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