ABSTRACT
The US and the European Union (EU) are seeking universal norms to protect the results of clinical trial data on new pharmaceutical products through bilateral and multilateral trade negotiations (see Chapters 6 and 7). These efforts, if successful, would confer a de facto exclusive right on clinical trial results as such, independent of other existing intellectual property rights (IPRs) in the underlying products, especially patents. If developing countries agree to this new form of intellectual property protection, their rights to promote the production of generic drugs and low-priced medicines generally, as recently clarified in the Doha Ministerial Declaration on the TRIPS Agreement and Public Health (see Annex 1) and a related implementing decision (see Annex 2), could become compromised by the new, exclusive rights in clinical testing data, which are not covered by those arrangements (see Chapter 6 and Rossi, 2004).
