Is it time to advocate for a global serialization standard for pharmaceuticals?

By Lisa McTigue Pierce in Anti-Counterfeiting on November 19, 2015

Healthcare expert Ian Lemon makes a case for how harmonized regulations and strong leadership can help combat counterfeiting and improve patient safety.

 

Up to 10% of all pharmaceuticals sold globally are counterfeit, according to the U.S. Food and Drug Administration. Serialization—adding a unique identification number to each package—can help track a product throughout the supply chain, making it harder to divert or counterfeit. But complex challenges still exist.

In a recent article “Tackling Counterfeiting through Serialization,” author Ian Lemon talks about the benefits of serialization, such as protecting consumers against subpar counterfeit products by tracking packages, as well as the challenges, including the costs of implementing solutions to comply with different regulations around the world.

As Essentra’s global product director, Health and Personal Care, Lemon is responsible for new product development to satisfy customer and category needs and demands. With more than 15 years of experience, he has worked with several leading fast-moving consumer goods (FMCG) businesses.

Packaging Digest asked Lemon about his ideas on how to simplify this complex issue.

 

You recommend adoption of common legislation globally for pharmaceutical serialization. Why?

Lemon: Counterfeiting is a global phenomenon and the criminals that place brands and lives at risk every day can be large, organized and increasingly sophisticated. These global risks require a unified and global response if we’re to make material and sustainable progress to counter their impact.

As serialization programs roll out across the globe, the volume of different coding and reporting requirements increases. Coding is being introduced on different levels of packaging with some countries adopting unit-level protection and others assuming codes on tertiary-level packaging.

The issuance of serialized numbers in some territories is centrally controlled while others delegate the generation of unique codes to the manufacturer. Some regulations require communication between stakeholders in the supply chain while others focus only on the point of prescription to the patient. Serialization, in some territories, requires dispensing records to be placed on central digital databases while others, at least for now, require paper records only.

This growing level of complexity and variation will inevitably result in regulatory or executional flaws which will present opportunities for counterfeiters to exploit. Equally, the cost and complexity of deploying discrete national regulatory arrangements with supporting reporting infrastructure may be too costly for some governments in parts of the world where the instance of counterfeiting is most prolific.

A global, standardized system would facilitate a coordinated and consistent attack on this damaging crime and would facilitate the maximum adoption of the practice around the world.

 

What is the likelihood this will happen, and why or why not?

Lemon: The likelihood is low.

A global anti-counterfeit initiative will only be possible when national governments are prepared to harmonize their legislation with regard to pharmaceutical manufacture and distribution and also their legal posture with regard to protection of intellectual property. In a period of time when national governments do not have standard definitions of what a counterfeit product is, then the likelihood of deploying global systems to address it are minimal.

 

What would be the benefits of a global standard for pharmaceutical serialization for all involved parties?

Lemon: Consistency creates an environment where cost and process efficiency can be realized to maximize the impact of serialization in undermining the counterfeit threat. The deployment of a single, global execution for pack-level serialization would require a system to be developed that can be universally adopted and executed in all countries and regions. It would allow development of standard enabling systems and information technology (IT) infrastructure, which would reduce the cost and complexity of deployment for both national/regional institutions and for the healthcare industry.

While the adoption of serialization for the protection of healthcare products is generally supported by pharmaceutical manufacturers and their upstream packaging partners, there is also a concern about the investment and variable cost impact of its deployment. The already significant challenges posed for system development and integration have been compounded by the different, and often dynamic, requirements of individual regulators. Companies are being required by the pressures of different deployment timetables around the world to invest significant development costs in an unclear and unstable environment.

Will the systems and data integration systems deployed today fully satisfy the requirements of the next nation state’s hybrid interpretation of what has been defined to date?   

 

What are the challenges of implementing uniform laws, and how should they be overcome?

Lemon: The key challenge is leadership. Harmonizing regulation is profoundly complex and difficult and can only be achieved if a strong, global, non-governmental body can establish sufficient authority and multinational support to drive progress.

 

You also advise establishing long-term relationships with strong partners that are able to help manage costs and minimize risks, in the light of regulatory uncertainty. Why is this so important?

Lemon: Pharmaceutical companies are experts in the research, development and deployment of health-enhancing products. Their core competency is not in data management, system integration or variable data printing.

Global companies with these latter core competencies exist that enjoy a well-developed and macro view of the emerging requirements across the globe. They are best placed to support the effective deployment of means by which the challenge of serialization can be effectively addressed.

 

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See anti-counterfeiting and track-and-trace packaging solutions at WestPack 2016, Feb. 9-11 in Anaheim, CA.

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