New technologies and production processes in the food industry have led to novel foods becoming increasingly important to both food manufacturers and the consuming public worldwide. This is very much the case across a number of jurisdictions in Southeast Asia. “Novel foods” refer to new food production processes, foods, and ingredients that have not yet been commonly used for human consumption, so these innovative foods require safety assessments before companies can produce and market them. While rules for these safety assessments are already part of novel food regulations in several other jurisdictions—such as the novel food regulations in the United Kingdom and European Union adopted in 2003, and the major reform of food safety laws in the United States passed in 2011 under the Food Modernization Act—similar rules governing the assessment of novel foods are relatively new or yet to be introduced in many parts of Asia. Nevertheless, it is important to understand the laws and practices that apply to safety assessments and the process of bringing novel foods to market in jurisdictions in the region. This article provides some clarity in this regard by summarizing important practical information on novel foods and the relevant required safety assessments in Indonesia, Thailand, and Vietnam.   Indonesia Regulator National Agency for Drug and Food Control (NADFC); frequently referred to as BPOM (Badan Pengawas Obat dan Makanan). Relevant Measures BPOM Regulation No. 27 Year 2018 concerning Public Service Standards in BPOM; Decision of the Director of Processed Food Standardization No. HK.02.02.51.511.06.21.21 Year 2021 concerning Public Service Standard Directorate Processed Food Standardization Definitions General “food ingredients” are basic fresh or processed ingredients that can be used to produce food; novel food is any food ingredient not listed in BPOM’s positive list of ingredients.

Following Myanmar’s recently announced notification requiring conversion of all foreign currency transfers and balances to Myanmar kyat (MMK), the Central Bank of Myanmar (CBM) has issued additional detailed guidance to banks on how to manage transfers, outbound remittances, and various other transactions involving balances in foreign currency. The CBM also announced that the union government and ministries are exempt from the foreign currency conversion requirements. The developments came on April 5, 2022, when the CBM issued Directive No. 5/2022, exempting these government bodies from the requirement, and Directive No. 6/2022, which provides instructions for banks licensed as authorized dealers (ADs) permitted to exchange currencies. The directive makes AD-licensed banks responsible for handling the conversion process by (1) transferring the amount in question to the concerned company’s account, (2) converting the amount to MMK at the CBM exchange rate, and (3) depositing it in an MMK-denominated account. The conversion process must be carried out within one working day of receiving the following types of funds: Export earnings Other earnings (including from services) Foreign currency investments (excluding foreign currency allowed by the CBM’s Foreign Currency Management Committee) The conversion process is also required for the following two types of funds, which require the AD-licensed bank to perform additional checks: Loans for investment. AD-licensed banks may only proceed with the conversion process after determining that CBM approval has been obtained in accordance with section 29(a) of the Foreign Currency Management Law and Rule 48 of the Foreign Currency Management Rules. Unilateral transactions. AD-licensed banks may only proceed with the conversion process after determining that CBM approval has been obtained in accordance with the rules 54 and 55 of the Foreign Exchange Management Rules. As noted in the previous notification instituting the foreign exchange requirements, outbound transfers of foreign currency by resident individuals and entities in Myanmar are to be carried

タイでは、汚職防止への関心が高まっていることから、2015年の外国投資家苦情処理センター（Complaint Center for Foreign Investors (CCFI)）の設立等、様々な施策が導入・実施されています。CCFIは、タイの公共部門における透明性と公正性を促進し、タイで事業を行う外国投資家の信頼を高めるために、公共部門腐敗防止委員会（Office of Public Sector Anti-Corruption Commission （PACC））によって設立された機関です。 CCFIは長年運営されてきましたが、タイでビジネスを行っている多くの外国人投資家は、CCFIを知らないか、タイの公務員に対する申立てがビジネスや私生活に悪影響を与えるのではないかとの懸念から、CCFIの利用に消極的でした。しかし、最近になって、PACCは、CCFIにつき、外国人投資家が不当なサービスや待遇を受けたり、タイの公務員からの利益要求に直面した場合に、外国人投資家が苦情を申し立てるのに適する方法であるとして、CCFIを促進するための新たな取り組みを行っています。   CCFIに対する苦情の申し立て CCFIは、「腐敗防止法」（B.E.2551）（2008年）の第58/2条に基づき、公共部門腐敗防止委員会（PACC）の責任を管理するために設立された機関です。同法は、PACCに対し、ライセンス促進法（Licensing Facilitation Act）を遵守していない規則又は手続きを有する州当局について、それが公共サービスに対する妨害や損害を及ぼしたり、政府のサービスに深刻な損害を与えると考えられる場合、その上部機関に通知する権限を与えています。 具体的には、法律に規定された範囲の苦情があった場合、投資家はCCFIに連絡することができ、CCFIは関係機関や政府当局に調査を依頼して対応します。機関の規則及び手続に関する苦情の場合には、関係機関の長に調査を依頼します。公的部門において違法行為が行われている場合には、PACCは閣僚会議及び国家汚職防止委員会に対し、権限に戻づいて必要な措置を講じるよう報告します。 政府機関に対するCCFIの通知については、当該機関の長が調査を進め、通知受領後60日以内に調査結果をPACCに報告しなければなりません。当該機関において改善又は是正が必 要であると判断された場合、同機関は、これらの是正措置がどのくらいかかるかについてもPACCに通知しなければなりません。 CCFIに対する苦情は、口頭又は書面で行うことができ、投資家は複数の方法を通じてCCFIに連絡することができます。 電話:1206 Email: [email protected] ウェブサイトwww.pacc.go.th 申立人がCCFIに身元を秘匿するよう求めた場合、PACCは関連情報を開示することが禁止されます。さらに、すべての申立人及びPACCに対する情報の提供者は、自己の安全のために自己の氏名又は身元の開示から保護され、公務員による不当な取扱いを防止する権利を有します。   備考：本和文は英文記事を翻訳したものです。原文については、以下のリンクをご参照ください。 Thailand Encourages Foreign Investors to Report Unfair Treatment

As Thailand has paid more and closer attention to anticorruption issues, a number of measures have been introduced and implemented over the years, including the establishment of the Complaint Center for Foreign Investors (CCFI) in 2015. The CCFI was set up by the Office of Public Sector Anti-Corruption Commission (PACC) to promote transparency and integrity in the Thai public sector and enhance the confidence of foreign investors conducting business in Thailand. Though the CCFI has been in operation for many years, many foreign investors conducting business in Thailand have either remained unaware of it or have been reluctant to use it because of concerns that acting against Thai public officials could cause problems for their businesses or in their personal lives. However, recently the PACC has made a renewed push to promote the CCFI as a suitable channel for foreign investors to lodge complaints when they face unfair services or treatment, or face requests for benefits from Thai public officials. Lodging a Complaint with the CCFI The CCFI was established to administer the PACC’s responsibilities under Section 58/2 of the Executive Measures in Anti-Corruption Act B.E. 2551 (2008), which authorizes the PACC to notify the superior of any state agency appearing to have regulations or procedures that fail to comply with the Licensing Facilitation Act; are deemed by the PACC to cause a nuisance or damages to a public service clientele; or cause severe detriment to a government service. Practically, this means that when investors have a complaint that fits the scope described in the law, they can contact the CCFI, which will take action by getting the relevant agency or government authority to examine the issue. In cases concerning agency regulations and procedures, this will be the head of the relevant agency, but if the circumstances indicate malpractice in the public sector,

On April 3, 2022, the Central Bank of Myanmar (CBM) issued far-reaching requirements for nearly all individuals, companies, and other organizations in Myanmar to convert foreign-currency income received from abroad to kyat (MMK) within one working day of its receipt. These requirements are effective immediately for all transfers, and apply retroactively to foreign currency balances already in the country. CBM Notification No. 12/2022 and Directive No. 4/2022, issued in accordance with the Foreign Exchange Management Law, instruct Myanmar banks that hold an authorized dealer (AD) license on converting foreign currency. Together, the notification and the directive stipulate that all foreign-denominated income received by “internal residents” from abroad into a foreign currency account opened at an AD-licensed bank must be exchanged into MMK within one working day, unless subject to regulatory exclusions. “Internal residents” include locally registered companies, organizations, and offices; Myanmar branches of foreign companies; and individuals residing or established in Myanmar for at least 183 days (excluding foreign diplomatic staff and foreign civil servants). As noted above, the notification and the directive have retroactive effect on foreign-currency accounts holding funds that had already entered Myanmar. This means that for the purposes of these regulations, these foreign-currency amounts are treated as if they were transferred into Myanmar after the date of issuance (i.e., April 3, 2022), and are to be converted to MMK in accordance with the new rules. The conversions are to be made at the official exchange rates set by the CBM, which for US dollars is currently USD 1 to MMK 1,850. Additionally, foreign-currency transfers out of Myanmar must be performed through AD-licensed banks with the permission of the CBM’s Foreign Exchange Supervisory Committee. Noncompliance with the notification or directive is punishable under the Foreign Exchange Management Law with imprisonment for up to one year, a fine, or both. Exceptions

Since the onset of the COVID-19 pandemic and the ensuing safety measures, many Thai retailers have shifted their sales toward online platforms. Unsurprisingly, counterfeiters have followed suit. The online sale of counterfeit healthcare and other life sciences products (e.g., food, cosmetics, and medical devices) is an area of significant concern, as it is particularly prevalent, damaging, and complex in relation to Thailand’s laws. This article outlines this type of counterfeiting activity in Thailand and explains some important tools brand owners have for fighting it. Counterfeiting Operations Although illicit operations seek to avoid being identified by authorities and brand owners, investigations by law enforcement and Tilleke & Gibbins on behalf of clients have yielded some insights into how these illegitimate sellers typically operate. Often, consumers are first exposed to these counterfeit life sciences products by paid social media advertisements that link to social media accounts set up by sellers impersonating brand owners. This brand impersonation may include unauthorized use of a trademark or trade name as part of the account name, and unauthorized reproduction of official advertisement artwork or product descriptions, taken directly from the official social media account. From the fake social media account, consumers are usually directed to a merchant website that contains consumer reviews, which are entirely fabricated. While not every counterfeiting operation follows this exact blueprint, employing some variation of these methods lends counterfeiting platforms the ability to proliferate through multiple iterations, as well as believability in the eyes of consumers. How Brand Owners Can Take Action Life sciences brand owners often discover that their products have been targeted by counterfeiters when a counterfeit item injures or negatively impacts a consumer. Thinking that the product is genuine, the consumer may then complain to the brand owner, or worse, file a complaint with the authorities. Many times this has resulted in brand owners

Trade dress, which refers to the visual appearance of a product and packaging, as well as the product’s placement at its point-of-sale (store layout), was at the center of an infringement case that recently obtained the highest damages award ever given for a trademark case in Thailand. Trade dress is an important branding consideration because it can create a commercial impression and enable the public to recognize the original source of goods and services, distinct from other traders. Trade dress comes in many different forms, but only a few of them find solid protection in Thailand, and only through creative use of existing intellectual property protections. For instance, a unique packaging design in the form of an unfolded paper box could be eligible for trademark registration. A distinctive product configuration or external design of a container might be eligible for registration as a three-dimensional trademark, or even as a design patent if it features lines or colors giving a special appearance to a novel product that has an industrial application. In addition, a product’s configuration could be subject to copyright protection as a “sculpture work” if it shows a figure with tangible volume. However, in Thailand, trade dress does not yet receive explicit recognition under the country’s Trademark Law—unlike in some other jurisdictions whose trademark laws permit the registration of trade dress. The protection and enforcement of trade dress in the form of “store layout” in particular has been a constant challenge in Thailand, given the lack of explicit laws and precedence. Consequently, brand owners may have a hard time protecting their trade dress in relation to their creative and unique store layout designs, despite a great deal of effort and financial investment. But now this appears to be changing: In December 2021, Tilleke & Gibbins successfully secured a precedent judgment on

For years, an inadequate compensation mechanism has been a limitation in resolving IP infringement disputes in Vietnam through civil measures. This limitation was once again highlighted in an appellate trial at the Superior People’s Court of Ho Chi Minh City on February 21, 2022, in which the appellate court reviewed a judgment of the People’s Court of Ho Chi Minh City dated April 28, 2021. Outline of the Case The facts of the case are quite simple. A Ho Chi Minh City-based company that provides educational equipment was discovered by the Inspectorate of the Ministry of Culture, Sports and Tourism to be using, without authorization, a specialized computer program from a company based in the United States. The inspection agency issued a decision to administratively sanction the Vietnamese company. The sanction included a small fine of VND 30 million (approximately USD 1,315) and the forced removal of the infringing computer program, which the infringer readily complied with. Thus, the administrative aspect of the case was completed. The company behind the software then filed a civil case against the infringer at the People’s Court of Ho Chi Minh City. Among the plaintiff’s claims, the most important was the amount of compensation for damages: over USD 500,000, equivalent to the value of the full-module computer program that was found to be illegally installed and copied on the defendant’s computer. In fact, the plaintiff has sold software licenses for this full module version through resellers in Vietnam for the same amount. In addition to claiming compensation for damages, the plaintiff also demanded that the defendant make a public apology and pay an additional VND 300 million (USD 13,150) to cover the plaintiff’s legal fees. Court Judgments The first-instance court determined that the defendant had indeed infringed the IP rights of the plaintiff and required the defendant to make