University of Groningen The right to health as the basis for universal access to essential medicines Perehudoff, Sammi-Jo Katrina

University of Groningen

The right to health as the basis for universal access to essential medicines Perehudoff, Sammi-Jo Katrina

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Perehudoff, S-J. K. (2018). The right to health as the basis for universal access to essential medicines: A normative framework and practical examples for national law and policy. Rijksuniversiteit Groningen.

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Normative framework

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In this chapter we briefly explain the development of the normative framework that serves as the assessment tool that we apply in our analysis of domestic laws and policies in Chapters 3.2 and 3.3.

WHO policy and legal frameworks

We identified overlapping principles in WHO’s policies for essential medicines and international human rights law that are relevant for access to medicines, particularly their affordability and the financial protection of vulnerable groups.

We identified principles in the following policies for essential medicines: • Developing and Implementing a National Drug Policy, second edition

(1),

• Equitable Access to Essential Medicines (2), • Six Building Blocks of a Health System (3),

• Access to Medicines from a Health Systems Perspective (4),

• Good Governance for Medicines programme and Model Framework (5).

We selected principles from international human rights law that concern States’ obligations towards social or health rights, the core obligation to provide essential medicines, and/or rights related to good governance. These legal instruments include:

• International Covenant on Economic, Social and Cultural Rights (6), • International Covenant on Civil and Political Rights (7),

• Optional Protocol to the International Covenant on Economic, Social and Cultural Rights (8),

• publications from the United Nations Committee on Economic, Social and Cultural Rights that interpret the scope and content of Covenant rights and obligations, including:

• States duties under the Covenant (General Comment No. 3 (9)),

• the right to health (General Comment No. 14 (10)),

• authors’ and inventors’ rights in the context of access to medicines (General Comment No. 17 (11)),

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• criteria to evaluate the reasonableness of State action in relation to available resources (2007 Statement (12)),

• the right to social security (General Comment No. 19 (13)), • the right to sexual and reproductive health, as part of the right

to health (General Comment No. 22 (14)).

Principles for access to medicines in national law and policy We identified overlapping principles for access to medicines through a multi-step, iterative process. The policy checklist was developed by two researchers (Katrina Perehudoff and Nikita V. Alexandrov) who shortlisted the relevant principles from source documents, independently piloted the short list on UHC laws to determine their applicability and adequacy, and revised the short list. Three right to health and pharmaceutical policy experts (Hans V. Hogerzeil, Brigit Toebes, and Ellen ‘t Hoen) reviewed the short list to ensure the principles were relevant and correctly defined.

Our final normative framework identifies 12 principles categorised in three domains (described below): legal rights and obligations, good governance, and technical implementation. The domains correspond to the structure-process-outcome framework for monitoring and evaluating the realisation of human rights by the UN Office of the High Commission for Human Rights. (15) Below we describe the principles assigned to each domain.

Legal rights and obligations

The ‘Legal rights and obligations’ domain reflects the essence of States’ overarching right to health commitments that should be legally recognised in domestic law and policy. This domain consists of the individual entitlement to the highest attainable standard of health (principle 1) and the State’s core obligation to provide essential medicines (principle 2). We developed these two principles throughout Chapter 2. These principles are primarily informed by the International Covenant on Economic, Social and Cultural Rights (ICESCR, art. 12) and the authoritative interpretation of essential medicines as a ‘core obligation’ of States in multiple General Comments. (6,9,10,13,14) To date, the only reference to human rights in the context of pharmaceutical policy is found in the Access to Medicines from a Health Systems Perspective framework proposed by Bigdeli and colleagues. (4) It includes a weak reference to human rights as a ‘value’.

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Nor ma tiv e fr amew or k Good governance

The ‘Good governance’ domain captures principles to guide the processes of State action (i.e. How should States act?). This domain consists of transparency (principle 3), participation and consultation of beneficiaries (principle 4), monitoring and evaluation of State commitment, efforts and results (principle 5), and accountability and redress (principle 6).

From a legal perspective the International Covenant on Civil and Political Rights (ICCPR) offers a firm foundation on which to ground three of our four Good governance principles. (7,16) Transparency corresponds to the right to freedom of expression, including to seek, receive, and impart information (art.19). (7,16) Participation relates to the right to take part in public affairs (art. 15). (7,16) Accountability is derived from the right to an effective remedy for rights violations (art. 2). (7,16)

In addition, the Committee on Economic, Social and Cultural Rights recognises in General Comment No. 14 that “good governance is essential to effective implementation of all human rights, including the realization of the right to health” (§55). (10) All four principles are reflected in General Comment No. 14 of the ICESCR. (10) The participation of beneficiaries is required in relation to health-related decision making and processes for health policy, programming, and the organisation of health facilities goods and services. (§11,17,54) (10) The monitoring and evaluation of State action for the realisation of health rights is a component of the right to health (§57-58). (10) Less specific are references to transparency and accountability in General Comment No. 14. A national health strategy and plan of action should be based on the principles of accountability and transparency (§43(f),55). (10) This concept creates a platform on which transparency and accountability can be related to State strategies and plans to realise the right to health. From a governance perspective, transparency, participation, and accountability emerge as common elements from the definitions of good governance provided by the International Development Association, the United Nations Development Programme, Office for the High Commissioner of Human Rights, former UN Commission on Human Rights, and other institutions (i.e. international financing institutions). (16) According to a governance approach, monitoring is not an explicit principle because it is considered to be a component of accountability. From the perspective of WHO policy, we can look to the Good Governance for Medicines programme and model framework. (5) This

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framework advances 10 components (based on ethical principles) to guide laws, policies, and procedures to improve the management of and reduce corruption in pharmaceutical systems. Of the 10 components in this Model Framework, several corroborate our four Good governance principles. Transparency corresponds with the principle of “transparent and accountable regulations and administrative internal and external audits” in which transparency is vaguely referenced (p.15). (5) Participation of beneficiaries is not strongly referenced in WHO’s Good Governance for Medicines framework. It can be related to “collaboration among anti-corruption and transparency initiatives” that includes civil society (p.15). (5) Monitoring is captured by the principle of “management, coordination, and evaluation” (p.16). (5) Accountability is contained in the ethical principle ‘accountable trusteeship’ in which public servants are stewards of public resources and therefore accountable to the society they serve (p.12). (5)

Technical implementation

The ‘Technical implementation’ domain specifies the intermediate steps or policy measures that States should take to discharge their right to health obligations in the context of medicines (i.e. What should States do?). In Chapter 2.1 one of the authors (Katrina Perehudoff) and Lisa Forman extensively examined how some of these principles are derived from international human rights law and WHO’s policies. Perehudoff and Forman propose that ‘reasonable’ State action to provide essential medicines requires governments to:

• ensure sufficient public spending, which is at least the minimum amount required to purchase a basic package of essential medicines for all (principle 8),

• generate efficiencies by seeking international (technical) cooperation and (financial) assistance to support domestic essential medicines programmes (principle 10),

• implement spending efficiencies through price control and use the flexibilities to the Trade Related Aspects of Intellectual Property (TRIPs) Agreement when all other measures fail to yield affordable medicines (principle 11),

• observe non-discrimination in national pharmaceutical policy through the financial protection of vulnerable groups, among other approaches (principle 12).

In addition, two other principles arose from overlapping concepts in WHO’s policies and international human rights law: the selection of

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essential medicines (principle 7) and the pooling of user contributions to increase the resources available for pharmaceuticals (principle 9).

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Nor ma tiv e fr amew or k Ta bl e 1. N or m at iv e fr am ew or k f or a cc es s to m ed ic in es in n at io na l l aw a nd p ol ic y. Pr in ci pl es Hu m an ri gh ts pr in ci pl e So ur ce o f l aw Ha rd la w is bo ld ed , so ft la w is ita lic ise d WH O es se nt ia l m ed ic in es po lic y De ve lo pe d in th es is ch ap te rs Ap pl ie d in th es is ch ap te rs Le ga l r ig ht s a nd o bl ig at io ns 1. R ig ht to h ea lth Ri gh t t o th e h ig he st at tai na bl e s tan dar d of h ea lth IC ES CR ar t. 12 Ge ne ra l C om m en t N o. 1 4 Hu m an ri gh ts ar e a ‘v al ue ’. (4 ) Th ro ug ho ut Th ro ug ho ut 2. S ta te o bl ig at io n to pr ov id e e ss en tia l me di ci ne s Co re o bl ig at io n to pr ov id e e ss en tia l me di ci ne s d efi ne d by WH O IC ES CR ar ts . 2 .1 , 1 2 Ge ne ra l C om m en t N o. 3 Ge ne ra l C om m en t N o. 1 4 Ge ne ra l C om m en t N o. 1 9 Ge ne ra l C om m en t N o. 2 2 Th ro ug ho ut Th ro ug ho ut Go od g ov er na nc e 3. T ra ns pa re nc y Tr an sp ar en cy IC CP R ar t. 19 IC ES CR ar t. 12 Ge ne ra l C om m en t N o. 1 4 In fo rm at io n to as se ss se rv ic e ac ce ss an d co ve rag e, an d pu bl ic ly av ai la bl e pr ic e in fo rm at io n fo r m ed ic in es . (1 ,3 ) A lso an as pe ct o f g oo d go ve rn an ce fo r m ed ic in es . (5 ) 2. 2, 2. 4 3. 2, 3. 3

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Nor ma tiv e fr amew or k 4. P ar tic ip at io n & co ns ul ta tio n Pa rti ci pa tio n IC CP R ar t. 15 IC ES CR ar t. 12 Ge ne ra l C om m en t N o. 1 4 Co lla bo ra tio n an d ac co un ta bi lit y of al l h eal th sy ste m s a ct or s, an d sta ke ho ld er co ns ul ta tio n. (1 ,3 ) Al so v ag ue ly re fe re nc ed in go od go ve rn an ce fo r me di ci ne s. (5 ) 2. 4 3. 2, 3. 3 5. M on ito rin g & ev al ua tio n Mo ni to rin g IC ES CR ar t. 12 Ge ne ra l C om m en t N o. 1 4 Ac hi ev ed th ro ug h ex pl ic it go ve rn m en t c om m itm en t, in di ca to r-ba se d su rv ey s, an d in de pe nd en t im pa ct ev al ua tio n. (1 ,3 ) A lso a co m po ne nt o f g oo d go ve rn an ce fo r m ed ic in es . (5 ) 2. 4 3. 2, 3. 3 6. A cc ou nt ab ili ty & re dr es s Ac co un ta bi lit y IC CP R ar t. 2 IC ES CR ar t. 12 Ge ne ra l C om m en t N o. 1 4 Ac co un ta bi lit y of al l h ea lth sy ste m s a ct or s. (3 ) A lso a co m po ne nt o f g oo d go ve rn an ce fo r m ed ic in es . (5 ) 2. 4 3. 2, 3. 3, 5

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Nor ma tiv e fr amew or k Te ch ni ca l i m pl em en ta tio n 7. S el ec tio n of es se nt ia l m ed ic in es (A ss ur ed ) q ua lit y of he al th se rv ic es (o f th e A A A Q ) IC ES CR ar tic le 1 2 Ge ne ra l C om m en t N o. 1 4 In clu de s t he es se nt ia l d ru gs co nce pt , p ro ce du re s t o de fin e an d up da te th e n at io na l l ist (s ) of es se nt ia l d ru gs , e xp lic it, ev id en ce -b as ed cr iter ia th at in clu de s c os t-e ffe ct iv en es s, an d se lec tio n m ec han ism s. (1 ,2 ) 2. 3 3. 2, 3. 3, 4 Du ty to ad op t ap pr op riat e le gi sla tiv e, ad m in ist rat iv e, bu dg et ar y an d ot he r me as ur es to a ma xi mu m of it s av ai lab le re so ur ce s. Co re o bl ig at io n to pr ov id e e ss en tia l me di ci ne s a s d efi ne d by W H O IC ES CR ar ts . 2 .1 , 9 , 1 2 Ge ne ra l C om m en t N o. 3 Ge ne ra l C om m en t N o. 1 4 Ge ne ra l C om m en t N o. 1 9 Ge ne ra l C om m en t N o. 2 2 8. G ov er nm en t fin an ci ng Re qu ire s a de qu at e f un di ng an d m ob ili sin g al l a va ila bl e pu bl ic re so ur ce s a nd in cr ea se fu nd in g fo r p rio rit y di se as es , an d th e v ul ne rab le . (1 –3 ) 2. 1 3. 2, 3. 3, 4 9. P oo l u se r co nt rib ut io ns Me di ci ne s r ei m bu rs em en t wi th u se r c ha rg es is a (te m po ra ry ) fi na nc in g op tio n. (2 ,3 ) -3. 2, 3. 3

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Nor ma tiv e fr amew or k 10. In te rn at io na l as sis tan ce an d te ch ni ca l co op er at io n Du ty to se ek in te rn at io na l as sis ta nc e a nd te ch ni ca l co op er at io n IC ES CR ar t. 12 Op tio na l P ro to co l t o IC ES CR Ge ne ra l C om m en t N o. 1 4 St at em en t b y t he C ESC R th e ob lig at ion to ta ke st ep s t o a ma xi mu m of a va ila bl e re so ur ce s In clu de s t he p os sib ili ty o f us in g de ve lo pm en t l oa ns fo r me di ci ne s fi na nc in g. (2 ) 2. 1 3. 2, 3. 3 11. E ffi ci en t a nd co st-eff ect iv e sp en di ng Du ty fo r t he effi ci en t us e o f a va ila bl e re so ur ce s IC ES CR ar t. 2. 1 Ge ne ra l C om m en t N o. 3 In clu de s t he effi ci en t u se o f re so urc es an d aff ord ab le pr ic in g th ro ug h: pr ic e c on tr ol ; a p ric in g po lic y fo r al l me di ci ne s; co mp et iti on th ro ug h ge ne ric p ol ic ie s a nd su bst itu tio n; g oo d pr oc ur em en t pr ac tic es ; pr ic e ne go tia tio n and in fo rm at io n; an d TR IP s-co m pl ian t me as ur es su ch as co mp ul so ry lic en sin g an d pa ra lle l i m po rt s. (1 –3 ) 2. 1, 2. 2 3. 2, 3. 3 Du ty to ta ke ap pr op riat e s te ps to en su re th at th e pr iv at e b us in es s se ct or is aw ar e o f, an d co ns id er th e im po rt an ce o f, th e rig ht to h ea lth in pu rs ui ng th ei r ac tiv iti es . IC ES CR ar t. 12 Ge ne ra l C om m en t N o. 1 4

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Nor ma tiv e fr amew or k 11. E ffi ci en t a nd co st-eff ect iv e sp en di ng (c on tin ue d) Du ty to p re ve nt un re as on ab ly hi gh co sts fo r a cce ss to es se nt ia l m ed ici ne s fro m u nd er m in in g th e r ig hts o f l ar ge se gm en ts of th e po pu la tio n to h ea lth . IC ES CR ar t. 15 Ge ne ra l C om m en t N o. 1 7 Du ty to se ek lo w -co st po licy o pt io ns Op tio na l P ro to co l t o IC ES CR St at em en t b y t he C ESC R on th e o bl ig ati on to ta ke ste ps to a m ax im um o f av ai lab le re so urc es 12. F in an ci al pr ot ec tio n of vu ln er ab le gr ou ps Du ty to w ar ds n on -di sc rim in at io n an d at te nt io n to th e vu ln er ab le IC ES CR ar ts . 9 , 1 2 Ge ne ra l C om m en t N o. 1 4 Ge ne ra l C om m en t N o. 1 9 In cr ea se g ov er nm en t f un di ng fo r p oo r a nd v ul ne ra bl e gr ou ps an d re du ce th e r isk o f ca ta str op hi c h ea lth sp en di ng . (2 ,3 ) -3. 2, 3. 3, 4 Ab br ev ia tio ns u se d i n t hi s ta bl e: a rt. = a rti cle ; IC ES CR =I nt er na tio na l Co ve na nt o n E co no m ic , So ci al , an d C ul tu ra l Ri gh ts; IC CP R= In te rn at io na l C ov en an t o n Ci vi l a nd P ol iti ca l R ig ht s; CE SCR = Co m m itt ee o n Ec on om ic , S oc ia l, an d Cu ltu ra l R igh ts ; W H O =W or ld He al th O rg an iz at io n; T RI Ps =T ra de R el at ed A sp ec ts o f I nt el le ct ua l P ro pe rt y; A A A Q =A va ila bi lit y, A cc es sib ili ty , A cc ep ta bi lit y, a nd Q ua lit y as el em en ts o f h ea lth ser vi ce s u nd er th e r ig ht to h ea lth .

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Nor ma tiv e fr amew or k References

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