Deepening Cooperation on Medical Goods and Services Trade
Box 3.5
129
Traceability and illicit trade in medical products in Africa
Illicit health products plagued many low- and middle-income countries before the COVID-19 pandemic, and challenges with supply chain integrity and transparency during the crisis made matters worse. The simple fact that no single country in all of Sub-Saharan Africa has a functioning traceability system may have cost many non-COVID-19 deaths indirectly attributable to the pandemic (Heuschen et al. 2021). The World Bank–hosted Global Steering Committee (GSC) for Quality Assurance launched broad-based public and private collaboration to help countries initiate global standards for medicines traceability. The onset of the pandemic heightened the focus and created new momentum around protecting the COVID-19 vaccines from theft and falsification through the rapid development of a verification system. Simple product barcoding and smartphone scanning apps offered a practical tool for the near term. This initial building block, while far short of the traceability goals embraced by some 25 African countries as part of the “Lagos Call to Action,” raised critical awareness and galvanized support within the COVID-19 Vaccines Global Access (COVAX) Facility.a For many African countries, the pandemic exposed weaknesses in the international trading system for health commodities. Without manufacturing capacity for essential medicines, let alone for COVID-19–related health products, poorer countries could only wait. Even as South Africa and others begin to fend for themselves with new vaccine manufacturing capacity, the basic structures that will ultimately determine the survivability of the infant pharmaceutical industry require parallel development efforts. Namely, medicines regulatory harmonization must advance across the dozens of small markets that make up Africa’s regional economic communities. Harmonized regulations and processes will support an overall recognition that raising the regulatory standard, while difficult and incremental, will enhance trade competitiveness and help Africa better serve its own billion consumer market. Shared national approaches to health product traceability are part and parcel of the access to safe and effective medicines imperative for lower-income regions like Africa. Already, every medicine manufactured in India bears a global standard–compliant two-dimensional barcode that contains critical data about the product. As those products cross borders and land in regions like Europe, that electronic data moves with the product and offers enhanced supply chain integrity and visibility. But when that product moves across borders and into a region like Africa, the lights go out—there is no attempt to follow the data. As a consequence, pharmaceutical manufacturers within Africa cannot hope to compete globally, nor can they provide quality assurance for their products to the potential customers in their neighboring country. Legitimate health products imported into the region suffer the same fate. They enter opaque and highly fractured supply chains that lack traceability and therefore cannot guarantee the integrity of the health care products. Fortunately, African regulatory leaders are embracing the health product traceability challenge. Nigeria, Africa’s largest consumer market, is not only helping to lead COVID-19 vaccine verification efforts but is also fully committed to the value of a national medicines traceability system through the National Agency for Food and Drug Administration and Control (NAFDAC). When it comes to quality health product access, there are few more tangible or more practical steps that lower-income regions like Africa could take than to advance common regulatory policies, including medicines traceability. Predictable, transparent, and stringent regulatory oversight promotes efficient trade in health commodities. Knowing where a product was manufactured, which supply route it traveled, and how it came to the patient will save lives. The COVID-19 pandemic did not create this lesson but it certainly reinforced it. a. The COVAX Facility is a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines, co-led by the Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI), the World Health Organization (WHO), and the United Nations Children’s Fund (UNICEF).
