The UNESCO Bioethics Declaration 'social responsibility' principle and cost-effectiveness price evaluations for essential medicines.

The United Nations Scientific, Education and Cultural Organisation (UNESCO) has commenced drafting a Universal Bioethics Declaration. Some in the relevant UNESCO drafting committee have previously desired to restrict its content to general principles concerning the application (but not necessarily the goals) of science and technology. As potentially a crucial agenda-setting statement of global bioethics, however, it is arguable important the Universal Bioethics Declaration transparently address major bioethical dilemmas in the field of public health, such as universal access to affordable, essential medicines. Article 13 (Social Responsibility) of the Preliminary Draft Universal Bioethics Declaration states: 'Any decision or practice shall ensure that progress in science and technology contributes, wherever possible, to the common good, including the achievement of goals such as: (i) access to quality health care and essential medicines, including for reproductive health and health of children.' Cost effectiveness pricing systems, such as that most notably used in Australia's Pharmaceutical Benefits Scheme (PBS), arguably represent one of the most scientifically effective mechanisms whereby public monies may be utilised to assist in the provision of medicines for the common good. They contain two essential elements: first, a process of scientific evaluation of objectively demonstrated therapeutic significance, and then, a fiscal lever (the government reimbursement price) attached to that evaluation. It is now well established that the US Pharmaceutical Research and Manufacturers Association (Pharma), through the assistance of the US Trade Representative (USTR), saw the Australia United States Free Trade Agreement (AUSFTA) as an opportunity to fulfill a legislative mandate to 'eliminate' the cost-effectiveness pricing system in Australia's PBS. One of the most remarkable features of the arguments raised against the PBS in this context was the fact that they made almost no reference to the normative discourse of bioethics or international human rights. Provisions such as Article 13 in UNESCO's Universal Bioethics Declaration, although they will create no immediate obligations under international law, may play an extremely valuable role in legitimising the use of bioethical and human rights concepts in access to medicines debates surrounding multilateral and bilateral international trade deals such as the AUSFTA.