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Improving anti-counterfeiting for pharmaceuticals
 What
is one thing the pharmaceutical industry can do to combat counterfeiting?
A panel of experts, including from Eli Lilly, offers suggestions.
If there was one thing you could do to improve the counterfeiting
situation, what would it be and why?
Michael J. Muller, Director of Global Anti-Counterfeiting
Operations, Eli Lilly: It would be to raise the level of
awareness of this threat to patient safety among government officials
and consumers. Unfortunately, too many patients see the attractiveness
of buying products at prices that are "too good to be true"
without asking where the product came from.
In addition, too many health regulatory agencies are looking for
an easy "magic bullet" to solve this complex issue—often
in the form of a track-and-trace technology solution. This is a
complex issue that needs to be attacked on multiple fronts, at its
source, its funding, and its distribution network.
Jim Rittenburg, vp of Healthcare and Life Sciences, Authentix:
We believe that use of serialization to uniquely identify items
at the unit level, and associated data management systems to verify
product in the supply chain, will certainly be a step forward and
an improvement; however, it will not provide the panacea that some
people believe. In association with serialization efforts, it will
also be important to engineer physical authentication systems into
both the products and their packaging.
It is inevitable that counterfeiters will continue to copy and
mass-produce whatever they can see on a product and its packaging,
including serialized information. As serialization and digital verification
become more routine and proactive processes, larger numbers of exceptions
will be identified and set aside for rapid follow-up and dispensation.
The ability to authenticate suspect samples through quick confirmation
of physical security characteristics will be an essential component
of an effective authentication/serialization system.
Vaughn Volpi, president, PICA
Corp.: Track-and and-trace technology (by itself) is
of limited value in combating counterfeiting. Overt authentication
systems will deter some wholesale and retail sales if the brand
holder aggressively commits to educating its supply chain and consumers
on the authentication of its products.
However, the primary market for counterfeit pharmaceuticals sits
outside the traditional supply chain, for example with smaller retail
and Internet vendors, third-world economies concerned with cost,
and others. Since counterfeiters tend to focus on the non-traditional
supply chain, these customers—both retail and wholesale—are
less likely to know or even care about authentication solutions,
let alone traceability technology.
Eli Lilly: Lilly believes that the use of technologies
deployed in the right manner and with the right resources will result
in improved supply chain integrity and enhanced patient safety.
However, the inherent success of any such measure largely depends
on the ability of all segments within the supply and distribution
chain to employ the same technologies, read and process the data
in real time, and share data without restriction— otherwise,
the use of such systems is simply an added cost of production to
the manufacturers.
Importantly, there are limitations to what traceability systems
can provide. Such systems must be part of a larger, more comprehensive
anti-counterfeit framework if they are to succeed. Track Track-and
and-trace systems only track the packaging of a product and not
the product inside. In addition, no one-technology solution can
be a magic bullet. These technologies can be replicated or compromised
by counterfeiters. These measures also do little to address the
flood of illegal products entering countries through Internet sales.
Dean Hart, executive vp, NanoGuardian:
First and foremost, any additional security features added to the
supply chain will most likely make the chain more secure, but I
do not believe there is a "silver bullet" technology
or approach that will bring an end to counterfeiting and illegal
diversion.
The most fundamental element in any security strategy is the layering
of security features—both overt and covert. For example, some
argue that on-package e-Pedigree initiatives, such as RFID and data
matrix bar codes, are indeed the silver bullet that will end counterfeiting
and illegal diversion; however, RFID and 2-D matrix bar codes fall
far short of a complete solution.
First, studies show that they can be copied, hacked, or reused.
Second, they are applied to the package only, and once a product
is repackaged, even legitimately, the protection provided by these
package-level technologies is lost. Only by combining together on-package
and on-dose security features that can provide field-level authentication
and dose-level tracing will pharma manufacturers take a significant
step towards protecting each and every dose from plant to patient.
PICA Corp: There needs to be closer day-to-day
interaction between public health and safety/police agencies and
brand owners to combat the problem. Both have a significant vested
interest in solving the problem, but each lacks what the other has.
Brand holders have industry and channel knowledge, resources, and
authentication capabilities, but must rely on the government for
meaningful enforcement. The government can create a deterrent through
enforcement, but lacks the resources and knowledge to start and
build cases. Linking these two is vital to the success of any anti-counterfeiting
campaign in the pharmaceutical or medical products industry.
Source: World Intellectual
Property Review, Nov/Dec 2008
From a White Paper sponsored by Authentix, NanoGuardian, and PICA
Corp. You can read the complete White Paper directly at www.nanoink.net.
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