible regulatory and policy responses that might channel development and adoption in a way that responsibly balances benefits and risks. The symposium will also refer to the discussion on how these deep technologies interact with or relate to the climate change challenge currently confronting humanity. Risks and opportunities stemming from the development and deployment of new technologies might be fruitfully analysed and addressed from an anticipatory governance perspective. The aim of this symposium is to shed light on the regulatory horizon, with contributions reflecting the latest transatlantic scholarly and policy debates on the breakthrough technological developments in the climate, AI and quantum technology domains.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139346007","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":"Transitioning towards Sustainable and Equitable Cities: Law and Governance Perspectives on Urban Climate Action","authors":"C. Colombo, M. Groenleer","doi":"10.1017/err.2023.75","DOIUrl":"https://doi.org/10.1017/err.2023.75","url":null,"abstract":"","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139345507","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":"ERR volume 14 issue 3 Cover and Back matter","authors":"","doi":"10.1017/err.2023.80","DOIUrl":"https://doi.org/10.1017/err.2023.80","url":null,"abstract":"","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139346616","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}
This article focuses on copyright issues pertaining to generative artificial intelligence (AI) systems, with particular emphasis on the ChatGPT case study as a primary exemplar. In order to generate high-quality outcomes, generative AI systems require substantial quantities of training data, which may frequently comprise copyright-protected information. This prompts inquiries into the legal principles of fair use, the creation of derivative works and the lawfulness of data gathering and utilisation. The utilisation of input data for the purpose of training and enhancing AI models presents significant concerns regarding potential violations of copyright. This paper offers suggestions for safeguarding the interests of copyright holders and competitors, while simultaneously addressing legal challenges and expediting the advancement of AI technologies. This study analyses the ChatGPT platform as a case example to explore the necessary modifications that copyright regulations must undergo to adequately tackle the intricacies of authorship and ownership in the realm of AI-generated creative content.
{"title":"ChatGPT: A Case Study on Copyright Challenges for Generative Artificial Intelligence Systems","authors":"N. Lucchi","doi":"10.1017/err.2023.59","DOIUrl":"https://doi.org/10.1017/err.2023.59","url":null,"abstract":"\u0000 This article focuses on copyright issues pertaining to generative artificial intelligence (AI) systems, with particular emphasis on the ChatGPT case study as a primary exemplar. In order to generate high-quality outcomes, generative AI systems require substantial quantities of training data, which may frequently comprise copyright-protected information. This prompts inquiries into the legal principles of fair use, the creation of derivative works and the lawfulness of data gathering and utilisation. The utilisation of input data for the purpose of training and enhancing AI models presents significant concerns regarding potential violations of copyright. This paper offers suggestions for safeguarding the interests of copyright holders and competitors, while simultaneously addressing legal challenges and expediting the advancement of AI technologies. This study analyses the ChatGPT platform as a case example to explore the necessary modifications that copyright regulations must undergo to adequately tackle the intricacies of authorship and ownership in the realm of AI-generated creative content.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44954191","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}
Online gambling emerged in the 1990s in the midst of a process of market liberalisation. Here, scholars have argued that the gambling industry actively seeks state regulation to authorise and legitimate its activities. Why then, since the emergence of the online gambling industry, have trade associations continually sought to develop responsible gambling codes of conduct? In this paper, I address this puzzle by documenting and tracing the development and deployment of responsible gambling codes of conduct by trade associations from the emergence of the online gambling industry in the early 1990s and through processes of increased market liberalisation at the national level and market integration at the European Union level. I argue that online gambling trade associations deploy responsible gambling codes of conduct at particular moments of opportunity to shape their members’ external legal and regulatory environment and to reproduce and embed a particular understanding of how gambling-related risks should be regulated.
{"title":"Reproducing Responsible Gambling through Codes of Conduct: The Role of Trade Associations and Codes of Conduct in Shaping Risk Regulation","authors":"Donal Casey","doi":"10.1017/err.2023.50","DOIUrl":"https://doi.org/10.1017/err.2023.50","url":null,"abstract":"\u0000 Online gambling emerged in the 1990s in the midst of a process of market liberalisation. Here, scholars have argued that the gambling industry actively seeks state regulation to authorise and legitimate its activities. Why then, since the emergence of the online gambling industry, have trade associations continually sought to develop responsible gambling codes of conduct? In this paper, I address this puzzle by documenting and tracing the development and deployment of responsible gambling codes of conduct by trade associations from the emergence of the online gambling industry in the early 1990s and through processes of increased market liberalisation at the national level and market integration at the European Union level. I argue that online gambling trade associations deploy responsible gambling codes of conduct at particular moments of opportunity to shape their members’ external legal and regulatory environment and to reproduce and embed a particular understanding of how gambling-related risks should be regulated.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44957489","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 recent years, various innovations aimed at counteracting perceived presentism and democratic decline have emerged. One primary concern is the issue of inadequate representation in parliaments, which has prompted the development of various proposals for reforming the selection mechanisms of parliamentarians. In this context, lottocracy (selection of representatives at random) and proxy democracy (selection models based on self-selection and flexible nominations that determine the relative influence of representatives) are candidates as selection rules to open democratic representation. Herein, I examine the normative and contextual trade-offs underpinning lottocracy and proxy democracy. While both systems outperform electoral alternatives on the dimensions under study, they induce tensions that are often overlooked. Nonetheless, clarifying the normative compromises is crucial to addressing the challenges facing democratic systems and to informing the deployment of the future of representative democracy.
{"title":"How to Open Representative Democracy to the Future?","authors":"Manon Revel","doi":"10.1017/err.2023.56","DOIUrl":"https://doi.org/10.1017/err.2023.56","url":null,"abstract":"\u0000 In recent years, various innovations aimed at counteracting perceived presentism and democratic decline have emerged. One primary concern is the issue of inadequate representation in parliaments, which has prompted the development of various proposals for reforming the selection mechanisms of parliamentarians. In this context, lottocracy (selection of representatives at random) and proxy democracy (selection models based on self-selection and flexible nominations that determine the relative influence of representatives) are candidates as selection rules to open democratic representation. Herein, I examine the normative and contextual trade-offs underpinning lottocracy and proxy democracy. While both systems outperform electoral alternatives on the dimensions under study, they induce tensions that are often overlooked. Nonetheless, clarifying the normative compromises is crucial to addressing the challenges facing democratic systems and to informing the deployment of the future of representative democracy.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42647674","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}
High pharmaceutical pricing practices in Europe have been increasingly on the radar of the European Union, academia and civil society as a risk to Member State health budgets. It is therefore hardly surprising that, in recent years, competition authorities have resuscitated the excessive pricing prohibition contained in Article 102(a) TFEU. Focusing on this phenomenon, this piece highlights the diverse ways in which the United Brands test has been applied in pharmaceuticals by conducting a comparative study of the decisional practice of national competition authorities. Several observations and arguments are then derived therefrom, demonstrating that, while difficult (most notably in respect to patent-protected products), competition authorities and courts have established sophisticated ways of determining whether a pharmaceutical price is excessive in the sense of Article 102(a) TFEU. These findings should encourage hesitant competition authorities and private plaintiffs to at least carry out preliminary investigations when they suspect excessive pricing in pharmaceuticals is taking place.
{"title":"Excessive Pricing in Pharmaceuticals under Article 102 TFEU","authors":"Jacquelyn D. Veraldi","doi":"10.1017/err.2023.49","DOIUrl":"https://doi.org/10.1017/err.2023.49","url":null,"abstract":"\u0000 High pharmaceutical pricing practices in Europe have been increasingly on the radar of the European Union, academia and civil society as a risk to Member State health budgets. It is therefore hardly surprising that, in recent years, competition authorities have resuscitated the excessive pricing prohibition contained in Article 102(a) TFEU. Focusing on this phenomenon, this piece highlights the diverse ways in which the United Brands test has been applied in pharmaceuticals by conducting a comparative study of the decisional practice of national competition authorities. Several observations and arguments are then derived therefrom, demonstrating that, while difficult (most notably in respect to patent-protected products), competition authorities and courts have established sophisticated ways of determining whether a pharmaceutical price is excessive in the sense of Article 102(a) TFEU. These findings should encourage hesitant competition authorities and private plaintiffs to at least carry out preliminary investigations when they suspect excessive pricing in pharmaceuticals is taking place.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":2.9,"publicationDate":"2023-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43264012","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 This paper critically evaluates the European Commission’s proposed AI Act’s approach to risk management and risk acceptability for high-risk artificial intelligence systems that pose risks to fundamental rights and safety. The Act aims to promote “trustworthy” AI with a proportionate regulatory burden. Its provisions on risk acceptability require residual risks from high-risk systems to be reduced or eliminated “as far as possible”, having regard for the “state of the art”. This criterion, especially if interpreted narrowly, is unworkable and promotes neither proportionate regulatory burden nor trustworthiness. By contrast, the Parliament’s most recent draft amendments to the risk management provisions introduce “reasonableness” and cost–benefit analyses and are more transparent regarding the value-laden and contextual nature of risk acceptability judgments. This paper argues that the Parliament’s approach is more workable and better balances the goals of proportionality and trustworthiness. It explains what reasonableness in risk acceptability judgments would entail, drawing on principles from negligence law and European medical devices regulation. It also contends that the approach to risk acceptability judgments needs a firm foundation of civic legitimacy, including detailed guidance or involvement from regulators and meaningful input from affected stakeholders.
{"title":"Acceptable Risks in Europe’s Proposed AI Act: Reasonableness and Other Principles for Deciding How Much Risk Management Is Enough","authors":"Henry Fraser, José-Miguel Bello y Villarino","doi":"10.1017/err.2023.57","DOIUrl":"https://doi.org/10.1017/err.2023.57","url":null,"abstract":"Abstract This paper critically evaluates the European Commission’s proposed AI Act’s approach to risk management and risk acceptability for high-risk artificial intelligence systems that pose risks to fundamental rights and safety. The Act aims to promote “trustworthy” AI with a proportionate regulatory burden. Its provisions on risk acceptability require residual risks from high-risk systems to be reduced or eliminated “as far as possible”, having regard for the “state of the art”. This criterion, especially if interpreted narrowly, is unworkable and promotes neither proportionate regulatory burden nor trustworthiness. By contrast, the Parliament’s most recent draft amendments to the risk management provisions introduce “reasonableness” and cost–benefit analyses and are more transparent regarding the value-laden and contextual nature of risk acceptability judgments. This paper argues that the Parliament’s approach is more workable and better balances the goals of proportionality and trustworthiness. It explains what reasonableness in risk acceptability judgments would entail, drawing on principles from negligence law and European medical devices regulation. It also contends that the approach to risk acceptability judgments needs a firm foundation of civic legitimacy, including detailed guidance or involvement from regulators and meaningful input from affected stakeholders.","PeriodicalId":46207,"journal":{"name":"European Journal of Risk Regulation","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"136020814","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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