April 3, 2014
Abbvie’s withdrawal of the case against the EMA was not entirely unilateral – it followed an agreement by the agency to accept a redacted version of the document they were going to publish in January 2013 and which was the subject of the legal challenge by Abbvie. Here is what the EMA said today:
EMA confirms withdrawal of two court cases concerning access to clinical-trial data
The European Medicines Agency (EMA) confirms that AbbVie has withdrawn both its court cases brought against the Agency concerning access to clinical-trial data. In particular, following the successful appeal against the interim rulings issued against the Agency in April 2013, the EMA was requested to consider an entirely new set of redacted documents and related justification for redaction proposed by the company. The very limited redactions proposed by AbbVie were consistent with the Agency’s redaction practices and also had no significant impact on the readability of the reports. Therefore, a decision accepting that new set of documents was notified to the company.
Another court case brought by InterMune against the Agency challenging a decision to grant access to clinical-study reports is still ongoing.
Without being able to see both documents, the version that the EMA originally intended to release and the version that they will actually release, it is difficult to assess the implications of the settlement in this case.
Perhaps there is a case for a request for access to the original document?
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