1. Access to AIDS Treatment and Intellectual Property Rights’ Protection in Thailand Jiraporn Limpananont, Associate Professor Dr. at Social Pharmacy Research Unit, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Thailand Achara Eksaengsri, Director, Research and Development Institute, Government Pharmaceutical Organization (GPO), Thailand Kannikar Kijtiwatchakul, Access to Essential Medicine Campaigner, MSF Belgium – Thailand

2. HIV/AIDS Epidemic in Thailand  1984 HIV first cases in Thailand were reported homosexual males; IDU, sex workers; mother-to- child transmission  1999 1M. people were living with HIV and 100,000 people were in need of treatment  2007, the Thai Working Group on HIV/AIDS estimated the accumulated number of PHA in Thailand was 1,102,628 including 50,620 children  An estimated 546,578 people living with HIV/AIDS. among those 13,936 people are newly infected.

3. Numbers of AIDS patients mortality and in Thailand from 1984 – June 2008

4. Under the 2007 Thai constitution, section 51 of Part 9 Right to Public Health Service and Welfare  Almost 75% or 47 M. of Thai population receive Universal healthcare coverage (UC) according by The National Health Security Act 2002  Since Oct. 2005 Antiretroviral treatment (HAART) has been included in the UC

5. Protesting the exclusion of ARV from the 30 baht scheme (UC), 2003

6. The legal framework for industrial property with emphasis in pharmaceutical patents  Thailand lost 13 yrs. to develop its domestic drug industry significantly and has been under strong pressure of US government pressure since 1985  1992 Thailand passed a law introducing pharmaceutical product patent protection and extended patent life from 15 to 20 years.  1999 Thai Patent Act was further amended, disbanding the Pharmaceutical Patent Review Board.  Early 2005, In the sixth round of the negotiation in Chiang Mai, US demands were worse than feared

7. Event on the 6 th round of Thai-US FTA negotiation Chiang Mai, Thailand Jan. 2006 The Thai-US FTA Negotiation has been stopped.

8. The history of the right to treatment of persons living with HIV and AIDS  Mid-1990’s, improving access to prevention and treatment of OIs was started by various related HIV/AIDS organizations, Although no access to ARV drugs in Thailand prior to 2001  The most important step was the successfully campaign to support for the National Health Security Act 2002 and to lobby for the inclusion of ARV into National Health Security Scheme in 2004.  1999 Coalition successfully challenged the validity of ddI patent held by Bristol Meyer Squibb opening the way for the GPO to start generic production of ARV.  2006 Thai social movement challenged the validity of GSK’s “evergreening patent” for the drug combination of lamivudine+zidovudine. Finally, GSK withdrew its application both in Thailand and India.

9. PLHIV Group Upper North Lower North North- East CentralEastWestSouth TNP+ Committee (2 Representatives from each region) Administrative Office- Bangkok Partners AIDS ACCESS Foundation and MSF-Belgium Thai Network of People Living with HIV/AIDS (TNP+)

10. Production of Antiretrovirals (ARVs) in Thailand Now, GPO manufactures 16 adult antiretroviral medicines and 8 paediatric antiretroviral medicines, including second line drugs Now, GPO manufactures 16 adult antiretroviral medicines and 8 paediatric antiretroviral medicines, including second line drugs List of ARV produced in Thailand by GPO List of ARV produced in Thailand by GPO ItemPacking unit 1. Didanosine chewable buffered tablets 25 mg (DIVIR ® )60’s 2. Didanosine chewable buffered tablets 125 mg (DIVIR ® )60’s 3. Didanosine chewable buffered tablets 200 mg (DIVIR ® )60’s 4. Indinavir capsules 200 mg (INAVIR ® )360’s 5. Indinavir capsules 400 mg (INAVIR ® )180’s 6. Lamivudine tablets 150 mg (LAMIVIR ® )60’s

11. 7.Lamivudine tablets 300 mg (LAMIVIR ® )3 0’s 8.Lamivudine syrup 10 mg/ml (LAMIVIR ® )60 ml 9.Lamivudine 150 mg + Stavudine 30 mg tablets (LASTAVIR ® )60’s 10.Nelfinavir mesylate tablets 250 mg (NAFAVIR ® )270’s 11.Nevirapine for oral suspension 10 mg/ml (NERAVIR ® )60 ml 12.Nevirapine tablets 200 mg (NERAVIR ® )60’s 13.Nevirapine200 mg + Lamivudine150 mg + Stavudine30 mg tablets (GPO-VIR S30 ® )60’s 14.Nevirapine200 mg + Lamivudine150 mg + Stavudine40 mg tablets (GPO-VIR S40 ® )60’s 15.Nevirapine200 mg +Lamivudine150 mg + Zidovudine250 mg tablets (GPO-VIR Z250 ® )60’s 16.Ritonavir oral solution 80 mg/ml (RINAVIR ® )60 ml 17.Stavudine capsules 15 mg (STAVIR ® )60’s 18.Stavudine capsules 20 mg (STAVIR ® )60’s 19.Stavudine capsules 30 mg (STAVIR ® )60’s 20.Stavudine for oral solution 5 mg/ml (STAVIR ® )60 ml 21.Zidovudine 300 mg + Lamivudine 150 mg tablets ( ZILARVIR ® ) 22.Zidovudine capsules 100 mg (ANTIVIR ® )100’s 23.Zidovudine capsules 300 mg (ANTIVIR ® )100’s 24.Zidovudine syrup 10 mg/ml (ANTIVIR ® )60 ml List of ARV produced in Thailand by GPO List of ARV produced in Thailand by GPO

12.  2002, GPO-VIR S®, was developed and manufactured, costs 1,200 baht per month, the cost reduction (estimated 800 M. Baht), enabled approximately 50,000 cases to receive antiretroviral medicine free of charge from GPO.  2002, Global Fund monies have provided an approximately 200 million Baht to purchase antiretroviral medicines for 10,000 cases.  2004, The use of generic medicines of GPO has reduced HIV infection rates in children decreased from 30 % to less than 3%  2006, the Thai government launched a universal access scheme for all HIV/AIDS patients, free antiretroviral treatment to more than 10,000 employees.

13. Transnational Pharmaceutical Companies Affecting Access to Treatment with ARV In Thailand Transnational Pharmaceutical Companies Affecting Access to Treatment with ARV In Thailand  Since amended the Patent Act 1992, under US trade pressure, the window of opportunity for local manufacturing of new drugs was closed. Transnational Pharmaceutical Companies Monopolize the Drug Market via Patent System Transnational Pharmaceutical Companies Monopolize the Drug Market via Patent System

14. The number of pharmaceutical plants and importers, and the value of locally produced and imported drugs, varied by time from 1996–2006. Year No. Of Industries No. Of Importers Locally produced drugsImported drugs Million Baht% GrowthMillion Baht% Growth 199617548018,174.40N/A10,435.30N/A 199717544919,591.607.8013,375.6028.18 199817648516,726.10-14.639,739.10-27.19 199917859019,033.9013.8014,232.3046.14 200017451020,995.9010.3116,700.3017.34 200117552123,087.909.9619,967.6019.56 2002174523 24,686.80 6.93 22,769.80 14.03 2003174527 27,563.30 11.65 29,588.10 29.94 2004171579 32,639.50 18.42 33,647.10 13.72 2005166600 31,130.60 -4.62 41,630.90 23.73 2006141600 32,745.10 5.19 48,589.10 16.71

15. The percentage of market share of locally produced and imported drugs year Locally produced drugs (mBaht) Imported drugs (mBaht) Total market value (mBaht) Locally produced drugs (% market share) Imported drugs (% market share) 199618,174.4010,435.3028,609.7063.5336.47 199719,591.6013,375.6032,967.2059.4340.57 199816,726.109,739.1026,465.2063.2036.80 199919,033.9014,232.3033,266.2057.2242.78 200020,995.9016,700.3037,696.2055.7044.30 200123,087.9019,967.6043,055.5053.6246.38 2002 24,686.8022,769.80 47,456.6052.0247.98 2003 27,563.3029,588.10 57,151.4048.2351.77 2004 32,639.5033,647.10 66,286.6049.2450.76 2005 31,130.6041,630.90 72,761.5042.7857.22 2006 32,745.1048,589.10 81,334.2040.2659.74

16. Transnational Pharmaceutical Companies Strengthen Themselves as Pharmaceutical Research and Manufacturers Association (PReMA) Transnational Pharmaceutical Companies Strengthen Themselves as Pharmaceutical Research and Manufacturers Association (PReMA)  In 1970, 35 Thai pharmaceutical companies banded together to form the original Pharmaceutical Producers Association (PPA) before PReMA inaugurated its new name and identity on 29 September 2004  Today, PReMA has 43 members, which employ nearly 12,000 staffs

17. The Strategies of TNCs and PReMA Affecting Access to Medicines  Lobby the government officers and politicians to strengthen the higher standard of IPRs through Patent Act amendment and FTA  Mass Media Advocacy Against the Use of CLs  Lobby the government to cancel the use of CL  Withdrawal of the new drug registration dossiers  Request to the USTR to place Thailand on the Priority Foreign Country (PFC) under the US trade law

18. Challenges: Availability, Accessibility and Sustainability

19. Local Civil Society in Respect to AIDS Treatment and Access to ARVs  Campaigning for the National Health Security Act 2002  Challenge the IPR court to revoke of ddI patent  Pre-grant opposition on Combid patent and others  Anti-TRIP plus in US-Thailand FTA  Campaign for TRIPS’ Flexibilities

20. Campaigning for the implementation of CL  November 29, 2006, Mr. Mongkol Na Songkla, the Minister of Public Health, announced for the first CL for Efavirenz, followed by the others 6 drugs ARVs29 Nov 06 24 Jan 07  CL on Efavirenz.  CL on Ritonavir+Lopinavir Heart Disease Medicine25 Jan 07  CL on Clopidogrel Cancer Drugs4 Jan 08 25 Jan 08  CL on Docetaxel  CL on Erlotinib  CL on Letrozole  CL on Imatinib The chronology of CL issuances in Thailand

21. The CL campaign was another significant development step, called the Tripartite Fight for Patients’ Rights by Prachachat Thurakit business newspaper: The State / Public stakeholders / Civil society “The campaign tried to tell Thai society and the global community that in the world of trade, whose aim is to make monetary gains, there is also a world that has to take into account the value of life and healthcare, whereby medicines are a fundamental factor relevant to everybody’s well-being.” “Thus, the movement of these people will continue in spite of the vigorous attacks from the multinational pharmaceutical industry and those who will lose their benefits because of this campaign.” The globalized triangle that moves the mountain

22. The main challenge  Development of networking for access to health care  Coalition of patients of the same diseases  Bringing medicine prices down to match the cost of living of the people in the country  Capacity building of domestic drug manufactures  Patent-related strategy  Promotion of rational drug use  New Drug Research and Development