The European Federation of Pharmaceutical Industries and Associations (EFPIA), the trade organization representing European pharmaceutical manufacturers, is advocating a comprehensive strategy to address counterfeiting of drugs. Among its recommendations is a proposal to extend good manufacturing practices (GMPs) to include good distribution practices (GDPs).
“While basic regulations exist to prevent traders, brokers, or agents from causing safety problems, these need to be more strictly enforced,” said EFPIA in its response. “The current system of GMP (good manufacturing practices) should be extended to GDP (good distribution practice) audits as well as to the entire supply chain in order to assure that measures taken with respect to product protection, packaging practices, and distribution practices are properly used and followed.”
EFPIA’s proposal for GDPs is part of a larger strategy to address drug counterfeiting. This strategy includes requiring tamper-evident packaging on all products, use of overt and covert authentication features, strengthening product identification at an individual pack level through a harmonized coding standard, banning repackaging of drugs, and strengthening measures for liabilities and criminal penalties.
EFPIA’s recommendations come at a time when the problem of counterfeit drugs is escalating. In 2006, 2.7 million medicinal products were seized at EU customs borders, a 384% increase over 2006, according to EU statistics released by EFPIA.
The entry of counterfeit drugs brings with it the risk of substandard active ingredients and an obvious risk to patients. More stringent anticounterfeiting measures, including GDPs, are crucial for ensuring the integrity of the pharmaceutical supply chain. The EU’s effort to strengthen and harmonize EU standards should also serve as a basis for global harmonization efforts to address the weak links in the worldwide pharmaceutical supply chain.