In association with the World Bank, Global Alliance for Vaccines and Immunisation (GAVI) and The Global Fund.
Almost ten years ago to the day, experts and key stakeholders gathered at Wilton Park to discuss the threat of illicit medicines. Today, substandard and falsified medicines, in Sub Saharan Africa and beyond, continue to pose an acute threat to the health and wellbeing of millions of individuals. In partnership with USAID,
GAVI, The World Bank and The Global Fund, this Wilton Park dialogue identified areas of weakness, explored opportunities for collaboration, and reinvigorated the fight against substandard and falsified medicines.
Key points
• Enhanced coordination is essential among diverse partners including medicines regulators, law enforcement, private sector, customs and health financing agencies.
• Nationally owned and driven efforts comprised of national interagency task forces can demonstrate strong results.
• Consensus built around the multifaceted benefits of national traceability systems based on GS1 global standards.
• The threat of falsified and substandard medicines together with widespread diversion and theft of health commodities severely impact the integrity of health systems and undermines health outcomes.
• Additional public and private resources must be deployed to raise awareness and deploy practical solutions, including stronger prosecutions for crimes related to illicit pharmaceuticals.
Introduction
Access to quality health commodities is a basic part of a functioning national health system. Challenges for health commodity supply chain integrity, equitable access and system failures that existed well before the COVID pandemic were accentuated during a period of global crisis and scarcity. Supply chain theft or ‘leakage’ may represent criminality and corruption on a large scale, which ultimately deprives patients of access to medicines and other health products. Furthermore, the transparent and effective delivery of safe health products is undermined by the persistent problems of illicit medicines that may take the form of deadly falsified or substandard quality products (SF), especially in lower- and middle-income countries. In those countries, an estimated 1 in 10 medicines is substandard or falsified. However, what was once considered a problem limited to developing and low-income countries has now become an issue for all. Both generic and innovator medicines can be falsified, ranging from products for cancer to treatments of pain. In addition, with the exponential increase in internet connectivity those engaged in the manufacture, distribution and supply of substandard and falsified medical products have gained access to a global marketplace. This means that substandard and falsified medical products contribute to antimicrobial resistance and drug resistant infections.
Despite policy dialogue, programmatic expenditure and national engagement, sustainable supply chain integrity solutions continue to elude stakeholders. Practical and widely used solutions, such as health commodity traceability, are widely deployed in developed countries, yet similar approaches are making only slow progress in most less developed regions. Despite significant investments in regulatory harmonization and strengthening, many countries remain vulnerable to supply chain challenges. There is a need for sustained public and private sector support.
1. Coordination across diverse stakeholders
Inter-agency collaboration (both within governments and across international stakeholders) will produce a more robust and multifaceted approach to combatting falsified medicines or diverted/stolen health commodities. No single agency has adequate tools or expertise to tackle pharma crime on their own. A regular coordination mechanism is required to ensure public and private sectors exchange ideas, avoid duplication of efforts and strategically allocate limited resources. Additionally, parties unaccustomed to working together need to move out of siloed activities. Routine collaboration among medicines regulatory authorities, development partners, the private sector, customs and law enforcement must be prioritized.
The Global Steering Committee for Quality Assurance (GSC) was repeatedly mentioned as the existing and effective coordination platform as it already has buy-in and trust among the public and private sectors. The addition of international law enforcement entities will further build up strategic coordination among stakeholders focused on lowerand middle-income regions.
Recommendations
• The Global Steering Committee (GSC) should serve as an ongoing voluntary coalition of medicines regulatory authorities, development partners, private sector and law enforcement to help coordinate across organisations combatting illicit pharmaceuticals.
• Meetings should be regular and ongoing to provide routine coordination opportunities and help stakeholders avoid duplication of efforts.
• International and national agencies must coordinate more effectively with entities outside of their normal network in order to effectively disrupt the trade in illicit medicines.