Condensed entry A state must have a policy in place geared at making essential medicines (1) available; (2) accessible without discrimination at a health facility within safe physical reach where the medicines are administered by skilled medical personnel when needed; (3) affordable to all, including those living in poverty and other disadvantaged groups and (4) of good quality. A state denies life-saving drugs if such a plan, including a national list of essential medicines, is not in place and implemented. Implementation requires the provision of adequate budgetary resources. Since genuine resource constraints may exist, other states share responsibility with the national state in making life-saving medicines available.
Comprehensive entry Article 12(1) of the ICESCR provides for the ‘right of everyone to the enjoyment of the highest attainable standard of physical and mental health’. [1] Steps taken by states to ensure the right to health include ‘those necessary for the prevention, treatment and control of epidemic, endemic, occupational and other diseases’[2] and ‘the creation of conditions which would assure to all medical service and medical attention in the event of sickness.’[3] According to the Committee on Economic, Social and Cultural Rights (CESCR) the right to health includes, as part of the minimum core of the right to health, access to essential medicines as defined by the WHO.[4] Essential medicines are selected nationally based on disease prevalence, efficacy, safety and comparative cost effectiveness.[5] The developmental level of a state may affect its possibility of giving effect to this right. However, the state has a duty to develop and implement policies that will effectively guarantee the right of access to medicines. Such a policy should be geared towards making quality essential medicines (1) available; (2)accessible, without discrimination, at a health facility within safe physical reach and administered by skilled medical personnel when needed; and (3) affordable to all, including those living in poverty and other disadvantaged groups.[6] A state may be in violatation of the right to essential medicines by not providing adequate budgetary resources.[7] Developed states have a duty to assist developing countries in making essential drugs available.[8] Pharmaceutical companies may also share some responsibility. The Human rights guidelines for pharmaceutical companies in relation to access to medicines developed by the UN Special Rapporteur on the right to health provides that pharmaceutical companies must ensure ‘that its medicines are affordable to as many people as possible … The arrangements should include, for example, differential pricing between countries, differential pricing within countries, commercial voluntary licences, not-for-profit voluntary licences, donation programmes, and Public Private Partnerships.’[9] International human rights monitoring bodies have not considered many cases dealing with access to essential medicines. In Jorge Odir Miranda et al v El Salvador, 27 persons living with HIV argued that El Salvador violated the[ir] right to life, health, and well being … inasmuch as it has not provided them with the triple therapy medication needed to prevent them from dying and to improve their quality of life.’[10] In its decision on the merits the Inter-American Commission found that the state had taken ‘what steps it reasonably could to provide medical treatment’.[11] These steps included the purchase of anti-retroviral drugs and the provision of such drugs to the complainants when needed. The Commission noted that no retrogressive steps had been taken. Deportation to a country where essential medicines are not accessible may constitute a human rights violation. This has been recognized by the ECtHR which held that deportation was prohibited in terms of article 3 of the ECHR (prohibiting inhuman or degrading treatment) where there would be no care for a terminally ill deported person in his or her country of origin.[12] Since there is no article on the right to health in the ECHR, in other cases, mainly dealing with HIV/AIDS, the ECtHR has held that since adequate treatment is in principle available though unaffordable there was no violation of the prohibition of inhuman or degrading treatment under the ECHR.[13] Litigation with regard to life-saving medicines has been more common at the national level.[14] The TAC case before the South African Constitutional Court dealt with access to nevirapine, a medicine that prevents transfer of HIV from mother to child. The South African government refused to provide nevirapine outside a few pilot sites. The South African Constitutional Court held that the policy for reducing the risk of mother-to-child transmission of HIV as formulated and implemented by government fell short of compliance with the requirements in [the South African Constitution] in that: i) Doctors at public hospitals and clinics other than the research and training sites were not enabled to prescribe nevirapine to reduce the risk of mother-to-child transmission of HIV even where it was medically indicated and adequate facilities existed for the testing and counselling of the pregnant women concerned.[15]
[1]See also CRC art 24(1), MWC art 28, CRPD art 25, ACHPR art 16, ACHR art 26, PSS art 10, ESC art 11. [2]ICESCR art 12(2)(c). [3]ICESCR art 12(2)(d). [4]General Comment 14 on the right to the highest attainable standard of health (art 12 of ICESCR) paras 12, 43(d). The WHO model lists of essential medicines (separate lists for adults and children) are regularly updated and available at www.who.int/medicines/publications/essentialmedicines/en/index.html. [5] HV Hogerzeil ‘Essential medicines and human rights: what can they learn from each other?’ (2006) 84(5) Bulletin of the World Health Organization 371-375. Over 150 countries have a national list of essential medicines. [6]General Comment 14 para 12. [7]General Comment 14 paras 33, 52. [8] General Comment 14 paras 38-40, 45. [9] UN Doc A/63/263, 11 August 2008, Annex, para 33. The guidelines were prepared by the UN Special Rapporteur on the Right to Health after extensive consultation. [10]Report 27/09, case 12.249, Merits (IAComHR 2009) para 2. [11]Para 108. [12] D v United Kingdom 1997 24 EHRR 423. N v United Kingdom, application 26565/05 (ECtHR 2008). [13] See N v United Kingdom and cases cited therein, paras 35-41. [14]See eg HV Hogerzeil et al ‘Access to essential medicines as part of the fulfillment of the right to health – is it enforceable through the courts?’ (2006) 368 Lancet 305-311. [15] Minister of Health and ors v Treatment Action Campaign and ors, Appeal to Constitutional Court, 2002 CCT 8/02; ILDC 517 (ZA 2002) para 135(2)(c).
A state must have a policy in place geared at making essential medicines (1) available; (2) accessible without discrimination at a health facility within safe physical reach where the medicines are administered by skilled medical personnel when needed; (3) affordable to all, including those living in poverty and other disadvantaged groups and (4) of good quality. A state denies life-saving drugs if such a plan, including a national list of essential medicines, is not in place and implemented. Implementation requires the provision of adequate budgetary resources. Since genuine resource constraints may exist, other states share responsibility with the national state in making life-saving medicines available.
Comprehensive entry
Article 12(1) of the ICESCR provides for the ‘right of everyone to the enjoyment of the highest attainable standard of physical and mental health’. [1] Steps taken by states to ensure the right to health include ‘those necessary for the prevention, treatment and control of epidemic, endemic, occupational and other diseases’[2] and ‘the creation of conditions which would assure to all medical service and medical attention in the event of sickness.’[3] According to the Committee on Economic, Social and Cultural Rights (CESCR) the right to health includes, as part of the minimum core of the right to health, access to essential medicines as defined by the WHO.[4] Essential medicines are selected nationally based on disease prevalence, efficacy, safety and comparative cost effectiveness.[5]
The developmental level of a state may affect its possibility of giving effect to this right. However, the state has a duty to develop and implement policies that will effectively guarantee the right of access to medicines. Such a policy should be geared towards making quality essential medicines
(1) available;
(2)accessible, without discrimination, at a health facility within safe physical reach and administered by skilled medical personnel when needed; and
(3) affordable to all, including those living in poverty and other disadvantaged groups.[6]
A state may be in violatation of the right to essential medicines by not providing adequate budgetary resources.[7] Developed states have a duty to assist developing countries in making essential drugs available.[8] Pharmaceutical companies may also share some responsibility. The Human rights guidelines for pharmaceutical companies in relation to access to medicines developed by the UN Special Rapporteur on the right to health provides that pharmaceutical companies must ensure ‘that its medicines are affordable to as many people as possible … The arrangements should include, for example, differential pricing between countries, differential pricing within countries, commercial voluntary licences, not-for-profit voluntary licences, donation programmes, and Public Private Partnerships.’[9]
International human rights monitoring bodies have not considered many cases dealing with access to essential medicines. In Jorge Odir Miranda et al v El Salvador, 27 persons living with HIV argued that El Salvador violated the[ir] right to life, health, and well being … inasmuch as it has not provided them with the triple therapy medication needed to prevent them from dying and to improve their quality of life.’[10] In its decision on the merits the Inter-American Commission found that the state had taken ‘what steps it reasonably could to provide medical treatment’.[11] These steps included the purchase of anti-retroviral drugs and the provision of such drugs to the complainants when needed. The Commission noted that no retrogressive steps had been taken.
Deportation to a country where essential medicines are not accessible may constitute a human rights violation. This has been recognized by the ECtHR which held that deportation was prohibited in terms of article 3 of the ECHR (prohibiting inhuman or degrading treatment) where there would be no care for a terminally ill deported person in his or her country of origin.[12] Since there is no article on the right to health in the ECHR, in other cases, mainly dealing with HIV/AIDS, the ECtHR has held that since adequate treatment is in principle available though unaffordable there was no violation of the prohibition of inhuman or degrading treatment under the ECHR.[13]
Litigation with regard to life-saving medicines has been more common at the national level.[14] The TAC case before the South African Constitutional Court dealt with access to nevirapine, a medicine that prevents transfer of HIV from mother to child. The South African government refused to provide nevirapine outside a few pilot sites. The South African Constitutional Court held that
the policy for reducing the risk of mother-to-child transmission of HIV as formulated and implemented by government fell short of compliance with the requirements in [the South African Constitution] in that: i) Doctors at public hospitals and clinics other than the research and training sites were not enabled to prescribe nevirapine to reduce the risk of mother-to-child transmission of HIV even where it was medically indicated and adequate facilities existed for the testing and counselling of the pregnant women concerned.[15]
[1]See also CRC art 24(1), MWC art 28, CRPD art 25, ACHPR art 16, ACHR art 26, PSS art 10, ESC art 11.
[2]ICESCR art 12(2)(c).
[3]ICESCR art 12(2)(d).
[4]General Comment 14 on the right to the highest attainable standard of health (art 12 of ICESCR) paras 12, 43(d). The WHO model lists of essential medicines (separate lists for adults and children) are regularly updated and available at www.who.int/medicines/publications/essentialmedicines/en/index.html.
[5] HV Hogerzeil ‘Essential medicines and human rights: what can they learn from each other?’ (2006) 84(5) Bulletin of the World Health Organization 371-375. Over 150 countries have a national list of essential medicines.
[6]General Comment 14 para 12.
[7]General Comment 14 paras 33, 52.
[8] General Comment 14 paras 38-40, 45.
[9] UN Doc A/63/263, 11 August 2008, Annex, para 33. The guidelines were prepared by the UN Special Rapporteur on the Right to Health after extensive consultation.
[10]Report 27/09, case 12.249, Merits (IAComHR 2009) para 2.
[11]Para 108.
[12] D v United Kingdom 1997 24 EHRR 423. N v United Kingdom, application 26565/05 (ECtHR 2008).
[13] See N v United Kingdom and cases cited therein, paras 35-41.
[14]See eg HV Hogerzeil et al ‘Access to essential medicines as part of the fulfillment of the right to health – is it enforceable through the courts?’ (2006) 368 Lancet 305-311.
[15] Minister of Health and ors v Treatment Action Campaign and ors, Appeal to Constitutional Court, 2002 CCT 8/02; ILDC 517 (ZA 2002) para 135(2)(c).