Category: Commercial Brand Protection

Pharmaceutical Case Study

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Author: Andree Bourgeois

Counterfeiters threaten $1 billion pipeline of medicine.

You are your company’s brand protection manager. Counterfeit copies of one of your major pharmaceutical brands turn up in the U.S. market. You have no security measures in place to allow patients or inspectors to tell the real stuff from the fake. Consequently, $1 billion worth of your product, already in the distribution pipeline, can’t be sold—at least not until you come up with some method of allowing patients and retailers to verify that your medicine is actually authentic.

Patient safety, your company’s hard-earned reputation not to mention $1 billion in sales are all under severe threat. Time to send out a SOS.

This is exactly the situation one of our customers found themselves in. And when they came to us for help, Authentix answered the call. Our customer desperately needed a way to instantly authenticate medicines in the field. No problem, we said.

We immediately jumped into action. The customer’s product was repackaged to include a variety of authentication features that could be identified by patients and inspectors, both in the field and in the laboratory. These included:

  • Overt, color-shifting inks can be readily distinguished by patients.
  • Covert, machine-readable inks can be detected in the field by inspection staff with appropriate readers.
  • Forensic markers can only be detected under laboratory analysis.
A happy ending

The Authentix solution to our customer’s counterfeiting problem provided a secure means of instantly identifying authentic from counterfeit medicines. The benefits were immediate and significant:

  • $1 billion worth of product frozen within the supply chain was released for sale
  • The expense of a full product recall was averted
  • The customer was able to mitigate the risk of potential lawsuits
  • And, our customer’s brand protection manager instantly became the organization’s authentication “superhero.”

Most importantly, confidence in the brand was restored among physicians, pharmacists and patients.

Every superhero needs a partner.

What would Batman be without Robin? The Green Hornet without Kato? Not much, if you ask us. If you want to be your company’s authentication superhero, contact us today. In true superhero style, Authentix is the partner with the innovative solution to boost your authentication powers!

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Case Study: Fast-Moving Consumer Goods

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Author: Andree Bourgeois

Brand protection solution to eliminate the diversion of products from legitimate distribution channels

The Challenge

A large, global hair care manufacturer produces category-leading brands with high consumer loyalty and demand. Their products are marketed through exclusive, professional beauty care channels via a complex supply chain with diverse manufacturing systems and multiple distribution outlets.

All of these elements make their products high-value targets for counterfeiters, organized theft rings, and gray market wholesalers. In fact, the manufacturer found they were being negatively impacted by diversion of its products from legitimate distribution channels into gray or retail markets. This situation was creating dissatisfied customers and weakening their market promotional efforts.

The Need

Clearly, the manufacturer needed an anti-diversion authentication solution that would help them maintain brand equity. It was imperative that the solution include the ability to authenticate product and verify its “product genealogy” throughout its life cycle. They also needed the ability to track product throughout their entire supply chain and make sure the right product was always delivered to the right location.

The Solution

The global hair care manufacturer turned to Authentix to implement an authentication solution of serialization and a track-and-trace system that identified product diversion in the brand’s distribution channels. The Authentix solution utilized multiple covert authentication features that allow item-level serialization, full product trace-ability from manufacturing to retail, as well as provisions to track repackaged products. In addition, the track-and-trace system was seamlessly integrated into manufacturing process controls for all of the manufacturer’s 13 production lines.

Itemized serialization was accomplished for over 165 million products, enabling full trace-ability from manufacturing to retail.

The Outcome

      • Successfully identified channel leaks within a complex distribution chain of over 2,500 channel partners and 15 distributors
      • Over 300 million units have been marked since the Authentix solution was implemented
      • 47 percent reduction in product diversion
      • Consequently, product sales increased by $77 million

Contact us if your company is struggling with lost revenue due to illicit activity throughout your supply chain.

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Case Study: Wine & Spirits

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Author: Andree Bourgeois

Addressing Counterfeiting and Adulteration Increases Sales by 25%

 

The Issue

Authentix implemented a program in South America to help address a spirits counterfeiting issue. With annual production of over 60 million bottles of various spirits (approx. 50 million liters), this market provided the largest single source of state government revenue—over $150M in previous years.

 

The Solution

To solve the issue, the program used a combination of in-product, on-package marking and distribution channel monitoring. For authentication purposes on packaging, an overt feature was added as tamper evidence for consumers and a covert feature was added for official retail inspectors via handheld field verification readers and test kits. In addition, covert features were incorporated into the spirit itself for field verification and forensic lab verification.

 

The Outcome

    • Within the first year of the program, 75
      million liters of spirits had been protected (approx. 100 million bottles).
    • More than 1300 inspectors in 28 states had inspected over 300 retail outlets.
    • Of these, 10% were found to contain counterfeits and 5 retail outlets were investigated resulting in arrests.
    • The brand owner experienced a 25% increase in sales over the same time period.

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Protecting Critical Care Drugs

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Author: Andree Bourgeois

Whitepaper – Protecting Critical Care Drugs

The trafficking of fake and altered drugs, including injectables, has reached epidemic levels in some parts of the world and is a growing problem in the United States.

According to the World Health Organization, 50% of drugs sold online are counterfeit.

What Brand Protection security measures do you have in place to protect your brand against these counterfeit drugs?

In this whitepaper you will learn:

Multi-layered solutions for positive identification
Importance of tracking products through the supply chain
Designs of a proactive, overarching anti-counterfeit strategy

 

 









Risk Assessment Strategy

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Author: Andree Bourgeois

Authentication in Pharmaceuticals: a 5-Step Risk Assessment Strategy Whitepaper

To learn more about how you can act quickly when authenticating a package in the field, visit us here.

Contact us to speak with an expert today.

DOWNLOAD IT HERE

Elevating Your Brand Protection Strategy with Multilayered Security Solutions

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Author: Andree Bourgeois

By: Jeff Conroy, Chief Scientist, Authentix

Many companies are thinking more broadly about how to implement coordinated anti-counterfeiting, anti-diversion strategies across their brands and throughout different regions of the world. Just as tamper-evident seals on bottles of pills and liquid formulations became more common due to a tampering scare in the 1980s, attitudes toward anti-counterfeiting technologies are beginning to evolve.

Once viewing such measures narrowly as an “extra feature” that only “added cost” to the bottom line, brand owners are beginning to realize the importance of protecting the integrity of their brands and the most important part of the equation: protecting the safety of consumers. As serialization technologies continue to evolve, the tracking of individual units through the supply chain could enable very secure and traceable evidence of authentic products being supplied by manufacturers and distributors to end users.

Different Features, Different Purpose

Anti-counterfeiting features that can authenticate products are both overt and covert, and they can be applied in numerous ways: on labels, onto closure seals, on cartons where containers of products are stored, into plastic parts of individual packaging, and even onto metal and glass components of packaging.

The different types of features all serve a different purpose, from enabling end users to quickly identify a branded product as genuine, to covert markings that enable a manufacturer or inspector to identify the source of diversion or other illicit activity. When combined with the careful design and production quality controls used in authentic product manufacturing, these features raise the bar of complexity for counterfeiters and make the product a less attractive target.

With that said, it’s worth considering the value of individual security features versus a multilayered approach.

Overt security features: Visible security features serve a valuable purpose in the authentication stack. They offer a way for individuals to inspect packaging without any specialized tools, and the specialized color-shifting inks (similar to those used on currency) are often difficult to reproduce using scanners or reprographic methods. There are other types of optically variable features as well, including holograms, micro-optics (like the blue stripe found on the current US $100 bill), and reflective features.

Visible security features are a starting point, but counterfeiters are extremely creative and clever. Even if a visible authentication feature is hard to recreate perfectly, a counterfeiter only needs to copy it closely enough to confuse a consumer who just gives a package a quick glance. Additional features create layers of security.

Covert security features: High security covert features can be embedded into labels, closure seals, or other features of product packaging. Although such markers are invisible to the naked eye, they can be detected using specialized handheld surface spectrophotometers. Field instruments use proprietary excitation and detection optics and detection algorithms for rapid, secure field authentication. Additional forensic layers of security are also embedded into the materials and can be confirmed through more extensive laboratory analysis. This additional layer of security proves very difficult for the counterfeiter, but easily verified by field inspectors.

Serialization: In the serialization process, a company marks individual units at the point of manufacture (giving each a unique serial number) and implements stations to read those markings, capture the tracking data, and drop that information into a managed database that allows authorized personnel to monitor where products go after they leave the manufacturing facility. You’re probably most familiar with this process as it applies to shipping a package overnight, when you can track it on the Internet until it reaches its destination.

An effective anti-counterfeiting solution contains multiple, layered components

As a brand owner, it’s good to have options. However, the counterfeiter also has options. Fortunately, technology continues to evolve to help you protect your end users. Today’s reality is that one level of security isn’t enough.

Recently a number of technologies have become available that offer the benefit of not having to add any additional features to the packaging, but the imaging requirements on the production lines can be quite demanding and difficult to implement at speed. Once captured, the identification of the package can take place with conventional cameras, allowing widespread authentication and tracking by inspectors, retailers, or even consumers.

Any combination of covert or overt features or serialization enhance your anti-counterfeiting, anti-diversion strategies. Click here to learn more about brand protection. You can also contact Authentix at info@authentix.com.

Inspector Led Authentication’s Contribution to Brand Protection Programs

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Author: Andree Bourgeois

By: Andrzej Hornostaj, VP Brand Solutions, Authentix

Identification of an at-risk product and implementing an authentication solution is not the end of the story, it is just the beginning. Constant inspection of the product in the supply chain and marketplace is required to ensure useful actionable insights is generated to minimize counterfeit and diversion practices while protecting your brand and bottom line.

Let’s Begin with Inspection Design

Inspection design is determined by the objectives of the inspection. Let’s consider two relevant approaches. Will the inspection be reactive to a specific counterfeit event, or proactive determining the scale of counterfeiting and generating actionable insights?

Ideally, inspections, like any investigation, should follow a holistic approach involving several stakeholder teams including product, brand protection, investigative, and legal. Each team has its own requirements for the actionable insights generated from an inspection. Some critical stakeholder questions may be as follows:

Product: What’s the scale and location of the counterfeiting problem for a product?

Brand protection: What’s the level of sophistication of the counterfeit operation (production and logistics)? Are security features being copied? Are packaging design changes required?

Investigative: Can the right data be gathered to support investigations into the counterfeit’s supply chain and to identify the manufacturing source? Is the evidence strong enough that it can be passed on to legal and law enforcement to perform raids and prosecutions?

Who will conduct the inspections?

The boots on the ground can either be members of the brand owner’s staff or third-party inspection agencies working on their behalf. Ideally, to infer useful insights from an inspection, the more data collected the better. This need pushes the brand toward engaging a third-party that can provide the coverage and inspector numbers to achieve data volume.

As always, inspector safety is paramount and consideration should be taken as to whether the inspector needs to be accompanied by law enforcement representatives.

Where to direct initial inspection efforts?

I would suggest initial efforts begin at the retail level where products of interest are typically more accessible to covert inspection. This type of insight helps to determine the scale or extent of the problem and generates a suitable baseline against which further inspections and remediation efforts may be compared. As pharmaceuticals are usually not accessible at pharmacies, other locations in the supply chain should be the initial focus.

Once a baseline is established, then testing of supply chain integrity should be performed. Keep in mind, some obstacles may be encountered at this stage as it is not always possible to accurately track the route by which products reach the end user beyond the first tier distributors.

To assist access / auditing of stock at distributors, brands should ensure that cooperation agreements allow for inspections with short notification times. This will prevent suspect items from being removed from the audit location by a guilty party.

Which inspection tools should be used?

Having the right tools during an inspection to automatically capture the data required for each stakeholder is important and ensures that repeat testing is minimised. With the right type of reader paired with a smart device, inspectors are equipped to not only identify counterfeit products, but also capture location data and photographs of the packaging. This complete picture of the scale and sophistication of the counterfeit operation can form the basis of effective enforcement actions.

Click here to learn more about brand protection. You can also contact Authentix at info@authentix.com.

There Are No Shortcuts To Safe Medicines

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Author: Andree Bourgeois

The Partnership for Safe Medicines® recently hosted a panel briefing of several former federal law enforcement officials and public health experts to discuss the merits of recent prescription drug importation proposals[1]. The panel highlighted one of the often overlooked aspects of these proposals aimed to quickly reduce the cost of prescription drugs to patients in need in the United States: the safety of these drugs that would circumvent current FDA regulated domestic supply chains.

Certainly the promise of lower cost prescription drugs is a powerful message to an electorate that sees the costs of these medicines continue to rise while stories of lower cost drugs in other parts of the developed world also make headlines. But those other countries have carefully negotiated and managed supply chains with pharmaceutical companies that ensure the safety of their drugs and often make it illegal to fill a prescription from outside the country. Such is the case in Canada, where Canadian pharmacies cannot fill prescriptions for U.S. patients. Instead, internet pharmacies that claim to be Canadian import drugs or counterfeits sell them to unsuspecting consumers. Like it has for so many other industries, the internet has enabled easy access of buyers and sellers, but with little accountability for product quality or authenticity. Consumers are left to trust the supplier is legitimate, often with no means for recourse if there is a problem.

So why not simply empower the FDA with oversight on importation of drugs from other countries to help ensure safety? That’s a reasonable proposal, but one that will undoubtedly add to the cost of importation. Furthermore, this is not a U.S. only policy problem. For example, if the U.S. and Canada were to legalize the import/export of drugs between the two countries, what would be the effect on Canadian drug prices? In 2014, total Canadian expenditures on prescription drugs was estimated to be $29B[2]. By comparison the United States spent $374B[3]. Even a mild influx of orders from the U.S. could stress the Canadian system, more importantly Canadians, affect pricing since drug companies will be forced to negotiate with Canada as an international supplier, and not a domestic single payer system, certainly driving up costs for Canadians.

The U.S. has left the pharmaceutical industry largely unregulated when it comes to pricing. We have no single payer system, we do not place limits on pricing, and we let the profit motivation of the free market system drive pricing, profit, investment, and innovation. And while we can certainly feel the effects of rising drug costs, we can also see that this system has of its own accord driven us to greater and greater innovation for treatments and cures, and has created a very secure supply chain for the sale and distribution of those medicines. There is almost certainly some kind of change and reform coming to healthcare costs in the U.S., and the pharmaceutical industry will have its part to play, but compromising safety cannot be part of the equation.

Counterfeiting and diversion of medicines and medical products are global issues that affect all countries. These illegal activities threaten the health and welfare of the citizens who receive fake or substandard product, as well as threaten the revenues of brand owners. These activities also undermine the efforts of the government to ensure the availability of affordable drugs to its citizens, thus enabling the proliferation of disease, which can lead to development of drug resistant pathogens.

Authentix is dedicated to the development of products and services that allow the authentication of products and their packaging in supply chains around the world. Authentix provides integrated programs that enable manufacturers to protect their products in complex supply and distribution chains, and informatics to monitor and report on problems as they become apparent.

For more information visit http://authentix.com/offerings/sherlox/.

1.) http://www.safemedicines.org/2017/04/the-fallacy-of-drug-importation.html
2.) https://www.cihi.ca/en/canadians-spent-288-billion-on-prescription-drugs-in-2014
3.) http://www.latimes.com/business/la-fi-drug-costs-20150414-story.html

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