1. Intellectual Property Law FDA Thailand Health Insurance in Thailand

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. 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 SOCIAL SECURITY SYSTEM

4. 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 in providing for HIV patients LIFE INSURANCE SCHEMES

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

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

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

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

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

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

11. DRUGCOMPANY PATENT EXPIRY DATE BENZAXOXINONE MERCK 30/07/2013 -MEDIVERA 30/07/2012 QUINNASOLINMERCK 04/05/2013 REVERSE TRANSCRIPTASE INHIBITORS

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

13. DRUGCOMPANY 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 QUINOSALINBAYER 25/01/2016 RITONAVIRABBOTT 04/12/2016 PROTEASE INHIBITOR

14. X 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 X DEVELOP NEW DRUG LIKE RITONAVIR RECOMMENDATION

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