According to the Commission, increased penetration of the classical supply chain by the counterfeiters has led to a sharp rise of counterfeit drugs and seized fake medicines at EU customs borders. The Commission plans to plug in the deficiencies in the supply chain integrity through strict adherence to Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) standards and transparency in the distribution chain.
The Commission has proposed collective action from the EU as a whole rather than unilateral action by the member states to thwart the counterfeiters from taking advantage of any potential loopholes that may arise out of variations in the EU internal market rules.
The consultation which will be conducted by the Commission’s Directorate-General (DG) Enterprise and Industry will focus on the production and marketing of active substances and finished medicines, plus related inspections, and on the import, export and transhipment of drugs. The DG intends to present new legislation after the summer break of 2008.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed the initiative of the Commission and has asked for a ban on repackaging, strict regulations and controls of the supply chain and severe penalties for trafficking in counterfeits. The EFPIA also plans to launch a pilot project in the area of mass serialization (2D barcoding system) towards the end of 2008 along with investment in anti-counterfeiting technologies to step-up product security.