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

On April 25, 2023, Myanmar’s Ministry of Planning and Finance issued a standard operating procedure (SOP) requiring entities and individuals remitting foreign currency equivalent to more than USD 10,000 out of Myanmar to clear their tax payments prior to the remittance. The SOP took effect on May 1, 2023. This is the latest development since Myanmar began imposing restrictions in April 2022 on the remittance of foreign currency out of the country, implemented by the Central Bank of Myanmar and the Foreign Currency Supervisory Committee. The SOP requires the remitters described above to obtain certain documents evidencing payment of all requisite taxes and duties, and to submit them to their licensed authorized dealer (AD) bank as part of the remittance process. The documents required as evidence differ depending on the purpose of the remittance. The SOP details three main categories, as summarized below. Payments for Interest, Royalties, Trademarks, Copyrights, or Services A remitter of foreign currency for payment of interest, royalties, trademarks, copyrights, or services, must first apply to the Internal Revenue Department (IRD) for evidence that all applicable withholding tax has been paid. In addition, if the country to which the payments are being remitted is party to an avoidance of double taxation agreement with Myanmar, evidence of the recipient’s tax residency must also be submitted to the AD bank. Payments for Goods A remitter of foreign currency to pay for goods must submit the necessary IRD forms along with evidence that corporate income tax and other applicable taxes have been paid. Evidence may include a tax clearance certificate for the fiscal year, the company name, the taxpayer name, and the taxpayer identification number (TIN). Salary Payments A person remitting, in foreign currency, salary earned in Myanmar must submit the required form showing that they paid income tax in the applicable fiscal year. New taxpayers

Southeast Asia’s remarkable growth as a destination for foreign investment—including a 42 percent increase in 2021, according to a joint ASEAN-UNCTAD report—has brought with it innovation as well as the desire to protect that innovation. Investors are increasingly seeking to patent the proprietary technology that is a crucial component of so many businesses today, and a burning question for patent applicants is whether artificial intelligence (AI) technology and software are patentable in Southeast Asia. The short answer is that it depends, as the patent laws in Southeast Asia are not uniform. Is it Patentable? While AI tools tend to be newer, the older and more familiar question is whether computer software is patentable, and many jurisdictions do have specific rules on this issue. Pure software, or software characterized only by source code, may not be patentable, but it can be protected under copyright laws. AI-related software may involve complex algorithms, datasets, and training methodologies that can be challenging to disclose in a manner that satisfies the enablement requirement in practice. Algorithms, mathematical methods, and abstract ideas are often considered non-patentable subject matter in many jurisdictions. While software implementing AI may involve innovative algorithms, securing patents for algorithms alone can be challenging in some jurisdictions. Also, the patent laws of Indonesia, Myanmar, Thailand, and Vietnam specifically list computer programs as unpatentable subject matter. However, a possible workaround would be to describe the software as connected to a tangible medium. This method could overcome an unpatentable subject matter rejection during substantive examination. Furthermore, in Indonesia, a computer program can be patentable if its characteristics (i.e., instructions) have a technical effect and function to solve a tangible or intangible problem. The most liberal of Southeast Asia’s patent regimes—Singapore’s—even addresses AI innovations. The country has a special fast-track scheme for examining AI patent applications called Accelerated Initiative for

Cambodia’s Ministry of Health (MOH) has issued a notification reminding advertisers of health products and cosmetics in the country to obtain the required advertising approvals from the MOH. Issued on April 21, 2023, MOH Notification Letter No. 2198 on the Unauthorized Advertising of Modern Medicines, Traditional Medicines, Health Supplements, Medical Devices, and Health Supporting Products confirms that the MOH is aware of unauthorized advertising taking place in Cambodia, and signals its intention to increase enforcement efforts. It is therefore important for advertisers not yet in possession of the necessary approval to obtain the required advertising authorizations before marketing their health products in Cambodia. Advertising Framework for Health Products in Cambodia To legally advertise a health product in Cambodia, it must first be registered with the MOH (except for cosmetics, which only require notification). Only then can advertising approval be sought from the MOH, which will review the content of the proposed advertisement for compliance with Cambodian law. Approval is subject to a time limit, depending on the manner of advertising. All forms of advertising are covered under the MOH’s purview, including online, offline, business-to-consumer (B2C), business-to-business (B2B), promotion to healthcare professionals, and any other form of advertising. Key regulations prescribing general advertising rules are the Law on Consumer Protection, the Law on E-commerce, and the Sub-Decree on the Management of Commercial Advertising of Products and Services. However, product-specific regulations may also apply, depending on the type of product. For example, certain products may be subject to the regulation that sets rules for trading cosmetics in Cambodia, the (amended) Law on the Management of Pharmaceuticals, or others. Usually, product-specific regulations apply first, with the general product advertising rules being applied in addition wherever they do not conflict with the product-specific regulations. A key issue found among both general and product-specific rules is the prohibition on exaggerating