Preface

The Personal Origins of my proposed Social and Clinical  Model of Exploitation with design of a new international legal instrument:

                     THE AFRICAN UNION ABS-DP TREATY

The new international economic and legal framework proposed in this  academic paper—the Social and Clinical Model of Exploitation (SCME)—is my  epistemological response to the systemic exclusion of Central,Eastern, Southern and Western Africa observed in the contemporary global economic order. My activism trajectory, dedicated to establishing sovereign frameworks for African food security and public health—exemplified by the Complete Maize Meal Cooking Encyclopedia and the Humanitarian COV-19 Vaccines initiative—has provided a distinct vantage point on these exclusionary mechanisms.

Specifically, the systematic rejection of African-led commercial initiatives by established Western financial instruments serves as a critical case study. The refusal of British International Investment (BII) to fund my  "Africa Auction TV"—a woman-led venture designed to decentralise trade logistics—is not merely an anecdotal commercial failure. Instead, it functions as a micro-exemplar of the macro-structural barriers documented by the British Business Bank (2024) and the UK Parliament (2023). These institutions create a "glass ceiling" of capital access that disproportionately affects African female entrepreneurs, thereby preventing the organic development of continental industrial capacity.

Consequently, we propose to demonstrate that existing bilateral and market-based solutions are insufficient. To overcome these entrenched geopolitical and financial blockages, African states must pivot toward supranational instruments. The proposed SCME and the AU ABS-DP Treaty are designed to bypass these barriers, moving the continent from a degrading and humiliating state  of extractive dependency to one of generative, continental-led Health Sovereignty.

My proposal to achieving African Health Sovereignty: Leveraging the Central African Pharmacopoeia to Reduce Female Mortality

Abstract

I formally propose a sophisticated Social and Clinical Model of Exploitation (SCME) centred on the African Union (AU). It pivots the pharmaceutical research paradigm in the Congo Basin from extractive biopiracy to Continental Health Sovereignty (AHS). The model introduces the design of a new international legal instrument—the AU Access, Benefit-Sharing, and Drug Production (AU ABS-DP) Treaty—to mandate technology transfer and local manufacturing across key member states (South Africa, Nigeria, Zimbabwe). My formal international social theory model proposal to the African Union and Central Africa Governments MInistries of Agriculture  defines a three-product portfolio (PanaVirex-CAF, CongoQuine-ML, AfriPulmo-LRI) derived from the Central African pharmacopoeia to target HIV/AIDS, Malaria, and LRI, the leading causes of female mortality. The SCME culminates in a Pan-African Resilient Logistics Model (PARLM) designed to achieve a minimum 50% reduction in African woman mortality attributed to these diseases within a 15-year time frame by guaranteeing affordable, sovereign-controlled drug access.

Chapter I: Legal and Diplomatic Tools for AU Health Sovereignty

1. Why do I propose a new international legal instrument or a new Supranational Regulatory Design

The current international legal architecture governing genetic resources, principally the Nagoya Protocol (NP), has proven inadequate for securing African health security. The Protocol’s reliance on a fragmented, bilateral Access and Benefit-Sharing (ABS) model privileges the negotiating power of multinational pharmaceutical entities over individual states. This asymmetry results in legal ambiguity, prohibitive transaction costs, and "benefits" that rarely materialise as substantive Industrial Capacity Transfer (ICT). Consequently, the status quo perpetuates a neocolonial dynamic where African biological data is extracted for external valorisation, leaving the continent dependent on re-imported, prohibitively expensive therapeutics.

2. What led me to design the proposed  African Union ABS-DP Treaty

To institutionalise African Health Sovereignty (AHS), my formal presentation proposes the ratification of the African Union Access, Benefit-Sharing, and Drug Production Treaty (AU ABS-DP Treaty). This instrument is founded on the doctrine of Pooled Continental Sovereignty (PCS), a radical departure from the Westphalian model of individual state rights. Under PCS, member states delegate their sovereign authority over medicinal Genetic Resources (GR) to a centralised supranational body: the AMA Bioprospecting Directorate.

2.1 Key International Law Principles and Mechanisms

Sovereignty Re-Conceptualisation (PCS)

The doctrine of Pooled Continental Sovereignty establishes a Multilateral Access Regime, effectively creating a "single counter-party" for external entities. By aggregating control over the Congo Basin’s biodiversity, the AU gains the requisite diplomatic leverage to compel external pharmaceutical partners into equitable engagement. This shift transforms sovereignty from a passive right of exclusion into an active instrument of industrial negotiation.

Mandatory Benefit-Sharing (Infrastructural Justice)

The Treaty introduces an Automatic Equity-Sharing Clause (ESC), which legally mandates the AU as a non-dilutable equity partner in any Intellectual Property (IP) derived from continental resources. Furthermore, the Treaty incorporates a Time-Bound Patent Forfeiture Clause. This provision compels the complete transfer of manufacturing rights, technical dossiers, and cell-line data to an AU-designated consortium either after a ten-year exclusivity period or upon the achievement of defined public health benchmarks.

Clinical Governance and Epistemic Decolonisation

Access to African GR is contingent upon adherence to the Pan-African Clinical Trials Registry (PACTR). The Treaty stipulates that Phase II and III clinical trials must be conducted predominantly within African member states. This requirement ensures that clinical data reflects local epidemiological realities and forces the transfer of high-level clinical research capacity to local institutions.

Strategic Industrial Diplomacy

The "Exclusivity for Production" Clause mandates that external partners must manufacture the finished pharmaceutical products on the continent. This is coupled with a predefined Cost-Plus pricing model, which decouples the price of essential medicines from global market volatility, ensuring a reliable and affordable supply for the African populace.

Chapter II: Clinical Profiling of Central African Forest Pharmacopoeia vital to reducing African Women high mortality rates

This section profiles specific phytochemical scaffolds identified within the Central African flora. These compounds exhibit high potency against the target disease burden and offer novel molecular mechanisms capable of circumventing existing drug resistance profiles.

1. Phytochemical Classes and Target Mechanisms

1.1 Alkaloids (Target: HIV/AIDS & Malaria)

Nitrogen-containing alkaloids represent a critical frontier in antiviral therapy. Specifically, Isoquinoline and Indole alkaloids have demonstrated efficacy as inhibitors of HIV-1 Reverse Transcriptase (RT) and Integrase. These compounds offer a vital second or third-line therapeutic option for patients exhibiting resistance to standard Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs). In the context of malaria, quinoline-like alkaloids interfere with Plasmodium falciparum heme detoxification and DNA transcription mechanisms, retaining efficacy where synthetic analogues fail.

1.2 Flavonoids and Phenolics (Target: LRI & Immunomodulation)

The pharmacopoeia’s flavonoid and poly-phenolic profiles offer potent antioxidant and anti-inflammatory properties. Their clinical utility lies in Cytokine Modulation; specifically, the suppression of pro-inflammatory cytokines such as IL-6 and TNF-$\alpha$. This mechanism is clinically pivotal as an adjunct therapy for Lower Respiratory Infections (LRI) in immunocompromised (HIV+) women, mitigating the "cytokine storm" that frequently precipitates sepsis, Acute Respiratory Distress Syndrome (ARDS), and mortality.

1.3 Terpenoids and Quinones (Target: Malaria Resistance)

Terpenoids act via Metabolic Interference, disrupting the Plasmodium parasite's Fatty Acid Synthesis (FAS II) pathway. This mechanism is distinct from the peroxide-bridge activation of Artemisinin, making terpenoid derivatives robust candidates for treating strains of malaria that have developed resistance to current Artemisinin Combination Therapies (ACTs).

The research imperative dictates the immediate acceleration of Bioassay-Guided Fractionation and Quantitative Structure-Activity Relationship (QSAR) modelling to refine these scaffolds into standardised, cGMP-compliant Active Pharmaceutical Ingredients (APIs).

Chapter III: International Supply Chain Design for Mortality Reduction

To demonstrate the  clinical potential in mortality reduction, my formal proposal to the African Union outlines the Pan-African Resilient Logistics Model (PARLM). This four-hub, multi-modal supply chain is optimised for thermal stability and speed, bypassing the infrastructural bottlenecks that historically impede drug distribution.

1. The Pan-African Resilient Logistics Model (PARLM)

• Hub 1: The Congo Basin Harvesting Hubs: Managed by Community Forest Entities (CFEs), these decentralised hubs ensure sustainable harvesting and immediate primary stabilisation of raw material, mitigating the risk of single-source supply failure.

• Hub 2: Central Processing Hubs (ZAF & NGA): These industrial nodes are responsible for API extraction and purification. The model leverages South Africa's (ZAF) advanced chemical engineering capacity for complex synthesis and Nigeria's (NGA) high-volume manufacturing base for mass-market formulation.

• Hub 3: Regional Distribution Hubs (ZWE): Located strategically for SADC/COMESA distribution, these hubs manage packaging, Quality Control (QC), and the maintenance of a mandatory 6-month Strategic Buffer Stock, financed by the AU to insulate the continent from geopolitical or pandemic supply shocks.

• Hub 4: The Last-Mile Clinical Network (LMCN): This network ensures direct delivery to AU-mandated Community Health Posts (CHPs), eliminating the "urban bias" of current distribution systems and reaching the rural populations where female mortality rates are highest.

2. Achieving the 50% Mortality Reduction Metric

The target of a 50% reduction in mortality is achievable through the synergistic effects of the my proposed Africa Health Sovereign Portfolio:

1. Price Parity (PanaVirex-CAF): Capping costs below $7.00/month eliminates economic barriers to adherence for HIV-positive women.

2. Resistance Mitigation (CongoQuine-ML): Novel mechanisms of action restore treatment efficacy in regions with high multi-drug resistance.

3. Co-Morbidity Management (AfriPulmo-LRI): Adjunct therapy directly addresses the secondary inflammatory causes of death in HIV/LRI co-morbid patients.

3. Sustainability and the SCME Feedback Loop

The SCME operates as a closed economic loop. A statutory levy of 10% of wholesale revenue is automatically reinvested into Hub 1 (Harvesting Hubs). This funding supports agri-silviculture programs and local healthcare infrastructure, ensuring that the exploitation of natural resources perpetually reinforces both environmental conservation and public health provision.

Chapter IV: Pan-African Pharmaceutical Product Portfolio and Economic Viability Assessment

In the lines of my commitment to African Women Gender Empowerment  would like to now  delineate my proposed African Union Pharmaceutical  Product Portfolio and the division of industrial labour, assigning production roles based on national regulatory maturity and industrial capacity. 

1. Rationale for Continental Manufacturing Hubs

Partner State

Strategic Rationale

Assigned Role

South Africa (ZAF)

Highest cGMP maturity; proven expertise in complex ARV and advanced formulation.

Primary API Derivatization and Advanced Formulation Hub

Nigeria (NGA)

Largest market; extensive existing manufacturing base for high-volume production.

Primary Phytomedicine Conversion and Tablet Encapsulation Hub

Zimbabwe (ZWE)

WHO ML3 regulatory status; strategic location for SADC/COMESA regional distribution.

Secondary Formulation and Regional Distribution/Packaging Hub

2. The African Union -Sovereign Product Portfolio and Budget

The pricing strategy utilises a Cost-Plus Viability model. By eliminating external IP royalties via the Treaty’s Patent Forfeiture Clause, the target factory prices are set significantly below global market rates.

Product

Clinical Target

API / Compound Class

Production Hub

Target Factory Price (PPM/TC)

PanaVirex-CAF

HIV/AIDS

Congo Isoquinoline Analog (CIA)-001 (Alkaloid)

South Africa (ZAF)

$5.00 – $7.00 per month

CongoQuine-ML

Malaria

Cryp-Falcifarin-10 (Quinoline/Terpenoid FDC)

Nigeria (NGA)

$1.50 – $2.50 per treatment course

AfriPulmo-LRI

LRI Adjunct

Flavo-Immunolin (Flavonoid Complex)

Zimbabwe (ZWE)

$2.50 – $4.00 per treatment course

Time-Bound Strategic Implementation Plan (TSIP)

The SCME execution strategy follows a strict 15-year timeline, structured to transition the continent from legal mobilisation to full pharmaceutical autonomy.

Phase

Duration

Core Objective

Key Deliverables & Milestones

Lead AU Body

Phase I: Legislative & Foundational Mobilisation

3 Years (Y1–Y3)

Establish the supranational legal and administrative authority.

Ratification of the AU ABS-DP Treaty by 50% + 1 member states. Establishment of the AMA Bioprospecting Directorate and 5 initial CFE pilot sites.

AU Commission, AMA, AFRICA CDC

Phase II: Pre-Clinical & Industrial Feasibility

4 Years (Y4–Y7)

Validate the clinical potential and achieve cGMP industrial readiness.

Clinical Milestone 1: Final selection, optimisation (QSAR), and completion of Pre-Clinical Trials for PanaVirex-CAF and CongoQuine-ML. Industrial Milestone 1: ZAF and NGA sites achieve cGMP readiness for API production.

AMA, Lead AU Partner States (ZAF, NGA)

Phase III: Clinical Translation & Supply Chain Construction

4 Years (Y8–Y11)

Conduct large-scale trials and build the resilient logistics backbone.

Clinical Milestone 2: Completion of Phase II/III Trials (using PACTR) for all three products. Establishment and operational testing of the Regional Distribution Hub (ZWE) and the first 100 LMCN sites.

PACTR, AMA, Partner States (ZWE)

Phase IV: Market Entry & Scale-Up Autonomy

2 Years (Y12–Y13)

Achieve initial regulatory approval and market penetration.

Regulatory Milestone: AMA grant of Continental Marketing Authorisation (CMA) for PanaVirex-CAF and CongoQuine-ML. Market Milestone: Target 30% market share of target patient population across the 5 pilot regions.

AMA, AU Commission

Phase V: Mortality Impact & IP Sovereignty

2 Years (Y14–Y15)

Execute the final IP transfer and verify the public health outcome.

Sovereignty Milestone: Activation of the Patent Forfeiture Clause transferring IP to the AU consortium. Public Health Milestone: Independent verification of a minimum 50% reduction in female mortality attributed to the target diseases within the LMCN network areas.

Independent External Review Board (IERB)

Conclusion of my Formal Proposal to the African Union

My formal proposal demonstrates the structural and chronological viability of the Social and Clinical Model of Exploitation (SCME). By integrating high-level geopolitical strategy—specifically the AU ABS-DP Treaty—with advanced pharmaceutical science and a resilient logistical model (PARLM), the project transforms the Congo Basin's biodiversity from a source of geopolitical vulnerability into a strategic asset for continental public health. My formal proposal to the African Union offers a clear, accountable, and sovereign pathway to dramatically reduce the mortality burden on African women,fulfilling one of African Union promises during this 2025 G20 Summit of working for full African Health Vaccine Sovereignty.

Ariane Denise Brito

www.arianebritoanalysis.org

 Bibliography 

African Union. Treaty for the Establishment of the African Medicines Agency (AMA). Addis Ababa: African Union, 2019.

Brito, Ariane. "Humanitarian COV-19 Vaccines."  https://sites.google.com/view/humanitarian-cov-19-vaccines-c/home.

Brito, Ariane. "The Complete Maize Meal Cooking Encyclopedia." Ariane Crafts, New York , 2025.

British Business Bank. "Closing the gender investment gap for female founders in the UK." British Business Bank, 2024. https://www.british-business-bank.co.uk/business-guidance/guidance-articles/finance/closing-the-gender-investment-gap.

Chibale, Kelly, et al. "Natural products in the discovery and development of new antimalarials." Journal of Ethnopharmacology 158, no. 1 (2014): 208-226.

Diederich, Francois. "The role of the African Union in promoting local pharmaceutical manufacturing and health sovereignty." The Lancet Global Health 10, no. 5 (2022): e753-e754.

Okereke, C., and G. N. Emeh. "Governing access and benefit sharing of genetic resources in Africa: Towards a harmonized continental approach." Environmental Science & Policy 69 (2017): 110-118.

UK Parliament. "Written evidence submitted by Mastercard [FEN0020]." Committees, UK Parliament, 2023. https://committees.parliament.uk/writtenchevidence/138896/pdf/.

WHO. Assessment of National Regulatory Authorities: Global Benchmarking Tool Report. Geneva: World Health Organization, 2023.