In December 2010 the European Medicines Agency (EMA) promised to disclose on demand clinical trial data (clinical study reports) for every drug it had reviewed.
In January 2013, two companies, AbbVie and InterMune, started court action to prevent EMA from releasing clinical study reports from trials on their drugs. They got a European court injunction in April 2013 pending later hearings. Bloomberg: AbbVie, InterMune sue to block clinical-trial data release
Between June and September 2013, hundreds of people and organisations wrote to the EMA in support of its proposals to publish clinical study reports. AllTrials: Response to EMA Consultation
Then, between February and April 2014, hundreds of citizens – and organisations representing thousands of people – wrote to their MEPs and Health Ministers urging them to support the EMA’s transparent publication of clinical study reports as part of changes to EU clinical trial regulations. AllTrials: Write your MEPs
On 2nd April 2014, the European Parliament overwhelmingly agreed with them and passed the new regulation. AllTrials: Europe votes for clinical trial transparency
The next day, 3rd April 2014, AbbVie announced it was dropping its case. The EMA said it had reached an agreement with AbbVie. AllTrials: AbbVie drops its case
On 16th May 2014, the EMA held a stakeholders meeting about its policy, which everybody expected to reflect both its previous commitment to transparency and its renewed mandate from the European Parliament and the will of European citizens…
Instead, these proposals, to the shock of participants, showed that:
- Clinical study reports would only be available for on-screen viewing and could not be saved, downloaded, printed or shared.
- Substantial parts of the reports could be redacted (hidden).
- Trial sponsors could redact their own clinical study reports.
At the end of May, InterMune dropped its case. AllTrials: InterMune drops its case
This week, in response to AllTrials’ letter of criticism about reneging on transparency, Guido Rasi, head of the EMA, indicated he felt unable to reach a better agreement with pharmaceutical companies.
It seems that the dropped court cases have come at a very high price. We know that sections of industry were trying to influence the outcome of the court proceedings started by AbbVie and InterMune against the EMA’s publication of trial reports. For example, in a leaked memo from the European Federation of Pharmaceutical Industry Associations (EFPIA) last year we noted this:
“EFPIA-PhRMA intervention in the AbbVie case: Victoria Kitcatt, [Senior Legal Adviser at] Pfizer, leads this work, in close cooperation with PhRMA and external legal counsel.”
Clearly the board of the EMA didn’t want to be fighting drawn out legal battles. But to overrule the recently expressed will of 506 million citizens (who are also patients!) in a backroom deal with a handful of companies with big law firms would be monstrous.
News update: We’ve just heard that our correspondence with the EMA are going to be tabled at their meeting on Thursday. Read our correspondence and letters from other organisations here.
This means we have 24 hours to persuade the EMA not to finalise their draft policy until the concerns are satisfactorily addressed. Add your voice now.