EGA Press Release

Wednesday, 20 January 2010

KEEP IN MIND THE OBJECTIVES OF THE EC PHARMACOVIGILANCE
LEGISLATIVE PROPOSALS: IMPROVING THE EU PHARMACOVIGILANCE SYSTEM
& CUTTING RED TAPE.

During the ongoing codecision procedure, policy makers must keep in mind the objectives of the European Commission pharmacovigilance legislative proposals which consist in strengthening, but also streamlining and rationalising, the Community pharmacovigilance system with a view to preventing unnecessary patient exposure to risks. This was the key message given by Suzette Kox, EGA Senior Director Scientific Affairs, at the EGA’s 3rd Pharmacovigilance Discussion Forum in London today. A number of national competent authorities and the European Consumers’ Organisation participated in the forum. “The Commission’s proposals are welcomed in general, but there are key issues at stake which need to be adequately addressed during the codecision process”, she said. “One of them is the reporting by marketing authorisation holders of all adverse reactions to one single point within the Community, namely the Eudravigilance database; this is a breakthrough proposal and should not be dismantled”. This EU database and data-processing network is the best available Community tool to detect early safety issues by using the maximum amount of information available. Another major EGA concern is the introduction of the new “summary of the essential information necessary to use the medicine safely and effectively” which is proposed to be included in the product information. The EGA has major problems with this new section as it will not equally apply to all patients and would thus be confusing and misleading for many of them, introducing new disharmony amongst products with the same active substance and it would also be very costly. “Any proposal should be proven to be of benefit to the patient before it is passed”, Ms. Kox concluded. The draft opinion of the European Parliament Committee on the Internal Market and Consumer Protection calls on the European Commission to come up with reflective proposals regarding the readability of product information within three years of the entry of the new directive. The on-going discussions also provide an opportunity to clarify the requirements for periodic safety update reports (PSURs) for generic medicines. In line with the proposed risk-based approach, there will no longer be routine PSURs for active substances with a well-established safety profile. However the single frequency for the submission of the reports for products containing the same active substance will be determined by the relevant competent authority. “Generic medicines will consequently follow the same submission cycle as the respective originator product thus allowing single safety assessment of related products for the benefit of the patient” explained Ms. Kox.

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For further information contact Suzette Kox
Tel: +32 (0)2 736 84 11