The Impact of Patent Extensions in Access to Pharmaceuticals.

Format:

Book

Author/Creator:

Elizee, Theona.

Language:

English

Subjects (All):

Generic drugs.

Intellectual property.

Physical Description:

1 online resource (240 pages)

Edition:

1st ed.

Place of Publication:

Bradford : Ethics International Press Limited, 2024.

Summary:

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.

Contents:

Intro

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Main Acronyms

Preface

Background

The problem which required investigation

Justification of the study

Methodological aspects of the study

Sources

Introduction

Patents and access

Legal Theory Relating to Intellectual Property Rights, (IPRs) and Access

The Influence of Patent Theory and Practice in Creating Monopolies.

The Impact of European IP Legislation on Patents and Access

The Impact of Canadian IP Legislation on Patents and Access

The Convergence of the Human Right to Health, Access and Patented Medicines

Explaining sui generis rights in the context of pharmaceutical access

The Europeanization of Patent Term Extensions

An Overview of the Canadian Pharma System's Approach to Regulation in the Context of Access

Understanding the Pharmaceutical Regulatory Environment in the Context of Access

Linkages between Access and Generics as key to forming Policy Considerations

Exploring the costs of patents in pharmaceuticals

A Snapshot of the Data on SPCs

Exploring the cost of SPCs on EU Drug Spending

An Evaluation of SPC's and Access from the standpoint of the Eu Pharmaceutical Sector.

Exploring Cost Savings for Pharmaceuticals in the EU Generics Context

Discussion on the Data

Strengthened patent monopoly vs pharmaceutical access

Dissecting Pharmaceutical Spending from a Canadian Standpoint

Explaining Cost Savings for Pharmaceuticals in the Canadian Generics Context

Investigating why Drugs are more costly in Canada

CETA and its Projected Impact on Access of Pharmaceuticals in Canada

The balancing act: coping mechanisms/alternatives for improved access

Exploring the Effectiveness of International Measures on Access

The Viability of Patent Pools in Addressing Access

Exploring Trade Secrets as a Tactical IP Measure in Pharmaceuticals

Lessons from the Canadian Cannabis Experience in Fostering Local Production

Mixed Attempts/Efforts at Addressing Access

Optimisation of legal frameworks for increased access

Legal and Industry Considerations to Access

Incorporation of Existing Legal Frameworks for Improved Access

EU and Improved Access to Pharmaceuticals.

Canada and Improved Access to Pharmaceuticals

LDCs and Improved Access to Pharmaceuticals

Conclusions

Bibliography.

Notes:

Description based on publisher supplied metadata and other sources.

Part of the metadata in this record was created by AI, based on the text of the resource.

ISBN:

1-80441-912-5

OCLC:

1468529366