EGA Press Release

Tuesday, 27 April 2010

EGA WELCOMES COMMITTEE ADOPTION OF FALSIFIED MEDICINES AND PHARMACOVIGILANCE REPORTS BY MEPS

FALSIFIED MEDICINES
“Today’s vote on falsified medicines has ensured that patient safety will be strongly secured by focusing anti-counterfeiting measures on high priced-high risk products. The European Parliament’s ENVI committee’s decision has also ensured that all safety features designed to secure the legitimate supply chain will be cost-effective, whilst guaranteeing the independence of databases. Moreover the MEPs have correctly focused measures to tackle the sale of counterfeited medicines on the internet where the major problem lies ” says Greg Perry, EGA director general, commenting on the ENVI vote.

The association also welcomes what it views as the wise and responsible decision of the committee to reinforce current audit systems and build upon greater international cooperation to control API and excipient production. “These measures provide an effective tool to prevent the infiltration of falsified APIs and excipients into the EU,” says Greg Perry “a mandatory EU inspection and certification system for all APIs and excipients without adequate resources, which was rejected by the committee, would have led to severe shortages of medicines for EU patients and healthcare systems”.

Building on this solid basis provided by the adoption of the report, negotiations with the Council should lead to a pragmatic and efficient approach in the fight against counterfeiting for patients’ safety, the EGA concludes. The EGA expects that the vote in plenary will follow the approach taken in ENVI.

PHARMACOVIGILANCE
With regard to ENVI’s assessment of the pharmacovigilance report, the EGA welcomes the deletion of the summary of essential information in the product information as proposed by the European Commission, as this would have been counterproductive. The EGA also welcomes the adoption of the alternative proposal by the European Parliament, which calls on the European Commission to come forward with a proposal to revise the product information, taking into account the needs of patients and healthcare professionals.

The EGA is pleased that the European Commission’s proposal regarding reports by marketing authorisation holders to Eudravigilance only has not been dismantled by the European Parliament. The EGA supports the view that Member States should be alerted electronically about serious suspected adverse reactions that take place on their territory. This ensures that national competent authorities do not miss or overlook this important information.

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For further information contact Julie Chauvet
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