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Life Sciences

Life Sciences

Key Contacts

Cambodia

Indonesia

Laos

Myanmar

Thailand

Vietnam

Alan Adcock

     +66 2056 5871

     [email protected]

Jay Cohen

     +855 23 964 210

     [email protected]

Wongrat Ratanaprayul

     +6221 2971 8099

     [email protected]

Alan Adcock

     +66 2056 5871

     [email protected]

Prisna Sungwanna

     +66 2056 5656

     [email protected]

Dino Santaniello

     +856 21 262 355

     [email protected]

Yuwadee Thean-ngarm

     +95 9 772 440 002

     [email protected]

Alan Adcock

     +66 2056 5871

     [email protected]

Atthachai Homhuan

     +66 2056 5610

     [email protected]

Hien Thi Thu Vu

     +84 24 3772 5606

     [email protected]

Kien Trung Trinh

     +84 24 3772 5567

     [email protected]

OVERVIEW

Our unified teams of legal and scientific professionals across Southeast Asia offer unparalleled expertise in the life sciences.

The Tilleke & Gibbins life sciences team combines experienced commercial attorneys, patent experts with technical degrees, and licensed pharmacists with industry experience to offer a full range of services to companies operating in pharmaceuticals, cosmetics, food and beverages, biotechnology, medical devices, veterinary products, consumer products, and other life sciences sectors. We stand ready to assist you with:

  • Regulatory Affairs.   Registration and prosecution of pharmaceuticals, biotech products, food and food supplements, narcotic and psychotropic substances, medical devices, cosmetics, hazardous substances, and animal and crop health products with national food and drug agencies and agricultural regulators.
  • Corporate and Transactional.   Advising on corporate establishment, cross-border and multi-jurisdictional transactions, labor and employment, due diligence, compliance investigations, IP valuation and licensing, assignments and acquisitions, franchising, distributorship, technology transfer, and tax and customs issues.
  • IP Registration.   Strategic portfolio management of patents, trademarks, trade secrets, copyright, and geographical indications, including IP search, registration, freedom-to-operate opinions, recordal, and prosecution.
  • IP Enforcement and Litigation.   Advising on pre-litigation and arbitration, IP litigation and strategy, validity challenges and invalidations, product liability, consumer complaints and recalls, and monitoring for infringing products in the market or under the application process.
Case Studies

Life Sciences Asia-Pacific Network

The Life Sciences Asia-Pacific Network (LAN) is a professional network of leading full-service law firms providing support to life sciences industry clients on a full range of legal and regulatory matters in the Asia-Pacific region. LAN brings together eight of the leading law firms in the region.

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Thailand | Life Sciences | Full Service

Thai Market Entry for World-Leading Cannabis Companies

Advising several leading global cannabis companies on structuring Thai partnerships for the research, development, and manufacture of medical cannabis and Cannabidiol (CBD) products in Thailand.

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Experience

  • Acted as counsel to a major pharmaceutical company by liaising with the Thai FDA on marketing compliance issues, verifying that the client’s marketing activities were in compliance with the complex regulations governing pharmaceutical practice in Thailand, and preventing and mitigating risk and loss.
  • Helped a multinational food company comply with Thai FDA requirements. Advised the client on advertising and promotional materials in Thailand, with particular emphasis on the requirements of the FDA and the consequences of improper ad content.
  • Acted on behalf of a major U.S.-based agrichemical manufacturer. The case involved termination of the client’s distributor for breach of contract and IP (patent and trademark) infringement. In addition, we represented the client in re-registration of its full range of products with the Thai Ministry of Agriculture.
  • Negotiated with the Thai FDA to reclassify a client’s drug product from a new chemical entity (NCE) to new combination (NCO) and secured the successful registration of this product.
  • Answered a critical client inquiry on whether their products could be imported without a certificate of formula disclosure provided to the Customs officer.
  • Secured an export license for the client in an efficient manner, as required by the head of the product group.
  • Coordinated the actions of multiple parties (the reviewers in Thailand, the foreign regulatory affairs authority, and the firm) to timely secure a pharmaceutical product license for the client.
  • Helped an Italian pharmaceutical company prepare an application dossier and obtain a license to operate in the area of medicinal products.
  • Handled a portfolio of products of a pharmaceutical client.  Our representation included assisting in the registration of the products, reviewing and advising on product labels, and assisting in transferring the products to a third company.
  • Secured medical device registration for a top shoe manufacturer and trader in Thailand by giving beneficial advice to the client and working closely with the client to resolve issues with its application.
  • Registered, in a seamless and efficient manner, a cosmetic product for a large importer in a limited period of time, which enabled the client to timely launch the product.
  • Advised a global pharmaceutical company on all aspects of doing business in Vietnam, including the formation and operation of a representative office, registration as a foreign pharmaceutical company, property transactions, and employment termination and labor disciplinary procedures.

PROFESSIONALS

RELATED INSIGHTS

October 25, 2023
One significant development in the health sector in Indonesia is the use of information technology and communication in the implementation of health efforts—particularly digital health services such as telehealth and telemedicine integrated into the country’s National Health Information System. This development was addressed in a major new piece of legislation for the healthcare sector in Indonesia. Enacted in August 2023, Law No. 17 of 2023 concerning Health (the “Health Law”) provides the updates needed to support the development of healthcare services in Indonesia. Under the Health Law, health information system (HIS) providers must: Carry out processing of data and health information in the territory of Indonesia, except for certain limited and specific processing activities that may be conducted outside Indonesia when permitted by the relevant authorities and in compliance with relevant regulations. Ensure the reliability of its HIS, including availability, security, maintenance, and integration with Indonesia’s National Health Information System. Provide quality health data and information. Process data and health information, which includes planning, collection, storage, inspection, transfer, utilization, and destruction. Record its data- and information-processing history. Protect every person’s data and health information. Obtain approval from the relevant personal data subject or comply with relevant regulations if the processing of data and health information involves an individual’s health data. Inform the data owner if there is a failure to protect data and individual health information. The Health Law’s personal data protection requirements listed above appear to be aligned with the provisions in Law No. 27 of 2022 concerning Personal Data Protection (the “PDP Law”). Under this law, data and information relating to health are identified as “specific personal data,” the processing of which carries a high potential risk of impacting the relevant personal data subject. In the implementation of digital health services, patients’ personal data or medical records
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October 19, 2023
Cambodia’s Law on Food Safety came into force on June 8, 2022. This law has been widely regarded as a major legal development of the food safety framework in Cambodia, providing new rules, clarifying existing rules, and setting a clear framework for its implementation and enforcement. In addressing some of the key features of this new law shortly after it was passed in 2022, we remarked that we eagerly await implementing regulations. Since then, various regulations have been adopted, such as two regulations (Sub-Decree No. 13 and Prakas No. 80) on food surveillance, recalls, and seizure. These implementing rules are essential in ensuring that enforcement officers can remove noncompliant and unsafe foods from the market. Another key aspect of the Law on Food Safety is that it requires Khmer-language labeling on prepackaged food products. There has been a notable increase in the inclusion of Khmer labeling on food products in the market since June 2022, but noncompliance is still considerable, especially for imported foods. Further interesting labeling rules set by the Law on Food Safety include a requirement to provide nutrition information. This requirement has not yet been widely adopted, with many in the industry highlighting that the details of this labeling requirement are not clear. Indeed, the relevant article of the Law on Food Safety itself only sets the requirement for food products to bear nutrition labeling and does not spell out what detailed information should be provided or in what manner. However, a prakas (ministerial regulation) adopted months prior to the Law on Food Safety does set out clear guidance on nutrition labeling. As long as this earlier regulation is not replaced or abrogated, and as far as it does not conflict with later laws or regulations, it can be relied upon for guidance. What are the
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September 20, 2023
Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019). Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could be renewed. The 2019 law also set out expiration dates for existing pharmaceutical products registered and approved prior to the implementation of the law (i.e., before October 13, 2019): Drug MAs issued before January 1, 1997, expire on October 13, 2024. Drug MAs approved between January 1, 1997, and December 31, 2007, expire on October 13, 2026. Drug MAs approved between January 1, 2008, and October 13, 2019, expire on October 13, 2028. Based on these dates, the first renewal period for drug MAs will commence in the fourth quarter of 2023. To facilitate the renewal process, the Thai Food and Drug Administration (FDA) has publicized draft regulations and notifications on the required application form and documents, the rules and conditions, and the process for renewing an MA. In May 2023, the Thai FDA issued Ministerial Regulation Re: Renewal of Drug MA Licenses B.E. 2566 (2023) to prescribe the essential requirements for filing a renewal application: To renew a drug MA, holders must submit their renewal application to the Thai FDA within the one-year period before the MA’s expiration date. Renewal applications can only be submitted online via the Thai FDA’s electronic system. The Thai FDA will grant approval for an MA renewal if the following conditions are satisfied: The documents in relation to efficacy and safety are up-to-date, accurate, and in accordance with academic principles. The specification and analytical method comply with the official pharmacopeias as prescribed in the Drug Act, as amended.
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September 15, 2023
In May 2023, Thailand issued a regulation on conditional approval for emergency use of medicinal products, replacing a series of similar notifications that had been issued to aid mitigation efforts during the COVID-19 pandemic. During the pandemic, regulatory authorities worldwide—including the Thai Food and Drug Administration (FDA)—reshaped the approval pathway for emergency drugs intended for the treatment of COVID-19. The Thai FDA published five Notifications Re: Conditional Approval for the Emergency Use of Medicinal Products to outline the registration requirements and channels of distribution for drugs intended for the diagnosis, treatment, or prevention of COVID-19. As the threat from COVID-19 was receding, the Thai FDA saw fit to prepare for the potential emergence of other serious communicable diseases by enabling the supply of timely medications for disease diagnosis, treatment, and prevention. The Thai FDA therefore cancelled the five COVID-19-related emergency use notifications, which were published in 2020 and 2022, and replaced them with the Notification Re: Conditional Approval for Emergency Use of Medicinal Products published in May 2023. Under the May 2023 FDA notification on emergency use, conditional approval can be applied to drugs supported by empirical scientific evidence demonstrating their capacity to diagnose, treat, alleviate, cure, or prevent a serious communicable disease. The drugs eligible for approval under this new emergency pathway include novel drugs that are not yet approved in Thailand, as well as existing drugs approved in Thailand but recently discovered to have additional potential indications for the diagnosis, treatment, alleviation, cure, or prevention of a serious communicable disease. Distribution The 2023 FDA notification also clearly defines permissible distribution channels based on the dosage form of drug products: Vaccines can be distributed to governmental organizations that have a duty to prevent or treat diseases, such as the Thai Red Cross Society (TRCS), the Government Pharmaceutical Organization
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AWARDS & RANKINGS
March 12, 2024
Tilleke & Gibbins has been nominated for three esteemed awards at the upcoming Chambers Asia-Pacific and Greater China Region Awards 2024: Thailand Firm of the Year Vietnam Firm of the Year Outstanding Firm for Diversity & Inclusion The nomination for Thailand Firm of the Year marks Tilleke’s fourth consecutive nomination and 10th overall since 2010, with the firm previously clinching the award in 2014. The firm is also a repeat nominee for the Outstanding Firm for Diversity & Inclusion award, while this is the first time Chambers has shortlisted Tilleke for the Vietnam Firm of the Year category in these awards. The winners of the Chambers Asia-Pacific and Greater China Region Awards 2024 will be announced at an exclusive in-person event scheduled to take place in Hong Kong on May 29, 2024. To learn more about the Chambers Asia-Pacific and Greater China Region Awards 2024 and browse the full list of nominations, please visit the Chambers and Partners website.
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January 30, 2024
The International Financial Law Review (IFLR) recently unveiled the shortlists for the IFLR Asia-Pacific Awards 2024, and Tilleke & Gibbins has been nominated for Thailand Firm of the Year at this competition recognizing outstanding legal firms and professionals across the Asia-Pacific region. The IFLR Asia-Pacific Awards are based on research by the IFLR team and careful selection by an internal panel of judges. The firm’s nomination conveys the firm’s continued commitment to excellence and its leading position in Thailand’s legal landscape. Winners of the IFLR Asia-Pacific Awards 2024 will be revealed at a gala dinner to be held in Hong Kong on March 20, 2024, at an event that will bring together industry leaders and legal professionals to celebrate excellence in the legal field. IFLR is a longstanding legal publication focusing on financial, transactional, and related matters in business law. To browse a full list of nominees for the IFLR Asia-Pacific Awards 2024, please see the shortlist on the IFLR website.
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January 18, 2024
Law.com International has unveiled the shortlists for the Asia Legal Awards 2024, and Tilleke & Gibbins has been nominated for awards in four categories.  The nominations include:  Southeast Asia Firm of the Year  Intellectual Property Firm of the Year (Asia-wide)  M&A Firm of the Year (Asia-wide)  TMT Firm of the Year (Asia-wide)   In addition to these regional firm nominations, Tilleke & Gibbins has also been acknowledged for its exceptional work in the field of restructuring and insolvency. The efforts of Tilleke & Gibbins’ dispute resolution team in connection with Thai AirAsia X’s business rehabilitation plan earned the firm a nomination for Restructuring and Insolvency Matter of the Year.   The winners of the Asia Legal Awards 2024 will be unveiled on March 14 at an in-person event in Singapore. For more information on the Asia Legal Awards 2024, and to browse a full list of nominees in all categories, please visit the Law.com International website. 
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January 18, 2024
Tilleke & Gibbins once again earned high marks across all six jurisdictions in the 2024 rankings from The Legal 500 Asia Pacific, which was released on January 17. This year, Tilleke & Gibbins’ rankings reflect continued excellence in the practice area rankings, plus new individual recognitions for eight more Tilleke & Gibbins practitioners. In total, Tilleke & Gibbins received 30 practice rankings—over a third of which are Tier 1.  The firm’s Thailand office earned 15 practice-area rankings:  Tier 1: Dispute Resolution, Intellectual Property, Labor and Employment, TMT (Technology, Media, and Telecommunications), Tax  Tier 2: Banking and Finance, Capital Markets, Corporate and M&A, Customs and International Trade, Insurance, Projects and Energy, Real Estate and Construction, Restructuring & Insolvency, Transport  Tier 3: Dispute Resolution: International Arbitration  Tilleke & Gibbins’ offices in Vietnam received rankings for 10 practice areas:  Tier 1: Data Protection, Intellectual Property (International Firms), Labor and Employment, TMT  Tier 2: Corporate and M&A   Tier 3: Dispute Resolution: International Arbitration, Dispute Resolution: Litigation   Tier 4: Banking and Finance, Projects and Energy  Firms to Watch: Real Estate and Construction  Tilleke & Gibbins earned five additional practice-area rankings in Cambodia, Indonesia, Laos, and Myanmar:   Tier 1: Laos (General Business Law), Myanmar (Corporate and M&A)  Tier 2: Cambodia (General Business Law); Indonesia (Intellectual Property); Myanmar (Projects)   In addition to the practice-area rankings, a record number of Tilleke & Gibbins lawyers were honored with individual recognitions. The Tilleke & Gibbins practitioners included in the 2024 rankings from The Legal 500 Asia Pacific are listed below:  Alan Adcock – Thailand – Intellectual Property  Athistha (Nop) Chitranukroh – Thailand – Insurance, TMT Chaiwat Keratisuthisathorn – Thailand – Real Estate and Construction Charunun Sathitsuksomboon – Thailand – Corporate and M&A Chusert Supasitthumrong – Thailand – Labor and Employment Darani Vachanavuttivong – Thailand – Intellectual Property  David Mol
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