The importance of prescription drugs to modern medical practice, coupled with their increasing costs, has strengthened imperatives for national health policies that ensure safety and quality, facilitate affordable access, and promote rational use. Australia has made universal and affordable prescription drug coverage a priority for decades, within a policy framework that emphasizes equity and increasing transparency in coverage design and payment decisions. By contrast, the U.S. lacks such a national policy. Furthermore, federal Medicare reforms aimed at making appropriate drug coverage (...) affordable and accessible employs two icons of the U.S. perception of fairness - the right to choose and the right to challenge coverage design limits - that mask the limited nature of the assistance. As the U.S. seeks to impose its values and priorities on other nations through the negotiation of bilateral and regional trade agreements, it becomes important to consider the two national experiences, in order to avoid trading illusory notions of fairness for true population equity. (shrink)

The role of government in assuring population access to affordable and appropriate health care represents a central question for any nation. Of particular concern is access to prescription drug coverage, not only because of the vital role played by drugs in modern medicine, but also because of their high costs. This article examines the sharply contrasting prescription drug coverage and payment policies found in Australia and the U.S. – strong political allies and international trading partners – and describes how key (...) U.S. interests have sought, through an aggressive trade agenda, to expand markets for U.S. goods and services, even when market expansions clash with other nations’ contrasting emphasis on social equity and fairness. Indeed, the nation’s bilateral free trade negotiations have brought the contours of this policy schism into sharp relief. (shrink)

The United States' pursuit of increasingly TRIPS-Plus levels of intellectual property protection for medicines in bilateral and regional trade agreements is well recognized. Less so, however, are U.S. efforts through these agreements to influence and constrain the pharmaceutical coverage programs of its trading partners. Although arguably unsuccessful in the Australia- U.S. Free Trade Agreement (AUSFTA), the U.S. nevertheless succeeded in its bilateral FTA with South Korea (KORUS) in establishing prescriptive provisions pertaining to the operation of coverage and reimbursement programs for (...) medicines and medical devices, which have the potential to adversely impact future access in that country. More recently, draft texts leaked from the current Trans Pacific Partnership Agreement (TPPA) negotiations show that U.S. objectives include not only AUSFTA-Plus and KORUS-Plus IP provisions but also ambitious inroads into the domestic health programs of its TPPA partners. This highlights the apparent conflict between trade goals — pursued through multilateral legal instruments to promote economic “health”— and public health objectives, such as the development of treatments for neglected diseases, the pursuit of efficiency and equity in priority setting, and the procurement of medicines at prices that reflect their therapeutic value and facilitate affordable access. (shrink)

The United States’ pursuit of increasingly TRIPS-Plus levels of intellectual property protection for medicines in bilateral and regional trade agreements is well recognized. Less so, however, are U.S. efforts through these agreements, to directly influence and constrain the pharmaceutical coverage programs of its trading partners. The pursuit of increasing levels of intellectual property protection in successive bilateral and regional trade agreements has been driven, at least in part, by a U.S. desire to achieve standards of protection it anticipated from the (...) TRIPS Agreement, but failed to secure. Despite the conclusion of a global agreement on IP standards that would establish significant protections in countries that had hitherto declined them, the U.S. pharmaceutical industry viewed TRIPS as falling well short of its objectives — particularly in light of the delayed introduction of patent protection in countries that are key suppliers of generic medicines, such as India. (shrink)

Misuse or misunderstanding of medication information is a common and costly problem in the U.S. The risks of misunderstanding medication information are compounded for the large and growing population of individuals with limited English proficiency that often lacks access to this information in their own language. This paper examines practices related to translation of medication information in the European Union that may serve as a model for future U.S. policy efforts to improve the quality and availability of medication information for (...) individuals with limited English proficiency. (shrink)

Access to clear and concise medication information is essential to support safe and effective use of prescription drugs. Patient misunderstanding of medication information is a common reason for non-adherence to medication regimens and a leading cause of outpatient medication errors and adverse drug events in the U.S. Medication errors are the most common source of risk to patient safety, leading to poor health outcomes, hospitalizations, and deaths. Over half a million adverse drug events occur in the outpatient setting each year (...) at a cost of approximately $1 billion annually.Nearly half of adults in the U.S. experience difficulty understanding and acting upon health information. Even individuals with high levels of general literacy may find medication information difficult to understand or use. The risk of misunderstanding medication information is compounded for patients with limited English proficiency who may not have access to this information in their own language. (shrink)