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

The guidelines for pharmaceutical companies have been prepared by the UN Special Rapporteur on the right to the highest attainable standard of physical and mental health, Paul Hunt in 2008.1

Between 2003 and 2006, the Special Rapporteur engaged in many discussions on access to medicines with numerous parties, including pharmaceutical companies.

During these numerous discussions, the human rights duties of States in relation to access to medicines were reasonably clear, and these duties are now explored.

However, it became apparent during these discussions that the nature and scope of pharmaceutical companies’ human rights responsibilities in relation to access to medicines were not clear. It became imperative, therefore, to address this situation.

There is no comparable human rights guidance for pharmaceutical companies in relation to access to medicines. In these circumstances, the Special Rapporteur’s priority focus was on human rights guidelines for pharmaceutical companies in relation to access to medicines.

The Guidelines are based on human rights principles that are enshrined in the Universal Declaration of Human Rights, including non-discrimination, equality, transparency, monitoring and accountability. The Guidelines are also informed by some features of the right to the highest attainable standard of health.2

Relevant clauses:3

General:

1. The company should adopt a human rights policy statement which expressly  recognises the importance of human rights generally, and the right to the highest attainable standard of health in particular […].

2. 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.

3. 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.

4. 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.

Disadvantaged individuals, communities and populations

5. […] the company should give particular attention to the needs of disadvantaged individuals, communities and populations, such as children, the elderly and those living in poverty. The company should also give particular attention to the very poorest in all markets, as well as gender-related issues.

Corruption

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

Public policy influence, advocacy and lobbying

18. 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.

Clinical trials

21. A company’s clinical trials should observe the highest ethical and human rights standards, including non-discrimination, equality and the requirements of informed consent. This is especially vital in those States with weak regulatory frameworks.

Neglected diseases

23. The company should make a public commitment to contribute to research and development for neglected diseases. Also, it should either provide in-house research and development for neglected diseases, or support external research and development for neglected diseases, or both.

Patents and licensing

26. The 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) (1994), which allow flexibility for the purpose of promoting access to medicines, including the provisions relating to compulsory licensing and parallel imports.

Pricing, discounting and donations

33. […] the company should consider all the arrangements at its disposal with a view to ensuring that its medicines are affordable to as many people as possible. In keeping with Guideline 5, the company should give particular attention to ensuring its medicines are accessible to disadvantaged individuals, communities and populations, including those living in poverty and the very poorest in all markets.


  1. http://business-humanrights.org/un-intl-orgs/un-intergovernmental-orgs/un/un-special-rapporteur-on-right-to-health []
  2. http://www.who.int/medicines/areas/human_rights/A63_263.pdf []
  3.  http://www.ohchr.org/documents/issues/health/guidelinesforpharmaceuticalcompanies.doc []

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