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Thailand CL: Lessons learned and the Way Forward

Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand. 2. Thai Health Goals. Lower middle income GDP $US 2,800 per cap/year. 9% (5 million) under poverty. 20% of people with 52% share of income. 78% under social welfare HI.Universal Access: National Health Security Act 2002 and Universal Access to ARVs since October 2003. Of more than 100,000 patients on 1st line, 70% non efavirenz. More than 10,000 require 2nd line, less than 15% receives it..

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Thailand CL: Lessons learned and the Way Forward

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    1. Thailand CL: Lessons learned and the Way Forward Dr. Suwit Wibulpolprasert M.D. Senior Advisor on Disease Control Ministry of Public Health, Thailand May 10th, 2007, Berlin, Germany.

    2. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 2 Thai Health Goals Lower middle income GDP $US 2,800 per cap/year. 9% (5 million) under poverty. 20% of people with 52% share of income. 78% under social welfare HI. Universal Access: National Health Security Act 2002 and Universal Access to ARVs since October 2003. Of more than 100,000 patients on 1st line, 70% non efavirenz. More than 10,000 require 2nd line, less than 15% receives it.

    3. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 3 Universal HI : Thailand

    4. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 4 The benefit package on the access to drugs in the three HI schemes The right of access to at least those drugs in the National List of Essential Medicines (NLEM). The current NLEM contains 629 drugs with 882 items, including 1st and 2nd line ARVs.

    5. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 5

    6. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 6 ‘Sharing’ not ‘breaking’ the patent for expansion of access in the low income groups

    7. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 7 Section 51 Thai Patent Act In order to carry out any service for public consumption,… …or for any other public service, any ministry, bureau or department of the Government may, by themselves or through others, exercise any right under Section 36 by paying a royalty to the patentee or his exclusive licensee under paragraph 2 of Section 48 and shall notify the patentee in writing without delay, notwithstanding the provisions of Section 46 (prior negotiation), 46 bis and 47………

    8. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 8 TRIPS Article 31 Other Use Without Authorization of the Right Holder

    9. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 9 Public Announcement of the intention on Government use of patent on 3 drugs Efavirenz, MSD: announced on November 29th 2006, Lopinavir+Ritonavir, Abbott: announced on Jan 25th 2007, Clopidogrel from Sanofi-Aventis announced on Jan 26th 2007, In the Thai patent act, article 51, there is no need to issue a CL, the right is there in the act. Announcement is for transparency purpose and open room for negotiation. However, local production and importation move on in parallel to the negotiation.

    10. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 10 Current Mechanisms on CL

    11. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 11 Can CL kill the whole IP regime? After 7 years of appearance, only 24% of non-patented new drugs have their generics Most of them have no rationale to apply CL Life style drugs: Erectile dysfunction syndrome Baldness Acne, etc.. “Me too” products with no sig. added value De Facto: Less than 5% of patented drugs that CL can be implemented, so it is only exceptional and can not be a routine mechanism to destroy the whole IP systems.

    12. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 12 Negotiations after CL MSD: three formal discussions with formal proposal of new global price of 65c/tab, a 45% reduction. 66,000 bottles generics have been imported at 53c/tab. Abbott: One formal discussion then pulled off 9 dossiers for new drugs. Mid April verbally proposed price reduction to 1,000 USD/year, with condition of not implementing CL. No formal proposal and resubmitting of the registration dossier so far. Clinton pooled procurement’s price at 695 USD/year. Sanofi: One formal discussion, verbally propose a new low price package for public market. Generics 20 times cheaper. No company interested in discussing the royalty fees

    13. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 13 Pressures on Thailand Industries using public media with crooked information and boycott by withdrawing registration dossiers USTR through revising the ranking of trade relation with the US - from WL to PWL citing non transparent CL, and trend to cut the GSP on some exports. Why not go to WTO/DSB? Internal pressures through some ministries and private sectors Through some IGOs – naďve proposal for negotiation and not use the CL Even TRIPs flexibilities are difficult, how about Doha declaration? Where is the WTO?

    14. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 14 The current and future movements The principle: free competition in the low income market, paid by the public resources. Negotiations go on in parallel to the process of implementing CL, import or locally produce, No CL will be implemented on any patented product that provide competitive price. Certain (5-10%) of credits given to patented drugs. Decision will not be long term binding but depend on the competition at each time of procurement.

    15. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 15 What have we learned? TRIPs flexibilities are possible with enough social, political and wisdom support Need strong civil society and media support . IGOs may be helpful with limitation Inadequate concerted efforts among ministries within countries. Negotiation is effective after real threats of CL. No long term binding, decides each time of purchase to allow continuous free competition.

    16. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 16

    17. Dr. Suwit Wibulpolprasert, Ministry of Public Health, Thailand 17 Important websites and email White paper on 10 burning issues: www.moph.go.th and go to English version Support to Minister Mongkol Na Songkhla: Mongkol7225@hotmail.com

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