European Medicines Agency's Management Board Endorses The Work Programme 2010 And Strengthens The Involvement Of Patients In The Work Of The Agency

Main Category: Public Health
Article Date: 17 Dec 2009 - 20:00 PDT

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The European Medicine's Agency's Management Board adopted the Agency's Work programme and draft budget for the year 2010, which marks the final year of the 'Road Map to 2010'. The budget totals € 198,187,000 (2009: € 194,389,000), which includes forecast fee revenue of € 152,780,000 (2009: € 140,966,000) and total EU contributions of € 37,112,000 (2009: € 46,790,000). The Board approved an increase of 37 posts in the staff numbers to a maximum ceiling of 576 (2009: 530).

In line with the road map, the priorities for the Agency in 2010, in addition to conducting its core-activities, include strengthening of the European medicines network, improving safety-monitoring of medicines, co-operating with international partners, fostering transparency and provision of information, and stimulating innovation and improved availability of medicines.

The Management Board endorsed a draft road map to 2015 that will be released in late January 2010 for 3 months' public consultation. The new road map builds on achievements under the current strategic document and focuses on improving the operation of the core-business, addressing public health needs, facilitating access to medicines and optimising the use of medicines in the coming years.

The Board endorsed a new strategy to further involve patients and consumers in the work of the Agency. The new strategy makes a number of proposals that considerably widen the scope of patients' and consumers' contribution to the Agency. This includes consultation during benefit-risk evaluation of medicines, participation as observers in meetings of the Pharmacovigilance Working Party and contribution to the Agency's safety communication.

The Management Board welcomed the Agency's publication of weekly influenza pandemic safety reports. This was seen to be a good initiative in improving transparency on adverse drug reactions. The Management Board also adopted the revision of its implementing rules on fees payable to the Agency. The revised rules will come into effect on 1 January 2010 to take into account the changes introduced by the new variations regulation (EC) No 1234/2008.

Notes

1. The 'Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures' are available here and the explanatory note here.

2. The 'Reflection Paper on the Further Involvement of Patients and Consumers in the Agency's Activities' endorsed by the Agency's Management Board is available here.

3. All other relevant documents adopted at the Management Board meeting can be found here.

Source
European Medicine's Agency

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