81315954-Support to strengthening regulatory harmonization and pooled procurement for increased availability of medical commodities in the EAC

The East African Community (EAC) region faces significant challenges in ensuring access to affordable and quality-assured medicines, a critical factor for public health security. Many Partner States import between 70% to 90% of their health commodities. This heavy dependence on imports strains public finances and weakens healthcare resilience, especially during global health crises like the COVID-19 pandemic when supply chains are disrupted. Strengthening local capacity is crucial to improving healthcare delivery and achieving the Sustainable Development Goals (SDGs), particularly SDG 3 (Good Health and Well-being) and SDG 5 (Gender Equality).

Limited availability and affordability of quality-assured Sexual and Reproductive Health (SRH) commodities further complicate the region's healthcare landscape. This gap negatively impacts maternal and neonatal health outcomes and heightens the risk of outbreaks of sexually transmitted infections such as HIV, Hepatitis B, and HPV. Improved access to SRH services and commodities would contribute to reducing maternal and neonatal mortality rates and promote better sexual and reproductive health outcomes in the EAC.

The region's vulnerability to infectious disease outbreaks, such as Mpox, Marburg, and Ebola, have heightened the need for a faster, coordinated emergency response. While recent improvements in stock management, forecasting, and collaboration with international partners have strengthened preparedness, challenges remain. Ensuring better access to essential health commodities, including those for SRHR, is vital in both emergency and non-emergency settings.

In response to these challenges, the European Union (EU) and the German Federal Ministry for Economic Cooperation and Development (BMZ) jointly aim for enhancing the availability of healthcare commodities in the EAC region. Both contributions align with the Team Europe Initiative on Sexual and Reproductive Health (TEI SRHR) and contribute to gender equality efforts.

The program"s primary objectives are: 1. a faster response to outbreaks of communicable diseases which have the potential to develop to epidemics or even pandemics, and 2. improved availability of commodities to address the population"s sexual and reproductive health commodity needs.

The EAC region continues to face persistent healthcare challenges that compromise its ability to respond effectively to disease outbreaks and ensure sustainable access to essential medical commodities. These challenges include: · Limited Procurement Capacity: Governments and Health Ministries in EAC countries often face budgetary constraints and competing priorities, the result of which is insufficient allocation of funds for SRH commodities and commodities relevant for managing disease outbreaks. The absence of a fully functional coordinated procurement mechanism among EAC Partner States is likely to contribute to stockouts, inefficiencies and higher costs. · Regulatory Fragmentation: Regulatory systems functioning below WHO Maturity level 3 with diverse regulatory pathways not only result in delays in product approvals but discourage pharmaceutical manufacturers from investing in new pipeline commodities. This results in high prevalence of substandard and falsified medical commodities circulating within the EAC. Fragmented certification procedures across EAC Partner States and the absence of mutual recognition exacerbate challenges in ensuring the quality and safety of medical commodities. · Ineffective Health Supply Chain Management: Inefficient supply chain systems, often characterized by shortage of trained staff and robust data-driven supply chain management hinders the effective acquisition and distribution of medical commodities. · Local Production Constraints: The region's heavy reliance on imported commodities leaves it vulnerable to supply chain disruptions and price volatility. Insufficient local manufacturing capacities, including heavy reliance on product ingredients, further exacerbate these issues, making the development of regional production capabilities a priority for sustainable and affordable access to health commodities.

To overcome these obstacles, the EAC is working to harmonize regulatory processes and establish a Pooled Procurement Mechanism (PPM). By placing bulk orders collectively, EAC Partner States can reduce stockouts, enhance efficiency, and achieve better pricing for essential commodities. The EAC Secretariat serves as the political partner for this initiative, with key involvement from the Social Sectors and Productive Sectors Directorates. The Principal Health Officer (PHO) within the EAC Health Department is a primary contact, alongside the Regional Center of Excellence for Vaccines, Immunization, and Health Supply Chain Management (RCE-VIHSCM). The RCE-VIHSCM plays a vital role in coordinating pooled procurement and harmonizing regulatory procedures in the EAC.

Other critical partners include national and regional regulatory authorities, pharmaceutical manufacturers, and non-state actors such as private sector organizations, non-governmental organizations, and women and youth advocacy groups. Ultimately, the EAC population will directly benefit from enhanced access to quality-assured healthcare commodities and improved epidemic preparedness.