The recently published OECD survey involving 43 member countries found that less than half of the countries require the publication of drug list prices, while the remaining countries are affected by legal and/or contractual constraints that prevent the publication of drug price information.
EU Regulation 2024/1689 on Artificial Intelligence has the aim to introduce strict rules for the design, implementation and placing on the market of Artificial Intelligence systems, to be applied both to suppliers established in European territory and to suppliers established outside the European Union.
In October 2024, the Health Sciences Authority (HSA) updated its Guidance on the Implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) Manufacturers (“Guidance”).
This is a timely amendment to the Guidance as the requirement for chemical DS manufacturers to provide evidence of GMP compliance became mandatory with effect from 1 October 2024, after a one-year grace period.
Last month ASIC announced that it is calling upon product issuers to ensure distribution practices are ‘up to scratch’. This announcement follows the release of Report 795 Design and distribution obligations: Compliance with the reasonable steps obligation by ASIC. Alan Kirkland, ASIC Commissioner, has said that improvements across the board are still required to ensure that consumers feel confident that the financial products they purchase will suit their needs.
Acting with other US regulators, the Commodities Futures Trading Commission (“CFTC” or “Commission”) recently issued two consent orders (“CFTC Orders”) and filed a complaint (“CFTC Complaint”) alleging fraud and false, misleading, or inaccurate reports relating to voluntary carbon credits (“VCCs”). As noted by CFTC Director of Enforcement Ian McGinley, “[these actions] demonstrate [the CFTC’s] commitment to vigorously fight frauds in its markets, whether long-established or new and evolving, such as the carbon credit markets.” These are the first CFTC actions for fraud in the VCC market, and closely follow the CFTC’s recently published final Commission Guidance Regarding the Listing of Voluntary Carbon Credit Derivative Contracts (“Final Guidance”).
On 24 October 2024, the Monetary Authority of Singapore (MAS) and Infocomm Media Development Authority of Singapore (IMDA) announced that the Shared Responsibility Framework (SRF) for phishing scams will be implemented on 16 December 2024 via a set of guidelines. Under the SRF, financial institutions (FIs) and telecommunication operators are assigned duties to mitigate phishing scams. The MAS and IMDA expect responsible entities to bear any scam losses arising from failure to fulfill any of the relevant duties under the “waterfall” approach.
The European Council adopted the new Product Liability Directive on 10 October 2024, and it is now awaiting publication in the Official Journal of the European Union. From its entry into force, member states will have two years to transpose it into their national law. The new directive derogates Directive 85/374/CEE. Considering the current context in which digitalization and business models based on sustainability and the circular economy are booming, it was crucial to carry out an update of the rules governing the civil liability of manufacturers and other operators of defective products.
The new EU Capital Requirements Directive establishes a new harmonized and more restrictive framework for cross-border banking and lending into the EU. The new third country branch rules will prohibit the provision of certain banking services into the EU on a cross-border basis by firms outside the EU, unless done in accordance with limited exemptions.
On 11 September 2024, the Australian Government released a much-anticipated bill which proposes to extend the anti-money laundering and counter-terrorism financing regime to real estate professionals, professional service providers including lawyers, accountants and trust and company service providers, and dealers in precious stones and metals.
On 4 October 2024, the Monetary Authority of Singapore (MAS) published the Consultation Paper on Proposed Regulatory Approach, Regulations, Notices and Guidelines for Digital Token Service Providers issued under the Financial Services and Markets Act 2022 (P010-2024) (“Consultation Paper”).
The Consultation Paper, which includes a number of Annexes, sets out the MAS’ proposed new regulatory framework for digital token service providers (DTSPs) that will be regulated under Part 9 of the Financial Services and Markets Act 2022 (FSMA). The MAS’ key proposals for the new regulatory framework for DTSPs center around licensing requirements, anti-money laundering and countering the financing of terrorism compliance, financial obligations and governance requirements