EU ombudsman probes link between AbbVie case and trial transparency U-turn

With days to go until the European Medicines Agency (EMA) meets to finalize its clinical trial data policy, the region's ombudsman has confirmed she is probing a possible link between a settlement with AbbVie ($ABBV) and a shift in the transparency plans.

AbbVie dropped a trial transparency lawsuit against EMA in April after the agency agreed to redact some information deemed commercially sensitive. Weeks later EMA released draft terms of use for the trial transparency law--which won overwhelming support from European politicians--and was promptly criticized for watering down the impact of the legislation. European ombudsman Emily O'Reilly questioned the legal basis for the shift but has yet to get a satisfactory answer.

Asked by Ed Silverman of Pharmalot--which has a new home at The Wall Street Journal--what caused the U-turn, O'Reilly talked about the AbbVie case. When asked whether the settlement had something to do with the policy shift, O'Reilly said: "That's what we're trying to find out. I can't speculate, but we've gone from a position of great openness and transparency that recognized, except in rare circumstances, trial data could not be considered commercial sensitivity. Now we have a larger number of barriers to researchers and general public."

Those barriers have significant implications for anyone hoping to slice and dice the clinical trial data. If the current draft policy is finalized, users will be able to view clinical study reports--which may be edited to remove information deemed confidential--but will be barred from downloading and editing the data. The restrictions effectively prohibit work like the Cochrane review of Roche's ($RHHBY) Tamiflu, which is exactly the sort of independent analysis transparency advocates hoped the law would enable.

- read Pharmalot's Q&A

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