Trade, investment, innovation and their impact on access to medicines : an Asian perspective / Locknie Hsu, School of Law, Singapore Management University.
2016
HD9665.4 .H78 2016 (Map It)
Available at Cellar
Formats
| Format | |
|---|---|
| BibTeX | |
| MARCXML | |
| TextMARC | |
| MARC | |
| DublinCore | |
| EndNote | |
| NLM | |
| RefWorks | |
| RIS |
Items
Details
Author
Title
Trade, investment, innovation and their impact on access to medicines : an Asian perspective / Locknie Hsu, School of Law, Singapore Management University.
Published
New York : Cambridge University Press, 2016.
Call Number
HD9665.4 .H78 2016
ISBN
9781107072732 (hardback)
1107072735 (hardback)
1107072735 (hardback)
Description
xxv, 459 pages ; 23 cm.
System Control No.
(OCoLC)944179280
Summary
"The last two decades have seen great economic change in Asia and this has impacted upon the vexed question of access to affordable healthcare and medicines in many Asian states. In this book Locknie Hsu examines the issue of access to medicines in Asia from a fresh perspective which embraces trade and investment law, innovation, intellectual property law, competition policy and public health issues. Hsu explores the key evolving legal issues in these areas, including ASEAN integration, free trade agreement negotiations (such as those for the TPP), bilateral investment agreements and significant court decisions. The book goes on to present proposals for steps to be taken in addressing access to medicines in Asia and will be useful to academic researchers, regulators, law-makers and global organizations involved in the issues surrounding access to affordable healthcare and medicines"-- Provided by publisher.
Bibliography, etc. Note
Includes bibliographical references and index.
Record Appears in
Gift
Purchased from the income of the Silver Fund
Gift
The Arthur W. Diamond Law Library
Purchased from the income of the Silver Fund
Table of Contents
List of figures
xiv
List of tables
xv
Foreword / Sundaresh Menon
xvii
Preface
xxi
Acknowledgements
xxiv
1.
Economic integration, Asia and medicines
1
1.1.
Introduction -- globalization and Asia
1
1.2.
Aging Asia: healthcare needs
4
1.3.
Diseases in Asia and the Pacific region
6
1.4.
Poverty in Asia
8
1.5.
growth of National Health Expenditure
9
1.6.
Medicines, R&D and Asia -- an overview
16
1.7.
Economic integration activities in Asia and health matters: an overview
22
1.8.
TRIPS-plus requirements and Asia -- an introduction
24
1.9.
New legal risks -- potential of investor-state claims
26
1.10.
Syncopation between the law, science and social policy
26
1.11.
role of international organizations
27
1.12.
global and regional context
29
1.13.
Economic reform and IPRs in Asia
41
1.14.
Conclusion
44
2.
Access to medicines, innovation and the debate at the multilateral level
46
2.1.
Globalization, trade and public health dimensions: The context
46
2.2.
Government reviews on the pharmaceutical sector and patents
56
2.3.
International patent commitments: from Paris to Uruguay and beyond
57
2.4.
promise of TRIPS: flexibilities for members
58
2.5.
Regulatory tensions
62
2.6.
place of patents in the debate
66
2.7.
very contentious debate
81
2.8.
Other relevant elements of the debate
83
2.9.
Conclusion
99
3.
Trade, investment and medicines: the existing legal and policy construct
101
3.1.
existing legal and policy construct
101
3.2.
ASEAN -- the need for greater clarity in the collective legal and policy construct
103
3.3.
Key elements
103
3.4.
Exhaustion of rights and parallel imports
159
3.5.
Conclusion
162
4.
Treaties in Asia: embedded risks and lessons from disputes elsewhere
164
4.1.
Legal obligations in TRIPS
164
4.2.
Examples of TRIPS disputes in the WTO system
165
4.3.
TRIPS-like and TRIPS-plus commitments in Asia FTAs
167
4.4.
FTAs and legal risks arising from negotiated language
168
4.5.
Non-FTA mechanisms with a bearing on national laws
172
4.6.
Types of TRIPS-plus FTA provisions
172
4.7.
treaty-based ISDS system -- legal risks and concerns
201
4.8.
"Counterweight" provisions relevant to the regulation of the pharmaceutical industry
214
4.9.
Conclusion
215
5.
importance of exceptions and flexibilities
219
5.1.
Introduction
219
5.2.
Exception provisions -- general considerations
221
5.3.
Applicability of GATT 1994 Article XX to WTO Accession Protocol commitments: lessons learnt
224
5.4.
Safe harbours: Asian treaties' general exceptions
225
5.5.
TRIPS principles and objectives in FTAs
227
5.6.
TRIPS exceptions and flexibilities
228
5.7.
Using a non-violation provision to safeguard the use of exceptions and limitations
266
5.8.
Investment treaty general exceptions and expropriation exceptions relevant to health
268
5.9.
Security exceptions
273
5.10.
Interpretational treaty signals
275
5.11.
Negotiating space
277
5.12.
Conclusion
281
6.
Innovation and competition
283
6.1.
Innovation, competition: seeking a balance
283
6.2.
Patents and competition law -- necessary bedfellows
286
6.3.
Emerging case law on competition law and pharmaceutical patentees' practices
289
6.4.
European Union: towards increased competition enforcement in pharmaceuticals sector
294
6.5.
Asia's first pay-for-delay case
297
6.6.
Developments in other jurisdictions
298
6.7.
Connecting refusals to licence patents and the essential facilities doctrine: the next logical step?
302
6.8.
Competition law and the pharmaceutical sector in Asia -- an evolving regional landscape
306
6.9.
Conclusion
332
7.
Setting new directions: the need for innovative legal and policy solutions
334
7.1.
need for new paradigms and strategies
334
7.2.
brief inventory of major initiatives
337
7.3.
evolving role of the state as a provider of incentives
342
7.4.
evolving paradigm in R&D: public-private partnerships to promote public health and innovation
344
7.5.
Exploring new funding models
348
7.6.
evolving role of business
352
7.7.
Rethinking clinical data protection
353
7.8.
Treaty-based approaches
366
7.9.
use of differential or tiered pricing: affordable prices and facilitative aspects in trade and investment treaties
377
7.10.
Dispute resolution provisions for public health
387
7.11.
Conclusion
388
8.
What next?
389
8.1.
Advancing access: important questions and trends for Asia to consider
389
8.2.
Clarifying critical matters in the multilateral trade system
389
8.3.
New incentives -- new ways of rewarding conduct that contributes to greater access
404
8.4.
Timely evaluations and coherent policy-making in growing areas
405
8.5.
Can industry do more?
411
8.6.
Can governments do more?
418
8.7.
Regional integration and pharmaceutical initiatives
422
8.8.
Watch this space: BRICS and health
430
8.9.
Encouraging new alliances and collaborations
432
8.10.
Preparing for the debate ahead: legal education and capacity-building
435
8.11.
Conclusion
436
Index
439