Compliance

Q2 2017

Regulatory

Serialization

Servier CDMO

Track and Trace

<h3>Increasing numbers of countries around the world are requiring some level of unit traceability in the pharmaceutical industry. While initially driven by regulations, the impacts of serialization will be far-reaching. Early adopters that implement a strategy that goes beyond compliance to leverage the vast quantities of newly generated data will be well positioned for success in the digital age.</h3>
<h4>Why Serialization In Pharma</h4>
<p>The World Health Organization (WHO) estimates that 1% of the drug supply in developed countries is counterfeit — including millions of prescriptions in the U.S. alone — with as much as 40% in developing nations.<sup>1</sup> Counterfeit medicines can pose serious, even life-threatening danger to patients.&nbsp;</p>
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<p>At the same time, the pharmaceutical supply chain has become more global and more complex, as drug companies increasingly rely on outsourcing partners for development and manufacturing support. Governments have responded by establishing serialization (track and trace) requirements, many of which have looming implementation deadlines.&nbsp;</p>
<p>On a fundamental level, serialization brings to the pharmaceutical industry tracking of drug products on a sales unit level throughout the supply chain, from initial manufacture through distribution and onto receipt by the patient. This technology is already widely applied in other sectors, but with the implementation of track and trace systems, the pharmaceutical supply chain is embarking on a new journey. Initially, track and trace will be required for each box; perhaps ultimately it will apply to each unit dose or vial.</p>
<p>The challenge is to mark the identity of each individual sales unit with full traceability during its passage through the supply chain. Doing so requires the generation and sharing of new types of data never previously managed by pharmaceutical companies. Collaboration across the supply chain to ensure security and integrity of the data is essential.</p>
<h4>Rapid Expansion Of Regulations</h4>
<p>During the last three years, the number of countries publishing serialization/unit traceability regulations has grown significantly. In general, it seems that governments are seeking to leverage the advanced technologies that are applicable to serialization to address a number of different issues. In Brazil, for example, serialization is sought to assist with tax control issues, while in Turkey the government is looking to limit fraudulent reimbursement claims and China is perhaps seeking to achieve a certain level of standardization and reassurance for dispensers.</p>
<p>At Servier we do business with countries that have both emerging and established economies — nearly 150 in all. We fully expect approximately 80% of the markets we serve to have serialization regulations in place by 2021. We see the need to comply with regulations in countries like Turkey, China, South Korea and Saudi Arabia as offering the opportunity to conduct pilot runs prior to being faced with the requirements of the EU.</p>
<h4>Widespread Impact</h4>
<p>Serialization is not simply applying a serial number to product packaging. It is truly a change in the bio/pharmaceutical industry that will impact all aspects of the supply chain, not just manufacturers that must install equipment and software systems. In fact, serialization will also impact distributors, wholesalers, clinicians, pharmacists, and patients. For instance, patients will have the opportunity to request reimbursement and file complaints on specific product units. Indeed, tracking and tracing of sales units on a global basis is just the tip of the iceberg; it will have a huge impact on the way people in the industry do their jobs.</p>
<p>For manufacturers, from a project management perspective, serialization is not a simple project with a defined scope. It is a complex initiative with numerous aspects that impact many different business processes. It is necessary to harmonize many different components and requires cooperation and collaboration across many different business units and with external members of the supply chain.&nbsp;</p>
<p>As a result, the impacts go beyond ensuring compliance with regulatory requirements. Other benefits of implementing serialization solutions include standardization of equipment and processes across facilities, improved quality, enhanced access to supply chain data, real-time verification of packages in transit and fraud prevention. The biggest questions related to the vast quantities of data that will be generated as a consequence of implementing track and trace capabilities are related to data ownership, security and integrity. All of these data management and business intelligence issues must definitely be thoroughly considered.</p>
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<h4 class="callout-title">In Brazil, for example, serialization is sought to assist with tax control issues, while in Turkey the government is looking to limit fraudulent reimbursement claims and China is seeking to achieve a certain level of standardization and reassurance for dispensers.</h4>
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<h4>Centralized Approach</h4>
<p>To ensure effective management of the physical equipment, software systems, and data generated at each of our multiple sites and compliance with varying country requirements, Servier determined in 2014 that the best strategy would be to develop a centralized track and trace solution and create a corporate-level serialization team.</p>
<p>We elected to conduct the vast majority of the project (and project management) in-house rather than bring in third-party suppliers. This strategy was selected so that we could develop the necessary internal expertise as rapidly as possible.&nbsp;</p>
<p>Our initial efforts have been focused on compliance with regulations in the many different countries that already require track and trace capabilities, including Argentina, Turkey, China, South Korea and Saudi Arabia, and those with looming deadlines, such as Egypt, Lebanon, Jordan, Taiwan, Russia and Europe (Servier does not sell products in the U.S., but serialization requirements are impending there as well).</p>
<p>A versatile system is being implemented that allows for compliance with different country serialization schemes and ensures full compatibility and connectivity with systems at our CDMO client companies. The program is sponsored by the supply chain director, but also incorporates representatives from marketing, distribution, production, finance and more.</p>
<p>The equipment, software and other program components will be the same at all nine Servier packaging plants to ensure harmonized operations. All employees will also receive the same training in order to accurately operate the new serialization systems and to develop the skill sets needed to quickly make effective decisions. This approach also facilitates technology transfer from one site to another.</p>
<p>One person is responsible for consolidation of all serialization legislation so that the system has the capability to meet the requirements for different countries. In addition, an organization is being put in place to maintain the system and work with all aspects of the businesses that are impacted by the serialization program.</p>
<p>The exposure Servier has to so many countries and their different serialization requirements is a challenge, but also creates opportunities. We make a point of establishing close relationships with the local agencies and regulatory authorities, which gives us an advantage. This access provides us additional information and a greater understanding of the nuances of each regulation and the motivations, goals and expectations of the authorities.</p>
<h4>Pay To Play</h4>
<p><span style="background-color: transparent">There is no argument that serialization requires an initial up-front investment. However, at a minimum it is essential to be compliant with track and trace regulations; careful investments can also lead to the numerous benefits cited above, particularly regarding access to information never previously available to pharmaceutical companies. In this case, you definitely have to be willing to pay to play — as the adage goes, you cannot compete if you don’t have a seat at the table.</span></p>
<p>At Servier, although a significant investment has to be made in serialization and aggregation per line, comprising bar-coding equipment, visions systems, software and line control systems, benchmarking within the industry has revealed that our level of expense per line remains competitive.</p>
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<h4 class="callout-title">Initially, serialization will be required for each sales box; perhaps ultimately it will apply to each unit dose or vial.</h4>
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<h4>CDMOs And Serialization Assurance</h4>
<p>Serialization is still a new concept, and as a result, we are finding that some clients of Servier CDMO are now beginning to ask detailed questions about our track and trace program. But generally, clients are looking for assurance that Servier is, or will be, in compliance with serialization regulations around the world as they come into force. The fact that Servier already has packaging lines equipped for serialization gives our customer confidence that we have the capability to manage the compliance aspects.</p>
<p>At Servier, we have a dedicated quality/validation role within the serialization project to ensure that risk assessments of all systems are conducted. This also includes making sure that all systems are fully audited. We also anticipate significant discussions regarding data exchange and how to control data security. Clients want to be assured that there is no risk of data breaches when products are released to the market. We place emphasis on stress testing and validation reporting. In fact, proof of validation and proof of security are essential. Because responsibility ultimately lies with the marketing authorization holders, including our clients, we do expect to see increasing numbers of questions about serialization going forward.</p>
<h4>Data Management And Opportunities</h4>
<p>In the pharmaceutical industry, serialization will become the new standard for unit traceability. Servier responded early to this issue and is on track to be in compliance with the many track and trace requirements of the countries we serve. We have committed to making security a large component of our serialization program strategy.</p>
<p><span style="background-color: transparent"> It is difficult to know where serialization is ultimately going, but it is patently clear that it will have impacts on the structure of the pharmaceutical industry well beyond compliance requirements, and in particular, regarding the management and analysis of serial number transactional data. </span></p>
<h4><span style="background-color: transparent;font-family: 'Roboto Slab', serif;font-size: 20px">References</span></h4>
<ol>
<li>World Health Organization, “Medicines: counterfeit medicines,” Fact sheet No 275 (Jan. 2010).</li>
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Serialization: The First Steps In Sales Unit Traceability and Data Management