1. The introduction of compulsory licenses for essential medicines in Thailand Sripen Tantivess International Health Policy Program, Ministry of Public Health, Thailand May 18, 2008

2. 2 Presentation outline Exercising CL for medicines, 2006-7 WHO mission to Thailand (WHA 60.30) CL for anti-cancer medicines, 2008 Medicines purchased under CL programme Difficulties in CL implementation Ongoing research on Thailand’s CL policy

3. 3 CL for ARVs and thrombolysis medicine First use of TRIPS flexibilities in Thailand: CL on EFZ (Nov 06), LPV/r and clopidrogrel (Jan 07) Justification: –Access to essential health services as a fundamental right –Substantial burdens of diseases –Needs for affordable, safe and effective medicines –In line with the TRIPS agreement and national patent law Debates against the policy –Negotiations with patent holders prior to CL –CL allowed for AIDS, TB and malaria medicines only –Unmet conditions of emergency and crisis –CL should be used as last resort –Discourage new medicine development

4. 4 Key actors and negative effects Supporters: domestic and international NGOs, patient groups, academics, international organisations, developing countries Opponents: industrialised countries, pharma industry Negative responses –Political pressure –Trade retaliations –Threaten to withdraw foreign investments –Threaten to file cases to the Administration and IP Courts –Withdrawal of new medicine registration application –PR campaigns to undermine the country’s image

5. 5 WHA 60.30 Public health, innovation and IP Para 3, sub-para 2: Requests the director general to ‘provide as appropriate, upon request, and in collaboration with other competent international organizations, technical and policy support to countries that intend to make use of the flexibilities contained in the agreement on Trade-Related Aspects of Intellectual Property Rights and other international agreements in order to promote access to pharmaceutical products, and to implement the Doha Ministerial Declaration on the TRIPS Agreement and Public Health and other WTO instruments;’

6. 6 WHO mission to Thailand according to resolution WHA 60.30 First introduction of WHA 60.30: 31 Jan – 6 Feb 08, Bangkok Members of the mission: WHO HQ, WHO SEARO, UNDP, UNCTAD, WTO, and WHO temporary advisor (academic) TORs: –provide relevant materials and guidelines for the use of TRIPS flexibilities –suggest possible indicators for future assessments by the Thai authorities of the measures –advise on the practical aspects and procedures for the use of TRIPS flexibilities –provide factual information on other countries experiences on the use of TRIPS flexibilities

7. 7 The report of the mission Improving access to medicines in Thailand: the use of TRIPS flexibilities ‘The report of the mission is not intended to make any evaluation or assessment of the use of TRIPS flexibilities in Thailand.’ (page 2) Contents: I. Cost-containment mechanisms for pharmaceutical products II. Non-voluntary licences for government use: practical aspects and procedures III. Other important TRIPS flexibilities to promote access to medicines IV. Information on country experiences with the use of TRIPS flexibilities to protect public health and access to medicines V. Guidelines and tools on the use of TRIPS flexibilities to promote access to medicines Final remarks: ‘4. WHO supports measures which improve access to essential medicines, including application of TRIPS flexibilities.’ (page 31)

8. 8 CL for anti-cancer medicines Announced in Jan 08 Four medicines: –Imatinib (CML and GIST; Glivec® – Novartis), –Erlotinib (NSCLC; Tarceva® - Roche), –Letrozole (CA breast; Femara® - Novartis), –Docetaxel (CA breast and lung; Taxotere® - Sanofi-Aventis) Price difference – original vs. generic products: 4-30 times

9. 9 Revisiting the CL for anti-cancer medicines New government took office in Feb 08 The CL policy on anti-cancer medicines reviewed by three ministries Data on epidemiology (numbers of new cases and survival period), indication & dosage according to CPG, prices of generic and original products and cost-saving Encouraged by one of the EC members Protests run by NGOs, patient groups and Rural Doctor Association Eventually, the policy was maintained

10. 10 Prices of anti-cancer medicines, March 07 MedicineOriginal productGeneric product Before negotiations After negotiations Erlotinib (baht/mg) 2,7501,895735 Letrozole (baht/tab) 120-230115-1486.50 Docetaxel (baht/tab) 37580-10716 Source: National Health Security Office, Thailand

11. 11 CA-lung cases in need of Docetaxel New cases 10,096 Platinum Obtain other treatment 50% - MIN: 50%= 5,048 - MAX: 60%= 6,058 Response MIN: 30%=1,514 MAX: 40%=2,423 Not response MIN: 60%=3,029 MAX: 70%=4,240 Recurrence, Docetaxel required MIN: 20%=303 MAX: 30%=727 Docetaxel required MIN: 30%=909MAX: 50%=2,120 2008 estimation

12. 12 Cost-saving over 5 years Maximum: 3,716-8,467 million baht Minimum: 2,088-3,425 million baht Source: National Health Security Office, Thailand

13. 13 Medicines purchased from Indian producers under CL programme, as of April 08 MedicineDateQuantityPrice Efavirenz 600 mg tab (Ranbaxy) Jan-May 0766,000 x 30 tab684 baht/30 tab Sep-Dec 07100,000 x 30 tab571 baht/30 tab Mar-June 08100,000 x 30 tab547 baht/30 tab Efavirenz 200 mg cap (Ranbaxy) Jan-Mar 0810,000 x 90 tab670 baht/90 tab LPV/r tab (Matrix)Jan-Mar 088,000 x 120 tab2,457 baht/120 tab Clopidogrel tab (Cadila) Apr 082 million tab159 baht/100 tab Source: Government Pharmaceutical Organization, Thailand

14. 14 Difficulties in CL implementation Medicine approval process – almost one year for clopidogrel 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 –Uncertain government policy Avoid leakage of CL medicines into the private market – not yet happen, but our concern

15. 15 Ongoing research on Thailand’s CL policy Introducing government use of patents on essential medicines in Thailand, 2006-2007 –Focus: roles of key stakeholders and contextual factors in the policy development and implementation –Funding agencies: WHO SEARO and Foundation Open Society Institute (OSI) The implications of CL on essential medicines in Thailand –Focus: positive and negative implications of the CL policy, in public health, economic and social aspects –Funding agency: Health Insurance System Research Office, Thailand