Europe votes for clinical trial transparency law

Members of the European Parliament has voted by a large majority to adopt the Clinical Trials Regulation, which will make it a legal requirement for pharma companies and other researchers to publish full trial data results.

The Regulation did not look solely at the issue of trial data disclosure – it also brings in a new single submission and overall streamlined assessment process for clinical trials – but the concerns over data transparency have taken centre stage in the legislation.

The MEPs voted 547 in favour and 17 against yesterday, with British MEP Glenis Willmott leading the negotiations on the Regulation, and achieving her goal of putting transparency at the heart of the new law.

The new legislation has come about because of long-running controversies surrounding non-disclosure of trial data by the pharma industry, where companies have been suspected of concealing negative data.

One of the most high-profile battles for full trial data in Europe has been around Roche’s flu treatment Tamiflu. Independent health researchers the Cochrane Collaboration requested access to full data in 2009 because of doubts about the drug’s efficacy data, but four years of wrangling and delay followed before Roche agreed to release the data.

The Regulation must now be formally adopted by Council, and is expected to come into effect in mid-2016 at the earliest. All EU member states will be obliged to adopt the laws into their own statutes.

The European Medicines Agency will now start building the new publicly accessible online clinical trial database.

Sile Lane, Director of Campaigns at Sense About Science, one of the co-founding organisations of the AllTrials campaign said: “This is fantastic. It will mean that researchers will in future know about trials as they are happening and will be able to scrutinise results soon after their end.”

The new Clinical Trials Regulation says information from Clinical Study Reports of trials should not be considered commercially confidential and will:

• Require that all drug trials in Europe are registered before they begin on the publicly accessible EU clinical trials register.

• Require that a summary of the results from these trials is published on the register within a year of the trial’s end.

• Require that a summary understandable to a lay person of what was found in the trial is published on the register.

• Require Clinical Study Reports (detailed documents normally produced for regulatory processes) to be made publicly available, where they are produced.

• Establish a new publicly accessible EU clinical trials register, to be set up and run by the European Medicines Agency.

• Require that all trials used in support of an application to run a new clinical trial are registered or have published results.

• Impose financial penalties on anyone running a clinical trial who does not adhere to these new laws.

 Dr Ben Goldacre, author of Bad Pharma and co-founder of AllTrials said: “This is an excellent small step forward after some really good work by MEPs. But the new EU legislation is only concerned with new trials. It does not address the far bigger problem, that we still don’t have full reporting for all trials on the medicines we are using right now, today, medicines which we will continue to use for the foreseeable future.”

He said informed decisions about treatments can’t be made when this information is routinely and legally withheld.

“We need all trials – on all uses of all currently prescribed treatments – to be made available, and urgently. There is no excuse for industry inflicting ongoing harm on patients, and on their own reputation, by continuing to campaign against this position. They should join their more ethical colleagues, and sign up to the pledge.”

EFPIA response

The European pharmaceutical industry’s representative body has not opposed the new legislation, but had previously favoured the existing self-regulation system. Responding to the news, EFPIA acknowledged the other aspects of the new legislation before addressing the transparency issue.

“The revised legislation is a good step towards more streamlined processes surrounding clinical trials in Europe, as well as towards a responsible transparency surrounding clinical trials — one that I see as in line with EFPIA-PhRMA Principles for Responsible Data Sharing,” said Richard Bergstrom, Director General of EFPIA.

“There is still work to be done. The success of this legislation will depend on how it is applied in practice. It will be essential to collaborate with relevant stakeholders and ensure they have the opportunity to provide input. This is a must if we are to achieve a system that will foster the innovation we need to improve patient outcomes.”

EFPIA says the success of the legislation depends on how it is implemented in each EU country – that collaboration between ethics committees needs to be promoted and efforts and clinical trial applications should be assessed in the shortest time frame possible.

EFPIA added that a key pillar of success will be the efficient operation of the EMA’s European Clinical Trials Database. EFPIA concluded that it looked forward to the European Clinical Trials electronic portal and database fully operational within the mandated timeline, the responsibility of the European Medicines Agency, and would be ready to contribute to support its development and implementation.


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