A/63/263
GlaxoSmithKline (see para. 2 above) did not specifically examine the draft
Guidelines, the mission provided an excellent occasion to reflect very closely on the
issues, and the Special Rapporteur is most grateful for that opportunity. A few
companies sent helpful written comments on the draft. Some 40 stakeholders sent
written comments, all of which were placed on the web, with a small handful of
exceptions where confidentiality was requested.
39. In summary, extensive written and oral comments on the draft were received
from a very wide range of stakeholders encompassing States, institutional investors,
pharmaceutical companies, specialized agencies, national human rights institutions,
non-governmental organizations, academics, and others. The Special Rapporteur
takes this opportunity to warmly thank all of those who provided their invaluable
comments, advice and information. A special thank you is due to Realizing Rights:
The Ethical Globalization Initiative. The Special Rapporteur, however, has sole
responsibility for the draft and final version of the Guidelines.
40. When the Special Rapporteur informed the General Assembly in October 2006
that he intended to prepare draft guidelines, he was encouraged to proceed with this
challenging project. He updated the Human Rights Council in March 2007 and the
General Assembly in October 2007. When reporting to the Human Rights Council in
March 2008, he confirmed his intention to finalize the text before the end of July
2008.
The Guidelines
41. The draft Guidelines were extensively revised in the light of the very
numerous written and oral comments. The final version of the Guidelines is
contained in the annex to the present report. Beginning 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.
42. The Guidelines should be read with the Special Rapporteur’s report to the
General Assembly on access to medicines (A/61/338). That report includes a section
on the responsibilities of States and another on the responsibilities of
pharmaceutical companies. The discussion and analysis will not be repeated here.
Instead, some interrelated points are briefly emphasized.
Health systems
43. At the heart of the right to the highest attainable standard of health lies an
effective and integrated health system, encompassing medical care and the
underlying determinants of health, which is responsive to national and local
priorities, and accessible to all. Medical care and access to medicines are vital
elements of an effective, integrated, responsive and accessible health system. Their
full realization crucially depends upon such a system being in place. In many
countries, however, health systems are failing and collapsing (see A/HRC/7/11).
There are, in many countries, extremely grave systemic obstacles to enhancing
access to medicines, such as clinics without health workers and the most basic
facilities. While immediate steps can be taken by a range of actors to enhance access
to medicines, it is imperative that systemic obstacles are recognized and tackled as a
matter of priority and urgency.
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