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Advancing healthcare policy

Transparent, independent health authorities

Transparent, independent health authorities: In brief

  To act first and foremost in the interests of citizens, drug regulatory agencies must develop independent decision-making processes and a culture of transparency towards data.

Clinical data held by drug regulatory agencies are a public good, and contribute to scientific knowledge about drugs.

Freedom of information: in the public interest
When requesting documentation, Prescrire makes use of legislation governing citizens' rights to access administrative documents.

In Europe, public access to documents held by European institutions is governed in particular by Regulation (EC) 1049/2001, adopted in 2001.

In addition, through their contributions to the 2004 overhaul of European regulations on medicines, Prescrire and the Medicines in Europe Forum played a role in requiring drug regulatory agencies to become more transparent.

Prescrire's constant and long-term commitment to greater transparency
Since its creation and more systematically since 2004, Prescrire has been monitoring drug regulatory agencies' compliance with their transparency obligations.

Prescrire especially keeps an eye on the practices of the European Medicines Agency (EMA), whose decisions apply to all European Union Member States.

Day in, day out, by calling upon regulatory agencies to fulfil their legal obligations, Prescrire works to instill better practices as regards access to documents.

When necessary (in the event of repeated and unjustified refusals to supply documentation, or unacceptably long response times), Prescrire lodges a complaint with the European Ombudsman.

By making sure that conflict of interest statements have been duly filed for the experts agencies consult, Prescrire is also one of the organisations helping to ensure that agencies' decision-making processes are free from undue influence.

©Prescrire November 2014