The EU-Thailand Free Trade Agreement is drawing a lot of interest as the fourth round recently concluded in Bangkok. Despite negotiations starting in 2013, there was a ten-year pause before we saw the first round of negotiations end in September 2023. The initial plan was for four rounds of negotiations, with the free trade agreement (FTA) finalized in 2025. However, following the fourth round it is clear that the negotiations are still ongoing. Now, the question is: how much closer are the EU and Thailand to concluding their FTA? The EU initially submitted 13 chapter proposals for the FTA, followed by a further 12, and these became the springboard for the negotiations. Given the complexity of agreeing on an accord of this size, there will probably be additional proposals submitted in 2025. These chapters have seen sector-specific negotiation groups formed, and although it has been difficult to truly gauge the status, steady progress has been made in each. Arguably one of the biggest points of discussion pertains to the customs process for imports and exports. Both sides aim to align their practices in relation to rules of origin and custom rates, with preferential tariff treatments offered to goods originating from Thailand and the EU, as well as talks of eliminating or reducing relevant taxes. The desire for a faster customs clearance can be seen in EU proposals for clearance of goods on arrival. Although there has been progress in agreeing to a more simplified customs process, more work needs to be done before we hear news of the agreed-upon fees and charges, or confirmation of what goods would be allowed temporary admission. When we consider customs clearance, it is important to also examine what this FTA could mean for rightsholders. One piece of good news is that it appears all three rounds

近年、タイはデジタル資産を規制し、金融エコシステムに統合するための重要な措置を講じてきた。本記事では、タイにおけるデジタル資産ビジネスを規制する枠組みについて検討し、主要な法律、規制対象の活動、および急速に進化するこの分野における最近の動向に焦点を当てている。 規制環境 2018年、タイはデジタル資産ビジネスに関する緊急法令を制定し、暗号通貨　（cryptocurrencies）およびデジタルトークン（digital tokens）に対するタイ国のアプローチにおいて重要な瞬間を迎えた。法令は、証券取引委員会（SEC: Securities and Exchange Commission）および財務省の監督の下、デジタル資産のプライマリー市場とセカンダリー市場の両方に対する包括的な規制枠組みを提供している。 プライマリー市場において、法令は、イニシャル・コイン・オファリング（ICO：initial coin offerings）を通じたデジタル資産の発行および販売を規制している。規制の重要な特徴は、ICOがSEC承認のICOポータルを通じて実施される必要があるということが要求されている点である。このアプローチは、デジタルトークン販売を通じて資金を調達しようとする企業に対して、構造化され監督された環境を提供することを目的としている。 セカンダリー市場において、法令は、デジタル資産取引所、ブローカー、ディーラー、アドバイザリーサービス、ファンドマネージャー、およびカストディアン(custodian)を含むさまざまなデジタル資産仲介業者に対する規制枠組みを概説している。 SECは、デジタル資産関連の政策を実施する際に、ライセンスを受けたデジタル資産仲介業者に対して継続的な義務を課している。これには、デジタル資産取引所での特定のデジタル資産の上場に対する制限や、支払手段としてのデジタル資産を仲介する業者に対する制限が含まれる。 規制の動向と展望 SECは、グローバルなトレンドや市場の発展に対応するために、デジタル資産規制を定期的に改正することに尽力している。このアプローチの顕著な例として、SECが規制外の即時利用可能なユーティリティトークンの分類を以下の2つのグループに分けて精緻化しようとしていることが挙げられる： グループ1：消費目的または認証のデジタル表現として発行された即時利用可能なユーティリティトークン（例：権利者が特定の権利を持つNFT、カーボンクレジットの認証）。 グループ2：グループ1に指定されていない即時利用可能なユーティリティトークン（例：ネイティブ/ガバナンストークンおよび取引所トークン）で、発行者がタイのデジタル資産取引所に上場する意図がないもの。 もう一つの興味深い潜在的な発展として、SECがデジタル資産ビジネス専用の規制サンドボックスの設立を提案していることが挙げられる。このサンドボックスでは、参加者が最大1年間、管理された環境内でイノベーションをテストすることができ、参加期間中はデジタル資産ビジネスのライセンス要件から免除される可能性が高い。 今後の展望 タイにおけるデジタル資産ビジネスの統治アプローチは、明確な規制枠組みと、市場の進展を支えるために継続的な更新が必要であるという理解を組み合わせたものである。 タイのデジタル資産分野で事業を展開している、または参入を検討している企業にとって、最新の規制更新について情報を常に把握し、新しい要件に適応する準備を整えることは、重要な競争優位性を提供し、タイのデジタル資産エコシステムに参加するための新たな機会を開く可能性がある。 タイのデジタル資産ビジネス規制の詳細については、Athistha (Nop) Chitranukroh又Pornpan Wichawutまでお問い合わせください。   備考：本和文は英文記事を翻訳したものです。原文については、以下のリンクをご参照ください。 Fintech Insights: Digital Asset Business Regulations in Thailand

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

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