the tpp and public health
TRANSCRIPT
The TPP and Public Health
Peter MaybardukGlobal Access to Medicines Program Director
Public Citizen - Washington, [email protected]
www.citizen.org/access
Presented March 4, 2012Melbourne
The TPP and Public Health Analysis and negotiating texts available e.g. at :
www.citizen.org/access– Aggressive text with low patentability standards
– Backtracks from Bush-era access commitments
– Strengthens, lengthens, broadens monopolies
– Would displace TRIPS standards in Asia-Pacific
Concern: TPP becomes a hemispheric rulemaking against public health
– Access to medicines and formularies– Regional production and innovation – Tobacco & alcohol control
Analysis of US proposal and Australian law
US demands changes to Australian law Patent term extensions
– New for patent prosecution; broader for reg review Data exclusivity
– Disclosed data; tries again on new uses (5+3 years)
Linkage– Attacks Australian measures intended to curb abuse
– EU formally requested Italy remove patent linkage due to delaying generic entry (Compliance w/2001/83/EC)
Pre-grant opposition– IP Australia: 1.5% applications opposed; most common
result narrowing of claims
Policy incoherence with patent quality & Raising the Bar: Bolar, pre-grant & presumption of patent validity.
Compounded regional dangers
Dramatic law changes in developing countries: Patentability: new uses for old medicines, methods,
extensions, procedural protections.
+ Limits on emerging medicines production Australia, Vietnam (Hep C & biologics), Malaysia
+ Broad regional reach---------= Reduced regional economies of scale; serious threats to access extending over years
Example: lopinavir+ritonavir for HIV
Second-line HIV/AIDS treatment NIH grant “led directly to invention of ritonavir”
– Public investment catalyzed ARV R&D activity
Exclusively licensed; heavily patented by Abbott 2003: Abbott raises cost 400% to competitors
– anticompetitive tie disincentives new products
Retards innovation while pricing publicly-funded drug beyond reach
Example: LPV/r
Major global problem scaling up 2nd line treatment Low-cost generics – but patent problem
– Ritonavir API patent should expire in 2014 - but hundreds more patent references
– Drug class now dominated by Abbott– Heat-stable combination patents until 2026
Pre-grant opposition India: defeated '339 application; protected supply
US text would have protected monopoly
Example: LPV/r and Vietnam
US proposal:
– Would eliminate pre-grant opposition– Would facilitate LPV/r evergreening
PEPFAR Vietnam COP Report FY 2010: – “Hopes that the cost of second-line treatments would fall
significantly have not been realized … A key driver is the cost of Abbott Lopinavir/Ritonavir products. Expectations that the cost of Lopinavir/Ritonavir would fall by 50% in 2009 due to the introduction of generic versions were dashed when it was discovered that Abbott has patents pending in Vietnam ...”
US trade policy vs. US AIDS policy
Health groups in every TPP country have objected in writing to US text
Examples: – Feb. 2011 letter from health groups in every
TPP country re: access to meds– Malaysia and Vietnam civil society
declarations– American Medical Association and other
public health associations calling for complete tobacco and alcohol carve out
Signed: Australian Fair Trade and Investment Network (AFTINET) Asia Pacific Network of PLHIV (APN+) Continental Social Alliance (ASC) Chile Forum on Democracy on Trade Foundation for Integrative AIDS Research (FIAR) Global Network of People Living with HIV (GNP+) Health Action International (HAI) Global Health Action International Peru Health GAP (Global Access Project) Initiative for Access, Medicines and Knowledge (I-MAK) International Treatment Preparedness Coalition (ITPC) Latin America-Caribbean-Global Alliance for Access to Medicines (Alianza
LAC-Global) Network: A National Catholic Social Justice Lobby Peoples Health Movement OZ (PHM OZ Australia) Peoples Health Movement Vietnam Peruvian Network for Globalization with Equity (RedGE) Positive Malaysian Treatment Access & Advocacy Group (MTAAG+) Public Citizen Public Health Association of Australia (PHAA) Universities Allied for Essential Medicines (UAEM)
Letter to Trade Ministers - Feb 15 2011
Vietnam declaration on TPP & Meds: 29 Feb: 100+ PLHIV groups against US text
… We call on:
The GOVERNMENT OF THE UNITED STATES to immediately withdraw any and all TRIPS- plus provisions in the intellectual property chapter of the TPFTA, and to immediately cease all other forms of pressure and lobbying against Vietnam and Vietnamese officials. ....
.. We, the undersigned, declare our opposition to the Trans-Pacific FTA as it puts the profits of multinational pharmaceutical companies ahead of the people’s right to health. ....
A shift in knowledge economy culture
IP maximalist culture may be on the wane– IT industry power on rise; content industry
lobbying power disproportionate– Large scale demonstrations (ACTA & EU-
India FTA); Legislative failure (SOPA) – Human rights and political freedom narrative
• Amnesty International: ACTA a “Pandora's box of potential human rights violations”
Innovation policy
Massive public inputs to innovation: – Largest funder of medical R&D: publicly-funded NIH. $30
billion/year.
– Universities
– Moving into translational research today
Deficiencies in pharma industry innovation: Massive marketing budgets / me-too drugs. Very little R&D for diseases of the poor. Inflated R&D estimates / non-transparency of data
Developing regional industry: innovation sequences:– Imitation & reverse engineering followed by incremental
innovation (Gervais / Kilic)
What evidence for TRIPS+?
Toward a better TPP
The TPP and Public Health
Peter MaybardukGlobal Access to Medicines Program Director
Public Citizen - Washington, D.C.
www.citizen.org/access
Presented March 4, 2012Melbourne