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].

On May 15, 2023, Vietnam’s Deputy Prime Minister Tran Hong Ha signed Decision No. 500 of the Prime Minister approving the National Power Development Plan for the period 2021-2030, with a vision to 2050 (“PDP VIII”), following extensive public consultations and multiple rounds of review since the first draft version was circulated in 2021. The plan was approved in the context that in the past few years, a number of large power projects have been behind schedule for operation, while new projects have not been able to be implemented due to waiting for additional planning. PDP VIII is the master plan for the development of the power source and transmission grid at 220kV or higher; services in renewable energy and new energy in Vietnam; and works connecting the power grids of Vietnam and neighboring countries. We set out below some quick updates regarding PDP VIII. 1. Development Targets Key development targets are summarized in the table below: Investors in coal, domestic gas, and LNG projects may need to have a conversion plan ready given the 2050 targets to convert to other sources of energy. 2. Solar Projects A list of 27 solar power projects that were planned for the period of 2021-2030 but which have not been assigned to investors are not allowed to be deployed but can be considered after 2030, except in the case of deployment in the form of self-production and self-consumption (Appendix IV). These projects represent 4,136.25 MW of capacity that will be left on the sidelines until 2030. 3. Hydropower Projects A list of 14 potential hydropower projects can be considered if economic and technical conditions allow for more hydropower development (Appendix III). These projects represent 1,244 MW of capacity that can be added to the hydropower targets for 2030. 4. Projects Prioritized for Investment Certain important projects will be prioritized for investment (Appendix II),

Thailand’s Office of the Securities and Exchange Commission (the “SEC Office”) has revamped various rules relating to private placements by listed companies with a view to streamlining the offering process and reducing the documentation required for submission to the SEC Office. Most of these rules were revised by the Capital Market Supervisory Board on December 28, 2022, and will come into effect on July 1, 2023. The key amendments in the new rules are summarized below. Elimination of Application Requirement Issuers are no longer required to apply to the SEC Office prior to offering their shares via private placement, according to new rules laid out in the Notification of the Capital Market Supervisory Board No. TorChor 28/2565 Re: Permission for Listed Companies to Offer Newly Issued Ordinary Shares via Private Placement (the “TorChor 28/2565 Notification”). The rules detailed in this notification will replace the current private placement rules under the Notification of the Capital Market Supervisory Board No. TorChor 72/2558 Re: Permission for Listed Companies to Offer Newly Issued Ordinary Shares via Private Placement. Under the TorChor 28/2565 Notification, issuers may offer their shares via private placements that are share offerings to no more than 50 high-net-worth or ultra-high-net-worth investors within 12 months, share offerings valued at no more than THB 20 million within 12 months, or share offerings to institutional investors (excluding share offerings to the issuer’s directors or employees), so long as the issuer complies with its information disclosure and corporate approval requirements, which remain mostly unchanged under the new notification. To fulfill these requirements, notice of a shareholders’ meeting must be submitted to all shareholders at least 14 days in advance, and the offering must be approved by a supermajority vote of the shareholders, which means approval by at least three-fourths of the shareholders present and entitled to vote at the