EMA plans greater transparency

The European Medicines Agency (EMA), singled out for criticism for conflicts of interest, particularly after its former Executive Director, Thomas Lönngren, went into employment in the pharmaceutical private sector in late 2010, has reacted  energetically. It argues that it has been implementing for several years a plan to enhance the transparency of its activities.

On 3 October, its Management Board expressed its support for the agency’s initiative of publishing the agendas and minutes of all its scientific committees. This decision was taken for the PharmacovigilanceRisk Assessment Committee in July2012, the Paediatric Committee in September

2012, the Committee for Orphan Medicinal Products in October 2012, the Committee on Herbal Medicinal Products in September 2013 and now for the Committees for Medicinal Products for Human Use and for Medicinal Products for Veterinarian Use. With its decision of 5 November 2012 to allow access to clinical trial reports for third parties that so request, the EMAencountered objections from two pharmaceutical firms, AbbVie and Inter-Mune. They brought actions before theEU General Court against the EMA, in January and February 2013, respectively (Cases T-73/13 and T-29/13). Pending ajudgement, the EMA was ordered by the  court, on 30 April, not to give access to reports on clinical trials conducted by AbbVie or InterMune. In its effort to boost transparency, the European Medicines Agency can count on the support of the British Medical Journal, the European Consumers’ Organisation (BEUC) and the European ombudsman, which officially support the EMA in these cases. 

For more information:

http://medcitynews.com/2013/10/eu-agency-defends-clinical-trial-data-sharing-policy/