19 September 2007
Draft for Consultation
Comments by 31
December 2007 to email@example.com
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
- Almost 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’s population consumes over 90% of the world’s
- The 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.
- The 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
- Medical care and access to medicines are vital
features of the right to the highest attainable standard of health.
- States 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.
- Under 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’ efforts by making recommendations.
- Accordingly, 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 – 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
- In 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
- The 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:
- Identification of the relevant national and international human
rights laws, norms and standards.
- Recognition 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
- Nonetheless, 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.
- Recognition 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.
- All 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).
- States have duties to respect, protect and fulfil the right to the
highest attainable standard of health.
- Because of their crucial importance, the analytical framework demands
that special attention is given to issues of non-discrimination, equality
- The 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.
- Developing 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
- The right to health requires that there are effective, transparent
and accessible monitoring and accountability mechanisms available at the
national and international levels.
- While 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
- Importantly, 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 – to Rajat Khosla at firstname.lastname@example.org.
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’s
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’s 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)).
- The company’s 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.
- The 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.
- The company should join the United Nations Global
- The 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.
- The 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.
- Whenever formulating and implementing its
strategies, policies, programmes, projects and activities that bear upon
access to medicines, the company should:
attention to disadvantaged individuals and communities, such as those living in
attention to gender-related issues;
attention to the needs of children;
attention to the very poorest in all markets;
facilitate the participation of all stakeholders, including disadvantaged
individuals and communities.
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 Guidelines 47-48 which
addresses the issue of an external, independent monitoring and accountability
mechanism. Guideline 10 reflects the importance that human rights attach to
- The company should have a governance system
that includes direct board-level responsibility and accountability for its
access to medicines strategy.
- The 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.
- The company should have clear management
systems, including quantitative targets, to implement and monitor its
access to medicines strategy.
- The company should have mechanisms that
encourage and facilitate stakeholder engagement and participation in the
formulation, implementation and management of its medicines strategy.
- The company should produce a comprehensive,
public, annual report, including qualitative and quantitative information,
enabling an assessment of the company’s 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.
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.
- The 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.
- The 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.
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).
company should make a public commitment to contribute to research and
development for neglected diseases.
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.
- The 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
- The company’s 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
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 ‘flexibilities’ 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.
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 (‘TRIPS-plus’ standards).
Also, the company should not, in practice, lobby for ‘TRIPS-plus’
- The company should always respect the letter and
spirit of the Doha Declaration on the TRIPS Agreement and Public Health
that recognises a State’s right to protect public health and promote
access to medicines for all.
21. The 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
22. Given 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. The 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.
- The 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.
- In 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.
- The company should not extend patent duration,
or file patents for new indications for existing medicines, in low-income
and middle-income countries.
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.
- The company should manufacture medicines of the
- The company should enter into technology
transfer agreements with local companies in low-income and middle-income
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).
company should ensure that its pricing and discount schemes:
account a country’s 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;
extend its differential pricing and discount schemes to all medicines; such
arrangements must not be limited to the company’s flagship products; they
should encompass non-communicable diseases, such as heart disease and diabetes.
- The company should have a board-approved policy
that fully conforms to the WHO’s Guidelines for Drug Donations.
- The company should disclose the absolute
quantity and value of its drug donations.
- The company should disclose the amount of any
tax benefit arising from its donations.
company should ensure that its discount and donation schemes and their
delivery channels are:
as possible e.g. the schemes should place the minimum administrative burden on
the beneficiary health system;
inclusive as possible e.g. the schemes should not be confined to restrictive
delivery channels that, in practice, exclude disadvantaged individuals and
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.
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.
- The company should have a board-approved code
of conduct and policy that fully conforms to WHO’s 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
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
- A company’s clinical trials should observe the
highest ethical and human rights standards. This is especially vital in
those States with weak regulatory frameworks.
- The 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.
- Additionally, 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.
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).
- When participating in a Public Private
Partnership, a company should continue to conform to these Guidelines.
- If a company joins a Public Private
Partnership, it should disclose any interest it has in the Partnership’s
decisions and activities.
far as these guidelines bear upon the strategies, policies, programmes,
projects and activities of Public Private Partnerships, they shall apply
equally to such Partnerships.
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 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
company should adopt effective anti-corruption policies and measures, and
comply with relevant national law implementing the United Nations
Convention against Corruption.
- In collaboration with States, the company
should take all reasonable measures to address counterfeiting.
Associations of pharmaceutical
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.
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.
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.
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:
assesses the impact of
the company’s strategies, policies, programmes, projects and activities on
access to medicines, especially for disadvantaged individuals and communities;
monitors, and holds the
company to account in relation to, these Guidelines.
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.
UN Special Rapporteur on the Right
to the Highest Attainable Standard of Health