Barriers to African Pharmaceutical Growth: Navigating Regulatory and Procurement Challenges
African Pharmaceutical Growth remains stifled by significant barriers, as highlighted in a recent plenary address at the Conference on Public Health in Africa (CPHIA) 2025 (reported by Health Policy Watch). Dr. Stavros Nicolaou, group senior executive for strategic trade at Aspen Pharmacare and chair of the Pharmaceutical Manufacturers in South Africa, delivered a candid critique of the obstacles hampering local drug manufacturing across the continent. He highlighted how protracted regulatory qualification processes—often lasting six years before market entry—severely undermine the competitiveness of African manufacturers, contrasting this with more efficient timelines achievable elsewhere. Nicolaou argued that these delays, coupled with entrenched import reliance, perpetuate a cycle of underutilization for local producers, despite their proven global reach, as evidenced by Aspen’s operations in 55 markets and leadership in generic anaesthetics outside the United States.
Procurement Flaws Fueling Import Reliance
Transitioning from regulatory frustrations, Nicolaou emphasized that flawed procurement practices by both national governments and international bodies exacerbate the continent’s vulnerability to supply disruptions, a lesson starkly underscored by the COVID-19 pandemic. He pointed out that Africa remains a “serial importer” despite bearing the world’s highest disease burden, with South Africa’s pharmaceutical market—valued at R70 billion (approximately $3.9 billion USD)—exhibiting a trade deficit exceeding 50%, or R39 billion, driven by imports of high-volume essentials like antiretrovirals, vaccines, tuberculosis medicines, and insulins. For instance, despite South Africa hosting 17% of the global HIV population and treating 6.6 million patients, the majority of these critical drugs continue to be sourced from abroad, primarily India, even when local options offer competitive pricing and economic multipliers through job creation and supply chain localization. This import dependency directly obstructs African Pharmaceutical Growth by sidelining domestic capabilities.
Multilateral Efforts Falling Short on Funding
Building on procurement shortcomings, Nicolaou challenged the effectiveness of recent multilateral efforts, including the African Vaccine Manufacturing Accelerator (AVMA), launched in 2024 to raise $1.2 billion over a decade for fill-and-finish vaccine production. While acknowledging AVMA as a foundational step toward the African Union’s (AU) ambitious goal of producing 60% of the continent’s vaccines domestically by 2040—a target announced over four years ago with minimal progress—he deemed the funding “modest” and the mechanism “not fit for purpose,” failing to provide sufficient incentives for sector expansion. He advocated for expedited pooled procurement mechanisms, akin to those used during the pandemic, to harness economies of scale, and criticized the sequential regulatory reviews by African bodies, which lag behind World Health Organization (WHO) assessments by two to three years, adding unnecessary costs and delays.
Three-Point Plan to Ignite Local Production
Nicolaou proposed a pragmatic three-point strategy to catalyze change:
- implementing priority reviews with parallel submissions to WHO standards for faster licensing;
- enhancing subsidies from organizations like Gavi, the Vaccine Alliance, to bolster vaccine production markets; and
- creating a continental procurement pool for vaccines, therapeutics, and diagnostics to drive volume and investment.
He stressed prioritizing fill-and-finish capabilities before backward integration into active substance development, warning that without domestic order flows, companies cannot scale. Such strategies are vital for unlocking true African Pharmaceutical Growth.
Africa’s Disconnect from Global R&D and Benchmarks
These insights align with reports from authoritative bodies highlighting Africa’s structural challenges in health manufacturing. Sub-Saharan Africa imports the majority of its pharmaceuticals, a dependency amplified by regulatory disharmony across 54 countries, which contrasts with more unified systems in regions like the European Union. Localizing vaccine production could save in import costs while generating jobs, yet progress lags due to underinvestment—Africa receives less than 1% of global R&D funding despite comprising 25% of the world’s disease burden. In contrast, India’s success in generic manufacturing, supported by streamlined regulations and export-oriented policies, demonstrates that targeted reforms can transform import-heavy markets into global suppliers, offering a model for African adaptation.
Trade Deficits Straining Health Budgets
These insights carry profound implications for health economics and outcomes research (HEOR), particularly in optimizing resource allocation amid fiscal constraints. By addressing regulatory and procurement bottlenecks, African nations could reduce trade deficits freeing public health budgets for expanded access to treatments for prevalent conditions like HIV/AIDS and tuberculosis, potentially improving health outcomes through reliable local supply chains and lowering per-unit costs via economies of scale. In terms of market access and reimbursement, shifting to pooled procurement could enhance bargaining power with global funders, enabling value-based pricing models that prioritize cost-effectiveness over import premiums.
Localization Incentives in Reimbursement Evolution
Reflecting on broader trends, these barriers intersect with evolving reimbursement frameworks, where international donors increasingly tie funding to localization incentives, as seen in Gavi’s 2023 strategy emphasizing equitable manufacturing in low-income regions. Implementing Nicolaou’s proposals could foster HEOR-driven policies, such as health technology assessments (HTAs) that incorporate local production efficiencies, ultimately supporting universal health coverage goals. Collaborative reforms are needed to position Africa as a hub for innovative, self-reliant health solutions.
