On 14 and 15 December 2021, Legislative Decree No. 184/2021 and Legislative Decree No. 195/2021, which significantly amended Legislative Decree No. 231/2001 on corporate liability and the Italian Criminal Code entered into force.
On 9 December 2021, the Medical Device Coordination Group published a question and answers document concerning obligations applicable to importers and distributors under Articles 13 and 14 of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
On 25 November 2021, the European Commission adopted Implementing Regulation (EU) 2021/2071 subjecting vaccines against COVID-19 and active substances used for the manufacture of same to export surveillance for a period of 24 months starting from 1 January. This Regulation will replace the existing regulatory framework requiring vaccine exports to be subject to an authorization by Member States.
Pending the full functionality of the European Database on Medical Devices, the European Commission made available two new modules, to be used on a voluntary basis, for the registration of medical devices by economic operators and for the registration of certificates of conformity by notified bodies.
On 29 November 2021, Legislative Decree No. 179/2021 was published in the Official Journal, introducing the applicable sanctions for violations of Regulation (EU) No. 528/2012 concerning the making available on the market and use of biocidal products. The new sanctions entered into force on 14 December 2021.
In March 2021, the EU approved new reporting rules in a directive known as DAC7. The directive will require the operators of online platforms for the sale of goods and certain services, to collect, verify and share data on their sellers and their transactions concluded on the online platform. EU member states have until 31 December 2022 to implement DAC7 into national law. Certain platform operators will become a reporting platform and will need to start collecting and verifying data points in compliance with the DAC7 reporting requirements. The collected data points must be reported to the tax authorities of the relevant EU member state annually.
On 4 November 2021, the Council of Ministers approved the Competition Bill for 2021 (“Competition Bill”), to be submitted to the Parliament for its examination. The provisions of the Competition Bill affect various sectors, including the healthcare one. In this regard, the most important innovations are those concerning (i) medicines for which the pricing and reimbursement procedure is still pending; (ii) the reimbursement of generic drugs; (iii) the distribution of medicines; and (iv) the production of blood-derivative drugs.
In connection with the opening of the first window for the presentation of FinTech projects in order to participate to the FinTech regulatory sandbox, which started on 15 November 2021 and will last until 15 January 2022 , the three Italian supervisory authorities in charge of running the experimentation, the Bank of Italy, the Consob, and the IVASS, issued a set of regulations that implement the administrative procedures required in connection with the admission to the FinTech regulatory sandbox and the other procedural phases of the experimentation.
On 8 October 2021, the Consob launched a public consultation concerning proposed amendments to the Consob Regulation No. 11971 of 14 May 1999 (the “Italian Issuers’ Regulation”). The amendments to the Italian Issuers’ Regulation aim at aligning the domestic regulations with the latest legislative developments on prospectus requirements at Italian and EU level.
On 24 November 2021, the Bank of Italy issued an order concerning amendments to the Bank of Italy’s Circular No. 285 of 17 December 2013 on “Supervisory provisions for banks” (the “Circular No. 285”). The amendments to the Bank of Italy’s Circular No. 285 aim at aligning the Italian regulations with the latest EU legislative developments on sound remuneration policies and practices, in particular exempted entities, financial holding companies, mixed financial holding companies, remuneration, supervisory measures and powers and capital conservation measures.