E-DRUG: EMEA consultation on transparency

E-drug: EMEA consultation on transparency
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Dear Colleagues,

The European Medicines Evaluation Agency (EMEA) recently asked
interested groups to respond to its consultation document on
transparency and access to documentation.

HAI and its network partner, the International Society of Drug
Bulletins (ISDB), both drafted replies to the document which included
suggestions to improve the EMEA's policy on transparency. The
organisations' comments were drawn up in consultation with a number of
their European and international contacts.

HAI and ISDB both believe that a great deal of information submitted
to the agency is veiled by secrecy. Often it is withheld according to
broad definitions of confidentiality. In their replies, the
organisations also highlighted the need for greater representation
by consumers and public health groups at the EMEA.
At present, only one consumer organisation is recognised by
the agency (as opposed to a much greater industry presence). HAI and
ISDB have also pointed out the danger of introducing significant
charges for access to information. The organisations fear that such
action could place important information beyond the reach of
non-profit organisations.

Those who are interested in receiving copies of the EMEA
consultation document as well as the replies from HAI and ISDB should
contact the HAI-Europe office at the e-mail address given. We welcome your
comments on the replies.

With best wishes,

Lisa Hayes
Health Action International Europe
Publications & Information Officer
E-mail: lisa@hai.antenna.nl
Snail mail: Jacob van Lennepkade 334 T, 1053 NJ Amsterdam, Netherlands
tel: +31 20 6833684, fax: +31 20 6855002

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