Attorneys from Tilleke & Gibbins have contributed the Laos and Thailand chapters to the newly released CMS Expert Guide to Cannabis Law and Legislation. The Thailand chapter was provided by Alan Adcock, partner and head of the firm’s regional life sciences team, while Dino Santaniello, head of Tilleke & Gibbins’ office in Laos, produced the Laos chapter. The guide provides an overview of the legal framework regulating cannabis in 33 jurisdictions around the world. It covers topics such as medical, recreational, and industrial use of cannabis, as well as the patentability of cannabis-based products. The guide’s chapters offer high-level information on the legal approach taken in each jurisdiction, as well as guidance for companies and business activities exploring possibilities in relation to cannabis and hemp. The Laos and Thailand chapters—as well as the full guide to cannabis law in 33 jurisdictions—are available on the CMS website.

Food safety is one important area of focus as Cambodia continues to improve its regulatory framework surrounding consumer protection. Last year, the new Law on Food Safety set out the main principles to regulate the food sector, providing general rights and obligations of food businesses and requirements for food products traded in Cambodia. Then in the first months of 2023, two implementing regulations were issued to clarify the overarching principles of the Law on Food Safety, as well as its enforcement mechanisms. The adoption of these enforcement-related regulations is once again a clear signal to the market that the Cambodian government is taking the enforcement of consumer protection laws seriously. Food Surveillance, Seizure, and Recalls The first of these implementing regulations was Sub-Decree No. 13 on the Conditions, Formalities and Procedures for Food Surveillance and Seizure, dated January 6, 2023 (SD 13), followed the next month by Prakas No. 080 on the Forms and Procedures to Seize Unsafe Foods or Foods Not Complying with Technical Regulations, dated February 22, 2023 (Prakas 80). These implementing regulations give clarity on how the authorities will monitor and inspect the food sector, and in what cases the authorities may resort to recalls or seizure of foods. Prakas 80 also provides the necessary paperwork for both inspecting officers and companies to use when reporting on unsafe foods to authorities and the public. Lastly, the regulations further clarify the obligations for food businesses and the penalties for noncompliance. The Consumer Protection, Competition, and Fraud Repression Directorate-General (CCF) of the Ministry of Commerce takes a key role as the main enforcement authority under the regulations. The CCF receives reports on unsafe foods, manages voluntary recalls, publishes warnings to the public regarding unsafe foods, seizes unsafe or otherwise noncompliant goods, and applies the administrative fines and penalties

Attorneys in Tilleke & Gibbins’ Jakarta office have contributed a new “Life Sciences Regulation in Indonesia” chapter to Practical Law’s updated Life Sciences Global Guide. The chapter covers a range of regulatory issues related to the development, manufacturing, and selling of pharmaceutical products and medical devices, including 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 Indonesia” chapter can be accessed on the Practical Law website

Tilleke & Gibbins’ life sciences specialists in Indonesia have contributed a new “Life Sciences Commercialization in Indonesia” chapter to the Life Sciences Global Guide from Practical Law. This Q&A guide to commercializing life sciences innovations in Indonesia provides important information that companies can use to shape their strategies for life sciences products and activities in the jurisdiction. Specifically, the chapter covers: 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 Indonesia” section can be found on the Practical Law website.