[Ip-health] Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines

[Thiru Balasubramaniam]

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[ Picked text/plain from multipart/alternative ]

http://www.ohchr.org/english/press/newsFrameset-2.htm

http://www2.essex.ac.uk/human_rights_centre/rth/



19 September 2007
Draft for Consultation

Comments by 31 December 2007 to rkhosl@essex.ac.uk

Human Rights Guidelines for Pharmaceutical Companies
in relation to Access to Medicines

Prepared by the United Nations Special Rapporteur on the right of
everyone to the enjoyment of the highest attainable standard of
physical and mental health

Introductory Note
A.=09Almost 2 billion people lack access to essential medicines.
Improving access to existing medicines could save 10 million lives each
year, 4 million of them in Africa and South-East Asia. Access to
medicines is characterised by profound global inequity. 15% of the
world=92s population consumes over 90% of the world=92s harmaceuticals.

B.=09The Millennium Development Goals, such as reducing child mortality,
improving maternal health, and combating HIV/AIDS, malaria and other
diseases, depend upon improving access to medicines. One of the
Millennium Development Goal targets is to provide, in cooperation with
pharmaceutical companies, access to affordable essential drugs in
developing countries.

C.=09The Constitution of the World Health Organisation (WHO) affirms that
the highest attainable standard of health is a fundamental right of
every human being. The Universal Declaration of Human Rights lays the
foundations for the international framework for the right to the
highest attainable standard of health. This human right is now codified
in numerous national constitutions, as well as legally binding
international human rights treaties, such as the International Covenant
on Economic, Social and Cultural Rights and the Convention on the
Rights of the Child.

D.=09Medical care and access to medicines are vital features of the right
to the highest attainable standard of health.

E.=09States have primary responsibility for enhancing access to
medicines. While on country mission, the Special Rapportour routinely
questions Governments about their national medicines policies, research
and development for neglected diseases, anti-counterfeiting measures,
and so on. Most of his report to the United Nations General Assembly,
on the human right to medicines, is devoted to the responsibilities of
States. However, since his appointment in 2002, many States have
emphasised the profound impact - positive and negative - of
pharmaceutical companies on the ability of governments to realise the
right to the highest attainable standard of health for individuals
within their jurisdictions.

F.=09Under his mandate, the Special Rapporteur is requested, inter alia,
to develop a regular dialogue and discuss possible areas of cooperation
with all relevant actors; to report on good practices most beneficial
to the enjoyment of the right to the highest attainable standard of
health, as well obstacles encountered domestically and internationally;
and to support States=92 efforts by making recommendations.

G.=09Accordingly, the Special Rapporteur has engaged in many substantive
discussions on access to medicines with numerous parties, including
pharmaceutical companies. These discussions have been informed by the
work of States, pharmaceutical companies, United Nations Global
Compact, Office of the High Commissioner for Human Rights, WHO, Special
Representative of the Secretary-General on the issue of human rights
and transnational corporations and other business enterprises, Business
Leaders Initiative on Human Rights, civil society organisations and
others. These discussions =96 and this work - have shaped these draft
Guidelines. The Special Rapporteur is especially grateful to Realizing
Rights: Ethical Globalization Initiative and the Access to Medicine
Foundation.

H.=09In 2000, the United Nations Committee on Economic, Social and
Cultural Rights confirmed that the private business sector has
responsibilities regarding the realisation of the right to the highest
attainable standard of health. While this general statement of
principle is important, it provides no practical guidance to
pharmaceutical companies and others. The present draft draws upon the
growing jurisprudence on the right to the highest attainable standard
of health and sets out human rights Guidelines for pharmaceutical
companies in relation to access to medicines. In this way, the
Guidelines aim to help pharmaceutical companies enhance their
contribution to these vital human rights issues. Additionally, the
Guidelines will assist those who wish to monitor the human rights
performance of the pharmaceutical sector in relation to access to
medicines.

I.=09The right to the highest attainable standard of health is complex
and extensive. In recent years, it has been analysed by courts, the
United Nations Committee on Economic, Social and Cultural Rights as
well as other international human rights treaty-bodies, WHO, civil
society organisations, academics and others, with a view to making it
easier for States, and others, to apply in practice. The key elements
of this right-to-health analysis may be briefly summarised as follows:

i.=09Identification of the relevant national and international human
rights laws, norms and standards.
ii.=09Recognition that the right to health is subject to resource
constraints and progressive realisation, requiring the identification
of indicators and benchmarks to measure progress (or the lack of it)
over time.
iii.=09Nonetheless, recognition that some obligations arising from the
right to health are subject to neither resource constraints nor
progressive realisation, but are of immediate effect e.g. the
obligation to avoid de jure and de facto discrimination.
iv.=09Recognition that the right to health includes freedoms (e.g.
freedom from non-consensual treatment and non-consensual participation
in clinical trials) and entitlements (e.g. to a system of health care
and protection). For the most part, freedoms do not have budgetary
implications, while entitlements do.
v.=09All health services, goods and facilities shall be available,
accessible, acceptable, of good quality and safe. Accessible has a
number of dimensions, such as affordable (i.e. financially accessible)
and transparent (i.e. accessible health-related information).
vi.=09States have duties to respect, protect and fulfil the right to the
highest attainable standard of health.
vii.=09Because of their crucial importance, the analytical framework
demands that special attention is given to issues of
non-discrimination, equality and vulnerability.
viii.=09The right to health requires that there is an opportunity for the
active and informed participation of individuals and communities in
decision-making that bears upon their health.
ix.=09Developing countries have a responsibility to seek international
assistance and cooperation, while developed States have some
responsibilities towards the realisation of the right to health in
developing countries.
x.=09The right to health requires that there are effective, transparent
and accessible monitoring and accountability mechanisms available at
the national and international levels.

J.=09While this analysis has been developed keeping in mind the
responsibilities of States, many of its elements are also instructive
in relation to the responsibilities of non-State actors, including
pharmaceutical companies. For example, the element requiring that
health services shall be accessible bears upon the policies of both
States and non-State actors, as does the requirement that there should
be effective monitoring and accountability mechanisms. The following
draft Guidelines are grouped into overlapping categories; at the
beginning of each group, there is a brief italicised commentary
signalling some of the elements of the right-to-health analysis that
are especially relevant to that category.

K.=09Importantly, the present Guidelines remain a draft. Comments on this
draft are invited and should be sent as soon as possible - and before
31 December 2007 =96 to Rajat Khosla at rkhosl@essex.ac.uk.

General
Formal recognition of human rights, and the right to the highest
attainable standard of health, resonates with I.i (see above) and
provides an important foundation upon which the company=92s activities
can be constructed (Guideline 1). Formal recognition, however, is not
enough: operationalisation is the challenge (Guideline 2). Many of the
following Guidelines suggest ways in which human rights considerations
can be operationalised or integrated into the company=92s activities.
Despite its limitations, the Global Compact remains the leading United
Nations human rights initiative for the private sector and companies
should participate in it (Guideline 3). The right to the highest
attainable standard of health has a particular pre-occupation with
disadvantaged individuals and communities, women, children and those
living in poverty (Guideline 6(i)-(iv)). It also demands access to
information, transparency and as much participation as possible
(Guideline 6(v)-(vi)).

1.=09The company=92s corporate mission statement should expressly recognise
the importance of human rights generally, and the right to the highest
attainable standard of health in particular, in relation to the
strategies, policies, programmes, projects and activities of the
company.

2.=09The company should integrate human rights, including the right to
the highest attainable standard of health, into the strategies,
policies, programmes, projects and activities of the company.

3.=09The company should join the United Nations Global Compact.

4.=09The company should always comply with the national law of the State
where it operates, as well as any relevant legislation of the State
where it is domiciled.

5.=09The company should refrain from any conduct that will or may
encourage a State to act in a way that is inconsistent with its
obligations arising from national and international human rights law,
including the right to the highest attainable standard of health.

6.=09Whenever formulating and implementing its strategies, policies,
programmes, projects and activities that bear upon access to medicines,
the company should:

(i)=09give particular attention to disadvantaged individuals and
communities, such as those living in poverty;

(ii)=09give particular attention to gender-related issues;

(iii)=09give particular attention to the needs of children;

(iv)=09give particular attention to the very poorest in all markets;

(v)=09be transparent;

(vi)=09encourage and facilitate the participation of all stakeholders,
including disadvantaged individuals and communities.

Management
Human rights, including the right to the highest attainable standard of
health, require effective, transparent and accessible monitoring and
accountability mechanisms, otherwise they can become little more than
window-dressing (see I.x above). The mechanisms come in various forms.
Usually, a mix of mechanisms will be required. While some mechanisms
are internal, others are external and independent. Both types of
mechanisms are needed. Guidelines 7-11 address the issue of internal
corporate monitoring and accountability. They should be read with
Guideline 47-48 which addresses the issue of an external, independent
monitoring and accountability mechanism. Guideline 10 reflects the
importance that human rights attach to participation.

7.=09The company should have a governance system that includes direct
board-level responsibility and accountability for its access to
medicines strategy.

8.=09The company should have a public global policy on access to
medicines that sets out general and specific objectives, time frames,
who is responsible for what, and reporting procedures.

9.=09The company should have clear management systems, including
quantitative targets, to implement and monitor its access to medicines
strategy.

10.=09The company should have mechanisms that encourage and facilitate
stakeholder engagement and participation in the formulation,
implementation and management of its medicines strategy.

11.=09The company should produce a comprehensive, public, annual report,
including qualitative and quantitative information, enabling an
assessment of the company=92s strategies, policies, programmes, projects
and other activities that bear upon access to medicines.

Public policy influence, advocacy and lobbying
Transparency is a cardinal human rights principle upon which several
other human rights considerations depend, such as participation,
monitoring and accountability. In the right-to-health analysis, this
principle is reflected in the requirement that as much health-related
information as possible should be made accessible (see I.v above). The
Guidelines in this category reflect these right-to-health issues in the
context of pharmaceutical company advocacy and lobbying.

12.=09The company and its subsidiaries should disclose all current
advocacy and lobbying positions, and related activities, at the
regional, national and international levels, that impact or may impact
on access to medicines.

13.=09The company should annually disclose its financial and other
support to key opinion leaders, patient associations, political parties
and candidates, trade associations, academic departments, research
centres and others, through which it seeks to influence public policy
and national, regional, and international law and practice. The
disclosure should extend to amounts, beneficiaries and channels by
which the support is provided.

14.=09The company board should give prior approval to all lobbying
positions (guideline 12) and financial support (guideline 13). The
board should also receive reports on such lobbying positions and
financial support. The requirement of prior approval by, and reporting
to, the board is subject to the nature and scale of the activity. Where
the relationship between the activity and access to medicines is
significant, or likely to be significant, there should be prior
approval by, and reporting to, the board.

Research and development for neglected diseases
The record confirms that research and development has not addressed the
priority health needs of low-income and middle-income countries. More
specifically, health research and development has given insufficient
attention to neglected diseases that mainly afflict the poorest people
in the poorest countries, although there is evidence that some
pharmaceutical companies are taking active measures to reverse this
trend. The right to the highest attainable standard of health not only
requires that existing medicines are accessible without discrimination,
but also that much-needed new medicines are developed and thereby
become available to those who need them (see I.v above). From the
perspective of the right to the highest attainable standard of health,
neglected diseases demand special attention because they tend to
afflict the most disadvantaged and vulnerable (see I.vii above).

15.=09The company should make a public commitment to contribute to
research and development for neglected diseases.

16.=09The company should consult widely with WHO, WHO/TDR, Drugs for
Neglected Diseases Initiative and other relevant organisations with a
view to enhancing its contribution to research and development for
neglected diseases.

17.=09The company should either provide in-house research and development
for neglected diseases; or support external research and development
for neglected diseases; or both. In any event, it should disclose how
much it invests in research and development for neglected diseases.

18.=09The company=92s contribution to research and development for
neglected diseases should focus on formulations for low-income and
middle-income country use and for all key affected patient groups,
including especially disadvantaged individuals and communities.

Patents and licensing
The right to the highest attainable standard of health requires that
medicines are available and accessible (see I.v above). Intellectual
property rights impact upon the availability and accessibility of
medicines; they attempt to strike a balance between the interests of
various stakeholders, for example by establishing various
=91flexibilities=92 within the TRIPS regime. Guidelines 19-26 aim to ensure
that the features of intellectual property rights that protect the
right to health of patients, the public and the most disadvantaged are
recognised, respected and applied.

19.=09The company should respect the right of countries to use, to the
full, the provisions in the Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS), which allow flexibility for the
purpose of promoting access to medicines, including the provisions
relating to compulsory licensing and parallel imports. The company
should make a public commitment not to lobby for more demanding
protection of intellectual property interests than is required by
TRIPS, such as additional limitations on compulsory licensing
(=91TRIPS-plus=92 standards). Also, the company should not, in practice,
lobby for =91TRIPS-plus=92 standards.

20.=09The company should always respect the letter and spirit of the Doha
Declaration on the TRIPS Agreement and Public Health that recognises a
State=92s right to protect public health and promote access to medicines
for all.

21.=09The company should support States that wish to implement the WTO
Decision on Implementation of paragraph 6 of the Doha Declaration on
the TRIPS Agreement and Public Health (30 August 2003), and issue
compulsory licenses for exports to developing countries without
manufacturing capacity.

22.=09Given that some least-developed countries are exempt from granting
and enforcing patents until 2016, the company should not lobby for such
countries to grant or enforce patents.

23.=09The company should develop arrangements with other manufacturers
for licenses and technology transfers to enhance access to medicines
for HIV/AIDS, tuberculosis and malaria, as well as an increasing number
of other treatments.

24.=09The company should have non-exclusive voluntary license agreements
to increase access to medicines in low-income and middle-income
countries; the terms of such agreements should be disclosed.

25.=09In low-income and middle-income countries, the company should
consent to National Drug Regulatory Authorities using test
data/override test data exclusivity for registration purposes.

26.=09The company should not extend patent duration, or file patents for
new indications for existing medicines, in low-income and middle-income
countries.

Quality and technology transfer
Guideline 27 (and Guideline 44) reflects the requirement arising from
the right to the highest attainable standard of health that medicines
are of good quality and safe (see I.v above). Guideline 28 reflects
that those in a position to assist have a responsibility to take
reasonable measures towards the realisation of the right to the highest
attainable standard of health in developing countries (see I.ix above).
This includes north-south and south-south assistance.

27.=09The company should manufacture medicines of the highest quality.

28.=09The company should enter into technology transfer agreements with
local companies in low-income and middle-income countries.

Pricing, discounting and donations
These Guidelines mainly derive from the right to health requirement
that medicines should be accessible, including financially accessible
or affordable (see I.v above). Access extends to disadvantaged
individuals and communities, including those living in poverty.
Guideline 29(ii) reflects that the right to health takes into account
resource availability within a country (see I.ii above). Regarding
Guidelines 30-33, while unsustainable in the long-term, carefully
targeted donations have a role to play in ensuring access, especially
to those living in poverty and other disadvantaged individuals and
communities in low-income countries (see I.v and vii above).

29.=09The company should ensure that its pricing and discount schemes:

(i)=09conform to guidelines 6(i)-(vi);

(ii)=09take into account a country=92s stage of economic development; prima
facie, the price of a medicine in a low-income country should be less
than the price of the same or equivalent medicine in a middle-income
country, which should be less than the price of the same or equivalent
medicine in a high-income country;

(iii)=09progressively extend its differential pricing and discount
schemes to all medicines; such arrangements must not be limited to the
company=92s flagship products; they should encompass non-communicable
diseases, such as heart disease and diabetes.

30.=09The company should have a board-approved policy that fully conforms
to the WHO=92s Guidelines for Drug Donations.

31.=09The company should disclose the absolute quantity and value of its
drug donations.

32.=09The company should disclose the amount of any tax benefit arising
from its donations.

33.=09The company should ensure that its discount and donation schemes
and their delivery channels are:

(i)=09as simple as possible e.g. the schemes should place the minimum
administrative burden on the beneficiary health system;

(ii)=09as inclusive as possible e.g. the schemes should not be confined
to restrictive delivery channels that, in practice, exclude
disadvantaged individuals and communities.

Ethical promotion and marketing
As already observed, transparency is a cardinal human rights principle
upon which several other human rights considerations depend, including
monitoring and accountability (see commentary to Guidelines 12-14). In
the right-to-health analysis, this principle is reflected in the
requirement that as much health-related information as possible should
be made accessible (see I.v above). Guidelines 34-35 reflect these
right-to-health issues.

34.=09The company should take effective measures to ensure that all
information bearing upon the safety, and possible side effects, of a
medicine are easily accessible to individuals so they can take informed
decisions about its possible use.

35.=09The company should have a board-approved code of conduct and policy
that fully conforms to WHO=92s Ethical Criteria for Medicinal Drug
Promotion. In the context of this code and policy, the board should
receive regular reports on its promotion and marketing activities.

Clinical trials
The right to the highest attainable standard of health includes certain
freedoms, such as freedom from non-consensual participation in clinical
trials (see I.iv above). Treatment must also be acceptable to the
individuals and communities involved i.e. respectful of medical ethics,
such as the requirements of informed consent (see I.v above).

36.=09A company=92s clinical trials should observe the highest ethical and
human rights standards. This is especially vital in those States with
weak regulatory frameworks.

37.=09The company should conform to the Declaration of Helsinki on
Ethical Principles for Medical Research Involving Human Subjects and
the WHO Guidelines for Good Clinical Practice.

38.=09Additionally, when undertaking clinical trials, the company must
respect the inherent dignity of the individual and all human rights
principles, such as non-discrimination and equality.

Public Private Partnerships
While Public Private Partnerships make an important contribution to
enhancing access to medicines, they are subject to human rights
considerations corresponding to those set out in these Guidelines.
Where conflicts of interest may arise, disclosure is important,
consistent with the human rights requirements of transparency and
access to information (see I.v above).

39.=09When participating in a Public Private Partnership, a company
should continue to conform to these Guidelines.

40.=09If a company joins a Public Private Partnership, it should disclose
any interest it has in the Partnership=92s decisions and activities.

41.=09So far as these guidelines bear upon the strategies, policies,
programmes, projects and activities of Public Private Partnerships,
they shall apply equally to such Partnerships.

42.=09A company that joins a Public Private Partnership should take all
reasonable steps to ensure the Partnership fully conforms to these
guidelines. If, despite warnings, a Partnership fails to conform to
these guidelines, a participating company should withdraw from the
Partnership.

Corruption
Corruption is a major obstacle to the enjoyment of the right to the
highest attainable standard of health, including access to medicines.
Those living in poverty are disproportionately affected by corruption
in the health sector because they are less able to pay for private
alternatives where corruption has depleted public health services.
Features of the right to health, such as participation, transparency,
access to information, monitoring and accountability, help to establish
an environment in which corruption cannot survive. A right-to-health
policy is also an anti-corruption policy.

43.=09A company should adopt effective anti-corruption policies and
measures, and comply with relevant national law implementing the United
Nations Convention against Corruption.

44.=09In collaboration with States, the company should take all
reasonable measures to address counterfeiting.

Associations of pharmaceutical companies
A company has a responsibility to ensure that its professional
associations are respectful of the human rights considerations set out
in these Guidelines, otherwise a company could use an association as a
way of avoiding its human rights responsibilities.

45.=09So far as these Guidelines bear upon the strategies, policies,
programmes, projects and activities of associations of pharmaceutical
companies, they shall apply equally to all those associations. For
example, the Guidelines on lobbying (Guidelines 12 and 19) and
financial support (Guideline 13) shall apply equally to all
associations of pharmaceutical companies.

46.=09A company that is a member of an association of pharmaceutical
companies should take all reasonable steps to ensure the association
fully conforms to these guidelines. If, despite warnings, an
association fails to conform to these guidelines, a member company
should resign from the association.

Monitoring and accountability
Effective, transparent, accessible and independent monitoring and
accountability mechanisms are an integral feature of human rights,
including the right to the highest attainable standard of health (see
I.x above). See the commentary accompanying Guidelines 7-11.
Implementation of Guideline 11 will contribute to Guidelines 47-48.

47.=09In the context of access to medicines, internal monitoring and
accountability mechanisms have a vital role to play, but they should
also be supplemented by a mechanism that is independent of the company.
There should be an effective, transparent, accessible and independent
monitoring and accountability mechanism that:

(i)=09assesses the impact of the company=92s strategies, policies,
programmes, projects and activities on access to medicines, especially
for disadvantaged individuals and communities;

(ii)=09monitors, and holds the company to account in relation to, these
Guidelines.

48.=09Where such a monitoring and accountability mechanism already
exists, the company should fully cooperate with it. If it does not yet
exist, the company should establish such a mechanism.

Paul Hunt
UN Special Rapporteur on the right to the highest attainable standard
of health

19 September 2007

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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
voice +41.22.791.6727
fax +41.22.723.2988
mobile +41 76 508 0997
thiru@keionline.org
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