Industry calls for ‘zero tolerance’ on European counterfeits
pharmafile | May 16, 2008 | News story | Manufacturing and Production |Â Â Â
European industry body EFPIA has demanded 'zero tolerance' on counterfeit medicines and proposed tough new security rules to combat the escalating problem.
The group believes a clamp down on the repackaging of drugs throughout the supply chain is essential, and that medicines should have to stay in the same format when they travel from manufacturer to patient.
In 2006 European customs officials seized 2.7 million medicinal products, an increase of 384% on the previous year, according to figures from the European Commission.
EFPIA's proposals come in response to the Commission's public consultation on how best to tackle the problem of counterfeit drugs.
Brian Ager, director general of EFPIA, said counterfeit drugs have serious consequences for patients and undermine public confidence in medicines.
"Recent seizures of counterfeit medicines in the EU have shed light on the vulnerability of the pharmaceutical supply system and on practices that undermine efforts made by the industry to protect patients," he added.
Under current EU rules, products can be re-boxed, re-labelled or stickered-over, which can remove the unique identification codes that ensure traceability, and make it hard to distinguish real medicines from fakes.
For an effective anti-counterfeiting strategy the integrity of a medicine's original packaging must be guaranteed throughout the entire supply chain, according to Efpia.
The industry body said liabilities within the distribution chain should be more defined, and it has plans for a pilot bar code system to enable the pharmacist to verify each medicine pack before dispensing it to the patient.
Some manufacturers, such as GSK and AstraZeneca, have introduced direct-to-pharmacy (DTP) schemes, which can make medicines more traceable and cut the opportunity for counterfeiting in the supply chain.
But another reason manufacturers want to avoid using a number of distributors with different prices is to protect their profits – an issue the Commission has recently investigated under claims it is anti-competitive.
The public consultation on counterfeit medicines is now closed, and the Commission has pledged to analyse all contributions before making any new draft policy. A summary of its outcome will be published on the Pharmaceuticals website of the Directorate-General Enterprise and Industry.
