EMEA Budget News for 2007
The European Community contribution to the European Medicines Agency (EMEA) budget has been cut in 2007 EU budget discussions but not to the degree first feared.
Although the Agency had originally requested 46.32 million EUR, initial indications suggested that the Agency would receive only a small increase over the 2006 level of 34 million EUR.
However, the EMEA management board petitioned the European Parliament, expressing the concerns expressed by a great number of patient organisations as to the proposed budget cuts and potential impact on important programmes for patient organisations.
As a result, the European Parliament’s budget committee voted for a substantial increase to the EMEA budget of 5.8 million EUR. This proposal will now be voted on by the Parliament in its plenary session at the end of October.
EMEA Transparency Measures on Commercially Confidential Information
Following the 2003 pharmaceutical legislation reform calling for improvement in the transparency of regulatory procedures and decision-making, the EMEA held an open consultation on Principles to be Applied for the Deletion of Commercially Confidential Information for the disclosure of EMEA documents.
This consultation resulted in the EMEA agreeing to publish information concerning the withdrawal by a company of its marketing authorisation application after the Agency’s opinion but before the Commission’s decision on marketing authorisation. The Agency will also publish information on withdrawals by applicants, and on refusals by the Agency, of applications concerning new indications for approved medicines.
According to the EMEA, the new measures currently apply only to applications concerning medicines for human use, but similar proposals concerning veterinary medicines will be made at a later time.
However, Health Action International Europe (HAI Europe) has criticised EMEA’s definition of commercial confidentiality as being over-broad and lacking explicit exclusion of data on a product’s safety and effectiveness. HAI Europe argues that this is inconsistent with the provisions on transparency within EU pharmaceutical legislation and unacceptable from a public interest viewpoint. HAI Europe recommends the adoption of a precise and limited definition of commercial confidentiality and more transparent regulatory procedures.
Related Links -
EPHA Section on Pharmaceuticals and Medical Devices
**Updated**EMEA/CHMO working group with patients’ organisations, 2006
