Phil Taylor in SecuringPharma reports on the International Authentication Association's critical stance of a recently published plan by the Obama Administration's US Joint Strategic Plan on IP Enforcement.
In this excellent July 30th SecuringPharma post, Mr. Taylor reports on the International Authentication Association (IAA) take on the US governments plan:
• US policymakers have "missed a golden opportunity" to make authentication technologies mandatory for intellectual property protection and protection against counterfeits, according to the International Authentication Association (IAA).
• 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.
While track and trace solutions are important in understanding the transactional process, it does not protect the consumer from fraudulent product.
All of the most recent counterfeit and fraudulent medication incidents that have resulted in death or significant health care issues with consumers have the appropriate track and trace pedigrees and would likely have been interdicted had their been an authentication process in place.
To read the entire SecuringPharma story, visit: http://www.securingpharma.com/40/articles/537.php.
To learn more about authentication solutions, visit: http://www.xstreamsystems.net/.
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2 comments:
The comments of the IAA highlight a larger issue which is the blurring of the line between track and trace and authentication, and the misconception that you are authenticating something simply by checking an ID number against a database. Even with well-established distribution systems, such as those of the major package delivery services that allow you to log onto their website and track a package from shipment to delivery, you are still not authenticating that the item received is the same item that was originally shipped.
There are many authentication technologies and cost is always a major consideration. It would not be realistic to expect governments to be prescriptive in mandating specific technologies however it would be very effective to establish performance based standards that must be met that enable an item to be authenticated. It could be viewed as component of product quality....that is the ability to authenticate a product at least to a minimum standard. This does not necessarily mean spending large sums of money on technology as many authentication features can be designed into a product by the manufacturer without necessarily procuring an expensive technology from a 3rd party technology supplier. The complementary use of track and trace systems, and authentication systems, will ultimately provide the best protection to both the consumer and the brand owner.
Jim Rittenburg, IAA chair
We at XStream could not agree more and encourage all members of the supply chain to deploy a variety of technologies and solutions to protect their inventories and defend consumers from the criminals intent on profiting on this potentially deadly act.
As it relates to a comprehensive solution we feel that knowing what is "inside" the box is more important than where the box has been which is what track and trace technologies do.
True authentication goes beyond the end use product but also should verify the quality and efficacy of the materials used to make it so in the case of pharmaceuticals the safety of the efficacy to the end use consumer is assured.
Alan Clock, SVP XStream Systems
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