Essential but expensive? The World Health Organization, access to medicines and human rights
| DOI | 10.1177/0924051919844373 |
| Published date | 01 June 2019 |
| Author | Keith Syrett |
| Date | 01 June 2019 |
| Subject Matter | Articles |
Article
Essential but expensive?
The World Health Organization,
access to medicines and
human rights
Keith Syrett
Professor, Health Law and Policy, Centre for Health, Law, and Society, School of Law, University of Bristol, Bristol, UK
Abstract
Now widely accepted as a component of the international human rights framework, the
concept of access to medicines nonetheless continues to generate controversial questions as
to its scope and application. Through critical analysis of relevant documentary materials, this
article seeks to explore the conjunction between human rights and the list of essential
medicines compiled biennially by the World Health Organization in the particular context of
the recent expansion of this list to embrace a number of very costly medical interventions.
Such extension is intended to stimulate access in the long run, but the expense of such
medicines may limit accessibility in the short term, as governments struggling to ensure the
sustainability of health systems choose to allocate finite resources elsewhere. This article
therefore examines the compatibility of limitations to access on grounds of unaffordability,
with international human rights obligations. It focuses especially upon Article 12 of the
International C ovenant on Econom ic, Social and Cul tural Rights but al so considers othe r
human rights which may be engaged.
Keywords
Medicines, World Health Organization, affordability, access, right to health
Introduction
Access to medicines is now regarded as an indispensable component of the right to the highest
attainable standard of health under Article 12 of the International Covenant on Economic, Social
Corresponding author:
Keith Syrett, Professor, Health Law and Policy, Centre for Health, Law, and Society, School of Law, University of Bristol,
Bristol BS8 1HH, UK.
E-mail: keith.syrett@bristol.ac.uk
Netherlands Quarterly of Human Rights
2019, Vol. 37(2) 139–156
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and Cultural Rights (‘ICESCR’).
1
A distinction is drawn between medicines deemed as ‘essential’
and those which are not, the former being those ‘defined by the World Health Organization
(‘WHO’) Action Programme on Essential Dr ugs’.
2
Provision of these essential medici nes, as
distinct from medicines which ar e not so listed, is specified as a core oblig ation by General
Comment No. 14 issued by the UN Committee on Economic, Social and Cultural Rights.
3
The
classification of medicines as ‘essential’ by the WHO is thus a significant act from the perspective
of international human righ ts.
4
The focus of the present analysis is upon the ‘unprecedented
development’
5
of the inclusion, in the most recent two iterations of the list of essential medicines
of a number of very high-cost technologies, ranging from US$60,000 to US$100,000 per treat-
ment.
6
This action is likely to generate difficult issues of affordability for large numbers of States,
including high-income economies, raising fresh and difficult questions concerning compliance
with international human rights obligations relating to medicines. This article will explore this
issue through an examination of relevant treaty provisions, reports of treaty bodies and special
rapporteurs, together with material on essential medicines produced by the WHO and other UN
actors.
Following a brief account of the development of the list, the article examines, first, the rationale
for, and implications of, the recent extension of the list in this direction; and, second, the extent to
which a failure by States to provide access to expensive medicines of this type – an increasingly
likely eventuality in light of their significant cost – may constitute a violation of international
human rights obligations.
1. Human Rights Council (HRC), ‘Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the
Highest Attainable Standard of Physical and Mental Health’ (13 September 2006) UN Doc A/61/338, para 40. As will be
discussed below, access to medicines connects additionally to other human rights.
2. Committee on Economic, Social and Cultural Rights (CESCR), ‘General Comment No. 14: The Right to the Highest
Attainable Standard of Health (Art. 12 of the Covenant)’ (11 August 2000) UN Doc E/C.12/2000/4, para 12(a).
3. ibid para 43(d).
4. It should be noted, however, that the status of General Comments remains a matter of contention. As Keller and Grover
observe, ‘reactions to General Comments have ranged from regarding them as ‘‘authoritative interpretations’’ of treaty
norms, to ‘‘broad,unsystematic, statementswhich are not always well founded,and are not deserving of being accorded
any particular weight in legal settings’’’.See Helen Keller and Leena Grover, ‘General Comments of the Human Rights
Committee and their Legitimacy’, in Helen Keller and Geir Ulfstein (eds), UN Human Rights Treaty Bodies: Law and
Legitimacy (Cambridge University Press 2012).For an example of the latter position in relation to General Comment No.
14, see United States State Department, ‘Observations by the United States of America on ‘‘The Right to Health, Fact
Sheet No. 31’’’ accessed 2 November 2018. Following Gostin,
this article views both General Comments and Special Rapporteur reports as ‘interpretive instruments’ which clarify the
nature of state obligations in international human rights law. See Lawrence Gostin, Global Health Law (Harvard
University Press 2014) 68; and further United Nations Human Rights Office of the High Commissioner, ‘Statement by
Mr. Zeid Ra’ad Al Hussein, United Nations High Commissioner for Human Rights, at the International Law Com-
mission’ (United Nations Human Rights Office of the High Commissioner, 21 July 2015),
NewsEvents/Pages/DisplayNews.aspx? NewsID¼16254&LangID¼E> accessed 2 November 2018 (‘human rights
treaty bodies ...play an important role in establishing the normative content of human rights and in giving concrete
meaning to individual rights and state obligations’).
5. UN Secretary General’s High-Level Panel on Access to Medicines, Report: Promoting Innovation and Access to Health
Technologies (United Nations 2016) 16.
6. Costs cited in Katrina Perehudoff, Brigit Toebes and Hans Hogerzeil, ‘A Human Rights-Based Approach to the
Reimbursement of Expensive Medicines’ (2016) 94 Bulletin of the World Health Organization 935, 935.
140 Netherlands Quarterly of Human Rights 37(2)
The essential medicines list
Development of the list
Initiated by a report by the Director-General in 1975, the WHO’s strategy to identify a limited
range of safe and efficacious medicines sought to address the ‘urgent need to ensure that the most
essential drugs are available at a reasonable price and to stimulate research and development to
produce new drugs adapted to the real health requirements of developing countries’.
7
The Orga-
nization was concerned that significant resources were being expended upon ‘expensive drugs that
are only marginally useful, or even totally irrelevant to the solution of countries’ main health
problems, whereas large segments of the population are in urgent need of essential drugs for
disease control and primary health care’.
8
It was also concerned with the phenomenon of ‘drug-
dumping’, whereby medicines which had failed to meet regulatory standards in the developed
world were offered for sale in lower-income countries, thus exacerbating health inequalities
between states.
The WHO published its first list, then entitled the Model List of Essential Drugs, in 1977 (the
‘essential medicines’ designation was adopted in 2002). It contained 204 items, and was divided –
as remains the case, although the number of medicines listed has almost doubled over time –
between ‘core’ medicines, currently described as ‘minimum medicine needs for a basic healthcare
system ...the most efficacious, safe and cost–effective medicines for priority conditions’, and
those which are ‘complementary’, that is, ‘essential medicines for priority diseases, for which
specialized diagnostic or monitoring facilities, and/or specialist medical care, and/or specialist
training are needed’. In cases where there is uncertainty as to the designation, the complementary
list may also include medicines ‘on the basis of consistent higher costs or less attractive cost-
effectiveness in a variety of settings’.
9
It should be noted that the designation of a medicine on one
list rather than the other ‘does not imply that only core medicines should be procured by the public
system, while complementary medicines are optional’,
10
and no distinction is drawn between the
lists as a matter of international human rights law.
Responsibility for creation of the list rests with the Expert Committee on Selection and Use of
Medicines, the members of which are appointed by the Director General, based upon equitable
geographical representation, gender balance and professional competencies. The list is updated on
a biennial basis and the current iteration (2017) is the twentieth. A separate list of medicines for
children up to twelve years of age was first issued in 2007.
Consistentwith the initial objective of rationalselection of medicines appropriateto the needs of a
particular population, the WHO emphasisedin 1977 that lists of essential drugs should be drawn up
locally, but that its‘‘‘guiding’’ or ‘‘model’’list should be understood as a tentative identification of a
‘‘common core’’ of basic needs whichhas universal relevance and applicability’.
11
This juxtaposition
7. World Health Organization, ‘Prophylactic and Therapeutic Substances: Report by the Director-General’ (3 April 1975)
A28/11, 2.
8. ibid 1.
9. WHO Expert Committee on the Selection and Use of Essential Medicines, ‘The Selection and Use of Essential
Medicines’ (WHO Technical Report Series 1006 2017) 424.
10. Nicola Magrini and others, ‘Tough Decisions on Essential Medicines in 2015’ (2015) 93 Bulletin of the World Health
Organization 283, 283.
11. WHO Expert Committee on the Selection of Essential Drugs, ‘The Selection of Essential Drugs’ (WHO Technical
Report Series 615 1977) 8.
Syrett 141
of local implementation and universalstandard-setting remains a characteristic of the Organization’s
essentialmedicines strategy and carriesimplications for the natureof human rights obligationswhich
will be explored subsequently in this article. Nonetheless, the WHO observes that existence of ‘the
Model List has led to a global acceptance of the concept of essential medicines as a powerful means
to promote health equity’.
12
This suggests that, notwithstanding the need for local adaptation and
implementation, ‘the essential medicines concept [...] has taken on somewhat of a moral univers-
ality, as a thing that has acquired enough stakeholders and commonsensical status that it is increas-
ingly difficultto argue against’.
13
Such medicinesmay be said to possess a particularstatus as global
public goods.
14
Evolution of the list
The concept of an ‘essential medicine’ has evolved over time. The 1977 list defined an essential
medicine as one ‘of utmost importance, basic, indispensable and necessary for the health and needs
of the population’.
15
The present definition, applied from the 2002 list onward, is that such
medicines ‘are those that satisfy the priority health care needs of the population’.
16
It is clear that
the latter is significantly broader in scope, and probably vaguer.
17
Similarly, the basis on which medicines are chosen for inclusion on the list has altered. Initially,
‘the selection of medicines wa s determined by the experience of th e members of the Expert
Committee. There was no systematic search and reporting of evidence to support the selection’,
18
with applications for inclusion being made as a consequence of representations made by WHO
staff or pharmaceutical companies.
19
In light of concerns as to lack of specificity and transparency
of rationales for inclusion, an evidence-based approach, which entailed systematic analysis of
efficacy, safety and comparative cost-effectiveness considerations, was adopted from 2001
onwards.
20
In principle, the new approach meant that a high absolute cost of a medicine was not a factor
which precluded inclusion of a medicine on the list if it met other selection criteri a.
21
While
patented medicines had not per se been excluded from inclusion on the original WHO list, the
12. WHO, ‘Essential Medicines’
also WHO Expert Committee on the Selection and Use of Essential Medicines, ‘The Selection and Use of Essential
Medicines’ (WHO Technical Report Series 914 2002) 38.
13. Jeremy Greene, ‘Making Medicines Essential: The Emergent Centrality of Pharmaceuticals in Global Health’ (2011) 6
Biosocieties 10, 28.
14. See Suerie Moon, ‘Medicines as Global Public Goods: The Governance of Technological Innovation in the New Era of
Global Health’ (2009) 2 Global Health Governance 1. As noted below (n 61), more than four out of five countries
globally currently have national medicines lists.
15. WHO Expert Committee on the Selection of Essential Drugs (n 11) 9.
16. WHO Expert Committee on the Selection and Use of Essential Medicines (n 12) 15.
17. See Victoria Marks, Stephen Latham, and Sandeep Kishore, ‘On Essentiality and the World Health Organization’s
Model List of Essential Medicines’ (2017) 83 Annals of Global Health 637, 639.
18. See Rianne van den Ham, Lisa Bero, and Richard Laing, The World Medicines Situation 2011: Selection of Essential
Medicines (WHO 2011) 3.
19. See Richard Laing and others, ‘25 Years of the WHO Essential Medicines Lists: Progress and Challenges’ (2003) 361
Lancet 1723, 1724.
20. WHO Secretariat, ‘WHO Medicines Strategy: Revised Procedure for Updating WHO’s Model List of Essential Drugs:
Report by the Secretariat’ (7 December 2001) EB109/8.
21. ibid para 15.
142 Netherlands Quarterly of Human Rights 37(2)
initial acknowledgment that ‘cost represents a major selection criterion’ had led, in practice, to
avoidance of most such medicines,
22
but from 2001, ‘affordability has been changed from a pre-
condition for listing an essential medicine to a consequence that mustbe managed after the decision
to list’.
23
Despite this alteration, it remained the case untilrecently that few patented medicines were
included: it was estimated in 2010 that 95%of the medicines listed were off-patent.
24
A further change has been in the scope of medicines covered, with an increasing number of the
medicines listed being targeted at non-communicable diseases. Thus, the 1977 list contained six
cancer medicines, while the 2015 list contained 46.
Recent developments: ‘Repositioning’ the list
This latter development points towards a shift in priorities in the WHO’s essential medicines
strategy. As noted previously, the 1975 Report of the Director-General had envisaged that the
creation of a list of essential medicines would primarily be of benefit to developing countries.
25
In
fact, the first list noted that:
there are convincing justifications for the WHO to propose ‘‘model’’ or ‘‘guiding’’ lists of essential
drugs as a contribution to solving the problems of those Member States whose health needs far exceed
their resources and which may find it difficult to initiate such an endeavour on their own.
26
The criteria for selection initially adopted were, however, not specifically oriented towards
medicines in such countries, prompting opposition from pharmaceutical companies concerned that
this would lead to the replacement of branded products by generic medicines worldwide.
27
In
consequence, the second iteration of the list made clear that the concept of essential medicines was
restricted to developing countries,
28
and until very recently, there has been a continuing focus upon
‘resource-constrained settings, and [ ...] the most basic medicines’.
29
The emphasis upon com-
municable diseases, which have traditionally been regarded as prevalent primarily in developing
countries,
30
is indicative of this initial focus.
The inclusion of a greater number of treatments for communicable diseases is, in part, explic-
able by the growing incidence of such conditions in low- and middle-income countries.
31
22. WHO Expert Committee on the Selection of Essential Drugs (n 11) 12. There were some exceptions, such as prazi-
quantel for the treatment of various parasitic worm infections.
23. Magrini and others (n 10) 283.
24. Elizabeth Siew-Kuan Ng, ‘Global Health and Development: Patents and Public Interest’ in Thomas Pogge, Matthew
Rimmer, and Kim Rubenstein (eds), Incentives for Public Health: Patent Law and Access to Essential Medicines
(Cambridge University Press 2010) 116.
25. WHO (n 7).
26. WHO Expert Committee on the Selection of Essential Drugs (n 11) 8. See also Albert Wertheimer and Thomas
Santella, ‘Innovation and the WHO’s Essential Medicines List: Giving Credit Where Credit is Due’ (2007) 3 Research
in Social and Administrative Pharmacy 137.
27. Greene (n 13) 19-20.
28. ibid 20.
29. Andy Gray and others, ‘Essential Medicines Are Still Essential’ (2015) 386 Lancet 1601, 1601.
30. IMS Institute for Health Informatics, Understanding the Role and Use of Essential Medicines Lists (IMS Health
Incorporated 2015) 5.
31. Note that the WHO estimates that more than 75%of global deaths from noncommunicable disease occur in such
countries. See WHO, Factsheet: Noncommunicable Diseases (1 June 2018).
Syrett 143
However, it also reflects the WHO’s contemporary perception of essential medicines as a ‘global
concept’, captured in its claim that ‘once thought of as rel evant only in resource-constrained
settings, the WHO Model Lists are now seen as equally relev ant to high-, middle- and low-
income countries’.
32
On this basis, today’s ‘essential medicines are not cheap medicines for poor
people in developing countries. They are the most cost-effective treatment for a given condition’.
33
The extension of essential medicines into a concept with global reach is further underlined by
the inclusion in the 2015 and 2017 lists of a number of high-cost patented drugs for the treatment of
hepatitis C, multidrug resistant tuberculosis, pre-exposure prophylaxis to prevent HIV infection,
and cancer. There appear to be two, related, rationales for this step.
First, these are conditions which are identified as strategically significant. In accordance with
UN Sustainable Development Goal 3 (to ‘ensure healthy lives and promote well-being for all at all
ages’),
34
the WHO has called for the elimination of viral hepatitis as a major public health threat,
35
for a reduction in global deaths from tuberculosis of 90%,
36
and to ‘end the AIDS epidemic’,
37
all
by 2030. Cancer has also long been a strategic priority,
38
and has recently been described as ‘a
growing public health concern’ in light of a projected 50%increase in incidence globally by
2030.
39
Second, and more generally, ‘access to safe, effective, quality and affordable medicines ...for
all’– which is a constituent element of achieving universal health coverage
40
– is seen as a ‘global
concern’ by the Organization.
41
Similarly, the availability and accessibility of medicines world-
wide has been identified as a priority by the UN General Assembly,
42
with the UN Secretary-
GeneralalsoconveningaHigh-LevelPanelin2015to‘reviewandassessproposalsandto
recommend solutions for remedying the policy incoherence between the justifiable rights of
inventors, international human rights law, trade rules and public health in the context of health
technologies’.
43
Inclusion of the high-cost treatments is rooted in scientific evidence of their clinical efficacy,
safety, and comparative cost-effectiveness. Reflecting the changing definition of ‘essential’ which
was outlined previously, these are therefore identified as the best medicines to address the ‘priority
health care needs’ of sufferers of those conditions which have been identified as being of particular
global significance. However, the WHO has also explicitly acknowledged that it is seeking to
‘reposition the Essential Medicines List ...to explore and emphasize roles that the EML could play
32. WHO (n 12). See also Hans Hogerzeil, ‘The Concept of Essential Medicines: Lessons for Rich Countries’ (2004) 329
British Medical Journal 1169.
33. Audrey Chapman, Global Health, Human Rights and the Challenge of Neoliberal Policies (Cambridge University
Press 2016) 207.
34. UNGA, ‘Transforming Our World: the 2030 Agenda for Sustainable Development’ (21 October 2015) A/RES/70/1.
35. See WHO, Global Health Sector Strategy on Viral Hepatitis 2016-2021 (WHO 2016) 9.
36. WHO, The End TB Strategy (WHO 2015) 5.
37. WHO, Global Health Sector Strategy on HIV 2016-2021 (WHO 2016) 23.
38. See World Health Assembly (WHA), ‘Cancer Prevention and Control’ (25 May 2005) WHA 58.22.
39. WHA, ‘Cancer Prevention and Control in the Context of an Integrated Approach’ (31 May 2017) WHA 70.12.
40. UNGA (n 34), see target 3.8 of the Sustainable Development Goals.
41. WHO, ‘Addressing the Global Shortage of, and Access to, Medicines and Vaccines: Report by the Director-General’
(19 March 2018) A71/12, para 5.
42. UN Office on Drugs and Crime, Outcome Document of the 2016 UN General Assembly Special Session on the World
Drug Problem (UNODC 2016) 2.
43. See High-Level Panel on Access to Medicines (n 5).
144 Netherlands Quarterly of Human Rights 37(2)
in improving global access to and selection and use of medicines’,
44
stating that listing constitutes
‘an important step in making them more affordable and more widely accessible’.
45
Listing of such
medicines thus also represents a component of a strategy to address problems of access to afford-
able medicines worldwide.
46
It therefore sits alongside other WHO initiatives such as the institu-
tion of a Fair Pricing Forum, which is ‘seen as a first step towards identifying an actionable agenda
towards fair pricing’.
47
Price reduction may occur in various ways: for example, identification of cost-effective medicines
on the WHO list provides a focus for national listing and thus engenders economies of scale for
procurement; it also increases consumption of the medicines and therefore reduces price. Additionally
(as explored further below), listing will generate pressure for access to medicines such that governments
– including those in high-income countries) – will feel both empowered and obliged to bargain with
pharmaceutical companies and/or to devise other means to reduce costs, thereby increasing access.
Hence, as indicated by the WHO Director of Essential Medicines and Health Products, ‘the Essential
Medicine List is one of the first steps in the direction of fair pricing because when we designate a
medicine as essential, buyers have some leverage in negotiating for the final purchase price’.
48
However, the WHO also concedes that, at least in the short term, the high cost of these
medicines is likely to inhibit, rather than to enhance, access.
49
That is, notwithstanding that they
have been deemed to be safe, effective and cost-effective, provision of access to these medicines at
current prices (for example, the listed drugs for the treatment of hepatitis C cost up to US$95,000
for a 12 week course of treatment)
50
is unlikely to be considered a priority for the expenditure of
scarce resources: ‘there is an ‘‘opportunity cost’’ of investing in some of these medicines: expen-
diture may lead to a reduction in the funds available for other interventions’.
51
Although allowance
must be made for time-lag in giving effect to WHO recommendations, there is already evidence of
difficulty in accessing such medicines. For example, Robertson and others note both that only 16%
of 135 countries surveyed included three expensive, ‘targeted’ cancer therapies, imatinib, ritux-
imab and trastuzumab, on national lists, and that there is a significant correlation between the
number of new cancer medicines nationally listed and gross national income, government health
44. WHO Expert Committee on the Selection and Use of Essential Medicines, ‘The Selection and Use of Essential
Medicines’ (WHO Technical Report Series 994 2015) 2.
45. WHO Expert Committee on the Selection and Use of Essential Medicines (n 9) 5. See also WHO Expert Committee on
the Selection and Use of Essential Medicines (n 44) 6: ‘it is expected that the addition of these medicines to the EML
will support efforts to reduce the prices’.
46. See further WHO, Ten Years in Public Health, 2007–2017: Report by Dr. Margaret Chan, Director-General, World
Health Organization (WHO 2017) 14, which estimates that ‘nearly 2 billion people have no access to basic medicines’.
47. WHO, ‘Fair Pricing Forum: 2017 Meeting Report’ (July 2017) WHO/EMP/IAU/2017.10, 7.
48. Suzanne Hill, quoted in Catherine Saez, ‘New WHO Essential Medicines List: Antibiotics, Hepatitis C, Leukaemia,
TB’ (Intellectual Property Watch, 6 June 2017)
biotics-hepatitis-c-leukaemia-tb/> accessed 10 May 2018. See further Michael McCarthy, ‘What Makes an Essential
Medicine?’ (2017) 358 British Medical Journal j3044; and a WHO-funded piece of research, which concludes that ‘a
wide range of the drugs on the EML can be profitably sold at very low prices in all countries’: Andrew Hill, Melissa
Barber and Dzintars Gotham, ‘Estimated Costs of Production and Potential Prices for the WHO Essential Medicines
List’ (2018) 3(1) BMJ Global Health e000571.
49. WHO Expert Committee on the Selection and Use of Essential Medicines (n 44) 6: ‘prices are likely to be major
barriers to access to these medicines’. See also Gray and others (n 29); Srinivasan Manikandan, ‘Are We Moving
Towards a New Definition of Essential Medicines?’ (2015) 6 Journal of Pharmacology and Pharmacotherapeutics 123.
50. Gray and others (n 29) 1601.
51. WHO Expert Committee on the Selection and Use of Essential Medicines (n 44) 5.
Syrett 145
expenditure and numbers of physicians.
52
Similarly, access to the listed medicines for treatment of
multidrug-resistant tuberculosis is extremely low, being estimated at just 5%of eligible patients in
March 2017.
53
Since States at all levels of devel opment seem certain to face difficult ies in affording the
expensive treatments recently included in the list, ostensibly there is likely to be an increased
incidence of non-compliance with international human rights obligations which relate to access to
essential medicines. However, whether this is in fact the case turns upon the precise nature of the
obligation which arises under Article 12 ICESCR. The next two sections of this article will explore
this issue, before other relevant human rights are considered.
Human rights and implementation of the WHO list
The relationship between the WHO list and the human right to access essential medicines under
Article 12 ICESCR was examined in the 2006 report of the Special Rapporteur. This stated that:
Guided by the WHOModel List of Essential Medicines,a State is required to prepare a nationalessential
medicines list,by way of a participatory inclusiveprocess. If a State declines to prepareits own national
essential medicines list, the WHO model list will apply, subject to any obvious contextual revisions. A
State has a core obligation of immediate effect — not subject to progressive realisation — to make
available and accessible throughout its jurisdiction the essential medicines on its national list.
54
Thus, although General Comment No. 14 had not been wholly explicit on this point,
55
the work
of the Special Rapporteur makes clear that the WHO list acts as a guide to national decision-
makers, who are expected to develop lists to reflect local health priorities, as ‘implementation of
the concept of essential medicines is intended to be flexible an d adaptable to many different
situations; exactly which medicines are regarded as essential remains a national responsibility’.
56
The matter was revisited in a subsequent report, published in 2013, which expanded upon the
process for development, and content of, national essential medicines lists. These were described
as being ‘based on the rationale that a limited range of priority medicines contributes to better
health care and optimizes the use of financial resources in resource-limited settings’.
57
However,
the Special Rapporteur acknowledged that the lists functioned as an incentive to cost-containment
measures in states at all levels of development:
58
hence, as discussed in the preceding section,
‘resource-limited’ is now best construed as relating also to affordability questions in high-income
countries, in addition to those low and middle-income states which have traditionally been the
focus of the WHO’s essential medicines strategy.
It may also be noted that the existence of such a list, its scope of coverage, the level of
expenditure upon, and the proportion of persons in the population with access to, essential
52. Jane Robertson and others, ‘Essential Medicines for Cancer: WHO Recommendations and National Priorities’ (2016)
94 Bulletin of the World Health Organization 735.
53. M´edicins sans Fronti`eres, Out of Step 2017 (M´edicins sans Fronti`eres 2017).
54. HRC (n 1) para 57, (Emphasis added).
55. See above (n 2) and accompanying text.
56. WHO Expert Committee on the Selection and Use of Essential Medicines (n 12) 16.
57. HRC, ‘Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard
of Physical and Mental Health, Anand Grover, on access to medicines’ (15 May 2013) UN Doc A/HRC/23/42, para 41.
58. ibid.
146 Netherlands Quarterly of Human Rights 37(2)
medicines, function as indicators for measurement of a state’s compliance with the right to health
by the UN.
59
Additionally, the WHO has stated that maintenance of a national and/or subnational
list is germane to measurement of the proportion of a population with access to affordable med-
icines and vaccines on a sustainable basis, which is an indicator of compliance with Sustainable
Development Goal 3.8, the achievement of universal health coverage.
60
Most countries (estimated at 86%by the WHO in 2007)
61
have adopted national lists of
essential medicines – with some also being compiled at provincial or state level – and in this
respect it can be said that the WHO list has ‘gained widespread acceptance ...[and] is considered a
cornerstone of national medicine policies’.
62
However, there is frequently significant disparity
between national lists and that compiled by the WHO, and the 2013 Special Rapporteur’s Report
identified a lack of uptake of medicines listed by the WHO on national lists as problematic,
63
an
observation which is borne out by academic research.
64
Lack of systematic mechanisms for
procurement and supply, poor healthcare infrastructure, and inadequate governmental commit-
ment have been identified as particularly important explanatory factors in this regard,
65
but it is
clear that the cost – and thus, the affordability – of medicines also plays an important role in the
choice of medicines listed at national level.
However, notwithstanding the co ncern expressed by the Special Ra pporteur, discrepancies
between national lists and the model version published by the WHO do not in themselves amount
to violations of the right to access essential medicines. The WHO list merely functions as a guide –
offering a definition of medicines which might be classified as essential – and is therefore non-
binding. By way of illustration, the list signifies similar clinical performance within a pharmaco-
logical class through use of a square box symbol; while the listed medicine is that for which there is
best evidence of effectiveness, it is merely representative, and it is accepted that those compiling
national lists may select alternatives within the class, for example for reasons of cost.
66
Further-
more, the selection of medicines at national level should reflect the priority needs of the popula-
tion; inevitably, burdens of disease vary across the globe and thus not all medicines contained on
the model list will be deemed ‘essential’ in every situation: for example, certain tropical diseases
have low prevalence in South Africa, and are therefore not nationally listed.
67
More
59. See UN International Human Rights Instruments, ‘Report on Indicators for Monitoring Compliance with International
Human Rights Instruments’ (6 June 2008) UN Doc HRI/MC/2008/3.
60. See WHO, World Health Statistics 2016: Monitoring Health for the SDGs (World Health Organisation 2016) 78.
61. van den Ham, Bero and Laing (n 18) 6.
62. IMS Institute for Health Informatics (n 30) 2.
63. HRC (n 57) para 45.
64. See eg Helena Lut´escia Coelho and others, ‘A Critical Comparison Between the World Health Organization List of
Essential Medicines for Children and the Brazilian List of Essential Medicines (Rename)’ (2013) 89 Journal de
Pediatra 171; Ali Tejani and Albert Wertheimer, ‘International Variations in Essential Medication Lists’ (2014) 5
Innovations in Pharmacy 147; Velisha Ann Perumal-Pillay and Fatima Suleman, ‘Quantitative Evaluation of Essential
Medicines Lists: The South African Case Study’ (2016) 16 BMC Health Services Research 687; Amanda Rowlands
and others, ‘WHO and National Lists of Essential Medicines in Mexico, Central and South America, and the Car-
ibbean: Are They Adequate to Promote Paediatric Endocrinology and Diabetes Care?’ (2016) 1(3) BMJ Global Health;
Robertson and others (n 52). The matter may also be raised in Concluding Observations issued by treaty bodies: see eg
CESCR, Concluding Observations on the Combined Third and Fourth Periodic Reports of Jamaica’ (10 June 2013) E/
C.12/JAM/CO/3-4, para 28(d).
65. Chapman (n 33); IMS Institute for Health Informatics (n 30).
66. van den Ham, Bero and Laing (n 18) 2.
67. Perumal-Pillay and Suleman (n 64).
Syrett 147
controversially, some medicines listed on the WHO list are excluded from national lists for cultural
reasons. Thus, emergency contraception, listed by the WHO, has been prohibited or limited in
certain Latin American countries, including Honduras and Costa Rica, and courts in Argentina,
Chile, Ecuador and Peru have intermittently upheld the legality of such restrictions, notwithstand-
ing the existence of a right to access medicines in such countries.
68
Similar issues arise with respect
to opioid substitutes such as methadone (given criminalisation of drug use in some jurisdictions),
and medical abortion pills.
69
Indeed, in the case of the latter, the WHO list contains an explicit rider
stating that selection is subject to national law and cultural appropriateness.
By contrast, the 2006 report of the Special Rapporteur specifies that States have an obligation of
immediate effectto make available those medicines whichare listed on their national lists (or where
no such list exists, those listed by the WHO). Thus, where a state does not secure accessibility to an
essential medicine included on its national list, a prima facie violation of the ICESCR occurs, since
the state is failing to comply with its ‘minimum core obligation to ensure the satisfaction of, at the
very least, minimum essential levels’ of the right enshrined in Article 12(2)(d).
70
TheStatemaybe
held accountable for its failures to meet such obligations through a variety of mechanisms for
accountability, including political, administrative and quasi-judicial, and at national, regional or
international levels. However, judicial accountability has proved to be of particular significance.
The right to access medicines which are nationally listed as essentialbut which have nonetheless not
been made available to the population has successfully been enforced in court on a number of
occasions, especially in South America,
71
although other such cases have failed; moreover, most
pleadings do not make specific reference to Article 12 and some make reference to other rights,
notably the right to life.
72
Perhaps unsurprisingly, however, many legal challenges seek to facilitate
access to medicines not included on national lists of essential medicines at all.
73
The human right to health and extension of the WHO list
The principles outlined in the preceding section provide a basis for analysing the interplay between
the expansion of the WHO list to embrace certain high-cost medicines which are not readily
affordable, access to which may therefore be limited or denied, and the human right to health.
68. Martin Hevia, ‘The Legal Status of Emergency Contraception in Latin America’ (2012) 116 International Journal of
Gynecology and Obstetrics 87.
69. HRC (n 57) para 41.
70. CESCR, ‘General Comment No. 3: The Nature of States Parties’ Obligations (Art. 2, Para. 1, of the Covenant)’ (14
December 1990) UN Doc E/1991/23, para 10. See also Alicia Yamin, ‘Not Just a Tragedy: Access to Medication as a
Right under International Law’ (2003) 21 Boston University Law Journal 325, 359.
71. For discussion, see eg Hans Hogerzeil and others, ‘Is Access to Essential Medicines As Part of the Fulfilment of the
Right to Health Enforceable Through the Courts?’(2006) 368 Lancet 305; Marina Machado and others, ‘Judicialization
of Access to Medicines in Minas Gerais State, Southeastern Brazil’ (2011) 45 Revista de Sa´
ude P´
ublica 590; Joa¨o
Biehl, Mariana Socal, and Joseph Amon, ‘The Judicialization of Health and the Quest for State Accountability:
Evidence from 1,262 Lawsuits for Access to Medicines in Southern Brazil’ (2016) 18 Health and Human Rights 209.
72. Hogerzeil and others, ibid.
73. See eg ibid; Vera Pepe and others, ‘Characterization of Legal Demands for the Supply of ‘‘Essential’’ drugs in the State
of Rio de Janeiro, Brazil’ (2010) 26 Cadernos de Sa´
ude P´
ublica 461; Siri Gloppen and Ole Norheim, ‘Litigating for
Medicines: How Can We Assess Impact in Health Outcomes?’ in Alicia Yamin and Siri Gloppen (eds), Litigating
Health Rights: Can Courts Bring More Justice to Health? (Harvard University Press 2011). But cf Biehl, Socal and
Amon (n 71).
148 Netherlands Quarterly of Human Rights 37(2)
As noted above, compliance with the content of the WHO list is not in itself a binding obligation
under Article 12 ICESCR, although it will apply where no national list is prepared. This would
suggest that States are, in principle, lawfully entitled to omit the treatments for cancer, hepatitis B,
multidrug-resistant tuberculosis, and prevention of HIV infection specified on the 2015 and 2017
lists from their national lists on grounds of affordability, just as they might any other medicine
selected as essential by the WHO. Since the right to access medicines which are not nationally
listed is one which, while encompassed by Article 12, is subject to progressive realisation in
accordance with Article 2(1) ICESCR, a State has a putatively lawful justification for lack of
availability and access on the basis of limits to its available resources. Given that these medicines
are especially expensive, this is a highly pertinent factor.
Nonetheless, as Yamin notes, ‘resource constraints cannot be used as a blanket excus e by
governments’.
74
Article 2(1) obliges a state to take steps towards progressive realisation of the
rights protected by the Covenant ‘to the maximum of its available resources’. This means tha t,
first, any wilful refusal to use all available resources to move ex peditiously towards provision of
such medicines as a dimension of the human right to health would amount to a violation, placing
a burden upon the state to demonstrate that it has made every effort to use its available
resources.
75
Second, ‘resource availability means that what is required of a developed State is
of a higher standard than what is required of a developing State’.
76
Thus, a justification of
scarcity of resources which may be open to a low- or middle-income country is less readily
available to the richest nations. Consequently, such States are under enhanced rights-based
pressure to ensure access to these expensive medicines, as well as the cheaper essential treat-
ments which, under earlier iterations of the essential medicines concept, it was assumed would
be routinely provided. This outcome clearly aligns with the WHO’s current perception of access
to medicines as a problem with global dimensions, rather than one which is confined to the
poorest states.
It should also be noted that denial of access resulting from omission of these essential medicines
from a national list may be considered more generally to amount to a violation of human dignity as
the basis of all human rights.
77
This is an argument which has been made successfully before
national courts in respect of other essential medicines, albeit on relatively few occasions.
78
By contrast, a decision to include the expensive treatments on a national list triggers the core
obligation under Article 12.
79
This obligation is described by General Comment No. 14 as being
non-derogable,
80
although the Committee on Economic, Social and Cultural Rights had originally
taken a more lenient position, under which a presumption of failure to comply could be rebutted by
demonstration by a state that it had made every effort to utilise all resources which were available
to it to satisfy the obligation to provide access to medicines deemed to be essential, and that it had
74. Yamin (n 70) 360.
75. CESCR (n 2) para 47.
76. HRC (n 1) para 55.
77. CESCR (n 2) paras 1, 3.
78. Hogerzeil and others (n 71) 309. As outlined in the preceding section, other bases of challenge in to failure to categorise
medicines on national lists may also be available, depending upon whether, and the manner in which, the human right
to health (and cognate rights) is given constitutional effect: as noted, courts will not necessarily uphold a rights claim in
this context.
79. HRC (n 1) and accompanying text.
80. CESCR (n 2) para 47.
Syrett 149
done so as a matter of priority.
81
As Forman and others have noted, there is significant scholarly
debate as to whether non-derogability is feasible or practical, suggesting that there remains a need
for greater clarity over the role of the core in conceptualising and realising the right to health.
82
There is also a more open-ended obligation upon a State to ensure that all existing medicines –
not simply those which are deemed by the WHO as essential – are available and accessible to a
population in sufficient quantities so that the State satisfies its human rights requirements to take
necessary steps to ensure both ‘the prevention, treatment and control of epidemic, endemic,
occupational and other diseases’ and ‘the creation of conditions which would assure to all medical
service and medical attention in the event of sickness’ (Articles 12(c) and (d) ICESCR).
83
Such an
obligation will be stronger in respect of those conditions which contribute significantly to the
burden of disease within a particular population.
Arguably,the easiest meansby which a State may complywith this limb of thehuman right to health
is to ensurethat it provides access,albeit not necessarilythrough designationon a national list, to those
treatments specified by the WHO, since these have already been evaluated to be safe, effective, and
cost-effective relative to other treatments for the same condition. Doing so will avoid the need for
duplicationof effort in assessment of the technology;moreover it provides an ‘off-the-peg’rationale
for the choiceof a particular treatmentover others for thesame condition, which mayprove especially
helpful in securing public acceptance of the expenditure of finite healthcare resources upon the
medicine in question. Additionally in this manner, therefore, listing of a medicine by the WHO,
although not determinative of decisions on health system coverage whicha state must make in order
to give effect to its human rights obligations, isnonetheless likely to be of significant weight.Inthis
sense, there isan alignment between the WHO listand a rights-based approach to medicines policies
and programmes,
84
even in theabsence of the specific obligationwhich arises throughnational listing.
There is therefore a strong incentive, in which compliance with human rights obligations plays
an important part, for States to adopt the high-cost medicines recently listed by the WHO, even if
they choose not to include them on a national list. But at least of equal importance is the pressure
which WHO listing will generate upon governments. WHO literature is quite explicit that ‘the
Model List and its supporting documentation serve as a valuable resource for advocacy ...at the
country level’.
85
Indeed, it goes so far as to issue a recommendation to NGOs and civil society to
‘support targeted litigation in support of ...access to essential medicines’.
86
This serves to under-
line the strategic dimension of the WHO list, which was noted previously. One means to secure a
reduction in the cost of medicines such as these is to stimulate ‘bottom-up’ movements which, by
demanding access, may induce governments (and/or pharmaceutical companies) to implement
81. CESCR (n 70) para 10. See also Yamin (n 70) 359.
82. Lisa Forman and others, ‘Conceptualising Minimum Core Obligations Under the Right to Health: How Should We
Define and Implement the ‘‘Morality of the Depths’’’ (2016) 20 The International Journal of Human Rights 531.
83. See HRC (n 1) paras 47-48.
84. Hans Hogerzeil, ‘Essential Medicines and Human Rights: What Can They Learn From Each Other?’ (2006) 84 Bulletin
of the World Health Organization 371.
85. van den Ham, Bero and Laing (n 18) 3.
86. Hans Hogerzeil and Zafar Mirza, The World Medicines Situation 2011: Access to Essential Medicines as part of the
Right to Health (WHO 2011) 9. Note that Hogerzeil was the WHO Director for Essential Medicines and Pharma-
ceutical Policies from 2008 to 2011, see
accessed 10 May 2018.
150 Netherlands Quarterly of Human Rights 37(2)
steps to reduce prices. The inclusion of a treatment on the WHO list provides a visible focus – a
rallying-point – for the establishment and activities of such movements.
The earlier campaign for access to antiretroviral treatments for HIV/AIDS provides an instruc-
tive illustration in this regard. As Meier and Yamin note,
87
the development of effective treatment
for prolonging the lives of those with HIV/AIDS led to a shift in focus for activists, away from
campaigns against discrimination and stigmatisation, and towards access to medicines as a human
rights claim under international or domestic law (in the latter instance, most famously manifested
in the South African case of Minister of Health v Treatment Action Campaign (No. 2)).
88
Such
advocacy and associated litigation had a significant practical impact, ‘transforming aspirational
declarations into justiciable obligations and implementing human rights through national policies
and programs’ across the world.
89
The WHO was not in the vanguard of this access movement:
indeed, its bureaucratic processes were ‘ironically cast as pathogenic factors in the spread of AIDS
itself’,
90
and thus its listing of antiretrovirals (in 2002) is best seen as a response to rights-based
advocacy rather than a stimulus to it. Nonetheless, as is intended of the 2015 and 2017 extensions,
the eventual listing connected to a broader strategy to secure greater transparency of, and ulti-
mately to reduce, prices of these medicines so as to enhance their accessibility and availability.
91
It seems inevitable that advocacy for access to the recently-listed expensive medicines by NGOs
and other civil society stakeholders will similarly adopt the discourse and legal form of human
rights, with the human right to health at the forefront of such claims. Indeed, examples of this
phenomenon are already emerging.
92
The role of other human rights
Although it is in the context of Article 12 ICESCR that the meaning and content of the right to
access medicines has been most comprehensively e laborated, the right also connects to other
human rights: this follows from the fact that indivisibility, interdependence and interrelatedness
amount to central characteristics of the contemporary international human rights framework. Two
such rights have been seen as particularly germane in this context: the right to life, and the right to
benefit from scientific progress.
93
How far, if at all, might those rights be engaged in a situation
where a state fails to ensure access and availability of the high-cost medicines which appear in the
most recent WHO lists?
87. Benjamin Meier and Alicia Yamin, ‘Right to Health Litigation and HIV/AIDS Policy’ (2011) 39(s1) Journal of Law,
Medicine and Ethics 81.
88. [2002] ZACC 15.
89. Meier and Yamin (n 87) 81.
90. Greene (n 13) 24.
91. WHA, ‘WHO Medicines Strategy’ (21 May 2001) WHA 54.11, para 2(2). See also Amy Nunn, Elize da Fonseca, and
Sofia Gruskin, ‘Changing global essential medicines norms to improve access to AIDS treatment: Lessons from Brazil’
(2009) 4 Global Public Health 131.
92. See eg Tobeka Daki Campaign for Access to Trastuzumab, ‘Access to Medicines is a Basic Human Right’, letter to UN
High Commissioner for Human Rights (8 March 2017)
human-rights-council-08-03-17.pdf> accessed 31 October 2018; Gisa Dang, Know Your Rights: Tuberculosis Pre-
vention, Diagnosis and Treatment (Treatment Action Group 2018) 2.
93. See Stephen Marks, ‘Access to Essential Medicines as a Component of the Right to Health’ in Andrew Clapham and
Mary Robinson (eds), Realizing the Right to Health (Ru
¯ffer & Rub 2009).
Syrett 151
The right to life
The right which is most obviously applicable is the right to life, protected in the UN system by
Article 6(1) of the International Covenant on Civil and Political Rights. Clearly, access to certain
medicines may be a necessary condition for survival; thus, policies which restrict or deny such
access can, in effect, amount to a deprivation of the right.
94
Importantly, the UN Human Rights
Committee has stated that the right should not be interpreted in a manner restricted to avoidance of
actions which directly cause death, but that it also requires positive steps on the part of States,
which should include ‘all possible measures to reduce infant mortality and to increase life expec-
tancy, especially in adopting measures to eliminate malnutrition and epidemics’.
95
Since the safe
and efficacious medicines listed by the WHO for the treatment of hepatitis C, cancer, tuberculosis
and prevention of HIV infection will enhance life expectancy (and in the case of the latter three
conditions, which can be terminal, may save lives), it would appear that a State which fails to
provide access to them is not taking ‘all possible measures’ to give effect to the right to life.
Moreover, the right to life – unlike the right to health – is not subject to progressive realisation,
with the consequence that it ‘can be invoked to u nderscore the urgency of taking immediate
measures with respect to providing access to medications’.
96
Its significance is further reinforced
by its non-derogability,
97
and, relatedly, a view of its status as a peremptory norm.
98
The right to life thus provides an especially potent basis for challenges to limitations on the
availability of these medicines, even where such limits are premised upon their unaffordability.
However, reflective of indivisibility, such challenges are frequently founded upon more than this
right alone. As previously noted, several South American cases concerning access to essential
medicines that are based upon domestic constitutional provisions have invoked the right to life and
the right to health in conjunction.
99
The right to benefit from scientific progress
While it is readily apparent that a connection exists between the rights to life and health and the
right to access medicines, the third human right engaged by the latter is considerably less self-
evident, largely because its normative content has been much less comprehensively developed.
Article 15(1)(b) ICESCR, which obliges state parties to the Covenant to recognise the right of
everyone to enjoy the benefits of scientific progress and its applications, ‘has remained rather
obscure and unexplored in human rights discourse’.
100
This is in part because unlike the right to health, Article 15(1)(b) ICESCR has not been the
subject of a General Comment by the Committee on Economic, Social and Cultural Rights, and
94. Yamin (n 70) 335-36.
95. HRC, ‘CCPR General Comment No. 6: Article 6 (Right to Life)’ (1982) para 5.
96. Yamin (n 70) 350.
97. See International Covenant on Civil and Political Rights, (adopted 16 December 1966, entered into force 23 March
1976), Article 4(2), 999 UNTS 171.
98. See Paul Gormley, ‘The Right to Life and the Rule of Non-Derogability: Peremptory Norms of Jus Cogens’, in
Ramcharan.Bertrand (ed), The Right to Life International Law (Martinus Nijhoff 1985).
99. See Hogerzeil and others (n 71) and further Patricia Asero Ochieng v Attorney General Petition No. 409 of 2009
(High Court of Kenya), para 56: ‘the right to health, life, and human dignity are inextricably bound’.
100. Leslie London, Helen Cox, and Fons Coomans, ‘Multidrug-Resistant TB: Implementing the Right to Health through
the Right to Enjoy the Benefits of Scientific Progress’ (2016) 18 Health and Human Rights 25, 26.
152 Netherlands Quarterly of Human Rights 37(2)
thus its scope, and the obligations which it imposes, remain somewhat unclear. However, a Report
prepared by the Special Rapporteur in the field of Cultural Rights, published in 2012, provides
some detail. This notes that the link to the right to health is ‘obvious’,
101
and identifies a right of
access to scientific knowledge, information and advances as the primary component of the nor-
mative content of Article 15.
Access may therefore be seen as the ‘touchstone concept’ of the right enshrined in Article
15(1)(b),
102
and since medicines are self-evidently products of scientific progress, it would seem
clear that the Article can be read to impose normative obligations upon States in respect of access
to medicines. Notably, paragraph 2 requires State Parties to take steps necessary for ‘the diffusion
of science’, as well as its development. This indicates that the State should make the outputs or
applications of scientific knowledge and discovery physically and economically accessible, and
since the right accrues to ‘everyone’, they must do so in a non-discriminatory manner (as also
required by Article 2 ICESCR). Thus, the Special Rapporteur identifies a ‘core principle’ that
‘innovations essential for a life with dignity’ – a description which surely embraces medicines,
although this is not explicitly stated – ‘should be accessible to everyone, in particular marginalized
populations’.
103
In part because of the lack of clarity as to its content, the precise role which this right might play
in respect of a scenario such as access to costly essential medicines is somewhat uncertain.
London, Cox, and Foomans argue that the right ‘provide[s] a number of levers complementary
to right to health claims’.
104
They observe that the right does not create an individual entitlement to
development of a new medicine for a particular condition, but that it sets up obligations to create an
enabling environment for scientific research, and to provide for diffusion of that research, as well
as to abstain from activities which would block or delay the availability of new drugs. In this
manner, it would appear that Article 15(1)(b) can lend a degree of additional weight to require-
ments to provide access to the expensive medicines recently added to the WHO list. It seems to
entail, as a bare minimum, that national decision-makers should give close consideration to the
need to provide coverage of such medicines – whether or not through inclusion on a national
medicines list, although this might be bureaucratically the most straightforward means of doing so
– since this will facilitate the diffusion of the benefits of scientific progress which such innovative
medicines represent, and thus ensure compliance with Article 15. This therefore serves to buttress
the incentivisation and pressuring functions of WHO listing which were explored in the preceding
section of this article.
It should be noted that Article 15(1)(c) ICESCR also enshrines a right ‘to benefit from the
protection of the moral and material interests resulting from any scientific, literary or artistic
101. HRC, ‘Report of the Special Rapporteur in the Field of Cultural Rights, Farida Shaheed: The Right to Enjoy the
Benefits of Scientific Progress and Its Applications’ (14 May 2012) UN Doc A/HRC/20/26, para 23. See also Yvonne
Donders, ‘The Right to Enjoy the Benefits of Scientific Progress: In Search of State Obligations in Relation toHealth’
(2011) 14 Medicine, Health Care, and Philosophy 371.
102. Lea Shaver, ‘The Right to Science and Culture’ (2010) 4 Wisconsin Law Review 121, 169.
103. HRC (n 101) para 29.
104. London, Cox, and Coomans (n 100) 38. Emphasis added. Note also the Venezuelan case of Lo
´pez and Others v
Instituto Venezolano de los Seguros Sociales, Expediente No. 00-1343, Sentencia No. 487 (Supreme Court of
Venezuela, Constitutional Division), 6 April 2001, in which the Supreme Court held that a lack of access to HIV
medicines and testing services constituted a violation not only of the right to health, but also of the right to life and of
the right to the benefits of science and technology, as enshrined in the state’s constitution.
Syrett 153
production of which he is the author’. This appears to set up a problematic tension in the case of
medicines, between access to the fruits of scientific progress on the one hand and the rights of those
inventing medicines on the other.
105
However, this apparent incompatibility is addressed in various
ways. First, the right under Article 15(1)(c) attaches primarily to individuals (‘authors’ or ‘crea-
tors’) or, in limited circumstances, groups of individuals or communities, but not entities such as
pharmaceutical companies.
106
Second, consonant with the principles of indivisibility, interdepen-
dence and interrelatedness, the right cannot be viewed in isolation from others protected by the
Covenant, hence
States Parties should therefore ensure that their legal or other regimes for the protection of the moral
and material interests resulting from one’s scie ntific, literary or artistic productions constitu te no
impediment to their ability to comply with their core obligations in relation to the rights to [ ...]
health [ .. .] as well as to enjoy the benefits of scientific progress and its applications.
107
Third, the Committee on Economic, Social and Cultural Rights makes clear that the scope of
protection of the moral and material interests of the author or creator does not necessarily coincide
with intellectual property regimes, thus envisaging that other forms of protection are permissible
and appropriate.
108
It is clear, therefore, that the intellectual property rights of pharmaceutical companies, such as
the patents which apply to the medicines recently added to the WHO list, cannot be ‘equate[d] ...-
with the human right recognized in Article 15, paragraph 1 (c)’.
109
They are to be regarded as
legally protected interests of a lower order than human rights such as those to health, life, and
enjoyment of the benefits of scientific progress.
110
Hence, a State cannot justify a failure to provide
access to such medicines merely because rights in intellectual property attach to them.
Of course, it has long been clear, certainly since the Agreement on Trade-Related Aspects of
Intellectual Property Rights (‘TRIPS’),
111
which came into force in 1995, that the existence of
patent protections constitutes a central obstacle to access to medicines. It is beyond the limited
scope of this article to explore this issue,
112
but it should be briefly noted, as previously indicated,
that a High-Level Panel on Access to Medicines was convened by the UN Secretary-General in
2015 in an attempt to address this ongoing conflict. The Panel’s Report called for full use of the
TRIPS flexibilities reaffirmed by the Doha Declaration of 2001,
113
negotiation of a binding
105. For a general discussion, see Aurora Plomer, Patents, Human Rights and Access to Science (Edward Elgar 2015).
106. CESCR, ‘General Comment No. 17: The Right of Everyone to Benefit from the Protection of the Moral and Material
Interests Resulting from any Scientific, Literary or Artistic Production of Which He or She is the Author (Art. 15,
Para. 1)’ (2006) UN Doc E/C.12/GC/17, paras 1, 7-8.
107. ibid para 35.
108. ibid paras 2, 10.
109. ibid para 3.
110. Marks (n 93) 89.
111. Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (adopted 15 April 1994, entered into
force 1 January 1995) 1869 UNTS 299.
112. For discussion, see eg Pogge. Rimmer and Rubinstein (eds) (n 24); Obijiofor Aginam, John Harrington, and Peter Yu
(eds), The Global Governance of HIV/AIDS: Intellectual Property and Access to Essential Medicines (Edward Elgar
2013); Joo-Young Lee, A Human Rights Framework for Intellectual Property, Innovation and Access to Medicines
(Routledge 2016).
113. World Trade Organisation, ‘Doha Declaration on the TRIPS Agreement and Public Health’ (14 November 2001) WT/
Min(01)/Dec/1.
154 Netherlands Quarterly of Human Rights 37(2)
research and development convention, regular review by States of access to health technologies in
light of human rights obligations, and enhanced transparency (covering measures taken by private
sector companies to improve access; costs of research and development, marketing and distribution
of health technologies; data on completed and discontinued clinical trials; and patent status).
114
The WHO has indicated that its work programme on access to medicines corresponds with
many of these recommendations,
115
although the Panel has also been criticised for being insuffi-
ciently bold in prioritising the human right to health against trade: for example, it might have
recommended (but did not) permanent suspension of TRIPS in respect of essential medicines for
low- and middle-income countries.
116
An obvious difficulty in pursuing even the modest trajectory
mapped by the Panel is that a divide continues to exist between some developed nations and other
States as to the relative primacy to be accorded to human rights as against intellectual property
considerations in the medicines context.
117
Perhaps unsurprisingly, the current US administration
has signalled its intention to impede implementation of the Panel’s recommendations.
118
Conclusion
It should be apparent from the preceding discussion that the relationship between the WHO list of
essential medicines and the international human rights framework is one of some complexity.
However, there is certainly scope fo r those seeking access to such medicine s to frame those
demands in terms of failures to comply with human rights obligations, perhaps most potently by
way of invocation of a combination of all three rights explored in this article. Since, at least in the
short term and even in high-income countries (to which the WHO now intends the list also to be
directed), there are likely to be particular difficulties in accessing the expensive medicines recently
included on the list, the potential for human rights arguments to be raised in this context appears to
have significantly increased.
A possible consequence of the extension of the list to embrace these costly medicines is,
therefore, that there will be an increase in health rights-related litigation, particularly at a domestic
level in jurisdictions where some degree of constitutional protection is afforded to the right to
health. It is not clear whether the WHO has considered this prospect: notably, elsewh ere, its
regional office for the Americas has expressed disquiet at the tendency of ‘judicialisation’ to
disrupt the process of rational priority-setting in health care.
119
That said, such judicial oversight
114. See High-Level Panel on Access to Medicines (n 5) 9-11.
115. WHO (n 41), Annex, para 31.
116. See Lisa Forman, Ifrah Abdillahi, and Jeannie Samuel, ‘Assessing the UN High-Level Panel on Access to Medicines
Report in Light of the Right to Health’ (2016) 5 Laws 43.
117. See HRC ‘Access to Medicines in the Context of the Right of Everyone to the Enjoyment of the Highest Attainable
Standard of Physical and Mental Health’ (18 July 2016) UN Doc A/HRC/RES/32/15.
118. See William New, ‘US Working To Block UN High-Level Panel On Access To Medicines Ideas In Geneva And
Capitals’ (Intellectual Property Watch, 22 January 2018)
high-level-panel-access-medicines-ideas-geneva-capitals/> accessed 10 May 2018.
119. Pan-American Health Organization, ‘Health Technology Assessment and Incorporation into Health Systems’ (16 July
2012) CSP 28/11, para 5. On the judicialisation of health care, see C´esar Rodriguez-Garavito, ‘The Judicialization of
Health Care’, in Randall Peerenboom and Tom. Ginsburg (eds), Law and Development of Middle-Income Countries:
Avoiding the Middle-Income Trap (Cambridge University Press 2014); Everaldo Lamprea, ‘The Judicialization of
Health Care: a Global South Perspective’ (2017) 13 Annual Review of Social Science 431; and articles in a special
section on ‘Judicial Enforcement of Health Rights: Focus on Latin America’ (2018) 20 Health and Human Rights 67-
197.
Syrett 155
is, of course, valuable as a means of rendering state actors accountable for actions taken, or not
taken, to ensure access, and it can thus contribute to the achievement of the Organization’s goals.
The WHO has chosen to list these expensive medicines because there is evidence of their safety,
efficacy and their comparative cost-effectiveness as treatments for particular conditions which are
regarded as being of international significance. However, the act of listing, with the intention that it
will serve to reduce prices in the longer term, also connects to a broader strategy to enhance global
access to medicines, given that ‘affordability is the cornerstone of access’.
120
From the perspective
of human rights – especially those dimensions of the right to health which relate to economic
accessibility and international obligations to reduce global health inequalities
121
– this is clearly a
laudable aim. It remains to be seen how successful it will prove to be.
Declaration of conflicting interests
The author declared no potential conflicts of interest with respect to the research, authorship, and/or publi-
cation of this article.
Funding
The author received no financial support for the research, authorship, and/or publication of this article.
120. WHO (n 46) 15.
121. See CESCR (n 2) paras 12(b), 38.
156 Netherlands Quarterly of Human Rights 37(2)
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