On Tuesday 13 November 2012, EPHA attended the event ‘Transparency in medical research to protect public health: Opening up EU clinical trial data for safe and effective medicines’. Organised with support from EPHA member, Health Action International (HAI), and the Transatlantic Consumer Dialogue (TACD), the event brought academics, experts, policy-makers, regulators and the European Commission together to discuss the clinical trials regulation.
More specifically, participants examined the opportunity, presented by the proposed regulation, to strengthen provisions around ethical standards, safety reporting systems and open access to data and reports from clinical trials.
Dr Ben Goldacre opened the session by noting that half of all clinical trials published in academic journals are not properly registered and one quarter are not registered at all – this breaks the commitment made by these journals to publish only those studies which have been appropriately registered. Dr Goldacre also highlighted the failure of non-voluntary measures, such as the 2007 Amendment Act of the U.S Food and Drug Administration (FDA), and commitments made by the European Medicines Agency (EMA) as regards the EudraCT database. Transparency, Dr Goldacre concluded, is not being guaranteed under the current provisions.
The ensuing debate featured contributions from Professor Peter Gotzsche, Director of the Nordic Cochrane Centre, Professor of Law, Dr Trudo Lemmens, Stefano Soro, Head of Unit for Medicinal Products in the European Commission, and Fergal O’Regan, Advisor to the European Ombudsman. Statements were also made by the three hosting MEPs, MEP Margrete Auken (Greens/EFA, Denmark), MEP Cristian Silviu Busoi (ALDE, Romania) and MEP Peter Liese (EPP, Germany).
Stefano Soro made clear that provisions do exist in the current draft of the regulation for the publication of all trial data submitted for marketing authorisation. However, other speakers noted that one of the key absent elements is the requirement for all clinical trial data to be published. Under the current draft, data gathered in trials which is not completed or which does not result in a marketing authorisation submission, is not required to be published on a publicly accessible database. This results in the replication of trials and the waste of public expenditure in repetition where scientists cannot access data from identical previous trials.
Professor Lemmens highlighted the human rights arguments in favour of full disclosure of information, relating to the right to life, physical integrity and self-determination. Mr O’Regan reaffirmed the ombudsman’s commitment to the publication of information where it is an obligation in the legislative framework.
The discussion concluded with an acknowledgement that the EU has lost its competitive edge in clinical trials but that this should not eclipse the broader possibilities presented by the proposed Regulation. Researchers, health professionals, patients and even industry can benefit from opening up access to medical research data in the EU.
Further information:
–Health Action International Europe
–Transatlantic Consumer Dialogue
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