160 likes | 427 Views
Possible Impact of Market Exclusivity Extension on Pharmaceuticals in Thailand. Chutima Akaleephan International Health Policy Program, Thailand 27 August 2005. IPR related Thai legal structures.
E N D
Possible Impact of Market Exclusivity Extension on Pharmaceuticals in Thailand Chutima Akaleephan International Health Policy Program, Thailand 27 August 2005
IPR related Thai legal structures • Thailand has amended its Patent Act to conform with the main points of TRIPs since 1992, eight years before the 2000 deadline in WTO agreement • Thai Patent Act and Trade Secret Act conform with all TRIPs’ requirements • However, the Patent Act still does not cover cross country CL of the Doha Declaration
US FTA with others countries: issues related to pharmaceuticals • Data exclusivity • Linkage between market registration and patent • Patent term compensation due to delay of patent approval • Patent term compensation due to delay of market authorization process • Intellectual property law enforcement • Restriction on CL to only the case of government use • Limitation or cancellation of parallel import • Limitation on patent cancellation
Proportion of Drug in Health Expense, 1996-2000 ($US million) Drug expenditure (retail price) Source: Thailand Health Profile 2001-2004
Possible impact of FTA on domestic manufacturers • Main features of the local industries • Mainly conventional dosage form • Limited capacity for production of raw materials • Limited capacity on bioavailability studies • Potential benefits of FTA: • improve standard and quality • increase export opportunities (AFTA, BIMST-EC) • opportunity for cheaper raw material • Negative impact of FTA: • reduce government’s revenue • Disappear or being taken over • longer period of expensive innovative drugs
Market authorization, market exclusivityandimplication of its extension
The 2002 imported drugs Total value ~ 500 million USD 1,136 generic names First 49.9% 74 generic names Patent search Generic drugs availability 42 items Non-patented but monopoly 14 items Patented drug 18 items Sample selection
2003 Current cost saving of 42 generic drug substitution ($US million)
Forecasted additional expense for minimum implications from three years market exclusivity extension ($US million)
Forecasted additional expense from ME extension (million USD)
Recommendation for alternative negotiation positions for Thai-US FTA Main position: zero negative public health implication Rationales: • Current patent system has already allowed 13.4 to 18.8 year of market exclusivity- very long. • Additional public burden from market exclusivity is very high (may double health expense) • Accept TRIPS plus means amendment of related laws which also benefit all other trade partners
Alternative position: least public health implications • No or shortest market exclusivity extension • Case by case basis on compensation for delayed patent registration and market authorization • Compulsory licensing in such condition as national emergency and extreme emergency must be retained • Prevention of abuse in the implementation of linkage between drug registration and patent
Measures to alleviate the possible future negative implication • Improvement of the patent registration process and database • close coordination between Department of IP and FDA • reevaluation of patent of new use of drug • closely monitor potential evergreening patent with heavy penalty • easy search of IP database • expert in pharmaceutical and/or chemistry could play important role in examination of patent application • Support more R&D capacity of domestic manufactures • Promotion of rational drug use and generic substitution • Support further improvement of GMP to international qualification
Thank you for your attention