Our February 2002 Newsletter reported on the WTO Ministerial Meeting in Doha in November 2001 which adopted a Ministerial Declaration that pointed out that in conditions where a health crisis exists, a number of options which are fully compatible with TRIPs are open to countries to address the situation. An issue arose, however, with respect to those countries that have no indigenous pharmaceutical industry that would enable them to take advantage of the permitted compulsory licensing provisions of TRIPs since such provisions do not permit the grant of compulsory licenses for the importation of drugs. On August 30, 2003 it was agreed by the WTO General Council that compulsory licensing may, for the least developed countries, be used to permit import of drugs made abroad to deal with health emergencies. Such compulsory licensing will, however, be subject to the importing country notifying the WTO of its actions, including notification of the expected amount of the drug to be imported and a requirement on the exporter of the drug to clearly identify drugs supplied under this scheme as being produced under the system through specific labeling or marking. Suppliers should distinguish such products through special packaging and/or special coloring/shaping of the products themselves, provided that such distinction is feasible and does not have a significant impact on price. Furthermore, such suppliers must post on a website the following information:


In general, the exporting country will be responsible for ensuring that the patentee is remunerated for the use of its invention by the compulsory licensee and importing countries are required to take reasonable steps to prevent re-exportation of any drugs imported under this scheme.