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