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: Commercialization (see more details here) and Regulation, which covers 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 Recent developments and reform 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 Vietnam” section can be found on the Practical Law website.

Southeast Asia has experienced a significant increase in foreign investment, which has not only brought innovation but also raised questions about protecting such innovation. Investors are increasingly interested in patenting the proprietary technology that plays a vital role in numerous businesses today. Recently, particular interest has been shown in innovations related to artificial intelligence (AI) technology and software. Are these types of innovations patentable, and if so, how? When it comes to Southeast Asia, the answers to these questions are not straightforward, due to the lack of uniform patent laws across the region. Issues of Patentability The patentability of computer software has long been a topic of discussion, predating the emergence of AI tools. Many jurisdictions have specific rules regarding the patentability of software. Pure software, defined solely by source code, may not qualify for patent protection but can be safeguarded under copyright laws. AI-related software often involves intricate algorithms, datasets, and training methodologies that pose challenges when it comes to satisfying the enablement requirement for disclosure. However, algorithms, mathematical methods, and abstract ideas are generally considered non-patentable subject matter in many jurisdictions. Although software implementing AI may incorporate innovative algorithms, obtaining patents solely for algorithms can be difficult in certain countries. For instance, Indonesia, Myanmar, Thailand, and Vietnam explicitly exclude computer programs from patentable subject matter. However, a potential workaround in these countries is to describe the software as being connected to a tangible medium. This approach could overcome rejections based on subject matter during substantive examination. Moreover, in Indonesia, a computer program can be eligible for patent protection if its characteristics (i.e., instructions) have a technical effect and serve to address a tangible or intangible problem. Among Southeast Asian countries, Singapore has the most lenient patent regime, even explicitly addressing AI innovations. The country has implemented a special fast-track scheme called the

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 to both local and foreign operators,

Vietnam’s Ministry of Information and Communications (MIC) organized a workshop with industry representatives on June 19, 2023, to discuss its future policy direction for over-the-top (OTT) telecom services and internet data center (IDC) and cloud computing services. OTT telecom services, in the MIC’s interpretation, are communication services such as text messages or voice calls provided over the internet—for example, the services of Zalo, WhatsApp, WeChat, etc. The workshop, the first in an expected series, focused only on the discussion of policy on how to regulate these services. Light-Touch Management Approach A very positive signal of the MIC in the workshop was its clear intention to apply a “light-touch” approach to management. For cross-border provision of OTT telecom services and IDC/cloud computing services, the MIC intends to require notification and a post-check mechanism, instead of a heavy licensing or commercial arrangement regime like the one applicable to traditional telecom services. In addition, there is no limitation on foreign investment if foreigners would like to provide these services in Vietnam. With regard to domestic service providers, the MIC proposes a registration regime with a similar post-check mechanism. The MIC’s reason for registration instead of notification is because the provision of these services by domestic companies may involve setting up data center/cloud systems which require consideration of various issues including location, electricity sources, and connection with telecom infrastructure such as marine cable. However, the MIC is also hoping to make the registration process as light as possible for enterprises (for example, using online registration) to provide a favorable environment and conditions to facilitate development of the industry without obstacles or cumbersome administrative procedures for companies’ operations. For providers of these services, the MIC is also considering an exemption from the responsibility to pay fees for telecommunications activities rights, and from payment to the Telecom Universal Service Fund,

April and May witnessed intriguing developments within Vietnam’s intellectual property community. On the legislation side, of particular note was the issuance of Decree No. 17/2023/ND-CP on April 26, coinciding with World IP Day. Decree 17 provides guidance on implementation of the 2022 Intellectual Property Law with regard to copyright and related rights, and has garnered significant attention due to several issues, especially the liability of intermediary (internet) service providers and copyright violation in the digital environment. Additionally, two noteworthy IP cases have emerged, albeit with limited public disclosure and awareness of specific details. Nonetheless, these cases are expected to have far-reaching implications. Copyright: Criminal Case Against Unauthorized Broadcasting of Football Matches For a considerable period of time, Vietnamese football enthusiasts have enjoyed being able to watch matches on TV and online from numerous top global football leagues. While many of these broadcasts were legitimate, with the rights purchased by Vietnamese and regional broadcasters, the unauthorized transmission and broadcasting of football matches on the internet has become increasingly prevalent. Authorities have seemingly faced challenges in curbing this issue through criminal action. In a positive development, in early May the Hanoi police decided to open a criminal proceeding against the unauthorized transmission and broadcasting of high-profile overseas football matches after a rigorous two-year investigation. Prior to this decision, authorities encountered difficulties in accurately determining the relevant laws and the nature of the violation to meet the requirements for prosecution. Specifically, they grappled with the question of whether a football match, or more specifically, a recorded video of a football match, could be considered a copyrighted work. If copyright protection extended to football matches and/or recorded videos, then transmitting and broadcasting these matches directly through the internet could be deemed illegal acts of copying or distributing (copyrighted) works, as outlined in Article 225 of the Criminal

Thailand is not a signatory to the Cape Town Convention. This means that upon an airline-lessee’s default, a lessor cannot present an Irrevocable Deregistration and Export Authorization (IDERA) document to easily repossess an aircraft. However, Thai law does allow for lessors to obtain aircraft deregisteration without the need to go to court. Pursuant to Clause 12 of the Civil Aviation Authority of Thailand (CAAT) Regulation No. 23 (Reg. 23), the Director General of CAAT has the authority to deregister an aircraft when the possessory right to the aircraft under a lease agreement has expired for any of the following reasons: The lease agreement has expired due to the lease term; The lease agreement has been terminated by either the lessor or the lessee in accordance with its termination clause; The lessor and lessee agree to terminate the lease agreement; The lessor notifies the termination of the lease agreement and submits an irrevocable deregistration power of attorney together with an application requesting the exportation of the aircraft, and the lessor or its agent submits an application for deregistration of the aircraft to the Director General. Under Reg. 23, a lessor can submit a deregistration application to CAAT asking CAAT to deregister. The deregistration application consists of evidence of the lease termination, a deregistration power of attorney (DPOA), the applicant’s certificate of incorporation, and the aircraft’s certificate of airworthiness and Certificate of Registration. CAAT will review the application and ask the lessee if it consents to the deregistration. If the lessee does not consent, CAAT may invite the lessor and lessee to one or more administrative hearings to give evidence on the dispute. If CAAT concludes that the lease has been validly terminated and the lessee no longer has possessory rights, CAAT will deregister the aircraft. Under Thai law, a lessor can terminate its aircraft lease agreement in

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].

At a conference organized by Vietnam’s Ministry of Public Security (MPS) on June 7, 2023, government officials provided more guidance on the recently issued Personal Data Protection Decree (PDPD), which is set to take effect on July 1, 2023. Key takeaways included the following: A national portal on personal data protection for online submission of notifications and registrations will be launched before July 1, 2023. The MPS also plans to issue templates for data processing impact assessments (DPIAs) and transfer impact assessments (TIAs) in the near future. The PDPD requires data controllers, data processors, and data controller-processors to prepare a DPIA at the start of personal data processing. The MPS clarified that the DPIA is expected to be prepared and submitted once. Only changes to its content would require submission of an updated DPIA. Both DPIAs and TIAs (which are for cross-border data transfers) must be prepared in Vietnamese. Since the sale and purchase of personal data is strictly prohibited unless explicitly permitted by law, the MPS has handled approximately 14 cases involving unlawful trading of personal data, including sensitive data. Under the PDPD, sensitive data has a broader definition than under the GDPR (the European Union’s General Data Protection Regulation), and also includes location data, creditworthiness, and personal financial data. Consent is not a legal basis for the trading of personal data, including sensitive data. The 72-hour timeline for responding to a data subject’s request does not mean 72 working or business hours. Rather, it means 72 actual consecutive hours. Any organization transferring the personal data of Vietnamese citizens outside of Vietnam must comply with the PDPD, regardless of the organization’s location. For organizations incorporated overseas that must comply with the PDPD, there is no requirement to appoint a local representative (unlike the GDPR)—but appointment of a data protection officer (DPO) may be required. As the enforcement for