Access to medicines is a core element of any pharmaceutical policy and one of the main priorities of public health policy. There are a number of challenges that we face in ensuring access to medicines including artificially low target levels of coverage, financially-strapped health care systems, limitations associated with medicine supply networks, and problems relating to access to health care services for a significant portion of the population. The situation is worse in the case of high-cost medicines, principally because of additional complexities associated with ensuring access to products that retain market exclusivity guaranteed under the patent system and granted as a means to stimulate pharmaceutical research and development. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) provides a set of flexibilities to assist governments to improve access to innovative therapies. Innovation for purposes of developing new health care technologies must be part of a broader framework within intersectoral efforts to improve health and development.1 A key component of access to medicines is affordability. The price of a medicine should not account for such a high percentage of income that consumers are either unable to afford the medicine or they are forced to sacrifice other basic needs to acquire them. In the case of medicines covered by social security systems which are either free or subsidized for users, cost is still relevant as it poses a threat to the financial sustainability of the health care system as a whole.

Asymmetries in information combined with the absence of market transparency represent other major obstacles to ensuring access. These problems must be addressed if we are to create the necessary conditions to improve access to new technologies within national health care systems in a manner that is rational, consistent with the evidence-based needs of health care.

In view of the above, it is now more critical than ever that countries in the Region of the Americas understand the need to implement coherent pharmaceutical policies. Moreover, policy implementation should be accompanied with impact assessments to ensure effective performance, bearing in mind key aspects such as innovation and management of intellectual property rights. The use of the evidence-based approach constitutes an important element for the formulation of sustainable public policies. Some of the new challenges discussed in this document have long been the focus of discussions at the international level; for example, the evaluation of health technologies and price regulation. It is now the time to review lessons learned with a view to implementing effective pharmaceutical policies in the countries of the Region, taking into consideration the recent Report of the Commission on Intellectual Property Rights, Innovation and Public Health of the World Health Organization (WHO). This document includes four chapters and two annexes. Chapter 1 provides information on background to the publication and its objectives. Chapter 2 discusses the issue of access to highcost, limited-source medicines from the public health perspective and within the framework of some WHO/PAHO initiatives. Chapter 3 describes the challenges that high-cost medicines pose for the Region, while Chapter 4 puts forward a series of strategies to help improve access to these medicines. With regard to the annexes included in this publication, Annex I provides background information on the First International Meeting on Access to High-Cost and Limited-Source Medicines, while Annex II summarizes some of the presentations given at that event...