1. Thailand, TRIPS, and Compulsory Licensing Tanyaporn Wansom 2007-2008 Global Health Chair, American Medical Student Association 2006 WHO Duke University Global Health Fellow 2006-2007 Fogarty-Ellison Fellow, RIHES, Chiang Mai, Thailand

2. Outline of presentation Important definitions to understand Important definitions to understand TRIPS TRIPS Doha Declaration Doha Declaration Generic Product Generic Product Patent Patent Compulsory Licensing Compulsory Licensing Current events surrounding Thailand’s compulsory license for Kaletra and the Abbott response Current events surrounding Thailand’s compulsory license for Kaletra and the Abbott response

3. What is TRIPS, anyway? What is TRIPS? What is TRIPS? Who needs to follow TRIPS? Who needs to follow TRIPS? What are the consequences for those who do not follow TRIPS? What are the consequences for those who do not follow TRIPS?

4. TRIPS Flexibilities Parallel Importation Parallel Importation Compulsory licensing Compulsory licensing Allows a government to produce or import a generic medicine without consent of the patent holder for a limited period of time Allows a government to produce or import a generic medicine without consent of the patent holder for a limited period of time The patent holder still receives compensation in the form of a royalty (usually a percentage of drug price) The patent holder still receives compensation in the form of a royalty (usually a percentage of drug price) Doha Declaration: Doha Declaration: Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.... Each Member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.... Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relation to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstance of extreme urgency. Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relation to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstance of extreme urgency.

5. Thailand and Compulsory Licensing Even though compulsory licensing is legal, under international trade law, few countries have been able to use it. Even though compulsory licensing is legal, under international trade law, few countries have been able to use it. Why? Why? US/Europe/Big Pharma pressure US/Europe/Big Pharma pressure Threat of sanctions Threat of sanctions Threat of investors/business Threat of investors/business The threat of compulsory licensing has also been used as leverage in negotiations with drug companies to reduce prices The threat of compulsory licensing has also been used as leverage in negotiations with drug companies to reduce prices Brazil and Kaletra Brazil and Kaletra

6. The MOPH and Compulsory Licensing Since last year, the MOPH has issued compulsory licenses for three drugs: Since last year, the MOPH has issued compulsory licenses for three drugs: Efavirenz (Merck) Efavirenz (Merck) Kaletra (Abbott) Kaletra (Abbott) Plavix (Sanofi-Aventix) Plavix (Sanofi-Aventix) This talk will focus on two CL’s: This talk will focus on two CL’s: Efavirenz CL, issued in November 2006 Efavirenz CL, issued in November 2006 Kaletra CL, issued in Jan 2007 Kaletra CL, issued in Jan 2007

7. Efavirenz Background EFV often used in first line regimens in Thailand (d4T/3TC/EFV, AZT/3TC/EFV) EFV often used in first line regimens in Thailand (d4T/3TC/EFV, AZT/3TC/EFV) Previously, EFV was being sold by Merck at a ‘no-profit’ price of 1400 baht/pt/month Previously, EFV was being sold by Merck at a ‘no-profit’ price of 1400 baht/pt/month Thailand placed an order with an Indian generic company that would reduce prices to 800 baht/ pt/mo; GPO said it could produce for 600-700 baht/pt/mo Thailand placed an order with an Indian generic company that would reduce prices to 800 baht/ pt/mo; GPO said it could produce for 600-700 baht/pt/mo

8. Conditions of Efavirenz CL (1) CL issued until 31st December 2011. (2) CL limited to the provision of Efavirenz to not more than 200,000 patients per year, for those covered under the National Health Security System Act B.E.2545, Social Security Act B.E. 2533, and the Civil Servants and government employees medical benefits scheme. (3) A royalty fee of 0.5 percent of the GPO total sale value of the imported or locally produced Efavirenz will be paid to the patent holder (Merck)

9. Feb 2007 Merck announces worldwide reduction in EFV prices Merck announces worldwide reduction in EFV prices Thailand’s new price is now 700 baht/pt/month Thailand’s new price is now 700 baht/pt/month

10. Kaletra Background Protease inhibitor combination (lopinavir/ritonavir) Protease inhibitor combination (lopinavir/ritonavir) Covered for patients under NAPHA program Covered for patients under NAPHA program One of the most expensive AIDS drugs currently registered in Thailand at $2200 (72,000 baht) per patient per year One of the most expensive AIDS drugs currently registered in Thailand at $2200 (72,000 baht) per patient per year

11. Kaletra CL Minister of Public Health Dr. Mongkol Na Songkhla: Minister of Public Health Dr. Mongkol Na Songkhla: “Public health interest and the interests of the people must come before commercial interest.” “Public health interest and the interests of the people must come before commercial interest.” Issuing a Kaletra CL would allow either importation or in-country generic production, reducing prices by 50% or more from current prices Issuing a Kaletra CL would allow either importation or in-country generic production, reducing prices by 50% or more from current prices

12. Kaletra CL conditions Under the following conditions for Kaletra: (1) Effective until 31st January 2012. (2) The use of the above patent rights will be limited to the provision of Efavirenz to not more than 50,000 patients per year, for those covered under the National Health Security System Act B.E. 2545, Social Security Act B.E. 2533, and the Civil Servants and government employees medical benefits scheme. (3) A royalty fee of 0.5 percent of the GPO total sale value of the imported or locally produced Lopinavir+Ritonavir will be paid to the patent holder.

13. Abbott’s response After Thailand issued the Kaletra CL, Abbott: After Thailand issued the Kaletra CL, Abbott: Withdrew all Abbott products currently undergoing registration in Thailand, including the heat-stable form of Kaletra Withdrew all Abbott products currently undergoing registration in Thailand, including the heat-stable form of Kaletra Announced that it would refuse to release any future (new) Abbott products on the Thai market Announced that it would refuse to release any future (new) Abbott products on the Thai market Abbott states that it will stick to its decision until Thailand reverses its decision on the Kaletra CL Abbott states that it will stick to its decision until Thailand reverses its decision on the Kaletra CL This kind of action is unprecedented and has never been attempted by any other pharmaceutical company This kind of action is unprecedented and has never been attempted by any other pharmaceutical company

14. April 2007 Abbott announced price cut from $2200 to $1000 for a one-year course of Kaletra in Thailand Abbott announced price cut from $2200 to $1000 for a one-year course of Kaletra in Thailand Clinton Foundation is offering a generic version for $695/year from Matrix Labs in India Clinton Foundation is offering a generic version for $695/year from Matrix Labs in India Thai MOPH states that he will not enforce CL’s if Pharma can match generic prices (May 2007) Thai MOPH states that he will not enforce CL’s if Pharma can match generic prices (May 2007)

15. Abbott Support US Trade Representative Susan Schwab – Thailand is now on the ‘Priority Watch List’ US Trade Representative Susan Schwab – Thailand is now on the ‘Priority Watch List’ Some US (pro-PhRMA) senators, such as Sen. Joe Lieberman Some US (pro-PhRMA) senators, such as Sen. Joe Lieberman PhRMA (Pharmaceutical Research and Manufacturers of America) PhRMA (Pharmaceutical Research and Manufacturers of America) Bayer – official support Bayer – official support USA for Innovation – new ‘nonprofit’ funded by Abbott as a PR firm to speak out against Thailand USA for Innovation – new ‘nonprofit’ funded by Abbott as a PR firm to speak out against Thailand

16. Thai support Many groups have come out in support of Thailand’s CL, including: Many groups have come out in support of Thailand’s CL, including: Thai NGO’s – Thai Network of People Living with HIV/AIDS (TNP+), AIDS Access Foundation, TTAG, and more Thai NGO’s – Thai Network of People Living with HIV/AIDS (TNP+), AIDS Access Foundation, TTAG, and more Global NGO’s – MSF, Oxfam, KEI, Third World Network, CP- Tech, Health GAP, etc. Global NGO’s – MSF, Oxfam, KEI, Third World Network, CP- Tech, Health GAP, etc. UNAIDS, Clinton Foundation UNAIDS, Clinton Foundation Rep. Henry Waxman + 30 other Reps sent a letter to the USTR asking for Thailand to be taken off the Priority Watch List (6/20/2007) Rep. Henry Waxman + 30 other Reps sent a letter to the USTR asking for Thailand to be taken off the Priority Watch List (6/20/2007) France has issued a statement of support for Thailand France has issued a statement of support for Thailand

17. Action on the Ground ACT-UP Paris and Abbott website ACT-UP Paris and Abbott website Abbott protests/birddogging Abbott protests/birddogging Chicago Chicago Boycott of Abbott products Boycott of Abbott products Speaking out against pro-PhARMA letters, ads, etc. in national and local newspapers (May media war) Speaking out against pro-PhARMA letters, ads, etc. in national and local newspapers (May media war) Standing up and continuing to pressure Abbott! Standing up and continuing to pressure Abbott!

18. More information Thai White Paper (www.moph.go.th) : Thai White Paper (www.moph.go.th) :www.moph.go.th ข้อมูลความจริง 10 ประเด็นร้อน การใช้สิทธิโดยรัฐต่อยาที่มี สิทธิบัตร 3 รายการ ในประเทศไทย ข้อมูลความจริง 10 ประเด็นร้อน การใช้สิทธิโดยรัฐต่อยาที่มี สิทธิบัตร 3 รายการ ในประเทศไทย Thai Network of People Living with HIV/AIDS (TNP+): Thai Network of People Living with HIV/AIDS (TNP+): www.thaiplus.net www.thaiplus.net www.thaiplus.net Abbott worldwide boycott Abbott worldwide boycott Sign-on letter (petition) to Abbott Sign-on letter (petition) to Abbott www.abbottsgreed.com www.abbottsgreed.com www.abbottsgreed.com www.essentialaction.org www.essentialaction.org www.essentialaction.org www.keionline.org www.keionline.org www.keionline.org