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EMA bows to pressure on its own transparency

Published on 08/10/13 at 11:18am
Guido rasi image
EMA executive director Guido Rasi has made clear his intention to shake up the way the regulator works

The European Medicines Agency (EMA)’s management board has agreed to publish agendas and minutes from the meetings of all the EMA’s scientific committees by the end of the year.

This means that the workings of the Committee for Medicinal Products for Human Use, as well as those of the Committee for Advanced Therapies and Committee for Medicinal Products for Veterinary Use, will be more open to scrutiny.

The EMA has wrestled with questions of transparency over the last couple of years, and received brickbats from some observers in pharma for taking the idea of what data should be publicly available too far.
       
But executive director Guido Rasi has made clear his intention to shake up the way the regulator works, announcing a new organisational structure for the EMA last month.

This restructure into four new divisions has the stated aim of better supporting the scientific work of the EMA’s committees, sharing more information and more effectively meeting the needs of the agency’s stakeholders and partners.

However, European pharma trade association EFPIA has already criticised the EMA’s proposals for data transparency – and earlier this year a leaked EFPIA memo revealed that pharma is trying to ‘mobilise’ patient groups to help stop new rules on releasing trial data.

Two firms - AbbVie and InterMune - are currently suing the EMA to stop it from disclosing data on their medicines.

While shining a spotlight on information from EMA committees does not directly impact on the debate over the dissemination of trial data, it will help to nail down for the first time exactly how the regulator reaches its decisions on the safety of drugs.  

The move is also a clear indication of the way the EMA thinks the wind is blowing ahead of the full disclosure of trial data in Europe next year - and is intended to respond to a view from critics that the agency has been secretive and paternalistic.

Unlike the FDA, its US counterpart, the EMA has in the past been sniffy about showing its working in public, suggesting instead that patients should trust pharma and regulators implicitly without needing to see the data.

The suspicion that there might be too close a relationshop between pharma and the regulator grew when former EMA executive director Thomas Lönngren left under controversial circumstances in 2010.

Just two weeks after leaving the EMA’s top job - with no intervening period of gardening leave - he joined the NDA pharma consultancy group in a role essentially designed to help pharma firms to get through the European regulatory process.

The European Commission expressed its feelings on Lönngren’s gamekeeeper-to-poacher move - and his potential use of details of EMA practices that could have given an unfair advantage to pharma firms using NDA - by delaying some back-dated funding to the agency until it cleaned up its act.

The EMA has been gradually working its way towards greater transparency over the last 18 months or so by making available minutes from the Paediatric Committee, the Pharmacovigilance Risk Assessment Committee, the Committee for Orphan Medicinal Products and - last month - the Committee on Herbal Medicinal Products.

Adam Hill

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