Africa Strategy for Pharmaceutical Traceability

Access to quality health products represents a foundational driving element of African Medicines Regulatory Harmonization (AMRH) overall health system functionality. As representatives from national and regional economic communities (RECs) from across Africa, we declare our support and commitment to undertake actions that will improve the availability of quality medicines, ensure greater visibility of products within the supply chain, and enable improved patient care.

Adoption of existing global supply chain standards for pharmaceutical traceability will help achieve these goals through stronger regional regulatory harmonization, global and national interoperability of supply chains and supporting information systems. These measures will also improve patient protection against substandard and falsified (SF) medicines. Pharmaceutical traceability will result in strengthening the health status of our citizens and in turn, improve the socio-economic development of our countries.

In recognition of unique national and regional environments and in full respect for national sovereignty, we signify our intent to explore and move toward implementation of pharmaceutical traceability policies, processes, and systems that will:

• Increase patient safety through mitigating the risk of entry of SF medicines into the legitimate supply chain;
• Provide data-driven visibility of health commodities in national supply chains and stronger interoperability with global supply chains;
• Improve reliable access to essential health commodities through supply chain efficiencies and stock availability; and
• Promote trust in the public and private pharmaceutical sectors and healthcare systems through supply chain security.

As national and RECs, we will work with one another, development partners, and the private sector to:

• Create sustainable governance structures that are country-driven, broadly collaborative, and coordinated across our government agencies;
• Strengthen regulatory policies and procedures – including standardized health commodity labeling guidelines – that reinforce pharmaceutical traceability goals;
• Implement automatic identification and data capture technologies and supporting process improvements to advance supply chain efficiencies; and
• Invest in the underlying health systems infrastructure that enables verification and track and trace of pharmaceuticals through the supply chain.

As part of our national and regional strategic planning:

• We commit to pursuing this agenda through existing regional institutions, such as the African Medicines Agency, to learn and leverage good practices from one another and ensure alignment and scalability both within our countries and across the region.
• We will work with international partners to establish robust, clear and coherent health commodity procurement guidelines that mutually reinforce broader traceability.
• As we embark on this long-term process, we will uphold the value of existing global supply chain standards as an essential tool in the pursuit of global interoperability and seek to avoid parallel and competing structures, striving to harmonize regionally, continentally, and with the rest of the world.

While different national efforts will move at different rates of exploration and implementation, this Call to Action acknowledges and proclaims our intention as participants in the GS1 Africa Regional Healthcare Conference in Lagos, Nigeria to steadfastly pursue pharmaceutical traceability as a key measure toward overall health systems strengthening efforts to ultimately ensure protections of patient.