PLC Life Sciences Global Guide 2017 – Thailand Chapter

Practical Law Company

September 22, 2017

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.