The Manufacturing Chemist anticounterfeiting roundtable: part II

In the second part of a two-part roundtable, Manufacturing Chemist speaks to a group of industry leaders about the additional benefits that can be achieved through serialisation beyond compliance and what comprehensive track and trace regulations, including aggregation, could mean for the future of the industry

Serialisation presents a huge challenge for pharmaceutical companies and their contract partners. The complexities associated with developing and implementing a solution across multiple lines, supplying to multiple markets and then managing the huge amounts of data generated as a result of serialisation are vast.

However, well prepared companies that are ready for the US and European regulatory deadlines ahead of time are increasingly realising that there are additional business benefits to be gained from serialisation and the end-to-end supply chain visibility it could potentially offer. Many companies are suggesting that serialisation and track and trace regulations could have wider business benefits beyond compliance. Have you found this to be true and, if so, how?

Staffan Widengren: At present, companies’ efforts should be focused primarily on ensuring their solution meets the compliance requirements of the FMD, while also being adaptable to future demands. This will help to ensure the transition to serialising products is as seamless as possible and that their solution can be tailored to future changes in legislation — and to their business — with minimum disruption. However, there are undoubtedly additional business benefits to be gained as a result of track and trace implementation. For example, the data visibility and sharing capabilities across the pharmaceutical supply chain will drastically increase beyond just sharing serialisation data, which should help to improve overall supply chain efficiency.

Carlos Machado: Serialisation may present a number of challenges because of the complexities involved; however, for those that prioritise planning for upcoming requirements, including the DSCSA and the EU FMD, wider business benefits can be achieved. Despite this, our recent survey highlighted that just 44% of respondents are intending to use the process to do so. Starting early creates an opportunity to review business processes and improve productivity and standard operating procedures (SOPs). For example, installing a data management system can help companies to document evidence on the quality of manufacturing, therefore supporting the reduction of quality control issues and recalls. This can strengthen brand reputation, which has a positive effect on overall business performance and profitability.

Dexter Tjoa: Serialisation can have huge benefits for the pharmaceutical supply chain. I think it is an important step towards enabling end-to-end visibility in pharma. However, the main benefit at the moment is that these regulations are forcing the pharmaceutical industry to confront concepts that are already more advanced and in wider use in other industries — such as electronic data exchange and cloud software solutions. I hope that serialisation will encourage the development of a more connected supply network approach wherein companies are better integrated to streamline their shared processes. This would also be one of the best ways to take further advantage of serialisation in terms of, for example, inventory management and demand planning.

Jean-Marie Aulnette: Although serialisation is costing the industry now, I strongly believe that the implementation of new systems and processes will generate long-term value beyond compliance. The main objective is, of course, to achieve compliance with the EU FMD and other global regulations. The full traceability of your drug means extra security for the patient and delivers clear benefits for the manufacturer in terms of tackling diversion. Additionally, manufacturers will be able to realise benefits derived from access to big data and analytics. It will be possible to track the movement of each drug, the market it is sold in and when it is moving to distributors, etc. This greater visibility will help to identify areas for improvement and generate supply chain efficiencies. The new processes for data exchange will also help to improve information sharing across the supply chain.

At our NEXUS conference in Barcelona in June, TraceLink announced the first compliance and digital information sharing platform, specifically for EU pharmacies. The mobile and web-based application enables any EU pharmacy to comply with the EU FMD verification and decommissioning requirements while accessing a real-time dashboard for business insights on medicine scans, expiry dates, dispensing trends and product inventory. The real-time information sharing comes into play through the pharmacist’s ability to opt in to receive specific and contextual pharmaceutical product information directly from the manufacturer — including details about indications, usage, best practices for product administration, and potential warnings and precautions and more. In particular, by having access to the unique identifier (UI) for each drug product and a new digital channel of communication, pharmacies can engage more directly with each manufacturer and vice versa, ultimately leading to a more informed dispenser and an improved patient experience.

MC: There’s been a lot of talk about the benefits of implementing aggregation, even for products intended for markets where it is not a regulatory requirement. What are your views on this?

Widengren: Aggregation is a double-edged sword, increasing the complexity of serialisation. From an operational perspective, it has the potential to reduce your overall equipment effectiveness (OEE) as a result of longer manufacturing and packaging processes, and additional data handling and storage requirements. There is a huge amount of extra data generated as a result of the parent-child relationship between the various levels of packaging, and this will need to be managed and stored accordingly.

In addition, the cost of aggregating across three tiers is also substantially higher. That being said, aggregation can improve the efficiency of track and trace throughout the entire supply chain by mitigating the need for unpacking and repacking to scan individual boxes. It can also help to reduce scrapping costs in the case of a recall as a pack can be easily replaced and recorded without affecting the validity of the other products within the batch.

Machado: Aggregation allows for a complete and secure supply chain to be established. Although companies may find the process to be complex, given the multiple packaging layers required, it can bring positive benefits in the fight against counterfeit medicines and adding another layer of traceability, but also in terms of generating supply chain efficiencies, particularly at the warehouse and distribution level. Although it is not a regulatory requirement in all markets at the moment, implementing aggregation as part of a standardised process across all facilities will improve business control by focusing on productivity and efficiency, warehouse processes and shipping and visibility into product movement for the entire business.

Tjoa: Aggregation is necessary if a company wishes to realise the full benefits of track and trace in the supply chain. But, even before that, the risk-based verification that some wholesalers will have to do would benefit greatly from receiving aggregated data for the corresponding shipments. Aggregated data would allow the wholesalers to implement a much more (cost and time) efficient process to execute these verifications. I think it is inevitable that aggregation will come to all markets that have a serialisation requirement; even if it’s not stipulated in the current legislation, it’s more a matter of when than if.

Aulnette: Aggregation will bring significant benefits to the supply chain, especially for logistics companies in terms of managing information and data as a product moves through the chain. Clearly, for the pharma company, aggregation can have an impact on the cost of serialisation. However, it’s important to remember that the ultimate goal is to serve the patient in the most efficient and cost-effective way. It is my belief that manufacturers will pay in some form during the supply chain if they don’t implement aggregation.

For example, the manual steps that occur during the distribution or warehousing stage in the absence of aggregation will add additional time and, therefore, cost to the process. Also, some markets, such as Russia, will be making aggregation mandatory and there is an argument that if you perform aggregation for specific markets, it makes sense to do it for all. We are also seeing some of the larger distributors and wholesalers making it compulsory, otherwise additional costs derived from the time burden must be covered by the manufacturer.

MC: How can companies prepare for future track and trace requirements as the global landscape continues to evolve?

Widengren: It is inevitable that following the initial regulations coming into force, there will be changes to the legislation. It is vital that companies ensure that their solution is flexible and can be adapted when required, whether this means adding additional levels of aggregation or including more information in the barcodes. A comprehensive understanding of various market requirements will also help to reduce any disruption caused by future changes.

Machado: Again, implementing a scalable and flexible solution will help companies to adapt quickly to evolving requirements in the future. These will undoubtedly differ across geographies, so companies will need to analyse their current footprint and account for regional operational variations, as well as future plans to enter new markets. Companies that operate across multiple sites can look to employ remote resources to manage deployment activity and ongoing maintenance. Creating a standardised process across all facilities is also critical, so that this can be easily replicated and scaled to meet future demand. Outsourcing the ongoing management of your set-up can also reduce costs as it removes the need to have dedicated support teams on-site.

Tjoa: Crucially, stay up to date with the latest information in your markets — either through your own mechanisms or through your trading partners — and have a review process in place to determine how this change impacts your business. Next steps really depend on the type of change and the type of business you’re in.

Aulnette: First, companies need to set up a dedicated track and trace team. Serialisation cannot be considered as an additional project for those with other responsibilities. There will be some evolution in terms of regulations and this team will need to stay up to date with market requirements. Regulatory departments should maintain complete visibility of the markets in which their drugs are distributed. Staying in touch with regulatory bodies and GS1 will help with this.

To ensure you can adapt to global changes in regulations, it’s important to engage with global partners that can assist you at an enterprise level, rather than a local level. Those partners with experience in multiple markets and that have already demonstrated the ability to adapt are best placed to serve the needs of pharmaceutical manufacturers now and in the future. In addition, partners that have the vision to achieve value beyond compliance are also important to the progress of the industry. Ultimately, serialisation programmes will not just exist for 3–5 years, but for 20–30 years, helping to form new connections throughout the supply chain.

Aside from protecting patient safety, which is of course paramount, this is where the true benefit of serialisation will come. In short, establish a dedicated team, select the right partners and consider the value that can be achieved post-February 2019 … and you’re on track for long-term serialisation success.

Companies