Analysis on the Regulatory Frameworks of Vaccine Manufacturing and Distribution in Ghana

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Alfred Addy
Shadrach Asamoah-Atakorah
Nana Betse Morson
Godfrey Konnyebal
Margaret Henneh Arhin

Abstract

Objective: Analyze Ghana's vaccine regulations framework to identify strengths, limitations and policy refinement opportunities regarding manufacturing/distribution.


Method: Structured CRuPAC legal review model encompassing comparative assessment of Food/Drugs Act and Public Health Act provisions based on identified criteria; investigation of rules, historical applications and guiding principles; counterargument evaluation; advice formulation integrates relevant case laws, specific legislation sections and academic literature.


Results: Robust ecosystem found but with bureaucracy/access constraints; precedent supports compulsory vaccination upholding safety/welfare principles.


Conclusions & Recommendations: Balance safety considerations and industrial growth incentives; expedite registration pathways for proven developers, offer tax incentives for local producers, leverage compulsory licensing during shortages; increase healthcare budgets for system strengthening.


Contributions: Granular legal analysis establishes evaluative baseline; structured CRuPAC assessment elucidates reform gaps; expansive literature review provides contextualization; reasoned interpretation of vague provisions based on legal theory; tailored, evidence-based recommendations.


Significance: Highlights precedents, incentives and measures to optimize policies for regulators/manufacturers/legislatures regarding emergency preparedness.

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