A/HRC/11/12 page 25 81. In some cases, the period of data exclusivity may run during the life of the patent. However, there are a number of circumstances in which exclusive rights over test data can restrict the availability of medicines. Data exclusivity, being independent from patent protection, can allow pharmaceutical companies to secure monopoly rights for off-patent or non-patentable medicines. Evidence from Jordan indicates that pharmaceutical companies are choosing to rely on data exclusivity to enforce their monopoly instead of filing for patents.92 In the context of developed countries, as evidence from Canada and Australia suggests, data exclusivity leads to higher costs of prescription medicines. 82. Data exclusivity may also block the production of generics after a compulsory licence is issued. Because marketing approval is independent from patent law, it is possible that a national DRA may refuse to approve a generic drug based on bioequivalence during the exclusivity period. This will pose a problem unless the law relating to data exclusivity provides an exception in the case of compulsory licences. However, even with this, there could be a delay in the entry of a generic version, as the marketing approval process may commence only after the compulsory licence is issued. 83. Data exclusivity is at odds with TRIPS flexibilities, such as those that allow governments to enforce their own criteria for granting patents, contest the validity of patents or issue compulsory licences. Therefore, in the context of developing countries and LDCs, data exclusivity may actually provide pharmaceutical companies with market monopoly without providing the public benefits and safeguards associated with the patent system. 3. Patent linkage 84. Patent linkage is another TRIPS-plus obligation imposed through FTAs. It makes the marketing approval of a medicine dependent on its patent status. Thus if the medicine is patented, no marketing approval would be given to its generic version. 85. The laws of a number of countries permit national DRAs to grant marketing approval to a medicine, irrespective of its patent status.93 Some countries, however establish a link between the patent system and drug marketing approval procedures.94 For many developing countries and LDCs, patent linkages are introduced through FTAs that require the national DRA either to refuse to grant marketing approval for the generic version or to disclose to the patentee the identity of a third party seeking approval. 92 A country analysis of public health and patent law in Jordan has shown that of 103 medicines registered and launched since 2001 that currently have no patent protection in Jordan, at least 79 per cent have no competition from a generic equivalent as a consequence of data exclusivity. See footnote 78 above, p. 9. 93 94 See footnote 90 above. Drug Price Competition and Patent Term Restoration Act (The Hatch-Waxman Act), United States 1984.