GROUP URGES ASIAN COUNTRIES TO APPROVE GENERICS BASED ON ORIGINATOR TEST DATA
South Centre, an intergovernmental organization of developing countries in Asia, Africa and Latin America, has stated that developing countries should allow regulatory authorities to approve generic drugs on the basis of the originator data from the time of its submission. The South Centre position has appeared in a study on "The Use of Flexibilities in TRIPS by Developing Countries: Can they Promote Access to Medicines?" published in April.
The study, completed in collaboration with the World Health Organization, also suggested that developing countries implement data protection legislation that is consistent with public health objectives to facilitate the entry of generic competitors.
On the issue of data protection, the study suggested that the use of test data
relating to quality, safety and efficacy as well as information on the composition
and the physical and chemical characteristics of a product submitted by the
originator company is fully compatible with the provisions of Article 39.3 of
the TRIPS Agreement.