Focus: Pharmaceuticals – Draft human rights guidelines for access to medicines
5 November 2007
In brief: Partner Annette Hughes and Senior Associate Rachel Nicolson provide an overview of the UN's draft Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines, released for public consultation in September 2007.
- A climate of increased scrutiny
- Action by pharmaceutical corporations
- The purpose of the guidelines
- The content of the guidelines
How does it affect you?
- These guidelines seek to impose specific and sometimes onerous obligations on the pharmaceutical industry, demonstrating the growing international and domestic expectations faced by that industry in the area of corporate social responsibility.
- Many pharmaceutical companies have published standards, including standards on human rights. These guidelines further inform the content of such standards.
- The guidelines may also be of assistance to pharmaceutical companies in their contracting or partnering arrangements, particularly outside of their home country.
- Should these standards become international law, they may also eventually be incorporated into pharmaceutical company home and host country domestic law regimes.
On 19 September 2007, Paul Hunt (the United Nations Special Rapportuer on the right to health) released the draft Human Rights Guidelines for Pharmaceuticals in relation to Access to Medicines (the guidelines) for public consultation. The guidelines were then introduced into the United Nations General Assembly on 25 October 2007.
Mr Hunt is an independent expert appointed by the former United Nations Commission on Human Rights. He launched the guidelines at the University of Toronto, Canada, commenting that '[p]harmaceutical companies have a profound impact both positive and negative on Governments' ability to realise the right to the highest attainable standard of health.' He said that '[i]t is time to identify what pharmaceutical companies should do to help realize the human right to medicine.' 1
The pharmaceutical industry has been subject to ongoing public criticism for a perceived pursuit of profit without adequate regard for human rights. In particular, this criticism has surrounded the issue of HIV/AIDS, with pharmaceutical companies accused of contributing to the HIV/AIDS crisis by enforcing patents in the developing world, and refusing to allow the production of generic anti-retroviral drugs by local manufacturers. Companies also come under fire for allegedly failing to adequately invest in research to treat and prevent diseases such as malaria, which are more or less eradicated in the developed world, but still affect large portions of the global population.
An increasing number of pharmaceutical corporations are adopting formal policy statements that explicitly refer to human rights, including: Azko Nobel, Alliance Boots, Bayer, GlaxoSmithKline, Novartis and Roche.2 For example, the corporate responsibility principles published on GlaxoSmithKline's website include a commitment to uphold the UN Universal Declaration of Human Rights and an undertaking to '...find sustainable ways to improve access to medicines for disadvantaged people...' 3
The guidelines are prefaced by an introductory note, which observes that nearly 2 billion people do not have access to essential medicines and that 90 per cent of the world's pharmaceuticals are consumed by just 15 per cent of the global population. The guidelines affirm the fundamental right of every human being to the highest attainable standard of health and confirm that medical treatment and access to medicines are 'vital features' of that right.
The guidelines are intended to perform two core functions, namely to:
- help pharmaceutical companies enhance their contribution to these vital human rights issues; and
- assist those who wish to monitor the human rights performance of the pharmaceutical sector in relation to access to medicines.4
There are 48 guidelines, which are divided among 13 'overlapping categories', including public policy influence, advocacy and lobbying; research and development for neglected diseases; patents and licensing; quality and technology transfer; pricing, discounting and donations; ethical promotion and marketing; clinical trials; public/private partnerships; corruption; associations of pharmaceutical companies and monitoring and accountability.
The guidelines emphasise transparency and equality. The guidelines state that companies should incorporate human rights into their 'strategies, policies, programmes, projects and activities' and that companies should comply with the laws of their home state as well as the nations in which they operate. The guidelines call for internal and external monitoring and accountability mechanisms, to ensure that observance of human rights is more than just 'window dressing'.
The obligations contained in the sections on patents and licensing, and pricing, discounting and donations are likely to be especially controversial. Many of these draft guidelines are specific, tangible and onerous. For example, guideline 26 provides that companies 'should not extend patent duration, or file patents for existing medicines, in low-income and middle-income countries.' Guideline 29 provides that pharmaceutical corporations should differentiate their pricing and discounting schemes to reflect a nation's level of economic development (and that differential pricing and discount regimes should be progressively extended to all medicines).
The guidelines are yet another move to recognise, articulate and enforce the human rights obligations of corporate entities. Like the draft Norms on the Responsibilities of Transnational Corporations and Other Business Enterprises with Regard to Human Rights, the guidelines acknowledge the paramount responsibility of states to protect human rights, but, at the same time, seek to impose substantial responsibilities on corporations.
The guidelines are open for public consultation until 31 December 2007. Any comments should be directed to Rajat Khosla at firstname.lastname@example.org.
- United Nations, Press Release, UN Independent Expert Launches Draft Human Rights Guidelines for Pharmaceutical Companies (19 September 2007), available at: <http://www.unhchr.ch/huricane/huricane.nsf/view01/497E81A16B31B9C8C125735B0059D7B0?opendocument>.
- http://www.business-humanrights.org/Documents/Policies .
- Available at: <http://www.gsk.com/responsibility/cr_report_2005/managing-cr/principles.htm>.
- Introductory Note, paragraph H.
- Sarah MathesonPartner,
Ph: +61 3 9613 8579
- Philip KerrSenior Patent / Trade Mark Counsel,
Ph: +61 2 9230 4937
- Andrew PascoePartner,
Ph: +61 8 9488 3741
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