Since the European Commission tabled its proposal to revise the Clinical Trials Directive last July, the focus in the debate has broadly shifted from supporting European research to patient safety and transparency, suggesting health campaigners have gained the upper hand over big pharmaceutical firms. The legislation will be debated in the European Parliament’s Environment Committee on 24 April.
Industry, doctors, health campaigners, researchers and patient groups are all in favour of revising the directive, though for different reasons.
The pharmaceutical industry says similar standards on clinical trials across Europe will speed up the approval of new medicines, while health campaigners are hoping that patients will be better protected than under current rules.
In its initial proposal tabled a year ago, the European Commission put the emphasis on strengthening the EU’s attractiveness in clinical research as the most important aim.
With over €20 billion of investment per year in the EU, clinical research makes a big contribution to the EU’s goal of supporting R&D and economic growth, the EU executive argued. However, the number of clinical trials conducted in the EU between 2007 and 2011 have fallen by 25% – from 5,000 to 3,800, less than half the number in the US.
According to the Commission, the existing Clinical Trials Directive, dating to 2001, had ensured a high level of patient safety, but its divergent transposition across the 27 EU states had ended up stifling clinical research.
Data generated in clinical trials are used by researchers in publications, and by pharmaceutical companies applying for marketing authorisations.
But since the Commission tabled its proposal, the debate has tended to shift around disclosure and transparency issues, with doctors, health campaigners and patient groups criticising it for creating loopholes for industry.
Their main worry is that industry could claim commercial confidentiality over the data generated by the tests, for example when a trial for a new drug has led to a negative result.
Industry representatives dispute this however. Angelika Joos, executive director for Regulatory Policy at Merck Sharp & Dohme (MSD), told EURACTIV that all clinical study data for a new drug are submitted and assessed by the regulator, the European Medicines Agency (EMA).
"If you only have the results of one of several trials, out of context, while the drug is under development, then you only get a little piece and not the full picture," Joos said.
In the marketing authorisation process, the EMA receives all data from research for review and makes a decisions based on the data according to clearly defined processes.
"The regulatory scrutiny ensures that the trial results and conclusions are an accurate representation of the research findings," Joos said.
What to disclose?
The question of transparency – what, how and when the results of clinical trials should be disclosed – has so far been seen differently by EU lawmakers who will be voting on the proposal.
In its proposal, the Commission requires a publication of a “summary of trial results” within a year of the end of the trial.
Joos said the industry would agree to make clinical trials results available 30 days after marketing authorisation as this is consistent with current law in the United States.
In addition, industry registers all its trials and posts the results on a publicly accessible website for several years.
Globally aligned rules would help to ensure good compliance, she says.
"However, what's important is that it is accepted that there is personal protected data and commercially confidential information which should not be published," Joos stressed.
British MEP Glenis Willmott, who is steering the European Parliament's position on the proposal for the Socialist and Democrats (S&D) group, wants to go even further by requesting drug makers to publish a full “Clinical Study Report”.
"This is the same document that companies must submit to regulators for approval of their medicine, and therefore contains a full account of how the clinical trial was conducted and what the results were," Willmott wrote on her website, adding: “It is time that all pharmaceutical companies and researchers made the full results of studies on new and existing drugs publicly available.”
Health campaigners say Clinical Study Reports are the most scientifically useful account of a clinical trial though being short of the publication of raw data. They are prepared for many, but currently not all, clinical trials.
Willmott claims that numerous academic studies have found that around half of all trials are never published, usually those with negative or disappointing results.
The two shadow rapporteurs, Philippe Juvin, from the European People's Party (EPP) and Cristian Silviu Bu?oi from the Alliance of Liberals and Democrats for Europe (ALDE), have backed the Commission's publication of a trial summary.
However, the shadow rapporteurs also want a new annex, setting out what should be contained in such a summary. They also propose amendments that would limit access to information on the database on which the trial summaries would be placed. Juvin further proposes a two year deadline for the publication of trial summaries.
This could allow a delay in disclosure of information until it is published in a scientific journal and companies to postpone disclosure indefinitely, merely by claiming that they intend to publish an article in a journal, critics say.
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The EU's Clinical Trials Directive was adopted in 2001 with a view to improving research standards and protecting patients.
But the directive has been heavily criticised by researchers who say insurance costs and red tape has increased without bringing any major benefit to patients, researchers or industry.
The Commission has therefore proposed revamping the directive to address those challenges.
Enhancing the competitiveness of clinical research was a primary aim of the directive's revision amid claims that Europe would become an unattractive place to conduct large-scale trials on potentially lucrative new medicines.
The new draft directive also speeds up how researchers get ethical approval for medical trials and seeks to improve standards in how new medicines are tested and manufactured.
- 24 April: Debate in the European Parliament's Committee on Environment, Public Health and Food Safety (ENVI)
- 29 May: Vote scheduled in Parliament committee
- 8 Oct.: Tentative date for vote in Parliament plenary
- Fostering EU's attractiveness in clinical research: Commission proposes to revamp rules on trials with medicines (17 July 2012)
- Clinical Trials homepage
- Proposal for a Clinical Trials Regulation - Questions and answers