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.
On 10 October 2022, President Ferdinand Marcos Jr. signed into law Republic Act No. 11934, otherwise known as the “Subscriber Identity Module (SIM) Registration Act”. The primary purpose of the Act is to mandate all public telecommunications entities to require the registration of SIM cards prior to their sale and activation, in an effort to promote accountability and provide law enforcement with an identification tool in resolving crimes .
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.
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.
On 9 December 2022, the Employment, Social Policy, Health and Consumer Affairs Council met to discuss a possible amendment to Art. 120 of Regulation 745/2017, with the purposes of deferring the transitional periods provided therein.
The UK’s Department of Health and Social Care has announced that the voluntary scheme payment percentage for 2023 will be set at 26.5% of sales for 2023 (representing almost GBP 3.3 billion). This is a further major increase to last year’s VPAS significant rate rise to 15% (around GBP 1.8 billion, rising from GBP 0.6 billion in 2021).
The Spanish Agency for Medicines and Health Products has streamlined the procedure for applying for the national code (NC) of centrally authorized medicinal products. In order to have more efficient management, this change has been included in a guide containing information on the documents required for the assignment of the NC. From now on it will be possible to send the NC application as soon as the final texts have been adopted by the applicant and the regulatory agencies. Finally, it will also be possible to present the European Commission’s decision in English.
The legal framework for the labelling of vegan and vegetarian alternatives to meat is continuously evolving and also differs from country to country. In Switzerland, the Federal Food Safety and Veterinary Office had put forward a very strict interpretation, deeming as deceptive and thus prohibited any use of animal designations in the labelling of vegan and vegetarian meat alternatives. In a recent decision, the Administrative Court of the Canton of Zurich rejected this strict approach and deemed the use of the terms “planted.chicken”, “like chicken”, “like pork”, “pulled pork”, “vegan pork” or “chicken from plants” on the packaging of vegan meat alternatives as not deceptive.
On 16 December 2022, the Competition and Consumer Commission of Singapore commenced proceedings in the State Courts against a retailer that sells alkaline water systems and its director. In particular, the CCCS applied for the court to make findings that the retailer engaged in unfair trading practices and to issue an injunction to restrain the retailer and its director from continuing such unfair trading practices.