The Trans-Pacific Partnership: Patent law, public health, and access to essential medicines, submission to the Productivity Commission, the Joint Standing Committee on Treaties, and the Senate Foreign Affairs, Trade, and References Committee

This submission provides a critical analysis of a number of Chapters in the <i>Trans-Pacific Partnership</i> addressing intellectual property, public health, and access to essential medicines – including Chapter 18 on Intellectual Property, Chapter 9 on Investment, and Annex 26 on ‘Healthcare Transparency.’ The United States Trade Representative has argued: ‘The Intellectual Property chapter also includes commitments to promote not only the development of innovative, life-saving drugs and treatments, but also robust generic medicine markets.’ The United States maintained: ‘Drawing on the principles underlying the “May 10, 2007” Congressional-Executive Agreement, included in agreements with Peru, Colombia, Panama, and Korea, the chapter includes transitions for certain pharmaceutical IP provisions, taking into account a Party’s level of development and capacity as well as its existing laws and international obligations.’ The United States Trade Representative also argued that the agreement protected public health: ‘The chapter incorporates the Doha Declaration on the TRIPS Agreement and Public Health, and confirms that Parties are not prevented from taking measures to protect public health, including to respond to epidemics such as HIV/AIDS.’ Australia’s Regulatory Impact Statement says that the Trans-Pacific Partnership is designed to ‘incentivise investment in new pharmaceutical inventions and products, while aiming to ensure TPP countries can take measures to protect public health and support timely and affordable access to medicines.’ In its National Interest Analysis, New Zealand maintains that there are sufficient and adequate safeguards for public health in respect of Intellectual Property, Investment, and ‘Health Transparency.’ Canada is currently holding an open consultation on the Trans-Pacific Partnership. Questions over intellectual property, public health, and access to essential medicines have been foregrounded by the incredible investor action by Eli Lilly against the Government of Canada under the North American Free Trade Agreement 1994. This analysis raises concerns that the provisions in the Trans-Pacific Partnership will threaten access to essential medicines across the Pacific Rim. <b>Recommendation 1</b> - Overall, the Trans-Pacific Partnership strengthens the substantive and procedural rights of pharmaceutical drug companies, medical manufacturers, and biotechnology organisations under the Intellectual Property, Investment, and ‘Transparency’ Chapters. <b>Recommendation 2</b> - There has been a great deal of concern about the influence of pharmaceutical drug companies, medical manufacturers, and biotechnology organisations in the secret negotiations over the Trans-Pacific Partnership. There has been inadequate input from public health advocates and defenders into the final agreement. <b>Recommendation 3</b> - The Trans-Pacific Partnership does little positive to provide for access to essential medicines across the Pacific Rim. Indeed, the combination of measures contained in the agreement will undermine access to essential medicines in the region. <b>Recommendation 4</b> - The Trans-Pacific Partnership will seek to lengthen, broaden, and strengthen the patent rights of pharmaceutical drug companies, medical manufacturers, and biotechnology organisations across the Pacific Rim. This will affect patient care, freedom of research, and the administration and cost of health-care. <b>Recommendation 5</b> - The Trans-Pacific Partnership also erects significant regulatory barriers – with data protection, market exclusivity for biologics, and civil and criminal remedies for trade secrets. <b>Recommendation 6</b> - The Trans-Pacific Partnership also enables intellectual property owners to bring actions under the investor-state dispute settlement regime established by the Investment Chapter. The investor dispute between Eli Lilly and the Government of Canada under the North American Free Trade Agreement 1994 highlights the dangers of such a regime. <b>Recommendation 7</b> - The Trans-Pacific Partnership also contains a ‘Health Transparency’ Annex, which contains provisions, which will enable pharmaceutical companies to oversee government decisions in respect of medicines and medical devices. <b>Recommendation 8</b> - The World Health Organization has expressed concerns about the impact of the Trans-Pacific Partnership and other mega-regional trade agreements upon the provision of public health-care. <b>Recommendation 9</b> - The United Nations Secretary General’s High Level Panel Report on Access to Medicines highlights concerns about the impact of trade agreements such as the Trans-Pacific Partnership upon access to medicines <u><font color="blue"><a href="http://www.unsgaccessmeds.org/#homepage-1"> The report</a></font></u> makes a number of recommendations as to how to promote the research, development, and deployment of essential medicines to better support global public health <b>Recommendation 10</b> - Furthermore, the Trans-Pacific Partnership will result in greater fragmentation and incoherence of international regulation and governance of access to medicines. The regional agreement will dilute the key role of international, multilateral organisations such as the World Intellectual Property Organization, the World Trade Organization, and the World Health Organization. Given that access to medicines is a global issue, the United Nations should play a key role in the field.

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