Japan's emerging role in the global pharmaceutical intellectual property regime: A tale of two trade agreements

• Published date: 01 March 2018
• Author: Belinda Townsend,Deborah Gleeson,Ruth Lopert
• DOI: http://doi.org/10.1111/jwip.12099
• Date: 01 March 2018

DOI: 10.1111/jwip.12099

ORIGINAL ARTICLE

Japan's emerging role in the global

pharmaceutical intellectual property

regime: A tale of two trade agreements

Belinda Townsend

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Deborah Gleeson

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Ruth Lopert

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1

School of Regulation and Global

Governance, Australian National University,

ACT, Canberra, Australia

2

School of Psychology and Public Health, La

Trobe University, Bundoora, Victoria,

Australia

3

Department of Health Policy and

Management, Milken Institute School of

Public Health, George Washington

University, Washington, DC, USA

Correspondence

Belinda Townsend, School of Regulation and

Global Governance, Australian National

University, ACT 2617, Canberra, Australia.

Email: belinda.townsend@anu.edu.au

This paper explores Japan's role in reshaping the global

pharmaceutical intellectual property regime by examining its

position on the expansion of intellectual property rights (IPR)

in negotiations for two regional trade agreements: the

Trans Pacific Partnership Agreement (TPP) and the Regional

Comprehensive Economic Partnership (RCEP). Through

systematic analysis of leaked negotiating texts documenting

its positions on key issues, we demonstrate Japan is now

playing a pivotal role in promoting the adoption of expanded

IPRs. We show that its position as IPR champion in the Asia

Pacific region reflects a domestic strategy initiated in 2013

to bolster pharmaceutical export growth. Drawing on past

experience and focusing on the RCEP negotiations, we

explore ways in which low and middle income countries

might respond to this shift in order to protect and promote

access to medicines.

KEYWORDS

access to medicines, intellectual property, RCEP, Regional

Comprehensive Economic Partnership Agreement, TPP, Trans

Pacific Partnership Agreement

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INTRODUCTION

Japan's recent role in promoting the expansion of IPRs in regional trade agreements signals a shift in th e

landscape once dominated by the United States (US) and European Union (EU). Japan was a latecomer to the

Trans Pacific Partnership Agreement (TPP); to date it is one of only two countries to have ratified the text, and

© 2018 The Authors. The Journal of World Intellectual Property © 2018 John Wiley & Sons Ltd

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wileyonlinelibrary.com/journal/jwip J World Intellect Prop. 2018;21:88–103.

has played a key role in attempting to revive the agreement with the 10 remaining part ies since the US

withdrawal in early 2017. Japan is also one of 16 countries currently participating in the Regional

Comprehensive Economic Partnership agreement (RCEP) negotiations across the Asia Pacific region. The final

text of the TPP mandated expanded IP rights that, if maintained by the remaining parties, will likely delay the

market entry of cheaper generic medicines in several of the countries (Labonte, Schram, & Ruckert, 2016). Of

potentially greater concern is that the countries participating in RCEP include key generic medicine producers

like India, posing global ramifications for access to medicines if high levels of IP protection are included in the

final agreement.

This paper explores the emerging role of Japan in reshaping the global pharmaceutical intellectual property

regime by examining its position in relation to the expansion of intellectual property rights (IPRs) in negotiations for

the TPP and RCEP. Through systematic analysis of leaked negotiating texts that document Japan's positions on key

issues, we demonstrate that as an artefact of the particular dynamics involved in these trade negotiations, Japan is

now playing a pivotal role in promoting the adoption of expanded IPRs—arguably one approaching that of the United

States or the European Union. We show that Japan's newfound position as IPR champion in the Asia Pacific region

reflects a domestic strategy initiated in 2013 to bolster pharmaceutical export growth. Drawing on past experience

and focusing particularly on the current RCEP negotiations, we explore ways in which low and middle income

countries (LMICs) might respond to this shift so as to protect and promote access to medicines. We find that LMICs

are best placed to maintain an ASEAN-centred response that reflects the different economic and social needs of

negotiating countries.

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BACKGROUND—THE PURSUIT OF TRIPS-PLUS IPRS AND BARRIERS

FOR ACCESS TO MEDICINES

The TPP and RCEP represent th e most recent forums in a prog ressive expansion of IPRs t hrough bilateral and

regional trade agreements ov er the last two decades. The World Trade Organization's Tra de Related-Aspects of

Intellectual Property Rights agreement (TRIPS) came into force in 1995 and effectively established a global

intellectual property ri ghts regime. It was brough t about through the United S tates and European Econom ic

Commission's extensive tr ade pressure on low and middle-i ncome countries (LMICs) an d the global lobbying

efforts of multinational IP-intensive industries,in particular the pharmaceutical industry (Drahos, 1995; Sell, 2003).

TRIPS obliges WTO member sta tes to implement certain st andards of IP protection, in cluding the grant and

enforcement of pharmaceuti cal product and process pate nts for a minimum period of 20 years ( World Trade

Organization, 2013).

High levels of IP protection can create barriers to access to medicines when market monopolies enable

unrestrained pricing. Shortly after TRIPS was signed, newly developed, patented lifesaving HIV/AIDS drugs

were priced out of reach for many patients, at more than tenthousanddollars(US)perpatientperyear(McNeil,

2002). The South African government introduced legislation to obtain more affordable generic versions of the

drugs and faced a multinational pharmaceutical industry lawsuit that claimed the legislation violated TRIPS

(Mandisa, 2013:139; Pharmaceutical Research and Manufacturers of America, 1999). Subsequent international

protests and the development of cheaper generic AIDS drugs by Indian firms bolstered a common position

amongst developing countries at the WTO, leading to the 2001 Doha Declaration in 2001 which confirmed that

TRIPS contained flexibilities for governments to override IPRs in order to protect public health (World Trade

Organization, 2001a).

In the years since TRIPS, the United States and European Union (EU) have each shifted the locus of their

respective expansionist IP agendas to bilateral and plurilateral trade and investment agreements, with the United

States successfully managing to secure TRIPS-Plus levels of IP protection in some 20 countries between 1995 and

2011 (Correa, 2006; Office of the United States Trade Representative, 2016). Text proposed by the EU to India,

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