This 24-page briefing considers the responsibilities of pharmaceutical companies for enhancing access to medicines in the context of sexual and reproductive health. It draws upon and amplifies the work of one of the authors, Paul Hunt, who acted as United Nations (UN) Special Rapporteur from 2002-2008. For the most part, he - and colleagues in the Right to Health Unit - looked at the duties of States in relation to access to medicines. However, States reported that when endeavouring to enhance access to medicines, the policies and practices of some pharmaceutical companies were a serious obstacle. After research and consultations over some years, Paul Hunt and Rajat Khosla wrote 'Human Rights Guidelines for Pharmaceutical Companies in relation to Access to Medicines'. These Guidelines were published by the UN General Assembly on August 11 2008.

To provide some substance with which to shape the responsibilities of the pharmaceutical industry, the briefing first examines the issue of access to medicine in the context of both HIV/AIDS and the human papillomavirus (HPV). Various statistics are provided to convey the severity of the situation, and the intersection with the fundamental rights to sexual and reproductive health. For instance, in developing countries, where 95% of HIV-positive people live, only 31% of people estimated to be in need of antiretroviral therapy (ART) were receiving it in 2007. The authors point to the need for pharmaceutical companies to take creative, wide-ranging steps to increase access to ART, keeping in mind the underlying issues that impact upon access in the first place. Similarly, in the case of HPV, the Gardasil vaccination is currently unaffordable to many millions in low-income and middle-income countries. In order to prevent widening the access gap, strong public-private partnerships need to be forged, the authors stress. Also, pharmaceutical companies have a key role to play in correcting misconceptions about HPV and the vaccinations (e.g., that the vaccine increases sexual risk-taking, sends mixed messages about abstaining from sexual intercourse, and usurps parental authority). The manufacturer of Gardasil, for instance, could develop culturally appropriate information packages to avoid a negative reaction against the vaccination. Critically, if access is to be enhanced, prices must come down.

Having provided this context, the authors outline the responsibilities of States to ensure that medicines are available, accessible, culturally acceptable, and of good quality. However, they stress that the pharmaceutical sector has an indispensable role to play in relation to the right to health and access to medicines; this is a shared responsibility. Thus, between 2003 and 2006, the Special Rapporteur (author Paul Hunt) engaged in many discussions on access to medicines with numerous parties, including pharmaceutical companies. It became clear that it is only reasonable to ask these companies to respect their human rights responsibilities in relation to access to medicines if specific guidance is provided and good practices identified. When a two-phase, five-year proposal to develop guidelines through constructive cooperation and collaboration with a number of major pharmaceutical companies fell through after only 2 companies agreed to participate, the Special Rapporteur himself prepared, for consultation, draft guidelines - drawing heavily upon the extensive discussions with pharmaceutical companies and others that had taken place between 2003-2006. The Special Rapporteur actively sought consultations, as well as comments on the draft version (released in September 2007). The draft Guidelines were then revised in light of numerous written and oral comments.

The final version of the Guidelines is included next, beginning on page 13 of the document. Opening with a Preamble, the Guidelines are grouped by themes such as transparency, management, monitoring and accountability, pricing, and ethical marketing. Each theme is followed by a brief Commentary. Here is an example, from the section on the theme of transparency: "It is not possible to properly understand and meaningfully evaluate access to medicines policies and practices without the disclosure of key information....Commonsense confirms that the principle of transparency...requires the information be made publicly available in a form that is accessible, manageable and useful (Guideline 7). An independent, trusted and informal body should be established to consider any disputes that may arise about whether or not a particular piece of information relating to access to medicines should be disclosed (Guideline 8). This body should also provide guidance on the legitimate grounds of non-disclosure. While Guidelines 6-8 have general application to access to medicines, other Guidelines apply the cardinal principle of transparency in specific contexts, such as public policy influence, advocacy and lobbying (Guidelines 17-19)."