After several public consultations on individual elements of Amount A, the OECD has now released a consolidated version of the draft operative provisions on Amount A in its Progress Report dated 11 July 2022. The new publication includes model rules for three building blocks of Amount A that had not previously been dealt with, namely: Segmentation, Marketing and Distribution Profits Safe Harbor, and Elimination of Double Taxation. The OECD welcomes comments from the public no later than 19 August 2022.
On 5 May 2022, the Council of Ministers preliminarily approved the bill to adapt the Italian legislation to the provisions of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The bills are currently being examined by the competent committees of the Italian Parliament.
From 26 May 2022, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has applied.
• The main changes introduced by the IVDR include (i) a new classification of devices, (ii) new conformity assessment procedures that differ according to the risk class and the specific characteristics of the device, (iii) reinforced requirements relating to clinical evidence aimed at demonstrating compliance with the safety and performance requirements of the device, (iv) the introduction of post-marketing follow-up obligations for manufacturers aimed at updating the performance evaluation throughout the life cycle of the device, (v) the provision of new obligations for manufacturers, authorized representatives, importers and distributors, and (vi) the obligation for manufacturers to appoint a person responsible for regulatory compliance.
The bill on the “Annual Market and Competition 2021”, approved by the senate on 30 May 2022 and currently under examination by the Chamber of Deputies, provides for the amendment of Article 15 of Law No. 219/2005, governing the Italian transfusion system and the production of blood-derived medicines.
On 20 June 2022, the new national pharmacovigilance network, which ensures the collection, management and analysis of suspected adverse reaction reports of medicines in Italy, became operative.
With Judgement No. 3278/2022, the Council of State confirmed the legitimacy of the decision by which the Italian Medicine Agency declared the forfeiture of an MA for failure to market the drug pursuant to Article 38, paragraph 7 of Legislative Decree No. 219/2006.
On 25 May 2022, the Federal Council passed an amendment to the Price Disclosure Ordinance. The purpose of the amendment is to ensure clarity and comparability of prices and to prevent the use of misleading prices. This latest amendment was precipitated by federal court ruling 4A_235/2020, which caused uncertainty on the question of the timing of price disclosure in online trade.
On 27 May 2022, the OECD released a new public consultation document presenting A Tax Certainty Framework for Amount A which will be the subject of this alert. Concurrently, a separate public consultation document dealing with Tax Certainty for issues related to Amount A was published, which is the focus of another alert. With these two new documents, the OECD has now released 7 out of 13 building blocks forming Amount A under Pillar One.
Baker McKenzie attorneys Paul Melling, Roman Butenko and Oleg Tkachenko contributed two articles to GIR – Europe, Middle East and Africa Investigations Review 2022 Digital Edition. The first article provides an overview of recent corporate anti-bribery enforcement trends and, taking into account those trends, tries to sum up the most important lessons to be learned by companies that strive to build compliant businesses in Russia. The second article is dedicated to key issues on compliance programs and their enforcement in Russia. The article provides an overview of recent anti-bribery and legislative corruption measures and the guidance provided to the Russian business community with regard to those measures and their enforcement.
The Spanish Agency for Medicinal Products and Medical Devices has launched a new application with the aim of facilitating the registration and improving the communication of biocidal products and of personal care products, as well as regarding facilities that manufacture, import and store biocidal products within the Spanish territory.