[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

Tue Aug 6 15:32:27 UTC 2013

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


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

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