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Did you know that 1 of 10 medical products in developing countries is substandard or falsified?₁ Or more than a million people die each year from counterfeit drugs?₂ These are just a couple of sobering facts about the global healthcare system and its impact on patient safety. Yet, the good news: Tens of billions of dollars’ worth of counterfeit drugs could be blocked with the help of standards.₃

During the three-day conference, the plenary sessions offered all participants opportunities to hear from notable healthcare leaders from around the world who addressed global health policies, traceability initiatives and real-world implementations for increased patient safety. One major message came through clearly: in Africa and other continents, momentum is accelerating to establish sustainable traceability systems that will help prevent fake medicines from entering the global supply chain.

On day one, keynote speakers Tom Woods, Chairman, Global Steering Committee, The World Bank, and Philippe François, Head of Sourcing & Supply Chain, The Global Fund, addressed why GS1 standards are critical for pharmaceutical traceability throughout the worldwide supply chain. Representing the World Health Organization, François-Xavier Lery, Coordinator for Technologies, Standards and Norms, provided an update on WHO’s policy brief on track and trace.

Moji Christianah Adeyeye, Director General, NAFDAC, outlined the African Medicines Regulatory Harmonisation Initiative (AMRH) and its accomplishments in enabling a harmonised regulatory environment for Africa’s pharmaceutical sector.

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On day two, Dr. Monica Eimunjeze, Director, NAFDAC, shared the agency’s efforts to strengthen supply chain security in Nigeria by embracing traceability. Teddy Berihun, Senior Health Information Systems Adviser, USAID, discussed Ethiopia’s Pharmaceutical Products Traceability Directive that encompasses new policies, technology, standards and processes. Teddy summed up the value of traceability in his elevator pitch, “Traceability enables you to ensure that the right medicine is in the right place.”

Dr. Haytham Abd El-Latiff Sabry, Ministry of Health, reported that GS1 standards are used in Egypt on secondary packages to enable a traceability system. It was noted that the first experiences were collected in a pilot project with 11 manufacturers. From theory to implementation, Rwanda’s strategy to implement traceability was presented by Munyangaju Jose Edouard, Drug and Food Inspection and Compliance Manager, Rwanda Food and Drug Authority and Kaitlyn Roche, Manager for Global Standards & Traceability, USAID Global Health Supply Chain Program.

This motivating discussion was followed by another story of traceability success. F. Hoffmann-La Roche’s Françoise Hirth, Serialisation Coordinator for Europe and EEMEA, shared details around the Falsified Medicines Directive regulation—it’s requirements, governance model and timeline—including its successful implementation by February 2019 and related activities. A major highlight on day two was UNICEF’s on-stage announcement about the recent decision of GAVI, the Vaccine Alliance, and UNICEF to support global standards. As of October 2019, vaccine tenders issued by UNICEF and backed by GAVI financing will require GS1 barcoding standards on secondary packaging by 31 December 2021.

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On the last day of the conference, manufacturers and healthcare providers shared their unique perspectives about ongoing implementation progress to achieve traceability of pharmaceutical products. Gregory Goger, Supply Chain Track and Trace Project Manager, AbbVie, revisited the US Drug Supply Chain Security Act (DSCSA), the milestones, and the progress of manufacturers and wholesalers as they lay the foundation for an interoperable, traceability system of pharmaceutical drugs throughout the U.S.

Françoise Hirth took the stage once again to describe the collaborative efforts of stakeholders to achieve product serialisation, including integrated data systems for traceability throughout Europe. Representing the Nigerian pharmaceutical manufacturer, May & Baker, Yetunde Adigun, Head of Pharma Plant Operations, described the company’s decision and ongoing journey to implement GS1 standards as a foundation for traceability, starting with the Global Trade Item Number® (GTIN®) for unique identification.

Cara Charles-Barks, CEO, Salisbury NHS Foundation Trust, UK delivered a strong conclusion to the day’s plenary, with an update on the trust’s implementation of GS1 standards to enable the automation of business and clinical processes as part of the NHS Scan4Safety Programme . As forerunners in implementing GS1 standards, NHS trusts participating in Scan4Safety are realising demonstrable benefits in their hospital operations and for their caregivers and patients. On behalf of the Salisbury trust, Cara confirmed the hospital’s significant advances in safety and efficiency—made possible with GS1 standards.

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1. World Health Organization. (28 November 2017). 1 in 10 medical products in developing countries is substandard or falsified. Retrieved from https://www.who.int/news-room/detail/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified
2. Southwick, Natalie. (6 October 2019). Counterfeit Drugs Kill 1 Mn People Annually: Interpol. Retrieved from https://www.insightcrime.org/news/brief/counterfeit-drugs-kill-1-million-annually-interpol/
3. McKinsey. (October 2012). Strength in unity: The promise of global standards in healthcare. Retrieved from https://www.gs1.org/docs/healthcare/McKinsey_Healthcare_Report_Strength_in_Unity.pdf

An incredibly inspirational moment for all participants was when Professor Adeyeye issued a call to action for the Africa Strategy for Pharmaceutical Traceability. In response, 25 African regulatory authorities and six health financing and donor organisations joined her on stage to sign the Call to Action, proclaiming their commitment to pursue pharmaceutical traceability by adopting global supply chain standards.

Relevant for beginners and experts, the panel session, “Establishing traceability: the building blocks,” provided an in-depth view of the major components that make-up a traceability system. To date, more than 50 countries have deployed regulations that address traceability. While the number of countries and regulations is increasing, the time window for deployment continues to shrink—driving the need for practical approaches to traceability implementation.

To kick off the panel discussion, Françoise Hirth started with traceability “basics” and how to lay a traceability foundation with GS1 standards. She shared the “big picture” view of full, inter-company traceability, complete with an explanation about internal traceability processes and benefits.

Dirk Van den Wouwer, Senior Manager, EMEA Deployment Digital Identification and Traceability, Johnson & Johnson Supply Chain, continued by explaining the details behind GS1 standards used in traceability. He addressed the regulations deployed globally, to date, and the importance for taking action. Dirk provided participants with seven pragmatic recommendations to get started with traceability implementation.

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When building a traceability system, it’s “all about the data.” GS1 standards enable the capture of data to make it available in an automated and secure way for use by healthcare stakeholders throughout the supply chain—allowing for products to be efficiently tracked and traced. What types of data should be collected and how? These questions and more were explored in the panel discussion, “Databases and infrastructure for traceability.”

Gregory Goger with AbbVie and Dirk Van den Wouwer, Johnson & Johnson Supply Chain, hosted this highly informative panel. Gregory examined the different types of data and how to determine the amount of data that should be collected to help solve issues like counterfeit detection. Two different types of traceability models were compared—point of dispense verification and full track and trace.

In his discussion, Dirk stressed the complex nature of working with multi-country regulations, assessing how traceability will impact different parts of a business and why traceability requires integrated processes and systems. He reviewed Europe’s point of dispense verification model and the phased rollout across 30 countries. His clear message for regulators: Don’t deviate from the standard!

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USAID is leading worldwide efforts to strengthen pharmaceutical systems by implementing GS1 standards for traceability and patient safety. In addition to the existing guidelines for their suppliers, USAID is working with other healthcare stakeholders on a new initiative called TraceNet.

USAID speaker Comfort Ogar, Principal Technical Advisor, MTaPS (Me3dicines, Technologies and Pharmaceutical Services) talked about the USAID programmes and initiatives focused on supporting regulatory bodies across Africa. Clerisse Lemke with the President’s Malaria Initiative (PMI) from USAID explained the progress made so far with TraceNet. This new initiative is being done in a collaborative forum to agree on the best approach to use GS1 standards to support traceability for long-lasting insecticidal nets (LLINs).

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You cannot manage what you cannot see—a truly accurate statement about data in the supply chain. Speakers discussed the data management and governance systems in Nigeria, Malawi, Australia and Europe. Interoperability can be achieved and the complexity of supply chains can be simplified with the use of GS1 standards-based processes. This dynamic discussion showed the value of standardised master data management in healthcare systems.

Alan Bornbusch, Division Chief of the Commodity Security and Logistics Division, and Stewart Stremel, Enterprise Architect, with USAID introduced the Global Family Planning Visibility & Analytics Network (Global FP VAN)—a centralised data management system for order/shipment management of pharmaceuticals and medical implants in Nigeria and Malawi. The Global FP VAN leverages GS1 standards-based product data provided by four manufacturers and two procurers, USAID and UNFRA . Stewart described how manufacturers to achieve a harmonised platform for publishing and managing complete, accurate product data use the Global Data Synchronisation Network (GDSN®) and other GS1 standards. Procurers and healthcare facilities then use these country-specific product catalogues for order transactions. Ugbede Abu, Supply Chain Advisor, USAID Malawi, provided the country view of how the national product catalogue delivers a “single source of truth” for Malawi’s healthcare provider. Abu tweeted, “GS1 standards, a potential game changer for Malawi. Malawi is open to international standards to improve agility, adaptation and alignment on supply chain.”

Tania Snioch, Director, Healthcare, GS1, presented Australia’s journey to a National Product Catalogue as the way for suppliers to provide standardised and accurate product data electronically to health providers. Her eight recommendations provide sound advice for those starting on the data management journey. Dirk Van den Wouwer, Johnson & Johnson Supply Chain, concluded with his discussion about the importance of using quality, standardised data in traceability processes, especially when implementing regulations from different countries.

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As the conference ended, keynote speaker Idowu Adebiyi, COO, Eye Foundation Hospital Group, presented the significant opportunities in Africa’s healthcare system for collaboration, innovation, learning, standardisation and a focus on patients as the key beneficiaries. And closing remarks by Tom Woods with The World Bank reminded all participants: “You are all ambassadors!”

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As this conference’s charity, the North East Children’s Trust (NECT) offers a safe haven for orphaned children, offering them a home for restoration, hope and growth. More than 50,000 children in Nigeria have been deprived of a normal childhood due to the Boko Haram insurgency. Dupe Killa-Kafidipe, Chief Strategy Officer, shared how NECT is designed to aid the entire cycle of care for these children: to nuture, renew and empower. For each completed conference survey, GS1 Healthcare contributed to this very worthy Nigerian cause. In response, the children sent a video of thanks to GS1 and all conference participants.

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