Intellectual Property Law

FDA Thailand

Health Insurance in Thailand

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

• 2 2 2% employee + % employer + % Gov.

• SSSSSSSS SSSSSSSSS SS SSS SS SSS SSSSSSSSSSSSSSSS• SSSSSSSS SSS SSSSSS SSS:

- SSSSSSS SSSSSS SSS

- provide drug as listed in National Drug

List (AZT, ddI, and ddC)

• S S SSSSSSSSS SSS SSS S SSSSSS SSS

SOCIAL SECURITY SYSTEM

• SS SSSSSSS SSS SSSSSSSSSSSSS/

• Popular for wealthy people and for people wi th stable incomes

• Scope of service is based on the contract bet ween insurer and insured

• No agent in Thailand offers insurance for AID S/HIV patients

• High potential in providing for HIV patients

LIFE INSURANCE SCHEMES

Clinical trials

Drug is registered under provisions

Thai FDA

80 days

FDA PROCESS

• Step 1

• Step 2

Safety evaluation

Drug is traditionally registered

Thai FDA

2 years or over

• Step 3

Asking for license to produce or import drugs

Company can produce or import drugs

Thai FDA

15 days for import drugs40 days for produce drugs

• Step 4

License to produce or import drugs

Company receives license to wholesale drugs

Company can sell drugs to licensee

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

PATENT ACT

Patentable invention new involves an inventive

step capable of industrial

application

Patentee Applicant

Term of patent Twenty years

INTELLECTUAL PROPERTY LAW

DRUG COMPANY PATENT EXPIRY DATE

BENZAXOXINONE MERCK 30/07/2013

- MEDIVERA 30/07/2012

QUINNASOLIN MERCK 04/05/2013

REVERSE TRANSCRIPTASE INHIBITORS

DRUG COMPANY PATENT EXPIRY DATE

HIV PEPTIDE VIRAL TECH. 11/10/2010

HIV ANTIGEN OSAKA U. 02/12/2012

VACCINES

DRUG COMPANY PATENT EXPIRY DATE

- ELI LILLY 18062013/ /

- SANKYO 06082013/ / - ELI LILLY 20/12/2013 - MERCK 30032014

- MERCK 03052014/ / - MERCK 29012016/ /

QUINOSALIN BAYER 25012016/ /RITONAVIR ABBOTT 04122016/ /

PROTEASE INHIBITOR

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

RECOMMENDATION

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