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In Antitrust / Competition

Italy: Competition Bill – Provisions concerning the healthcare and pharmaceutical sector

by and 2 Mins Read

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.

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In Cybersecurity, Data and Tech

Germany: New government new rules – an overview of the health-related plans of the new German three-party coalition

by 3 Mins Read

The heads of the Social Democratic Party, the Green Party and the Free Democratic Party presented the coalition agreement of the newly elected German federal government on Wednesday, 24 November 2021. One focus lies on the healthcare and life sciences sector. From driving forward the digitalization of the healthcare market, ensuring the sufficient supply of medicinal products and vaccines, and more restrictions on the prices of medicinal products, to strengthening pharmacies in underserved areas and legalizing recreational cannabis, the new government has set itself a substantive health agenda for the next four years.

In AML & Financial Services Regulatory

North America: Criminal proceeds – When does the “taint” expire?

by 1 Min Read

In this article published in The Review of Securities & Commodities Regulation, Thomas Firestone and Terence Gilroy provide an overview of the elements of criminal money laundering under US law and consider when a person is deemed to have knowledge that a transaction involves the proceeds of crime. They then suggest criteria to apply in determining whether assets remain tainted as the connection with criminal activity becomes more attenuated.

In Europe

United Kingdom and European Union: Separate product safety reform initiatives continue with no guarantee of alignment

by , , , and 9 Mins Read

The UK Office for Product Safety and Standards (OPSS) has published its response to the recent call for evidence on product safety in the UK (“Response”). In line with the government’s aim to capitalise on Brexit opportunities, the Response emphasises that the UK now has a genuine opportunity to “think boldly” about how to regulate product safety. One concern that is not addressed in detail in the Response is the risk that divergence from the EU product safety and regulatory regime could actually make the UK less attractive for business and in fact discourage innovation within the UK.

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In AML & Financial Services Regulatory

Spain: Registry opened for crypto-exchanges and custodian wallet providers

by 2 Mins Read

As a consequence of Spain’s late implementation of the 5 AML Directive, the Registry of Crypto Exchanges and Custodian Wallet Providers at the Bank of Spain has only been recently activated. Since the end of October 2021, the procedure together with the necessary forms are now available at the Bank of Spain’s website to apply for registration as Exchange Providers of Virtual Currency into Fiat and Electronic Wallets Service Custodians, as provided for in the Spanish Act 10/2010, dated 28 April, on anti-money laundering and terrorism financing.

In Europe

Italy: Regulatory Financial Newsletter – General Italian Law

by 2 Mins Read

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.

In Corporate Compliance

Italy: Regulatory Financial Newsletter – Investment Services – Consob’s Supervision

by 4 Mins Read

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.

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In AML/Money Laundering

Italy: Regulatory Financial Newsletter – Payment and Banking Services – Bank of Italy’s supervision

by 7 Mins Read

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.

In Asia-Pacific

China: New Regulatory Requirements for Imported Food Products

by and 8 Mins Read

On 12 April 2021, the General Administration of Customs of China issued Order No. 248, which sets out new requirements for the registration of qualified foreign food producers that are allowed to export food products to China, effective from 1 January 2022. This Order represents a significant move toward tightening up the regulation of foreign made food products imported into China.

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