European medicines’ regulator forced to withhold trial documents
29 May 2013
Despite the best intentions of the European Medicines Agency injunctions issued against it in two court cases have spilled over to chill other requests for clinical trial information. There are at least 100 pending requests seeking trial results. Over the past 24 hours researchers have received letters telling them the EMA cannot release documents it holds from clinical trials of medicines currently used in Europe.
The letter from the EMA states that “in the course of on-going legal proceedings before the General Court of the European Union, the Agency has been ordered to suspend the implementation of certain decisions granting access to documents submitted by marketing authorisation holders of medicinal products.”
The legal proceedings are the cases brought by two pharmaceutical companies, InterMune and AbbVie, who challenged the Agency’s decisions to grant access to clinical study reports from clinical trials of drugs from each of these companies. On 25th April the President of the European Court issued injunctions preventing the EMA from releasing this information.
The EMA says it has been forced to decide not to release further clinical study reports from clinical trials of other medicines as it has been advised that it would put itself at risk of additional legal action by other pharmaceutical companies. In a statement the EMA said it is committed to continue its work on clinical trial transparency and intends to publish its draft policy on release of clinical trial data at the end of June 2013.
Peter Doshi, Fellow in Comparative Effectiveness Research, Johns Hopkins University who received a letter from EMA: “The European Medicines Agency’s November 2010 policy on access to documents has revolutionized the ability of independent researchers to critically examine data. Nearly 2 million pages of Clinical Study Reports and other documents have been released by EMA, and only two companies–AbbVie and InterMune–have challenged EMA’s releases in court. If AbbVie and InterMune win their cases, there is a real chance that EMA’s revolution in data transparency will come to an abrupt end, returning us to the old status quo of data secrecy. GSK, Roche, Pfizer, Merck, AstraZeneca, Johnson and Johnson, Eli Lilly and other pharmaceutical companies cannot silently stand on the sidelines and watch. They need to declare now where they stand: do they agree with European regulators that ‘clinical trial data should not be considered commercial confidential information’ –or not?
“I am not aware of any evidence that any harm to public health has ever resulted from the sharing of clinical trial data.”
Carl Heneghan, Director, Centre for Evidence Based Medicine who has a request for information pending: “We requested information relevant to a Cochrane review on ‘Direct thrombin inhibitors and factor Xa inhibitors for atrial fibrillation,’ that we are presently undertaking. An email from the EMA on the 19th April stated it would provide us ‘with sets of documents at regular intervals in response to this request.’ The Agency stated at the time that ‘the provision of information in an open and transparent manner is part of the mission of the Agency.’ But we now find that the provision of important information relevant to our review, and direct patient care, is in jeopardy. The effectiveness of interventions should be based on all the available evidence. However, this is now in doubt; it is clearly a bad day for openness and transparency. Regulators and manufacturers should consider, and declare, whether the current use of treatments based on partial information is an appropriate use of scarce healthcare resources.”
European Medicines Agency statement on the interim injunctions http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/04/news_detail_001779.jsp