After dragging their feet in opposition to proposed European rules that would require public sharing of clinical trial data, pharma companies have conceded, agreeing to make certain information widely available.
Big Pharma's two major trade groups, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), today announced an agreement that would dramatically increase the amount of clinical trial data available to researchers, patients, and members of the public.
Under the new commitments, pharma companies must make available on request patient-level clinical trial data, study-level trial data, full clinical study reports, and protocols from clinical trials in the U.S. and the European Union. Companies will also have to work with regulators to provide patients who participate in clinical trials with accurate summaries of trial results.
In the agreement, companies also reaffirmed that they will publish clinical trial results regardless of the outcome. Pharma companies will begin implementing the commitments on Jan. 1, 2014.
The two trade groups had initially pushed back against the rules proposed by the European Medicines Agency, assembling a counterattack by patient groups, according to a story that ran earlier this week in The Guardian. A leaked memo revealed the organizations' strategy to get allied patient groups to complain that the transparency move would incite public health scares triggered by the misinterpretation of newly available data. According to the British newspaper, GlaxoSmithKline ($GSK), AstraZeneca ($AZN) and Novartis ($NVS) in Europe; and Eli Lilly ($LLY), Pfizer ($PFE) and Merck ($MRK) in the U.S. all received the memo.
Glaxo has been leading the charge toward greater transparency--and Roche ($RHHBY) has been following suit--and GSK has said it isn't involved in this campaign.
- here's the press release
- read the outline of EFPIA and PhRMA commitments (PDF)
- get more from the Financial Times (sub. req.)