A major court battle over access to information about medicines is currently underway in Europe, with potentially far-reaching implications for researchers, doctors and patients worldwide. The case pits the European Medicines Agency (EMA), which wants to release information on a drug in response to a Freedom of Information request, against a pharmaceutical company seeking to keep that information out of the public realm.
In late September, the EMA appealed an interim order by the General Court of the European Union that prevents the agency from releasing information on a drug for patients with Duchenne’s muscular dystrophy that is already being sold in Europe. The outcome of the case will determine what information independent researchers and the public will be able to access in future, an issue that has long pitted patient advocates against the pharmaceutical industry.
AllTrials campaign manager, Dr Till Bruckner, commented that:
Access to information about medicines is vital for progress in medicine and patient safety. There have been numerous cases in which pharmaceutical companies have failed to tell regulators, doctors and patients the full story about the drugs they sell. It’s good to see the EMA standing up for the public’s right to information about medicines by appealing this court order. We are following this case closely.
Dr Sile Lane, director of campaigns and policy at the charity Sense about Science which runs AllTrials said:
While hundreds of patient groups and research bodies fight for an open, honest system of reporting clinical trials, others are fighting hard to cling on to secrecy. In granting this order the European courts are indicating that they are on the wrong side of history. However as AllTrials has made clear, the interests of patients will prevail despite these attempts to subvert them.
In response to a Freedom of Information request, the EMA had planned to release a Case Study Report for the drug after making limited redactions. The Case Study Report had originally been submitted to the EMA by a pharmaceutical company seeking marketing authorisation for the drug. The company later objected to the report’s release, citing concerns about commercial confidentiality, and has prevented disclosure by securing a court order that blocked the release. The EMA is now appealing that decision.
Our position [is] that clinical reports are not confidential per se… [A] sort of ‘blanket’ protection from disclosure for documents supporting an authorisation for a medicine seems neither consistent with the legislation nor advocated by our stakeholders… We will welcome a clear indication on this point from the Court of Justice.
Writing in STAT, industry expert Ed Silverman observed that:
The battle follows controversy over the EMA and its approach toward releasing clinical trial data. After implementing its new disclosure policy five years ago, the agency began pushing companies to release more trial data. But in 2013, the EMA found itself in court when AbbVie objected to the release of information about its best-selling Humira rheumatoid arthritis treatment. The EMA backed down and allowed AbbVie to redact certain information as part of a settlement.
This prompted a two-year investigation by the European Ombudsman, who concluded the EMA should not have allowed AbbVie to redact certain data and that agency officials should take a tougher stand against companies that claim certain data is commercially confidential in order to push for redactions. The EMA was also reminded to weigh public interests against commercial interests when considering whether data should be accessible to other researchers seeking to duplicate findings.
The episode was closely watched because it arose as the pharmaceutical industry faced growing disclosure pressure following scandals over safety or effectiveness data that were not publicly shared.
In a separate development, the EMA is currently preparing for the first proactive release of clinical study reports, planned to take place later this year. The move seems likely to increase pressure on other medicines regulators, notably the US Food and Drug Administration, to follow suit and also grant public access to clinical study reports.