title: Extension of market exclusivity and its impact on the accessibility to essential medicines, and drug expense in Thailand: analysis of the effect of TRIPs-Plus proposal.
abstract: BACKGROUND
  In Thailand and the US negotiating FTA, the 'TRIPs-Plus' is one of the US proposal which would result in an extension of market exclusivity of innovative drugs. In addition, it would foreseeably lead to high and unaffordable medicine prices and inaccessibility to essential medicines.
  
  
  OBJECTIVE
  To quantify the impact on medicine expense and medicine accessibility.
  
  
  METHODS
  Based on 2000 to 2003 Thai Food and Drug Administration (FDA)'s and the Drug & Medical Supply Information Center (DMSIC), costs and accessibility were estimated upon the price and quantity costing between innovative drugs and their generics plus some parameters found from their competitive behaviour. Thereafter, we simulated the 10-year potential additional expense on the 2003 unit price of the patented and monopolized non-patented medicines.
  
  
  RESULTS
  In 2003, the availability of generics helped to save 104.5% of actual expense and the accessibility would increase by 53.6%. By extension of market exclusivity, given that there were 60 new items approved annually, the cumulative potential expense was projected to be $US 6.2 million for the first year to $US 5215.8 million in tenth year.
  
  
  CONCLUSIONS
  The TRIPs-Plus proposal would result in a significant increase in the medicine expense; and a delay in the increase in drug accessibility via generics. Several options as well as other related mechanisms to help reduce the negative impact are proposed.
authors.affiliation: International Health Policy Program-Thailand, Ministry of Public Health, Tiwanon Road, Muang, Nonthaburi 11000, Thailand. chutima@ihpp.thaigov.net
authors.forename: Chutima
authors.initials: C
authors.lastname: Akaleephan
authors.forename: Suwit
authors.initials: S
authors.lastname: Wibulpolprasert
authors.forename: Rungpetch
authors.initials: R
authors.lastname: Sakulbumrungsil
authors.forename: Paithip
authors.initials: P
authors.lastname: Luangruangrong
authors.forename: Anchalee
authors.initials: A
authors.lastname: Jitraknathee
authors.forename: Achara
authors.initials: A
authors.lastname: Aeksaengsri
authors.forename: Siripa
authors.initials: S
authors.lastname: Udomaksorn
authors.forename: Viroj
authors.initials: V
authors.lastname: Tangcharoensathien
authors.forename: Sripen
authors.initials: S
authors.lastname: Tantivess
mesh_terms: D000465:Algorithms; D003906:Developing Countries; D016527:Drug Costs; D018954:Drugs, Essential / Q000191:economics* / Q000600:supply & distribution*; D016568:Drugs, Generic; D006297:Health Services Accessibility; D018973:Intellectual Property; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D040541:Marketing; D013785:Thailand
chemical_list: D018954:Drugs, Essential; D016568:Drugs, Generic