REGULATORY NEWS National news 1. Initial Act 2013-316 of 16 April 2013 in force. Before its modification by the “Sapin 2 Act” of 2016, the “Blandin Act” comprised a sectorial definition of whistle-blower, in the field of public health and the environment. Other provisions of the “Blandin Act”, still in force: the obligation to keep a registry of external alerts for expert assessment or research organisations in the field of health or the environment, which include the Institute for Nuclear Safety and Radiation Protection - IRSN (see Decree 2014-1628 of 26 December 2014); the creation of an administrative commission: the national Commission for ethics and alerts concerning public health and the environment (cnDAspe). 2. Study of the Conseil d’État: The whistle-blower right: report, process, protect of 25 February 2016. 3. Act 2016-1691 of 9 December 2016 (initial version). 4. Act 2022-401 of 21 March 2022 aimed at improving whistle-blower protection and Constitutional Act 2022-400 of 21 March 2022 aiming to reinforce the role of the Defender of Rights regarding whistle-blowing. Also see opinions 404000 and 404001 of 4 November 2021 from the Conseil d’État regarding the Bills. 5. The inadequacies in the protection afforded to whistle-blowers by the “Sapin 2 Act” were notably identified in the Parliamentary information report of July 2021 on the evaluation of the impact of Act 2016-1691 of 9 December 2016 (AN report n° 4325). 6. Directive (EU) 2019/1937 of the European Parliament and Council of 23 October 2019 on the protection of persons reporting violations of EU law. ACTS AND ORDINANCES • Constitutional Act 2022-400 of 21 March 2022 aiming to reinforce the role of the Defender of Rights regarding whistleblowing and Act 2022-401 of 21 March 2022 aimed at improving whistle-blower protection Before the so-called “Sapin 2 Act” 2016-1691 of 9 December 2016, seven sectoral Acts comprised measures to protect whistleblowers, notably the “Blandin Act” 2013-316 of 16 April 2013 “relative to the independence of expert assessment in the field of health and the environment and the protection of whistle-blowers(1)”. Incorporating the recommendation of a study from the Conseil d’État(2) on the adoption of a common core, Act 2016-1691 of 9 December 2016 “relative to transparency, the fight against corruption and the modernisation of economic life(3)” comprises a common definition of a whistle-blower and implements a common and graded alert procedure. Constitutional Act 2022-400 of 21 March 2022 and Act 2022-401 of the same date(4) reinforce the whistle-blower protection system(5) and transpose EU Directive 2019/1937 of 23 October 2019 which defines a common framework for this protection(6). A broader definition of whistle-blower, simplification of the alert procedures, reinforcement of the whistle-blower protections, a new status for the entourage of the whistle-blower and an expansion of the roles of the Defender of Rights with regard to whistle‑blowing are the main contributions of these Acts. • Ordinance 2022-582 of 20 April 2022 adapting French law to regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 regarding medical devices The European regulations concerning medical devices were modified in 2017 by European regulation (EU) 2017/745, adopted by the European Parliament and the Council of the European Union (EU). The purpose of this new regulatory framework is to take account of a certain number of changes, based on experience, in order to guarantee patient safety, and technological developments in the medical devices sector. The year 2022 was marked by the publication of important texts, notably concerning whistle-blowers, the environmental assessment, nuclear civil liability, the creation of a new nuclear interministerial programme delegation, radioactive waste, radon and radiation protection. This year also saw continued work to revise the Order of 7 February 2012 laying down the general rules relating to Basic Nuclear Installations (known as the “BNI Order”). 30 ABSTRACTS – ASN Report on the state of nuclear safety and radiation protection in France in 2022
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