In April 2021, the Vietnamese government made public a draft decree to amend Decree No. 43/2017/ND-CP of the Government dated April 14, 2017, on goods labeling (“Decree 43”), which is the primary legislation in Vietnam on the labeling requirements for domestically circulating goods and imported goods. Some noteworthy differences between the draft and the current Decree 43 include the following: 1. Original labels for imported products For imported goods, the draft adds a requirement on compulsory information for original labels, which is not mentioned in Decree 43. In particular, the original product label for goods being imported to circulate on the Vietnam market must contain the following compulsory information in a foreign language or in Vietnamese before customs clearance: Product name; Name and address of the entities responsible for the products; Product origin or place where the final production stage to complete the product was conducted. (If this information is not presented on the original product label, it must be included in the import documents accompanying the product.) 2. Vietnamese labels for imported products Under the draft, if it is impossible to determine the product origin under rules/guidance on determining product origin in Vietnam, it is acceptable to instead indicate on the product label the place(s) where the final production stage to complete the product was conducted. 3. Nutritional information for food Instead of being optional information as mentioned in Decree 43, “nutritional value” is compulsory information on labels for some food products under the draft. The Ministry of Health will have a roadmap for carrying out nutritional labeling and will provide appropriate guidance to manufacturers and importers, as well as issue regulations on types of food that are partially or entirely exempt from declaration of nutritional value. The draft has not yet been finalized and is subject to

Developing and launching a new drug on a commercial scale requires an enormous amount of time and investment in research and development (R&D), including pre-clinical testing and clinical trials. When considering the aggregate amount of drug development costs, it is important to recognize that this includes not only the investment in developing new drugs that get approved by a government food and drug regulator and are successfully brought to market, but also the R&D expenditures on a large number of potential pharmaceutical compounds and products that never actually make it to market. In particular, considerable investment is required in order to conduct and produce clinical trial data—to prove safety, efficacy and effectiveness of a new drug—that would warrant marketing approval by the regulatory authority. Such data is proprietary in nature and highly valuable for a research-based pharmaceutical company that develops an original drug. On the other hand, patent law typically confers generic drug manufacturers with the ability to engage in various preparatory activities with a view to obtaining marketing approval for a generic product before the patent for the original drug expires (commonly known as a “Bolar provision”). Since a generic drug maker may submit an application for marketing approval of a generic product before the relevant patent expires, the extent to which the drug originator’s data submitted to the regulatory authority is protected—or in other words, the extent to which the generic company may rely on the drug originator’s previously filed data, which underpins the safety and efficacy of the drug, to support the generic marketing approval application—becomes a critical issue. Availability of data exclusivity thus provides a form of market exclusivity outside that provided by patent rights. While some countries offer exclusivity or protection of the drug originator’s data submitted to the regulatory authority for marketing approval

Lawyers from Tilleke & Gibbins’ Bangkok office have authored the Thailand chapter of the 2021 edition of Chambers & Partners Aviation Finance & Leasing Guide. John Frangos, partner and deputy director of Tilleke & Gibbins’ dispute resolution practice; Santhapat Periera, partner in the firm’s corporate and commercial department; and Nuanchun Somboonvinij, senior associate in the firm’s dispute resolution group, provided the Thailand update for the publication, which covers the most important legal developments affecting aircraft lessors, lessees, and financiers in 32 jurisdictions worldwide. The guide provides in-depth details on the legal regimes affecting all aspects of aircraft sale and purchase, aircraft and engine leasing, and aircraft debt finance, including sale and lease agreement terms; taxation; lease registration and enforcement; lease assignment/novation; insurance and reinsurance; debt structuring; securities; liens; and many others that affect the day-to-day operations of leading players in the aviation industry. Chambers and Partners’ Global Practice Guides provide in-house counsel with expert legal commentary focusing on practical legal issues affecting business, and enable readers to compare legislation and relevant procedures across a range of key jurisdictions. The full Chambers & Partners Aviation Finance & Leasing Guide—including the Thailand chapter—is available for free on the Chambers and Partners website, and the Thailand chapter be downloaded as a stand-alone PDF through the button below.

A 13-year extension of the least developed country transition period for applying the Agreement on Trade-Related Aspects of Intellectual Property Rights has long-term implications for Southeast Asia’s least developed nations.