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 Thailand 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 Thailand guide. The Pharma Legal Handbook: Vietnam, like all of the country guides from Pharma Boardroom, is available for purchase on the Pharma Boardroom website.

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

Cambodia’s Law on Seed Management and Plant Breeder’s Rights was enacted in 2008, but it was not until recently that new plant varieties could successfully be registered for protection in the country. Although the law has been in place for some time, recent developments confirmed the application process and a schedule of charges for the registration of new plant varieties. With these developments, breeders have been able to register their new plant varieties in Cambodia since March 1, 2024. Applicants for new plant variety protection must be Cambodian nationals, foreign nationals domiciled in Cambodia, or permanent residents of either a country that is a contracting party to the International Union for the Protection of New Varieties of Plants (UPOV) Convention or a country with which Cambodia has signed a memorandum of understanding on plant variety protection. Applicants can also claim a priority date from the first application for the same plant variety filed in any contracting party of the UPOV Convention within 12 months of the earliest application’s filing date. To be eligible for protection, new plant varieties must satisfy the following criteria: Novelty: A variety is considered “new” if, at the date of filing the application for new plant variety protection, it has not been sold, marketed, or otherwise disposed of others—by or with the consent of the breeder—for more than: One year for any plant variety in Cambodia; Six years for trees and vines or four years for all other plant varieties in countries besides Cambodia. Distinctiveness: A variety must be clearly distinguishable from any other existing varieties. Uniformity: A variety must be sufficiently uniform in its relevant characteristics. Stability: A variety must remain unchanged in its essential characteristics at the end of each cycle of propagation and in each generation. The last three criteria are often

On October 28, 2024, Indonesia officially amended its existing Patent Law when the president ratified Law Number 65 of 2024. This comprehensive update—the third such amendment in the history of Indonesia’s Patent Law—introduces several key changes that will significantly impact patent protection and application processes in Indonesia. Key highlights and changes are outlined below. Definition of Invention The new law broadens the definition of “invention” to explicitly include systems, methods, and uses. Additionally, the law introduces formal definitions for traditional knowledge and genetic resources. Patentability Criteria Notable changes include: Computer programs are now excluded, with an exception for computer-implemented inventions. Theories and methods in science and mathematics are added to the list of excluded inventions. Previous restrictions on new uses of existing products are removed. Grace Periods The grace periods for some patent-related actions have been adjusted: The grace period for disclosures has been extended to 12 months (from 6 months previously), providing inventors with more flexibility in filing patent applications after initial disclosure. A newly introduced item is the grace period for a conventional patent application claiming priority rights, which is 4 months after the 12-month filing deadline under the Paris Convention. The grace period for annuity payments is 6 months (from 12 months previously) with a fine for late payments of 100% of the annual fee payable. Patent Holder Rights and Obligations Patent holders can now grant permissions to enforce patents. There is a new requirement for patent holders to submit annual statements on patent implementation in Indonesia. Compulsory Licensing Significant changes to compulsory licensing include: Establishment of licenses based on the principle of expediency. Limitations on license scope and transferability. Prioritization of domestic market needs. New provisions for technical improvements and economic significance. Government Patent Exploitation The new law contains specific provisions for the government’s implementation