Title: The Impact of Patent Extensions in Access to Pharmaceuticals
Subject Classification:  Healthcare, Law and Legal Ethics, Business and Management  
BIC Classification: MBP, LA, KJ
BISAC Classification: LAW050020, MED071000, BUS070130
Binding: Hardback, eBook
Planned publication date: Jan 2025
ISBN (Hardback): 978-1-80441-911-3
ISBN (eBook): 978-1-80441-912-0

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Description

This book critically assesses the development of pharmaceutical patent Term Extensions, and their impact; in particular, the practical impact on generic market entry. It focusses on European Supplementary Protection Certificates (SPCs), and the extent and effect on access to cheaper medication in terms of cost and availability.

Policy making for pharmaceuticals requires considerations on availability and price. For developing countries, it appears impossible to form policy without promoting generic medicines, which are proven as an effective health care remedy to access and availability. A 20-year maximum patent term is generally recognised by originators to be insufficient. The European Union’s response saw the initiation of SPCs, officially administered since the 1980’s, and despite numerous complaints on their efficacy and fitness for purpose, SPCs provide significant barriers to entry for generic medications.

Conclusions are drawn based on legislative review and re-analysis/interpretation of published data which considers the means of optimising existing legal structures, and presents practical solutions for addressing access and public health obligations under International Law. This is especially relevant for countries with little or no manufacturing capabilities.

Biography

Author(s):  Dr. Theona R. Elizee is a lawyer and lecturer based in Croydon, United Kingdom.

Reviews

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