In this excellent July 30th SecuringPharma post, Mr. Taylor reports on the International Authentication Association (IAA) take on the US governments plan:
• Referring to the USA's recently-published Joint Strategic Plan on IP Enforcement document, the IAA says that it is "disappointed to see the only reference to authentication methods is the proposal to establish a mandatory requirement for a track and trace system for pharmaceuticals and medical products."
• The strategic plan was drawn up by the USA's IP Enforcement Coordinator (IPEC) and sets out a series of measures to tackle the trade in counterfeit and pirated products, including pharmaceuticals, both domestically and internationally.
• "The plan does not go far enough and should have been stronger in endorsing the use of authentication technologies and methods - not just track and trace - for IP protection," said the organisation in a statement.
• Track and trace can help to secure the supply chain from the infiltration of counterfeiting but it cannot in itself identify nor confirm whether products distributed beyond legitimate supply chains are genuine or not, it pointed out.
• "The national plan to fight counterfeiting should include references and guidance on the means of authentication, because detecting fakes is a key part of any anti-counterfeiting strategy," said Jim Rittenburg, the IAA's chairman.
• He pointed out that the International Organisation for Standardisation (ISO) has been developing performance criteria for authentication tools used in anti-counterfeiting, and has said that "...track and trace technology when used alone is not considered to be an authentication solution."
• "We would like to see the IP Enforcement Coordinator look at the broader role of authentication technologies and programs for the next strategic plan," said Rittenburg.
Secure Pharma Chain agrees and endorses IAA’s criticism of the recently published plan and its lack of authentication as a proposed standard and strategy. The Joint Strategic Plan missed an opportunity to provide global leadership, regualtory guidance and protect industry and consumers from dangerous and potentially deadly criminal activity.
Authentication of the products is the critical component of enforcing intellectual property and protecting supply chains and consumers from fraudulent, adulterated and counterfeit products.