More often than not, track and trace is discussed in terms of compliance. With regulations in place – or coming into force – across large parts of the world, the majority of the world’s prescription medicines are now protected by traceability legislation.

In the US, the applicable law is the Drug Supply Chain Security Act (DSCSA), which was introduced in 2013 and is being applied in the years up to 2023. We have already passed through the first phase of implementation: since 2015, manufacturers, wholesalers and repackagers have needed to provide lot-level serialisation.

Currently, we are in the second phase, in which serialisation must be provided at a unit level. The original deadline for manufacturers was November 2017, but this was subsequently extended. In the third phase, which ends in 2023, every bottle or package will need to be traceable back to its manufacturer.

In Europe, the Falsified Medicines Directive (passed in 2011) includes similar requirements. As of February 2019, all prescription medicines in the EU will need to be serialised on an individual product basis. In practice, this means featuring a globally standardised unique identifier, with batch number, expiry date and a random serial number issued by the manufacturer, in a two-dimensional barcode. The globally harmonised approach of employing GS1 standards are used by suppliers trading their products in the EU member states for which the FMD will take effect.

A foundation of traceability is being able to communicate clearly and concisely with your trading partners and other necessary stakeholders about the items being tracked and traced.
– Tania Snioch

All the difference in the world

Many other countries have their own traceability requirements, which are beyond the scope of this article to cover in depth. Ultimately, though, all are working to the same end – to eliminate the problem of drug counterfeiting and ensure product integrity throughout the supply chain, ideally following a globally harmonised approach to identification and barcoding.

Some manufacturers may still require time to adopt track and trace solutions and reach full benefit, but a 2012 McKinsey report stated a pharma manufacturer with $4 billion in annual revenues could realise significant cost advantages from adopting track and trace. These could include $90 million a year from inventory cuts, up to $12 million per year from reducing the costs of recalls, and $25–35 million per year from reducing the financial impacts of counterfeiting.

While manufacturers, along with their supply chain partners, know they need to comply, the issue is often framed in terms of meeting deadlines and avoiding penalties. What is less frequently discussed is the business case for traceability. As Tania Snioch, director of healthcare at GS1 explains, the business benefits from implementing traceability can be wide-ranging.

“Many organisations are leveraging their traceability implementations to drive internal efficiencies and streamline processes with their trading partners. This is very exciting to see,” she says. “Some examples of where traceability can deliver benefits beyond regulation are facilitated by the visibility provided by uniquely identifying the items moving through your business. Benefits include helping to reduce exposure to risk, manage and reduce costs, as well as increase accuracy.”

For instance, traceability can help with product quality and safety management to identify expired products and assist in inventory management. This in turn will speed up recalls and withdrawals, making the process more targeted, accurate and efficient.

Snioch adds that traceability can benefit all parts of the supply chain, from the manufacturer right the way to the specific patient.

“Ultimately, traceability in healthcare is about making sure that the correct, and authentic, product is at the correct location for the patient when they need it,” she says. “Traceability is achieved by using unique identification of the items being tracked and traced, plus the location they are going to.”

For the most part, these identifiers are encoded in barcodes, to ensure information is captured accurately. This data capture activity is coupled with information sharing – product master data, transactional data and event data.

“Put together, the result is the opportunity to leverage visibility for every stakeholder about what is moving where within their business and between themselves and their trading partners,” Snioch says. “The extent to which traceability delivers value to all supply chain actors depends on their vision for what this information could provide to their business.” Dr Jyrki Syvaeri, head of global process management operations at Boehringer Ingelheim, agrees that, if value is to be delivered, everyone in the supply chain needs to share the same aims.

“To deliver value across the entire supply chain, full track and trace needs to be established, and transparency of the transactions need to be guaranteed,” he says. “As long as some participants of the supply chain are not able or willing to share data it will be hard to gain value from any traceability project.”

For the time being, he says the lack of data sharing poses an impediment – at Boehringer Ingelheim, track and trace is mostly a matter of compliance and patient safety, and has little to do with meeting business goals.

“At the moment, we do not receive back any business-relevant data from markets such as Turkey, South Korea or Argentina, where full track and trace is in place,” he says. “In the EU, we have serialisation only, so we are not able to track our products in the markets and we are not granted access to point of sales data. This means we are not privy as to where our products are being sold.” Ultimately, he feels that all partners in the supply chain, including wholesalers and pharmacists, need to be involved and willing to share information.

“As long as there is ‘serialisation only’ in place, traceability is nearly impossible to achieve,” he says. “We might, if available, embark in pilots to have a more in-depth look into this topic in the future.”

He adds that analytics tools can be helpful in this process, as there will be an enormous amount of data to be interpreted. If conclusions are drawn correctly, it will lead to having the products in the right place in the right quantities at all times. This will mean stock-outs and product destructions can be avoided, delivering the value anticipated.

To deliver value across the entire supply chain, full track and trace needs to be established, and transparency of the transactions need to be guaranteed.
– Dr Jyrki Syvaeri

This year’s model

Robert Jan van der Horst, CIO of DSM Sinochem Pharmaceuticals, believes that serialisation taken alone could perhaps benefit some companies more than others.

“If the processes of serialisation and supply chain management are fully integrated, serialisation data as such would not provide significant new insight in the company’s total data set,” he says. “For companies not integrated, they will be able to profit from a data set that was not earlier available.”

DSM Sinochem Pharmaceuticals is structured slightly unusually, insofar as both the marketing and final packaging of its products are the responsibility of its partners. The company itself acts a middleman, providing active pharmaceutical ingredients and finished dosage formations. Within this business model, one of the main values of serialisation is as a form of data exchange and integration.

“It offers details exchanged from system to system that already possess rich data, and we fully incorporate the logistic data provided by serialisation with our own real time logistic processes,” he says. “This enables a number of efficiencies that we would never be able to realise without serialisation.”

He adds that since serialisation is not yet fully live – (legally all EU companies have until February 2019 – it is too early to say whether it can be used for future marketing purposes as well.

Broadly, though, he thinks that success in this domain comes down to how you approach the projects – a company needs to think about integrating its business processes, as well as promoting efficiency.

“This can only be realised if you begin well in advance, giving yourself sufficient time to view and position the project from an overarching strategic perspective,” he says. “Ultimately, the IT landscape of the company – either harmonised or scattered – will set the tone. Different types of IT tools need to be applied for different landscapes. The more your own house is in order, the better the strategic fit can be more quickly and easily realised with traceability projects.”

It is worth mentioning that companies such as DSM Sinochem Pharmaceuticals only have access to their own customer data, and cannot see what is happening across the rest of the pharmaceutical supply chain. Such overall data can only be purchased via a service provider, which delivers subsets of data for a fee.

Building the foundations

Snioch thinks there a few things pharma companies can do to ensure their traceability projects are set up most strategically. First, she thinks it’s important not to work in isolation. Rather, manufacturers should collaborate with their partners and be aware of the direction regulation is taking.

“Second, base your implementation on a globally harmonised approach,” she says. “A foundation of traceability is being able to communicate clearly and concisely with your trading partners and other necessary stakeholders about the items being tracked and traced. This is not possible if different stakeholders use internal proprietary identification, data capture or data sharing solutions.”

Thirdly, she feels that stakeholders looking to implement GS1 standards should try to take advantage of the support on offer to them, not least from GS1 itself.

“Most of the challenges I’ve seen result from the implementers perhaps not having full knowledge,” she says. “This may impact the alignment of their interpretation of the global standard, at the same time causing challenges for their trading partners up and down the supply chain. Any deviation from a globally harmonised approach impacts all stakeholders, so an informed implementation is always going to deliver the best outcome.”

“Having a future vision of how the data resulting from traceability could benefit your organisation and incorporating this vision into your current planning is absolutely key,” she concludes.

Snioch’s final piece of advice, then, is to think of future possibilities, not just what needs to be done today.