European Medicines Agency Unexpectedly Waters Down Draft Policy On Sharing Drug Safety Data

from the surely-not dept

For some time, Techdirt has been reporting on the attempt to open up critical drug safety information in Europe. Despite fierce opposition from the pharmaceutical industry, in April the European Parliament adopted the Clinical Trials Regulation by a huge majority — 547 in favor and 17 against. Needless to say, that’s not the end of the story. Here’s what’s happened recently, as reported by the AllTrials site, which has led the campaign for access to this information held by the European Medicines Agency (EMA):

The EMA has produced a further draft of the policy which would introduce barriers to access to clinical trial data that would make the job of researchers who want to scrutinise it almost impossible.

The policy introduces terms of use which say that researchers can access the data on screen only with printing, sharing or saving of the data forbidden.

It allows the company who supplied the data to the EMA to decide which information to redact so researchers may never know what information is being kept hidden.

The EMA’s draft policy also asks researchers to agree that the companies who produced the trial data can take legal action directly against the researchers if the trial sponsor considers the researchers broke any of the conditions, introducing a new and unpredictable risk of high legal costs into routine academic work.

Clearly, that’s a far cry from the unfettered access that researchers have been seeking, and which the European Parliament has mandated, but which does not come into force until 2016. As a result, the AllTrials groups wrote an open letter to the head of the EMA, explaining why the watered-down draft policy would be “all but useless to independent researchers” because of the unreasonable constraints placed upon their use of the clinical trials data. The EMA chief replied with his own letter (pdf), but as the AllTrials blog politely put it:

his letter does not leave us in a satisfactory place.

A letter was also sent to the EMA by BEUC, an umbrella organization of 41 national consumer groups in Europe. It makes the following important point regarding clinical trials data [pdf]:

The volunteers who take part to clinical trials put their own life at risk of unexpected adverse drug reactions. They do so to contribute to scientific progress for the benefit of society. Therefore the results of the trials belong to them and to society at large . Everybody has the right to access the evidence used by EMA scientific committees to determine the benefits and risks of medicines.

Despite that public-spirited risk-taking by volunteers, pharmaceutical companies are trying to claim the resulting data as “commercially confidential information” that belongs exclusively to them, not to society. The BEUC letter ends by posing an interesting question:

we take this opportunity to ask you to clarify the impact — if any — of the settlement with AbbVie on the definition of the new policy.

This refers to the rather mysterious decision of the US pharmaceutical company AbbVie to drop its legal action against the EMA, in which AbbVie had sought to prevent the agency releasing information from clinical trials of its drugs. By an amazing coincidence, the other company suing the EMA, InterMune, has this week also cancelled its own lawsuit. BEUC wonders whether there might be some connection between AbbVie’s move and the EMA’s unexpected decision to bring out a new — and neutered — draft of its data sharing policy. Surely not….

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Comments on “European Medicines Agency Unexpectedly Waters Down Draft Policy On Sharing Drug Safety Data”

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Anonymous Coward says:

An academic perspective from the US

We would never accept data for study under these restrictive/byzantine preconditions because we couldn’t possibly guarantee that it was a representative sample, that it was statistically significant, or that it hadn’t been cherry-picked to lead us to conclusions espoused by its providers.

It’s very, VERY clear that drug companies are trying to rig things not just to avoid independent peer review, but to game the process so that analysis carried out in good faith leads inexorably to pre-selected outcomes favorable to their business. If that analysis can even be done, and given the conditions they’re trying to impose, it would be difficult.

Anonymous Coward says:


You do have to wonder. The pharma industry does not hold any cards in the game. Let’s say the condition of regulatory approval was that all clinical trial data was to be made publicly available in EU. Pharma has 2 choices: Do what they’re told, or give up the EU market. But if they give up the EU market because they won’t open data, then the rest of the world would wonder about what they are hiding.

If the regulators say jump, they may not ask how high, but they will grudgingly move their feet off the floor.

Makes you wonder what has gone on.

That One Guy (profile) says:

Re: Why?

If the regulators say jump, they may not ask how high, but they will grudgingly move their feet off the floor.

Hardly. If the regulators tried that, the pharma people would just tell them, ‘That’s our line. Now, if you(or more likely the politicians with clout over the regulators) want to continue receiving those nice, hefty ‘donations’, let’s see how high you can jump.’

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