The latest edition of Practical Law’s Life Sciences Global Guide features contributions from Tilleke & Gibbins attorneys in the firm’s Yangon office. One of the sections they have provided for the Myanmar chapter of this Q&A-style guide to life sciences regulatory frameworks worldwide is “Medicinal Product Regulation and Product Liability in Myanmar.” The section includes discussion of a range of regulatory issues related to the marketing and selling of pharmaceutical products, including the following topics: Regulatory overview: Authorities, scope, and general procedures for pharmaceuticals, biologicals, and medical devices and health care IT Pricing, government funding, and reimbursement: National health care system, price regulation, and reimbursement Clinical trials Manufacturing and distribution Marketing: Authorization for marketing medicinal products, parallel imports and cross-border trade in medicines Restrictions on dealings with health care professionals Selling restrictions Advertising and promotion Data privacy Packaging, labeling, and tracking Product safety, quality, and liability Local establishment, representation, and residency requirements Reform The full “Medicinal Product Regulation and Product Liability in Myanmar” section can be accessed on the Practical Law website. 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. Tilleke & Gibbins also supplied “Pharmaceutical IP and Competition Law in Myanmar,” which was published in the Life Sciences Global Guide  at the same time.

Attorneys from Tilleke & Gibbins in Myanmar have contributed to the latest edition of Practical Law’s online Life Sciences Global Guide. The guide is a Q&A-style overview of the regulatory frameworks for the life sciences industry across multiple jurisdictions worldwide, and this year the Myanmar chapter includes two sections, one of which is “Pharmaceutical IP and Competition Law in Myanmar.” This section runs through the country’s legal and regulatory environment for patents and trademarks—particularly as they relate to pharmaceutical business in the jurisdiction. The section then turns to IP and competition law issues, with questions and answers focusing on how the country’s competition laws and regulations affect the pharmaceutical sector. Readers are also given information on how to properly comply with Myanmar law on competition, including when it comes to licensing of medicines and pharmaceutical technology. The full Pharmaceutical Intellectual Property and Competition Law in Myanmar guide can be accessed on the Practical Law website. 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. Tilleke & Gibbins also supplied the “Medicinal Product Regulation and Product Liability in Myanmar,” which Practical Law published in its Life Sciences Global Guide  at the same time.

Across the globe, the demand for COVID-19 vaccinations has been understandably high, with many regulatory authorities (e.g., U.S. Food and Drug Administration, Medicines & Healthcare Products Regulatory Agency in the U.K., European Medicine Agency, Swissmedic, etc.) issuing emergency use authorizations for COVID-19 vaccines. Similarly, the Thai Food and Drug Administration (Thai FDA) has published the Notification Re: Conditional Approval for Emergency Use of Medical Products, which allows drug importers to register COVID-19 vaccines under the conditional approval scheme.  While as of the date of this article, the Thai FDA has yet to authorize any COVID-19 vaccines, this should follow shortly as clinical trials are completed and government procurement negotiations progress. Under the notification, it appears that the channel of distribution of a COVID-19 vaccine under the conditional approval scheme would be strictly controlled by the Thai FDA. This channel includes the vaccine’s distribution to relevant government agencies (e.g., Department of Disease Control of Thailand and public hospitals specified by the Thai FDA). However, questions have been raised regarding which private hospitals would be included in the distribution list and how the Thai FDA would distribute the vaccine to private hospitals. This confusion over the role of private hospitals was seen recently when one private hospital advertised that it could secure the COVID-19 vaccine from one developer whose product had already been approved elsewhere, until the Thai FDA then stepped in and claimed that the advertisement violated the Drug Act. The Thai FDA notification also enumerates several essential criteria that must be fulfilled in seeking approval for a COVID-19 vaccine, including the following: The available scientific data must substantiate both the efficacy and safety of vaccine. Further, the risk-benefit analysis must indicate that the medicine’s benefits outweigh its risks. A risk management plan, including risk minimization measures, must be submitted.

At a meeting on December 21, 2020, the Thai Board of Investment (BOI) approved a series of stimulus packages aimed at encouraging local and foreign investment, as the government seeks to boost Thailand’s economic recovery from the COVID-19 pandemic. The additional investment incentives, which will be promoted by the BOI in the upcoming year, include a number of sector- and project-specific stimulus measures.   Additional Tax Incentives for Large-Scale Projects Projects in target industries with investment of at least THB 1 billion (approx. USD 33 million) over a 12-month period, starting from the issuance of the BOI promotion certificate, will be entitled to an additional 50% corporate income tax (CIT) deduction for a period of five years, calculated on top of the standard 5–8 year CIT exemptions offered under the normal BOI tax-incentive scheme. To obtain this special tax incentive, eligible projects may apply to the BOI from January 4 to December 30, 2021.   Stimulus Package for Digital Economy and Software Industry Projects that support digital technology adoption, such as software integration, artificial intelligence, machine learning, or big data analytics, may benefit from 50% CIT exemptions on profits generated from their existing BOI projects for an additional three years. Applications for the exemption must be submitted by the end of 2022.   Application Deadline Extensions for Special Economic Zones and Five Southern Provinces Measures relating to special economic zones cover more than 300 investment promotion categories, with both tax and non-tax incentives, including an additional tax incentive for target industries such as textiles, agriculture, home furniture, jewelry, and others. These incentives are available to projects located in the border areas of Thailand (i.e., the 10 special economic zones in the provinces of Chiang Rai, Kanchanaburi, Mukdahan, Nakhon Phanom, Narathiwat, Nong Khai, Sa Kaeo, Songkhla, Tak, and Trat), with the