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Thai experience of using TRIPS 

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flexibilities: need and impact

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y A Joint Technical Symposium by WHO, WIPO and WTOGeneva, WTO

28 October 2015

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ealth 28 October, 2015

Chutima Akaleephan, PhD

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ion Chutima Akaleephan, PhD

International Trade and Health ProgramInternational Health Policy Program

Inte

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t y gMinistry of Public Health, Thailand 

Outlinend

• Health system in Thailand

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• Legal context related to TRIPS flexibilities• Issuing the GUL

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• Impact of GUL

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Thailand at glance nd

• Population  65.7 million• GDP  (2014)  US$ 5,519.4

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n • Gini index 39.4 (2013)• Fiscal space:  Tax   17.6% GDP (2011), 

Revenue 21.3% GDP (2011)

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ram GGHE 15.3% GGE (2011)

• Total Health Expenditure (2012 NHA) • US$215 per capita 3 9% GDP

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y • US$215 per capita, 3.9% GDP, • Public 68%, SHI 8%, Private 24%, OOP 14% 

of THE 

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ealth • HRH density: doctor/nurse/midwife

24.7/10,000pop.• Health status 

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• Life expectancy at birth  74.1  • Total fertility rate  1.5 (2011)• U5MR 14

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• U5MR  14 • MMR (per 100,000 live birth) 26 (2014)  

• ANC & hospital delivery  99% (2014)

Thailand’s path to universal health coverage against GNI per capita 1970 2010against GNI per capita, 1970‐2010

4Ref: McManus J, et al (2012). Thailand’s universal coverage scheme: achievements and challenges: an independent assessment of the first 10 years (2001‐2010), synthesis report.

The Three Dimensions of Achieving Universal Health Coverage 

i• X axis:  – 99% population coverage by 3 schemes [UCS 75%, SHI 20%, CSMBS 5%]

• Y axis:Y axis: – Free at point of services, very minimum OOP, – Low incidence of catastrophic health expenditure and medical impoverishment

• Z axis:

5

• Z axis: – Extensive and comprehensive benefit package, very small exclusion list, – Most high cost interventions were covered: dialysis, chemotherapy 

Health care interventions and medical treatments included in the UCS benefit packagep g

Basic health Care (on capitation basis)Basic health care• Out-patient (OP)• Hospitalization (IP)

( p )

Universal ARTHospitalization (IP)

• HC, AE, Disease management• P&P• Rehabilitation• Capital replacement

Renal replacement therapy(Pilot project in FY2007 and extend to the whole country in FY2009)Capital replacement

• EMS• Thai traditional • No-fault liability• etc.

(NCD

(2nd prevention for DM/HT)(Pilot project in FY2009 extend

to the whole country in FY2009)

etc

Mental health(medicine)

(Pilot project in FY2009, extend to the whole country in FY2010)

(Pilot project in

Benefit Starting year

(Pilot project in FY2010, extend to the whole country in FY2011)

2002 20112006 2009 20106

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However…

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1987 – 2012 trend and value of imported and locally produced western medicines

ndlocally produced western medicines

Mil THB %Mil THB %

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66 1 65 5 66 170.0

80.0

160,000 

180,000 

Mil THB %Mil THB %

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ram 66.1 65.5 66.1 60.2 59.1

54.1 52.0

40 3 36 2 40 0

50.0

60.0

100,000 

120,000 

140,000 

Patent

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y 40.3 35.436.2

31.2

20.0

30.0

40.0

40 000

60,000 

80,000  Patent1992

1999

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0.0

10.0

0 

20,000 

40,000 

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total import total produced %tproduced

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Source: FDA database8

Burden of diseases in 2004

9Ref: Burden of Diseases and Injuries of the Thai Population 2547

UHC and health systemnd

In summary:

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• All health insurance schemes (UCS, SHI and CSMBS) are tax financed, benefit package is extensive and comprehensive

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ram comprehensive.

• Fiscal burden to the country, though great achievement, hence needs for technical efficiency

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y hence needs for technical efficiency.• Medicines and medical technologies are major cost 

drivers and high cost hinders access to health care.

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ealth drivers and high cost hinders access to health care.

• Demographic and epidemiologic transition results in people live longer and more NCD for which NCD 

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medicines are expensive, e.g. NCD and cancer treatment are out of reach by people.

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ISSUING Government Use of License on

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Legal context on patentnd

• Thailand has amended its Patent Act to conform with the main points of TRIPS since 1992 eight

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n with the main points of TRIPS since 1992, eightyears before  the 2000 deadline in WTO agreement

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• Currently, the Thai Patent Act is 2nd amended 

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y(1999)

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ealth • Thai Patent Act and Trade Secret Act conform 

with all TRIPS’ requirements. However, the Patent Act still does not cover exporting CL as agreed in

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ion Act still does not cover exporting CL as agreed in the Doha Declaration on the TRIPS Agreement and public health

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Legal context: GUL (Section 51) nd

• Government Use of License for

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– public utility; or national defense; or natural resource and environment reservation; or relieve severe h f f d d h i d

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or for public benefits

A i i t b d t t f

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y • Any ministry, bureau or department of government can issue GUL

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Office, Ministry of Commerce

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• Notification to the patent holders without delay 

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In 2006…, Process of GULSelection criteria: essential with access constraint, high price, monopoly, patented 

Subcommittee on medicine selection 

Price negotiation no GULCommittee on 

succeed

Price negotiation  no GUL

Recommendation for

price negotiation

C itt

fail

Recommendation for decision makers 

Committee on operational support 

Authorized policy makers

Registration and marketing approval 

by TFDA

Issuing GUL Supply (import/ produce) management p ) gand logistics by GPO

Adapted from Dr Siriwat’s presentation 14

Issuing GUL on 7 medicines

Efavirenz (EFV) 29 Nov 2006

Anti‐retroviral

Efavirenz (EFV) 29 Nov 2006

Lopinavir/Ritronavir  24 Jan 2007(LTV/RTV)

Cardiovascular Clopidogrel  25 Jan 2007

Docetaxel 4 Jan 2008

AntineoplasticLetrozole 4 Jan 2008

Erlotinib 4 Jan 2008Erlotinib  4 Jan 2008

Imatinib (conditional GUL) 4 Jan 2008

15

Reactions…nd

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Impact on access to medicines

Ref: NHSO

17

Impact on access to medicines (cont.)nd

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Ref: NHSO 18

Impact on government budgetnd

Cost saving comparing with originated product priceAntiretroviral drug (GUL)

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YearCost saving

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ram Year Mil THB Mil USD

2010 866.3  27.3 

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y 2011 1,732.8  56.8 2012 2,319.0 74.6

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ealth 2012 2,319.0  74.6 2013 2,377.1  77.3 2014 2 870 0 88 4

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ion 2014 2,870.0  88.4 

Total saving 10,165.2  338.8 

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Ref: NHSO 19

Impact on government budget (cont.)nd Cost saving comparing with originated product price

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Oncology drug and Clopidogrel (CL)Year Cost saving

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gMil THB Mil USD

2010 108 0 3 4

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y 2010 108.0  3.4 2011 1,738.5  57.02012 1 172 6 37 7

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ealth 2012 1,172.6  37.7 2013 1,429.0  46.5 20 2 382 3 3 3

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ion 2014 2,382.3  73.3 

Total saving 6,830.4  227.7 

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Ref: NHSO20

Impact on economics: Export sectornd

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Ref:  Yamabhai, et al. Globalization and Health (2011) 21

Impact on economics: Foreign Direct Investmentnd

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1st & 2ndGUL

3rd GUL

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Ref:  Yamabhai, et al. Globalization and Health (2011) 22

Ensuring quality of medicines nd

• Quality assurance on GUL medicines:

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– Determining medicinal specification for every item, referred to multisource knowledge and 

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ginformation• Pharmacopoeia

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y • Expert s’ and stakeholders’ opinion

– Pre‐marketing surveillance by Department of 

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– Post‐marketing surveillance for quality control

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Access to affordable medicinesnd

• Factors contributing to improving access to medicines in Thailand

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n medicines in Thailand– GUL is a means for country to lower the price by acceleration generic substitution and negotiation with

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ram acceleration generic substitution and negotiation with 

the original– Capacity of GPO/ generic manufacturers in locally 

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Capacity of GPO/ generic manufacturers in locallyproduced generics or in import with technology transfer

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ealth – Medicine registration and marketing approval

– Central procurement to increase bargaining power, as 

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– Nation‐wide medicine delivery and healthcare service 

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Acknowledgementnd

Information, data and presentations from

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• Dr Siriwat Tiptaradol, Ex‐advisor to the Health Minister Ex SG of TFDA Ex DPS of MOPH

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ram Minister, Ex‐SG of TFDA, Ex‐DPS of MOPH

• HITAP (Health Intervention and Technology Assessment Program) Inthira Yamabhai et al

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y Assessment Program) Inthira Yamabhai, et al• NHSO (National Health Security Office), NetnapisSuchonwanich, et al

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ealth Suchonwanich, et al

• GPO (Government Pharmaceutical Organization) Achara Eksaengsri, et al

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• DIP (Department of Intellectual Property) Ratchawan Jindawat

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  25 

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THANK YOU

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