[open-science] Fw: [TACD TTIP] Big Pharma wish list for TTIP/TAFTA : block clinical trial transparency, higher IPR barriers for generics and lower med authorization requirments

[Jenny Molloy]

Forwarding as this only went to open-science-dev...

---------- Forwarded message ----------
From: Javier Ruiz <javier at openrightsgroup.org>
Date: Tue, Aug 6, 2013 at 4:32 PM
Subject: [open-science-dev] Fw: [TACD TTIP] Big Pharma wish list for
TTIP/TAFTA : block clinical trial transparency, higher IPR barriers for
generics and lower med authorization requirments
To: open-science-dev at lists.okfn.org


§  *disclosure of nonpublic data submitted in clinical and preclinical
dossiers and patient-level data sets risks damaging both public health and
patient welfare*


-- 
Javier Ruiz
javier at openrightsgroup.org
+44(0)7877 911 412
@javierruiz
www.OpenRightsGroup.org
Winners of Liberty's Human Rights Campaigner of the Year Award 2012


*Subject:* [TACD TTIP] Big Pharma wish list for TTIP/TAFTA : block clinical
trial transparency, higher IPR barriers for generics and lower med
authorization requirments

*The US-EU Free Trade Agreement: Tipping Over the Regulatory Barriers
[1]<https://mail.google.com/mail/u/0/?shva=1#140504f8baca73f4__ftn1>
*

*U.S. House of Representatives Committee on Energy and Commerce*

*Subcommittee on Commerce, Manufacturing, and Trade*

*July 24, 2013  official record *

*
*

*John Castellani, President and CEO, Pharmaceutical Research and
Manufacturers of America*

1.     *In 2011, 80% of medicines in development were researched and tested
in US and in EU.*

2.     *The costs to develop new medicines continue to increase and global
ecosystem grow more hostile to innovation.*

*3.*     *PhRMA supports TTIP to eliminate unnecessary nontariff barriers
between these regions and establishes a model for future trade agreements.*

*4.*     *US –EU negotiations should address both regulatory compatibility
and IPR, market access provisions and customs and public procurement
measures.*

*5.*     *Our industry are concerned about the current European environment
because:*

*1.*     *Shortsighted cost-containment measures, especially as responses
to financial crisis*

§  *Measures were implemented without predictable, transparent and
consultative processes.*

§  *These measures raises serious concern about EU member states’
commitment to reward innovation.*

*2.*     *EMA current and proposed data disclosure policy*

§  *disclosure of nonpublic data submitted in clinical and preclinical
dossiers and patient-level data sets risks damaging both public health and
patient welfare*

§  *PhRMA urge US government to ensure responsible data sharing with EU.*

*3.*     *Market Access Commitments*

§  *PhRMA recommend to include a US-Korea FTA like commitments in US-EU
trade agreement*

§  *The commitments should recognize the value of biopharmaceuticals and
the value they play in reducing more costly medical interventions and the
increased quality of life*

*6.*     *Both EU and US should recognize IP as the lifeblood of innovation
and strong IPR rules within legal regimes. Any agreements must not dilute
IPR.*

*7.*     *PhRMA, FDA and EMA has proposed a number of regulatory
compatibility initiatives to reduce regulatory burden. (e.g. reduce
redundant testing, seeking mutual recognition of manufacturing  and
clinical principles)*



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