Many regulations for track-and trace and serialization are still being finalized. What advice can you give to a pharma company that wants to be prepared?
Shabbir Dahod, President and CEO, TraceLink: The biggest advice we can give to be prepared is to look at the challenge holistically – and not just as a packaging problem of putting serial numbers on bottles. Much of the industry is viewing serialization as a packaging line problem, when in fact, that’s only one piece of the challenge. For companies to succeed at serialization, they need to consider that they are no longer just shipping drug products. They must now ship data for every product, and creating, managing, storing, and accessing that data has a unique and complex set of requirements.
The scalability limitations of using EPCIS-based Relational Database Management Systems (RDBMS) to process vast amounts of serialization data;
- The network implications of sharing data with contract partners, downstream customers and governments; and,
- The high cost of continuously monitoring new and changing compliance laws, and the resource constraints on internal staff to maintain software updates when compliance regulations change. Typically, we find that pharma companies have underestimated three critical success factors:
- Without a deep understanding of these challenges and their respective implications, pharma companies run the risk of not being able to ensure drug supply to patients who need medicines.
Andrew Pietrangelo, President, North America, Antares Vision: With so many new regulations emerging, proper preparation and careful vendor selection are important. Pharma companies must consider the impact serialization has not only on their packaging lines but also the other, often overlooked, tangential details such as package design, SOPs, and warehouse re-aggregation (and workflow).
For vendor selection, it is not only important for large multinational pharmaceutical companies with plants throughout the world, but it is also important to small pharmaceutical companies with only one plant. With the continued globalization of the pharmaceutical industry, many more companies are shipping products internationally.
The new and emerging serialization regulations add an additional layer of complexity. It is critical to identify a serialization solution provider who has experience packaging and serializing products globally for the countries whose regulations are finalized. Companies with this global experience and knowledge will be able to help manufacturers navigate through the emerging regulations. In addition, countries continue to announce new regulations. Make sure the solution provider has a system which is flexible enough to adapt to changes in regulations without the need for complete revalidation of the system. The additional benefits of choosing an experienced solution provider is that your implementation timeline, cost, and risk will be reduced.
Glenn Siegle, President, Omega Design Corporation: The sooner a company starts the sooner they’ll be able to reap the benefits of serialization. Many of the largest Pharma companies are years into their serialization initiatives and are finding that rolling out the subsequent lines can be straight forward after going through the hiccups of the original lines. The best advice is to give yourself time and leverage the experience of your vendors.
What anti-counterfeiting and anti-diversion technologies show the most promise to thwart illegal activities and why?
Dahod: Any anti-diversion or anti-counterfeiting strategy must not only solve a particular supply chain problem, but also offer relevance to different types of individuals across the supply chain who will interact with the technology. The technology must be cost-effective to deploy, possess a familiar experience and easy-to-use interface, and must fit seamlessly into existing business processes and user workflows.
As a result of the sharply declining cost of mobile development and the rapidly-increasing penetration of smartphones and wireless connectivity on a global basis, a mobile-first approach to tackling counterfeit and diverted products shows great promise for manufacturers looking to stem the tide of these supply chain problems. Using a mobile-first authentication solution, a manufacturer and its downstream trading partners can take advantage of investments already made for serialization, and gain real-time access into product movements and potential supply chain irregularities.
Our success developing and deploying an anti-diversion solution to market with a top-5 global pharma manufacturer in 2015 demonstrates a clear market need for more value-added applications in this area.
Pietrangelo: We are seeing that layered technologies that combine overt and covert printed features are showing the most promise. In addition to the traditional UV inks, there are several companies who have developed proprietary new inks that can be very easily added to some serialization systems. This enables pharmaceutical companies to turn their investment in serialization from merely a compliance requirement to something that adds value to their business.
Siegle: Full track and trace utilizing secure aggregation shows the most promise. It patches up the holes in the supply chain with near real time data on a saleable unit basis. Each company knows where each of its products should be and when its last known location was. This has been known as the leading mechanism for thwarting illegal activities for over a decade now, but fear of the complexities involved delayed stakeholders from getting on board.
What are some of the biggest barriers to implement track and trace technologies? Cost? Complexity? Lack of regulatory guidelines?
Dahod: The biggest barrier to successfully implementing track and trace technology is thinking that existing infrastructures and approaches used for enterprise resource planning or warehouse management can adapt to address the complex requirements of track and trace. Companies that attempt to solve track and trace with traditional system architectures will face a high degree of system customization, with no guarantee that these customizations will fully address the company’s drug traceability needs. What’s more, is that these customizations create significant cost increases, time delays, and the need for even more customization as regulations evolve over time – a costly, never-ending cycle.
The real scope of track and trace is more akin to tracking the status updates of every person using Facebook. Tracking the unique movements of every user, every update they make, and making all of that information instantly available to an individual’s Facebook network is, in principle, similar to what is required for the pharmaceutical supply chain to track and trace drugs from ingredient to patient. The sooner companies recognize that traditional technologies and information architectures are not capable of supporting this kind of unit-level tracking and instant information sharing across large networks of participants, the more rapidly they can move beyond implementation barriers and deploy a successful track and trace solution that minimizes the cost and risk of not meeting compliance deadlines on time.
Pietrangelo: There is not one barrier facing pharmaceutical companies that stands out above the rest. All of the things mentioned present challenges. Depending on a company’s individual situation, some barriers may rise above others. However, in addition to cost, complexity, and regulation, companies must also be careful to manage OEM capacity, line packaging line availability for implementation, and data system integrations.
Perhaps the biggest barriers are cultural and organizational. Track and trace is a landscape where skilled people are still relatively rare, and where pharmaceuticals companies – especially smaller ones – are still experiencing difficulties evolving their operating models to comprise more effective exchanges across their organization and with the partners.
Siegle: The largest hurdle we hear from our customers is the downtime on their lines. That has to be planned for and in detail. Introducing serialization to a facility is an opportunity to reform packaging lines and identify similarities that can utilize similar systems and differences requiring unique devices.
What segment of the industry is really driving advances in track and trace/serialization? Government? Industry? Vendors? Why? Who has the most to gain, or lose?
Dahod: While regulations are pushing investment, true innovation is being sparked by the growing collaboration between the industry and solution providers. Governments and regulators don’t have a deep appreciation for the massive data sets, huge transaction volumes, and complex network interactions which industry needs to master in meeting track and trace/serialization regulations. Identifying, tracking and reporting upon the tens of billions of drug products produced globally each year by the tens of thousands of pharmaceutical manufacturers serving the industry is a herculean task.
As a result, vendors have partnered with the industry to understand two key areas in this emerging digital supply chain:
- How can emerging cloud technologies, plug-and-play network connectivity and other innovations address the scalability and networking challenges created by serialization and serialized product management across the supply chain?
- What are the opportunities for improving patient care, ensuring drug quality, and enhancing supply network efficiency by smartly integrating precise information about products and their transactions into daily business operations?
Everyone can gain by these advances, as long as they are designed from a network-perspective rather than from a traditional enterprise architecture perspective. The transformative value for patients and businesses only occurs by leveraging the network effect stimulated by these global regulations.
Pietrangelo: Advances in the industry are being driven by both the industry and vendors. With the new regulations, pharmaceutical companies are facing many challenges. As these companies begin the implementation process, they are pressing vendors to deliver solutions that minimize the impact to their SOPs and operational efficiency (ODE). As a means of differentiating themselves, many of the vendors recognize the needs of the industry and are proactively developing unique solutions to satisfy these industry needs.
That said, on the whole this is good for all stakeholders – companies, vendors and the general public. Track and trace efforts exemplify a virtuous cycle, one in which governments are the triggering point in pushing the industry to comply with regulations; in turn, the industry benefits from the costs sustained for compliance in terms of reduced losses from counterfeiters, better visibility in the supply chain and user feedback. Given a long enough timeline, all these efforts will pay for themselves in increased business efficiencies, consumer safety and patient satisfaction.
Siegle: The government played a large role by passing legislation, but it is the manufacturers and distributors that are driving the process. To do so they are teaming up with their vendors to develop more standardized approaches as a platform to utilize across facilities. Distributors took it upon themselves to encourage and in some instances force an earlier adoption of industry wide aggregation which makes the entire system of identifying each product in the supply chain possible. Criminals have the most to lose.
Do you foresee regulatory agencies around the globe coming to a joint consensus on track and trace regulations in the near future?
Dahod: Consensus on regulations, the information they require and transaction sets they cover is unlikely to occur anytime soon. There has been a gradual convergence towards a core set of identifiers for product identification, including a drug product trade identifier, lot number, expiration date and serial number. In addition, alignment on GS1 standards for the structure of this information and its carrier has been increasing. Outside of these two areas, though, there continues to be great diversity across track and trace regulations which create massive complexity for pharmaceutical companies and their supply networks. Regulatory agencies are fighting a diverse set of issues from country to country, with anti-counterfeiting, diversion, reimbursement and taxation being four major drivers of track and trace regulations. Depending on the focus of the regulator, different compliance data sets, packaging level identification, supply chain traceability rules, product verification requirements and compliance reporting regulations are and will continue to be developed.
So, track and trace regulations in the US, EU, China and elsewhere will remain fundamentally diverse for the foreseeable future and the pharmaceutical supply needs to build the necessary flexibility and agility into their compliance infrastructure to deal with this reality.
Pietrangelo: Full global consensus on regulations is very unlikely, as the drivers for countries adopting the new regulations vary. Because of this, the requirements of a country’s regulation will vary in order for them to achieve their specific goals. The good news is that many countries seem to be gravitating towards the GS1 standard which will help the industry. It will not provide full consensus but can help significantly.
Siegle: In the near future, no. Each regulatory agency has their own specific priorities for thwarting criminal activity in their area and encouraging modern supply chains capable of product visibility at all phases.