1 Boring Old Man

EMA’s release of regulatory data — trust but verify

British Medical Journal blog

by Tom Jefferson

7 Oct, 14

The European Medicines Agency [EMA] has now released the final version of its policy on the prospective release of clinical reports of trials, which are submitted by sponsors to support marketing authorisation applications [MAAs]. The agency has said that it will—at a future date—determine how to release individual participant data [IPD].

Scope
The policy—to become effective from 1 January 2015—explains what will be released and how. Full clinical study reports will not be released. Rather, selected parts of clinical study reports will be released, including the “core report” [although this is not labelled as such in the text], the statistical analysis plan, protocol and its amendments, and a blank case report form. [To those familiar with clinical study reports, these are sections 1-15, 16.1.1, 16.1.2, and 16.1.9 of the ICH E3 guidelines.] The policy document does not explain why full clinical study reports will not be released.

You can’t always get what you want
But if you try sometimes
Well you just might find
You get what you need

Redactions
The EMA’s policy states: “The Agency respects and will not divulge CCI [commercially confidential information]. In general, however, clinical data cannot be considered CCI.”  That said, commercially confidential information will be redacted, “where disclosure may undermine the legitimate economic interest of the applicant/market authorization holder” and in items that may facilitate identification of trial participants. Sponsors will have primary responsibility for redacting study reports for EMA’s approval prior to their being made accessible under the new policy.

The policy puts primary responsibility for redacting information into the hands of trial sponsors. This means that they get to suggest which information submitted to the EMA should be kept hidden. The EMA has a policy that the information in clinical trial reports should not generally be considered commercially confidential [this is echoed in the EU Clinical Trials Regulation] but it may never become clear which information is being kept hidden.

The policy is a landmark, as for the first time it ensures access to clinical study reports of drugs that have obtained a MAA or on which a decision has been made. The EMA may be the first regulator to allow such access and the Nordic Cochrane Centre, the European Ombudsman, and the EMA deserve credit for that.

There’s a lot of good news for researchers in the final version of the policy. Gone is the “Peeping Tom” clause of “viewing only” access to data—described by users of comparable policies as “science through a periscope”—and there is no trace of a threat of legal proceedings for those who produce research that is disagreeable to sponsors.

In a previous post I urged users to adopt Reagan’s maxim of “trust but verify” when reading the EMA’s policies. Ultimately, we will not know how usable and transparent this policy is until it has been in use for some time.

Yesterday, the likely European Commissioner for industry who will oversee the regulation of medicines and the EMA said there are risks that need to be balanced with greater clinical trial transparency. MEPs have been questioning the candidates for the new European Commission and, if approved by MEPs, Elzbieta Bienkowska will lead the industry department [DG ENTR].

The new president of the European Commission, Jean-Claude Juncker, recently moved the responsibility for the regulation of medicines from the health to the industry department. When asked whether this move would allow industry lobbying to affect drug regulations, Ms Bienkowska said, “All my professional experience shows that I am lobbyist-proof. I’m absolutely lobbyist-proof”. Glenis Willmott MEP said, “It is disappointing Ms Bienkowska didn’t answer directly whether or not she thinks pharmaceutical and medical devices should really be in the health commissioner’s portfolio.”

Ms Willmott also asked Ms Bienkowska if she will ensure the EMA’s commitment to greater clinical transparency will continue. Ms Bienkowska replied that clinical trial transparency is important for Europe; “however, you have to look at the other side and ensure there are adequate levels of safety when it comes to the potential misuse of data.” We’ve heard this claim before and we responded on our “Myths & Objections” page. MEPs will vote to appoint the candidates to the European Commission on 22nd October.

This battle is anything but over.  In the other shoe… I ended with a picture of Niccolò di Bernardo dei Machiavelli, the author of The Prince – the Renaissance treatise on how to gain and wield power at any cost. I think of him once again this evening. There is no stopping place for the cause of Data Transparency. PHARMA is always in the background. They have unlimited resources and teams of people being well-paid to spend their days working whatever angles are necessary to win the day and allow PHARMA to hold onto control of the data from clinical trials. It’s not paranoia that leads me to this cynical conclusion, it’s self-evident experience. The only thing to say is that their offering this much consistent resistance says that we’re fighting the right battle. And by the way, endless thanks to MEP Glenis Willmott [see on the right track…]. She’s a true champion for the cause [and it is a cause]…