Toronto, Canada (PRWEB) September 13, 2013
In 2010, the EMA began releasing patient-level data from the clinical trials used to approve new medicines in Europe, but the program was shut down in 2013 due to legal action by AbbVie and InterMune.
(See European Court of Justice Interim decision C-389/13 P, EMA v. AbbVie, C-390/13 P, EMA v. InterMune U.K. and Others which puts a hold on the release of data by EMA.)
[For background on EMA, the legal suit "RxISK Seeks Reports from AbbVie Customers as part of campaign launched today by Dr. David Healy on PRWEB"]
"Patients and their doctors need access to the data provided to regulators for drug approval," says RxISK CEO Dr. David Healy. "This is a global problem because the same chemicals — often under different brands — are used around the world. Access to this data can help patients, their doctors, and researchers assess the benefits and risks of these medications."
The petition to InterMune and AbbVie has been launched in English, French, Italian, and Chinese. German, Hindi, Punjabi, Urdu, Telugu, Spanish, Dutch, Swedish, Serbian, Yoruba, Russia, Welsh, Malayalam, and Czech versions will be released over the next two weeks.
“This is the most important legal action in healthcare for a generation and could have profound long lasting negative effects on individual health and health costs. Patients can’t be kept in the dark,” says Healy. “We have had over 2,300 signatures covering 44 countries and people from all walks of life sign the petition so far.”
The posts in multiple languages together with links to the petition itself are available at RxISK
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