On 11 January 2023, Decree Law No. 4 on “Urgent provisions regarding the procedures for the repayment of the medical device expenditure ceiling overrun” was published in the Italian Official Gazette. Article 1 of the Decree extends to 30 April 2023 the deadline by which companies that supplied medical devices to NHS during the years 2015-2018 must pay the required payback amounts.
On 22 December 2022, the Court of Justice of the European Union ruled on Case C-530/20 concerning the interpretation of Articles 86, 87, and 90 of Directive 2001/83/EC on the advertising of medicinal products for human use.
The Federal Court’s recent decision in Australian Securities and Investments Commission (ASIC) v Scholz (No 2) [2022] FCA 1542 has important implications for those who discuss financial products and services on social media platforms. Handed down on 20 December 2022, the Court’s judgment heralds a warning that social media ‘finfluencers’ may be considered to be carrying on a financial service business and thus are required to have an Australian Financial Services License.
Requests for preliminary rulings made by courts of EU Member States have always been dealt with by the European Court of Justice. Over the years the CJEU handled numerous customs cases on tariff classification, customs valuation, origin and procedural customs law. Due to capacity restraints at the CJEU, an alternative distribution of jurisdiction between the CJEU and the lower EU General Court is proposed by the CJEU. More specifically, the CJEU requests that the EU Commission propose a change to the Treaty of the Functioning of the EU, such that preliminary ruling requests for, amongst others, VAT and customs matters, are to be submitted to the General Court.
The Australian Government has released its Strategic Plan for Payments System: Consultation Paper. It is significant insofar as it demonstrates the current Government’s commitment to reform by creating a fit-for-purpose regulatory framework in respect of payments mirroring international developments. It is also significant in that the paper expressly states that the reform agenda includes implementing a tiered licensing framework for payment services providers. Interested parties are invited to comment on this consultation. Responses are due on 6 February 2022.
This January 2023, the Law for Improper Advertising Practices was declared unconstitutional by the Supreme Court of Justice, considering that it violates the human rights of freedom to work, free contracting, freedom to trade and autonomy of will. However, this ruling is one isolated criterion which is not binding and has no general application yet, as it will only protect those who are parties in the “amparo” action that gave origin to the court ruling (since it is not a general declaration of unconstitutionality). Nonetheless, this is an important precedent that should be used by all the courts to grant the “amparos”, and also will help to pursue in the future a general declaration of unconstitutionality.
Belgium has finalized the basic banking service framework for companies, among others, by creating the long-awaited basic banking service chamber, as a result of which the new rules can now finally take effect.
In the period between 2020 and 2022, the new Law on Environmental Protection and its guiding Decree No. 08/2022/ND-CP were promulgated, providing a fundamental legal framework for extended producer responsibility (EPR). EPR-related regulations impose a number of obligations on manufacturers and importers of certain types of products and packaging in Vietnam. Nonetheless, the EPR legal framework is not yet complete.
The P2SK Law introduces the concept of financial instrument managers and trust fund managers. Both are designed as specific purpose entities licensed by Otoritas Jasa Keuangan and established to perform asset securitization and/or trustee fund management activities. The government expects the existence of SPVs to contribute to financial instrument diversification. Trustees, on the other hand, are regulated with the aim of increasing participation by financial market players and bringing about improvement in disclosure and good corporate governance regulations.
On 14 December 2022, the Securities and Exchange Commission proposed four separate rulemakings under the Securities Exchange Act of 1934 that would create a federally defined best execution standard for broker-dealers and overhaul the US equities market structure. If adopted in their current form, these proposals would meaningfully impact market participants and practices. Given the nearly 1,700 pages of combined rules proposals, firms may need to devote significant resources just to digest their potential impact on particular business models.