GLOBAL REGULATORY ASYMMETRIES AND THE STRUCTURAL DRUG LAG: TIME TO MARKET AUTHORIZATION IN CÔTE D’IVOIRE
Author(s)
Vassiki Sanogo, BA, MSc, PhD1, Madhusudan Kabra, MD2;
1Integrity Analytics, HEOR | Data Scientist, Haines City, FL, USA, 2MK Global Consultants Ltd, Bushey, United Kingdom
1Integrity Analytics, HEOR | Data Scientist, Haines City, FL, USA, 2MK Global Consultants Ltd, Bushey, United Kingdom
OBJECTIVES: To quantify delays in market authorization and product life span for new chemical entities and biologics in Côte d’Ivoire, and to evaluate whether establishment of the Agence Ivoirienne de Régulation Pharmaceutique (AIRP) altered time to acquisition (TTMA) across four therapeutic areas.
METHODS: We performed a longitudinal registry analysis of AIRP records current to 8 January 2026. From 6,694 therapies we extracted oncology, diabetes, stroke, and infectious disease entries. Key variables included marketing authorization identifiers, acquisition and expiration dates, INN, and MAH country. The date of first global approval was obtained from public sources. The primary outcome was TTMA in Côte d’Ivoire. Analyses included descriptive statistics, Kaplan-Meier survival estimates comparing pre- and post-AIRP periods, and Cox proportional hazards models with and without inverse probability of treatment weighting (IPTW) to adjust for observable confounding.
RESULTS: Post-AIRP medians increased across all areas. Diabetes TTMA rose from 6 to 12 years; infectious disease from 43 to 57 years; oncology from 14 to 29 years; and stroke from 23 to 46 years. Kaplan-Meier curves showed consistent rightward shifts post-AIRP. Cox models indicated large, therapy-specific changes in hazard of acquisition: Diabetes post-AIRP HRs were markedly elevated (exp(coef)≈24-27), oncology HRs increased (≈3.0), stroke HRs modestly increased (≈1.1-1.3), while infectious disease showed reduced hazard estimates (exp(coef)≈0.04-0.11), reflecting extreme delays and censoring patterns. IPTW adjustment produced similar directional effects, supporting robustness to measured confounding.
CONCLUSIONS: Contrary to expectations, AIRP establishment coincided with lengthened drug lag across major therapeutic areas in Côte d’Ivoire. Infectious disease therapies experienced the most severe structural delays, often spanning decades. Findings implicate regulatory asymmetries, resource constraints, and market incentives as drivers of delayed access. Policy reforms emphasizing regulatory reliance, expedited pathways, regional harmonization, and manufacturer engagement are urgently needed to shorten TTMA and improve equitable access to essential medicines.
METHODS: We performed a longitudinal registry analysis of AIRP records current to 8 January 2026. From 6,694 therapies we extracted oncology, diabetes, stroke, and infectious disease entries. Key variables included marketing authorization identifiers, acquisition and expiration dates, INN, and MAH country. The date of first global approval was obtained from public sources. The primary outcome was TTMA in Côte d’Ivoire. Analyses included descriptive statistics, Kaplan-Meier survival estimates comparing pre- and post-AIRP periods, and Cox proportional hazards models with and without inverse probability of treatment weighting (IPTW) to adjust for observable confounding.
RESULTS: Post-AIRP medians increased across all areas. Diabetes TTMA rose from 6 to 12 years; infectious disease from 43 to 57 years; oncology from 14 to 29 years; and stroke from 23 to 46 years. Kaplan-Meier curves showed consistent rightward shifts post-AIRP. Cox models indicated large, therapy-specific changes in hazard of acquisition: Diabetes post-AIRP HRs were markedly elevated (exp(coef)≈24-27), oncology HRs increased (≈3.0), stroke HRs modestly increased (≈1.1-1.3), while infectious disease showed reduced hazard estimates (exp(coef)≈0.04-0.11), reflecting extreme delays and censoring patterns. IPTW adjustment produced similar directional effects, supporting robustness to measured confounding.
CONCLUSIONS: Contrary to expectations, AIRP establishment coincided with lengthened drug lag across major therapeutic areas in Côte d’Ivoire. Infectious disease therapies experienced the most severe structural delays, often spanning decades. Findings implicate regulatory asymmetries, resource constraints, and market incentives as drivers of delayed access. Policy reforms emphasizing regulatory reliance, expedited pathways, regional harmonization, and manufacturer engagement are urgently needed to shorten TTMA and improve equitable access to essential medicines.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
RWD126
Topic
Real World Data & Information Systems
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory), SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity), SDC: Infectious Disease (non-vaccine), SDC: Oncology, STA: Multiple/Other Specialized Treatments