One of the more positive outcomes of the COVID-19 pandemic is that telemedicine has become remarkably important as an interactive system between patients and healthcare professionals. Thailand, which ranks near the top as a world medical hub, is a highly favored destination in Asia for expat workers. Currently, the Thai market has both Thai-based and foreign-based platforms with information about healthcare providers and telemedicine readily available. “Doctor Locator,” “Weed Map,” and “Find a Teeth Aligner Dentist” are examples of online platforms connecting patients with medical and telemedicine services. These digital platforms provide information about the location of specialized clinics, cannabis dispensaries, pharmacy stores, and orthodontic practitioners in Thailand. These platforms act as intermediaries between medical care businesses and consumers. As actual medical services are not offered or provided, these digital platforms do not have to be regulated under the Medical Facility Act of Thailand. However, healthcare digital platform services that act as an intermediary or conduit managing information used to connect medical clinics or cannabis dispensaries with patients or customers via a computer network are now regulated under the soon-to-be-implemented Royal Decree on Digital Platforms, regardless of whether payment is actually made via the platform. The regulatory authority for this is the Electronic Transactions Development Agency (ETDA). Under this royal decree, digital platform providers that intend to operate a digital platform service must notify the ETDA prior to initiating operations. The extent of the details to be included in the notification to the ETDA will be more comprehensive if the digital platform: has annual revenue (before expenses) for digital platform services within Thailand exceeding THB 1.8 million (approx. USD 51,200) for an individual operator or THB 50 million (approx. USD 1.42 million) for a corporate or entity operator; or has more than 5,000 users (on average) per month. Apart from these notification requirements, digital platform

On June 30, 2023, the Ministry of Health of Vietnam issued Circular No. 14/2023/TT-BYT stipulating the process and procedure for building bidding package prices for procurement of goods and services in the field of medical devices at public health facilities (“Circular 14”). Circular 14 took effect on July 1, 2023, and will be valid through the end of 2023. Circular 14 applies to the procurement of medical devices/equipment and their accessories, spare parts, and supplies, as well as related services of repair, maintenance, inspection, and calibration. Under Circular 14, there are three methods of determining the price of bidding packages: Collecting quotations provided by suppliers of goods and services in the field of medical devices. Surveying the winning bid prices of similar goods and services on the national bidding network system (https://muasamcong.gov.vn). Using the results of price appraisal of a competent state agency that conducts price appraisal, or a specialized price appraisal enterprise. Method (i) must be used first; the two remaining methods can be applied only after method (i) has been unsuccessful. If the investor/procuring entity uses two or more methods to determine the price of bidding packages, it can select the highest price that is suitable to its financial capacity and professional requirements. Circular 14 further sets out the specific step-by-step process to build prices for procuring products and services in the field of medical devices/equipment. Transitional Provision For bidding packages that have already approved a contractor selection plan before July 1, 2023, the approved contractor selection plan will be followed. For bidding packages for which a contractor selection plan has been submitted by the investor/procuring entity but the plan has not yet been approved, the competent person can decide on the approval of the submitted plan or can request the investor/procuring entity to rebuild the bidding package price according to the provisions of Circular 14.

Tilleke & Gibbins is pleased to announce the release of Employment Law Basics in Southeast Asia. This publication serves as an indispensable resource for businesses navigating the complex landscape of employment law in Cambodia, Laos, Myanmar, Thailand, and Vietnam. Authored by Tilleke & Gibbins’ regional team of employment law specialists, the guide provides a detailed overview of key employment law topics essential for businesses operating or planning to expand their operations in Southeast Asia. From employment contracts to termination procedures, each topic is examined in depth to ensure businesses are well-equipped to comply with local regulations and protect their interests. Key topics covered in the guide include: Employment contracts Probationary period Minimum wage Social security and statutory payments Working hours Leave and holidays Work rules Termination Foreign employees Data protection Remote work AI and automation Our guide offers multinational corporations establishing a presence in the region and local enterprises alike practical insights and actionable advice tailored to the unique regulatory environments in Cambodia, Laos, Myanmar, Thailand, and Vietnam. To access the full guide, please download the PDF below.

Cambodia has the potential to be one of the top countries in the world for generating renewable energy through solar, based on the average amount of sunlight hours available per day and the consistent sunshine throughout the year. The Cambodian government has recognized this potential and has made major updates to its energy policies in recent years. Solar power is now taking over a much larger portion of the total energy mix in Cambodia, especially as a number of utility-scale solar power plants have come online in recent years. The long-term Power Development Master Plan 2022–2040 sets out the long-term energy policy for Cambodia and requires a bigger role for renewables. The use of solar power will play a key role in this aim to increase the role of renewables, with the plan foreseeing almost 30% of all national power generated through solar technologies by 2040. Two of the latest legislative and regulatory steps by the government are the Ministry of Mines and Energy’s guidelines for rooftop solar systems, and most recently the long-awaited Environment and Natural Resources Code, which was enacted on June 29, 2023. Rooftop Solar Projects Many companies, from small startups to multinationals, are exploring the potential for rooftop solar in Cambodia. However, despite the favorable natural factors, the regulatory framework was not always clear or friendly to rooftop solar, hampering investment. This started slowly changing with the adoption of the first solar energy regulation in 2018, which provided the country’s first official guidance on both solar power plants and rooftop solar. It provided some much-needed clarity, but the 2018 solar energy regulation—and especially the subsequent electricity tariff schemes—often kept rooftop projects from being financially viable. Many players in the industry voiced their doubts about the regulations and tariffs, focusing especially on the capacity charge—a monthly electricity charge based on the total capacity

Following Laos’ announcement requiring importers and exporters to register with the Ministry of Industry and Commerce (MOIC), the MOIC has released a comprehensive list of products that are subject to the registration requirement. Traders that import or export goods on the list, which was finalized on June 9, 2023, and made public on June 28 in MOIC Notification No. 1224, must register with the MOIC by August 31, 2023, to obtain a certificate authorizing their import or export activities. The notification specifies four main categories of goods for which importers and exporters must register with the Department of Import and Export (DIMEX) of the MOIC: agricultural products, construction materials, and edible and nonedible consumer goods. The exact products in each category are listed below, along with the corresponding Harmonized System codes from the World Customs Organization: Enterprises engaged in the import and export of the goods listed in the table above must complete registration by August 31, 2023. Imports and exports of the listed goods by any enterprise not registered with the DIMEX will be prohibited after the deadline. The MOIC is also expected to add certain goods to the list in the future, but information on the timing and content of these additions is not yet available. Enterprises that have completed registration must also ask the Bank of Lao PDR (BOL) to certify their accounts held at commercial banks, after which they must ask the relevant commercial banks to convert their current bank accounts into import-export accounts. For more details on Laos’ new registration rules for importers and exporters, or on any aspect of international trade involving Laos, please contact Tilleke & Gibbins at [email protected].

The amended IP Law adopted by the National Assembly of Vietnam on June 16, 2022, which took effect on January 1, 2023, revises the definition of an industrial design, which had been unaltered since the introduction of the first IP Law in 2005. This amended definition will certainly have a significant influence on the understanding, application, and interpretation of regulations on protection of industrial designs in Vietnam. The revised definition reads as follows, with the new additions in bold (no words were removed from the old definition): Article 4.13: Industrial design means the external appearance of a product or a component for assembly of a complex product represented in shapes, lines, colors, or any combination thereof, and visible during the utilization of the product or complex product. This definition can be separated into two groups of objects: Group 1 Industrial design means: 1.1: the external appearance of a product 1.2: represented in shapes, lines, colors, or any combination thereof, and 1.3: visible during the utilization of the product. Group 2 Industrial design means: 2.1: the external appearance of a component for assembly of a complex product, 2.2: represented in shapes, lines, colors, or any combination thereof, and 2.3: visible during the utilization of the complex product. In principle, Group 2 must include at least one object that is not covered in Group 1, because if Group 2 is completely covered by Group 1, it would be unnecessary to revise the definition to reflect the “new” group of objects. We will consider the above definition in such spirit.   Group 1 Objects Under the revised definition, conditions 1.1 and 1.2 are unchanged, and condition 1.3 is added. Condition 1.3 essentially reflects the exclusion already specified in Article 64.3 of the IP Law, i.e., “the external appearance of a product that is invisible during the utilization of the product is not registrable as an industrial

Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world. The Life Sciences Global Guide is divided into two sections: Regulation (see more details here) and Commercialization, which covers the following topics: 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 to the public and engagement with patient organizations Advertising to healthcare professionals and organizations: Gifts and incentives and transparency and disclosure 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 Vietnam” section can be found on the Practical Law website.

Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world. The Life Sciences Global Guide is divided into two sections: Commercialization (see more details here) and Regulation, which covers 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 Recent developments and reform 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 Vietnam” section can be found on the Practical Law website.