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Annual Report 2002 - Essential Drugs and Medicines Policy: Supporting Countries to Close the Access Gap
(2003; 20 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentDeveloping a monitoring culture to improve impact
View the documentTraditional and complementary medicine: putting policy into action
View the documentKey country support in Africa and Eastern Mediterranean
View the documentWHO Collaborating Centres: supplying active support for medicines work
View the documentHow is TRIPS affecting access to medicines?
View the documentDevelopment of the essential drugs concept over the past 25 years
View the documentMeasuring access to antimalarials
View the documentStrengthening regional and national bulk procurement
View the documentLearning from successful supply systems
View the documentWorking out the cost of medicines
View the documentSupporting MDG target on access to essential medicines
View the documentCommon guideline for evaluating new medicines in Baltic countries
View the documentNGO toolkit for improving access to HIV/AIDS treatment
View the documentHarmonizing medicines regulation in the Americas
View the documentGood manufacturing practice in China: rapid progress
View the documentPharmacovigilance: detecting and reporting adverse drug reactions
View the documentVariations in prescribing information in 26 countries
View the document10th ICDRA: an international basis for medicines regulation
View the documentFighting poor-quality drugs
View the documentImproving medicines use in hospitals in Cambodia and Lao PDR
View the documentWHO-India Essential Drugs Programme: multiplying impact
View the documentOman: improving antibiotic use in primary health care
 

How is TRIPS affecting access to medicines?

The Network for Monitoring the Impact of Globalization and TRIPS (the Agreement on Trade-Related Aspects of Intellectual Property Rights) on Access to Medicines consists of four WHO Collaborating Centres in Brazil, Spain, Thailand and the United Kingdom. Additional input is provided from experts in appropriate pharmaceutical selection, intellectual property and economics.

The Network has developed indicators and an assessment tool to conduct baseline surveys and ongoing monitoring of: national intellectual property laws; pharmaceutical consumption; pharmaceutical pricing; medicines regulatory systems; and investment in pharmaceutical research, development and manufacturing. The tool is currently being revised based on results from field tests and will be published in 2003.

To date, assessment has been carried out in 11 countries in East Asia, Eastern Europe and Latin America. It provides valuable information on country situations as well as a means of comparative analysis. The data shed light on key policy questions, including: whether country reliance on quality generics is increasing or decreasing; the extent to which countries are making use of flexibility built into the TRIPS Agreement; the extent to which TRIPS and globalization is spurring foreign investment and technology transfer in developing countries; and the extent of pharmaceutical patenting in particular countries. As it accumulates, the data will become increasingly important in monitoring the impact of the TRIPS Agreement on access to medicines, making it possible to analyse changes in policies, prices and consumption over time.

Further data will be collected in additional countries, including in Africa, in 2003 and 2004.

Illustrative data for Eastern Europe from the Network for Monitoring the Impact of Globalization and TRIPS

 

Bulgaria

Croatia

Turkey

Has legislation been modified to conform with TRIPS?

Yes

Yes

Yes

Did or will the country use the transition period?

No, modified IP law before WTO accession

No, modified IP law before WTO accession

Yes, until 1999

Does the Ministry of Health intervene in the patent review process?

No

No

No

Have compulsory licenses been granted for pharmaceuticals

No

No

No

Can the drug regulatory authority approve or register a pharmaceutical from a person, company or other entity that is not the patent holder?

-

Yes

No

Can the health authority rely on information submitted by a prior registrant to approve a subsequent application to make a generic product?

Yes

Yes

Yes

 

IP = intellectual property
WTO = World Trade Organization

 

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The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: March 20, 2014