Abstract: The Trans Pacific Partnership Agreement (TPP) is a large regional trade agreement involving 12 countries. It was signed in principle in February 2016 but has not yet been ratified in any of the participating countries. The TPP provisions place a range of constraints on how governments regulate the pharmaceutical sector and set prices for medicines. This article presents a prospective policy analysis of the possible effects of the TPP on these two points in Canada and Australia.
The New Zealand Parliamentary Committee on Foreign Affairs, Defence and Trade has posted draft legislation to bring its law into compliance with the Trans Pacific Partnership, as well comments on the legislation, all of which are available here. The following excerpt from the comments submitted by Google New Zealand focuses on the importance of a “flexible and dynamic” copyright exception.
Google believes that in order to promote innovation and creativity, New Zealand should adopt copyright exceptions that allow the market, new technologies and new creativity to evolve. New Zealand needs not only technologically neutral copyright protections, but also dynamic, technology neutral exceptions that allow new, legitimate uses of copyright and services to evolve as technology evolves.
Submissions are due by 5pm on Monday, 8 August 2016
Consultation document (PDF)
On 11 July 2016, Ministry of Business, Innovation and Employment released a consultation document seeking feedback on proposed regulations to implement the patent term extension provisions in the Trans-Pacific Partnership Agreement Amendment Bill. The Bill will, when it enters into force, amend the Patents Act 2013 to provide for patent term extensions for:
- Unreasonable delays in patent grant; and
- Unreasonable curtailment of the effective patent term as a result of the Medsafe approval process.
The Pennsylvania Fair Trade Coalition (PFTC) has released questionnaires completed by candidates Sanders and Clinton on their views on the Trans Pacific Partnership. The questionnaires consist of ten questions and allow the candidates to give detailed answers. Topics include intellectual property and medicines, labor, environment, and fast track. Both candidates’ fully completed questionnaires are available in the PFTC press release. Question 4, on intellectual property and access to medicine, and each candidates’ full answer, are reproduced below:
[Joint civil society letter, Link] Dear Member of Congress: As organizations concerned with public health in the United States and across the world, we are alarmed by the implications for access to medicines of the Trans-Pacific Partnership (TPP), signed by the U.S. and 11 other countries on February 4th, 2016. The intellectual property (IP), investment, and pharmaceutical and medical device reimbursement listing provisions included in the TPP would do more to undermine access to affordable medicines than any previous U.S. trade agreement. We therefore urge you to reject the TPP in its current form.
The following submission was made last week by Peter Jaszi, Michael Carroll, Sean Flynn and Meredith Jacob to the New Zealand Ministry of Business, Innovation and Employment. It was in response to a consultation document released by the Ministry on the implementation of TPP intellectual property obligations.
Abstract: One of the purposes of the Trans‐Pacific Partnership (TPP) is to harmonize standards and create a uniform climate for trade and investment. As lawmakers deliberate the terms of the deal, they must consider what the long‐term impact of agreeing to its sweeping provisions will be. As they do so, they should keep in mind that the gaps between the agreed‐upon principles and local implementation, and the differences between local implementation – some of them by design – are often quite great. Drawing upon the existing literature, this short essay provides a survey of the extent of harmony and disharmony in the 20 years that have passed since ratification of the TRIPS agreement, with a focus on its patent provisions.
Summary: On 9 March 2016, the Minister of Commerce and Consumer Affairs announced the release of a consultation document that seeks feedback on how the Government proposes to implement the intellectual property changes required to ratify the Trans-Pacific Partnership (TPP) Agreement.
Baker BK (2016) Trans-Pacific Partnership Provisions in Intellectual Property, Transparency, and Investment Chapters Threaten Access to Medicines in the US and Elsewhere. PLoS Med 13(3): e1001970. doi:10.1371/journal.pmed.1001970
A new Pacific-Rim trade agreement threatens future access to affordable medicines in the United States and abroad. Buried in 6,000-plus pages of text, annexes, and side letters, there are multiple provisions—complex in their articulation, but simple in their effect: they dramatically increase monopoly protections for the transnational originator pharmaceutical industry.
[Posted on eff.org, Link (CC-BY)] When the text of the Trans-Pacific Partnership (TPP) was first released in November last year, it included provisions dictating the kinds of penalties that should be available in cases of copyright infringement. Amongst those provisions, the following footnote allowed countries some flexibility in applying criminal procedures and penalties to cases of willful copyright infringement on a commercial scale:
As readers of this blog are well aware, one of the most controversial issues in the Trans Pacific Partnership was the length of data exclusivity for biologic drugs. The U.S. sought a twelve year period (which would be consistent with current U.S. law) during which competitors would be unable to enter the market to compete with innovator firms unless they duplicated safety and efficacy data to obtain regulatory approval. Other countries sought lesser terms, arguing that long periods of data exclusivity raised the price of biologic medicines by blocking generic competition.
The Trans-Pacific Partnership (“TPP”) is a massive new trade agreement recently negotiated between the US and a host of countries including Australia, Japan, Canada, Mexico, Singapore, and Chile. The TPP’s IP Chapter (PDF) includes a series of provisions that address rightsholder abuse. While the agreement’s acknowledgment of abuse is salutary, and the protections it affords to users are real, these provisions rely largely on the discretion of judicial or administrative authorities, making the agreement’s protections for users less certain than protection for rightsholders.