Health, Medicines and the PBS: Risks posed by the Trans Pacific Partnership Agreement and likely outcomes for the PBS Deborah Gleeson School of Public Health and Human Biosciences, La Trobe University 11 th Annual Future of the PBS Summit Sydney 5-6 th May, 2014
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Dr Deborah Gleeson, La Trobe University, Examining the governance changes likely to arise under the Trans Pacific Partnership Agreement
Dr Deborah Gleeson delivered the presentation at 2014 Future of the PBS Summit.
The 11th annual Future of the PBS Summit marks a wonderful opportunity to review future frameworks and preferred outcomes for pharmacy regulators, pharmaceutical companies and wholesalers, practitioners, educators and consumers.
For more information about the event, please visit: http://www.informa.com.au/futurepbs14
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Health, Medicines and the PBS: Risks posed by the Trans Pacific Partnership Agreement and likely outcomes for the PBS
Deborah Gleeson School of Public Health and Human Biosciences,
La Trobe University
11th Annual Future of the PBS Summit
Sydney 5-6th May, 2014
Outline
• Introduction to the TPP
• Overview of health risks associated with the TPP
• Trade agreements, patents and medicines
• US proposals for pharmaceuticals in the TPP
– Intellectual property
– Pharmaceutical pricing and reimbursement
– Investor-state dispute settlement
• Australia’s position
Trans Pacific Partnership Agreement (TPP)
Currently negotiating: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, United States, Vietnam South Korea has formally expressed interest in joining
More countries may join: Thailand, The Philippines, Taiwan, etc
Trans Pacific Partnership Agreement (TPP)
• Negotiations began 2010
• 19 negotiating rounds completed
• Now in final stages
• Agenda set primarily by the US
• Set to become a free trade zone of the Asia Pacific – and beyond
• Negotiated in secret
• Limited public health input
Photos: TPP negotiating venue, San Diego, July 2012
Overview of health risks
Chapters/annexes presenting most overt risks to health care and
public health policy:
– Intellectual Property
– Transparency Chapter Annex on Healthcare Technologies
– Investment
– Technical Barriers to trade (TBT)
• Including annexes on wine and distilled spirits;
• Australia worked with US and Japan on revising the healthcare transparency annex
Media reports suggest:
• Revised text may be more similar to AUSFTA Annex 2-C than the previous drafts
* Risks still remain in attempting to import Annex 2-C provisions into the TPP context
Investor State Dispute Settlement
• Potential avenue for industry to challenge:
– unfavourable formulary listing and pricing decisions (depending on regulatory and judicial frameworks)
– reforms to pharmaceutical policies and regulatory processes
– decisions regarding patents (e.g. Eli Lilly v Canada)
• The existence of the mechanism in and of itself may be sufficient to undermine evidence-based formulary decision making
Former Australian Labor Government position
• Commitments in the Trade Policy Statement, April 2011:
– To ‘preserve the right of Australian governments to
make laws in important policy areas’
– Not to accept provisions that would ‘limit its capacity to
put health warnings or plain packaging requirements on
tobacco products or its ability to continue the
Pharmaceutical Benefits Scheme.’
Current Australian Government position
• Coalition’s Policy for Trade
“The Coalition will take a pragmatic approach to trade negotiations and will consult widely with industry bodies and associations to ensure that stakeholder priorities are taken into account.
This includes remaining open to utilising investor-state dispute settlement (ISDS) clauses as part of Australia’s negotiating position.” (p. 4)
• No mention of health, medicines, PBS or tobacco plain packaging (or any health, social or environmental issues)
• Recent statements
– “…we will not entertain anything that compromises the integrity of our health system or PBS” (Andrew Robb, 11 Dec 2013, http://www.theaustralian.com.au/national-affairs/tpp-no-threat-to-medicine/story-fn59niix-1226780157587 )
– Prepared to consider ISDS
• Blocked an order by the Senate to make the text public before signing
• Three areas of the TPP could compromise access to affordable medicines: – Intellectual property chapter
– Healthcare “transparency” annex
– Investor-state dispute settlement mechanism
• Outcomes may be less extreme than early draft proposals suggest
• BUT threats remain, particularly: – IP proposals for data exclusivity (up to 12 years for biologics),
wider application of patent term extension, patent linkage
– Potential for transparency annex to be AUSFTA+ in content and/or effects
– ISDS mechanism available to pharmaceutical industry
Publications – TPP and medicines Gleeson, D. and Friel, S. (2013) Emerging threats to public health from regional trade
agreements. The Lancet, Early Online Publication, 1 March 2013. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)60312-8/fulltext
Lopert, R. and Gleeson, D. (2013). The high price of “free” trade: US trade agreements and access to medicines. Journal of Law, Medicine and Ethics, 41(1): 199-223. http://onlinelibrary.wiley.com/doi/10.1111/jlme.12014/pdf
Gleeson, D, Lopert, R, and Reid, P. (2013) How the Trans Pacific Partnership Agreement could undermine PHARMAC and threaten access to affordable medicines and health equity in New Zealand. Health Policy (published online 30 August 2013). http://www.sciencedirect.com/science/article/pii/S0168851013002108
Gleeson, D.H., Tienhaara, K.S. and Faunce, T.A. (2012) Challenges to Australia’s national health policy from trade and investment agreements. Med J. Aust 196(5): 354-356. https://www.mja.com.au/journal/2012/196/5/challenges-australia-s-national-health-policy-trade-and-investment-agreements
Gleeson, D. and Legge, D. (2012) Strengthening public health engagement in trade policy: PHAA’s policy on Trade Agreements and Health. Australian and New Zealand Journal of Public Health, 36(1); 7-9. http://onlinelibrary.wiley.com/doi/10.1111/j.1753-6405.2012.00823.x/abstract