If developed countries agreed to any of these solutions, they are likely to demand the establishment of certain “safeguards”, as indicated in the submissions by the USA and the EC and their Member States to the Council for TRIPS of March 2002. Such safeguards would aim at ensuring that any agreed solution is not utilized to attain objectives other than those related to the protection of public health in the countries with no or insufficient manufacturing capacity for the economically viable production of pharmaceuticals.

A basic safeguard would be the provision of mechanisms to prevent the diversion of products exported to a country qualifying under paragraph 6 to other countries⁹⁹, and that the entire output of the relevant pharmaceuticals manufactured be exported to the Member in need. The notification to other Members of actions taken has also been mentioned¹⁰⁰.

⁹⁹ However, it may be excessive (due to complexity and costs) to impose the burden of monitoring and preventing such a diversion on the importing country in need of pharmaceuticals. The European Commission has noted that “the industry acknowledges that to date there is no reimportation of medicines from the poorest developing countries into the EU, i.e. the problem of reimportation is still largely theoretical” (European Commission, 2002, p. 10). In addition, restrictions on the export of products may violate Article XI of GATT (prohibitions or restrictions on the importation or exportation of products).

¹⁰⁰ See IP/C/W/340. One additional question might be if, in order to be validated under a paragraph 6 exception, certain pricing conditions would be attached to the exported products.