EGA welcomes the european parliament vote on falsified medicines
16/2/2011 - EGA welcomes the european parliament vote on falsified medicines and anticipates an intense implementation phase
The European Generic medicines Association (EGA) welcomes today’s vote by Members of the European Parliament which seeks greater protection for EU patients by preventing the proliferation of falsified medicinal products in the EU.
Greg Perry, EGA Director General, declares “the EGA is keen to co-operate with the Commission and responsible stakeholders to develop a cost-effective system to validate the authenticity and identification of individual packs, which must take into consideration the particularities of certain categories of medicines, such as generic medicines, both during and after the implementation phase.”
The EGA also calls on the Commission to ensure that the “white list” approach for all prescription medicines and the risk assessment criteria, used for assessing risk status and adopting provisions related to safety features, do not put an unnecessary burden on low risk products, such as generic medicines. Therefore setting up a sound risk-based assessment will ensure strong patient safety and focus efforts on maximizing the prevention of counterfeiting to correctly target high-priced, branded medicines at risk of being counterfeited. “The EGA expects that only a reduced number of generic medicines will fall into this category due to their low cost and low exposure to risk: no counterfeit generic medicine has yet been found in the legitimate supply chain in Europe” Hugo Carradinha, EGA Senior Manager Health Economics Affairs says.
The EGA congratulates the efforts by MEPs on implementing specific measures to tackle the sale of falsified medicines on the internet. As stated by the World Health Organization “more than 50% of medicines are sourced from the internet”.
On the quality side, the introduction of a clearer and more comprehensive GMP and GDP supervision of all actors of the pharmaceutical supply chain — particularly intermediates — will be key to ensuring quality of medicines and their components. “Key success factors for a rapid, effective and pragmatic implementation of the GMP aspects of the falsified medicines directive will be 1) a continuous exchange and consultation between stakeholders, 2) the high prioritisation of regulatory dialogue with key API exporting countries and 3) the securing of the necessary budget for Eudra Databases, cornerstones of a dynamic yet smooth information system” says Julie Maréchal-Jamil, EGA Senior Manager Regulatory Affairs.
The EGA highlights the crucial importance of detailing the practical implementation measures derived from the falsified medicines directive and is strongly committed to supporting and actively contributing to the implementation process.
