Clinical Trials Transparency Debate

The EurActiv released on 30 August 2013 an article entitled “Health experts critical of pharma industry's new transparency rules”, and shows that the balance between the commercial interest of pharmaceutical companies and the benefit for patients is still being contested at EU level.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published new ethical commitments on clinical trials aimed at allaying accusations that a lack of transparency on how new drugs are tested is hurting patients, but has also warned that full transparency would hurt the industry, which relies on protection of trade secrets to compete in Europe and across the world.

As EurActiv points out however “critics are unconvinced”: the European Medicines Agency (EMA) considers that the biggest risk in the regulatory debate is violation of patient confidentiality and that opening up clinical trial data could provide major benefits for the industry, while the European Patient's Forum (EPF) highlights the importance for both clinicians and patients to have access to all relevant information to make informed decisions.

Background

In 2012, EMA started a process towards proactive publication of data from clinical trials supporting the authorisation of medicines once a marketing-authorisation decision has been taken.

On 29 May 2013, the Clinical Trials Directive was adopted unanimously by the ENVI Committee. Rapporteur for the dossier, Glenis Willmott (S&D, UK), made transparency of data a central component of her Report and amended the draft text to improve transparency, by requiring that detailed summaries be published in a publicly accessible EU database, with full Clinical Study Reports (CSR) published once a decision on authorisation is complete.

Next steps

  • By end 2013: Expected publication of the EMA’s final policy on the publication and access to clinical-trial data.
  • 1 January 2014: EMA expects the policy to come into force. It can depend on the Court decision and the discussions on the Regulation on Clinical Trials.
  • March 2014: Parliament’s indicative plenary sitting date, Clinical Trials Directive first reading.

The full article is available here



Date: 27/09/2013 | Tag: | News: 189 of 590
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