The Trans Pacific Partnership Agreement negotiations and the health of Australians

The Trans Pacific Partnership Agreement has the potential to negatively impact the health of Australians by raising the cost of medicine and limiting the government\u27s ability to regulate tobacco and alcohol, argues this policy brief based on publicly available and recently leaked negotiating documents. Executive summary The purpose of this policy brief is to inform the debate from a health perspective in the final stages of the negotiations on the Trans Pacific Partnership Agreement (TPPA), particularly during meetings of chief negotiators and ministers in February 2014. This policy brief outlines the evidence about the potential health effects on the Australian community of actions related to the TPPA, based on publicly available and recently leaked negotiating documents. The purpose of the TPPA is to enhance each of the countries’ economic development and that this may lead to improved social and health development. However, although there may be positive impacts on the health and wellbeing of Australians resulting from economic growth, there are also many ways in which the TPPA has the potential to have negative impacts on the health of Australians. This policy brief examines the potential impact of provisions proposed for the TPPA on the health of Australians, focusing on two specific issues: the cost of medicines, and the ability of government to take major steps to improve the health of Australians by regulating the areas of tobacco and alcohol policy. In each of these areas we trace some of the pathways through which provisions that have been proposed for the TPPA may impact on the health of the Australian population, and the health of specific groups within the population. We highlight the ways in which some of the expected economic gains from the TPPA may be undermined by health and economic costs. Concerning the cost of medicine we focus on how proposed provisions in the TPPA could impact the affordability of medicines through several different routes: by delaying the availability of cheaper generic medicines, by altering the operation of the Pharmaceutical Benefits Scheme (PBS) making it more difficult to keep costs down, and by enabling pharmaceutical companies to sue the government over its pharmaceutical policies. These changes would increase the cost of the PBS for the government and taxpayers. Strategies to compensate for an increase in medication costs include increased cost-sharing, with patients assuming higher co-payments, or funding reallocation from other parts of the healthcare system. Provisions in the TPPA may impact the ability of Government to enforce existing policies and implement new policies that support public health. Australia is internationally recognised for the success of comprehensive strategies to reduce tobacco smoking. And more recently, there are multiple initiatives being proposed to achieve similar success to reduce harmful use of alcohol. We outline several of the many provisions in the TPPA that could affect tobacco and alcohol policies in Australia. Concerning tobacco these include an investor-state dispute settlement mechanism clause in the TPPA would provide more opportunities for tobacco companies to sue the Australian government over strong tobacco control measures. Rules about ‘indirect expropriation’ (i.e. depriving an investor of property, which, if broadly defined, can include intellectual property such as trademarks) and ‘fair and equitable treatment’ provide additional grounds for corporations to argue that their assets are being unfairly affected by government policies and laws. Provisions in the TPPA may impact the Government’s ability to implement effective alcohol control policies such as restrictions on liquor licences, bans or limits on alcohol advertising, and alcohol health warning labels. Concerning alcohol these include provisions in the Technical Barriers to Trade (TBT) Chapter of the TPPA which could limit possibilities for introducing innovative alcohol policies, such as requiring health warning labels. Provisions in the wine and spirits annex to the TBT Chapter may limit the options available to create a fully effective alcohol warnings scheme for wine and spirits. If Australia agrees to an investor-state dispute settlement (ISDS) mechanism applying to Australia, the alcohol industry will have access to a new legal channel to sue the Australian Government over alcohol policy decisions that adversely impact their investments. We conclude that while there is some potential for the TPPA to contribute to economic development, there is also significant risk that the economic gains which the TPPA may represent, as well as the health of the Australian community, will be threatened if certain proposed provisions are adopted for the TPPA. These include increased direct costs in terms of providing health care and increased use of hospitals, higher costs of obtaining pharmaceuticals, indirect costs associated with lost productivity across society, continuing or exacerbating inequalities in society, and worsening the health of Australia’s already vulnerable communities. Authored by: Katie Hirono, Centre for Health Equity Training, Research and Evaluation, University of New South Wales Deborah Gleeson, School of Public Health and Biosciences, La Trobe University Fiona Haigh, Centre for Health Equity Training, Research and Evaluation, University of New South Wales Patrick Harris, Centre for Health Equity Training, Research and Evaluation, University of New South Wale

Unpacking “Health Reform” and “Policy Capacity”; Comment on “Health Reform Requires Policy Capacity”

Health reform is the outcome of dispersed policy initiatives in different sectors, at different levels and across time. Policy work which can drive coherent health reform needs to operate across the governance structures as well as the institutions that comprise healthcare systems. Building policy capacity to support health reform calls for clarity regarding the nature of such policy work and the elements of policy capacity involved; and for evidence regarding effective strategies for capacity building

Negotiating healthy trade in Australia: health impact assessment of the proposed Trans-Pacific Partnership Agreement

Drawing on leaked texts of potential provisions of the proposed Trans-Pacific Partnership Agreement, this health impact assessment found the potential for negative impacts in the cost of medicines, tobacco control policies, alcohol control policies, and food labeling. Overview The Centre for Health Equity Training Research and Evaluation (CHETRE) has been working with a group of Australian academics and non-government organisations interested in the health of the Australian population to carry out a health impact assessment (HIA) on the Trans-Pacific Partnership Agreement (TPP) negotiations. In the absence of official publicly available drafts of the trade agreement, the health impact assessment drew on leaked texts of potential provisions and formulated policy scenarios based on high priority health policies that could be affected by the TPP. The HIA found the potential for negative impacts in each of the four areas under investigation: the cost of medicines; tobacco control policies; alcohol control policies; and food labeling. In each of these areas, the HIA report traces the relevant proposed provisions through to their likely effects on the policy scenarios onto the likely impact on the health of Australians, focusing particularly on vulnerable groups in the Australian community. The report makes a number of recommendations to DFAT regarding the TPP provisions and to the Australian Government regarding the TPP negotiating process

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

Under the influence: is the World Trade Organization a forum for industry influence over global alcohol policies? A qualitative analysis of discussions on alcohol health warning labelling, 2010-2019

Background Accelerating progress to implement effective alcohol policies is necessary to achieve multiple targets within the WHO’s Global Strategy to Reduce the Harmful Use of Alcohol and the Sustainable Development Goals. Yet, the alcohol industry’s role in shaping alcohol policy through international avenues, such as trade fora, is poorly understood. We investigate whether the World Trade Organization (WTO) is a forum for alcohol industry influence over alcohol policy. Methods We studied discussions on alcohol health-warning labelling policies at WTO’s Committee on Technical Barriers to Trade from 2010-2019 using written meeting minutes (n=83 documents). We identified instances where WTO members indicated that their statements represented industry. We further developed and applied a taxonomy of industry rhetoric to identify whether WTO member statements advanced arguments made by industry in domestic forums. Findings WTO members made 212 statements on ten alcohol labelling policy proposals. Statements featured many arguments used by industry to stall alcohol policy at the domestic level. They included de-scaling and re-framing the nature and causes of alcohol-related problems, promoting alternative policies such as information campaigns and industry partnerships. WTO members stated that their claims represented industry in 3.3% of statements, whereas 55.2% of statements featured industry arguments. Interpretation WTO discussions on alcohol health-warnings advance arguments used by the alcohol industry in domestic settings to undermine effective alcohol policy. WTO members appear to be influenced by alcohol industry interests, despite a minority of challenges explicitly referencing industry demands. Greater transparency about vested interests may be needed to overcome industry influenc

Industry influence over global alcohol policies via the World Trade Organization: a qualitative analysis of discussions on alcohol health warning labelling, 2010–19

Background: Accelerating progress to implement effective alcohol policies is necessary to achieve multiple targets within the WHO global strategy to reduce the harmful use of alcohol and the Sustainable Development Goals. However, the alcohol industry's role in shaping alcohol policy through international avenues, such as trade fora, is poorly understood. We investigate whether the World Trade Organization (WTO) is a forum for alcohol industry influence over alcohol policy. Methods: In this qualitative analysis, we studied discussions on alcohol health warning labelling policies that occurred at the WTO's Technical Barriers to Trade (TBT) Committee meetings. Using the WTO Documents Online archive, we searched the written minutes of all TBT Committee meetings available from Jan 1, 1995, to Dec 31, 2019, to identify minutes and referenced documents pertaining to discussions on health warning labelling policies. We specifically sought WTO member statements on health warning labelling policies. We identified instances in which WTO member representatives indicated that their statements represented industry. We further developed and applied a taxonomy of industry rhetoric to identify whether WTO member statements advanced arguments made by industry in domestic forums. Findings: Among 83 documents, comprising TBT Committee minutes, notifications to the WTO of the policy proposal, and written comments by WTO members, WTO members made 212 statements (between March 24, 2010, and Nov 15, 2019) on ten alcohol labelling policies proposed by Thailand, Kenya, the Dominican Republic, Israel, Turkey, Mexico, India, South Africa, Ireland, and South Korea. WTO members stated that their claims represented industry in seven (3·3%) of 212 statements, and 117 (55·2%) statements featured industry arguments. Member statements featured many arguments used by industry in domestic policy forums to stall alcohol policy. Arguments focused on descaling and reframing the nature and causes of alcohol-related problems, promoting alternative policies such as information campaigns, promoting industry partnerships, questioning the evidence, and emphasising manufacturing and wider economic costs and harms. Interpretation: WTO discussions at TBT Committee meetings on alcohol health warnings advanced arguments used by the alcohol industry in domestic settings to prevent potentially effective alcohol policies. WTO members appeared to be influenced by alcohol industry interests, although only a minority of challenges explicitly referenced industry demands. Increased transparency about vested interests might be needed to overcome industry influence. Funding: None

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%

Trade Agreements and Direct-to-Consumer Advertising of Pharmaceuticals

Abstract There is growing international concern about the risks posed by direct-to-consumer advertising (DTCA) of prescription pharmaceuticals, including via the internet. Recent trade agreements negotiated by the United States, however, incorporate provisions that may constrain national regulation of DTCA. Some provisions explicitly mention DTCA; others enable foreign investors to seek compensation if new regulations are seen to harm their investments. These provisions may thus prevent countries from restricting DTCA or put them at risk of expensive legal action from companies seeking damages due to restrictions on advertising. While the most recent example, the Trans-Pacific Partnership Agreement (TPP), collapsed following US withdrawal in January 2017, early indications of the Trump Administration’s trade policy agenda signal an even more aggressive approach on the part of the United States in negotiating advantages for American businesses. Furthermore, the eleven remaining TPP countries may decide to proceed with the agreement in the absence of the United States, with most of the original text (including the provisions relevant to DTCA) intact