In April 2023, the Health Sciences Authority detected potent ingredients in two products marketed separately for pain and cough relief and alerted the public against purchasing them.
On 4 April 2023, the Health Sciences Authority issued an update on products found and reported by overseas regulators to contain potent ingredients that are prohibited and may cause side effects.
On 26 April 2023, the European Commission finally published its Proposal to revise the EU Pharmaceutical legislation, the most momentous reform for over 20 years. This is an eagerly anticipated overhaul of the EU’s pharmaceutical system that has generated a lot of debate and concern since earlier leaked documents showed the far-reaching effect of the measures that were being considered and the impact these could have on the industry. The review is part of the EU’s Pharmaceutical Strategy for Europe, and its aim is to make medicines more available, accessible and affordable whilst at the same time supporting innovation and boosting the competitiveness of the EU pharmaceutical industry.
On 20 April 2023, the Central Bank of Argentina issued Communication “A” 7746 introducing modifications to the access to the foreign exchange market for the payment of certain services abroad. Communication “A” 7746 determines that the prior approval of such entity will be required to make certain payments abroad, provides a term of 180 calendar days for the sworn statements for transactions with securities, and extends the list of persons and entities that may access a special remunerated account based on the evolution of the reference exchange rate of Communication “A” 3500.
Singapore High Court in Rio Christofle v Malcolm Tan Chun Chuen [2023] SGHC 66 concludes that the bona fide buying and selling of cryptocurrency without a licence or exemption is not to be a contravention of licensing provisions where there is no “carrying on a business of providing any type of payment service”. Three indicia suggest that a person is carrying on a business of providing a payment service: (1) whether profit has been made; (2) the number of transactions in question; and (3) whether the person is acting as an intermediary.
On 13 April 2023, the Federal Trade Commission (FTC) issued a letter containing a Notice of Penalty Offenses Concerning Substantiation of Product Claims to approximately 670 advertisers, putting each company on notice that deceiving consumers with advertisements that make unsubstantiated product claims could subject the company to civil penalties of up to USD 50,120 per violation under 15 U.S.C. § 45(m)(1)(B).
On 3 April 2023, FDA issued a draft guidance for industry, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions, for manufacturers whose medical devices use machine learning technologies to improve patient care. Through the draft guidance, FDA intends to provide a least burdensome approach to support iterative improvements to machine learning-enabled device software functions or ML-DSFs through modifications, while continuing to provide a reasonable assurance that the device is safe and effective. In essence, manufacturers can proactively seek FDA’s concurrence with the intended modifications to the applicable devices without additional marketing submissions for each modification in the future.
AI has permeated much of the financial industry and significantly changed some aspects of how its businesses operate. Not as radical transformation of the industry, however, but as a steady trickle of new technologies and applications across the sector. Considerable risks also remain, as does uncertainty about regulatory approaches to AI. Baker McKenzie spoke with four experts to explore how AI use is likely to evolve in the financial industry in the years to come.
We provided an overview perspective on EU Whistleblowing Directive: Local Implementation which includes updates on the latest EU employment and compliance developments.
The European Whistleblowing Directive was supposed to be implemented by the European Union’s 27 member states by no later than 17 December 2021, impacting employers with operations in those jurisdictions.
The South African Department of Finance has published Directive 8 on the compulsory screening of employees for competence and integrity. Failure to comply means that such businesses will risk sanction, including a fine of up to ZAR 50 million. Accountable institutions must record how the screening has been conducted and keep records of the outcome of such screening, which must be made available to the Financial Intelligence Centre upon request. It has been stipulated that screenings should begin as soon as possible.