EGA Press Release

Thursday, 20 March 2008

EGA WELCOMES COMMISSION PROPOSAL AGAINST COUNTERFEITING
OF MEDICINES — KEY ACTIONS AND INITIATIVES HIGHLIGHTED

The European Generic medicines Association (EGA) welcomes the European Commission Public Consultation in Preparation of a Legal Proposal to Combat Counterfeit Medicines for Human Use. The EGA sees this initiative as an encouraging step forward in the fight against the counterfeiting of medicines.

The EGA considers the key proposals in the consultation paper are well designed to target the genuine problems behind counterfeiting. These include tightening up the requirements for manufacturing, trading and distribution (eg, licensing of wholesalers), extending the legal framework to encompass API GMP, and enhancing supervision and enforcement.

Furthermore, the EGA believes that the proposal for an impact assessment by the Commission will provide a positive framework for determining specific actions to take within this effort to ensure the safety of the medicines supply. It is likely that certain technical solutions may be suitable for specific categories of medicines (ie, where a clearly increasing trend in counterfeiting is evident), while other measures may be called for in different instances.

The EGA is pleased to note that the Commission’s Public Consultation document is in line with the ideas advanced by the EGA in earlier papers, confirming the increasing tendency to counterfeit popular life-style drugs and other expensive treatments. To date, generic medicines have not been reported as the target of counterfeiters, mainly because of their low price and, consequently, of their reduced profit potential. Generic medicines generally fall outside the parameters considered as the main drivers for counterfeiting.

However, although no documented cases of counterfeit generic medicines have been reported to date, the EGA, together with other interested European groupings, including the pharmacists and wholesalers associations, are not willing to remain complacent in the face of counterfeit medicines and have joined together in a “Medical Supply Chain Integrity Pact” which is closely aligned in its aims with the key ideas put forward by the European Commission. Aiming to cover the full spectrum of the supply chain and to present viable solutions to specific problems, the Pact focuses on strengthening any weak links in the supply chain and on increasing transparency in the roles and activities of supply chain actors.

The EGA is highly committed to maintaining the fight against the counterfeiting of medicines and has been a pro-active contributor to several initiatives sponsored by various authorities, and has been at the origin of other activities related to the fight against the counterfeiting of medicines.

<< Back

---

For further information contact the EGA on
Tel: +32 (0)2 736 84 11 - .