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In Environment

Singapore: Proposed Revisions to the Cleaning Business Licence Regulatory Framework

by , and 3 Mins Read

The Environmental Public Health Amendment Bill, introduced in Parliament on 9 January 2023, has proposed revisions to the cleaning business license regulatory framework in a bid to drive capabilities and raise public health standards of cleaning businesses. The existing framework, which was introduced in September 2014, only provides for one type of cleaning business license. However, the revised framework, which is intended to come into force from 1 January 2024, will provide for three different classes of cleaning business licenses.

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In Environment

Singapore: Passing of Electric Vehicles Charging Act 2022

by , and 4 Mins Read

The Electric Vehicles Charging Act 2022 that seeks to regulate the provision of safe and reliable charging of Electric Vehicles and the expansion of the EV charging infrastructure in Singapore was passed by Parliament in January 2023. The Act is expected to take effect in the second half of 2023. Notably, the Act sets out a licensing regime for EV charging operators and also prescribes certification requirements that all EV chargers would have to meet before the chargers can be installed and used in Singapore.

In Corporate Compliance

United States: Now is the time to evaluate your online content moderation program

by and 7 Mins Read

US laws have traditionally given online services significant leeway to moderate user-generated content however they see fit. In particular, there is a long history of US courts relying on Section 230 of the Communications Decency Act (CDA 230) to reject a wide range of claims seeking to hold online services providers liable for hosting, displaying, removing or blocking third-party content, including under contract, defamation, tort and civil rights laws. CDA 230 does not protect online services providers from all claims related to third-party content. For example, there are statutory exceptions for IP infringements and criminal violations. But many commentators credit CDA 230 as one of the most important laws in the development of the internet by allowing online services providers to focus on growing their user base without having to discharge unduly burdensome duties to continuously review, assess and moderate user-generated content.

In AML & Financial Services Regulatory

United Kingdom: “What does 2023 hold? Key upcoming developments and enforcement trends”

by , , and 2 Mins Read

Baker McKenzie are pleased to share with you their annual briefing looking at financial services regulation and enforcement in 2023, “What does 2023 hold? Key upcoming developments and enforcement trends”. The London Financial Institutions Regulatory and Enforcement experts explore the key developments and trends expected to dominate the regulatory landscape this year.

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In AML & Financial Services Regulatory

United Kingdom: Treasury sets out vision for cryptoasset regulation

by , and 2 Mins Read

HM Treasury has finally published its much anticipated consultation and call for evidence on a future financial services regulatory regime for cryptoassets. Building on the forthcoming stablecoin regulatory regime, the Treasury’s consultation sets out proposals to bring a broad set of cryptoassets within the Financial Services and Markets Act 2000 regulatory perimeter. This will result in a fundamental change in the way that cryptoasset businesses operate in the UK: the key outcomes of the consultation are that (a) cryptoasset service providers will require full FCA authorization to operate where they do so in the UK (or have customers in the UK), and (b) a new bespoke regime will be brought in governing public offers of cryptoassets and admission to trading of those assets on platforms.

In Trade and Foreign Investment

Germany: The new German Batteries Act

by and 4 Mins Read

On 1 January 2021, a revised version of the German Batteries Act (Batteriegesetz, “BattG”) entered into force. This change was triggered by the fact that the former German system of battery take-back was no longer sustainable. The former legal structure had imposed an unfair burden upon GRS Batterien, Europe’s largest collection scheme, which had become increasingly financially unattractive and therefore had been abandoned by many battery manufacturers who had set up their own take-back schemes.

In Product Regulation & Liability

United States: With China’s re-opening: staying ahead of FDA drug cGMP enforcement

by , and 4 Mins Read

The US Food and Drug Administration ensures the quality of drug products by carefully monitoring both domestic and foreign drug manufacturers’ compliance with its Current Good Manufacturing Practice regulations. With over 350 manufacturing establishments supplying the US drug market, China represents one of the two countries with the most foreign drug establishments subject to FDA inspection.

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In Product Regulation & Liability

European Union: Upcoming reforms in the pharmaceutical sector

by 2 Mins Read

2023 is gearing up to be an interesting year for those in the life sciences sector, with upcoming reforms to the established regulatory and IP landscapes that will impact innovator strategies in R&D, commercialization, and patent enforcement. While reforms are currently under draft by the European Commission, the key areas of anticipated change are highlighted in a newly published article in The Life Sciences Lawyer.

In Product Regulation & Liability

Hungary: Regulatory authority weighs in on Medical Science Liaison position

by and 3 Mins Read

Pharma companies often employ Medical Science Liaisons (MSLs) in order to provide healthcare professionals (HCPs) with high-quality professional and scientific information that lacks promotional content thereby distinguishing it from the information provided by medical sales representatives.
In a recently published decision, the National Institute of Pharmacy and Nutrition (NIPN) stated that it does not support distinction between professional and promotional communication. This position leaves pharma companies with two options: either to register MSLs with the NIPN as a medical sales representative, or to try to severely restrict the information an MSL may share with HCPs.

In Product Regulation & Liability

United States: With China’s re-opening: staying ahead of FDA drug cGMP enforcement

by , and 4 Mins Read

The US Food and Drug Administration ensures the quality of drug products by carefully monitoring both domestic and foreign drug manufacturers’ compliance with its Current Good Manufacturing Practice regulations. With over 350 manufacturing establishments supplying the US drug market, China represents one of the two countries with the most foreign drug establishments subject to FDA inspection.

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