The CounTerfeiT Crisis

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          The CounTerfeiT
                                                                    In the age of internet connectivity, it is not only online
                                                                    fraudsters putting the public at risk from bogus
                                                                    pharmaceuticals. Colin Mackay of EFPIA looks at how the
                                                                    supply chain needs to be strictly monitored and what
                                                                    technologies should be implemented to give the best results.

                 ounterfeiting is one of the oldest criminal activities
                 and onje of the major risks comes from counterfeit              Contributor profile
                 pharmaceutical products being passed off as genuine                          Colin Mackay is the Director of Communications and
          versions of real medicines. These may contain substandard                           Partnerships for EFPIA, the Brussels-based European
                                                                                              Federation of the Pharmaceutical Industries and
          or below therapeutic levels of active ingredient, no active                         Associations. He is involved in the pilot EFPIA coding
          ingredient at all or even dangerous, toxic substitutes. They                        project, validating the concept of an end-to-end verification
          can range from crude, amateur copies to highly sophisticated                        system based on a 2D data matrix, to reduce counterfeiting.
          duplicates, increasingly difficult to differentiate from the
          genuine article. Counterfeiting is a big business and growing
          bigger; in some developing countries the infiltration of               indeed. The problem is not limited to Europe; in 2006 alone,
          counterfeit medicines is estimated as high as 50%, a situation         the US Food and Drug Administration (FDA) investigated
          fuelled by weak law enforcement of supply chain legislation            more than 50 cases of counterfeit medical products.
          and inappropriate product registration. The tempting
          combination of high potential for profit and a low risk of             Supply chain solutions
          being caught make it an attractive area for criminals.                 The Commission proposes two key elements as a solution;
                                                                                 firstly, the need to guarantee the integrity of product packs
          Europe: a prime target                                                 throughout the supply chain. This introduces a requirement
          Counterfeiters have shown their flexibility to seize                   to apply safety features such as overt, covert and/or forensic
          opportunities; the threat of H1NI influenza has allowed                devices on packaging, allowing authenticity checks. However,
          Tamiflu to surpass Viagra as the most counterfeited medicine           these features alone would be ineffective unless they are
          in Europe. The internet is not the only source of counterfeit          combined with tamper-evident features that can guarantee the
          medicine. Presumably encouraged by the promise of                      integrity of the product itself. Clearly, tamper-evident features
          substantial returns, the legitimate supply chain is increasingly       and the use of authentication technologies can only provide
          becoming a target. The European Commission has recognised              a primary layer of security. They can still be copied – and
          the need for legislation, and included counterfeiting as part          modern scanning and printing technologies facilitate this
          of the 2008 ‘Pharmaceutical Package’ of measures designed to           – so in isolation do not provide an insurmountable barrier
          ensure the industry remained competitive and generated safe,           to the determined counterfeiter. The European Federation
          innovative and accessible medicines. The third element of the          of Pharmaceutical Industries and Associations (EFPIA) has
          package was a ‘proposal aimed at strengthening EU legislation’         argued for a total ban of repackaging. However, the proposal
          by ‘protecting the legal distribution chain from infiltration’.        does not support this approach. The other strand of the
          Counterfeit medicines are a growing problem everywhere, and            Commission’s proposal is to ensure traceability through
          if public confidence in the supply chain is undermined, the            individual product codes (product serialisation) on the
          consequences could be severe.                                          packaging. These will be read by legal actors in the distribution
                                                                                 chain, including pharmacies. Sophisticated traceability systems
          If public awareness of the threat within the legitimate supply         will need to form a key part of any effective and comprehensive
          chain is low, it is partly because the number of counterfeits          anti-counterfeiting strategy. At the moment, it is not possible
          entering by this route is relatively low; at least in comparison       to guarantee identification of individual packs, with product
          to internet-based sources. However, the UK Government’s                traceability only feasible at batch level. Where it does happen,
          Medicines and Healthcare products Regulatory Agency                    the dispensing pharmacists scans a standard (one-dimensional
          (MHRA) has presided over nine batch recalls of counterfeit             or linear) barcode, which supplies limited information.
          medicines in the last five years, with counterfeit versions of
          products including Casodex, Lipitor, Plavix and Zyprexa all            Harmonisation required?
          found the legitimate supply chain. These are not treatments            The reality of the procedure that applies across Europe is that
          that can be classified as ‘lifestyle’ treatments , such as those for   it varies by country, with each national system using its own
          weight loss or erectile dysfunction; these are therapies for life-     codes and own system. With the lack of a harmonised system,
          threatening conditions like cancers and serious mental health          and with substantial movements of goods between countries
          problems. The potential consequences of this are very serious          via parallel trade, traceability across Europe is a considerable

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challenge. There is an absence of direction from the
Commission’s proposal, and alongside member states’ unique
systems, this has encouraged the European research-based
pharmaceutical industry to put forward its own proposal
for a harmonised system. The proposal, led by EFPIA,
recommends developing a system based on a 2D data matrix
code (ECC 200), containing a randomised serial number to
enable the unique identification of each unit. The code would
also include the existing product code (identifying the product
and its manufacturer), the expiry date and the batch number.
The data matrix is ideal for use with small packs, as it can
encode up to 50 characters readable at 2 or 3mm. It also works
well in low-contrast situations. Such an approach would mean
minimal changes to existing packaging.

Other traceability solutions are available, including RFID, but
this remains a high-cost solution. There are also some doubts
over whether such systems are capable of functioning at such
a granular level. In EFPIA’s analysis, the 2D barcode solution
is a proportionate response. To effectively minimise the risk
of substandard or counterfeit products reaching the patient,
there is one crucial juncture at which it is vital to know that
the product is precisely what it is supposed to be. This is at
the final link in the supply chain, where the product passes
from the pharmacist – retail or hospital – to the patient. This,
EFPIA believes, can be achieved by a systematic control of the
serial number at the point of dispensing, checking against the
relevant manufacturer’s database via a web-based service.

Traceable technology
EFPIA is in the process of developing an end-to-end product
verification that will achieve this objective. By scanning each
2D barcode pack at the point of dispensing, the pharmacist
will be able to see whether that individual product has been
dispensed before. This will verify the authenticity of each
dispensing unit before it reaches the patient. Unlike an
electronic system that permits the tracking and tracing of each
pack throughout the supply chain, this end-to-end product
verification system cannot guarantee the genuine nature of the
product contained within the coded product pack. However,
it can provide a method by which the product information,
including expiry date and batch codes, can be tracked,
minimising the risks of counterfeiting or tampering.

Realistically, this is the only type of traceability technology that
could feasibly be implemented in any reasonable timeframe
– around three to four years – at anything approaching a
reasonable cost. EFPIA is conducting a pilot version in Sweden
to verify the practicality of the system. The eventual aim
would be to integrate the system into pharmacy software.
While this system cannot and will not be able to fully prevent
counterfeiting or make the supply chain 100% secure, it can
go a long way towards providing high standards of security,
integrity and safety. It would also improve patient safety in
other ways, such as detecting out-of-date packs and could also
significantly reduce dispensing errors. Most importantly, it
offers increased security benefits for patients, helping to deliver
the right product to the right patient. That should be the
ultimate concern for all stakeholders. WPF

                                                                       WorldPharmaceuticalFrontiers   119