1 Boring Old Man

Europe Does a U-Turn on Trial Data Policy, Says Ombudsman

WSJ: Pharmalot

by Ed Silverman

June 4, 2014

Late last month, the European Medicines Agency circulated a long-awaited draft policy on disclosure of clinical trial data by drug makers. Transparency has been a contentious topic following scandals over safety or effectiveness data that was not publicly shared. Initially, the EMA committed to ensuring data is accessible in ways that are easily analyzed and indicated data would not be considered confidential commercial information, which drug makers cite as a key reason for limiting access.

Now, though, the EMA is being accused of backtracking. The proposed policy, which will be voted on June 12, would not allow anyone to do more than view clinical study reports, which collect and summarize trial data, on computer screens. And some information, including details of trial designs and study results, can be redacted if a drug maker believes the information is commercially confidential.

The apparent switch comes shortly after the EMA settled a legal action with one drug maker, AbbVieABBV -0.02%, which attempted to prevent the EMA from releasing trial data about one of its medicines. In response, European Union Ombudsman Emily O’Reilly wrote the EMA to object to what she calls a “significant” policy change and plans to contact the European Commission for an opinion. We spoke with her about the implications. This is an excerpt.

Pharmalot: You wrote the EMA that you’re concerned about significant changes. What concerns you most?
O’Reilly: Let me start by saying that the European Union Ombudsman has actually been working on this issue for a number of years, regarding a number of drugs where there were concerns about transparency. And we were critical of [EMA] decisions. The result was that EMA eventually decided to completely revamp its transparency policy toward clinical trial data. They decided, in the future, they would have trials publicly accessible in a way they described in 2009 as ‘targeted understandable accessible information.’ They also noted that only in rare circumstances could data be described as commercially confidential information. All that was important. But that now seems to have changed.

Pharmalot: What happened, do you think, to cause this?
O’Reilly:  I’m not sure. But we asked if we could be part of the AbbVie case [that involved another drug maker, Intermune, which also sought to block the EMA from releasing trial data]. At the time, we were waiting for EMA to produce its final transparency policy. The court case had some relevance, of course, to the issue. But then a couple of months ago, it was announced that AbbVie had withdrawn the case and that it was settled. But as part of settlement, there was further redaction of the records.

Pharmalot: You mean the records pertaining to AbbVie and its drug?
O’Reilly: Yes. And we asked EMA to see the redacted records and they declined, at which point we used our powers to inspect the documents. We have a right to see any documents we need to see in the courts, anything that will help our investigation. We wanted to see if the redactions were appropriate.

Pharmalot: It would appear you’re suggesting the settlement with AbbVie had something to do with the policy changes.
O’Reilly: 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. My role is to ask for an explanation. I do know that a couple of weeks ago, we were invited to a stakeholder meeting by EMA to see a draft of the new transparency plan. When the policy was sent, we saw it appeared to be quite a reversal to what they committed to doing a few years ago. They put lots of terms and conditions on what they said they would do. Rather than a proactive policy, the companies now have a great deal of say about how researchers and members of public have access. It’s a ‘look, but don’t touch’ policy. In our view, the draft represents a major step back. The interest of public health outweighs considerations of commercially sensitive information.

Pharmalot: Can you be more specific?
O’Reilly: You can read things on screen, but can’t use them. You are not allowed to download or save or edit the information. But you have to sign on to terms and conditions that would appear to put a lot of restrictions [on individuals who seek access]. They also have to disclose how they want to use the information and sign something that recognizes the information could be commercially sensitive. And so if they distributed the information in an unauthorized way, they could be liable to litigation. The draft policy also doesn’t say how the EMA will deal with trial information that is sought through freedom of information requests.

Pharmalot: In your view, what’s at stake?
O’Reilly: These clinical study reports don’t give the recipe for a drug – they just tell us what happened afterward. There’s nothing in the reports that could point to how a drug is made or manufactured, which are commercial secrets and certain of which could be useful to competitors. But these only show what happens when the drug is taken. A lot of researchers are concerned and alarmed. We’ve been inundated from various research bodies around the world. We need to be reassured, as individuals who decide which medicines to take or give to our families, that we have all the information we need to be assured the drugs are safe, and any information that points to a potential harm is publicly available. We also need to be assured there is independent verification of these trials. Part of that verification is from EMA and other agencies around the globe, but also by independent researchers who are looking at these trials and provide assurance that they are what the companies say they are and the drugs are what the tests have shown.

hat tip to jamzo…

So, I’m glad to hear that Emily O’Reilly [the European Ombudsman] validates how obstructive this change of plans really seems to her, because as someone who has actually worked in this environment, it feels huge. It’s also nice to hear that she’s "been inundated from various research bodies around the world." My name has been on some of those complaints, but It’s confirming that many that look at this new plan are equally outraged. I, too, think they are way overdoing the restrictions claiming safety and protection issues they’re really using those claims to make any real transparency next to impossible. What’s worse, the EMA is going along with it [or doing it for them]. And EMA Executive Director Guido Rasi’s upbeat letter is anything but reassuring to any of us [to be continued…].

Pharmalot: You mean the records pertaining to AbbVie and its drug?
O’Reilly: Yes. And we asked EMA to see the redacted records and they declined, at which point we used our powers to inspect the documents. We have a right to see any documents we need to see in the courts, anything that will help our investigation. We wanted to see if the redactions were appropriate.
Pharmalot: It would appear you’re suggesting the settlement with AbbVie had something to do with the policy changes.
O’Reilly: 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.