Practitioners from Tilleke & Gibbins’ Vietnam offices contributed content for the latest edition of the Practical Law Life Sciences Global Guide. The guide provides a comparative overview, in Q&A format, of laws and regulations on pharmaceuticals, medical devices, and other life sciences products in dozens of jurisdictions around the world. The Life Sciences Global Guide is divided into two sections: Regulation (see more details here) and Commercialization, which covers the following topics: 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 to the public and engagement with patient organizations Advertising to healthcare professionals and organizations: Gifts and incentives and transparency and disclosure 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 Vietnam” section can be found on the Practical Law website.

On May 25, 2023, Laos published Decision on the Registration of Importers and Exporters of Goods No. 0752, which requires importers and exporters to register their activities and the related goods with the Ministry of Industry and Commerce (MOIC). The MOIC’s goal is to create a database to monitor imports and exports and collect data on the flow of goods in and out of Laos. The decision also aims to regulate the import and export of goods to and from Laos by foreign traders who do not have a local presence. Once the decision takes effect on July 6, 2023, import and export of goods will be possible only upon registration by the importers or exporters with the MOIC. This registration requirement is in addition to the current mandate that importers and exporters operating in Laos obtain a Business Operating License from the MOIC. Activities Subject to the Decision Under the decision, the obligation to register applies to individuals and entities that import or export goods for which the revenues and payments are controlled by the government as well as “goods that have a quick impact on the lives of the population.” Although it is not yet clear which products the MOIC has in mind, further clarifications are expected. Under the current regulatory framework in Laos, some goods need an import-export permit prior to crossing the Lao border, in accordance with a 2022 regulation listing goods subject to the permitting requirement. It is possible that the goods regulated by the new decision could be the same as those defined in the 2022 list (see here for a Lao-language list)—such as drugs, medical products, land vehicles, petrol, and hazardous chemicals—but further confirmation and clarification will be necessary to determine this. Importers and Exporters Subject to the Decision The decision applies

Myanmar’s Customs Department issued an internal order reducing customs duty on imports of semi-knocked-down (SKD) and completely knocked-down (CKD) vehicle systems effective for the period of June 1, 2023, to May 31, 2024. The order follows Ministry of Planning and Finance (MOPF) Notification 37/2023, which reduced customs duty on SKD and CKD vehicles and repealed the similar MOPF notifications issued in 2020 and 2021. The order announced the following new customs duty rates for SKD systems: Passenger vehicles: 5% (reduced from 7.5%) Motorcycles: 1.5% (reduced from 3%) Three-wheeled motorcycles: 3% (reduced from 7.5%) Buses: 3% (reduced from 7.5%) Trucks and trucks for body building: 3% (reduced from 7.5%) The customs duty rates for CKD systems have been set as follows: Passenger vehicles: 3% (reduced from 5%) Motorcycles: 1.5% (reduced from 3%) Three-wheeled motorcycles for transportation of passengers: 1.5% (reduced from 5%) Three-wheeled motorcycles for transportation of goods: 3% (reduced from 5%) Buses: 3% (reduced from 5%) Trucks and trucks for body building: 3% (reduced from 5%) The September 2021 suspension of permits for the import of new completely built-up (CBU) vehicles from abroad is unlikely to be impacted by the announcement. For more details on these customs duty reductions, or on any aspect of Myanmar’s regulations surrounding international trade, please contact Tilleke & Gibbins at [email protected].

Vietnam’s Law on the Protection of Consumer Rights (“Consumer Protection Law” or “CPL”) was passed in 2010 and has been effective since July 1, 2011, providing a legal framework for protecting the rights of consumers in Vietnam. Over the past 12 years of implementation and application, however, the CPL has revealed its shortcomings and limitations. For example, there are issues related to inconsistency between the CPL and other laws such as the Civil Code, Law on Competition, Enterprise Law, and Cybersecurity Law. The current CPL also has not kept pace with modern consumption practices, especially the rapid changes and emerging trends in e-commerce, cross-border transactions, and services via digital platforms. The government of Vietnam has therefore entrusted the Ministry of Industry and Trade (MOIT) to take the lead in drafting a new amended CPL to replace the old one, to improve the policies and legislation on consumer protection, and protect the vulnerabilities of consumers in transactions with businesses. During the 5th session of the National Assembly at the end of May 2023, the National Assembly discussed and reviewed the latest draft of the CPL (“Draft CPL”), which is expected to be approved on June 21, 2023. The following are some key contents of the Draft CPL: 1. Revised Subjects of Application Unlike the current CPL, which applies only to consumers; traders of goods and services; and agencies, organizations and individuals involved in consumer protection activities within the territory of Vietnam, the Draft CPL adds “the Vietnamese Fatherland Front, socio-political organizations and social organizations participating in protecting consumers’ interests” as new subjects of its application, and clarifies that “agencies, organizations, and individuals” include both domestic and offshore agencies, organizations, and individuals involved in activities of consumer rights protection. The Draft CPL also removes “within the territory of Vietnam” from the