A/HRC/11/12 page 15 40. Countries with little or no manufacturing capacity face difficulties in utilizing compulsory licences to import generic medicines as, article 31 (f) of TRIPS requires that goods produced under a compulsory licence should be for “predominantly” local use. This difficulty was recognized by the Doha Declaration, pursuant to which the WTO General Council provided a framework to address this issue through the decision of 30 August 2003. This decision is contained in a Protocol which if signed by two thirds of the WTO members by 31 December 2009 would become a formal amendment to TRIPS. 41. Countries have faced difficulties in implementing the 30 August decision as it entails complex administrative procedures. Even though a number of potentially exporting countries amended their national laws to incorporate the 30 August decision, their regulations have added further administrative requirements that make it difficult to implement.44 The first and only case of export of a patented medicine under the 30 August decision occurred in 2008 to Rwanda, five years after the adoption of the decision. The case of Rwanda highlights the need to revisit the decision. 4. Parallel importation and international exhaustion 42. Parallel importation refers to the purchase of a patented medicine from a lawful source in an exporting country and its importation without seeking the consent of the “parallel” patent holder in the importing country.45 It can be a useful tool for countries to save money as it allows them to import a patented product from countries where they may be sold at a lower price than on the domestic market. 43. Parallel importation depends on the principle of exhaustion. While a patentee has the exclusive right to prevent others from manufacturing or marketing the patented product, the principle of exhaustion bars the patentee from further exercising exclusive rights once the product is sold on the market. Article 6 of TRIPS specifically allows countries to determine the point at which IP rights have been exhausted, giving member States the discretion to choose the exhaustion principle applicable to their patent regimes. 44. The principle of exhaustion can be applied at, the national, regional and international levels. Under the national exhaustion principle, the patentee can oppose the importation of patented products marketed abroad. International exhaustion, on the other hand, prevents the patentee from exercising further control over the product once it has been sold in any part of the world and therefore facilitates parallel importation. 45. Countries have varied in the choice of exhaustion regime. While countries including South Africa, Kenya, Honduras and members of the Andean Community have adopted the 44 Richard Elliott, “Pledges and pitfalls: Canada’s legislation on compulsory licensing of pharmaceuticals for export”, International Journal of Intellectual Property Management, vol. 1, No. 1/2 (2006), p. 94. 45 See footnote 9 above, p. 123.