The Trans Pacific Partnership Agreement: Implications for public health regulation and access to medicines

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PHM Oz is concerned about proposed provisions in the Trans Pacific Partnership Agreement (TPPA) that could undermine public health policy and access to essential medicines.

The TPPA is a large regional trade and investment agreement currently being negotiated between eleven countries around the Pacific Rim: Australia, Brunei, Canada, Chile, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States, and Vietnam. Japan and Thailand are considering joining.

The TPPA presents unprecedented threats to public health. It is an ambitious agreement which includes not just traditional trade issues such as removing tariffs and other barriers to trade, but also extends further beyond national borders than previous trade agreements into areas which have traditionally been the domain of domestic policy making – including health programs and policies. Public health issues are now being decided in a forum where there are limited opportunities for public input and where trade-offs are likely between economic and public health objectives. The implications are global – more countries are likely to join, and the TPP will set a template for future trade agreements.

As the trade negotiations gather momentum, so too does an international civil society movement seeking greater transparency in the negotiating process and the prioritizing of health and other public interest issues over corporate interests in the TPP.


Contents

Public health implications

Access to affordable medicines

The United States Trade Representative has put forward proposals for the TPPA that, if adopted, would compromise access to affordable medicines.

Proposals in the TPPA negotiations threaten to undermine access to medicines in two ways.

Firstly, US negotiators have made specific proposals to extend intellectual property rights for pharmaceutical companies. These companies already have patent rights to charge monopoly prices on medicines for 20 years. Extensions of patent periods and delays in the introduction of cheaper generic drugs benefit these companies, but increase costs to consumers and the health system.

These proposals include:

  • allowing patents which make only minor changes to an existing medicine, thus enabling the repeated extension or "ever-greening" of patents;
  • allowing patents for diagnostic, therapeutic and surgical methods;
  • extension of patent terms to compensate for delays in issuing patents or providing marketing approval;
  • eliminating the process for third parties to oppose patent claims before they are granted;
  • longer data exclusivity periods, where generic manufacturers are not able to use clinical trial data to register their products; and
  • a patent linkage provision which would delay regulatory approval of generic drugs.

These intellectual property proposals would delay production of generic medicines, and add to the costs of Australia’s Pharmaceutical Benefits Scheme and national drug expenditure in other countries.

In each of these areas, the US proposals for the TPPA provide much stronger intellectual property rights than the provisions in the World Trade Organization's TRIPS Agreement and the Australia-US Free Trade Agreement. They would be very particularly damaging for developing countries such as Vietnam and Peru where access to medicines is already low.

Secondly, US negotiators are seeking to place greater restrictions on pharmaceutical coverage programs such as Australia's Pharmaceutical Benefits Scheme and New Zealand's PHARMAC, which ensure affordable access to medicines.

The US is seeking to:

  • preclude assessments of innovation based on therapeutic significance ("therapeutic reference pricing");
  • extend opportunities for pharmaceutical companies to participate in decision making regarding listing, pricing and reimbursement;
  • introduce an appeals process able to overturn listing and pricing decisions;
  • legalize direct-to-consumer advertising of prescription drugs via the internet; and
  • establish mechanisms with capacity for ongoing US influence over pharmaceutical policy and programs.

Threats to public health regulation, including tobacco plain packaging

Proposed expropriation and investor-state dispute settlement (ISDS) provisions in the TPPA could enable foreign corporations to mount legal challenges in international tribunals over public health policies that may affect the value of their investments. The risks are clearly illustrated by Philip Morris Asia's challenge to the Australian Government's tobacco plain packaging laws through the ISDS clause in an investment treaty between Australia and Hong Kong.

Inclusion of an ISDS clause in the TPPA would provide further opportunities to Big Tobacco, Big Pharma, Big Alcohol and Big Food to challenge the attempts of national governments to regulate these industries to protect public health.

Many other chapters and provisions of the TPP could also make it more difficult for governments to introduce policy interventions such as tobacco control policies, nutrition and alcohol labelling, and restrictions on the advertising and sale of unhealthy goods.

The Australian Government's position

The Australian Government's Trade Policy Statement Trading our Way to More Jobs and Prosperity was released in April 2011. In this statement, the Government makes explicit commitments to rejecting provisions that might constrain the ability of Australian governments to make laws on 'social, environmental and economic matters'. The trade policy statement says: 'The Government has not and will not accept provisions that limit its capacity to put health warnings or plain packaging requirements on tobacco products or its ability to continue the Pharmaceutical Benefits Scheme' (p. 14). The statement also excludes investor-state dispute resolution procedures in trade agreements.

The Australian Government is likely to come under increasing pressure from the US to include TRIPS Plus intellectual property provisions and ISDS provisions in the TPPA. It is essential that the Australian Government stands firm and continues to reject these provisions.

Campaign activities

In February 2011, PHM Oz joined with many other civil society organisations in signing an open letter to Julia Gillard and Craig Emerson protesting the secrecy under which TPPA negotiations are being conducted, and calling for an open and transparent negotiation process. Read the AFTINET Press Release

In October 2011, PHM Oz again joined with AFTINET and many other organisations to ask for the release of a secret memorandum of understanding that reportedly binds the participating countries to keeping negotiating documents secret for four years.

PHM Oz has also endorsed an AFTINET sign-on letter to the trade ministers of the TPPA negotiating countries. This letter urges the parties to consider excluding intellectual property and pharmaceuticals provisions from the TPPA or at least to table alternatives to the TRIPS-plus model.

Further information

Visit the AFTINET (Australian Fair Trade and Investment Network) website

Public Citizen's Global Access to Medicines webpage on the TPPA, including leaked text and analysis

Leaked trade negotiation documents

Summaries of the health issues

Gleeson, D and Friel, S. (2013) Emerging threats to public health from regional trade agreements. The Lancet, 381 (9876): 1507-1509.

Gleeson, D.H., Tienhaara, K.S. and Faunce, T.A. (2012) Challenges to Australia’s national health policy from trade and investment agreements. Med J. Aust 196(5): 354-356.

AFTINET Leaflet: Don't Trade Away Health

Gleeson, D. & Legge, D. Public health at risk in trade talks. The National Times, 14 September 2011.

Ranald, P. New trade agreement threatens Australia’s laws on medicines and tobacco. Croakey, 1 September 2011.

Gleeson, D. Trade agreement threatens health in Australia and Pacific. The Canberra Times, 3 August 2011.

Intellectual property provisions and access to medicines

Letter from six Australian NGOs to Julia Gillard, February 2012: Preserving access to medicines in the Trans Pacific Partnership Agreement (TPPA)

Gleeson, D. (2012) Australia should defend neighbours in Trans Pacific Partnership negotiations. The Conversation, 20 March 2012.

Lopert, R. and Gleeson, D. (2013) The high price of "free" trade: US trade agreements and access to medicines. Journal of Law, Medicine and Ethics, 41(1): 199-223.

Kilic, B, Maybarduk P. Dangers for Access to Medicines in the Trans Pacific Partnership Agreement. Comparative Analysis of the U.S. Intellectual Property Proposal and Australian Law. Public Citizen, 2012.

Flynn S, Kaminski M, Baker BK, Koo JH. Public Interest Analysis of the US TPP Proposal for an IP Chapter. Draft Version 1.2, November 14, 2011. Program on Information Justice and Intellectual Property, American University Washington College of Law; 2011.

MSF Issue Brief: Trading Away Health: How the U.S.'s Intellectual Property Demands for the Trans-Pacific Partnership Agreement Threaten Access to Medicines

Faunce, T. A., & Townsend, R. (2011). The Trans-Pacific Partnership Agreement: challenges for Australian health and medical policies. MJA, 194(2), 83-86.

Public Citizen (2011) Briefing memo: Vietnam and the Trans Pacific Partnership Agreement

Bilaterals.org (2011) US breaks UN AIDS summit commitment on access to treatment

The Bangkok Declaration on Free Trade Agreements & Access to Medicines

Leaked US paper on eliminating pre-grant opposition

Public Citizen analysis of the US paper on eliminating pre-grant opposition

Leaked US Draft Trans Pacific Partnership Intellectual Property Rights Chapter

Public Citizen Analysis of the U.S. Intellectual Property Proposal and Australian Law

Faunce, T. & Townsend, R. (2010) Potential Impact of the TPPA on Public Health and Medicine Policies Submission to the Department of Foreign Affairs and Trade.

Gleeson, D. (2011) Trade talks set to undermine access to medicines for the world's poor. The Conversation, 16 September.

Pharmaceutical coverage programs

Gleeson, D. Health Experts Excluded while Big Pharma Calls the Tune. Croakey, 7 December 2012.

Gleeson, D. (2012) US Proposal on PHARMAC a Bitter Pill. New Zealand Herald, 24 September 2012.

Gleeson, D. (2012) Analysis of the June 2011 Leaked TPP Transparency Chapter Annex (Annex on Transparency and Procedural Fairness for HealthCare Technologies). Submission to the Department of Foreign Affairs and Trade, 7 September 2012.

Investment provisions and tobacco plain packaging

Ranald, P. (2012) The Philip Morris case illustrates some wider dangers for public health from trade agreements. Croakey, 25 January 2012.

Tienhaara, K. & Faunce, T. (2011) Gillard must repel big tobacco’s latest attack. Canberra Times.

Gleeson, D. & Legge, D. (2011) Big Tobacco v Australia: dangers looming in the Trans Pacific Partnership Agreement. The Conversation, 7 July.

Tienhaara, K. (2010) Investor-State Dispute Settlement in the Trans-Pacific Partnership Agreement. Submission to the Department of Foreign Affairs and Trade, 19 May 2010.

Ranald, P. (2011) Investor-state dispute settlement (ISDS): The threat to health, environmental and other social regulation. Paper presented at the Stakeholders Forum, eighth round of Trans-Pacific Partnership negotiations, September 10, 2011, Chicago, USA.

Media releases and related media coverage

PHAA media release, 1 March 2012: NGOs call on government to prioritise access to medicines over trade interests

Joint PHAA & AFTINET media release, 1 September 2011 Trans-Pacific Partnership Agreement proposals increase corporate rights, reduce access to affordable medicines, say public health and fair trade groups.

Cook, H. Patent talks lift fear of drugs price rise. The Canberra Times, 2 September 2011

Other useful references

Gleeson, D. and Legge, D. (2012) Strengthening public health engagement in trade policy: PHAA’s policy on Trade Agreements and Health. Australian and New Zealand Journal of Public Health, 36(1); 7-9.

Ranald, P. (2011) The experience of the Australia-US Free Trade Agreement: lessons for the Trans-Pacific Partnership Agreement negotiations. Paper presented at the Stakeholders Forum, seventh round of Trans-Pacific Partnership negotiations, June 19, 2011, Ho Chi Minh City, Vietnam.

Order the book 'No Ordinary Deal: Unmasking the Trans-Pacific Partnership Free Trade Agreement, edited by Jane Kelsey (2010). About the book: At a time when the global financial crisis has exposed deep flaws in the global free market, the US, Australia, New Zealand, Brunei, Chile, Peru and Vietnam are negotiating a free-trade agreement initiated by the US which resurrects the issues raised by the US-Australia Free Trade Agreement in 2004, including higher prices for Australian medicines, less local media content and deregulation of GE food. Jane Kelsey and her international team of expert commentators, including Dr Patricia Ranald, expose the myths of yet another neo-liberal adventure.

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