Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good

摘要

? Expert evaluations of the safety, efficacy and cost-effectiveness of pharmaceutical and medical devices, prior to marketing approval or reimbursement listing, collectively represent a globally important public good. The scientific processes involved play a major role in protecting the public from product risks such as unintended or adverse events, sub-standard production and unnecessary burdens on individual and governmental healthcare budgets. ? Most States now have an increasing policy interest in this area, though institutional arrangements, particularly in the area of cost-effectiveness analysis of medical devices, are not uniformly advanced and are fragile in the face of opposing multinational industry pressure to recoup investment and maintain profit margins. ? This paper examines the possibility, in this context, of States commencing negotiations toward bilateral trade agreement provisions, and ultimately perhaps a multilateral Treaty, on safety, efficacy and cost-effectiveness analysis of pharmaceuticals and medical devices. Such obligations may robustly facilitate a conceptually interlinked, but endangered, global public good, without compromising the capacity of intellectual property laws to facilitate local product innovations.