Extent and Causes of the Collapse in the Registration of Innovative Medications in Lebanon: A Mixed-Methods Analysis
Author(s)
Mina Wadih, Sr, MSc, PharmD1, hanadi Nahas, Mrs, EMBA, PharmD2, Maria Rita Lteif, MPH BS in pharmacy3, Rita Karam, PhD4, Fadi EL Jardali, Sr, PHD5, Lou Garrison, PhD6, Soumana Nasser, PharmD7.
1Institut National de Santé Publique, d’Épidémiologie Clinique et de Toxicologie-Liban (INSPECT-LB), Beirut, Lebanon, 2GM, Accesscore, Beirut, Lebanon, 3Accesscore, Beirut, Lebanon, 4Lebanese University, BEIRUT, Lebanon, 5American Univ of Beirut, beirut, Lebanon, 6The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, Seattle, WA, USA, 7Lebanese American University, Byblos, Lebanon.
1Institut National de Santé Publique, d’Épidémiologie Clinique et de Toxicologie-Liban (INSPECT-LB), Beirut, Lebanon, 2GM, Accesscore, Beirut, Lebanon, 3Accesscore, Beirut, Lebanon, 4Lebanese University, BEIRUT, Lebanon, 5American Univ of Beirut, beirut, Lebanon, 6The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, Seattle, WA, USA, 7Lebanese American University, Byblos, Lebanon.
OBJECTIVES: Delays in innovative drug registration across countries, or the “drug approval lag”, can cause inequities in treatment access, thereby worsening patient outcomes. Registration delays hinder the first step in making treatments available, and are often linked to regulatory inefficiencies, constrained healthcare financing, and fragmented decision-making. Since late 2019, Lebanon's health system has suffered a multitude of socioeconomic and political crises, yet their impact on innovative drug registration remains undocumented. This study aimed to measure this impact by comparing Lebanon’s drug approval lag before (2014-2019) and after (2020-2024) the crisis and to develop an interpretive framework exploring the rationale behind an informal policy to delay innovative drug registration.
METHODS: A mixed-methods approach was adopted. Only innovative medications approved by the Food and Drug Administration (FDA) or the European Medicines Agency (EMA) between 2014 and 2024 were included and compared to local registration timelines in Lebanon. In-depth interviews with policymakers, industry leaders, and healthcare providers were conducted to develop the interpretive framework
RESULTS: Findings revealed a dramatic fall in innovative drug registrations post-crisis over these two periods. The proportion of FDA-approved innovative medications registered in Lebanon dropped from 43.6% to 0% and EMA-approved medications dropped from 59.4% to 0%. Pre-crisis, average registration time was under two years; post-crisis, delays are estimated to exceed four years. Our interpretive framework suggests the intermediate effects of delaying innovative drug registration are mainly to control costs and reduce reimbursement pressures on the Ministry of Public Health. However, key stakeholders believe the adverse effects of this delay outweigh the short-term benefits
CONCLUSIONS: Health systems are complex adaptive systems and policies affecting the drug approval lag can lead to delays in access to innovative treatments. As such, evidence-informed policies, supported by health technology assessment, are essential to restore Lebanon’s healthcare standing.
METHODS: A mixed-methods approach was adopted. Only innovative medications approved by the Food and Drug Administration (FDA) or the European Medicines Agency (EMA) between 2014 and 2024 were included and compared to local registration timelines in Lebanon. In-depth interviews with policymakers, industry leaders, and healthcare providers were conducted to develop the interpretive framework
RESULTS: Findings revealed a dramatic fall in innovative drug registrations post-crisis over these two periods. The proportion of FDA-approved innovative medications registered in Lebanon dropped from 43.6% to 0% and EMA-approved medications dropped from 59.4% to 0%. Pre-crisis, average registration time was under two years; post-crisis, delays are estimated to exceed four years. Our interpretive framework suggests the intermediate effects of delaying innovative drug registration are mainly to control costs and reduce reimbursement pressures on the Ministry of Public Health. However, key stakeholders believe the adverse effects of this delay outweigh the short-term benefits
CONCLUSIONS: Health systems are complex adaptive systems and policies affecting the drug approval lag can lead to delays in access to innovative treatments. As such, evidence-informed policies, supported by health technology assessment, are essential to restore Lebanon’s healthcare standing.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR212
Topic
Health Policy & Regulatory
Topic Subcategory
Health Disparities & Equity, Reimbursement & Access Policy
Disease
No Additional Disease & Conditions/Specialized Treatment Areas