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

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.