EGA welcomes MEPs decisions on falsified medicines and pharmacovigilance reports

Generics and biosimilars Initiative

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EGA welcomes MEPs decisions on falsified medicines and pharmacovigilance reports

INICIO/Noticias Farmacéuticas | Posted 11/06/2010 0 Post your comment

On 27 April 2010, ENVI (The Committee on the Environment, Public Health and Food Safety) of the European Parliament voted to adopt reports on both falsified medicines and pharmacovigilance. The measures included in these reports are intended to increase patients’ safety. This can only be good news for the generics sector, as this should result in increased consumer confidence and as a result encourage acceptance and increase sales of generics.

Falsified medicines

The Director General of the European Generic Medicines Association (EGA), Mr Greg Perry, supported ENVI’s decision to ensure that “safety features designed to secure the legitimate supply chain will be cost-effective, whilst guaranteeing the independence of databases. Moreover the Members of European Parliament (MEPs) have correctly focused on measures to tackle the sale of counterfeited medicines on the internet where the major problem lies” he commented.

The committee intends to reinforce current audit systems and build upon greater international cooperation to control active pharmaceutical ingredient (API) and excipient production. The EGA feels this should provide an effective tool to prevent the infiltration of falsified APIs and excipients into the EU.

The EGA expects that the vote in the plenary session of the European Parliament will follow the approach taken in ENVI. Adoption of this report should lead to a pragmatic and efficient approach in the fight against counterfeiting helping to ensure patients’ safety, the EGA concludes.

Pharmacovigilance

The EGA welcomes ENVI’s assessment of the pharmacovigilance report, in adopting the European Commission’s proposal to revise the product information, taking into account the needs of patients and healthcare professionals.

The view that Member States should be alerted electronically about serious suspected adverse reactions that take place on their territory was also supported by the EGA, stating that this ensures that national competent authorities do not miss or overlook this important information.

Reference:

EGA Press Release, Brussels, 27 April 2010