The long-awaited implementation in statutory law of the fight against medical devices and in vitro diagnosis medical devices shortages mechanism is currently being discussed in the French Parliament, in a bill containing various provisions adapting French law to European Union law on diverse topics and particularly in the field of public health.
On 24 November 2022, the French Agency for the Safety of Medicines and Health Products issued three sentences against pharma companies that have failed to meet their reporting obligation regarding the risk of a medicinal products supply shortage or a supply shortage.
In brief This publication features the latest Employment developments in Italy. New laws and regulations Extension of the…
The German Bundestag passed the German Whistleblower Protection Act on 16 December 2022. After initially not being expected to be passed this year, the bill did make it onto the agenda of the last session day of the year at short notice and was passed in a version amended by the Legal Affairs Committee (Rechtsausschuss) with the coalition’s majority. The next step is for the Bundesrat to approve the bill. However, this is not expected until the first plenary session in February 2023 at the earliest.
On 10 November 2022, the National Coordination Centre for Ethics Committees published the updated versions of the ‘Contract for the performance of clinical trials on medicines’, the ‘Contract for the performance of independent clinical trials on medicines’ and the ‘Contract for the performance of clinical investigations on medical devices that are not CE marked or CE marked but used outside their intended use’.
On 1 December 2022, Implementing Regulation EU 2022/2347 on the reclassification of groups of certain active medical devices without an intended medical purpose, as listed in Annex XVI to Regulation EU 2017/745, was published in the Official Journal of the EU.
Equal pay for men and women has been enshrined in UK law since 1970. Since then, and particularly since the turn of the century, equal pay claims have tended to take the form of mass claims in the public and retail sectors. In recent years, however, there has been renewed focus on individual equal pay claims. We expect that the Financial Conduct Authority will step up its scrutiny of equal pay and remuneration policies.
On 11 November 2022, the Ministry of Ecological Transition answered the Confindustria’s question on whether the packaging of medicines for human use, medical devices and in-vitro diagnostic medical devices must comply with the environmental labelling requirements set forth in Article 219, Section 5, of Legislative Decree 152/2006, starting from 1 January 2023.
On 9 December 2022, the Italian Government preliminary approved the draft legislative decree implementing Directive EU 2019/1937 (so called “Whistleblowing Directive”), aimed at protecting whistleblowers against retaliation and other negative consequences.
Several Regions and Autonomous Provinces published the measures requiring medical device companies to pay, within 30 days, payback amounts aimed at covering the overrun of the expenditure ceiling for the purchase of medical devices for the years 2015, 2016, 2017 and 2018.