Post on 14-Jan-2016
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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
Nov 29th 06
Jan 25-26th 07
Jan 25th 08
•Efavirenz – MSD
•Lopinavir+Ritonavir - Abbott•Clopidogrel - Sanofi-Aventis
•Four anticancer drugs
Public Announcements of the intention on Government use of patented essential drugs during 2006-08
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
1 IMF2 NESDB
All Thais have to have right to access to essential medicines.
*Source : Bureau of AIDS, Tuberculosis and Sexually-transmitted Infections and Bureau of Epidemiology
National ART programme, Thailand
Budget for Universal Access to ARV
universal coverage in 2002,under the National Health Security Act
Million baht
Sorce: Ministry of Public Health and National Health Security Office (2008)
Diagram to demonstrate that the Government Use of patent does not affect much on the existing market size of patented products
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”
LowIncome
High
% of population at each income level
62 million Thais
Social Welfare = 48.5 million
Social Security = 8.5 mil.Civil Servant MedicalBenefit Scheme = 5 mil.
Out ofpocket payment
– “Existing monopolized
market for high price patented
drugs”“Commercial
use”
Two
mill
ion
fore
ign
patie
nts
Two
mill
ion
fore
ign
patie
nts
Sorce: Ministry of Public Health and National Health Security Office (2007a:7)
We expand the access to those who have never had access due to high price.
Strategy: A triangle that moves the mountain
• International NGOs
• Domestic NGOs• WHO mission• Public Media• Etc.
• Leadership• Laws-TRIPS article 31-Thai Patent Act
• Negotiation Committee : MoPH• Sub-committee to propose CL : NHSO
• Selection criteria• Committee to
coordinate implementation• Past experience on IP-related issues
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
Drugs CLs announcement
Registration Import Distribution/delivery
Efavirenz Nov 06 Jan 07 Jan 07 Jan 07-NAPHA
LPV/r Jan 07 Oct 07 Jan 08 Jan 08-NAPHA
Clopidogrel Jan 07 Sept 07 Aug 08 Sept 08-GPODocetaxel Jan 08 March 07 Sept 08 In processLetrozole Jan 08 In process - -Erlotinib Jan 08 - - -
Source: FDA, NHSO and GPO Thailand, September 2008
Increasing access to medicine : Efavirenz and LPV/rNo. of pts
*Source : National Health Security Office
CL-Ef
LPV/r
Negative responses
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
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.
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
•Introducing government use of patents on essential medicines in Thailand, 2006-2007http://ihppthaigov.net/index.php?option=com_content&task=view&id=138&Itemid=142
•The implications of CL on essential medicines in Thailand
CL studies in Thailand
Health/drug expenditure
Export values
Foreign direct investments
Access to medicines (+/-)
Quality of generic drugs under CL
Health gains
Productivity
Country image
Public awareness on IP and human rights issues
Long-term effects:
• innovations
• confidence in investments
Economics Health PsychosocialAssessment framework
Thank you for your attention
For more information, please contact : inthira@ihpp.thaigov.net