The Trans-Pacific Partnership and its Threats to the Affordability of Medical Products in Developing Countries

Author:Marc Stuhldreier
Position:LLM (Dubl), PhD Candidate in Law, Northumbria University Newcastle
Pages:175-195
© 2016 Shauna Keniry and Dublin University Law Society
THE TRANS-PACIFIC PARTNERSHIP
AGREEMENT AND ITS THREATS TO THE
AFFORDABILITY OF MEDICAL PRODUCTS
IN DEVELOPING COUNTRIES
MARC STUHLDREIER*
Introduction
The Trans-Pacific Partnership Agreement (TPP) is a long-awaited and
ambitious agreement which implements high standards for global trade. It
was concluded in early October, 2015, and signed on 4 February 2016
following 6 years of negotiation. There are currently 12 nations from the
Asia-Pacific region party to the treaty.1 It is estimated that this region is the
world’s fastest growing market, predicted to have a middle class of about
3.2 billion people by 2030.2 The aim of the agreement is to enhance trade
and investment between the nations by resolving legal, political, and trade
issues, including the protection of intellectual property (IP) rights.3
However, the introduction of the TPP should not be construed as an
unmitigated success. There are concerns in relation to the disproportionate
impact it will have on countries at various stages of development, as well as
different sections in society.4
The TPP acknowledges the benefits which a high standard of
protection for IP rights has for the promotion and development of
pharmaceuticals. However, it has been subject to criticism for allowing
* LLM (Dubl), PhD Candidate in Law, Northumbria University Newcastle. The author would
like to dedicate this article to his parents, Maria and Heinrich, and to his sister Sabrina. The
author would further like to thank his supervisor Professor Sue Farran for her comments and
suggestions on earlier drafts of this article.
1 These are Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru,
Singapore, the United States of America, and Vietnam is-tpp>
(visited 15 February 2016).
2 United States Trade Representative, The TPP Intellectual Property Chapter Summary (United
States Government, 2015)
Intellectual-Property.pdf> (visited 28 January 2016), at 8.
3 George Pike, “The Trans-Pacific Partnership and Intellectual Property” (2015) 32 Information
Today 13.
4 See, for example Arne Ruckert, Ashley Schram and Ronald Labonté, “The Trans-Pacific
Partnership Agreement: Trading away our health?” (2015) 106 Canadian Journal of Public
Health E249.
Trinity College Law Review [Vol 19
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multi-national corporations, in particular, the pharmaceutical industry,5 to
exercise considerable influence over the drafting process.6 This involvement
was criticised for promoting economic aims and maximisation of profits
over public health interests in having affordable medicines, which are of
particular importance for developing countries.
The IP section of the TPP significantly changes the current
international patent regime by introducing increased data exclusivity
provisions, creating the possibility of “evergreening” patents due to the
patentability of new uses of known products, and by increasing IP protection
terms for office delays in granting patents and marketing approval.7 The
TPP has therefore been accused of depriving people of adequate treatments
by delaying generic competition in the pharmaceutical sector. This
Agreement is likely to be unfavourable to those with serious health
conditions who cannot afford adequate treatment.8 Several Non-
Governmental Organisations (NGOs) have therefore warned that the
Agreement threatens the lives of millions of human beings.9 This view is
supported by Médecins Sans Frontières which argues that increased patent
provisions keep lifesaving treatment out of reach for large parts of the
population of developing countries.10
This paper expounds the potential threats that the TPP creates for the
affordability of essential medical products in developing countries. To begin
with, I propose to look at the content of the agreement’s IP section in respect
of (a) its data exclusivity provisions, (b) the scope of patentable subject
matter, and (c) term adjustments for office delays and the potential dangers
to access to medicine. Secondly, I will consider the highly criticised Investor
State Dispute Settlement (ISDS) provisions of the treaty with regards to
5 Deborah Gleeson, Pat Neuwelt, Erik Monasterio, Ruth Lopert, “How the Transnational
Pharmaceutical Industry Pursues its Interests Through International Trade and Investment
Agreements: A Case Study of the Trans Pacific Partnership” in De Jonge and Tomasic eds.,
Handbook of Research on Transnational Corporations (Edward Elgar Publishing Ltd.,
Forthcoming) (visited 8 January 2016) at 9.
6 Mike Beard, “Trans-Pacific Partnership Agreement and the public health” (2015) 128 The
New Zealand Medical Journal (Online) 41.
journal/all-issues/2010-2019/2015/vol-128-no-1415/6550> at 41.
7 Ruckert, Schram, Labonté, note 4, at E250.
8 Chris McCall, “Trans-Pacific trade pact triggers fears over drug prices” (2015) 385 The
Lancet 2450, at 2450.
9 Amy Kapczynski, “The Trans-Pacific Partnership – Is It Bad for Your Health?” (2015) 373
The New England Journal of Medicine 201, at 201.
10 Médecines Sans Frontières, Trans-Pacific Partnership Agreement – Trading Away Health
(visited 16
February 2016).

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