In Southeast Asia, artificial intelligence (AI) products and services are being leveraged across industries such as finance, healthcare, retail, agriculture, and manufacturing. Governments across the region are recognizing the benefits of harnessing AI and the positive impact of AI technology on economic development. As the rise in AI deployment creates opportunities for economic growth in Southeast Asia, regulatory and digital governance efforts should focus on ethical, inclusivity, and cybersecurity concerns to help ensure that the widespread use of AI technology in the region is sustainable. Two jurisdictions in the region that have already made significant strides in developing initiatives surrounding AI are Singapore and Thailand. Singapore Due to its more advanced technological infrastructure, Singapore was one of the first countries in the region to address AI-related issues. Singapore has been aligning its data protection policies and regulations with the changing digital landscape since 2012—the year Singapore passed its Personal Data Protection Act. In 2019, Singapore unveiled its National AI Strategy to increase the use of AI technologies and deploy “scalable, impactful AI solutions in key verticals by 2030.” The goal is to align talent, regulation, and business growth to ensure AI applications serve society. Singapore’s approach is to facilitate innovation while safeguarding consumer interests, as it strives to become one of the regional leaders in the field of AI. In terms of Singapore’s regulatory landscape, Singapore’s Personal Data Protection Commission (PDPC) oversees data and AI, including AI developers and AI-using companies, which consist of backroom operations, front-end usage companies, and distributors of equipment with AI features. The Singapore Academy of Law (SAL) oversees all laws applicable to AI systems and decides on issues that impact the AI industry. Singapore has joined various bilateral and regional trade arrangements to facilitate research, development, and collaboration in support of its growing digital economy. Singapore’s Info-Communications Media

Thailand’s labeling requirements have new rules on product label font size and readability following the issuance of Announcement of the Label Committee Re: Characteristics of the Label for Label-Controlled Goods No. 3, which is a bylaw of the Consumer Protection Act (CPA). The announcement takes effect on June 18, 2023, and applies to all “label-controlled goods,” which are described under the CPA and its bylaws as goods either produced by factories in Thailand or imported into Thailand for sale. The labels of these goods must meet current labeling requirements, such as having information about the product name, quantity, intended use, cautions, and expiry date. Label readability—specifically in terms of the size of text on labels—is also a mandatory requirement, and is the focus of this latest announcement. Text size requirements are an important part of ensuring that consumers are fully aware of the details of a product before deciding to purchase the goods. According to the announcement, any statement or text displayed on a label must be easily visible and readable. The size of the text must be proportional to the label area. Specifically, the text height must not be less than 2 millimeters (or 1.5 millimeters for labels with an area of less than 35 square millimeters). The announcement does not clarify exactly how the height of the text will be determined. Some companies have expressed concern that these requirements are too strict and will be challenging to meet, especially for small businesses. The text size requirements may be expensive to implement, as the larger text requires more space on the label, potentially leading to larger labels or packages, higher production costs, or even expensive recalls to affix new labels. In some cases, text size requirements may even make it impossible to fit all the required information on the label. A violation

In April 2022, Myanmar’s State Administration Council established the Foreign Exchange Supervisory Committee (FESC) to approve foreign currency conversion, make exemptions to foreign exchange restrictions, and permit overseas foreign currency transfers. Because of the FESC’s establishment and related regulatory changes, companies that would like to transfer funds out of Myanmar for capital reduction, share capital for liquidated companies, share transfers, or share dividends must abide by the FESC’s requirements, which vary depending on the type of company. The Myanmar Investment Commission (MIC) has announced that companies permitted by or endorsed under the Myanmar Investment Law must submit various supporting documents when applying to transfer foreign currency internationally. These documents, which must be addressed to the MIC chairman, include the following: Prescribed form for transfer of foreign currency; Application letter giving a specific reason for the transfer; Original board of directors’ resolution; Audited financial statements for the relevant financial year; Up-to-date bank statement of the company; Tax assessment confirmation letter for the relevant financial year; Tax clearance certificate for the relevant financial year, in the case of liquidated companies; and Copy of the updated quarterly performance report using the form prescribed by the MIC. If the transferor cannot submit the documents in person, the required documents need to be accompanied by a power-of-attorney or appointment-of-representative letter. Though the FESC has not announced its own documentation requirements, experience shows that MIC companies must submit an application to the MIC Investment Monitoring Division before submitting their offshore remittance application to the FESC. Once the MIC has received a complete application, it will request a recommendation from the Central Bank of Myanmar (CBM). With this recommendation in hand, the Investment Monitoring Department will then seek FESC approval internally. Aside from MIC companies, DICA companies (i.e., companies that do not require approval from the MIC for their business activities) must submit their applications for offshore transfers

Life sciences specialists from Tilleke & Gibbins have supplied the Thailand and Vietnam contributions to the International Bar Association (IBA) Healthcare and Life Sciences Law Committee’s global telemedicine survey. The survey, spanning 54 jurisdictions worldwide, functions as a comparative legal guide on the provision of telemedicine and related products and services. It offers practitioners and industry users access to relevant rules and regulations, addressing key aspects such as regulation, data privacy, liability, and recent developments in telemedicine. Telemedicine has emerged as a transformative force in healthcare, revolutionizing the way medical services are accessed and delivered. As in many other jurisdictions, telemedicine has gained prevalence in Thailand and Vietnam, as it enables patients to remotely consult with healthcare professionals, access diagnostic services, and receive timely medical advice while minimizing physical contact. As the global healthcare landscape continues to evolve, understanding the legal and regulatory aspects of telemedicine becomes paramount, making initiatives like the IBA’s telemedicine survey vital for practitioners and industry stakeholders. The IBA is a globally recognized organization that brings together legal professionals and bar associations from around the world, and its Healthcare and Life Sciences Law Committee plays a crucial role in addressing legal issues and developments in the healthcare industry. The complete surveys for Thailand and Vietnam­—and the 52 other participating jurisdictions—are available on the IBA website.

The draft Royal Decree on Artificial Intelligence System Service Business, which was introduced by the Office of the National Digital Economy and Society Commission earlier for public comment in October last year, focuses on potential risks from artificial intelligence (AI) systems to public health, safety, and freedoms. The framework emphasizes the importance of risk assessment, reporting requirements, and the establishment of specific measures and criteria deemed necessary to minimize AI risks. AI Systems Defined by the Decree Under the draft royal decree, an AI system is defined as a machine-based system that can make predictions, recommendations, or decisions that affect real or virtual environments pursuant to the objectives set by humans. The definition clarifies that artificial intelligence systems are designed to operate at different levels of autonomy, including: machine learning AI; logic-based and knowledge-based AI; statistical AI; Bayesian estimation AI; and search and optimization AI. Risk-based Approach The draft AI royal decree takes a risk-based approach to regulation and specifically identifies prohibited or high-risk AI services that could cause harm or engage in unethical practices to ensure that AI systems do not pose major risks to public health, safety, or freedoms. The extent of regulatory scrutiny applied to an AI system corresponds to the level of risk presented by the AI system. For example, AI systems that pose unacceptable risks are generally prohibited, AI systems considered to be high-risk are subject to a conformity assessment, and AI systems considered to be limited-risk are subject to transparency requirements. Compliance with specified criteria and procedures to minimize potential risks of each AI service would be further outlined in subregulations. Prohibited AI Systems The draft AI royal decree prohibits AI systems that: employ subliminal techniques to covertly influence human behavior (below the threshold of conscious awareness); utilize social scoring; access sensitive personal information like age or disabilities; or employ real-time remote biometric identification in public areas. Extraterritorial Application AI system

Life sciences specialists at Tilleke & Gibbins’ office in Bangkok have contributed a new “Life Sciences Commercialization in Thailand” chapter to the Life Sciences Global Guide from Practical Law. The Q&A-style guide provides strategic information for companies active in the life sciences sector in Thailand. The chapter covers a number of key areas: Overview of the life sciences sector Pricing, government funding, and reimbursement: National health care system, price regulation and reimbursement Distribution and sale Cross-border trade and parallel imports Advertising and engagement with patient organizations Patents: Conditions for patentability, registration, length of protection, infringement, international treaties Trademarks: Requirements, registration Competition law issues: Authorities and legislation, commercial contracts and competition law, licensing approvals and formalities Product liability: Regulators, medicinal product liability law, liable partners, defenses, product liability claims, remedies Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Commercialization in Thailand” section can be found on the Practical Law website.

The latest update to Practical Law’s Life Sciences Global Guide includes a new “Life Sciences Regulation in Thailand” chapter by attorneys in Tilleke & Gibbins’ Bangkok office. The chapter covers a range of regulatory issues related to development, manufacturing, and selling of pharmaceutical products and medical devices in Thailand. The chapter provides important information on the following topics: Pharmaceuticals: Laws and regulatory authorities Clinical trials: Legal, regulatory, and procedural requirements Manufacturing and distribution Marketing: Authorization for marketing medicinal products, monitoring compliance and penalties, pharmacovigilance and other commitments, foreign marketing authorizations Data privacy Packaging, labeling, and tracking Biological medicines Medical devices: Legislation and regulatory authorities, definition and classification Healthcare IT Combination products and borderlines Natural health products Developments, reforms, and proposals Practical Law, produced by Thomson Reuters, is the world’s leading legal know-how resource for business lawyers, publishing a huge range of guides covering hundreds of jurisdictions and practice areas. The full “Life Sciences Regulation in Thailand” chapter can be accessed on the Practical Law website.

On May 16, 2023, Myanmar’s Intellectual Property Department (IPD) announced an extension of one more month for submission of notarized appointment of representative forms (or “TM-2 forms”) and for payment of official filing fees for trademarks. The new deadline for payment and submission is June 30, 2023. The IPD had announced in April 2023 that fee payments and submission of notarized TM-2 forms for trademarks prior to the enforcement of the Trademark Law (i.e., from October 1, 2020, to April 2, 2023) had to be completed by May 31, 2023. However, technical issues have hindered the IPD’s online filing system, which has had to undergo maintenance procedures. The extension until June 30, 2023, gives mark owners more time to prepare the necessary notarized TM-2 forms for their mark applications filed prior to enforcement of the Trademark Law . For more information on the country’s new trademark system, or on any aspect of protecting intellectual property rights in Myanmar, please contact Tilleke & Gibbins at [email protected].