European Medicines Agency Launches Public Consultation On New Transparency Policy

Main Category: Public Health
Also Included In: Respiratory / Asthma
Article Date: 22 Jun 2009 - 1:00 PDT

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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.

Source
EMEA