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Intellectual Property Law

Health Insurance in Thailand. FDA Thailand. Intellectual Property Law. HEALTH INSURANCE IN THAILAND. Health care systems in Thailand : 2 main types: 1) Public system - Public hospital - Health center - Village drug cooperatives - Health card fund 2) Private system

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Intellectual Property Law

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  1. Health Insurance in Thailand FDA Thailand Intellectual Property Law

  2. HEALTH INSURANCE IN THAILAND Health care systems in Thailand : 2 main types: 1) Public system - Public hospital - Health center - Village drug cooperatives - Health card fund 2) Private system - Physicians - private hospital - Insurance schemes - Social security system - Free medical care project

  3. SOCIAL SECURITY SYSTEM • 2% employee + 2% employer + 2% Gov. • Sickness insurance is one of the responsibilities • Criteria for treatment: • - general treatment • - provide drug as listed in National Drug • List (AZT, ddI, and ddC) • No exception for AIDS treatment

  4. LIFE INSURANCE SCHEMES • Handled by private company/industry • Popular for wealthy people and for people with stable incomes • Scope of service is based on the contract between insurer and insured • No agent in Thailand offers insurance for AIDS/HIV patients • High potential inproviding for HIV patients

  5. Clinical trials Thai FDA 80 days Drug is registered under provisions FDA PROCESS • Step 1

  6. Safety evaluation 2 years or over Thai FDA Drug is traditionally registered Step 2

  7. Asking for license to produce or import drugs Thai FDA 15 days for import drugs 40 days for produce drugs Company can produce or import drugs Step 3

  8. License to produce or import drugs Company receives license to wholesale drugs Company can sell drugs to licensee Step 4

  9. List of Anti-HIV drugs currently in Thailand ARV Drugs Registered in Thai Pharmacopoeia In the Process • Crixivan (Indinavir) • Fortovase (Saquinavir) • Stocrin (Efavirenz) • Viracept (Nelfinavir) • Viranune (Nevirapine) • Ziagenavir (Abacavir) • Norvir (Ritonavir) • Epivir (Lamivudine) • Hivid (Zalcibabine) • Videx (Didanosine)

  10. INTELLECTUAL PROPERTY LAW PATENT ACT Patentable invention new involves an inventive step capable of industrial application Patentee Applicant Term of patent Twenty years

  11. REVERSE TRANSCRIPTASE INHIBITORS DRUG COMPANY PATENT EXPIRY DATE BENZAXOXINONE MERCK 30/07/2013 - MEDIVERA 30/07/2012 QUINNASOLIN MERCK 04/05/2013

  12. VACCINES DRUG COMPANY PATENT EXPIRY DATE HIV PEPTIDE VIRAL TECH. 11/10/2010 HIV ANTIGEN OSAKA U. 02/12/2012

  13. PROTEASE INHIBITOR DRUG COMPANY PATENT EXPIRY DATE - ELI LILLY 18/06/2013 - SANKYO 06/08/2013 - ELI LILLY 20/12/2013 - MERCK 30/03/2014 - MERCK 03/05/2014 - MERCK 29/01/2016 QUINOSALIN BAYER 25/01/2016 RITONAVIR ABBOTT 04/12/2016

  14. RECOMMENDATION LICENSING • The patentee may license to any other person to exercise his patent right • shall not stipulate any condition, restriction or compensation which is unfair & limits competition • DEVELOP NEW DRUG LIKE RITONAVIR

  15. CONCLUSIONS • Health Insurance • - Not prevalent • - Very few qualify for coverage • FDA • - 3 years for approval after clinical trial • Intellectual property • - Patents enforceable • - Abbot Labs has applied for a patent for Ritonavir in Thailand

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