Hostname: page-component-7b7567c8c-kwt9d Total loading time: 0 Render date: 2026-11-15T05:52:14.400Z Has data issue: false hasContentIssue false
  • English
  • Français

Public Health and the Trans-Pacific Partnership Agreement

Published online by Cambridge University Press:  22 August 2014

Andrew D. MITCHELLOpen the ORCID record for Andrew D. MITCHELL[Opens in a new window],
Tania VOONOpen the ORCID record for Tania VOON[Opens in a new window] and
Devon WHITTLE
Andrew D. MITCHELL
Affiliation:
University of Melbourne, Australiaa.mitchell@unimelb.edu.au
Tania VOON
Affiliation:
University of Melbourne, Australiatania.voon@unimelb.edu.au
Devon WHITTLE
Affiliation:
University of Melbourne, Australiadevonwhittle@gmail.com
Rights & Permissions [Opens in a new window]

Abstract

The Trans-Pacific Partnership Agreement (TPP) has an ambitious agenda and could radically reshape trade in the Asia-Pacific. At the same time, TPP obligations have the potential to significantly restrict the ability of governments to regulate in the interests of public health. This paper examines the impact the TPP could have on two areas of public health regulation—tobacco control and access to medicines. It concludes that a number of legitimate concerns arise from the known content of the TPP, that the inclusion of a general health exception would be the preferable means of safeguarding the regulatory space of governments in relation to public health, and that the United States’ proposals for stronger intellectual property protections be resisted. With negotiations shrouded in secrecy, TPP parties’ desires to promote international trade and investment must not overshadow the need of governments to be able to implement sensible and effective public health policy.

Information

Type
Articles
Information
Asian Journal of International Law , Volume 5 , Issue 2 , July 2015, pp. 279 - 309
Copyright
Copyright © Asian Journal of International Law 2014 

The Trans-Pacific Partnership Agreement (TPP) has been heralded as a twenty-first century agreementFootnote 1 with an ambitious agenda and the potential to set a new baseline for future trade and investment agreements.Footnote 2 With twelve countries currently involved in negotiations as they reach their final stages,Footnote 3 and others also expressing interest in joining in the future, the TPP is likely to have a broad geographic scope, accounting for nearly forty percent of global GDPFootnote 4 and covering a comprehensive range of topics.Footnote 5 However, the breadth and depth of the TPP, and its potential to restrict governments’ policy space, have been a cause for concern for a range of commentators including some public health advocates and legal scholars.Footnote 6 Particularly intense objections have been made to the lack of transparency in the negotiations and the influence of corporate interests in the formulation of the TPP to the exclusion of other voices.Footnote 7 Health concerns about the TPP extend beyond the treaty itself, given that the provisions negotiated in the TPP may well form the starting point for negotiation of many other future agreements in the realm of international trade and investment.

The original basis of the TPP was the Trans-Pacific Strategic Economic Partnership Agreement between New Zealand,Footnote 8 Singapore,Footnote 9 Brunei Darussalam,Footnote 10 and Chile.Footnote 11 Building on that agreement, formal negotiation of the TPP began in March 2010 between eight countries—Australia, Brunei Darussalam, Chile, New Zealand, Peru, Singapore, the United States (US), and Vietnam.Footnote 12 Since that date, numerous additional rounds of negotiation have taken place and four more countries have joined the negotiations to date—Canada, Japan, Malaysia, and Mexico.Footnote 13 Many of the negotiating states have previously concluded preferential trade and bilateral investment agreements between themselves.Footnote 14 However, the TPP is likely to go significantly beyond those commitments in further liberalizing markets and imposing additional obligations.

The TPP has “five defining features”,Footnote 15 being designed to:

  1. 1. Ensure “comprehensive market access”;

  2. 2. Be a “fully regional agreement”;

  3. 3. Deal with “[c]ross-cutting trade issues”—namely, regulatory coherence, competitiveness and business facilitation, small- and medium-sized enterprises’ engagement in international trade, and development;

  4. 4. Deal with “[n]ew trade challenges”, including the digital economy and green technologies; and

  5. 5. Be a “living agreement”, one that can be updated as needed to deal with new issues as they arise and to include new members in the future.Footnote 16

In addition to reducing tariffs and subsidies and increasing market access, the TPP is expected to include obligations in relation to, among other things, the protection of intellectual property rights, the protection of foreign investment, the coherence of internal regulations and the process for developing them, and government transparency. These obligations are intended to reduce non-tariff barriers to trade (e.g. regulation “behind the border”), but they have been criticized as unduly interfering with governments’ regulatory autonomy.Footnote 17 In particular, the US has been accused of using the TPP to push a stronger intellectual property agenda and to impose on TPP parties mandatory regulatory practices that favour corporate interests.Footnote 18

This paper examines the implications of the TPP for public health regulation within the broader legal framework surrounding the TPP. In particular, the paper takes account of TPP parties’ existing obligations under the World Trade Organization (WTO) agreements, preferential trade agreements (PTAs), and bilateral investment treaties (BITs). After examining the cross-cutting issue of investor-state dispute settlement (ISDS) in the TPP in connection with health, the paper focuses on two key areas of health regulation in turn: tobacco control and access to medicines.

The paper notes that while serious attention must be paid to the scope and structure of ISDS in the TPP, the availability of this dispute settlement mechanism (which operates on a reciprocal basis among treaty parties) may be significant in attracting inbound and protecting outbound investment. Moreover, many criticisms of ISDS may be addressed by clarifying substantive investment obligations in the TPP to provide sufficient policy space, and by ensuring sufficient exceptions for health are included in the treaty. Similarly, excluding tobacco products from the treaty as a whole may have unintended effects that do not necessarily benefit health and may in fact undermine public health objectives. Nevertheless, any health exception would need to be broad enough to cover all tobacco control-related concerns. In addition, the push towards regulatory coherence and transparency in the TPP must not undermine legitimate efforts to exclude the tobacco industry from the formulation of tobacco control regulation beyond what is absolutely necessary. Finally, as regards access to medicines, leaked TPP proposals and negotiating texts suggest a worrying move towards increased protections for pharmaceutical patents, and heightened prescription of processes and outcomes in government regulation of pharmaceutical pricing and purchasing.

I. Investor-State Dispute Settlement in the TPP

A. Origins and Development of Investor-State Dispute Settlement

ISDS mechanisms have been routinely included in BITs and some PTAs with investment chapters (collectively, international investment agreements or IIAs), enabling foreign investors (e.g. individuals or corporations) to bring actions directly against a host state for breach of the relevant treaty. This form of dispute settlement contrasts with WTO dispute settlement, under which only WTO members (which are states or state-like entities such as the European Union and Hong Kong, China) may bring claims against other WTO members for breach of WTO law. ISDS also differs from the “state-state” dispute settlement that is typically available in BITs and PTAs, under which one treaty party may bring a claim against another treaty party for a treaty breach. Allowing an investor to bring a direct claim against the host state means that the investor need not rely on its home state to bring an action, which may present a barrier to the investor's claim given the home state's various political, strategic, and economic interests in the relationship with the host state.

Historically, IIAs in general and ISDS provisions in particular have been designed to ameliorate the conditions for foreign investment in the participating countries, in order to encourage foreign investment. The availability of ISDS may be particularly important in promoting investment in countries lacking strong dispute settlement institutions, by guaranteeing investors independent venues for the resolution of disputes over their investments.Footnote 19 IIAs in general and ISDS in particular may thus help increase investment between vastly different jurisdictions and legal systems and to countries that are otherwise subject to high levels of sovereign risk.Footnote 20 The security provided by ISDS may be particularly important for investments involving high up-front infrastructure and similar costs, such as in the resources sector, where a change in the regulatory or other aspects of the host state environment cannot be easily addressed through a move to another country.Footnote 21 Even for developed economies, ISDS has been said to be a significant factor in attracting foreign investment. South Korea's deputy trade minister notably described ISDS as “essential in wooing foreign investment”.Footnote 22

Traditionally, IIAs were seen as protecting the interests of investors from developed countries in developing countries, and ISDS was expected to be used primarily by developed country investors against developing country host states, including within the North American Free Trade Agreement(NAFTA)Footnote 23 between the US, Canada, and Mexico.Footnote 24 However, over time these expectations have not been borne out. IIAs are being concluded between developed countries and between developing countries, often on a regional basis,Footnote 25 and ISDS claims are being brought against a broader range of respondent states, including developed countries.Footnote 26 Within NAFTA, claims are routinely brought by Mexican investors against the US or Canada.Footnote 27 ISDS claims against developed and developing countries relevant to public health have concerned matters such as pharmaceutical imports, marketing, and sales;Footnote 28 medical services;Footnote 29 blood treatment and processing;Footnote 30 health insurance;Footnote 31 and environmental health effects of products such as pesticides,Footnote 32 fuel additives,Footnote 33 and water contamination through mine waste disposal.Footnote 34

B. The June 2012 Leaked TPP Investment Chapter

In June 2012, a draft of the TPP's investment chapter was leaked, including a proposed set of ISDS provisions.Footnote 35 Under this draft, aggrieved investors would be able to engage TPP parties in mandatory consultationsFootnote 36 and arbitration if they believe they have suffered a loss as a result of a TPP breach.Footnote 37 Health-based and broader critiques of this leaked chapter reflect two separate but related matters. First, distrust of ISDS mechanisms themselves as being too protective of corporate interests and too restrictive of government policy-making.Footnote 38 Second, concerns about the substantive investment obligations of the TPP that would be enforceable through ISDS. We address these two matters below, before turning to the use of exceptions to preserve governments’ autonomy in regulating for health.

C. Utility and Impact of Investor-State Dispute Settlement

Numerous commentators have suggested that the inclusion of an ISDS mechanism in the TPP would privilege corporate interests over broader public interests such as the protection of health, restricting governments’ ability to regulate effectively in the public health arena.Footnote 39 Specific fears expressed regarding the process and substance of ISDS in connection with the TPP include: the lack of transparency of arbitral proceedings, the lack of independence and impartiality of arbitrators, the lack of public health expertise of arbitrators, the granting of advantages to foreign investors in comparison with domestic entities,Footnote 40 and the high cost of investment treaty arbitrations.Footnote 41 The prospect of being engaged in expensive, drawn-out, and uncertain arbitration is also said to have a chilling effect on government action and to inappropriately hinder governments’ regulatory ability.Footnote 42 Many of these concerns are not specific to the TPP. The utility and impact of ISDS have been increasingly questioned. Scholars and non-governmental organizations alike have queried the appropriateness of an ISDS arbitral tribunal as a venue for the resolution of disputes about government policy.Footnote 43

Particular difficulties have been highlighted with the use of ISDS in connection with tobacco control regulation (discussed in more detail below). In 2012, the world's first standardized (or “plain”) tobacco packaging regime was fully implemented in Australia,Footnote 44 with Ireland,Footnote 45 New Zealand,Footnote 46 and the UKFootnote 47 now taking steps towards similar measures. Philip Morris Asia Limited has brought an investment treaty challengeFootnote 48 against Australia's plain packaging regime pursuant to Australia's BIT with Hong Kong.Footnote 49 Philip Morris Switzerland has also brought a claimFootnote 50 against certain aspects of Uruguay's tobacco labelling and packaging requirements pursuant to the BIT between Switzerland and Uruguay.Footnote 51 Both disputes have been put forward in relation to the TPP negotiations as evidence that ISDS clauses make governments vulnerable to challenge by tobacco companies and thus will benefit the tobacco industry at the expense of sound public health policy.Footnote 52

The Australian Productivity Commission has questioned the traditional understanding that ISDS increases foreign investment.Footnote 53 Partly as a result of that body's recommendations, and before the Philip Morris dispute against Australia began, Australia's then Labor government, led by former Prime Minister Julia Gillard, announced a new policy under which ISDS would not be pursued where it would grant greater rights to foreign investors than to domestic investors.Footnote 54 Accordingly, Australia's position on the TPP was clear: no ISDS for Australia, even if the treaty was to include ISDS for other parties.Footnote 55 Australia's position in this regard was reflected in the leaked TPP investment chapter.Footnote 56 However, Australia's September 2013 election led to a new conservative government led by the current Prime Minister Tony Abbott and a new “case by case” approach to ISDS.Footnote 57 Shortly after the election, reports suggested that the government would be maintaining Australia's opposition to ISDS in the TPP,Footnote 58 but that position was later modified to indicate that the government had not yet reached a firm conclusion regarding ISDS in the TPP.Footnote 59

General and TPP-specific criticisms of ISDS often focus on its potential negatives without taking into account the potential benefits that these types of provision can provide for investors and, in turn, for governments seeking to encourage inbound foreign investment and protect outbound foreign investment, in both cases to support economic growth and development.Footnote 60 In contrast, Associate Professor Julien Chaisse of the Chinese University of Hong Kong argues that although “the ISDS process has deficiencies and that the substantive rules it applies need refinement”,Footnote 61 removing ISDS protections will leave members and investors at the mercy of “the (arbitrary) political realm of diplomatic protection, on the one hand, and (non-neutral) domestic courts on the other”.Footnote 62 Commenting on the Gillard government's trade policy statement of 2011, Professor Luke Nottage of the University of Sydney, Australia, cautions:

[A] reversion to ad hoc inter-state political solutions seems unlikely to be conducive to economic activity, and risks either needlessly escalating disputes or dampening legitimate claims by investors against host states. A better approach is to rebalance legal and political mechanisms to meet contemporary needs and expectations.Footnote 63

Similarly, Professor Trakman of the same university points out that “by insisting that local courts, not investment arbitration decide BIT disputes, Australia places its investors at risk in host states where local court systems do not apply a conception of the rule of law with which Australia identifies”.Footnote 64

If ISDS is to be included in the TPP, at least some of its adverse effects could be dealt with by incorporating in the treaty appropriate procedural and institutional arrangements—for example, through the use of appropriate arbitral rules, conflict/independence requirements for arbitrators, and empowering arbitrators to regulate spurious claims made against states.Footnote 65 Conversely, if ISDS is excluded from the TPP (generally or for some countries only, such as Australia), the obligations of the treaty will still be subject to enforcement by way of any state-state dispute settlement mechanism included in the final text. Ultimately, therefore, whatever dispute settlement mechanisms are established under the TPP, health objectives must also be taken into account in crafting and assessing the substantive obligations and exceptions under the treaty.

D. Substantive Investment Obligations

As noted above, several problems perceived to stem from ISDS relate more to the underlying investment obligations imposed by IIAs on states than to the ISDS mechanism itself. To begin with, the leaked TPP text includes a very broad definition of “investment”,Footnote 66 leading to concerns that the TPP obligations regarding expropriation and the minimum standard of treatment of foreign investors could extend to tobacco control measures affecting the use of trademarks,Footnote 67 an issue we return to below. However, this broad definition of investment is common to IIAs and does not necessarily preclude sensitive application in respect of public health issues.

The potentially negative impact of ISDS on public health could be mitigated by carefully crafting investment obligations to prevent overreaching. More nuanced approaches to core obligations such as non-discrimination, expropriation, and fair and equitable treatment are found in various IIAs, and similar clarifications could be included in the TPP. This could include, for example, clarifying that:

  1. 1. The scope of the most-favoured-nation (MFN) obligation to ensure that it does not allow an investor to invoke more preferable dispute settlement procedures from other IIAs.Footnote 68 A provision in the leaked TPP investment chapter does specify that the MFN provision “does not encompass international dispute resolution procedures or mechanisms such as those included in Section B” on ISDS.Footnote 69

  2. 2. The obligation to accord fair and equitable treatment does not go beyond the minimum standard of treatment of aliens required under customary international law.Footnote 70 A qualification of this kind does appear in the leaked TPP investment chapter.Footnote 71

  3. 3. The obligation not to engage in unlawful expropriation does not generally preclude non-discriminatory regulatory actions to achieve public welfare objectives.Footnote 72 Indeed, a square bracketed passage in Annex 12-C of the leaked TPP investment chapter states: “Except in rare circumstances, non-discriminatory regulatory actions by a Party that are designed and applied to protect … legitimate public welfare objectives such as public health, safety, and the environment, do not constitute indirect expropriations.”Footnote 73 An additional bracketed note specifies: “For greater certainty, the list of legitimate public welfare objective[s] in this subparagraph is not exhaustive.” A specific exception from the expropriation obligation also applies to the “issuance of compulsory licenses granted … in accordance with”Footnote 74 the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights(TRIPS).Footnote 75

This third example of how to draft an investment obligation without unnecessarily impinging on public health objectives brings us to the question of explicit exceptions to obligations on the grounds of health.

E. Health Exceptions to Investment Obligations

A general exception for the protection of public health could provide significant protection to governments from ISDS claims by foreign investors in connection with health regulation. An exception provides a fall-back position for governments. If a challenged measure is found to violate an obligation of the treaty (notwithstanding the incorporated flexibilities as described above), the exception offers a further means of avoiding liability. Of course, any exception must be carefully drafted to ensure it achieves sufficient coverage without being open to abuse.

An exception for public health regulation in the TPP could apply to the agreement as a whole, to the investment chapter, or to ISDS in particular. Several IIAs preclude ISDS in relation to disputes concerning particular obligations or particular measures or areas, such as property and real estate,Footnote 76 prudential measures,Footnote 77 taxation measures,Footnote 78 or security issues.Footnote 79 Many IIAs also contain general exceptions modelled on international trade law, explicitly referring to “human, animal or plant life or health”. An example of an exception derived from the general exceptions in Article XX(b) of the WTO's General Agreement on Tariffs and Trade 1994 (GATT)Footnote 80 and Article XIV of the General Agreement on Trade in Services(GATS)Footnote 81 is found in a Canadian model agreement:

Subject to the requirement that such measures are not applied in a manner that would constitute arbitrary or unjustifiable discrimination between investments or between investors, or a disguised restriction on international trade or investment, nothing in this Agreement shall be construed to prevent a Party from adopting or enforcing measures necessary:

(a) to protect human, animal or plant life or health …Footnote 82

Some IIAs include similar exceptions but without including a “necessity” requirement, reducing the threshold at which a measure will be exempt. For example, some IIAs specify:

The provisions of this Agreement shall not in any way limit the right of either Contracting Party to apply prohibitions or restrictions of any kind or take any other action directed to the protection of its essential security interests, or to the protection of public health or the prevention of disease and pests in animals or plants.Footnote 83

Chaisse rightly points out that exceptions developed in the international trade law context do not necessarily transpose well into international investment law, where jurisprudence has developed generally in the absence of such exceptions, so that their late introduction may be superfluous or create unnecessary interpretative difficulties.Footnote 84 Careful drafting of exceptions is obviously crucial to ensure clarity and consistency across the treaty. Nevertheless, from the perspective of a government concerned about public health protection, an additional mechanism for fending off challenges to legitimate regulation may be preferred to enhance certainty in its regulatory activities.

The leaked TPP investment chapter does include the following exception with respect to the investment chapter as a whole:

[Nothing in this chapter shall be construed to prevent a Party from adopting, maintaining or enforcing any measure otherwise consistent with this Chapter that it considers appropriate to ensure that investment activity in its territory is undertaken in a manner sensitive to environmental [, health, safety, or labour] [, health or safety] concerns.]Footnote 85

The TPP may also include a general exception directed towards health regulation to supplement this exception in the investment chapter, providing protection in relation to the other TPP obligations as well. It would not be unsurprising to find such an exception in the final text, particularly given the location of the square brackets in the provision above, which may suggest that the issue of labour is more controversial among the negotiating parties than the issue of health. The likelihood of a general health exception is supported by a 2013 statement by the United States Trade Representative (USTR).Footnote 86

II. Tobacco Regulation and the TPP

A. A Carve-Out for Tobacco in the TPP?

Tobacco has long being recognized as a serious health risk and major risk factor for non-communicable diseases. As a result, many governments have instituted measures designed to inform consumers of the health risks associated with tobacco consumption and to reduce tobacco consumption within their borders. Measures such as cigarette warning labels, advertising restrictions, and high tax rates have been successful in reducing smoking levels and the incidence of non-communicable diseases.Footnote 87

Against this background, exceptions specifically relating to tobacco have been extensively discussed in the TPP negotiations. The Office of the United States Trade Representative released details of one draft proposal in May 2012Footnote 88 and a revised proposal in August 2013Footnote 89 that was tabled on 26 August 2013 during the 19th round of TPP negotiations held in Brunei Darussalam. On the same day, Malaysia tabled a separate, broader proposal to carve out tobacco.Footnote 90 If accepted, such a proposal would have wide-ranging implications for not just the TPP's ISDS provisions but also, arguably, for the trademark and regulatory coherence provisions of the TPP, which are discussed later in this paper.Footnote 91

These US proposals have faced criticism from “both sides”,Footnote 92 that is, tobacco control advocates and businesses. Both US proposals would not have affected market access obligations; that is, TPP parties would have obligations to reduce tariffs on tobacco and tobacco products as with other products.

The original US proposal would have “explicitly recognize[d] the unique status of tobacco products from a health and regulatory perspective” and would “include language in the ‘general exceptions’ chapter that allows health authorities in TPP governments to adopt regulations that impose origin-neutral, science-based restrictions on specific tobacco products/classes in order to safeguard public health”.Footnote 93 Health-based concerns were raisedFootnote 94 about the restriction of the exception to “regulations” (and potentially excluding laws or statutes), the requirement that the exempted restrictions be “origin-neutral” (meaning they would have to be non-discriminatory, which has already presented a problem for US regulation on tobacco flavouring in the context of the WTO),Footnote 95 and the reference to restrictions being “science-based” (which could create particular problems, for example, for tobacco control measures that have not been implemented elsewhere in the world, as was the case for Australia's plain packaging measure when it came into effect at the end of 2012).

The revised US proposal confirmed that a general exception covering health would be included, but added in regard to tobacco merely that “[w]e will propose including a provision indicating that the TPP Parties understand that general exception applies to tobacco health measures”.Footnote 96 In addition, the US indicated that it would “propose adding a provision requiring that before a Party initiates a challenge through TPP dispute settlement to another Party's tobacco regulatory measure, the health authorities of the concerned Parties shall meet to discuss the measure”.Footnote 97 This procedural requirement poses a very limited barrier to litigation against tobacco control measures and appears to pose no barrier at all to litigation in the form of ISDS (as opposed to state-state/party-party dispute settlement). Unsurprisingly, then, from a public health perspective this revised proposal was seen as a significant step backwards from the original proposal.Footnote 98

The Malaysian proposal goes further than both US proposals in excluding tobacco from the TPP, reportedly shielding tobacco control measures from both ISDS and state-state dispute settlement challenges under the treaty, leading to general praise from the public health community.Footnote 99 However, at the time of writing, very few details have been officially released regarding the precise wording of the proposal or its scope, including its impact on market access, such as ceilings or reductions on tariffs for tobacco product imports.

A specific exemption for tobacco from the TPP's ISDS or investment provisions or the entire agreement may offer protection for tobacco control regulations from the TPP's specific obligations,Footnote 100 but it could have deleterious effects on other trade and investment agreements if they do not contain similar wording.Footnote 101 For example, might a tobacco carve-out in the TPP be used to contend that its absence in another IIA reduces governments’ flexibility with respect to tobacco? Might a TPP tobacco carve-out also suggest within the TPP that other health areas are less significant and undermine any general health exception?

To ensure that tobacco control measures are sufficiently protected from ISDS or indeed state-state challenges under the TPP, a better approach would be to make the TPP's general health and safety exceptions inclusive enough to incorporate tobacco control measures, and indeed any future genuine public health measures, and to ensure that these exceptions apply to the entire TPP. This would obviate the need for specific mention of each individual public health issue facing governments and avoid a potential weakening of international trade and investment law's ability more generally to accommodate governmental action to protect public health.

Relying on general exceptions rather than a broad carve-out for a specific product also aligns better with the objectives of international trade law and international investment law, which include liberalizing trade and promoting foreign investment for the purpose of increasing economic and social welfare. Imposing market access barriers such as tariffs on tobacco products may be one way of increasing prices and thus decreasing demand in order to achieve health objectives, but it is not the only way. Sales or excise taxes can also be used across the board to increase prices and decrease demand, without discriminating against foreign investments or imported products.Footnote 102 Allowing discrimination contrary to the usual trade and investment rules may give the misleading impression that discriminating against foreign tobacco companies is acceptable because their products are somehow more harmful, when in fact tobacco produced domestically by locals is generally equally harmful because of the nature of the product itself. Similarly, excluding a product from subsidies disciplines (which is one effect of excluding a product from a PTA like the TPP) risks encouraging subsidization of the production of that product: in this case, tobacco.

Thus, although the underlying health objectives are genuine and well founded, the solution of a tobacco product carve-out is not necessarily effectively tailored to those objectives. Tobacco is certainly unique in the sense of killing half of its long-term users when used as intended,Footnote 103 but many other legal products also pose risks to health,Footnote 104 from asbestosFootnote 105 and rat poisonFootnote 106 to alcoholFootnote 107 and fast food.Footnote 108 As Lester has observed:

[P]rotection of domestic tobacco producers is no more sensible … than in other sectors. Protection for domestic producers is not a good way to reduce smoking, and there are many effective alternatives.Footnote 109

Focusing only on the immediate threat of tobacco may unintentionally diminish governments’ ability to respond appropriately to future public health threats in other areas.

B. The Rights of Owners of Tobacco Trademarks

In addition to the ISDS claim brought against Australia in relation to its mandatory plain packaging laws as noted above,Footnote 110 those laws have been challenged under Australia's ConstitutionFootnote 111 and by five countries (at the time of writing) at the WTO.Footnote 112 A common claim in the domestic and investment treaty challenges is that the Australian government has acquired or expropriated tobacco companies’ rights as owners of intellectual property (in particular trademarks) by not allowing the use of colours, logos, non-standard text, or graphics on tobacco packaging.Footnote 113 Partly as a result of these disputes, significant scholarly debate has arisen over whether particular international or domestic jurisdictions guarantee trademark owners a “positive” right to use their trademarks (as opposed to merely a “negative” right to prevent others from using them).Footnote 114 The answer to this question may differ by jurisdiction according to the particular wording of the relevant legislation or treaty. However, that wording on its face will not necessarily be determinative. For example, in the High Court of Australia, despite domestic legislation that could appear on its face to confer a positive right on trademark owners to use their trademarks, a majority implied in the constitutional challenge to Australia's plain packaging laws (which the government successfully defended) that the rights of trademark owners under Australian law are essentially negative.Footnote 115

The leaked TPP investment chapter, in describing intellectual property rights as potential “assets” falling within the notion of “investment”, refers to “intellectual property rights [which are conferred pursuant to domestic laws of each Party]”.Footnote 116 If the text were eventually finalized with these square-bracketed words, domestic law could play a defining role in relation to the scope of intellectual property rights protected by the TPP, enhancing the scope for regulatory autonomy in respect of intellectual property-related health issues.

An August 2013 negotiating text of the TPP's Intellectual Property Chapter was the most recently leaked document, in November 2013.Footnote 117 Article QQ.C.3 of that draft chapter states:

Each Party shall provide that the owner of a registered trademark shall have the exclusive right to prevent third parties not having the owner's consent from using in the course of trade identical or similar signs, [PE/MY/VN/CA/MX oppose: including subsequent geographical indications,] for goods or services that are related to those goods or services in respect of which the owner's trademark is registered, where such use would result in a likelihood of confusion.Footnote 118

The relevant part of this wording, in relation to the nature of trademark rights, tracks that of Article 16(1) of the TRIPS Agreement, which provides:

The owner of a registered trademark shall have the exclusive right to prevent all third parties not having the owner's consent from using in the course of trade identical or similar signs for goods or services which are identical or similar to those in respect of which the trademark is registered where such use would result in a likelihood of confusion.Footnote 119

The TRIPS wording has been interpreted by a WTO panel to suggest that the TRIPS Agreement does not require WTO members to confer a positive right to use trademarks on registered trademark owners.Footnote 120 In our view, WTO panels and the Appellate Body are likely to confirm this interpretation in the WTO cases against Australia (should they proceed to a formal decision). Accordingly, the TPP wording, if it follows the leaked US proposal in this regard, will not diminish parties’ rights to regulate with respect to tobacco packaging, as long as the relevant tobacco control measures do not diminish trademark owners’ rights to maintain their registrations and to prevent others from improperly using their trademarks.

C. Regulatory Coherence, Transparency, and Disclosure

The TPP's regulatory coherence provisions are aimed at reducing unnecessary barriers to trade by encouraging a reduction in regulatory and non-tariff barriers to trade and promoting a “best practice” approach to the development of regulations.Footnote 121 A US proposal for the regulatory coherence chapter from early 2010 was leaked in 2011.Footnote 122 Although the TPP's general transparency chapter has not yet been released or leaked,Footnote 123 it is expected that it will oblige governments to allow for “active participation” by stakeholders in decisions that affect them and will impose other obligations such as prompt publication of regulations and the provision of explanations and reasons for new regulations.Footnote 124 The provisions in both the regulatory coherence and transparency chapters have the potential to impact significantly on how governments develop and implement tobacco control regulations. Professor Jane Kelsey of the University of Auckland, New Zealand, among others, has interpreted the regulatory coherence and transparency provisions as being “pro-market” or “pro-business” and as providing large corporations such as tobacco companies untoward access to the regulatory process.Footnote 125

One concern raised about these chapters from the perspective of tobacco control is the potential for the TPP to require governments to engage with the tobacco industryFootnote 126 in a manner contrary to the requirements of the WHO Framework Convention on Tobacco Control (FCTC).Footnote 127 The FCTC is the first treaty negotiated pursuant to the treaty-making power of the World Health Organization (WHO). The 177 parties to the FCTC (most of which are also WTO members) include all TPP negotiating countries, apart from the US, which is a signatory but not a party.Footnote 128 Article 5.3 of the FCTC provides:

In setting and implementing their public health policies with respect to tobacco control, Parties shall act to protect these policies from commercial and other vested interests of the tobacco industry in accordance with national law.

The implementing guidelines for this provision state, among other things:

  1. 2.1 Parties should interact with the tobacco industry only when and to the extent strictly necessary to enable them to effectively regulate the tobacco industry and tobacco products.

  2. 2.2 Where interactions with the tobacco industry are necessary, Parties should ensure that such interactions are conducted transparently.Footnote 129

TPP obligations requiring interaction contrary to the FCTC and its implementing guidelines would clearly be problematic from the perspective of tobacco control. Some of the leaked provisions appear less concerning than the debate might suggest. Article X.3(7) of the leaked regulatory coherence proposal, for example, states:

Each Party should consider a variety of methods that can contribute to successful collaboration among Parties and their respective stakeholders with respect to covered regulatory measures, such as … information exchanges, dialogues, or meetings with interested stakeholders, including small- and medium-sized enterprises, of other Parties …Footnote 130

In requiring TPP parties to consider methods to increase successful collaboration, this provision does not oblige governments to institute any specific mechanism or institution.

However, Article X.6 states that a “Committee on Regulatory Coherence” established under the TPP will “establish mechanisms to ensure meaningful opportunities for interested persons to provide views on approaches to enhance regulatory coherence through the Agreement”. The TPP parties would need to ensure that in doing so the tobacco industry was not invited to the table in a manner contrary to the FCTC.

Of equal potential concern is Article X.2(1) of the leaked regulatory coherence proposal, which includes the following passage:

Accordingly, each Party shall endeavor to ensure that it has a process or mechanism to facilitate central coordination and review of certain new regulatory measures (“covered regulatory measures”) at the central level of government, and should consider establishing and maintaining a national coordinating body for this purpose.Footnote 131

The ISDS mechanism would not be expected to cover this obligation; ordinarily ISDS would cover only the obligations in the investment chapter of the agreement. However, Article X.8 of the leaked chapter specifies that the TPP (state-state) dispute settlement chapter applies (only) to “the obligation to have ‘processes or mechanisms to facilitate central coordination and review of certain new regulatory measures …’”,Footnote 132 indicating that Article X.2(1) is more than just a “best endeavours” clause. Commentators such as Kelsey have accordingly decried the leaked Article X.2(1) requirements as providing “a range of opportunities for TPP states and corporations to enter the domestic policy and legislative domain and influence decisions in their favour” and as being “unrealistic” for developing countries.Footnote 133

The leaked chapter states that the national co-ordinating body “should generally encourage relevant regulatory authorities” to conduct Regulatory Impact Assessments (RIAs).Footnote 134 An RIA creates a structure for the development of regulation that focuses on economic efficiency and regulatory necessity, aiming for decisions that are “based on the best reasonably obtainable scientific, technical, economic and other information …”.Footnote 135 This type of prescriptive structure requiring particular kinds of evidence may create difficulties, as noted above, for newer tobacco control measures that may not yet have been used or extensively studied over a large number of years. The need to develop RIAs has also been seen as a further way to push pro-industry regulatory measures, complicate the implementation of tobacco control measures, and increase the cost of doing so.Footnote 136

Given the history of ongoing evidence of the tobacco industry's extensive use of freedom of information provisions in domestic settings to hinder and delay tobacco control regulation,Footnote 137 the use of these seemingly innocuous “best practice” type measures should be viewed with some caution. Even if not phrased as positive legal obligations, these kinds of mechanism may introduce additional avenues for tobacco industry interference. Yet this is not necessarily a tobacco-specific problem. International rules requiring specific approaches to the development of regulation may not take sufficient account of domestic legal frameworks and political processes, unnecessarily promoting harmonization and creating the potential for abuse by those with the means to unduly influence decision-making.

The corollary of transparency of government processes may be seen as disclosure of tobacco industry documents and information. Some reports have indicated that a Malaysian proposal for an annex to the “technical barriers to trade” chapter of the TPP will prevent governments from requiring the disclosure of product formulas as a condition of marketing the product in their jurisdiction, contrary to the requirement in Article 10 of the FCTC that parties require tobacco manufacturers to disclose the “contents and emissions of tobacco products”.Footnote 138 However, the details of the Malaysian proposal are not clear, and thus its potential impact on disclosure regulations is unknown.Footnote 139 Moves to limit disclosure obligations, for example by allowing companies to provide merely the names and not the amounts of ingredients in products,Footnote 140 would be adverse to attempts to limit tobacco use.

III. Access to Medicines and the TPP

In addition to tobacco control, a major public health related concern arising from leaked provisions and negotiations towards the TPP is the potential impact of the treaty on access to medicines. In particular, increased intellectual property protection for patented pharmaceutical products in the TPP have been carefully scrutinized and heavily criticized in this regard. The IP chapter of the TPP has been described as its “most contentious”.Footnote 141 A US proposal for certain intellectual property provisions related to pharmaceutical products and medicines in the TPP, leaked in September 2011Footnote 142 and forming the basis of much of the content of the most recent leak of the TPP's IP provisions,Footnote 143 resulted in a number of concerns being raised regarding access to medicines.Footnote 144 This Section examines three concerns that have been raised with respect to pharmaceutical patents: increased data exclusivity provisions; increased scope of patentable subject matter, which may increase the opportunity for “evergreening” of patents;Footnote 145 and an increased term for pharmaceutical patents beyond what has been accepted previously in trade agreements, for example under TRIPS.Footnote 146 In addition, this Section discusses concerns expressed with respect to health in connection with government regulation of pharmaceutical pricing and purchasing.

A. Increased Protection for Pharmaceutical Patents

1. Data exclusivity for marketing approval

Data exclusivity provisions prevent generic drug manufacturers from using pre-existing clinical research relating to drugs already on the market in a country, for a given period, when applying for marketing approval of generic versions of the same drugs.Footnote 147 These provisions provide an additional form and period of protection to “innovator” pharmaceutical products by forcing competing generic manufacturers to duplicate clinical trials (with potential ethical difficulties)Footnote 148 or delay the introduction of their products until the expiry of the relevant exclusivity period. In the context of the TPP, Professor Susy Frankel of the Victoria University of Wellington, New Zealand, has described data exclusivity provisions as potentially acting “as a patent-term extension even if the intention is to protect the data”.Footnote 149 Other commentators have described the TPP's data exclusivity provisions as “[m]ost concerning”, as they would delay the “entry of cheaper generic medicines into the market” and increase costs for Australia's pharmaceutical purchasing subsidy regime.Footnote 150

The data exclusivity provisions being advocated by the US mandate a minimum of five years’ data exclusivity for new pharmaceutical products from the “date of marketing approval”,Footnote 151 and three years for chemical entities that have been previously approved but are being used in a new pharmaceutical product.Footnote 152 These proposals appear to be opposed by Australia, Peru, Vietnam, New Zealand, Chile, Malaysia, Singapore, and Brunei.Footnote 153 The five-year data exclusivity period for new pharmaceutical products is consistent with past US PTAs with Singapore,Footnote 154 Chile,Footnote 155 Korea,Footnote 156 and Australia.Footnote 157 Its inclusion in the TPP would apply it to a wider group of countries.

The US has also proposed an exception, but only for measures to protect public health that are in accordance with:

A. The Declaration of the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2) (the “Declaration”);

B. Any waiver of any provision of the TRIPS Agreement granted by WTO Members in accordance with the WTO Agreement to implement the Declaration and in force between the Parties; and

C. Any amendment of the TRIPS Agreement to implement the Declaration that enters into force with respect to the Parties.Footnote 158

This is a very narrow exception, directed at compulsory licensing allowed pursuant to TRIPS to assist developing countries with insufficient pharmaceutical manufacturing capacity to address serious public health concerns.Footnote 159 Furthermore, in the IP chapter leaked in November 2013, the TPP parties have agreed to “understandings regarding certain public health measures”.Footnote 160 The agreed “understandings” include that:

The obligations of this [IP] Chapter do not and should not prevent a Party from taking measures to protect public health by promoting access to medicines for all, in particular concerning cases such as HIV/AIDS, tuberculosis, malaria, [US oppose: chagas] and other epidemics as well as circumstances of extreme urgency or national emergency. Accordingly, while reiterating their commitment to this Chapter, the Parties affirm that this Chapter can and should be interpreted and implemented in a manner supportive of each Party's right to protect public health and, in particular, to promote access to medicines for all.Footnote 161

The emphasized text in this provision has been suggested as “mak[ing] it seem as if the provision is primarily about ‘HIV/AIDS, tuberculosis, malaria … and other epidemics as well as circumstances of extreme urgency or national emergency,’ instead of all medicines and diseases, including cancer”.Footnote 162 Thus the proposed public health exception for TRIPS measures could be read narrowly, given the “understandings” included in the leaked IP chapter.Footnote 163 A reference to “health”, “human health”, or “public health” would provide broader protection for health-related access to medicines concerns than an exception targeting compulsory licensing for some developing countries. For example, the US PTA with Chile includes an exception to data exclusivity provisions where “necessary to protect the public”.Footnote 164

2. Evergreening through patenting new uses

A US proposal in relation to patent protection, which appears to have Australia's support, would require TPP parties to “confirm that … patents shall be available for any new uses or methods of using a known product” and that a patent will not be denied “solely on the basis that the product did not result in enhanced efficacy of the known product when the applicant has set forth distinguishing features establishing that the invention is new, involves an inventive step, and is capable of industrial application”.Footnote 165 This proposal reflects part of the language used in the Australia-United States Free Trade Agreement (AUSFTA),Footnote 166 but goes further by specifically requiring that patent applications are not to be capable of rejection “solely on the basis” that there is no enhanced efficacy.Footnote 167

The proposed wording also closely tracks an earlier proposal of the US that was leaked in February 2011 (although it removes the earlier requirement that “new forms” of products be patentable).Footnote 168 The earlier proposal was criticized as requiring countries to allow companies to patent new uses of existing drugs even if the drug and its efficacy are unchanged, effectively extending the patent term (a practice known as “evergreening”).Footnote 169 As under TRIPS,Footnote 170 it is arguable that under both proposals an “inventive step” would still be required to justify a patent, when read in the context of the entirety of each provision. For example, the relevant provision in the latest leaked negotiating text begins:

… each Party shall make patents available for any invention, whether a product or process, in all fields of technology, provided that the invention is new, involves an inventive step, and is capable of industrial application.Footnote 171

However, the interaction between these two parts of this provision is open to interpretation. At the least, the proposal indicates that the absence of enhanced efficacy does not preclude a new use from qualifying as patentable. This creates a risk that patented pharmaceuticals will receive greater—or longer—protection, potentially limiting the access of innovative or generic medicines into the market. As noted by Associate Professor Kimberlee Weatherall of the University of Sydney, the contentious nature of intellectual property rights and the complexity of the TPP negotiations is likely to lead to a “‘blurry text’, the meaning of which is unclear”.Footnote 172 Such a result would mean greater uncertainty for TPP parties as a result of “the increasing fragmentation of international IP lawmaking”.Footnote 173 Thus, regardless of the precise legal position under the proposed text, the lack of clarity in relation to these “evergreening” positions may itself be problematic, as governments attempt to ensure that their domestic regimes comply with their international obligations.

3. Extension of pharmaceutical patent term to compensate for delays in approval

In addition to the potential for evergreening to effectively increase patent terms, concerns have been raised over the US's proposed provisions relating to extending patent terms to compensate for delays in granting a patent and for delays in marketing approval times for pharmaceutical products.Footnote 174

In the document leaked in November 2013,Footnote 175 Article QQ.E.XX (proposed by the US, and opposed by Canada, New Zealand, and Japan) requires TPP parties, when requested by patent owners, to “adjust the term of a patent to compensate for unreasonable delays that occur in the granting of the patent”. The US proposal also specifies that “an unreasonable delay shall include a delay in the issuance of a patent of more than four years from the date of filing of the application … or two years after a request for examination … whichever is later”. Further, leaked Article QQ.E.14 (also proposed by the US) requires adjustment of pharmaceutical patent terms to compensate for “unreasonable curtailment of the effective patent term as a result of the marketing approval process”. Frankel has noted that the minimum twenty-year patent term agreed under TRIPS was justified in part by reference to the potential for delays in other regulatory approval processes.Footnote 176 Thus, such delays have arguably already been incorporated into patent terms, making unwarranted the further extension of patent terms due to delays in the patent grant process.

The leaked provisions do contain some protections against abuse of these term adjustment provisions. First, TPP parties are obliged to adjust patent terms only to “compensate for unreasonable delays … in the granting of the patent” (specified as including at least delays of more than four years from filing or two years from a request for examination, whichever is later, and excluding delays caused by the applicant)Footnote 177 or for “unreasonable curtailment of the effective patent term as a result of the marketing approval process”.Footnote 178 Second, Article QQ.E.14(d)(ii) states that TPP parties may “require the basis for the adjustment to be the first marketing approval granted to the” new product in the country, thus limiting the extent to which companies can use staged marketing approval applications to extend patent terms. Article QQ.E.14(d)(iii) also allows TPP parties to limit any adjustment made to a patent term granted to compensate for delays in marketing approval to five years, regardless of the actual length of the delay. These minimal qualifications, however, do little to prevent the further extension of patent terms to the detriment of access to medicines.

B. Government Regulation of Pharmaceutical Pricing and Purchasing

Increased intellectual property protections may have an indirect impact on access to medicines, for example by increasing the cost of medications.Footnote 179 In addition, commentators such as Dr Deborah Gleeson of La Trobe University, Australia, have criticized the TPP's proposed transparency provisions as having the potential to restrict directly the ability of governments to operate “pharmaceutical reimbursement and pricing schemes”.Footnote 180 In October 2011, a US proposal dated 22 June 2011 for an annex to the Transparency Chapter on ‘Transparency and Procedural Fairness for Healthcare Technologies’ (Transparency Annex) was leaked.Footnote 181 Although the Transparency Annex explicitly affirms the importance of principles such as “adequate access to high-quality pharmaceutical products and medical devices”,Footnote 182 it also contains a number of provisions that are said to negatively affect government programmes designed to ensure affordable access to medicines. The Annex also refers to the Government Procurement chapter, although that text has not been leaked to date, and it is unclear how it will relate to the provisions described in this Section. In particular, the Transparency Annex specifically notes:

Pharmaceutical formulary development and management shall be considered to be an aspect of government procurement of pharmaceutical products for health care agencies that engage in government procurement. Chapter X (Government Procurement), rather than this Chapter, shall apply to government procurement of pharmaceutical products.Footnote 183

At the same time, the substantive provisions in paragraph X.3 of the Transparency Annex, examined below, apply when:

[H]ealth care authorities of a Party's central level of government maintain procedures for listing pharmaceutical products, medical devices, or indications for reimbursement, or for setting the amount of reimbursement for pharmaceutical products or medical devices, under health care programs operated by its central level of government …Footnote 184

The leaked texts thus reveal some lack of clarity in relation to what types of programme will fall under which provisions of the TPP.

A number of TPP negotiating governments administer programmes designed to increase the affordability of, and access to, medicines.Footnote 185 New Zealand, for example, operates a Pharmaceutical Management Agency,Footnote 186 while Australia's Pharmaceutical Benefits Scheme (PBS) has been described as Australia's “principal mechanism for ensuring access to medicines”.Footnote 187 These programmes typically reimburse or subsidize purchases of specific listed medicines when purchased by consumers, and in particular consumers from lower socioeconomic backgrounds. The ability of governments to afford such schemes is usually dependent on their ability to negotiate “prices for drugs with suppliers of pharmaceuticals using [their] … effectively monopsonist powers”.Footnote 188

The Australian PBS provides a good example of how such schemes operate. Pharmaceutical products listed in the PBS Schedule are made available at significantly reduced cost to consumers.Footnote 189 Listing takes place following an application by a manufacturer and review by the Pharmaceutical Benefits Advisory Committee (PBAC), which considers the efficacy of the pharmaceutical product and its cost in comparison to other treatments.Footnote 190 The PBS also utilizes the Pharmaceutical Benefits Pricing Authority (PBPA) to review the price of listed products and to recommend prices for new listings.Footnote 191 The ultimate price of listed products is the result of negotiations between the government and the manufacturer, informed by the recommendations of the PBPA.Footnote 192 The price listed in the PBS Schedule is the wholesale price paid by pharmacists to purchase the listed product, and who are then able to add a retail profit margin and dispensing fees to the price paid by consumers.Footnote 193 Further, the price paid by consumers who are eligible for a concession is capped, with the government subsidizing the rest of the purchase price.Footnote 194

Programmes such as Australia's PBS offer effective means for governments to regulate the price of essential medicines and resolve potential equity issues in relation to their access.Footnote 195 Unsurprisingly, governments have fiercely defended such programmes during trade negotiations.Footnote 196 The fear of public health advocates is that provisions such as those contained in the TPP's leaked Transparency Annex, for which pharmaceutical companies advocate, may restrict the ability of governments to run such programmes effectively, in particular hampering governments’ ability to negotiate low prices for medicines. In Australia, similar concerns were raised in relation to the AUSFTA, and Australia did introduce some changes to the PBS as a result of the AUSFTA.Footnote 197

Paragraph X.3(d) of the Transparency Annex requires TPP parties to ensure that their determination of “reimbursement amount[s]” paid for medication is based on “competitive market-derived prices in the Party's territory, or an alternative transparent and verifiable basis consisting of other benchmarks that appropriately recognize the value” of the relevant product. Paragraph X.3(d) arguably allows governments to take account of a product's efficacy and therapeutic benefit in determining the reimbursement amount, particularly given that the “Agreed Principles” of the Transparency Annex refer to a product's “objectively demonstrated therapeutic significance”.Footnote 198 However, the reference to “market-derived prices” in paragraph X.3(d) may diminish the ability of governments to negotiate discounts for pharmaceutical products based on public purchasing power.Footnote 199 Further, although paragraph X.3(d) provides for the possibility of an alternative non-market-based system for determining prices, that method still requires appropriate recognition of the “value” of the relevant product. As noted by Sean Flynn of the American University Washington College of Law and his co-authors, for patented products that value is set by the monopolist patent owner.Footnote 200 Paragraph X.3(e) does go some way towards recognizing that the prices governments set for products should be “based on evidence … [of] the product's superior safety, efficacy or quality as compared with comparator products”, at least in relation to manufacturers’ applications for increased reimbursement amounts.Footnote 201

The Transparency Annex also requires that TPP parties allow direct marketing of pharmaceutical products through a manufacturer's website:

Each Party shall permit a pharmaceutical product manufacturer to disseminate to health professionals and consumers through the manufacturer's Internet site registered in the territory of the Party, and on other Internet sites registered in the territory of the Party linked to that site, information that is truthful and not misleading regarding its pharmaceutical products that are approved for sale in the Party's territory, provided that the information includes a balance of risks and benefits and is limited to indications for which the Party's competent regulatory authorities have approved the marketing of the pharmaceutical products.Footnote 202

Direct marketing of pharmaceutical products to consumers has been associated with unwarranted demand, changes to prescribing practice,Footnote 203 “the medicalisation of normal health and ageing”, and “negative effect[s] on health funding”.Footnote 204 Paragraph X.4 of the Transparency Annex provides no exceptions to the direct marketing obligation, apart from stating that the marketing must be “truthful and not misleading” and “limited to indications for which … competent regulatory authorities have approved the marketing of the pharmaceutical products”. As Gleeson points out,Footnote 205 this contrasts with, for example, the AUSFTA, which allows Australia and the US to limit such marketing under their own “laws, regulations and procedures”.Footnote 206

Finally, concerns have been raised regarding regulatory consultation obligations—for example, paragraph X.2.2's requirement that regulations be published a “reasonable time” before becoming effective,Footnote 207 and the potential for undefined terms such as “objective” administration leading to litigation opportunities for pharmaceutical companies.Footnote 208 Many of the TPP's regulatory provisions are designed to move TPP parties towards regulatory best practice, enhance transparency in government decision-making, and thus enhance participation and understanding of regulatory outcomes. Nevertheless, a requirement (for example) to “make available an opportunity for independent appeal or review of recommendations or determinations relating to reimbursement for pharmaceutical products”Footnote 209 may impose unnecessary costs and delays on government programmes designed to increase affordable access to medicines. Some of the increased regulatory burden envisioned by the Transparency Annex also does not appear to consider the position of developing country TPP parties, who may not be as well resourced as their developed country counterparts.Footnote 210 Language modifying these obligations to take into account local circumstances could help enhance their implementation on a feasible and equitable basis.

IV. Conclusion

The TPP is likely to impose significant restrictions on certain forms of government action. These restrictions are significant not only to TPP parties, but also to other trading nations to the extent that they may affect the negotiation of future PTAs.Footnote 211 A number of legitimate concerns arise from the potential impact of the TPP on certain aspects of public health regulation, including tobacco control regulation and ensuring equitable access to medicines. Public health concerns are elevated by the inclusion of ISDS in the treaty, even though an ISDS mechanism may bring benefits to TPP parties. A general health exception applicable to the treaty as a whole—complemented with clarification of the extent of investment obligations—would be preferable to a product-specific exclusion of tobacco. However, TPP parties must take care to avoid overly prescriptive regimes with respect to regulatory coherence or transparency, given the risk of tobacco industry interference in tobacco control regulation and the potential of placing government agencies in a position of conflict, in view of FCTC obligations in particular. The TPP's intellectual property provisions must also be crafted taking account of the need to enable access to medicines, including in respect of pharmaceutical patent protection.

As described by Australia, negotiating the TPP necessarily involves parties putting forth “ambit claims” and working from starting positions to achieve a compromise.Footnote 212 Media reports indicate that many of the negotiating countries will resist attempts to constrain their “ability to regulate legitimately on social, environmental or other important public policy matters, including healthcare”.Footnote 213 Pharmaceutical products in particular have been a point of contention throughout the negotiations, with “TPP countries … rejecting many of the US proposals related to drugs” and slowing negotiations due to their resistance.Footnote 214 Australia has stated that it “would not accept an outcome in the TPP that would negatively impact upon the integrity of Australia's public health system”;Footnote 215 Malaysia “has strongly raised objections towards proposals that could delay the entry of generic drugs into the market” or increase the price of medicines;Footnote 216 and Peru has indicated that it will not accept harsher intellectual property terms than those in its trade agreement with the US.Footnote 217 Further, the August 2013 leaked IP chapter demonstrates significant resistance from other TPP parties to US proposals that seek to increase patent protection for pharmaceutical products.Footnote 218

As the TPP negotiations enter their final stages, the broader community can only speculate on how the text has progressed since the leaking of particular provisions, proposals, and chapters. Unfortunately, critiques of the final text after the conclusion of the treaty are unlikely to have much practical effect, and academic and public debate while the negotiations are ongoing has gone largely into a vacuum, with little indication of the extent to which concerns are being taken into account by negotiators. This is a common flaw of the treaty negotiation processes in many countries, and a particular flaw of the TPP negotiations. In the case of public health, among other issues, the goal of promoting sensible and effective policy should continue to be balanced in the development of PTAs with the goal of promoting international trade and investment. Open and vigorous discussion of this balance may help achieve the optimal solution, not only in the TPP but also in other future trade and investment agreements.

Footnotes

†

Professor, Melbourne Law School, The University of Melbourne. Andrew is a member of the Australian Government's Expert Advisory Group on Plain Packaging of Tobacco Products (an unpaid position). We gratefully acknowledge the generous financial support provided for this independent research by the Australian National Preventive Health Agency (Grant ID 203MIT2011) and the Australian Research Council (Linkage Project LP120200028). Thank you also to James Munro and Elizabeth Sheargold for valuable research assistance and to Jessica Casben for editorial assistance at the proof stage. The opinions expressed here are our personal views as academics and are not necessarily shared by any government, employer, or other entity. Any errors or omissions are ours. This paper was largely finalized in November 2013.

‡

Professor and Associate Dean (Research), Melbourne Law School, The University of Melbourne; Former Legal Officer, Appellate Body Secretariat, World Trade Organization.

♯

Researcher, Melbourne Law School, The University of Melbourne; Legal Officer, Australian Attorney-General's Department.

1. FERGUSSON, Ianet al., “The Trans-Pacific Partnership Negotiations and Issues for Congress”, Report for Congress No R42694, Congressional Research Service, 17 June 2013, online: <http://www.fas.org/sgp/crs/row/R42694.pdf> at 2.

2. NOTTAGE, Luke, “Throwing the Baby Out with the Bathwater: Australia's New Policy on Treaty-Based Investor-State Arbitration and Its Impact in Asia” (2013) 37 Asian Studies Review 253 at 258.

3. See “Trans-Pacific Partnership Leaders Statement” (8 October 2013), online: <http://www.dfat.gov.au/fta/tpp/131008-tpp-leadership-statement.html>.

4. Office of the United States Trade Representative, “Joint Statement of TPP Ministers: Trans-Pacific Partnership Ministers Chart Path Forward on Key Issues and Confirm Next Steps on Japan's Entry (Press Release)” (20 April 2013), online: USTR <http://www.ustr.gov/about-us/press-office/press-releases/2013/april/joint-statement-tpp-ministers>.

5. Office of the United States Trade Representative, “Outlines of the Trans-Pacific Partnership Agreement (Fact Sheet)” (12 November 2011), online: USTR <http://www.ustr.gov/about-us/press-office/fact-sheets/2011/november/outlines-trans-pacific-partnership-agreement>.

6. See e.g. KELSEY, Jane, “How the Trans-Pacific Partnership Agreement Could Heighten Financial Instability and Foreclose Governments’ Regulatory Space” (2010) 8 New Zealand Yearbook of International Law 3.

7. FLYNN, Sean, “Law Professors Call for Trans-Pacific Partnership (TPP) Transparency” InfoJustice (9 May 2012), online: InfoJustice <http://infojustice.org/archives/21137>.

8. Trans-Pacific Strategic Economic Partnership Agreement, 18 July 2005 (provisionally entered into force 1 May 2006; officially entered into force 28 May 2006).

9. Ibid.

10. Trans-Pacific Strategic Economic Partnership Agreement, 2 August 2005 (entered into force 12 July 2006).

11. Trans-Pacific Strategic Economic Partnership Agreement, 18 July 2005 (entered into force 8 November 2006).

12. Department of Foreign Affairs and Trade (Cth), “Update on the First Round of Trans-Pacific Partnership (TPP) Negotiations—A Strong Start” (10 December 2012), online: DFAT <http://www.dfat.gov.au/fta/tpp/100326-tpp-stakeholder-update-1.html>.

13. Office of the United States Trade Representative, “Round 17: Lima, Peru”, online: USTR <http://www.ustr.gov/trade-agreements/free-trade-agreements/trans-pacific-partnership/round-17-peru>.

14. See WILLIAMS, Brock, “Trans-Pacific Partnership (TPP) Countries: Comparative Trade and Economic Analysis”, Report for Congress No R42344, Congressional Research Service, 10 June 2013, online: FAS <http://www.fas.org/sgp/crs/row/R42344.pdf>: see Table A-1 for a full list of agreements between the TPP negotiating countries.

15. Outlines of the Trans-Pacific Partnership Agreement (Fact Sheet), supra note 5.

16. Ibid.

17. Kelsey, , supra note 6.

18. FAUNCE, Thomas and TOWNSEND, Ruth, “The Trans-Pacific Partnership Agreement: Challenges for Australian Health and Medicine Policies” (2011) 194 Medical Journal of Australia 83 at 83.

19. SALACUSE, Jeswald and SULLIVAN, Nicholas, “Do BITs Really Work? An Evaluation of Bilateral Investment Treaties and Their Grand Bargain” (2005) 46 Harvard International Law Journal 67 at 75.

20. ROJID, Farazet al., “No Coverage for Tobacco Industries with Regard to Tobacco-Control Measures—the Future of International Investment Agreements?” (2012) 9 Transnational Dispute Management 120 at 129.

21. See e.g. KURTZ, Jürgen, “Australia's Rejection of Investor-State Arbitration: Causation, Omission and Implication” (2012) 27 ICSID Review: Foreign Investment Law Journal 65 at 76−77.

22. “Seoul not to Scrap Investor-State Dispute Mechanism in Korea-US FTA” Korea Times (22 February 2012), online: Korea Times <http://www.koreatimes.co.kr>.

23. Signed 17 December 1992, 32 ILM 289 and 605 (entered into force 1 January 1994).

24. KURTZ, Jürgen, “Review Essay: The Shifting Landscape of International Investment Law and Its Commentary” (2012) 106 American Journal of International Law 686 at 686.

25. UNCTAD, World Investment Report 2013—Global Value Chains: Investment and Trade for Development (2013) 103−115.

26. Investor-State Dispute Settlement—Public Consultation: 16 May–9 July 2012 (2012) [1].

27. See <https://nafta-sec-alena.org/Default.aspx?tabid=95&language=en-US>.

28. See e.g. Apotex Holdings v. USA, Request for Arbitration, ICSID Case No ARB(AF)/12/1 (29 February 2012); Apotex v. USA (Award on Jurisdiction and Admissibility) (14 June 2013); Les Laboratoires Servier v. Poland (Final Award), Permanent Court of Arbitration (14 February 2012).

29. Melvin Howard v. Canada (Order for the Termination of the Proceedings and Award on Costs) (UNCITRAL Arbitration Rules, PCA Case No 2009-21, 2 August 2010).

30. Luke Eric PETERSEN, “US Businessmen are Latest to Bring Poland to International Arbitration” (28 September 2010) 3 Investment Arbitration Reporter (online).

31. Achmea (formerly Eureko) v. Slovak Republic (Award on Jurisdiction) (UNCITRAL Arbitration Rules, PCA Case No 2008-13, 26 October 2010); HICEE v. Slovak Republic (Partial Award) (UNCITRAL Arbitration Rules, PCA Case No 2009-11, 23 May 2011); HICEE v. Slovak Republic (Supplementary and Final Award) (UNCITRAL Arbitration Rules, PCA Case No 2009-11, 17 October 2011); Luke Eric PETERSEN, “UNCITRAL Tribunal Chaired by Christopher Greenwood Declines to Let Claimant Use MFN Clause to Detour Around Highly-Restrictive Arbitration Clause” (22 January 2013) 6 Investment Arbitration Reporter (online).

32. Chemtura Corporation v. Canada (Award) (UNCITRAL Arbitration Rules, Ad Hoc Tribunal, 2 August 2010); Dow Agrosciences LLC v. Canada, Notice of Arbitration under the UNCITRAL Arbitration Rules and NAFTA (31 March 2009); Dow Agrosciences LLC v. Canada, Settlement Agreement (25 May 2011).

33. Ethyl v. Canada (Award on Jurisdiction) (UNCITRAL Arbitration Rules, Ad Hoc Tribunal, 24 June 1998); Department of Foreign Affairs, Trade and Development, Ethyl Corporation v. the Government of Canada, online: <http://www.international.gc.ca/trade-agreements-accords-commerciaux/topics-domaines/disp-diff/ethyl.aspx?lang=eng>.

34. Gallo v. Canada (Award) (UNCITRAL Arbitration Rules, Ad Hoc Tribunal, 15 September 2011).

35. Citizens Trade Campaign, “Section B (‘Investment Chapter’)” (June 2012), online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2012/06/tppinvestment.pdf>.

36. Ibid., art. 12.17(1).

37. Ibid., art. 12.18.

38. See e.g. HARTEN, Gus VANet al. “Public Statement on the International Investment Regime” Osgood Hall Law School (31 August 2010), online: Osgood Hall Law School <http://www.osgoode.yorku.ca/public-statement/documents/Public%20Statement%20%28June%202011%29.pdf>.

39. See e.g. GLEESON, Deborahet al., “Challenges to Australia's National Health Policy from Trade and Investment Agreements” (2012) 196 Medical Journal of Australia 354 at 355. See also SY, Deborah, “Warning: Investment Agreements are Dangerous to Your Health” (2011) 43 George Washington International Law Review 625; RIMMER, Matthew, “Plain Packaging for the Pacific Rim—Tobacco Control and the Trans-Pacific Partnership” in Tania VOON, ed., Trade Liberalization and International Co-operation: A Legal Analysis of the Trans-Pacific Partnership Agreement (Cheltenham: Edward Elgar, 2013), 75 at 89–95.

40. RIMMER, Matthew, “A Dangerous Investment: Australia, New Zealand and the Trans-Pacific Partnership” The Conversation (2 July 2012), online: The Conversation <https://theconversation.com/a-dangerous-investment-australia-new-zealand-and-the-trans-pacific-partnership-7440>.

41. See e.g. Gleeson, , supra note 39 at 354–355; KELSEY, Jane, “The Trans-Pacific Partnership Agreement: A Gold-Plated Gift to the Global Tobacco Industry?” (2013) 39 American Journal of Law & Medicine 237 at 251.

42. Kelsey, , supra note 6 at 5; STUMBERG, Robert, “Safeguards for Tobacco Control: Options for the TPPA” (2013) 39 American Journal of Law & Medicine 382 at 396.

43. See e.g. Sharon TREAT et al., “An Open Letter from US State Legislators to Negotiators of the Trans-Pacific Partnership Urging the Rejection of Investor-State Dispute Settlement” Public Citizen (5 July 2012), online: Public Citizen <http://www.citizen.org/documents/State-Legislators-Letter-on-Investor-State-and-TPP.pdf>; Van Harten et al., supra note 38.

44. Tobacco Plain Packaging Act 2011 (Cth).

45. Department of Health (Ireland), “Ireland Set to Become Second Country in the World to Introduce Plain Pack Cigarettes” (28 May 2013), online: DOHC <http://www.dohc.ie/press/releases/2013/20130528.html>. See also Department of Health, “Tobacco Free Ireland: Report of the Tobacco Policy Review Group” (October 2013).

46. TURIA, Tariana, “Biennial Oceania Tobacco Control 2013” Beehive (23 October 2013), online: Beehive <http://www.beehive.govt.nz/speech/biennial-oceania-tobacco-control-2013>: “our Government is committed to introducing plain packaging as part of our drive to Smokefree 2025”.

47. United Kingdom, Parliamentary Debates, House of Commons, 28 November 2013, col 25WS (Jane Ellison); United Kingdom Department of Health, “Independent Review of Standardised Packaging for Tobacco” (28 November 2013), online: DH <https://www.gov.uk/government/news/independent-review-of-standardised-packaging-for-tobacco>; The Scottish Government, “Tobacco Plain Packaging: Scottish Government to Press Ahead with Plans” (7 September 2013), online: SG <http://news.scotland.gov.uk/News/Tobacco-plain-packaging-3ce.aspx>.

48. Philip Morris Asia Ltd v. Australia (Permanent Court of Arbitration Case No 2012-12, UNCITRAL Arbitration Rules, ongoing).

49. Agreement Between the Government of Hong Kong and the Government of Australia for the Promotion and Protection of Investments, 15 September 1993, 1748 U.N.T.S. 385 (entered into force 15 October 1993).

50. Request for Arbitration: FTA Holdings SA (Switzerland) v. Uruguay (19 February 2010); Philip Morris Brands Sarl v. Uruguay, ICSID Case No ARB/10/7, Decision on Jurisdiction (2 July 2013). See also MCGRADY, Benn, “Implications of Ongoing Trade and Investment Disputes Concerning Tobacco: Philip Morris v. Uruguay” in Tania VOON et al., eds., Public Health and Plain Packaging of Cigarettes: Legal Issues (Cheltenham: Edward Elgar, 2012), 173.

51. Agreement Between the Swiss Confederation and the Oriental Republic of Uruguay on the Reciprocal Promotion and Protection of Investments, 7 October 1988, 1976 U.N.T.S. 389 (entered into force 22 April 1991).

52. See e.g. GLEESON, Deborah and FRIEL, Sharon, “Emerging Threats to Public Health from Regional Trade Agreements” (2013) 381 The Lancet 1507 at 1508; RANALD, Patricia, “The Trans-Pacific Partnership Agreement: Contradictions in Australia and in the Asia Pacific Region” (2011) 22 The Economic and Labour Relations Review 81 at 92.

53. Productivity Commission, “Bilateral and Regional Trade Agreements: Productivity Commission Research Report” (2010) 271–4, online: <http://www.pc.gov.au/__data/assets/pdf_file/0010/104203/trade-agreements-report.pdf>.

54. Department of Foreign Affairs and Trade, “Gillard Government Trade Policy Statement: Trading Our Way to More Jobs and Prosperity” (April 2011), online: DFAT <http://www.acci.asn.au/getattachment/b9d3cfae-fc0c-4c2a-a3df-3f58228daf6d/Gillard-Government-Trade-Policy-Statement.aspx> at 14.

55. See e.g. MARTIN, Peter, “Marles Vows Not to Cave to US Pressure” Sydney Morning Herald (15 July 2013), online: SMH <http://www.smh.com.au>.

56. Investment Chapter, supra note 35, Section B (ISDS), note 20 (in square brackets): “Section B does not apply to Australia or an investor of Australia. Notwithstanding any provision of this Agreement, Australia does not consent to the submission of a claim to arbitration under this Section.”

57. See e.g. BISHOP, Julie, “Free Trade Focus” On Line Opinion (28 March 2013), online: OO <http://www.onlineopinion.com.au/view.asp?article=14855>. See also “Australia May be More Open to ISDS in TPP with Government Change” (15 March 2013) 31 Inside US Trade (online).

58. MARTIN, Peter, “Robb Stands Firm on Foreign Lawsuits” Sydney Morning Herald (23 September 2013), online: SMH <http://www.smh.com.au/business/robb-stands-firm-on-foreign-lawsuits-20130922-2u7tv.html>.

59. See e.g. “New Australian Government Says No Position Yet on ISDS in TPP” (27 September 2013) 31 Inside US Trade (online). See also Rimmer, supra note 39 at 90–1.

60. Nottage, , supra note 2 at 258–261.

61. CHAISSE, Julien, “TPP Agreement: Towards Innovations in Investment Rule-Making” in Chin Leng LIM et al., eds., The Trans-Pacific Partnership (Cambridge: Cambridge University Press, 2012), 147 at 154.

62. Ibid.

63. Nottage, , supra note 2 at 269.

64. TRAKMAN, Leon, “Investor State Arbitration or Local Courts: Will Australia Set a New Trend?” (2012) 1 Journal of World Trade 83 at 91. See also Kurtz, , supra note 21 at 73.

65. Rojid, , supra note 20 at 129; Nottage, , supra note 2 at 263–264.

66. Investment Chapter, supra note 35, art. 12.2.

67. FOOKS, Gary and GILMORE, Anna, “International Trade Law, Plain Packaging and Tobacco Industry Political Activity: the Trans-Pacific Partnership” Tobacco Control (20 June 2013), online: Tobacco Control <http://tobaccocontrol.bmj.com/content/early/2013/06/19/tobaccocontrol-2012-050869.full> at 4.

68. Cf. Maffezini v. Kingdom of Spain (Decision on Jurisdiction) (ICSID Arbitral Tribunal, Case No. ARB/97/7, 25 January 2000) [64]. See also Vannessa Ventures Ltd v. Venezuela (Award) (ICSID Arbitral Tribunal, Case No ARB(AF)/04/6, 16 January 2013) [133], where the Tribunal rejected an argument that attempted to apply a BIT's MFN provisions to the definition of “investment” to expand its coverage.

69. Investment Chapter, supra note 35, art. 12.5.2.

70. Cf. Australia-United States Free Trade Agreement, signed 18 May 2004, [2005] A.T.S. 1 (entered into force 1 January 2005), art. 11.5.2 [AUSFTA].

71. Investment Chapter, supra note 35, art. 12.6.2.

72. AUSFTA, supra note 70, annex 11-B.

73. Investment Chapter, supra note 35, annex 12-C, art. 4(b). See also alternative wording in the Investment Chapter's annex 12-D, art. 5: “Except in rare circumstances to which paragraph 4 applies, such measures taken in the exercise of a state's regulatory powers as may be reasonably justified in the protection of public welfare, including public health … shall not constitute and [sic] indirect expropriation … Non-discriminatory regulatory actions by a Party that are designed and applied to achieve legitimate public welfare objectives, such as the protection of public health … do not constitute indirect expropriation.”

74. Investment Chapter, supra note 35, art. 12.12.5.

75. Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 U.N.T.S. 3 (entered into force 1 January 1995), annex 1C. See also MITCHELL, Andrew and VOON, Tania, “Patents and Public Health in the WTO, FTAs and Beyond: Tension and Conflict in International Law” (2009) 43 Journal of World Trade 571; World Trade Organization, “Intellectual Property Meeting Mulls Irish Tobacco Plan, Drug Tariffs, Sport, Non-violation” WTO News (10−11 October 2013), online: WTO News <http://www.wto.org/english/news_e/news13_e/trip_10oct13_e.htm>.

76. Cameroon-Turkey Bilateral Investment Treaty (2012), art. 10(4).

77. See e.g. Canada-Jordan Foreign Investment Promotion and Protection Agreement (2009), arts. 17, 47; China-Japan-Republic of Korea Investment Agreement (2012) arts. 15, 20.

78. See e.g. Canada-Peru Bilateral Investment Treaty (2006), art. 16; Canada-Latvia Bilateral Investment Treaty (2009) arts. XII−XIII; Peru-China Free Trade Agreement (2009), art. 142.

79. India-Malaysia Comprehensive Economic Cooperation Agreement (2011), art. 12.2.5, annex 12-2.

80. GATT Doc LT/UR/A-1/A/1/GATT/2, signed 30 October 1947, as incorporated in the Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 U.N.T.S. 3 (entered into force 1 January 1995), annex 1A.

81. Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 U.N.T.S. 3 (entered into force 1 January 1995), annex 1B.

82. Canadian Model Agreement for the Promotion and Protection of Investments (2004), art. 10. See also e.g. Singapore-Jordan Bilateral Investment Treaty (2004), art. 18(b); Canada-Armenia Bilateral Investment Treaty (1997), art. XVII: 3(b).

83. Czech Republic-Singapore Bilateral Investment Treaty (1995), art. 11; India-Mauritius Bilateral Investment Treaty (1998), art. 11(3). See also Romania-Mauritius Bilateral Investment Treaty (2000) art. 2(1); New Zealand-Hong Kong Bilateral Investment Treaty (1995), art. 8(3) (emphasis added).

84. See generally CHAISSE, Julien, “Exploring the Confines of International Investment and Domestic Health Protections—Is a General Exceptions Clause a Forced Perspective?” (2013) 39 American Journal of Law & Medicine 332.

85. Investment Chapter, supra note 35, art. 12.15.

86. USTR, “Fact Sheet: New US Proposal on Tobacco Regulation in the Trans-Pacific Partnership” (21 August 2013): “The TPP agreement will, like other trade agreements, contain a general exception for matters necessary to protect human life or health.”

87. See e.g. CHALOUPKA, Franket al., “Effectiveness of Tax and Price Policies in Tobacco Control” (2011) 20 Tobacco Control 235; RIORDAN, Meg, “Tobacco Warning Labels: Evidence of Effectiveness” Campaign for Tobacco-Free Kids (19 March 2013), online: <http://www.tobaccofreekids.org/research/factsheets/pdf/0325.pdf>; Melanie WAKEFIELD et al., “Introduction Effects of the Australian Plain Packaging Policy on Adult Smokers: A Cross-sectional Stud”’ (2013) BMJ Open 3:e003175.

88. USTR, “Fact Sheet: TPP Tobacco Proposal” (18 May 2012).

89. USTR, “Fact Sheet: New US Proposal on Tobacco Regulation in the Trans-Pacific Partnership” (21 August 2013).

90. See “Malaysia Poised to Table Complete Carveout from TPP for Tobacco Measures” (25 August 2013) Inside US Trade (online) [Malaysia's Carveout Proposal].

91. At this time it is unclear whether tobacco products would still be subject to tariff reduction obligations under the Malaysian proposal.

92. See e.g. PALMER, Doug, “US Tobacco Trade Proposal Draws Fire From Both Sides” Reuters (22 August 2013), online: Reuters <http://www.reuters.com/article/2013/08/22/us-usa-tobacco-trade-idUSBRE97L0ZD20130822>. BOLLYKY, Thomas, “The Tobacco Problem in US Trade” Council on Foreign Relations (5 September 2013), online: CFR <http://www.cfr.org/trade/tobacco-problem-us-trade/p31346>.

93. USTR, supra note 88.

94. Stumberg, , supra note 42 at 427–428, 430–2,

95. See Appellate Body Report, United States—Measures Affecting the Production and Sale of Clove Cigarettes, WTO Doc WT/DS406/AB/R (circulated 4 April 2012, adopted 24 April 2012). See also VOON, Tania, “International Decision: United States—Measures Affecting the Production and Sale of Clove Cigarettes” (2012) 106 American Journal of International Law 824; VOON, Tania and MITCHELL, Andrew, “Implications of International Investment Law for Tobacco Flavouring Regulation” (2011) 12 Journal of World Investment & Trade 65.

96. USTR, supra note 89.

97. Ibid.

98. See e.g. BLOOMBERG, Michael, “Why is Obama Caving on Tobacco?” New York Times (22 August 2013), online: NYT <http://www.nytimes.com/2013/08/23/opinion/why-is-obama-caving-on-tobacco.html>; “Anti-Tobacco Group Urges US To Support Malaysian TPP Tobacco Proposal” (26 August 2013) Inside US Trade (online). Cf. “A Bad Smoke: The US Tries to Exempt Tobacco Regulation from Pacific Trade Talks” Wall Street Journal (8 September 2013), online: WSJ <http://online.wsj.com/news/articles/SB10001424127887324463604579040833940586254>.

99. Malaysia's Carveout Proposal, supra note 90; Carey BIRON, “US, Malaysia Skirmish over Free-Trade Tobacco” Inter Press Service (7 September 2013), online: IPS <http://www.ipsnews.net/2013/09/u-s-malaysia-skirmish-over-free-trade-tobacco/>.

100. See Rimmer, , supra note 39 at 104–105.

101. See “US Businesses Quick to Reject New USTR Tobacco Proposal in TPP” (2013) 31 Inside US Trade (online); Malaysia's Carveout Proposal, supra note 90.

102. For a similar view, see LESTER, Simon, “Free Trade and Tobacco: Thank You for Not Smoking (Foreign) Cigarettes” (15 August 2012) 49 Free Trade Bulletin 1 at 4.

103. See e.g. WHO, WHO Report on the Global Tobacco Epidemic, 2013: Enforcing Bans on Tobacco Advertising, Promotion and Sponsorship (2013) at 22.

104. Lester, , supra note 102 at 4.

105. Appellate Body Report, European Communities—Measures Affecting Asbestos and Asbestos-Containing Products, WTO Doc WT/DS135/AB/R (circulated 12 March 2001, adopted 5 April 2001) [114], [118], [162], [172].

106. See e.g. Transcript of Proceedings, JT International v. Commonwealth [2012] HCA Trans 091 (17 April 2012) 700, 2500, 3315, 3675, 3750, 3880–935; Transcript of Proceedings, JT International v. Commonwealth [2012] HCA Trans 092 (18 April 2012) 3950, 5075–85; Transcript of Proceedings, JT International v. Commonwealth [2012] HCA Trans 031 (19 April 2012) 7290–305.

107. See e.g. WTO Committee on Technical Barriers to Trade, Minutes of the Meeting of 23–24 June 2010: Note by the Secretariat, G/TBT/M/51 (1 October 2010), [237]–[251].

108. See e.g. WHO, Interventions on Diet and Physical Activity: What Works—Summary Report (WHO, 2009).

109. Lester, , supra note 102 at 4.

110. See supra note 48 and corresponding text.

111. JT International SA v. Commonwealth of Australia [2012] HCA 43. See also LIBERMAN, Jonathan, “Plainly Constitutional: The Upholding of Plain Tobacco Packaging by the High Court of Australia” (2013) 39 American Journal of Law & Medicine 361; VOON, Tania, “Acquisition of Intellectual Property Rights: Australia's Plain Tobacco Packaging Dispute” (2013) 2 European Intellectual Property Review 113.

112. See Australia—Certain Measures Concerning Trademarks and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for the Establishment of a Panel by Ukraine, WTO Doc WT/DS434/11 (17 August 2012); Australia—Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for the Establishment of a Panel by Honduras, WTO Doc WT/ DS435/16 (17 October 2012); Australia—Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for the Establishment of a Panel by the Dominican Republic, WTO Doc WT/DS441/15 (14 November 2012); Australia—Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for Consultations by Cuba, WTO Doc WT/DS458/1 (7 May 2013); Australia—Certain Measures Concerning Trademarks, Geographical Indications and Other Plain Packaging Requirements Applicable to Tobacco Products and Packaging: Request for Consultations by Indonesia, WTO Doc WT/DS467/1 (25 September 2013).

113. See Philip Morris Asia Limited, Notice of Arbitration (21 November 2011) [1.3]; FTR Holding SA (Switzerland) v. Uruguay (Request for Arbitration) (ICSID Arbitral Tribunal, 19 February 2010) [6], [43], [81], [83]; JT International SA v. Commonwealth [2012] HCA 43, [149] (Gummow J).

114. See e.g. VADI, Valentina, “Tobacco Wars: Tobacco Control-related Investment Disputes in a Comparative Public Law Perspective” (2012) 9 Transnational Dispute Management 86 at 89; DAVISON, Mark, “Plain Packaging of Tobacco and the ‘Right’ to Use a Trade Mark” (2012) 8 European Intellectual Property Review 498; FRANKEL, Susy and GERVAIS, Daniel, “Plain Packaging and the Interpretation of the TRIPS Agreement” (2013) 46 Vanderbilt Journal of Transnational Law 1149.

115. JT International SA v. Commonwealth of Australia [2012] HCA 43, [36], [43] (French CJ), [248] (Crennan J), [348] (Kiefel J), cf. [107] (Gummow J).

116. Investment Chapter, supra note 35, art. 12.2 (Definitions).

117. WikiLeaks, “Secret Trans-Pacific Partnership (TPP)” (13 November 2013), online: Wikileaks <http://www.wikileaks.org/tpp> [IP Chapter].

118. Emphasis added, citations removed.

119. Emphasis added.

120. Panel Report, EC—Trademarks and Geographical Indications (Australia), [7.610]-[7.611].

121. Fergusson et al., supra note 1 at 43; Kelsey, supra note 41 at 246. See also “USTR Highlights Four TPP Areas Where Negotiations Mostly Wrapped Up” (2013) 31 Inside US Trade (online).

122. Citizens Trade Campaign, “Regulatory Coherence Proposal” (4 March 2010), online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificRegulatoryCoherence.pdf>.

123. But see infra note 181 and corresponding text.

124. Kelsey, , supra note 41 at 249.

125. Ibid.; KELSEY, Jane, Preliminary Analysis of the Draft TPP Chapter on Domestic Coherence (2011) Citizens Trade Campaign, online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacific_RegCoherenceMemo.pdf>. See also Stumberg, supra note 42 at 38, noting that “[t]hese elements are modelled after administrative procedures that tobacco companies are using to challenge tobacco-control measures in the domestic courts of New Zealand”.

126. See e.g. Kelsey, , supra note 125, Preliminary Analysis of the Draft TPP Chapter on Domestic Coherence 2; Stumberg, supra note 42 at 392.

127. WHO Framework Convention on Tobacco Control, opened for signature 16 June 2003, 2302 U.N.T.S. 166 (entered into force 27 February 2005) [FCTC]. See also WHO, Confronting the Tobacco Epidemic: In a New Era of Trade and Investment Liberalization (WHO, 2012).

128. Parties to the WHO Framework Convention on Tobacco Control, WHO FCTC, online: <http://www.who.int/fctc/signatories_parties/en/>. See also generally, WHO, Confronting the Tobacco Epidemic: In a New Era of Trade and Investment Liberalization (WHO, 2012).

129. WHO Framework Convention on Tobacco Control Conference of the Parties, Guidelines for Implementation of Article 5.3 of the WHO Framework Convention on Tobacco Control, FCTC/COP3(7) (22 November 2008).

130. Regulatory Coherence Proposal, supra note 122, art. X.3(7) (emphasis added).

131. Ibid., art. X.2(1).

132. And only where harm is demonstrated to have been caused by non-compliance.

133. Kelsey, , supra note 41 at 249.

134. Regulatory Coherence Proposal, supra note 122, art. X.3(1).

135. Ibid., art. X.3(1)(b)(4).

136. Kelsey, , supra note 41 at 249.

137. See e.g. AGUINAGA, Stella and GLANTZ, Stanton, “The Use of Public Records Acts to Interfere with Tobacco Control” (1995) 4 Tobacco Control 222; Department of Health and Ageing, “List of Tobacco FOI Requests on Hand in the Department of Health and Ageing” (Document Tabled Before Senate Community Affairs Legislation Committee, Parliament of Australia, Canberra, 20 October 2010); Kevin DUNION, Scottish Information Commissioner, Decision 129/2011 Philip Morris International and the University of Stirling (30 June 2011), online: <http://www.itspublicknowledge.info/applicationsanddecisions/Decisions/2011/201100481.aspx>.

138. Stumberg, , supra note 42 at 394.

139. “US Backs Malaysian TPP Proposal Aiming to Protect Product Formulas” (2013) 31 Inside US Trade (online).

140. Ibid., see comments by the Grocery Manufacturers of America: “there is no reason that manufacturers should be required to disclose the precise weight or percentage of each ingredient.”

141. BRACKEN, Len, “TPP Chief Negotiators, Key Experts Gather in Salt Lake City to Advance Negotiations” Bloomberg International Trade Daily (18 November 2013).

142. Citizens Trade Campaign, “TPP IP Rights Chapter (Selected Provisions)” (September 2011), online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificIP1.pdf>.

143. IP Chapter, supra note 117.

144. See e.g. Médicins Sans Frontières, “Countries Must Fix Critical Access to Medicines Flaws in Trans-Pacific Trade Pact” (14 May 2013), online: MSF <http://www.msfaccess.org/about-us/media-room/press-releases/countries-must-fix-critical-access-medicines-flaws-trans-pacific>.

145. See e.g. Médicins Sans Frontières, “Briefing Note: Trading Away Health” (2013), online: MSF <http://www.msfaccess.org/sites/default/files/MSF_assets/Access/Docs/Access_Briefing_TPP_ENG_2013.pdf>; Gleeson, supra note 39.

146. FRANKEL, Susy, “Intellectual Property in New Zealand and the TPPA” in Jane KELSEY, ed., No Ordinary Deal: Unmasking the Trans-Pacific Partnership Free Trade Agreement (Wellington: Bridget Williams Books, 2011), 163, 165–6.

147. See e.g. Médicins Sans Frontières, “Issue Brief: Trading Away Health” (August 2012), online: MSF <http://aids2012.msf.org/wp-content/uploads/2012/07/TPP-Issue-Brief-IAC-July2012.pdf> at 11.

148. FLYNN, Seanet al., “The US Proposal for an Intellectual Property Chapter in the Trans-Pacific Partnership Agreement” (2012) 28 American University International Law Review 105 at 169, note 206.

149. Frankel, , supra note 146 at 173.

150. Gleeson, , supra note 39.

151. IP Chapter, supra note 117, art. QQ.E.16(1)(a).

152. Ibid., art. QQ.E.16(1)(c).

153. Ibid., at 36.

154. United States-Singapore Free Trade Agreement, signed 6 May 2003 (entered into force 1 January 2004) art. 16.8 [US-Singapore FTA].

155. United States-Chile Free Trade Agreement, signed 6 June 2003 (entered into force 1 January 2004) art. 17.10(1) [US-Chile FTA].

156. United States-Korea Free Trade Agreement, signed 30 June 2006 (entered into force 15 March 2012) art. 18.9.1(b) [US-Korea FTA].

157. AUSFTA, supra note 70, art. 17.10(1)(a).

158. IP Chapter, supra note 117, art. QQ.E.16(2).

159. See Mitchell, and Voon, , supra note 75; WTO News, supra note 75.

160. IP Chapter, supra note 117, art. QQ.A.5.

161. Ibid., art. QQ.A.5(a) (emphasis added) (citations removed) (square bracketed text in original).

162. LOVE, James, “KEI Analysis of Wikileaks Leak of TPP IPR Text, from August 30, 2013” Knowledge Ecology International (13 November 2013), online: KEI <http://keionline.org/node/1825>.

163. See MCGRADY, Benn, “Narrowing of the Doha Declaration in the Draft TPPIP Chapter” O'Neill Institute, Trade, Investment & Health (15 November 2013), online: <http://www.oneillinstitutetradeblog.org/narrowing-doha-declaration-draft-tpp-ip-chapter/>.

164. US-Chile FTA, supra note 155, art. 17.10(1).

165. IP Chapter, supra note 117, art. QQ.E.1(1).

166. AUSFTA, supra note 70, art. 17.9(1).

167. Public Citizen, “What's New in the WikiLeaks TPP Text?” (13 November 2013), online: <http://www.citizen.org/documents/Whats%20New%20in%20the%20WikiLeaks%20TPP%20Text-11.pdf> at 2−3.

168. See Knowledge Ecology International, online: <http://keionline.org/sites/default/files/tpp-10feb2011-us-text-ipr-chapter.pdf>, art. 8.1: “In addition, the Parties confirm that: patents shall be available for any new forms, uses, or methods of using a known product; and a new form, use, or method of using a known product may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the known efficacy of that product.”

169. Frankel, supra note 146, 166; Flynn et al., supra note 148, 155–6.

170. See also e.g. TRIPS, art. 27.

171. IP Chapter, supra note 117, art. QQ.E.1(1) (citations omitted).

172. WEATHERALL, Kimberlee, “The TPP as a Case Study of Changing Dynamics for International Intellectual Property Negotiations” in Tania VOON, ed., Trade Liberalisation and International Co-operation: A Legal Analysis of the Trans-Pacific Partnership Agreement (Cheltenham: Edward Elgar, 2013), 50 at 73.

173. Ibid., at 74.

174. Frankel, , supra note 146 at 168.

175. IP Chapter, supra note 117, art. QQ.E.XX.

176. Frankel, , supra note 146 at 168. See also Flynn et al., supra note 148 at 161.

177. IP Chapter, supra note 117, art. QQ.E.XX (emphasis added).

178. IP Chapter, supra note 117, art. QQ.E.14(c) (emphasis added).

179. Gleeson, and Friel, , supra note 52 at 1508; Gleeson, supra note 39 at 2.

180. Gleeson, , supra note 39 at 2. See also FLYNN, Seanet al., “Public Interest Analysis of the US TPP Proposal for an IP Chapter” PIJIP Research Paper 21 (12 June 2011), online: <http://digitalcommons.wcl.american.edu/research/21> at 50−4.

181. Citizens Trade Campaign, “Transparency Annex” (22 June 2011), online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificTransparency.pdf>. At the same time, the US proposed text dated 19 March 2010 was leaked containing Annexes to the Technical Barriers to Trade chapter for medical devices, pharmaceutical products, and cosmetic devices: online: <http://www.citizenstrade.org/ctc/wp-content/uploads/2011/10/TransPacificTBTwMedicalAnnexes.pdf>.

182. Transparency Annex, supra note 181, para. X.1.

183. Ibid., at 3, note 1.

184. Ibid., para. X.3.

185. Fergusson, , supra note 1 at 38.

186. Ibid.

187. DUCKETT, Stephen, “Drug Policy Down Under: Australia's Pharmaceutical Benefits Scheme” (2004) Health Care Financing Review 55 at 56.

188. SWEENY, Kim, “Trends in the Use of and Cost of Pharmaceuticals Under the Pharmaceutical Benefits Scheme”, Centre for Strategic Economic Studies, Working Paper No 5, June 2002, online: <http://vuir.vu.edu.au/15922/1/15922.pdf> at 5, discussing Australia's PBS.

189. MITCHELL, Andrew and VOON, Tania, “Australia-United States Free Trade Agreement” in Simon LESTER and Bryan MERCURIO, eds., Bilateral and Regional Trade Agreements (Cambridge: Cambridge University Press, 2009), 6 at 17.

190. Ibid.; National Health Act 1953 (Cth), s 101(3A); Department of Health (Cth), PBS Frequently Asked Questions, online: <http://www.pbs.gov.au/info/general/faq#WhatisthePharmaceuticalBenefitsSchemePBS>.

191. Sweeny, , supra note 188 at 6.

192. Ibid., at 7.

193. Ibid.

194. See Department of Health (Cth), About the PBS, online: <http://www.pbs.gov.au/info/about-the-pbs>.

195. HAMILTON, Cliveet al., “Barrier to Trade or Barrier to Profit? Why Australia's Pharmaceutical Benefits Scheme Worries U.S. Drug Companies” (2004) 4 Yale Journal of Health Policy, Law & Ethics 373 at 382.

196. See e.g. statements by Australia: Letter from the Australian Permanent Mission to the UN Geneva to the United Nations Special Rapporteur on the Right to Health (23 November 2011), online: <https://spdb.ohchr.org/hrdb/19th/Australia_23.11.11_(4.2011).pdf> at 2; Michael JANDA, “Leaked Document Shows Big Rifts in Proposed Pacific Trade Deal” Australian Broadcasting Corporation (14 November 2013), online: ABC <http://www.abc.net.au/pm/content/2013/s3891114.htm>: “the Government will not permit any outcome in its trade negotiations which undermines the PBS or Australia's health system more generally”; Ministry of International Trade and Industry (Malaysia), “Brief on the Trans-Pacific Partnership (TPP)”, online: MITI <http://www.miti.gov.my/cms/storage/documents/1ed/com.tms.cms.document.Document_c5ada311-c0a8156f-72160910-3ecfcd41/1/TPP%20-%20Briefing%20Notes%20-%20Website%20%28FINALrev1%29.pdf> at 5.

197. See FAUNCE, Thomas and TOWNSEND, Ruth, “Public Health and Medicine Policies” in Jane KELSEY, ed., No Ordinary Deal: Unmasking the Trans-Pacific Partnership Free Trade Agreement (Wellington: Bridget Williams Books, 2011), 149 at 154.

198. Ibid., para. X.1(c). See also AUSFTA, supra note 70, annex 2-C (Pharmaceuticals), art. 1(d).

199. Flynn, et al., supra note 180 at 52.

200. Ibid.

201. See also ibid.

202. Transparency Annex, supra note 181, para. X.4.

203. See e.g. GILBODY, S.et al., “Benefits and Harms of Direct to Consumer Advertising: A Systematic Review” (2005) 14 BMJ Quality & Safety 246.

204. TOOP, Les and RICHARDS, Dee, “New Zealand Deserves Better. Direct-to-Consumer Advertising (DTCA) of Prescription Medicines in New Zealand: For Health or for Profit?” (22 August 2003) 116 The New Zealand Medical Journal, online: <http://journal.nzma.org.nz/journal/116-1180/556/>. See also MINTZES, Barbara, “Direct to Consumer Advertising is Medicalising Normal Human Experience” (2002) 13 British Medical Journal 324. See also LOPERT, Ruth and GLEESON, Deborah, “The High Price of ‘Free’ Trade: US Trade Agreements and Access to Medicines” (2013) The Journal of Law, Medicine & Ethics 199 at 206.

205. Deborah GLEESON, “Submission to the Department of Foreign Affairs and Trade” Department of Foreign Affairs and Trade (Australia) (7 September 2012), online: DFAT <https://www.dfat.gov.au/fta/tpp/subs/tpp_sub_gleeson_120911.pdf> 3 at 5−6.

206. AUSFTA, supra note 70, annex 2-C.

207. Gleeson, , supra note 205 at 4.

208. Flynn, et al., supra note 180 at 51.

209. Transparency Annex, supra note 181, para. X.3(i). See also Gleeson, , supra note 205 at 5.

210. See Kelsey, , supra note 41 at 247, regarding “resistance” from some TPP parties “who believe that best practice should be sensitive to each state's individual system of governance, constitutional structure, national priorities, and constitutional and international obligations”.

211. Nottage, , supra note 2 at 258.

212. Letter from the Australian Permanent Mission to the UN Geneva to the United Nations Special Rapporteur on the Right to Health, supra note 196 at 2.

213. Ibid., at 1.

214. Gleeson, and Friel, , supra note 52 at 1508. See “US Mulls Strategy on TPP Medicines Proposal in Light of Stiff Resistance” (2012) 30 Inside US Trade (online); “USTR Highlights Four TPP Areas Where Negotiations Mostly Wrapped Up” (2013) 31 Inside US Trade (online). See also “TPP Countries Slowly Restart Formal Talks on Pharmaceutical IP Protections” (2013) 31 Inside US Trade (online).

215. Letter from the Australian Permanent Mission to the UN Geneva to the United Nations Special Rapporteur on the Right to Health, supra note 196.

216. Brief on the Trans-Pacific Partnership (TPP), supra note 196.

217. “Ministro Silva: no se negociará más sobre la propiedad intelectual en el TLC con EE.UU” La Republica (12 June 2013), online: <http://www.larepublica.pe/12-06-2013/ministro-silva-no-se-negociara-mas-alla-de-lo-establecido-en-el-tlc-con-eeuu>.

218. For example, art. QQ.E.1(a) (the US's proposed expansion of the scope of patentable inventions, or “evergreening” provision) is supported only by Australia but opposed by Brunei, Canada, Chile, Mexico, New Zealand, Peru, Singapore, and Vietnam; art. QQ.E.XX (the US's proposed requirement that patent terms be adjusted to account for unreasonable delays in the patent approval process) is opposed by Canada, Japan, and New Zealand; art. QQ.E.14 (the US's proposal for patent term adjustments for delays in marketing approval) is opposed by Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam; and art. QQ.E.16(1) (the US's data exclusivity proposal) is opposed by Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Vietnam, and Singapore.

† Professor, Melbourne Law School, The University of Melbourne. Andrew is a member of the Australian Government's Expert Advisory Group on Plain Packaging of Tobacco Products (an unpaid position). We gratefully acknowledge the generous financial support provided for this independent research by the Australian National Preventive Health Agency (Grant ID 203MIT2011) and the Australian Research Council (Linkage Project LP120200028). Thank you also to James Munro and Elizabeth Sheargold for valuable research assistance and to Jessica Casben for editorial assistance at the proof stage. The opinions expressed here are our personal views as academics and are not necessarily shared by any government, employer, or other entity. Any errors or omissions are ours. This paper was largely finalized in November 2013.

‡ Professor and Associate Dean (Research), Melbourne Law School, The University of Melbourne; Former Legal Officer, Appellate Body Secretariat, World Trade Organization.

♯ Researcher, Melbourne Law School, The University of Melbourne; Legal Officer, Australian Attorney-General's Department.