Marks_Access to Essential Medicines

7/29/2019 Marks_Access to Essential Medicines

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Health: A Human Rights Perspective 82

Access to essentiAl

Medicines As A coMponent

of the Right to heAlths p. Mark

Introduction

In Human Rights Obligations of Non-State Actors, Andrew Clapham wrote,Perhaps the most obious threat to human rights has come rom the in-

ability o people to achiee access to expensie medicine, particularly in the

context o HIV and AIDS.1 He was reerring to threats to human rights

rom intellectual property agreements under the World rade Organiza-

tion, which are oten seen as obeying a dierent and many would say ut-

terly incompatible logic than human rights. Te right to health, in the

interpretation o the Committee on Economic Social and Cultural Rights,

means that States Parties hae a duty to preent unreasonably high

costs or access to essential medicines.2

Tis chapter will explain the signicance and place o the human right

to essential medicines as a deriatie right within the broader right to the

highest attainable standard o physical and mental health. As a component

o the right to health, the right to essential medicines depends not only on

the production, distribution, and pricing o medicines, but also on the in-

centies or research and deelopment o drugs needed to treat diseases in

deeloping countries, unctioning health systems so that drugs are part o

a rational system o quality treatment and care, as well as on inrastructure,


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Access to Essential Medicines as a Component of the Right to Health 83

so that they can be deliered to all areas where they are needed. Consider-

ing that these broader issues are examined in other chapters, this chap-

ter will ocus more on the impediment to the realization o the right to

essential medicines caused by the protection o intellectual property. Tis

chapter begins with an oeriew o some o the basic data about the health

impact o the current leel o access to medicines, especially in deeloping

countries. Ten the essential eatures o the international trade regime that

aect access to medicines are discussed, including how that regime unc-

tions in constant tension with the international human rights regime. Te

recent trend in legislation, litigation, and adocacy to aour access to es-

sential medicines oer protection o patent-holders will then be examined

beore analysing the most salient ormulations o the right to access to es-

sential medicines. Finally, seeral o the proposals currently under consid-

eration to oercome the economic obstacles to realizing the right to essen-

tial medicines are presented.

Access to medicines in the global burden o disease

Te trend in access to medicines, particularly in poor countries, proides

the eidence or policies in global heath to increase access at all stages o

the process rom setting research priorities or the deelopment o newdrugs, to manuacturing, pricing, marketing, and distribution. Essential

medicines, according to the World Health Organization (WHO), are those

that satisy the priority health care needs o the population and are in-

tended to be aailable within the context o unctioning health systems at

all times in adequate amounts, in the appropriate dosage orms, with as-

sured quality, and at a price the indiidual and the community can aord.3

Te United Nations Deelopment Group denes access in this context as

haing medicines continuously aailable and aordable at public or pri-

ate health acilities or medicine outlets that are within one hours walk

rom the homes o the population.4

In 1975, hal o the worlds population was without access to lie-sa-

ing and other essential medicines.5 While the proportion has decreased

to about one-third o the worlds population, the absolute number has re-

mained constant at approximately two billion people.6 According to the

WHO, expanding access to existing interentions, including medicines, or

inectious diseases, maternal and child health, and noncommunicable dis-

eases would sae more than 10.5 million lies the year by 2015.7


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Signicantly, the MDG Gap ask Force addressed the relation between the

MDG issue o access to medicines and the right to health by noting that:

the national constitutions dene the undamental political principles

o a country and usually guarantee certain rights to their people. Health

is a undamental human right recognized in at least 135 national consti-

tutions. Access to health care, including access to essential medicines, is

a prerequisite or realizing that right. Howeer, only e countries speci-

ically recognize access to essential medicines and technologies as part o

the ullment o the right to health.8

Te MDG Gap ask Force also notes Most national constitutions do not

specically recognize access to essential medicines or technologies as part

o the ullment o the right to health.

Te Working Group on Access to Essential Medicines o the United Na-

tions Millennium Project approached the problem rom the human rights

perspectie. It opened its report by stating: Te lack o access to lie-sa-

ing and health-supporting medicines or an estimated 2 billion poor peo-

ple stands as a direct contradiction to the undamental principle o health

as a human right.9 Te Group gae priority consideration to improing ac-

cess to medicines in resource-poor settings and promoting research on newmedicines or diseases o poerty. It identied six barriers to access the

medicines: Inadequate national commitment, inadequate human resourc-

es, ailure o the international community to keep its promises to deelop-

ing countries, lack o coordination o international aid, obstacles created by

the rade-Related Aspects o Intellectual Property Rights (RIPS) agree-

ment, and the current incentie structure or research and deelopment

o medicines and accines to address priority health needs o deeloping

countries.10 In examining the solutions to the problem, the UN Working

Group underscored the consensus that human rights should incorporate

the ability o indiiduals to maintain and restore good health through ac-

cess to at least a basic leel o primary care, including essential medicines11

and listed among the general principles underpinning issues o increasing

access to medicines the human right to health, as well as womens inequal-

ity and gender disparities.12

Among the Working Groups recommendations to improe aailability

o medicines is improing the rate and releance o innoation and deel-

oping more reliable procurement and supply systems at the national and


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international leels.13 Te Group also recommended specic steps or pro-

moting the saety, aordability, and appropriate use o medicines.14 Final-

ly, it deoted attention to the barrier created by the system o intellectual

property protection, specically citing the conclusion o the UN Millenni-

um Project ask Force on rade that the RIPS agreement, and RIPS Plus

proisions o ree-trade agreements, will oer time probably hae a nega-

tie impact on access to drugs in deeloping countries.15 Tis trend clearly

creates tension with the obligations o states to realize the right to health

under the international human rights regime.

Te tension between the international trade regime and the interna-

tional human rights regime

In dissenting rom the Working Group report just discussed, the represent-

atie o the pharmaceutical industry explained,

We do not believe that the main problem in barring medicines to the poor

is patent protection, nor do we accept that individual company pricing prac-

tices are fundamental to explaining why one-third of the worlds poor lack

access to basic, low-cost essential medicines. An inaccurate and subjective

link is orged between rights, monopoly pricing, and global inequities inaccess to medicines We also believe that our private sector research model

is worthy o presering rather than abandoning on the risky premise that

more public inestment will by itsel yield miracle cures against the com-

plex scientic challenge o ghting resistant strains o inectious disease

In short, the report ails to proide the balanced and accurate perspec-

tie necessary to stimulate resh policy approaches that could make a real

dierence in the lies o the poor.16

From the perspectie o the primary legal regime goerning trade in prod-

ucts inented and manuactured by business entities, essentially transna-

tional corporations, the issues o access to medicines is a clear-cut matter o

the patenting o a new chemical product and the process or its use, as well

as the protection o the patents inoled in the markets where the produc-

ers intend to sell them. Te patents, which protect the inentor rom any-

one copying the product without license, and allow the inentor to set the

price, are protected internationally under the WO Agreement on rade-

Related Aspects o Intellectual Property Rights (RIPS). RIPS requires


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WO members to protect patents o pharmaceuticals or 20 years, thus gi-

ing drug companies exclusie rights to preent unauthorized use, subject to

domestic and international enorcement. Countries that ail to protect pat-

ents may be brought beore the dispute settlement body o the WO. As a

result, in part due to the outcry oer drug pricing in countries conronted

by the HIV/AIDS pandemic, the least-deeloped countries, who were origi-

nally supposed to comply by 2006, now hae until 1 January 2016 to imple-

ment RIPS. Howeer, all other WO Members are bound, and een the

poorest countries will be bound in less than a decade.

In addition to the delayed compliance until 2016, deeloping countries

may aail themseles o exibilities to aoid patent protections through

parallel importing (importing cheaper ersions o drugs rom countries

where pharmaceuticals are not patented or where their term o protection

has expired) and compulsory licensing (manuacturing generic ersions o

patented medicines without patent holders authorization under certain

conditions).17 Most agree that the patent system is necessary and bene-

cial to promote innoation in the pharmaceutical industry, but there are

arious barriers to deeloping countries taking ull adantage o the ex-

ibilities, and hundreds o ree trade agreements impose greater restrictions

than RIPS (RIPS-plus proisions).

Access to patented medicines as the pharmaceutical dissent to theWorking Group report quoted aboe stresses is not the sole or een the

principal obstacle to adequate proision o health products and medical de-

ices to the poor population o deeloping countries. In act, one study by

Amir Attaran claims that, o the 319 products on the WHO Model List o

Essential Medicines, only seenteen are patentable. Furthermore, many

o those are not actually patented, bringing the patent incidence down to

1.4%.18 Te author not only challenges the assumptions among actiists

that patents cause lack o access to aordable medicines in poor countries

and within the pharmaceutical industry,19 that IPRs are necessary to pro-

tect to assure uture research and deelopment, but also expresses doubt

that compulsory licensing can be made practicable, considering that ze-

ro generic medicines hae been manuactured this way in the past decade,

treating zero patients in any country worldwide.20 In response to Atta-

rans study, the Director o Medicines Policy and Standards at WHO wrote

that a statement on the percentage o patented medicines on the Model

List is thereore not possible without speciying the geographical area and

the specic time and a ew patented medicines can greatly aect health


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expenditure, noting that the economic alue and public health impor-

tance o the market o ARVs and uture essential medicines or neglected

disease are buried in the statistics o the quoted study.21 Be that as it may,

the point or the purposes o a putatie human right to essential medicines

is that challenging IPRs and urging use o RIPS exibilities do not consti-

tute the only path toward realizing that right.

Numerous actors contribute to making essential medicines aaila-

ble in poor countries, including aordable prices; goernment commit-

ment through a well conceied and implemented national medicines policy

(NMP); adequate, sustainable and equitable public sector nancing; generic

substitution; transparent and widely disseminated consumer inormation;

ecient distribution; control o taxes, duties and other markups; and care-

ul selection and monitoring.22

As thoroughly demonstrated by Lisa Forman, corporate innoation or

diseases aecting poor countries does not occur or commercial reasons but

in response to growing public pressure oer corporate ailures to address

deeloping country needs.23 Drawing on the experience o the 1997 to 2001

litigation and trade pressure by the US Goernment and 40 pharmaceuti-

cal companies to resist South Aricans law aimed at gaining access to a-

ordable medicine, which she considers the tipping point o the struggle,

Forman demonstrates how the reatment Action Campaign case broughthuman rights arguments drawn rom international and domestic law, argu-

ing that the right to health proided constitutional authority or the legis-

lation itsel, and was a legal interest that should be prioritized oer corpo-

rate property rights.24 She concludes that this experience can be seen to

proide a strategic roadmap or adancing the completion o the process o

normatie diusion, so that access to medicines as a human right starts to

assume a taken or granted quality in politics, law, and public opinion.25

Te normatie diusion is reected by the Intergoernmental Work-

ing Group on Public Health, Innoation and Intellectual Property (IGWG),

whose Global Strategy and Plan o Action was adopted by the World Health

Assembly on 24 May 2008.26 Tis group was set up in 2006 as a ollow-up

to the Commission on Intellectual Property Rights, Innoation and Pub-

lic Health with the aim o securing an enhanced and sustainable basis or

needs-drien, essential health research and deelopment releant to dis-

eases that disproportionately aect deeloping countries.27 Te IGWG con-

sidered inputs not only rom goernments but also rom academia, public-

priate partnerships, product-deelopment partnerships and industry.28 In


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its Global Strategy, the IGWG both acknowledges that intellectual property

rights are an important incentie or the deelopment o new health-care

products and quotes the proisions o the Uniersal Declaration o Human

Rights on sharing in scientic adances and its benets and protection o

moral and material interest resulting rom scientic production.29

Tus, or the IGWG, the context o its global strategy includes intel-

lectual property rights, human rights and the importance o exibilities in

intellectual property agreements to acilitate increased access to pharma-

ceutical products by deeloping countries.30 Gien the diersity o stake-

holders inoled, it is signicant that the importance o all three was ac-

knowledged. In enumerating the principles o the strategy, the IGWG

inserted the ollowing: Te enjoyment o the highest attainable standard

o health is one o the undamental rights o eery human being without

distinction o race relation, political belie, economic or social condition.31

It is clear rom this eort, which will continue through the urther elab-

oration and implementation o the elements and plan o action, that the

claim o a human right to essential medicines has been a dicult case to

make. But oer the past decade, the tide appears to hae shited in aour o

the human right to essential medicines and perhaps een more broadly to

health products and medical deices.

Armation o the human right to essential medicines

As mentioned aboe, the human right to essential medicines is much broad-

er than a claim against the negatie impact o IPRs. Neertheless, the with-

drawal o the challenge by 40 pharmaceutical companies to South Aricas

access to drugs law, the Doha Declaration, the deliberations o IGWG and

similar eents hae used the tension with the international trade regime as

a motiation or the armation o this right.

Te RIPS exibilities proide a legal basis or poor countries to aoid

the consequences o the patent system with regard to their capacity to make

essential medicines aailable to their populations. Te international trade

regime is based on the logic o the global market and globalization. It has

adjusted to the political imperatie o promoting deelopment and strate-

gies dened by the international nancial institutions in the poerty reduc-

tion programs and the UN system in the Millennium Deelopment Goals.

It has not, so ar, been receptie to the claim that a human right to health,

including access to essential medicines, preails oer RIPS. With the


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exception o the approach taken by the Working Group on Access to Essen-

tial Medicines o the UN Millennium Project (discussed aboe), these de-

elopment approaches rarely articulate the human right to essential medi-

cines. Te armation o this right rom the human rights perspectie can

be made, howeer, on the basis o core human rights instruments. Tese in-

struments hae been applied to the problem o access to medicines by UN

bodies including: the Oce o the High Commissioner or Human Rights,

the Commission on Human Rights and its Sub-Commission, the Commit-

tee on Economic, Social and Cultural Rights, and the Special Rapporteur on

the right o eeryone to the enjoyment o the highest attainable standard

o physical and mental health as well as by a number o non-goernmental

and academic initiaties.

Te right to essential medicines in the core human rights instruments

Access to essential medicines can be armed as a human right on the ba-

sis, not only o the right to health (Article 12 o the International Coenant

on Economic, Social and Cultural Rights (ICESCR)) but also on two other

rights set out in the ICESCR, namely, the rights to the protection o the

moral and material interests resulting rom any scientic, literary or ar-

tistic production (Article 15(1)(c)) and to share in scientic adancement

and its benets (Article 15(1)(b)). Te ormer is the human rights basis orintellectual property protection, according to which creatie ideas and ex-

pressions o the human mind that possess commercial alue receie the le-

gal protection o property rights called intellectual property rights (IPRs).

Te major legal mechanisms or protecting IPRs are copyrights, patents,

and trademarks. IPRs enable owners to select who may access and use their

property, and to protect it rom unauthorized use.

Tere is an apparent contradiction between these two rights when ap-

plied to access to medicines: Article 15(1)(c) seems to protect the right o

pharmaceutical companies to earn a prot rom the drugs they deelop, by

setting prices that render medicines inaccessible to the destitute sick, while

Article 15(1)(b) seems to protect the right o those destitute sick to benet

rom the deelopment o new drugs. Te way out o this dilemma is to dis-

tinguish intellectual property rights rom human rights and consider them

a temporary monopoly established or the alid social purpose o encourag-

ing scientic inention and artistic creation. In other words, an IPR is a le-

gally protected interest o a lower order than a human right, which implies

a superior moral and legal claim. Tis distinction should not be interpret-


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ed to imply that IPRs do not hae social alue or, indeed, they hae a ery

high alue, justiying limiting Article 15 rights reasonably to promote inno-

ation and creatiity.

Human rights organs hae progressiely addressed this dilemma, ar-

ticulating in dierent stages the human right to essential medicines. Te

Commission on Human Rights adopted a resolution in 2001, in which it

recognized that access to medication in the context o pandemics such as

HIV/AIDS is one undamental element or achieing progressiely the ull

realization o the right o eeryone to the enjoyment o the highest attain-

able standard o physical and mental health.32 Among a list o measures, it

called on states, to rerain rom taking measures which would deny or limit

equal access or all persons to preentie, curatie or palliatie pharmaceu-

ticals or medical technologies used to treat pandemics such as HIV/AIDS or

the most common opportunistic inections that accompany them33 and,

clearly with RIPS in mind, to ensure that their actions as members o in-

ternational organizations take due account o the right o eeryone to the

enjoyment o the highest attainable standard o physical and mental health

and that the application o international agreements is supportie o pub-

lic health policies which promote broad access to sae, eectie and aord-

able preentie, curatie or palliatie pharmaceuticals and medical technol-

ogies.34

Te United States was the only goernment to abstain rom thisresolution, which was adopted on 23 April 2001 by 52 otes with no otes

against.

Te Oce o the High Commissioner prepared a report in 2001 on

the impact o the RIPS Agreement on human rights;35 and the Sub-Com-

mission on the Promotion and Protection o Human Rights took this up

in its resolution the same year on Intellectual Property Rights and Hu-

man Rights.36 Te resolution, adopted by consensus, reerred to the actual

or potential conict between the implementation o the RIPS Agree-

ment and the realization o economic, social and cultural rights.37 In the

context o the upcoming Doha Ministerial meeting o the WO, the Sub-

Commission alluded to the need to clariy the scope and meaning o se-

eral proisions o the RIPS Agreement, in particular o Articles 7 and 8 on

the objecties and principles underlying the Agreement in order to ensure

that states obligations under the Agreement do not contradict their bind-

ing human rights obligations.38 It reminded all goernments o the pri-

macy o human rights obligations under international law oer economic


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policies and agreements, and request[ed] them, in national, regional and

international economic policy orums, to take international human rights

obligations and principles ully into account in international economic pol-

icy ormulation.39 Signicantly, it urged all goernments to ensure that

the implementation o the RIPS Agreement does not negatiely impact

on the enjoyment o human rights as proided or in international human

rights instruments by which they are bound.40

One o the most signicant eents, legally and politically, or the right to

essential medicines was indeed the Doha Ministerial meeting o the WO,

which adopted the Doha Declaration on the RIPS Agreement and Public

Health. In an unusually direct statement emanating rom the WO, better

known or highly technical and legally complex sentences, the meeting de-

clared: Te RIPS agreement does not and should not preent members

rom taking measures to protect public health in particular to promote

access to medicines or all.41 o be perectly clear, the declaration added,

In this connection, we rearm the right o WO members to use, to the

ull, the proisions in the RIPS Agreement, which proide exibility or

this purpose, meaning parallel importing and compulsory licensing. Te

text acknowledges that [e]ach member has the right to grant compulsory

licences and the reedom to determine the grounds upon which such licenc-

es are granted [and] the right to determine what constitutes a nationalemergency or other circumstances o extreme urgency, it being understood

that public health crises, including those relating to HIV/AIDS, tubercu-

losis, malaria and other epidemics, can represent a national emergency or

other circumstances o extreme urgency.42 Te next paragraph instructed

the Council or RIPS to nd an expeditious solution to the problem o

compulsory licensing or countries with insucient or no manuacturing

capacities in the pharmaceutical sector,43 which was done in August, 2003.

Te Doha Declaration also extended the deadline to 1 January 2016 or the

least-deeloped countries to apply proisions on pharmaceutical patents.

Position of the Committee on Economic, Social and Cultural Rights

Te Committee threw down the gauntlet at the time o the Seattle Tird

Ministerial meeting o the WO in 1999 when it urged WO members to

ensure that their international human rights obligations are considered as

a matter o priority in their negotiations which will be an important testing

ground or the commitment o States to the ull range o their international


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obligations.44 wo years later, on 26 Noember 2001, the Committee held

a day o general discussion on Article 15(1)(c), ollowing which it issued a

Statement on Human Rights and Intellectual Property, in which it consid-

ered that intellectual property rights must be balanced with the right to

enjoy the benets o scientic progress and its applications.45 It made ex-

plicit reerence to the deelopment o new medicines in the context o the

Doha Declaration on the RIPS Agreement and Public Health as an exam-

ple o the need to strike a balance between the right to enjoy the benets o

scientic progress and its applications under Article 15(1)(b) and the right

to benet rom the protection o the moral and material interests under Ar-

ticle 15(1) (c).46 Te Committee concluded by calling or a mechanism or a

human rights reiew o intellectual property systems.47

Te Committee claried urther the human right to essential medicines

in two o its General Comments, an earlier one on the right to health, and

one based on the 2001 Statement. Indeed, in 2000, the Committee, in its

General Comment 14, had interpreted the obligation under Coenant Ar-

ticle 12(2)(d) o the Coenant (Te creation o conditions which would as-

sure to all medical serice and medical attention in the eent o sickness)

to include the proision o essential drugs.48 In clariying the obligations

o states parties, the Committee included among the acilities, goods and

serices which must be aailable in sucient quantity within the stateessential drugs, as dened by the WHO Action Programme on Essential

Drugs.49 As part o the obligation to protect, states parties hae a duty to

control the marketing o medical equipment and medicines by third par-

ties,50 which strongly suggests that the states should interene where mar-

keting o drugs by pharmaceutical companies is detrimental to the right to

health.

But it was in General Comment 17, adopted in 2006, that the Commit-

tee challenged head-on the assumption o the international trade regime

that the rights o companies holding patents oer essential drugs were o

the same order as the rights o those who need the drugs, by treating the

ormer as a temporary, reocable monopoly, and the latter as human rights.

Indeed, the Committee armed,

In contrast with human rights, intellectual property rights are generally of

a temporary nature, and can be reoked, licensed or assigned to someone

else. While under most intellectual property systems, intellectual property

rights, with the exception of moral rights, may be allocated, limited in time


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and scope, traded, amended and even forfeited, human rights are timeless

expressions o undamental entitlements o the human person 51

States Parties should, the Committee continued,

ensure that their intellectual property regimes constitute no imped-

iment o their ability to comply with their core obligations in relation to

the right to health States thus have a duty to prevent that unreasonably

high license fees or royalties for access to essential medicines undermine

the right o large segments o the population to health 52

Non-governmental and academic promotion of the right to access essential

medicines

Seeral non-goernmental organizations (NGOs) hae taken up the issue o

access to medicines rom a human rights perspectie, principal among them

are Mdecins Sans Frontires (MSF) and Oxam. In 1999, MSF launched the

Campaign or Access to Essential Medicines and became the leader o the

adocacy campaign aimed at improing access to existing medicines, diag-

nostics, and accines and at promoting the deelopment o urgently need-

ed better medical tools or people in poor countries.53 In 2000 Oxam also

launched a major access to medicines campaign. Tis adocacy included o-cusing on a series o lawsuits rom the pharmaceutical industry, including a

requently cited case against the South Arican goernment.54

Parallel to the adocacy work o NGOs are the ital priate research

initiaties, such as Management Sciences or Health (MSH), a priate non-

prot consultancy organization, which is headed by the ormer director o

the WHOs essential medicines department. MSH has a strong ocus on

technical support and capacity building, and has expertise in supply chain

management and deliery o medicines. One o its key programmes, Strat-

egies or Enhancing Access to Medicines, is unded by the Gates Founda-

tion. Te Gates Foundation is a major player in enhancing access to medi-

cines, as is the Clinton Foundation, which has negotiated reduced prices or

antiretroirals by guaranteeing purchases and continuous demand. Other

innoatie nancing mechanisms include UNIAID (which uses the pro-

ceeds o a solidarity tax on airline tickets to purchase drugs and diagnostics

or HIV/AIDS, malaria and tuberculosis); Adance Market Commitments

or accines (AMC) (which uses donor commitments to proide incenties

to accine makers to produce accines or deeloping countries); Te Global


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Fund to Fight AIDS, uberculosis and Malaria; and the United States Presi-

dents Emergency Plan or AIDS Relie (PEPFAR). Tese eorts, howeer,

rarely make reerence to access to essential medicines as a human right.

Seeral academic initiaties hae utilized an explicit human rights ap-

proach, including international ocials and academics writing in scholarly

journals.55 A leading scholar, Tomas Pogge, has ound the patent system

morally problematic because patents on biological organisms and phar-

maceutical products directly or indirectly, impede the global poors access

to basic oodstus and essential medicines.56 He proposes a ull-pull plan

(as opposed to a push plan, which unds a particular innoator) according

to which all potential innoators, such as pharmaceutical companies, would

hae an equal chance or a substantial reward rom public unds during the

lie o the patent, in proportion to the extent to which the new drug or oth-

er product reduces the global burden o disease (GBD).57

Te Uniersity o Montral hosted a workshop o scholars (including

Pogge), national and international ocials and NGO actiists rom 30 Sep-

tember to 2 October 2005, on the Human Rights and Access to Essential

Medicines: Te Way Forward. Te meeting considered the burden o dis-

ease due to lack o access to medicines and adopted the Montral State-

ment on the Human Right to Essential Medicines.58

Ater nding the current lack o access to medicines to be contrary toethical and legal duties, including human-rights obligations, the authors o

the statement posit the obligation to make policies, rules, and institutions

conducie to the realization o the right to essential medicines at the na-

tional and global leels.59 Echoing the position taken in General Comment

14, the Montral Statement, drawing on the WHO denition cited at the

beginning o this chapter, denes essential medicines as those that sat-

isy the priority health care needs o the population, in light o their public

health releance, proen quality, ecacy and saety, and comparatie cost-

eectieness. Te right to these medicines is part o the core obligations

o parties to the ICESCR, requiring immediate and eectie measures and

is not subject to progressie implementation.60 Te statement urther calls

on national goernments in deeloping countries to allocate resources to

making essential medicines aailable, and to update national lists o essen-

tial medicines, as well as to use trade exibilities and saeguards, such as

compulsory licensing and parallel importing. It calls on afuent countries

to ensure airer trade relations, alleiate crippling debt and increase assist-


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ance to acilitate this right.61 Finally, the statement takes issue with the

present system o incenties or innoation, which is based on return on

inestment rather than priority health needs and outcomes, and adocates

alternatie innoation systems that ensure that research and deelopment

are sucient to meet priority health needs.62

Building on the Montral Statement, a group o institutions, rom

Qubec and Brazil, organized a workshop at the Uniersit de Quebec on

20 Noember 2007, ealuating, rom the right to deelopment perspectie,

arget 17 o the Millennium Deelopment Goals.63 Other academic initi-

aties include Uniersities Allied or Essential Medicines (UAEM), which

adopted the Philadelphia Consensus Statement at their annual conerence

held in Philadelphia at the beginning o October 2006, stating: We beliee

that access to medical care and treatment is a basic human right.64

Draft Guidelines by the Special Rapporteur

As part o his mandate as UN Special Rapporteur on the right o eeryone

to the enjoyment o the highest attainable standard o physical and mental

health, Paul Hunt submitted a report to the General Assembly in 2006 sum-

marizing the responsibilities o states and o pharmaceutical companies

with respect to access to medicines,65 and circulated on 19 September 2007,

a Drat or Consultation o a set o Human Rights Guidelines or Pharma-ceutical Companies in relation to Access to Medicines.66

Following consultation with states, NGOs, academics, pharmaceuti-

cal companies, UN agencies, national human rights institutions and other

stakeholders, Hunt presented the Guidelines to the General Assembly in

2008, explaining that the central objectie o the Guidelines is to proide

practical, constructie and specic guidance to pharmaceutical companies

and other interested parties, including those who wish to monitor compa-

nies and hold them to account.67 Tese orty-seen Guidelines deal with

general policy; the disadantaged; transparency; management, monitoring

and accountability; corruption; public policy inuence, adocacy and lobby-

ing; quality; clinical trials; neglected diseases; patents and licensing; pric-

ing, discounting and donations; ethical promotion and marketing; public-

priate partnerships; and associations o pharmaceutical companies. Tey

call upon companies to recognize the importance o human rights in their

corporate mission and proide board-leel responsibility and accountabil-

ity or its access to medicines strategy, with a public commitment to con-


15/20


tribute to research and deelopment or neglected diseases, and respect the

right o countries to use RIPS exibilities. Te Guidelines then address

questions o management, including an eectie, transparent, accessible

and independent monitoring and accountability mechanism, both inter-

nal and external, as well as participation rom a human rights perspectie.

Other Guidelines would hae companies comply with arious international

standards on corruption, good manuacturing practice, human subject re-

search, and other areas. Special proisions relate to promoting research and

deelopment on neglected diseases. Regarding patents and licensing, the

Guidelines call on drug companies to respect the right o countries to use,

to the ull, the proisions RIPS , which allow exibility or the pur-

pose o promoting access to medicines, including the proisions relating to

compulsory licensing and parallel imports and respect the letter and spir-

it o the Doha Declaration

Conclusion

Te human right to essential medicines is a deriatie right rom the rights

to health and to lie. When the main human rights instruments were drat-

ed, the idea that lack o access to medicines was contrary to human rights

was not considered, except that access to medicines was one o a numbero reasonable measures constituting healthcare. Subsequently, and particu-

larly as a result o the AIDS pandemic, the ital need or treatment o HIV

positie indiiduals contributed to the progressie acknowledgement that

access to essential medicines, including antiretroiral treatments (ARs),

was an internationally recognized human right. Tis argument has been ex-

tended rom HIV/AIDS to the ull range o diseases that account or the dis-

proportionate leels o mortality and morbidity in deeloping countries.

It may be useul to draw a parallel with the emergence o an implied de-

riatie human right to water, ormally acknowledged by the Committee

on Economic, Social and Cultural Rights in 2002 in its General Comment

on the Right to Water.68 Te analogy with the right to water is reinorced

by drawing on three main arguments used by the Committee, one based on

eidence, one on logic, and the third on legal construction.

First, knowledge o the problem o water, created by the ailure to guar-

antee access to it, was uncontested and acknowledged as requiring urgent

action. Te Committee noted that Oer one billion persons lack access to

a basic water supply, while seeral billion do not hae access to adequate


16/20


sanitation, which is the primary cause o water contamination and diseas-

es linked to water.69 Nearly two billion people do not hae access to essen-

tial medicines and an estimated our million people could be saed annually

in Arica and Southeast Asia i diagnosis and treatment with appropriate

medicines were aailable. Te criteria o magnitude and urgency o the

problem are met.

Te second argument is based on a logical construction, according to

which water as a human right is a necessary consequence o the nature o

this commodity. Te Committee argues as ollows: Water is a limited natu-

ral resource and a public good undamental or lie and health. Te human

right to water is indispensable or leading a lie in human dignity. It is a pre-

requisite or the realization o other human rights.70 Appropriate medi-

cines are similarly indispensable to the health o people eerywhere and the

most basic drugs are a public good.71

Te third basis or positing the right to water as a human right was

the legal interpretation o existing human rights norms. Te title o Gen-

eral Comment 15 mentions Articles 11 and 12 o the International Coenant

on Economic, Social and Cultural Rights and the Committee explains how

these two rights (adequate standard o liing and health) are inextricably

related to the right to water. Te Committee relates the right to water to

other human rights, including inter alia the right to lie, the right to ade-quate ood, the right to gain a liing by work, the right to take part in cul-

tural lie. Te right to essential medicines is similarly inseparable rom the

rights to an adequate standard o liing, education, ood, and housing.

Following the pattern o other general comments, the Committee then

addresses the normatie content o the right to water in terms o aailabil-

ity, quality, accessibility, and inormation, and deotes special attention to

issues o discrimination and ulnerable groups. Te Working Group on Ac-

cess to Medicines organized its analysis and recommendations into three

main categories: Aailability, aordability, and appropriateness,72 and then

deals with quality73 as well as crosscutting issues o human resources and

gender.74 In other words, the ull range o essential and interrelated ele-

ments o the rights, that treaty bodies coer in their general comments, are

applicable to the human right to essential medicines.

Te deelopments described in this chapter are signs that the human

right to essential medicines has adanced in terms o its normatie con-

tent and its legal recognition, although it remains a daunting challenge to

nd accommodation with the international trade regime, bridge the gaps


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98Health: A Human Rights Perspective

in political will, nd incenties or innoation and aordable pricing, and

create the aailability o adequate human and nancial resources to ensure

distribution networks. All this needs to be achieed in order or this right

to be o practical alue or the two billion who currently lack access to es-

sential medicines.

1 Andrew Clapham, Human Rights Obligation o

Non-State Actors (Oxord: Oxord Uniersity

Press, 2006), at 175.

2 Committee on Economic, Social and Cultur-

al Rights, he right o eeryone to beneit rom

the protection o the moral and material interests

resulting rom any scientiic, literary or artistic

production o which he or she is the author (ar-

ticle 15, paragraph 1(c), o the Coenant), Gener-

al Comment No. 17 (2005), UN doc. E/C.12/GC/1,

January 12, 2006, para. 35.

3 World Health Organization, Essential Medi-

cines: Deinition, aailable at http://www.who.int/medicines/serices/essmedicines_de/en/.

See also MDG Gap ask Force, Millennium Devel-

opment Goal 8: Delivering on the Global Partnership

for Achieving the Millennium Development Goals:

MDG Gap ask Force Report 2008 (New York: Unit-

ed Nations, 2008) at 36.

4 MDG Gap ask Force, supra note 3, at 35.

5 UN Millennium Project, Prescription for Healthy

Development: Increasing Access to Medicines, Report

of ask Force on HIV/AIDS, Malaria, B and Access

to Essential Medicines, Working Group on Access

to Essential Medicines, 2005, at 4.

6 World Health Organization, WHO Medicines Strat-

egy 20002003: Framework for Action in Essen-

tial Drugs and Medicines Policy 20002003 (Gene-

a: WHO, 2000), aailable at www.who.int/medi

cines/strategy/strategy2000=2003.shtml.

7 he WHO Medicines Strategy 20042007, (Gene-

a: WHO, 2004), WHO/EDM/2004.5, page v.

8 MDG Gap ask Force, supra note 3, at 42.

9 Ibid., at 1.

10 Ibid., at 2931.11 Ibid., at 35.

12 Ibid., at 106.

13 Ibid., at 106110.

14 Ibid., at 110118.

15 Ibid., at 7273.

16 Ibid., at 136.

17 RIPS Art. 31 proides or the use o a patented

product without the authorization o the right

holder, under the ollowing condition: () Any


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99Access to Essential Medicines as a Component of the Right to Health

such use shall be authorized predominantly or

the supply o the domestic market o the Member

authorizing such use; and (h) he right holder

shall be paid adequate remuneration in the cir-

cumstances o each case, taking into account theeconomic alue o the authorization. hus, com-

pulsory licensing is not aailable to many coun-

tries without a signiicant pharmaceutical sector.

18 Amir Attaran, How Do Patents And Econom-

ic Policies Aect Access o Essential Medicines

In Deeloping Countries? 23(3) Health Affairs

(2004), 155156, at 157.

19 Ibid., at 159.

20 Ibid., at 161.

21 E-DRUG, WHO Model List o Essential Medi-

cines and Patents, posting on essentialdrugs.org

by Hans Hogerzeil on 23 March 2005, aailable at

http://www.essentialdrugs.org/edrug/archie/

200503/msg00071.php.

22 he WHO essential medicines strategy has the

ollowing seen components: (1) National poli-

cies on medicines; (2) National policies on tra-

ditional medicine and complementary and alter-

natie medicine; (3) Sustainable inancing mech-

anisms or medicines; (4) Supplying medicines;

(5) Norms and standards or pharmaceuticals; (6)

Regulation and quality assurance o medicines;

(7) Using medicines rationally. World Health Or-

ganization, WHO Medicines Strategy 20042007:

Countries at the Core, WHO publication No. WHO/

EDM/2004.5, 2004, at 25129.

23 Lisa Forman, Rights and Wrongs: What Utility

or the Right to Health in Reorming rade Rules

on Medicines? 10(2) Health and Human Rights:An International Journal (2008).

24 Ibid.

25 Ibid.

26 WHO Resolution 61.21 adopted by the Sixty-irst

World Health Assembly on 24 May 2008. It is sig-

niicant or the purpose o the present examina-

tion o the tensions between international trade

and human rights to note the shit in the title o

the Commission to that o the IGWG with respect

both to the order o the terms and the deletion o

rights attached to intellectual property.

27 WHO Resolution 59.24 adopted by the Fity-ninth

World Health Assembly on 27 May 2006, para. 3.

28 World Health Organization, Public Health, Inno-vation, and Intellectual Property: Progress Made by

the Intergovernmental Working Group, Report by

the Secretariat, 5 April 2007, WHO publication

number A60/27, para. 4.

29 World Health Organization, Global Strategy and

Plan of Action on Public Health, Innovation, and In-

tellectual Property, 24 May 2008, WHO publica-

tion number WHA61.21, annex, paras. 7 and 10.

30 Ibid., para. 12.

31 his language, taken orm the WHO constitu-

tion, was retained ater an additional proision

on human rights was deleted ollowing a diisie

debate.

32 Commission on Human Rights resolution

2001/33, Access to medication in the context o

pandemics such as HIV/AIDS, UN Doc. E/CN.4/

RES/2001/33, 20 April 2001, para. 1.

33 Ibid., para. 3(a).

34 Ibid., para. 4(b).

35 UN Doc. E/CN.4/Sub.2/2001/13, 27 June 2001.

36 he Sub-Commission on the Promotion and Pro-

tection o Human Rights, Intellectual Property

Rights and Human Rights, resolution 2001/21,

UN Doc. E/CN.4/SUB.2/RES/2001/21, 16 August

2001.

37 Ibid., preamble.

38 Ibid.

39 Ibid., para. 3.

40 Ibid., para. 5.41 World rade Organization, Ministerial Coner-

ence, Fourth Session, Doha, 914 Noember 2001,

Declaration on the RIPS agreement and public

health, adopted on 14 Noember 2001, Doc. W/

MIN(01)/DEC/2, 20 Noember 2001, para. 4, aail-

able at http://www.wto.org/English/thewto_e/

minist_e/min01_e/mindecl_trips_e.htm.

42 Ibid., para. 5.

43 Ibid., para. 6.


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100Health: A Human Rights Perspective

44 Statement of the United Nations Committee on Eco-

nomic, Social and Cultural Rights to the hird Min-

isterial Conference of the World rade Organization

(Seattle, 30 Noember to 3 December 1999), UN

Doc. E/C.12/1999/9, 26 Noember 1999, para. 8.45 Human rights and intellectual property: Statement

by the Committee on Economic Social and Cultur-

al Rights, UN Doc. E/C.12/2001/15, 14 December

2001, para. 4.

46 Ibid., para. 17.

47 Ibid., para. 18.

48 Committee on Economic, Social and Cultural

Rights (CESCR), General Comment No. 14 on the

right to the highest attainable standard of health, 11

August 2000, UN Doc. E/C.12/2000/4, at para. 17.

49 Ibid., para. 12 (a).

50 Ibid., para. 35.

51 CESCR, General Comment No. 17 on the right of eve-

ryone to benefit from the protection of the moral and

material interests resulting from any scientific, liter-

ary or artistic production of which he or she is the au-

thor, 12 January 2006, UN Doc. E/C.12/GC/17, at

para. 2.

52 Ibid., para. 35.

53 MSFs Campaign is described at http://www.

accessmed-ms.org/.

54 At the national leel, major adances in the right

to essential medicines were made by such NGOs

as reatment Action Campaign (AC) in South

Arica, which sued the South Arican goernment

or not proiding to pregnant women a drug

known to reduce mother-to-child-transmission

(MC) o HIV and won this case on the basis o

the South Arican constitutional guarantee o theright to health: reatment Action Campaign (AC)

v Minister of Health, Constitutional Court (2002) 5

SA 721 (CC).

55 See or example, Phillippe Cullet, Human Rights

and Intellectual Property Protection in the RIPS

Era 29(2) Human Rights Quarterly (2007) 403430;

Carlos Mara Correa, Implications o Bilateral

Free rade Agreements on Access to Medicines

84(5) Bulletin of the World Health Organization

(2006) 399404; Michael A. Santoro, Human

Rights and Human Needs, Dierse Moral Princi-

ples Justiying hird World Access to Aordable

IV/AIDS Drugs 31(4)North Carolina Journal of In-

ternational Law and Commercial Regulation (2006)

923942; Hans V. Hogerzeil et. al. Is Access to Es-sential Medicines as Part o the Fulillment o the

Right to Health Enorceable hrough the Courts?

368 he Lancet (2006) 305311; Hans V. Hogerzeil,

Essential Medicines and Human Rights: What

Can hey Learn rom Each Other? 84(5) Bulletin

of the World Health Organization (2006) 371375,

at 371; Hans Hogerzeil, Access to Essential Med-

icines as a Human Right 33 Essential Drugs Mon-

itor (2000) 2526; homas Pogge, World Poverty

and Human Rights: Cosmopolitan Responsibilities

and Reforms, Second expanded edition (UK and

Malden MA: Polity Press 2008), chapter 9 entitled

Pharmaceutical Innoation: Must We Exclude

the Poor?, 222261.

56 Pogge, supra note 55.

57 Ibid., at 244261. Under certain conditions, Nor-

man Daniels considers that Pogges incentie

schemes could be a way o moing some coun-

tries closer to satisying a right to health, con-

necting the eort to human rights goals as he

does.: Norman Daniels, Just Health: Meeting

Health Needs Fairly (New York: Cambridge Uni-

ersity Press, 2008), at 353.

58 he text is aailable in homas Pogge, Montral

Statement on the Human Right to Essential Med-

icines 16(1) Cambridge Quarterly of Healthcare

Ethics (2007), at 104108.

59 Ibid., para. 3.

60 Ibid., paras. 45.61 Ibid., paras. 611.

62 Ibid., paras. 1415.

63 he participating institutions were lAssociation

pour la sant publique du Qubec, Initiatie lu-

so-rancophone sur laccs au medicament et

la protection du citoyen, Program on Human

Rights in Deelopment o the Harard School

o Public Health, Canadian Institutes o Health

Research, le Rseau de recherche en sant des

populations du Qubec, and le Groupe dtude sur


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101Access to Essential Medicines as a Component of the Right to Health

linterdisciplinarit et les reprsentations social-

es de lUQAM.

64 See www.essentialmedicine.org.

65 Paul Hunt, Report of the Special Rapporteur on

the right to health, 13 September 2006, UN Doc.A/61/338.

66 he online ersion o the Guidelines was made

aailable at http://www2.essex.ac.uk/human_

rights_centre/rth/.

67 Paul Hunt, Report of the Special R apporteur on the

right to health, 11 August 2008, UN Doc. A/63/263,

at para. 46. Quotations rom the Guidelines are

rom the ersion in the annex to that document.

68 CESCR, General Comment No. 15 on the right to wa-

ter, 20 January 2003, UN Doc. E/C.12/2002/11

(2002).

69 he Committee cited WHO data or this claim.

See, ibid., para. 1, note 1.

70 Ibid.

71 he ull implications and related strategy or

treating access to essential medicines as a pub-

lic good are presented by homas Pogge in Hu-

man Rights and Global Health: A Research Pro-gram which rst appeared in Christian Barry and

homas Pogge (eds.), Global Institutions and Re-

sponsibilities: Achieing Global Justice, special

issue oMetaphilosophy, 36(12), January 2005,

and currently aailable as Chapter 9: Pharma-

ceutical Innoation: Must We Exclude the Poor?,

Pogge, supra note 55.

72 Supra note 5, 5882.

73 Ibid., 8285.

74 Ibid., 2122.

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