Franz Ludwig of Bosch Packaging Technology talks to Pharma about trends in counterfeiting and the technologies used by Bosch to help manufacturers win the war against the pharmaceutical counterfeiters.
How big and real is the threat of counterfeiting to the pharma industry?
Counterfeit APIs and medicines pose a growing threat to patients worldwide, with numbers increasing in Europe and the US. For example, seizures of counterfeit medicines at European borders have risen explosively during the last 5 years. According to a report by the European Commission, 118 million counterfeit products were stopped by customs in 2009, of which 10% accounted for medical goods.1 In addition, medication is increasingly sold via the Internet, making it much easier to put counterfeit products into circulation. As a result, many pharmaceutical companies are realizing the need to implement anticounterfeiting measures for their products.
Is there a trend in the type of drugs being counterfeit.
The extent of the problem of counterfeit drugs is vast. According to the World Health Organization, antibiotics, hormones, analgesics, steroids and antihistamines make up almost 60% of the drugs counterfeited.2 Currently, the most popular medicines that are being counterfeited are Sildenafil citrate, which is sold as Viagra and various other trade names, and weight-loss drugs. This is because these products are predominantly ordered online, providing an opportunity for counterfeiters to more easily disguise the fake products and sell them as originals compared with walk-in pharmacies where fake products would be quickly detected.3
What are some of the technologies being employed to combat pharma counterfeiting?
Regulation of the serialization of pharmaceutical products is currently in place or being implemented in several countries, among them Turkey, France and the US, to curtail the number of counterfeit products on the market. To address this, Bosch Packaging Technology offers comprehensive anticounterfeiting solutions by using a combination of technologies, including mass serialization and tamper-evident packaging combined with 3D holograms to help manufacturers reduce counterfeiting of their products.
During the last 2 years, Bosch has conducted scientific examinations and extensive trials with currently available printing systems, including thermal inkjet, continuous inkjet, drop-on-demand inkjet and laser printers. As a result, we have amassed extensive expertise in this field and can offer solutions for tracking products and for mass serialization. Our Track & Trace Carton Print System (CPS), which uses either drop-on-demand or laser printer depending on customer packaging material demands, provides superior print quality and speed and offers the highest format flexibility on the market.
In addition, our engineering and development teams are evaluating other innovative possibilities to offer manufacturers a variety of additional options to further enhance their anticounterfeiting efforts. For example, we are currently running an experiment with nanoparticles to test how an infrared spectrum could be included in the matrix that is printed on the package. These nanoparticles are invisible to the human eye, but can be detected by a sensor, adding a new, highly advanced level of security to the Track & Trace solution.
How do these work?
With our Track & Trace system, a unique identifying code is printed onto each product after it has been packaged, which allows for the traceability of individual products throughout the supply chain and facilitates the identification of counterfeit products. It also provides manufacturers with documented proof of what has been produced at item level.
The Track & Trace system uses a CPS module consisting of a printer and camera, which automatically prints and verifies products. To trace each product individually, a unique serial number and an expiration date are printed on the package. The information also includes a batch number and global trade item number (GTIN). The system encodes the data into a machine-readable 2D datamatrix code, which is printed on the package, eliminating the possibility for human error in the tracking process.
Printed tracking data is automatically checked for accuracy by the camera, which reads and verifies each printed digit (optical character recognition/verification). Within milliseconds the camera cross-checks the humanreadable text with the 2D datamatrix code . All information is then stored in a centralized database, ensuring that tracking and tracing of the product are possible after each package exits the factory. The database can also be modified to provide the printed data to regulatory bodies such as FDA or the Ministry of Health.
How smart are drug counterfeiters - can they keep pace with the new technologies designed to stop them?
Generally, counterfeiters are well equipped with the necessary resources to offer fake products to the market. Yet, anticounterfeiting technologies that incorporate security details on products, such as a unique serial number, are one way that pharmaceutical manufacturers can start to win the fight against counterfeit drugs.
In addition, the quicker new developments can be incorporated into existing anticounterfeiting systems, the harder it will be for counterfeiters to keep pace and adapt. This will help achieve the ultimate goal of eliminating the problem of counterfeiting.
How do you think Track & Trace technology will evolve?
Track & Trace as an end-to-end solution will be firmly established within Europe by 20 1 5 as many manufacturers are starting to identify the need to protect their brands and, ultimately, their consumers. The adoption of this technology would mean that every pharmaceutical drug would have a serial number, allowing each product to be authenticated in pharmacies before it is sold to the patient. I also expect to see measures put in place to protect consumers when shopping online for pharmaceutical products. For example, consumers buying medical items from online pharmacies will have the option to authenticate their purchases within seconds using web-based or mobile solutions.
[Sidebar]
Getting it Right
The current buzz topics within the pharmaceutical industry are authentication, serialization and Track & Trace. This is a result of a combination of legislative initiatives and advances in technology convincing people that unique item level marking is possible and will allow consumers, healthcare professionals and brand owners to identify an individual product and where it has been. Yet, despite what some companies would have brand owners believe, serialization without security is not authentication and serialization without aggregation and integration is not Track & Trace.
Some companies purport the idea that placing a unique and checkable code onto a product provides authentication. This is not so. Codes can be copied, sequences can be guessed and databases can be stolen. For 'true'authentication you need to have security built into the serialization programme. Codes, therefore, need to be difficult for counterfeiters to replicate. Brand owners need to consider systems that work via encryption and potentially include other security features that support each other, providing a 'lock and key' approach. Serialization can only really be seen as true authentication if other factors are involved and it is not the only means of defence.
Track & Trace involves the monitoring of products as they go through the supply chain, such as checking the progress of courier packages online (tracking) and finding out where a product has come from (tracing). There is an erroneous notion that serialization effectively acts as a Track & Trace system. Serialization provides no such facilities in its own right. A unique code can only be used as a Track & Trace device when monitored and recorded at each point along the supply chain. For this to work, the unique code has to be associated with each packaging unit so information can be aggregated. For example, the code on the pack is associated with the carton it goes into, which in turn is linked to the shipping case it enters. A better understanding of these issues will result in increased efficiency and security for the pharmaceutical industry.
For further information
Richard Burhouse
Business Development Manager
Payne Security
www.payne-security.com
[Reference]
References
1. European Commission, Report on EU Customs Enforcement of Intellectual Property Rights (2009).
2. www.who.int/medicines/services/counterfeit/overview/en/
3. www.policynetwork.net/sites/default/files/keeping_it_real_2009.pdf
[Author Affiliation]
For more information
Franz Ludwig
Product Manager Track and Trace
Bosch Packaging Technology
No comments:
Post a Comment