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Compulsory Licensing in Thailand

Compulsory Licensing in Thailand. Inthira Yamabhai Researcher, Health Intervention and Technology Assessment Program Bureau of Policy and Strategy-Ministry of Public Health, Thailand.

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Compulsory Licensing in Thailand

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  1. Compulsory Licensing in Thailand Inthira YamabhaiResearcher, Health Intervention and Technology Assessment Program Bureau of Policy and Strategy-Ministry of Public Health, Thailand Five years from the Decision to the action – is the 2003 August 30 Decision “the expeditious solution” for access to medicines we need? 25 September, 2008

  2. Public Announcements of the intention on Government use of patented essential drugs during 2006-08 • Lopinavir+Ritonavir • - Abbott • Clopidogrel • - Sanofi-Aventis • Four anticancer drugs • Efavirenz – MSD Jan 25th 08 Nov 29th 06 Jan 25-26th 07

  3. Thailand: Facts at a glance • Population: 65.69 million (UNSD,2007) • GNI per capita: US $2,990 (World Bank, 2006) • GDP per capita (PPP US$ 2007): $9,400 1 • Poverty (national poverty line): 11.25 % 2(2004) • Universal coverage policy • Civil Servant Medical Benefits Scheme • Social Security Scheme • Universal Coverage Scheme All Thais have to have right to access to essential medicines. 1 IMF 2 NESDB

  4. National ART programme, Thailand *Source : Bureau of AIDS, Tuberculosis and Sexually-transmitted Infections and Bureau of Epidemiology

  5. Budget for Universal Access to ARV Million baht universal coverage in 2002, under the National Health Security Act Sorce: Ministry of Public Health and National Health Security Office (2008)

  6. % of population at each income level 62 million Thais Social Welfare =48.5million Social Security =8.5mil. Civil Servant Medical Benefit Scheme =5mil. Income Low High People paid by public budget with no or limited access to patented drugs – “New competitive market for drugs from Government Use” “Public non-commercial use” Diagram to demonstrate that the Government Use of patent does not affect much on the existing market size of patented products We expand the access to those who have never had access due to high price. Two million foreign patients Out of pocket payment – “Existing monopolized market for high price patented drugs” “Commercial use” Sorce: Ministry of Public Health and National Health Security Office (2007a:7)

  7. Strategy: Atriangle that moves the mountain • Negotiation Committee : MoPH • Sub-committee to propose CL : NHSO • Selection criteria • Committee tocoordinate implementation • Past experience on IP-related issues • International NGOs • Domestic NGOs • WHO mission • Public Media • Etc. • Leadership • Laws • -TRIPS article 31 • -Thai Patent Act

  8. Difficulties in CL implementation • Delayed importation of generic products: • Patent holders threatened generic producers concerning illegal use of CL • Setting a condition for the GPO to shoulder the costs if the patent holders file court cases over patent violations • Uncertainty of the government policy Source: FDA, NHSO and GPO Thailand, September 2008

  9. Increasing access to medicine : Efavirenz and LPV/r No. of pts LPV/r CL-Ef *Source : National Health Security Office

  10. Priority Watch List (PWL) status and trade retaliation GSP cut on three exports (flat-screen TV, gold jewelry, ethylene terephthalate) Threaten to withdraw foreign investments Threaten to file cases to the Administration and IP Courts Withdrawal of new medicine registration application Propaganda to undermine the country’s image Negative responses

  11. The current and future movements • In February 2008, the new minister announced reconsideration of the CL. The SG of the FDA was moved. The GPO board was revised. • Strong public reactions brought back the CL implementation and the minister is now out of office. The GPO board was brought back. • The National Health Security Board re-establishes the Committee to improve the access to essential medicines. This is the committee that works on the CL proposal. • Establishing improving access to medicine committee which consist of MOPH,MOF,MFA,MOC,MOI,PREMA, Patient network.

  12. What have we learned? • TRIPs flexibilities are possible with sufficient knowledge and skills and social and political support. • TRIPs flexibilities did bring the prices down and improve access to essential medicines. • Logistics management

  13. CL studies in Thailand • Introducing government use of patents on essential medicines in Thailand, 2006-2007 • http://ihppthaigov.net/index.php?option=com_content&task=view&id=138&Itemid=142 • The implications of CL on essential medicines in Thailand Economics Health Psychosocial Health/drug expenditure Access to medicines (+/-) Country image Public awareness on IP and human rights issues Export values Quality of generic drugs under CL Assessment framework Foreign direct investments • Long-term effects: • innovations • confidence in investments Health gains Productivity 13

  14. Thank you for your attention For more information, please contact : inthira@ihpp.thaigov.net

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