A/HRC/23/42 Raltegravir, Darunavir and Etravirine have not. It is important therefore to ensure that the revisions to the WHO EML are conducted in an inclusive and transparent manner that addresses concerns of all groups. The Special Rapporteur also notes that in some States, patented medicines are included on the NEMLs to bring them within the purview of costcontrol mechanisms that ensure their affordability. It has come to his attention however that some countries exclude patented medicines from the NEML, and thereby from cost-control measures to which they would otherwise be subject, which can detrimentally impact on the affordability to patients. Essential medicines, be they patented or off-patent, should be included in both the WHO EML and NEMLs in a timely manner where indicated by evidence of the burden of disease. 44. Non-communicable diseases (NCD) also disproportionately impact developing countries, which face 80 per cent of the global NCD burden.62 However, only 22 per cent of the 359 essential medicines on the 2003 WHO EML relate to NCDs.63 Several applications for the treatment of mental health, cancers and cardiovascular diseases are pending review by the WHO Expert Committee. Underrepresentation of medicines for NCDs in the WHO EML also limits guidance for States in the development of their NEMLs. 45. During the consultations, concerns were raised about the lack of uptake by States of certain essential medicines listed on the WHO EML due to political, cultural and legal considerations, especially of medicines for mental health, palliative care, drug dependence and sexual and reproductive health. For example, access to medical abortion pills such as mifepristone with misoprostol, though included on the WHO EDL, are culturally and legally restricted in many States, limiting women’s accessibility to sexual and reproductive health.64 Criminalization of the activities of drug users in many States also restricts the availability of opioid substitutes, buprenorphine and methadone, proven to be effective in treating drug dependence, despite the fact that they are listed on the WHO EML.65 The Special Rapporteur recalls that access to essential medicines for vulnerable and marginalized groups should not be impeded by political, legal and cultural considerations. States should take steps to ensure that these medicines are included in their NEMLs and are made available and accessible to such groups. 46. States have devised ingenious ways in resource-limited settings to ensure access to the most essential medicines, as was highlighted during the Special Rapporteur’s consultations. For example, in one country essential medicines are classified into different segments as per product: vital medicines (e.g. emergency medicines), essential medicines (e.g. to treat fever, headaches) and necessary medicines (e.g. multivitamins). According to the procurement rules in that country, health facilities should procure the required quantity of vital medicines first, then essential, and finally necessary medicines. This helps minimize stock-outs affecting the most vital health concerns while more sustainable solutions are devised to meet the needs for other medicine. The Special Rapporteur encourages such innovative approaches, which are tailored to local conditions and are consistent with the core right to health obligation of ensuring the availability and accessibility of essential medicines. 62 63 64 65 14 Global status report on noncommunicable diseases, WHO (2011), p. 9. T. K. Mackey and B A Liang, “Patent and Exclusivity Status of Essential Medicines for NonCommunicable Disease”, PLOS ONE, vol. 7, No. 11 (2012). A/66/254, paras. 21 and 26. See also, Jane Cottingham and Marge Berer, “Access to essential medicines for sexual and reproductive healthcare: the role of pharmaceutical industry and international regulation”, Reproductive Health Matters (2011), vol. 19, No. 38, pp. 69-84, p. 73. See The War on Drugs and HIV/AIDS, “How the Criminalization of Drug Use Fuels the Global Pandemic”, Report of the Global Commission on Drug Policy (2012).

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