Re:Opening up data at the European Medicines Agency
Letter to the editor
We are writing in response to the Analysis
'Opening up data at the European Medicines
Agency', which was published by Peter C
Gotzsche and Anders W Jorgensen on the website
of the British Medical Journal on 11 May 2011,
and Mr Andreas Pott's letter published on 13 May 2011.
According to this letter, the authors allegedly
failed to acknowledge steps taken by the
European Medicines Agency towards increasing
its transparency over recent years.
Formindep is an independent, self-funded association of health
professionals and citizens advocating for a
medical information and education transparent
and freed from any other interest than the
patients'. Our own experience of EMA
transparency policy implementation does concur
with Mr Gotzsche and Mr Jorgensen's findings.
Transparency is governed in European institutions, including EMA, by
Whereas this regulation has been in force for a decade, its main
requirements are still
ignored by the Agency.
Mr Pott in his letter announces that 'reactive disclosure of documents
will be complemented
by an extended proactive publication of these
documents over the next years'.
In plain terms, the EMA plans to roll out
sometime in the indefinite future the public
register of documents that should have been
implemented as early as 2001, as laid in article
11 of the said regulation.
Abiding by the law, a fortiori with such delay, cannot be construed as
EMA experts' involvement and 'public' declarations of interests
remain undisclosed, although they are key to the mission of the Agency to
provide independent scientific opinion. The European Parliament
resolution adopted on 10 May reads: '(the EP)
Finds it unacceptable that the Agency does not
apply the relevant rules effectively, resulting
in the fact that there is no guarantee that the evaluation of human
medicines is performed by independent experts'.
Should they wish to exercise their right of access to check these
declarations, citizens from all over Europe are invited to come to the EMA
premises in London and consult the original paper declarations onsite. Contrary to national counterparts such as the French AFSSAPS, the EMA has indeed constantly refused to
publish these documents online.
Two years ago, Formindep requested the disclosure of two internal
audit reports from the EMA. The first one focused on the evaluation of
human medicines, the second on access to documents. But EMA is not even
transparent about transparency itself, and refused the access. Formindep
as well had to lodge a complaint before the European Ombudsman, that is
Only under the pressure of the European Ombudsman - who concluded in
several decisions that EMA repeated refusals to disclose public documents
indeed constituted acts of 'maladministration'- did the
EMA start to evolve, very recently.
A.Chailleu: Member of the Management Board, Formindep
P.Foucras: President, Formindep
Competing interests: A.Chailleu: Member of the Management Board, Formindep