PLC Life Sciences Global Guide is a Q&A-style chapter that provides an overview of the regulatory frameworks of the life sciences industries across multiple jurisdictions worldwide. Legal practitioners from Tilleke & Gibbins contributed to the Thailand chapter of the guide, which is comprised of the following two sections:
Medical Product Regulation and Product Liability in Thailand
- Pharmaceutical legislation and regulatory authorities
- Regulation of biologicals and combination products, and medical devices and diagnostics
- National healthcare system
- Pricing, state funding, and reimbursement
- Clinical trial regulations
- Medical product manufacturing
- Marketing authorization procedures, and commitment and pharmacovigilance obligations
- Parallel imports
- Restrictions on dealings with healthcare professionals
- Restrictions on sales and marketing, and advertising
- Data protection
- Packaging and labelling
- Product liability
- Proposals for reform
Pharmaceutical IP and Competition Law in Thailand
- Pharmaceutical patent legislation and scope of protection
- Patent application process, duration of protection, and revocation
- Patent infringement, claims, and remedies
- Non-patent barriers to competition for pharmaceutical protection
- Pharmaceutical trademark legislation and scope of protection
- Trademark application process, duration of protection, and revocation
- Trademark infringement, claims, and remedies
- Regulatory powers and enforcement against pharmaceutical counterfeiting
- Competition law framework and implications for the pharmaceutical sector
- Competition issues related to licensing of pharmaceutical technology and patents, and market entry of generic products
- Market dominance issues in the pharmaceutical sector
- Parallel imports
- Foreign patent and trademark licenses, and payment of royalties
Tilleke & Gibbins was also contributed the guide’s Vietnam chapter.