Possible Impact of Market Exclusivity Extension on Pharmaceuticals

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 l 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 l Thai Patent Act and Trade Secret Act conform with all TRIPs’ requirements l However, the Patent Act still does not cover cross country CL of the Doha Declaration

US FTA with others countries: issues related to pharmaceuticals l Data exclusivity l Linkage between market registration and patent l Patent term compensation due to delay of patent approval l Patent term compensation due to delay of market authorization process l Intellectual property law enforcement l Restriction on CL to only the case of government use l Limitation or cancellation of parallel import l 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 l Main features of the local industries ¡ Mainly conventional dosage form ¡ Limited capacity for production of raw materials ¡ Limited capacity on bioavailability studies l Potential benefits of FTA: ¡ improve standard and quality ¡ increase export opportunities (AFTA, BIMST-EC) ¡ opportunity for cheaper raw material l Negative impact of FTA: ¡ reduce government’s revenue ¡ Disappear or being taken over ¡ longer period of expensive innovative drugs

Market authorization, market exclusivity and implication of its extension

Sample selection 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

Average months for Market Authorization, 1983 -2003

Market exclusivity (14 Patented drugs) Type of invention Patent filing to market authorization (years) Market exclusivity (years) Drug substance (n=3) 6. 6 [4. 9 -9. 1] 13. 4 [10. 9 -15. 1] Process of intermediate /polymorph /crystalline form (n=4) 1. 5 [1. 2 -2. 9] 18. 5 [17. 1 -18. 8] Formula (n=7) 1. 2 [0. 2 -2. 9] 18. 8 [17. 1 -19. 8]

2003 Current cost saving of 42 generic drug substitution ($US million) Drugs 42 items Per item Expense Total on expenditure innovative Expense on generic - local manufacturing Expense on genericimport Expected expense without GS Cost saving 252. 8 166. 5 42. 4 43. 8 517. 0 264. 3 6. 0 4. 0 12. 3 6. 3

Forecasted additional expense for minimum implications from three years market exclusivity extension ($US million) year 1 2 3 4 5 0. 7 0. 8 Per item 0. 1 0. 5 New drug 60 items in 1 st year 6. 4 27. 7 30. 6 6. 4 27. 7 New drug 60 items in 2 nd year New drug 60 items in 3 rd year … 4 th year … 5 th year 10 4. 5 Cumulative 13. 9 6. 4 … 6 th year … 7 th year … 8 th year 30. 6 … 9 th year 27. 7 … 10 th year 6. 4 Total 6. 4 34. 2 64. 8 558. 9

Forecasted additional expense from ME extension (million USD) Years of extension Additional expense per item Additional expense of 60 items (1 year) min max 1 0. 1 1. 1 6. 4 65. 9 2 0. 6 2. 5 34. 2 152. 4 3 1. 1 4. 7 64. 8 279. 2 4 1. 7 7. 2 103. 9 431. 0 5 2. 5 12. 0 151. 7 722. 5 6 3. 4 19. 2 204. 5 1151. 9 7 4. 5 29. 3 272. 3 1755. 9 8 6. 7 43. 2 403. 3 2593. 9 9 9. 4 62. 3 565. 0 3737. 2 10 13. 9 90. 2 836. 7 5411. 4

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. l Additional public burden from market exclusivity is very high (may double health expense) l Accept TRIPS plus means amendment of related laws which also benefit all other trade partners l

Alternative position: least public health implications l No or shortest market exclusivity extension l Case by case basis on compensation for delayed patent registration and market authorization l Compulsory licensing in such condition as national emergency and extreme emergency must be retained l Prevention of abuse in the implementation of linkage between drug registration and patent

Measures to alleviate the possible future negative implication l 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 l Support more R&D capacity of domestic manufactures l Promotion of rational drug use and generic substitution l Support further improvement of GMP to international qualification

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