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

In Myanmar, a Union Tax Law is enacted each year to announce the rates of tax set out in the Income Tax Law 1974, the Commercial Tax Law 1990, and the Special Goods Tax Law 2016. The Union Tax Law 2023 (UTL 2023) came into force on April 1, 2023. It sets the rates of special goods tax (SGT), income tax (IT), and commercial tax (CT) for the period of April 1, 2023, to March 31, 2024, and exempts certain goods and services from these taxes. The key changes implemented by the UTL 2023 are summarized below. Special Goods Tax The UTL 2023 exempts battery electric vehicles (BEVs) from SGT. At the same time, it increases the rate of SGT on imported liquor. Previously, the rate of SGT ranged from 190 MMK per liter to 60 percent of the per-liter price of imported liquor in the previous fiscal year. The UTL 2023 raises the minimum rate to 209 MMK per liter while leaving the upper rate unchanged. Commercial Tax and Customs Tariffs BEVs imported into Myanmar were made exempt from CT under the Law Amending the Union Tax Law 2022. The UTL 2023 extends the exemption until the end of the 2023–24 fiscal year, along with two- and three-wheeler BEVs, BEV batteries, and related parts for specific use in BEVs. The CT exemption for battery charging services for BEVs, also introduced in 2022, has similarly been extended. Following enactment of the UTL 2023, the Ministry of Planning and Finance (MOPF) issued Notification No. 31/2023, reducing to zero the customs tariffs on imported BEVs, including those imported completely built up (CBU), completely knocked down (CKD), or semi-knocked down (SKD). The tariffs on spare parts and materials for BEVs have also been reduced to zero. In addition to exempting BEVs from SGT and CT, the UTL 2023 exempts