On January 9, 2023, Vietnam’s National Assembly voted to approve a draft resolution on the continued implementation of policies for the prevention and control of the Covid-19 pandemic. Under this resolution, marketing authorizations (MAs) for the following drugs and medicinal ingredients will be extended to December 31, 2024, allowing continued use in Vietnam: Drugs and medicinal ingredients whose MAs expire from January 1, 2023, to December 12, 2024, and whose extension dossiers have been submitted but have not yet been approved in accordance with the Law on Pharmacy; and Drugs and medicinal ingredients whose MAs have been extended as per Resolution No. 12/2021/UBTVQH15 and have not been extended in accordance with the Law on Pharmacy. The extension does not apply to the following cases: Drugs and medicinal ingredients that have been recalled by the Law on Pharmacy; Drugs with signs of being unsafe for users that have been suspended from circulation/use and sealed for preservation in accordance with the Law on Pharmacy; and Drugs with MAs having a validity term of three years in accordance with the Law on Pharmacy. The Ministry of Health will announce the list of drugs and medicinal ingredients whose MAs are subject to be extended as described above.

Tilleke & Gibbins’ insurance specialists in Yangon have contributed the Myanmar overview to the Insurance and Reinsurance Global Guide, published by Thomson Reuters Practical Law. The guide is a Q&A-style overview of insurance and reinsurance law, with entries from legal experts in 47 jurisdictions worldwide. Tilleke & Gibbins’ Myanmar contribution provides a comprehensive look at the market for insurance and reinsurance in the country, and it covers the following topics: Market trends Regulatory framework Authorization – Laws and bodies, insurance intermediaries, exemptions and foreign insurers, fronting, legal forms, restrictions and insurance activities Ownership restrictions Ongoing requirements Penalties for noncompliance Sales and marketing Transfer of risk Reinsurance contracts and risk Contracts and policies – Content requirements and common clauses, implied terms, customer protections, standard policies or terms Claims – Establishing a claim, time limits, subrogation, third-party claims, insurance of punitive damages, remedies for breach of policy Dispute resolution Insolvency Tax Insurtech The Q&A closes with a brief update on the new draft Insurance Business Law to reform the Myanmar insurance market. Practical Law brings together guides to key legal practice areas around the world for business lawyers. Tilleke & Gibbins contributes many overviews on various legal practice areas for all of the firm’s jurisdictions in Southeast Asia. To read the full Myanmar overview, please visit the Practical Law website.

The updated Thailand chapter of The Pharma Legal Handbook, published by Pharma Boardroom, is a comprehensive guide to the legal framework regulating the healthcare and life sciences industries in Thailand. The latest Thailand chapter was authored by four of Tilleke & Gibbins’ life sciences specialists in Bangkok: Alan Adcock, partner and and head of the firm’s regional life sciences practice; Dr. Atthachai Homhuan, director of regulatory affairs; San Chaithiraphant, senior associate; and Kittiya Nopparatrunroj, regulatory affairs consultant. The handbook is a must-read for healthcare and life sciences companies that are interested in exploring expansion into the Thai market. The guide is broken into ten easy-to-read sections that delve into various aspects of local regulations: Regulatory, Pricing, and Reimbursement Overview Preclinical and Clinical Trial Requirements Marketing, Manufacturing, Packaging and Labeling, Advertising Traditional Medicines and Over-the-Counter Products Product Liability Patents and Trademarks Regulatory Reforms Cannabinoid Drugs, Medical Cannabis, and Opioid Drugs Orphan Drugs and Rare Diseases Localization Biosimilars and Biologics A preview of the Thailand chapter is provided via the PDF button below, and the complete guide is available for purchase on the Pharma Boardroom website (use promotional code Tilleke10 for a 10% discount).

The delisting of cannabis as a controlled narcotic in Thailand on June 9, 2022, was a breakthrough moment for the industry.  Not only are farmers and others in the industry elated that such a step was taken, it has triggered the establishment of an abundance of cannabis dispensaries in Bangkok and other popular domestic and international tourist destinations in Thailand, including Chiang Mai, Pattaya, Phuket, and many islands. Vulnerable populations, such as children, accessing cannabis has also become a hot-button issue. Thailand’s Ministry of Public Health (MOPH) was initially criticized by some for its policy of allowing cannabis to be sold with few restrictions. On June 17, 2022, the MOPH followed up with the Announcement Re: Controlled Herbs (Cannabis) under the Thai Traditional Medical Knowledge Act, which seemed to implement a viable mechanism to regulate cannabis dispensaries. This announcement contained prohibitions on selling cannabis to vulnerable populations (minors, expectant women, and breastfeeding mothers) and on smoking cannabis in public. Furthermore, the draft Cannabis and Hemp Act includes provisions related to sales and distribution channels and advertisements for particular dispensaries. However, the draft act has been delayed due to disagreements among some political parties during the reading of the legislation, and is unlikely to be implemented in 2022 as had been widely expected.  The tug-of-war among the political parties has caused concerns about whether the country’s recent liberalized cannabis policy will be revisited and cannabis relisted as a narcotic. With this uncertainty over when the draft Cannabis and Hemp Act will be implemented, the MOPH has focused on identifying gaps in current regulation that might allow the misuse of cannabis. The minister of the MOPH has announced that the MOPH announcement of June 17, 2022, will be repealed and replaced by the November 11, 2022, Announcement Re: Controlled Herbs (Cannabis).