Uh Oh – Did I Speak Too Soon?

Posted by jim on 03/04/14

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:

03/04/2014
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The European Medicines Agency (EMA) confirms that AbbVie has withdrawn both its court cases brought against the Agency concerning access to clinical-trial data.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?

One Response to Uh Oh – Did I Speak Too Soon? »»

  1. jim
    Comment by jim | 2014/04/04 at 00:11:12

    According to Bloomberg:

    AbbVie said it decided to withdraw its lawsuits at the EU General Court, the bloc’s second-highest tribunal, after the EMA accepted redacted documents from the company and also its “rationale for removing certain commercially confidential information from the clinical study reports that are at the center of the litigation.”
    “A significant portion of data will be disclosed while protecting the information that is commercially sensitive,” AbbVie said in an e-mailed statement.

    http://www.bloomberg.com/news/2014-04-03/abbvie-drops-eu-court-bid-to-block-clinical-trial-data-release.html


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