A/HRC/11/12 page 28 93. The Special Rapporteur also notes possible concerns that recent developments in national legislation105 and international negotiations on an anti-counterfeiting trade agreement (ACTA) may impose a TRIPS-plus enforcement regime.106 The lack of transparency and secrecy surrounding the negotiations is of particular concern. V. CONCLUSIONS AND RECOMMENDATIONS 94. The framework of the right to health makes it clear that medicines must be available, accessible, acceptable, and of good quality to reach ailing populations without discrimination throughout the world. As has been evident, TRIPS and FTAs have had an adverse impact on prices and availability of medicines, making it difficult for countries to comply with their obligations to respect, protect, and fulfil the right to health. 95. Similarly, lack of capacity coupled with external pressures from developed countries has made it difficult for developing countries and LDCs to use TRIPS flexibilities to promote access to medicines. 96. Flexibilities were included in TRIPS to allow States to take into consideration their economic and development needs. States need to take steps to facilitate the use of TRIPS flexibilities. 97. The Special Rapporteur therefore recommends that developing countries and LDCs should review their laws and policies and consider whether they have made full use of TRIPS flexibilities or included TRIPS-plus measures, and if necessary consider amending their laws and policies to make full use of the flexibilities. 98. LDCs should make full use of the transition period and in relation to medicines revoke or suspend their patent laws, if necessary, for the balance of the period. LDCs should also consider asking for a further extension of the transition period. 99. LDCs should use the transition period to seek the most effective technical and other assistance from countries and institutions to develop technical capacity and also explore options to establish local manufacturing capabilities. 100. Developing countries and LDCs should establish high patentability standards and provide for exclusions from patentability, such as new forms and new or second uses, and combinations, in order to address evergreening and facilitate generic entry of medicines. 101. Developing countries and LDCs should adopt the principle of international exhaustion and provide for parallel importation with simplified procedures in their national laws. 105 Kenya Anti-Counterfeit Act and Uganda anti-counterfeit bill. 106 EU Parliament resolution, INI/2008/2133 of September 2008.

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