FOCUS
PHARMACEUTICALS
November 2007 DRAFT HUMAN RIGHTS GUIDELINES FOR ACCESS TO MEDICINES
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.
New UN guidelines HOW DOES THIS BACKGROUND
on access to On 19 September 2007, Paul Hunt (the AFFECT YOU? United Nations Special Rapportuer on the right medicines could • These guidelines seek to impose specifi c to health) released the draft Human Rights have a major impact and sometimes onerous obligations on the Guidelines for Pharmaceuticals in relation pharmaceutical industry, demonstrating to Access to Medicines (the guidelines) for on pharmaceutical the growing international and domestic public consultation. The guidelines were then expectations faced by that industry in the introduced into the United Nations General corporations area of corporate social responsibility. Assembly on 25 October 2007. • Many pharmaceutical companies have Mr Hunt is an independent expert appointed published standards, including standards on by the former United Nations Commission on human rights. These guidelines further inform Human Rights. He launched the guidelines at the content of such standards. the University of Toronto, Canada, commenting • The guidelines may also be of assistance that ‘[p]harmaceutical companies have a to pharmaceutical companies in their profound impact – both positive and negative contracting or partnering arrangements, – on Governments’ ability to realise the right particularly outside of their home country. to the highest attainable standard of health.’ • Should these standards become international He said that ‘[i]t is time to identify what law, they may also eventually be incorporated pharmaceutical companies should do to help into pharmaceutical company home and host realize the human right to medicine.’1 country domestic law regimes.
1. United Nations, Press Release, UN Independent Expert Launches Draft Human Rights Guidelines for Pharmaceutical Companies (19 September 2007), available at:
INCREASED • help pharmaceutical companies enhance their contribution to these vital human rights SCRUTINY issues; and • assist those who wish to monitor the human The pharmaceutical industry has been subject rights performance of the pharmaceutical to ongoing public criticism for a perceived sector in relation to access to medicines.4 pursuit of profi t without adequate regard for human rights. In particular, this criticism has surrounded the issue of HIV/AIDS, THE CONTENT OF with pharmaceutical companies accused of contributing to the HIV/AIDS crisis by enforcing THE GUIDELINES patents in the developing world, and refusing to allow the production of generic anti-retroviral There are 48 guidelines, which are divided drugs by local manufacturers. Companies among 13 ‘overlapping categories’, including also come under fi re for allegedly failing to public policy infl uence, advocacy and lobbying; adequately invest in research to treat and research and development for neglected prevent diseases such as malaria, which are diseases; patents and licensing; quality and more or less eradicated in the developed world, technology transfer; pricing, discounting and but still affect large portions of the global donations; ethical promotion and marketing; population. clinical trials; public/private partnerships; corruption; associations of pharmaceutical ACTION BY PHARMACEUTI- companies and monitoring and accountability. CAL CORPORATIONS The guidelines emphasise transparency and An increasing number of pharmaceutical equality. The guidelines state that companies corporations are adopting formal policy should incorporate human rights into their statements that explicitly refer to human ‘strategies, policies, programmes, projects and rights, including: Azko Nobel, Alliance Boots, activities’ and that companies should comply Bayer, GlaxoSmithKline, Novartis and Roche.2 with the laws of their home state as well as the For example, the corporate responsibility nations in which they operate. The guidelines principles published on GlaxoSmithKline’s call for internal and external monitoring and website include a commitment to uphold the accountability mechanisms, to ensure that UN Universal Declaration of Human Rights and observance of human rights is more than just an undertaking to ‘...fi nd sustainable ways to ‘window dressing’. improve access to medicines for disadvantaged The obligations contained in the sections on people...’3 patents and licensing, and pricing, discounting and donations are likely to be especially THE PURPOSE OF controversial. Many of these draft guidelines are specifi c, tangible and onerous. For example, THE GUIDELINES guideline 26 provides that companies ‘should not extend patent duration, or fi le patents for The guidelines are prefaced by an introductory existing medicines, in low-income and middle- note, which observes that nearly 2 billion people income countries.’ Guideline 29 provides that do not have access to essential medicines and pharmaceutical corporations should differentiate that 90 per cent of the world’s pharmaceuticals their pricing and discounting schemes to refl ect are consumed by just 15 per cent of the a nation’s level of economic development global population. The guidelines affi rm the (and that differential pricing and discount fundamental right of every human being to regimes should be progressively extended to all the highest attainable standard of health and medicines). confi rm that medical treatment and access to medicines are ‘vital features’ of that right.
2. http://www.business-humanrights.org/Documents/ 4. Introductory Note, paragraph H. Policies . 3. Available at:
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 rkhosl@essex. ac.uk.
CONTACTS
Annette Hughes Sarah Matheson Philip Kerr Partner, Melbourne Partner, Melbourne Partner & Trade Marks Attorney Ph: +61 3 9613 8430 Ph: +61 3 9613 8579 Sydney [email protected] [email protected] Ph: +61 2 9230 4937 [email protected] Bangkok Beijing Brisbane Peter James Andrew Pascoe Ted Marr Hanoi Partner, Brisbane Partner, Perth Consultant, Hong Kong Ho Chi Minh City Hong Kong Ph: +61 7 3334 3360 Ph: +61 8 9488 3700 Ph: +852 2903 6210 Jakarta [email protected] [email protected] [email protected] Melbourne Perth Phnom Penh Port Moresby Have your details changed? Shanghai Singapore If your details have changed or you would like to subscribe or Sydney unsubscribe to this publication or others, please go to 10895 www.aar.com.au/general/subscribe.htm or email [email protected] www.aar.com.au