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).