The global drug counterfeiting trade is growing every day. WHO estimates that 7–15% of all medicines in circulation in the developed world are fakes, and the figure rises to up to 25% in developing countries. But how do these kinds of drugs make it into the supply chain in the first place? The answer lies in poor serialisation and supply chain management, as well as the complex regulatory environment that governs how pharmaceutical products travel across borders.

The EU’s response to the escalating problem has been obligatory pack serialisation – the standardising of how medical products are labelled and inspected. The result is the Falsified Medicines Directive (FMD), and it comes into force for most EU countries in 2017 –  a deadline that is fast approaching.

Manufacturers have a lot to do before they can be fully compliant with the new rules, and FMD will affect everything, from the look and feel of packaging to the ways that production is managed and supply chains are run. The legislation is firmly focused on serialisation and verification requirements, with producers obliged to provide a central EU office with information on all of their products, which is then passed on to national partners. Clinicians can then verify the barcodes against centralised information to guarantee authenticity.

Manufacturers in the US face similar hurdles. The 2013 Drug Supply Chain Security Act, to be implemented in three phases over the next ten years, places a major degree of importance on traceability along the supply chain, obligating manufacturers to supply a transaction history of all goods. For large manufacturers with big profits, this is not a huge issue, although it is costly. But for smaller companies with smaller profits, it could be a matter of financial life or death to be compliant by the deadline.

Outsourcing requirements

For many, the solution is a simple one: work with a third-party logistics (3PL) provider.

Many smaller manufacturers outsource their 3PL requirements, often because they do not usually have the scale to develop a team fully in-house, or they need someone else to manage the myriad infrastructure and processes needed to ship directly to customers in other markets.

Amid the clamour to meet the new anti-falsification requirements, one company may have an approach that could be helpful to the industry: the Westborough, Massachusetts-based Covectra has launched a serialisation platform aimed at smaller pharmaceutical companies that need to comply with EU and US requirements on medical device traceability in a short space of time.

AT Prime was developed to to adapt to evolving serialisation compliance roll-outs, offering a practical, low-cost solution.

The platform is called AT Prime, and it uses the company’s AuthentiTrack software to send serialised information to print and packaging facilities, making sure that all goods are compliant with EU (and, if necessary, US) regulations. It is an out-of-the-box approach that uses the AT cloud interface to enable market authorisation holders to send information directly to EU serialisation hubs. According to Steve Wood, Covectra president, speaking ahead of the launch, the new system is cost-effective, powerful, compact, and yet provides comprehensive functionality.

“Increasing international regulations such as UDI (unique device identification), FSMA (Food Safety & Modernization Act), and DSCSA (Drug Supply Chain Security Act) are impacting the way companies do business today,” he argued. “Many manufacturers are struggling to meet compliance in a timely fashion to avoid fines and disruptions to their supply chain network.

“AT Prime was developed to adapt to evolving serialisation compliance roll-outs, offering a practical, low-cost solution that increases visibility and control, and that can be deployed quickly and efficiently to serialise the units of trade to enable track and trace and deter counterfeiting.”

The packaging security technology is applied as additional layers of brand protection, from labels and cartons with proprietary taggants to sophisticated, unique holograms. By combining these layers of security, so the argument goes, a product travels from manufacturing, through packaging, into distribution, retail and into the hands of the consumer with maximum traceability, safety and integrity.

“AT Prime is designed for rapid installation and validation, recognising the pressure on today’s pharmaceutical serialisation budgets,” Wood told, a website focused on counterfeiting.

It works fairly simply. AT Prime provides access to Covectra’s AuthentiTrack cloud to download directly to a server, which provides serialised data to the packaging line and to a printer for the primary package.

One man’s problem

In many ways, these new regulatory challenges are great for businesses devoted to these kinds of outsourced logistical challenges. Investment and corporate advisory firm N+1Singer, for example, has argued that packaging firms are well placed to benefit from, for example, new rules in the US.

“Serialisation is expected to increase capex (capital expenditure) requirements to upgrade legacy packaging lines and bring them into compliance with the new regime,” the company explains. “In our view, this is likely to drive further outsourcing from pharma companies that are either unable or unwilling to invest.”

But how does working with 3PL providers on logistics compare with going it alone, and will companies that adopt the kind of approach offered by Covectra get a better deal? The company is certainly not the only one on the market offering the kind of platform that small manufacturers need to quickly comply with new regulations. California-based med-tech firm rfXcel, for example, recently announced the latest edition of its compliance and serialisation platform designed to massively improve the functionality of existing barcode-scanning functionality.

“The latest product release dramatically improves scalability to handle hundreds of millions of serial numbers and expands the breadth of global compliance solutions to include both China and South Korea,” the company announced in a press release.

“The platform enhancements further build on industry-leading serialisation and traceability capabilities, and provide numerous benefits, enabling customers to take advantage of dramatic scale, security and functionality improvements.”

Produmex is another software and med-tech company providing outsourced serialisation solutions to medical device manufacturers. Launched, again, as a response to increasingly strict measures by governments and supranational organisations cracking down on counterfeiting, the PDMX Suite expands on the company’s other business software to make serialised item management integral.

“The result is great visibility of inventory by serial number (or by batch) combined with on-demand traceability to meet regulatory requirements; for recalls, service and support; and to prevent counterfeiting,” says Produmex, which offers a broader suite of products intended to help smaller companies with logistical challenges, from shelf-life management to 3PL-services invoicing.

Challenges across industries

While the medical device and pharmaceutical businesses are relatively new to this need for outsourcing traceability requirements, there are plenty of lessons they can learn from another field where end-to-end visibility is critical to staying compliant: the food industry. Much of the advice given to manufacturers who are working to keep up with FDA requirements applies equally in this industry, and here, using 3PL is commonplace. For one thing, collaborating with suppliers is essential, and the same traceability challenges exist.

It is certainly tempting for smaller companies, and, in some instances at least, outsourcing to 3PL partners means that the regulations can apply differently. In the US, for example, the strict provisions of the Drug Supply Chain Security Act do not apply in the same way.

As regulators demand even more stringent surveillance of production, the demands placed on manufacturers can only grow.

“Third-party logistics providers are exempt from these traceability and serialisation requirements,” writes Sarah K Rathke, a lawyer at Squire Patton Boggs specialising in manufacturing litigation, “Because 3PL handling does not transfer ownership of pharmaceutical products (although we would not be surprised if 3PL customer contracts require 3PLs to collect and maintain this type of information).”

“The DQSA contains interesting new requirements for 3PLs, as a result of the federal government’s attempts to create national 3PL pharmaceutical licensing standards. This means that, very soon, there will be new 3PL licensing requirements that will likely impact the entire industry. For instance, under the DQSA, states can no longer regulate 3PLs in the pharmaceutical industry as ‘wholesalers’.”

Ultimately, the decision whether or not to outsource logistical requirements is really dependent on the type of company and its requirements. While it is a necessity for smaller companies that simply have to outsource, larger manufacturers, too, may feel compelled to do it to cut costs.

“Consider whether it is in your best long-term financial interest to commit to the continual infrastructure and technology investments needed to comply with constantly evolving state and federal product integrity, track-and-trace, and support pedigree requirements,” advises Neil DeHenes, director of 3PL sales, Cardinal Health Specialty Solutions.

The medical device supply chain industry is big business, recently valued at over $300 billion a year globally, and as regulators crack down on counterfeiting and demand even more stringent surveillance of production, the demands placed on manufacturers can only grow. In this climate, it is obvious that turning to third-party logistics solutions makes sense, but whether it makes money will depend on the company.