Regulatory sandboxes in the European Union: Regulating innovation between principles and practical applications
DOI:
https://doi.org/10.32091/RIID0211Keywords:
Regulatory sandboxes, European Union, Coregulation, Artificial intelligenceAbstract
This contribution examines the evolution of the EU’s regulatory approach in addressing the challenges posed by emerging technologies, highlighting the transition from a technology-neutral model to innovative and flexible tools such as regulatory sandboxes. These instruments, central to the framework of the AI Act, are designed as actual regulatory laboratories, enabling the assessment of existing rules and the implementation of targeted modifications to address evolving technical and social needs. Despite the opportunities they offer, specific critical issues demand attention. Concerns about transparency, equitable access, and the allocation of responsibilities among innovators, public authorities, and civil society raise significant questions. Establishing clear and uniform selection criteria and oversight mechanisms is essential to prevent regulatory fragmentation among Member States and mitigate the risks of regulatory capture. This contribution seeks to shed light on how regulatory sandboxes, if properly implemented, can become strategic tools for evidence-based regulation, fostering constructive dialogue between regulators and innovators. Aligned with the principles of transparency and inclusivity enshrined in the European Union, they represent a new frontier for a governance model capable of addressing the complexities of emerging technologies.
References
H. Allen (2020), Sandbox Boundaries, in “Vanderbilt Journal of Entertainment & Technology Law”, vol. 22, 2020, n. 2
H. Allen (2019), Regulatory Sandboxes, in “George Washington Law Review”, vol. 87, 2019, n. 3
J. Armour, M. Sako (2020), AI-enabled business models in legal services: from traditional law firms to next-generation law companies?, in “Journal of Professions and Organization”, vol. 7, 2020, n. 1
A. Attrey, M. Lesher, C. Lomax (2020), The role of sandboxes in promoting flexibility and innovation in the digital age, in “OECD Going Digital Toolkit Policy Notes”, OECD Publishing, 2020
F. Bagni (2023), The Regulatory Sandbox and the Cybersecurity Challenge: from the Artificial Intelligence Act to the Cyber Resilience Act, in “Rivista italiana di informatica e diritto”, 2023, n. 2
D. Baldini, K. Francis (2024), AI Regulatory Sandboxes between the AI Act and the GDPR: The role of Data Protection as a Corporate Social Responsibility, in “CEUR Workshop Proceedings”, vol. 3731, 2024
I. Bar-Siman-Tov (2018), Temporary legislation, better regulation, and experimentalist governance: An empirical study, in “Regulation & Governance”, vol. 12, 2018, n. 2
M.E. Bartoloni (2021), La regolazione privata nel sistema costituzionale dell’Unione europea. Riflessioni sulla disciplina relativa al settore dell’innovazione, in “Osservatorio sulle fonti”, 2021, n. 3
G. Buchholtz (2020), Artificial Intelligence and Legal Tech: Challenges to the Rule of Law, in T. Wischmeyer, T. Rademacher (eds.), “Regulating Artificial Intelligence”, Springer, 2020
T. Buocz, S. Pfotenhauer, I. Eisenberger (2023), Regulatory sandboxes in the AI Act: reconciling innovation and safety?, in “Law, Innovation and Technology”, vol. 15, 2023, n. 2
S. Chesterman (2021), Through a Glass, Darkly: Artificial Intelligence and the Problem of Opacity, in “The American Journal of Comparative Law”, vol. 69, 2021, n. 2
D. Collingridge (1982), Social Control of Technology, Continuum International Publishing Group Ltd., 1982
Consiglio dell’Unione europea (2020), Conclusioni del Consiglio sugli spazi di sperimentazione normativa e le clausole di sperimentazione come strumenti per un quadro normativo favorevole all’innovazione, adeguato alle esigenze future e resiliente che sia in grado di affrontare le sfide epocali nell’era digitale, 16 novembre 2020
A. de Boer (2018), Scientific assessments in European food law: Making it future-proof, in “Regulatory Toxicology and Pharmacology”, vol. 108, 2018
European Commission (2023), Better Regulation Toolbox, 2023
European Commission (2023-a), Launch of the European Blockchain Regulatory Sandbox, 2023
European Law Institute (2022), Principles on Blockchain Technology, Smart Contracts and Consumer Protection, Report of the European Law Institute, 2022
Expert Group on Regulatory Obstacles to Financial Innovation (2019), 30 Recommendations on regulation, innovation and finance, 2019
C. Faralli (2019), Diritti e nuove tecnologie, in “Tigor. Rivista di scienze della comunicazione e di argomentazione giuridica”, 2019, n. 2
Financial Conduct Authority (2017), Regulatory sandbox lessons learned report, October 2017
Financial Conduct Authority (2015), Regulatory sandbox, November 2015
Financial Stability Board 2020, The Use of Supervisory and Regulatory Technology by Authorities and Regulated Institutions: Market developments and financial stability implications, 9 October 2020
T. Freund (2003), Kommunale Standardöffnungs- und Experimentierklauseln im Lichte der Verfassung, WVB, 2003
S. Garben (2020), A taste of its own medicine: Assessing the impact of the EU Better Regulation Agenda, in “European Law Journal”, vol. 26, 2020, n. 1-2
K. Garnett, G. Van Calster, L. Reins (2018), Towards an innovation principle: An industry trump or shortening the odds on environmental protection?, in “Law Innovation and Technology”, vol. 10, 2018, n. 1
A. Genus, A. Stirling (2018), Collingridge and the dilemma of control: Towards responsible and accountable innovation, in “Research Policy”, vol. 47, 2018, n. 1
M. Gomez Santos (2021), Régimen jurídico del “regulatory sandbox” en España, in “Revista de Derecho del Sistema Financiero: Mercados, operadores y contratos”, 2021, n. 1
S. Greenstein (2022), Preserving the rule of law in the era of artificial intelligence (AI), in “Artificial Intelligence and Law”, vol. 30, 2022, n. 3
M. Hildebrandt, L. Tielemans (2019), Data protection by design and technology neutral law, in “Computer Law & Security Review”, vol. 29, 2019, n. 5
H.D. Horn (1989), Experimentelle Gesetzgebung unter dem Grundgesetz, Duncker & Humblot, 1989
W.G. Johnson (2023), Caught in quicksand? Compliance and legitimacy challenges in using regulatory sandboxes to manage emerging technologies, in “Regulation & Governance”, vol. 17, 2023, n. 3
B.R. Knight, T.E. Mitchell (2020), The Sandbox Paradox: Balancing the Need to Facilitate Innovation with the Risk of Regulatory Privilege, in “South Carolina Law Review”, vol. 72, 2020, n. 2
E. Leckenby, D. Dawoud, J. Bouvy, P. Jónsson (2021), The Sandbox Approach and its Potential for Use in Health Technology Assessment: A Literature Review, in “Applied Health Economics and Health Policy”, vol. 19, 2021
V. Maaß (2021), Experimentierklauseln für die Verwaltung und ihre verfassungsrechtlichen Grenzen, Duncker & Humblot, 2021
D. Martin (2019), Article 20 CFR, in M. Kellerbauer, M. Klamert, J. Tomkin (eds.), “The EU Treaties and the Charter of Fundamental Rights: A Commentary”, Oxford University Press, 2019
M. Milanesi (2023), Lo sviluppo delle sandbox regolatorie italiane tra dubbi e opportunità, in “federalismi.it”, 2023, n. 15
OECD (2023), Regulatory sandboxes in artificial intelligence, OECD Digital Economy Papers No. 356, OECD Publishing, 2023
OECD (2018), Oslo Manual 2018: Guidelines for Collecting, Reporting and Using Data on Innovation, 4th Edition, OECD Publishing, 2018
D. Quan (2019), A few thoughts on regulatory sandboxes, Stanford University, Stanford PACS, 2019
S. Ranchordás (2020), Innovation-Friendly Regulation: The Sunset of Regulatory Sandboxes?, in “Law & Policy”, vol. 42, 2020, n. 3
S. Ranchordás, M. van’t Schip (2020), Future-Proofing Legislation for the Digital Age, in S. Ranchordás, Y. Roznai (edited by), “Time, Law, and Change: An Interdisciplinary Study”, Hart Publishing, 2020
S. Ranchordás, V. Vinci (2024), Regulatory sandboxes and innovation-friendly regulation: between collaboration and capture, in “Italian Journal of Public Law”, vol. 16, 2024, n. 1
G. Rugani (2024), La promozione di strumenti di co-regolazione dell’intelligenza artificiale nell’AI Act, con particolare riferimento alle regulatory sandboxes, in “Quaderni AISDUE”, 2024, fasc. speciale n. 2
A. Saltelli, D.J. Dankel, M. Di Fiore et al. (2022), Science, the endless frontier of regulatory capture, in “Futures”, vol. 135, 2022
J.S. Sherkow (2022), Regulatory Sandboxes and the Public Health, in “University of Illinois Law Review”, 2022, n. 1
F. Simonelli, A. Renda (2019), Study supporting the interim evaluation of the innovation principle – Final report, Publications Office, 2019
J.-H. Stahl (2010), L’expérimentation en droit français: une curiosité en mal d’acclimatation, in “Revue Juridique de l’Économie Publique”, 2010
H. Surden, M.A. Williams (2016), Technological Opacity, Predictability, and Self-Driving Cars, in “Cardozo Law Review”, vol. 38, 2016
M. Trapani (2022), L’utilizzo delle sandboxes normative: una ricognizione comparata delle principali esperienze di tecniche di produzione normativa sperimentali e il loro impatto sull’ordinamento, in “Osservatorio sulle fonti”, 2022, n. 3
J. Truby, R.D. Brown, I.A. Ibrahim, O. Caudevilla Parellada (2022), A sandbox approach to regulating high-risk artificial intelligence applications, in “European Journal of Risk Regulation”, vol. 13, 2022
G. Umbach (2024), Futures in EU governance: Anticipatory governance, strategic foresight and EU Better Regulation, in “European Law Journal”, vol. 30, 2024, n. 3
V. Vaassen (2022), AI, Opacity, and Personal Autonomy, in “Philosophy & Technology”, vol. 35, 2022
K. Yeung (2017), Are human biomedical interventions legitimate regulatory policy instruments?, in R. Brownsword, E. Scotford, K. Yeung (eds.), “The Oxford handbook of law, regulation and technology”, Oxford University Press, 2017
V.K. Yordanova (2019), The Shifting Sands of Regulatory Sandboxes for AI, in “Centre for IT and IP law blog”, July 2019
World Bank Group (2020), Global Experiences from Regulatory Experiences. Finance, Competitiveness & Innovation Global Practice, Fintech Note, no. 8, 2020
D.A. Zetzsche, R.P. Buckley, J.N. Barberis, D.W. Arner (2017), Regulating a Revolution: From Regulatory Sandboxes to Smart Regulation, in “Fordham Journal of Corporate & Financial Law”, vol. 23, 2017, n. 1
F. Zunzunegui (2020), Aproximación al espacio controlado de pruebas, (Commentary on Spanish Regulatory Sandbox Act), in “Revista General de Derecho de los Sectores Regulados”, Working Paper 6/2020
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