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3 results on '"Hancher, Leigh'

1. Balancing Power: The Impact of Legal Review on Harmonising the European Electricity Market.

Author

Hancher, Leigh and Rumpf, Julius

Subjects
*ELECTRIC utility laws, *ELECTRICITY markets, *LINEAR network coding, *EUROPEAN Union law, *ECONOMIC impact
Abstract

European electricity regulation has evolved to include a novel category of binding sectoral rules known as terms, conditions, and methodologies (TCMs). These are created within a regulatory framework outlined in delegated Commission regulations by private electricity firms and approved by technocratic agencies, most notably the EU Agency for the Cooperation of Energy Regulators (ACER). Despite their technical nature, TCMs have significant economic impact. This prompts frequent appeals of ACER's TCM decisions, questioning ACER's role and the overall institutional equilibrium of the TCM procedure. ACER's TCM decisions are subject to dual-level legal review – internal by ACER's Board of Appeal and external by European Courts. This paper uses two case studies to examine how dual-level legal review impacts the institutional balance of the TCM procedure. We find that the two levels of review engage poorly, so that contrary to expectations, legal review creates uncertainty rather than clarity, allowing for considerable pragmatism. These findings show the importance of considering legal review when studying sectoral governance. Policy implications are also significant, as the identified issues inhibit innovation and problem-solving, the raison d'etre of the TCMs. [ABSTRACT FROM AUTHOR]

Published
2024
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3. Revision of the Regulatory Framework for Medical Devices in the European Union: The Legal Challenges

Author

M.E. Foldes and Leigh Hancher

Subjects
Health professionals, Status quo, business.industry, media_common.quotation_subject, Member states, Authorization, Public relations, Consumer Organizations, Risk regulation, Subject matter, media_common.cataloged_instance, Business, European union, Safety Research, Law, media_common
Abstract

This special edition of the European Journal of Risk Regulation deals with a highly topical, complex and controversial subject matter – the reform of the regulation of medical devices in the European Union.At first sight, and as further detailed in the following articles, there appears to be a general consensus about the need to improve the EU (and indeed the US) regulatory framework on medical devices, especially for high-risk categories of devices. Stakeholders including representatives of the industry, patient and consumer organizations, national authorities, healthcare professionals, agree that there is a need for change. However, opinions differ on what needs to be changed and how. Three alternatives for reform of the current EU systemof regulation have been debated over the past years: the adoption of a pharmastyle system of pre-market authorisation; maintaining the status quo but strengthening implementation and supervision in the Member States; or finally, introducing common technical specifications together with specific guidelines for certain high-risk devices.

Published
2013
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