Experts from Tilleke & Gibbins have provided updates for the latest edition of The Pharma Legal Handbook: Vietnam, published by Pharma Boardroom. This comprehensive guide to the legal framework regulating the healthcare and life sciences industries in Vietnam was authored by by the Hanoi-based team of Hien Thi Thu Vu, head of regulatory affairs for Vietnam, and Mai Thi Le, regulatory affairs consultant, the handbook is a must-read for healthcare and life sciences companies that are interested in the Vietnam market. The guide includes eight sections on various important aspects of local regulations: Regulatory, Pricing, and Reimbursement Overview Preclinical & Clinical Trial Requirements Marketing, Manufacturing, Packaging & Labeling, and Advertising Traditional Medicines and Over-the-Counter Products Product Liability Patents and Trademarks Regulatory Reforms Orphan Drugs and Rare Diseases Tilleke & Gibbins has also authored The Pharma Legal Handbook: Thailand, which was updated at the same time as the Vietnam guide. The Pharma Legal Handbook: Vietnam, like all of the country guides from Pharma Boardroom, is available for purchase on the Pharma Boardroom website.

Attorneys from Tilleke & Gibbins in Bangkok have provided updates for the latest edition of The Pharma Legal Handbook: Thailand, published by Pharma Boardroom. This comprehensive guide to the legal framework regulating the healthcare and life sciences industries in Thailand was authored by Alan Adcock, partner and director, intellectual property, and head of the firm’s life sciences practice; Dr. Atthachai Homhuan, manager of regulatory affairs; and San Chaithiraphant, senior associate. The handbook is a must-read for healthcare and life sciences companies that are interested in exploring expansion into the Thai market.

Vietnam is a world leader in blockchain adoption and growth, appearing near the top of most rankings of cryptocurrency ownership and blockchain investment. Although the country has taken a cautious approach toward cryptocurrency (banning the use of cryptocurrencies like Bitcoin as a means of payment, for example), the government actively supports blockchain technology and its applications in non-financial sectors. Recognizing blockchain as a core technology of the Fourth Industrial Revolution, as a part of Vietnam’s broader digital transformation agenda, the government issued Decision No. 1236/QD-TTg on October 22, 2024, providing the National Strategy for Blockchain Application and Development to 2025, with Orientation to 2030. Like the National Strategy on Digital Infrastructure, the National Strategy on Blockchain outlines a very ambitious vision to position Vietnam as a regional leader in blockchain technology. The strategy aims for Vietnam to master and apply blockchain across all socio-economic sectors, supporting the nation’s goal of becoming a stable and prosperous digital nation by 2030. The specific goals set for 2025 include developing Vietnam’s blockchain infrastructure and ensuring compliance with cybersecurity and data protection laws; advancing blockchain research through three national innovation centers; building and upgrading 10 facilities dedicated to blockchain research and workforce training; and expanding blockchain education by integrating it into university programs. The strategy also aims to establish at least one blockchain center, special zone, or area, as a pilot, to build a national blockchain network; and foster a blockchain ecosystem by promoting its application across sectors such as banking and finance, transportation, healthcare, education and training, commerce, logistics, postal services, industrial production, energy, tourism, agriculture, public services, and more. The goals for 2030 include strengthening Vietnam’s national blockchain infrastructure to support both domestic and international services, positioning Vietnam as a global and regional leader in blockchain research, application, and development. The strategy also aims to

On November 21, 2024, the National Assembly of Vietnam adopted a law amending and supplementing the 2016 Law on Pharmacy (“Amended Law on Pharmacy”). The Amended Law on Pharmacy simplifies some procedures for the pharmaceutical field, and will take effect on July 1, 2025, except for regulations on drug registration and rights and responsibilities of certain types of pharmaceutical business. Some outstanding points in the Amended Law on Pharmacy are presented below. E-commerce Distribution The Amended Law on Pharmacy allows trading in pharmaceutical products by the e-commerce channel, including e-commerce trading floors, e-commerce sales applications, and e-commerce sales websites with online ordering functions. Accordingly, e-commerce retail of non-prescription drugs is permitted if the drugs are neither specially controlled drugs nor drugs included in the list of drugs restricted for retail sale, and e-commerce wholesale of drugs and drug materials is permitted, as long as they are not specially controlled drugs. New Rights for Import FIEs The amendment provides some additional rights to foreign-invested enterprises (“FIEs”) that import drugs, including the rights to: Repurchase drugs and drug materials manufactured through the technology transfer of the FIE itself in Vietnam, and sell such products to wholesalers; Import drug materials to supply to drug manufacturers in Vietnam that are hired by or receive technology transfer from the FIE itself under a processing contract or technology transfer contract; Deliver and transport drugs and drug materials the FIE has imported, outsourced for processing, or transferred technology for in Vietnam, from the FIE’s warehouse to its wholesalers; Deliver and transport drugs used in aid, sponsorship, humanitarian, and disease prevention and control programs to medical facilities receiving funding; and Transport drug materials imported by the FIE from its warehouse to drug manufacturers that are hired by or receive technology transfer from the FIE itself under a processing contract or technology transfer contract, and transport drugs imported

In Vietnam, litigation is generally treated as a last resort in dispute resolution. Businesses often strive to avoid court proceedings, given the potential for disrupted relationships, higher costs, and lengthy timelines. Yet, litigation is sometimes unavoidable, whether to secure a remedy or respond to a claim. Familiarity with Vietnam’s court system and procedures is therefore crucial for any party involved in such matters. Civil Litigation in Vietnam offers a concise overview of the country’s civil court system and litigation process. The guide a highlights essential points for navigating legal disputes in Vietnam, whether as a plaintiff or a defendant. Tilleke & Gibbins also publishes a similar guide for Thailand. The full Civil Litigation in Vietnam guide is available as a PDF through the button below.

Litigation is usually the last resort in resolving disputes. Most parties to a dispute try to avoid litigation altogether, fearing that seeking recourse with the courts or arbitration will lead to a disruption in commercial relationships, result in increased legal expenses, and generally lengthen the period in which the dispute remains unresolved. While some of these concerns may indeed be legitimate, sometimes litigation is the only means for a party to obtain relief. For parties contemplating such recourse, it is reassuring to know that the Thai court system is generally an accessible, unbiased, and balanced vehicle for the resolution of disputes. Civil Litigation in Thailand aims to introduce some of the fundamentals of Thai civil court procedures and practices. This brief guide covers the main issues concerning civil litigation in Thailand as either a plaintiff or a defendant. Tilleke & Gibbins also publishes a similar guide for Vietnam. The full guide is available through the button below.

On November 30, 2024, the National Assembly of Vietnam issued a new Law on Data (“Data Law”), the first of its kind in the country. Initiated by a legislative proposal in February 2024, the Data Law underwent an accelerated preparation process and was officially promulgated just nine months later. It is worth noting that the Data Law is not the same as the Personal Data Protection Law, which is still in draft form and is expected to be submitted to the National Assembly in November 2025. The scope of application of the Data Law is broader, including not only personal data but also other types of data. The Data Law governs digital data, the National Data Center, the National General Database, digital data products and services, digital data management, and the rights, obligations, and responsibilities of agencies, organizations, and individuals related to digital data activities. Set to take effect on July 1, 2025, the Data Law is expected to have a significant impact on businesses involved in data-processing activities. Below are some key takeaways from this pivotal legislation. Cross-Border Data Transfer and Processing The Data Law recognizes and protects the freedom of cross-border data transfer and processing, as well as the legitimate rights and interests of relevant agencies, organizations, and individuals. The government is assigned the responsibility to provide detailed regulations on cross-border data transfer and processing activities, including the transfer of offshore data into Vietnam. National Data Center Resolution No. 175/NQ-CP issued by the Vietnamese government in October 2023 set out ambitious goals for a new National Data Center, which will integrate and manage human-related data from the national database, databases of ministries and central and local authorities, and other databases. The National Data Center is expected to be a core platform to provide data-related services, support policy drafting, simplify administrative procedures, and lead

On October 16, 2024, Thailand’s Anti-Corruption Cooperation Committee (ACCC) issued a notification to enhance anticorruption standards in public procurement. The new notification (officially “Notification of the Anti-Corruption Cooperation Committee on the Procurement Budget and Minimum Standards of the Policy and Directions for Anticorruption in Relation to Procurement according to Section 19 of the Public Procurement and Supplies Administration Act B.E. 2560”) supersedes previous guidelines and imposes stricter compliance requirements on business entities involved in the government procurement processes. The updates not only align with the goals of Thailand’s Public Procurement and Supplies Administration Act B.E. 2560 (2017) but also reflect the government’s resolution to mitigate corruption, particularly in high-value public contracts. The ACCC’s new notification introduces additional definitions, lowers budget thresholds for compliance, and strengthens business obligations. Key Components The new notification continues the previous guidelines’ requirement that businesses seeking to bid on government procurement projects meet the specified minimum standards—such as communicating and implementing anticorruption policies at all organizational levels, establishing a code of conduct, and providing related training programs to employees. The notification also introduces a number of changes, the most notable of which are detailed below. “Entrepreneur” definition. The definition of this term is narrowed to entities involved in the public procurement bidding process. Previously, the definition broadly applied to all business entities engaged in selling goods or services. Threshold for mandatory compliance. The project budget threshold that necessitates compliance with the minimum standards is  THB 300 million—a reduction from the previous threshold of THB 500 million. Minimum standards to prevent unfair competition. The new notification introduces a specific definition for “disturbing fair competition,” establishing clear parameters around actions that disrupt competitive fairness within public procurement. Continued compliance requirements. Businesses’ compliance with the minimum standards must now extend from the date of bid submission to the final payment installment. Training and policy review. Businesses