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.

On March 3, 2023, the government of Vietnam issued Decree No. 07/2023/ND-CP (Decree 07) amending Decree 98/2021/ND-CP on medical device management (Decree 98) to resolve many urgent problems in the healthcare sector in Vietnam. Decree 07 took effect on the same day and amends and supplements several articles in its predecessor, Decree 98, which originally took effect on January 1, 2022. Some outstanding points of Decree 07 are summarized below. 1. Registration of Medical Devices The compulsory implementation of the ASEAN Common Submission Dossier Template (CSDT) in registration applications for medical devices will be delayed until January 1, 2024, instead of the deadline of January 1, 2023 under Decree 98. In addition, if after three rounds of amendment/supplementation as requested by the authority, the registration dossiers still have not been approved, the applicants must submit new registration dossiers. 2. Withdrawal of Registration Number Decree 98 adds one case for withdrawing the registration number of a medical device, which is when the documents in the registration dossier are concluded by the authority to be noncompliant with the provisions of law. 3. Listing Price of Medical Devices It is required for establishments manufacturing or trading medical devices to list their prices in locations stipulated under Article 17 of Decree No. 177/2013/ND-CP implementing the Law on Prices (such as at transaction or selling locations of the trading establishments) or on the online portal of the Department of Medical Equipment and Construction’s (DMEC). 4. Price Declaration It is no longer required to declare prices of all medical devices circulating on the Vietnam market. Instead, the Ministry of Health will issue and adjust the list of medical devices subject to price declaration, depending on management requirements and the actual situation, especially when there are abnormal fluctuations in prices affecting the supply of medical devices,

According to the Ministry of Health of Vietnam, many healthcare facilities in the country are facing a shortage of drugs, medical devices, and materials/chemicals. To address the urgent needs of medical examination and treatment in public healthcare facilities, on March 4, 2023, the government of Vietnam promulgated Resolution No. 30/NQ-CP on continuing to implement solutions to ensure the availability of drugs, medical equipment, and healthcare supplies (“Resolution 30”). Resolution 30 amends item 4 of Resolution No. 144/NQ-CP dated November 5, 2022, allowing medical examination and treatment expenses to continue to be covered by health insurance for technical services carried out with medical devices supplied by contractors after winning tenders to supply materials and chemicals. The new mechanism brings more benefit to patients by removing the previous ending date of November 5, 2023, and will be applicable until there is further guidance from the government. Resolution 30 also allows the use of medical devices that were donated or gifted by domestic and foreign entities (including those that were provided under now-expired joint ventures or cooperation contracts) regardless of whether those entities have fulfilled the procedures for ownership establishment. Technical services that are performed by such devices will be covered by health insurance. This provision will help address the shortage of medical devices used in public hospitals. The determination of bid price is also a highlight of Resolution 30, which pilots a simpler price determination procedure for the purchase of drugs and medical devices. Instead of requiring purchasers to obtain quotations from three suppliers, Resolution 30 allows them to compare prices based on the quotations actually received, even from only one or two suppliers. Alternatively, price determination can be based on the winning bid price for a similar medical device procurement package that was awarded within the last 120 days. This

On December 28, 2022, the Ministry of Health of Laos issued Decision No. 3789/MOH on the Control of Hemp for Medication and Products (the “Decision”). The Decision approves the regulated cultivation, extraction, production, processing, storage, distribution, utilization, import-export, and transport of hemp. The Decision also authorizes the use of hemp and hemp-related products by the general population, although use of certain products is limited to those with medical prescriptions. Background In 2019, the Lao government established an ad hoc committee to consider the legalization of cannabis, as reported previously. The government permitted certain local companies to grow cannabis in specific zones under pilot programs, although it continued to strictly prohibit the use and commercialization, as well as consumption, of cannabis-related products, regardless of the level of psychoactive tetrahydrocannabinol (THC) in the products. Overview of the Decision The Decision was issued by the Ministry of Health (which led the ad hoc committee) and permits authorized companies to engage in certain activities involving the use of hemp and the consumption of hemp and hemp-related products. The Decision defines hemp (“porkeo” in Lao) as a “plant that belongs to the same family as ganja and bears the scientific name Cannabis Sativa L. (Cannabis sativa L. subsp. sativa var. sativa) which is a subspecies of ganja (Cannabis Sativa L.).” This definition aims at differentiating hemp from the general definition of ganja or marijuana, which continues to be listed as a prohibited narcotic in Laos. The Law on Narcotics (2007) and the Penal Code (2017) still prohibit the production, trade and use of all types of cannabis. These laws will need to be amended to ensure that they are aligned with changes set out in the Decision.  Authorized Hemp Activities The Decision allows approved companies to engage in the cultivation, extraction, production, processing, storage,