Mental HealthEuropean Medicines Agency Launches Public Consultation On New Transparency Policy
The European Medicines Agency is inviting comments on its draft
transparency policy until 25 September 2009.
Since its inauguration in 1995, the Agency has worked continuously to
improve the transparency of its operations, often extending the levels
of transparency beyond the existing legal requirements. Bringing
together all these initiatives, the new draft transparency policy
describes for the first time in one comprehensive document the Agency"s
vision on its level of openness towards its stakeholders.
The policy proposes to focus on three main objectives for achieving a
robust and consistent approach towards transparency in all areas of its
activity:
-- To make the daily operations of the Agency more transparent: this will
not only include a re-assessment of the currently applied balance
between transparency and protection of commercially confidential
information, but will also lead to more proactive disclosure of
information about the scientific evaluation of medicines. All of this
will help to better explain how the Agency operates and how it reaches
its scientific conclusions.
-- To strengthen the Agency"s interaction with its stakeholders, in
particular patients and healthcare professionals: the existing
interaction will be further developed with a view to consulting patients
and healthcare professionals on the scientific evaluation of medicines
at the level of the Agency"s scientific committees.
-- To promote a harmonised approach to transparency across the European
medicines network: the Agency will be working closely with the medicines
regulatory authorities in the EU Member States to provide for a
harmonised approach to transparency, including consistent implementation
across the European Union.
As part of the public consultation process, the Agency will be holding a
second workshop on transparency, in October 2009, to analyse and review
all comments and feedback received. The draft transparency policy will
be updated accordingly before its final adoption and publication, which
is currently planned for the end of 2009.
Notes
1. The draft EMEA transparency policy can be found here.
2. All comments should be sent using the comments form provided here.
3. The second workshop on development of the EMEA transparency policy is
scheduled to take place at the EMEA on 19 October 2009. Details will be
provided, closer to the time, in the "Events" section of the Agency"s
website.
EMEA