Network for Monitoring the Impact of Globalization and TRIPS on Access to Medicines, Meeting Report, 19-21 February 2001, Chulalongkorn University, Bangkok, Thailand - Health Economics and Drugs Series No. 011
(2002; 67 pages) View the PDF document
Table of Contents
Open this folder and view contents1. Introduction
View the document2. Highlights of opening address of Dr Supachai Panitchpakdi
Open this folder and view contents3. 1Globalization, TRIPS and Access to Pharmaceuticals
View the document4. Further Reading
View the document5. Template of selected model indicators for studying the impact of globalization and TRIPS on access to medicines
Close this folder6. Selected indicators for studying the impact of globalization and TRIPS on access to medicines
View the documentRespondent data
Close this folderContents
View the documentI. Definitions used in the template**
View the documentII. Trends in total pharmaceutical consumption
View the documentIII. Health care coverage
View the documentIV. Structure of public and private pharmaceutical prices
View the documentV. Regulations relating to intellectual property rights protection and marketing authorization
View the documentVI. Prices of pharmaceutical products
View the documentVII. Market share of domestic and foreign firms
View the documentVIII. Regulation of pharmaceutical consumption - A stakeholder analysis
View the document7. The Collaborating Centres
 

V. Regulations relating to intellectual property rights protection and marketing authorization

System of patent protection

1. Is patent protection provided for pharmaceutical products?

Yes/No

a) If yes, how long ago was patent protection introduced?

b) If yes, is this a process or product patent (circle as appropriate)?

Process/Product/Both

c) What is the duration of the patent term?

Please add any comments on the product/process patent issue that may be relevant to your country
________________________________________________________________________
________________________________________________________________________

2. If the country is a WTO Member, has national legislation been modified to implement the TRIPS Agreement (Agreement on Trade Related Aspects of Intellectual Property Rights)? yes/no

a) If yes, when did it take effect?

b) If not, when is this likely to take place?

c) Is the country availing itself of the transition period provided by Article 65 of the TRIPS Agreement?

d) If the country is a least-developing country (LDC), has it availed itself of the transitional period accorded to LDCs in Article 66 of the TRIPS Agreement?

3. Have parallel importing provisions been incorporated into national legislation?

Yes/No/Currently being discussed

a) If yes, have these parallel importing provisions been applied for pharmaceuticals?

Yes/No

b) What regime of exhaustion is incorporated into national legislation?

International/Regional/National

4. Have compulsory licensing provisions been incorporated into national legislation?

Yes/No/Currently being discussed

a) If yes, have these compulsory licensing provisions been applied for pharmaceuticals?

Yes/No

b) If yes, under what conditions?

National emergency/Public non-commercial use/Remedying anti-competitive practices/Other (please specify)/Don’t know

5. Are generic pharmaceutical manufacturers allowed to use patented inventions for the purpose of obtaining marketing approval prior to patent expiration; i.e has a Bolar provision been incorporated in national legislation? (see definitions page 38-39)

Yes/No/Currently being discussed

6. Are there provisions granting a minimum term of data exclusivity for the protection of test data submitted for the marketing approval of a pharmaceutical product? (see definitions page 38-39)

Yes/No/Currently being discussed

Table F: Patent and/or data exclusivity status

Product

Dates of patent expiration
(if applicable)

Date of data exclusivity expiration
(if applicable)

Erythromycin

   

Ciprofloxacin

   

Rifampicin

   

Doxycycline

   

Cyclophosphamide

   

Hydrochlorothiazide

   

Atenolol

   

Salbutamol

   

Candesartan

   

Celecoxib

   

Orlistat

   

Sildenafil

   

Olanzapine

   

Levofloxacin

   

Atorvastatin

   

Montelukast

   

Esomeprazol

   

Fluconazole

   

Zidovudine

   

Nevirapine

   

Azithromycin

   

Didanosine (ddI)

   

Indinavir

   

Lamivudine

   

Ofloxacin

   

Lamivudine + Zidovudine

   

Zidovudine + Lamivudine + Abacavir

   

Pre-marketing authorization

1. Which authority is responsible for granting marketing approval (registration)?

________________________________________________________________________
________________________________________________________________________

2. What is its affiliation with the Ministry of Health?

________________________________________________________________________
________________________________________________________________________

3. Is there any linkage between the processes of drug registration (Ministry of Health or Drug Regulatory Authority) and the grant of patent (National Patent Office)?

Yes/No

4. What is the average length of time required for approval of a new pharmaceutical product? (Please indicate with reference to any given year)

 

Year

 

Length of time (in months)

5. What is the average length of time required for approval of a generic pharmaceutical product upon patent expiration? (Please indicate reference to any given year)

 

Year

 

Length of time (in months)

6. How many pharmaceutical products are approved by the health registration authority in 2001?

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: June 25, 2014