Evidence-Based Decision-Making Within Australia's Pharmaceutical Benefits Scheme

Provides an overview of Australia's Pharmaceutical Benefits Scheme and its consideration of both comparative effectiveness and cost-effectiveness in deciding on drug subsidies. Outlines its framework, structure, and impact on policy and practice

Paying for "End-of-Life" Drugs in Australia, Germany, and the United Kingdom: Balancing Policy, Pragmatism, and Societal Values

Analyzes British, Australian, and German health systems' policies on covering expensive end-of-life drugs while maintaining equity and efficiency, such as requiring evidence of comparative clinical and cost-effectiveness. Outlines challenges for the U.S

What is fair? Choice, fairness and transparency in access to prescription medicines in the United States and Australia

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

How the Trans Pacific Partnership Agreement could undermine PHARMAC and threaten access to affordable medicines and health equity in New Zealand

New Zealand\u27s Pharmaceutical Management Agency (PHARMAC) has been highly successful in facilitating affordable access to medicines through a combination of aggressive price negotiations, innovative procurement mechanisms, and careful evaluation of value for money. Recently the US government, through the establishment of a series of bilateral and plurilateral “free” trade agreements, has attempted to constrain the pharmaceutical access programs of other countries in order to promote the interests of the pharmaceutical industry. The Trans Pacific Partnership Agreement (TPPA) represents the latest example; through the TPPA the US is seeking to eliminate therapeutic reference pricing, introduce appeals processes for pharmaceutical companies to challenge formulary listing and pricing decisions, and introduce onerous disclosure and “transparency” provisions that facilitate industry involvement in decision-making around coverage and pricing of medicines (and medical devices). This paper argues that the US agenda, if successfully prosecuted, would be likely to increase costs and reduce access to affordable medicines for New Zealanders. This would in turn be likely to exacerbate known inequities in access to medicines and thus disproportionately affect disadvantaged population groups, including Māori and Pacific peoples

Toward a definition of pharmaceutical innovation

Ongoing debates in the pharmaceutical sector about intellectual property, pricing and reimbursement, and public research investments have a common denominator: he pursuit of innovation. However, there is little clarity about what constitutes a true pharmaceutical innovation, and as a result there is confusion about what kind of new products should be pursued, protected and encouraged through health policy and clinical practice. If the concept of pharmaceutical innovation can be clarified, then it may become easier for health policy-makers and practitioners to evaluate, adopt and procure products in ways that appropriately recognize, encourage and give priority to truly valuable pharmaceutical innovations

The Trans Pacific Partnership Agreement, intellectual property and medicines: Differential outcomes for developed and developing countries

The final text of the Trans Pacific Partnership Agreement (TPP), agreed between the 12 negotiating countries in 2016, included a suite of intellectual property provisions intended to expand and extend pharmaceutical company exclusivities on medicines. It drew wide criticism for including such provisions in an agreement that involved developing countries (Vietnam, Peru, Malaysia, Mexico, Chile and Brunei Darussalam) because of the effect on delaying the introduction of low-cost generics. While developing nations negotiated transition periods for implementing some obligations, all parties would have eventually been expected to meet the same standards had the TPP come into force. While the TPP has stalled following US withdrawal, there are moves by some of the remaining countries to reinvigorate the agreement without the United States. The proponents may seek to retain as much as possible of the original text in the hope that the United States will re-join the accord in future. This article presents a comparative analysis of the impact the final 2016 TPP intellectual property chapter could be expected to have (if implemented in its current form) on the intellectual property laws and regulatory regimes for medicines in the TPP countries. Drawing on the published literature, it traces the likely impact on access to medicines. It focuses particularly on the differential impact on regulatory frameworks for developed and developing nations (in terms of whether or not legislative action would have been required to implement the agreement). The article also explores the political and economic dynamics that contributed to these differential outcomes

Assessing the impact of alternative patent systems on the cost of health care: the TPPA and HIV treatment in Vietnam

In the Trans Pacific partnership Agreement (TPPA) negotiations, the United States has proposed expanded patent protections that will likely impact the affordability of medicines in TPPA partners. This includes antiretroviral (ARV) medicines used in the treatment of HIV/AIDS. Vietnam has the lowest GDP per capita (US$1,911 in 2013) of the 12 countries participating in the TPPA negotiations. By the end of 2013 antiretroviral (ARV) therapy was provided to 68% of those meeting the clinical criteria for such medicines. Using the current Vietnamese patent regime as our base case, we analyse the potential impact of alternative patent regimes on access to ARVs in Vietnam. The two other scenarios investigated are a patent regime making full use of TRIPS flexibilities, and a regime based on the US proposals in the 2014 leaked draft of the TPPA intellectual property chapter. We identified the most commonly used ARV medicines and examined patent data sets to discover patents that had been registered for these. We then used information from these patents to identify which might be granted under alternative patent regimes. We then estimated prices under the three patent scenarios. The current ARV budget was used as a constraint. Our results indicate 82% of the HIV population eligible for treatment would receive ARVs under a full TRIPS flexibility scenario, while only 30% of Vietnam's eligible HIV patients would have access to ARVs under the US 2014 TPPA proposals - more than halving the proportion treated compared to the current 68%