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, buyers’ ability to pay, and the solvency of the

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 pilot procedure for

The newly released Licensing 2023 guide published by Lexology Getting the Deal Through features a chapter on Vietnam by four licensing specialists from Tilleke & Gibbins. The comparative guide provides companies and other interested readers with information on licensing law and practice in various jurisdictions around the world. Licensing 2023 provides detailed information on the following topics: Restrictions, laws and licensing arrangements Intellectual property issues: Paris Convention for the Protection of Industrial Property, contesting the validity of licensor’s IP rights, invalidity and expiry of IP rights, security interests, proceedings against third parties, sublicensing, jointly owned IP, first to file, scope of patent protection, trade secrets, copyright Software licensing: Perpetual licensing, legal requirements, user restrictions Royalties and payments, currency conversion, and taxes: Relevant legislation, restrictions, taxation of foreign licensors Competition law issues: Restrictions on trade, legal restrictions, and IP-related court rulings Indemnification, disclaimers, and damages: Prevalence and enforceability of indemnity provisions and contractual waivers of damages Termination: Right to terminate, impact of termination Bankruptcy: Impact of licensee or licensor bankruptcy Dispute resolution: Governing law, arbitration, enforceability, injunctive relief, contractual waivers The Vietnam chapter was authored by Linh Thi Mai Nguyen, partner and head of Tilleke & Gibbins’ trademark team in Vietnam; Son Thai Hoang, trademark executive; and Chi Lan Dang, associate, of Tilleke & Gibbins’ trademark team, along with corporate and commercial senior associate Tu Ngoc Trinh, who has extensive experience in franchising and competition law. The Vietnam chapter is available below as a PDF. Tilleke & Gibbins also contributed the Thailand chapter to Licensing 2023. To browse all jurisdictions covered by the guide, please visit the Getting the Deal Through website.

Two of Tilleke & Gibbins’ life science specialists in Bangkok have contributed the Thailand chapter to the newly issued Licensing 2023, a comprehensive guide from Lexology Getting the Deal Through to licensing in various jurisdictions around the world. The Thailand chapter covers the following topics: Laws and licensing arrangements: Unfair Contract Terms Act, Trade Competition Act, pre-contractual disclosure, registration of international licensing, implied obligations, Civil and Commercial Code, Trademark Act, Patent Act, Trade Secrets Act Intellectual property issues: Paris Convention for the Protection of Industrial Property, contesting the validity of licensor’s IP rights, invalidity and expiry of IP rights, security interests, proceedings against third parties, sublicensing, jointly owned IP, first to file, scope of patent protection, trade secrets, copyright Software licensing: Perpetual licensing, legal requirements, user restrictions Royalties and payments, currency conversion, and taxes: Relevant legislation, restrictions, taxation of foreign licensors Competition law issues: Restrictions on trade, legal restrictions, and IP-related court rulings Indemnification, disclaimers, and damages: Prevalence and enforceability of indemnity provisions and contractual waivers of damages Termination: Right to terminate, impact of termination Bankruptcy: Impact of licensee or licensor bankruptcy Dispute resolution: Governing law, arbitration, enforceability, injunctive relief, contractual waivers The full Thailand chapter is available below as a PDF. Tilleke & Gibbins also contributed the Vietnam chapter to Licensing 2023. To browse all jurisdictions covered by the guide, please visit the Getting the Deal Through website.

In Cambodia, the Ministry of Commerce takes the lead on many consumer protection matters, issuing and enforcing regulations that contribute greatly to a fairer and more transparent legal framework. The regulations protect consumers while simultaneously creating a more a level playing field for businesses. On September 2, 2022, the ministry issued a new regulation concerning household chemical products. The regulation, named Prakas No. 192 on the Requirements for the Labeling of Household Chemical Products, is another big leap forward in light of the consumer protection framework that the Cambodian government has been rapidly updating in recent years. Interesting issues in the regulation include household chemical product classification, labeling and language requirements, product storage requirements, recall requirements, and obligations for companies engaging in business activities related to household chemicals. In addition, the regulation reminds household chemicals businesses operating online of the need to obtain additional e-commerce licensing. Cambodia’s consumer protection authority, the Consumer Protection, Competition and Fraud Repression Directorate-General—commonly known as the CCF—has already started to enforce the new regulation, as the three-month transition period under the regulation has now passed. Classifying and Defining Household Chemicals The regulation classifies household chemicals into three groups based on the product’s purpose—namely detergents, pesticides, and substances for home and garden protection. There is also a separate list of household chemicals identified as “chemicals not allowed for use in food.” This list is just a reminder, as existing legislation already prohibits the use of the identified chemicals in food. The regulation defines household chemicals as finished chemical products, or chemical additives to products, that can be harmful to health and that have one of the three purposes mentioned above. The regulation further states that the products are for use in “normal life,” such as in homes, workshops, or gardens, or for other public use. The regulation lists many examples of household chemicals—including

Influencer marketing and the creation of sponsored content is an increasingly popular way for brands to reach their target audience. Although there is no universal definition of an “influencer,” the term is broadly used to describe people who are able to affect purchasing decisions of others through their relationship with their audience. In the context of social media and the creator economy, influencers are usually people with significant followings on platforms such as Instagram, TikTok, Twitch, or YouTube who are viewed as celebrities, opinion leaders, trendsetters, or experts in their respective field. Based on a study conducted by Nielsen in 2022, 80% of social media users in Asia who follow influencers are likely to purchase products recommended by the influencers. Brand owners should be aware of five key legal considerations when entering into influencer marketing agreements. 1. Making informed decisions through due diligence Every collaboration with an influencer is a business relationship. Brands must conduct thorough due diligence on potential influencers prior to engaging them. This may include deep dives into the individual’s old social media posts, as well as requests for disclosure of prior controversial incidents and existing brand associations. For example, a health and fitness brand may not want—for both legal and commercial reasons—to be publicly associated with an influencer who is a brand ambassador of electronic cigarettes, no matter how impressive the latter’s Instagram following or deadlift record is. Brands should also ensure that their influencer marketing agreements include relevant representations and warranties that the influencer has not and will not commit a crime or act in a way that may cause negative publicity for the brand. This may include racist, extremist, homophobic, violent, or misogynistic acts, or any other acts that are obscene or against public order. 2. Clearly defining the scope of engagement Brands must first ensure they are

For most in-house counsel, the thought of defending a civil case brought against the company is typically an unpleasant proposition—even more so when the matter is proceeding in a foreign or unfamiliar jurisdiction in which the substantive law and court procedures differ from those in one’s home jurisdiction. But different procedures, even if unfamiliar, can sometimes be advantageous to a defendant. This is particularly true with respect to certain aspects of the discovery process in Thai civil court proceedings. For in-house counsel in certain jurisdictions, the specter of litigation not only entails the potential risks posed to the company and the time and financial costs inevitably incurred, it can also mean lengthy and costly discovery battles. However, as discussed in more detail below, due to the nature of Thai discovery procedures, these types of discovery battles are typically rare in Thai civil court proceedings. Further, due to the limited scope and mechanisms for discovery practice in Thailand, the whole discovery process tends to be rather expedient and straightforward, particularly when compared to that in jurisdictions with extensive discovery practice. In this article, the authors provide an overview of some of the more notable features of the process for discovery under the Thai Civil Procedure Code (“CPC”), particularly those that may differ from those in jurisdictions with a more vigorous and wide-reaching discovery process. (We note that this article addresses only discovery procedures in civil proceedings in Thai courts; the discovery process in criminal proceedings is subject to the Thai Criminal Procedure Code and differs from the process in civil courts in some respects.) Rules of Evidence Before taking a closer look at some of the discovery provisions in the CPC, it is important to understand a few fundamental principles of Thai evidence law, as these provide the general guidelines that a Thai court

Vietnam’s Ministry of Information and Communications (MIC) has been working to replace the outdated 2009 Telecom Law with a new version more suited to today’s digital economy. A draft Telecom Law was made available for public consultation from October 27 to December 27, 2022. On January 17, 2023, the MIC submitted an amended draft (the “Draft”) to the Ministry of Justice for appraisal (the Vietnamese version of the Draft and accompanying documents in the dossier can be accessed here). The Draft is scheduled to be discussed by the National Assembly in May 2023 and submitted for approval in October 2023. The key content and changes of the Draft as compared to the existing law are set out below. 1. Licensing Telecom Services For domestic enterprises, the 2009 Telecom Law only provides two types of licenses—telecom network establishment licenses and telecom service business licenses—without differentiating the conditions and licensing procedures for various types of telecom services. This no longer meets management requirements and does not encourage enterprises to participate in providing new services on already existing infrastructure. Although the Draft retains the two main types of licenses—licenses to provide telecom services with network establishment for a term of not more than 15 years; and licenses to provide telecom services without network establishment with a term of no more than 10 years—it also provides different licensing conditions for different types of telecom service provision, with three kinds of licensing: (i) individual licenses for certain enterprises with specific conditions and obligations based on telecom management objectives at the time of licensing; (ii) class licenses for businesses that meet the prescribed licensing conditions; and (iii) registration, which requires businesses only to submit registration information according to the prescribed form to be licensed. In addition, to avoid the situation of licensed telecom network enterprises delaying or not implementing telecom