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In Product Regulation & Liability

United States: Federal Trade Commission finalizes new rule making it easier for consumers to “Click-to-Cancel” subscriptions and memberships

by , and 8 Mins Read

On 16 October 2024, the Federal Trade Commission (FTC) announced its final “Click-to-Cancel” Rule that applies to businesses that offer goods and services through automatically renewing payment plans, free or discounted trials that convert into full plans, or other “negative option features” that interpret a consumer’s silence as permission to keep charging them (collectively, “recurring subscriptions”). Under the finalized rule, the FTC may seek civil penalties of over USD 50,000 per violation, injunctive relief and consumer redress for companies that violate the requirements of having detailed transparent, consent and simple cancellation processes for recurring subscriptions and memberships.

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In AML & Financial Services Regulatory

Australia: Taming the Solvency Sea Dragon

by and 3 Mins Read

Directors in corporate groups can take greater comfort when relying on financial support from related entities, following a recent Full Court of the Federal Court decision in the case of Canstruct Pty Ltd v Project Sea Dragon Pty Ltd (Subject to a Deed of Company Arrangement) [2024] FCA 112.
Last year, doubt was cast on the adequacy of financial support that is not fully documented or binding to establish the solvency of a related company. This decision has reset that position in favor of such arrangements potentially being sufficient, provided actual support is given.

In Product Regulation & Liability

European Union: Substantial reform of European product safety law to come into force on 13 December 2024

by and 6 Mins Read

On 13 December 2024, the new Regulation (EU) 2023/988 on general product safety (GPSR) will finally apply in all EU Member States, replacing the current Directive 2001/95/EC on general product safety.
The GPSR addresses risks related to new technologies and online trading, covering a wide range of products. It represents the most comprehensive reform of European product safety law in over 20 years and will impact most economic operators (manufacturers, importers, distributors, fulfillment service providers, etc.) in the EU market.

In AML & Financial Services Regulatory

United States: The SEC adopts EDGAR Next – What public companies need to know now

by , and 7 Mins Read

On September 27, 2024, the Securities and Exchange Commission (SEC) approved final rules as part of technical amendments to EDGAR (collectively, referred to as “EDGAR Next”) to enhance the security of the system. The rulemaking amends Rule 10 and 11 of Regulation S-T, Form ID (needed to obtain EDGAR access codes) and updates the EDGAR Filer Manual.
EDGAR Next will significantly change how filers access EDGAR, make filings, and manage accounts.

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In Cybersecurity, Data and Tech

Taiwan: New anti-fraud regulations for online advertising platforms

by and 5 Mins Read

In response to the persistent issue of fraud, the Fraud Crime Hazard Prevention Act (FCHPA) was passed by the Legislative Yuan and came into force on 31 July 2024. The FCHPA requires financial institutions, virtual asset service providers, telecom enterprises, online advertising platform operators, third-party payment service providers, e-commerce and online gaming companies to respectively take certain fraud prevention measures.
In September 2024, the Ministry of Digital Affairs (MODA) published the criteria of the online advertising platforms that would be subject to the FCHPA, designated four foreign online advertising platform operators that meet the criteria, and asking them to report their legal representative (can be a law firm) in Taiwan by 31 October 2024.

In AML & Financial Services Regulatory

Canada: Deadline approaching for registration under the Retail Payment Activities Act

by , and 6 Mins Read

Registration for payment service providers under the new Retail Payment Activities Act is fast approaching. Individuals or entities performing retail payment activities in Canada have a 15-day window between 1 November 2024 and 15 November 2024 to submit their applications with the Bank of Canada to avoid a 60-day delay in performing their retail payment activities, a notice of violation under the Act, or significant monetary penalties. If you or your entity may be required to be registered as a payment service provider under the Retail Payment Activities Act, and you have not yet prepared your application materials, please contact us as soon as possible and we will help.

In Product Regulation & Liability

United States: Company fined by FTC for false claims about supplements reducing alcohol cravings and consumption

by , and 4 Mins Read

On 7 November 2024, the FTC announced it will be sending refunds to 536,000 consumers deceived by Rejuvica’s and its owners’ unsupported claims that Sobrenix, a dietary supplement marketed and sold by Rejuvica, could reduce and eliminate alcohol cravings and consumption. In addition to the refunds, the FTC’s proposed order requests a permanent injunction and other relief due to violations under the FTC Act and the Opioid Addiction Recovery Fraud Prevention Act of 2018

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In Product Regulation & Liability

European Union: OECD survey – confidential agreements and barriers to transparency in drug pricing

by , and 1 Min Read

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.

In Product Regulation & Liability

European Union: The impact of AI Act (EU Regulation 2024/1689) on legacy and in-house medical devices

by , and 2 Mins Read

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 Product Regulation & Liability

Singapore: Health Sciences Authority updates guidance on implementation of Good Manufacturing Practice (GMP) Evidence for Drug Substance (DS) manufacturers

by and 2 Mins Read

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.

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