Human Rights Responsibilities
of Pharmaceutical Companies
in Relation to Access to Medicines
Joo-Young Lee
Friday, 4 May 2013
(Photos from the Guardian)
OUTLINE
• Global Lack of Access to Medicines
• Access to Medicines as a Human Right
• Normative Content of the Right to Access to Medicines
• Whose Responsibilities?
• Capacity of Pharmaceutical Companies: Impact upon Access to Medicines
• Human Rights Obligations: Only for States?
• The UN Guiding Principles on Business and Human Rights
• The Right to Health Responsibilities of Pharmaceutical Companies in Relation to Access to Medicines
• Pharmaceutical Companies: Voluntary Norms
• Way Forward
Global Lack of Access to Medicines
• Approximately, two billion people lack access to essential medicines (WHO Medicines Strategy 2004-2007)
Why? Major obstacles are:
Infrastructure
Research and Development
Costs of Medicines
• Few medicines exist for the so-called neglected diseases Why?
Medi i es fo egle ted diseases a e ot p ofita le
10 % of global public health research 90 % of the global disease burden (the 10/90 gap)
Access to Medicines as a Human Right
• Critical component of the right to life and the right to health
• Right to health: Article 12 of the International Covenant on Economic, Social and Cultural Rights
• Right to life: Article 6 of the International Covenant on Civil and Political Rights
• The Constitution of the World Health Organization
• The Convention on the Elimination of All Forms of Discrimination Against Women
• The Convention on the Rights of the Child
• General Comment No. 14 of the CESCR
• National constitutions, Jurisprudence
Normative Content of
the Right to Access to Medicines
Needed medicines must be
• Available in sufficient numbers
• Accessible physically and economically (affordability)
• Acceptable : culturally appropriate and sensitive to gender and life cycles
• Of good quality : safe and efficacious
(General Comment No. 14 of the CESCR)
Access to Medicines a Human Right:
Whose Responsibilities?
• Primary responsibilities to ensure everyone access to medicines States
• States have
Obligations to respect
O ligatio s to p ote t i ludi g p ote tio agai st o pa ies’ hu a rights abuse)
Obligations to fulfill
• Globalisation: I ade ua y of “tates’ o ligatio to p ote t
Capacity of Pharmaceutical Companies:
Impact upon Access to Medicines
• Pharmaceutical companies are largely responsible for determining
For which diseases medicines are developed
Where medicines are sold
At what cost
• Patent-holding companies: exclusive control of the patented medicines for a limited period of time (TRIPS)
• Capacity of transnational pharmaceutical companies
The profits of large pharmaceutical companies > the GDP of many states (e.g. the revenues of Pfizer) (Fortune 500 2011, IMF 2010)
Global pharmaceutical sales: USD 856 million (2010) > all but the o ld’s 5 la gest atio al e o o ies IFPMA , IMF
Human Rights Obligations:
Only for States?
• P ea le of U i e sal De la atio of Hu a Rights e e y i di idual a d e e y o ga of so iety … shall st i e … to p o ote espe t fo these ights and freedoms and by progressive measures, national international, to se u e thei u i e sal a d effe ti e e og itio a d o se a e.
• A ti le of the UDHR Nothi g i this De la atio ay e i te p eted as implying for any State, group or person any right to engage in any activity or to perform any act aimed at the destruction of any of the rights and f eedo s set fo th he ei .
The UN Guiding Principles
on Business and Human Rights (1)
• The Protect, Respect, and Remedy Framework
(John Ruggie, UN Special Representative on Business and Human Rights)
The State duty to protect against corporate human rights abuses
The Corporate responsibility to respect human rights
Access to effective remedy
• Corporate Responsibility to respect human rights Companies should
Express their commitment to meet human rights responsibility
Carry out human rights due diligence
Put i pla e p o esses to e a le the e ediatio of a y ad e se human rights impacts they cause or to which they contribute
The UN Human Rights Guiding Principles
on Business and Human Rights (2)
Human Rights Due Diligence
• Companies should assess
actual and potential human rights impacts
integrate and act upon the findings
track how their human rights are addressed
communicate how these impacts are addressed
The Right to Health Responsibilities
of Pharmaceutical Companies
in Relation to Access to Medicines
• A shared responsibility among States, companies, donors, and others
• Companies should
Integrate the right to health into their policies, programmes, and projects (e.g. pricing, IP, R & D, clinical trials, and marketing)
Use impact assessments, and prevent or address any adverse impacts of their activities on access to medicines
Within a viable business model, take reasonable steps to make the medicine as accessible as possible (differential pricing, voluntary licensing etc.)
Ensure that medicines are developed for children, the elderly, pregnant and lactating women, and for various climates
Pharmaceutical Companies:
Voluntary Norms
• All of the o ld’s la gest pha a euti al o pa ies – codes of conduct, a statement on access to medicines
• GSK – 2010 Corporate Responsibility Report the right to health
Pha a euti al o pa ies, i ludi g G“K, ust ake thei edi i es as affo da le as possi le to people i the o ld’s poo est o u ities, i a sustainable manner. We must invest in research into diseases of the
developing world because new prevention tools and treatments are
urgently needed. We must work with others to find innovative solutions to delivering our medicines and vaccines to the people who need them
ost.
• Inadequacy of self-imposed codes of conduct and voluntary guidelines
Way Forward
• Strengthening the accountability of pharmaceutical companies in relation to access to medicines
Creative use of existing mechanisms: e.g. UN expert working group on business and human rights, the revised OECD Guidelines, the UN
Co issio o I fo atio a d A ou ta ility fo Wo e ’s a d Child e ’s Health
Towards a Framework Convention on Global Health creating legally binding rules on global health, founded upon the right to health:
(Anand Grover, the current Special Rapporteur on the right to health) - Obligations of pharmaceutical companies among other actors
should be clarified
- Accountability mechanisms: adjudication, investigation, promotional function
