The Politics of the Pharmaceutical Industry and Access to Medicines

Hans Löfgren is Associate Professor in Politics and Policy Studies, Deakin University, Melbourne, Australia.

The Pharmaceutical Industry and Access to
Medicines in India

The Pre-1972 Product Patent Period

The Process Patent Era 1972–2005

Full TRIPS-compliance from 2005

Financial and Economic Crisis and Access to

Medicines for All




Challenges of Regulation of Medicines in India
Price Regulation

Weeding Out of Irrational Medicines: A Necessary

Complement to Price Control

Law on Banning Irrational Medicines

Towards Ethical Marketing and Promotion of Medicines

Promoting Transparency and Declarations of Conflict

of Interest

General Review of all Legislations

Other Issues

Conclusion




CIPLA: Patients before Patents
Modest Beginnings

Yusuf Hamied Living up to his Legacy

India’s Patent Law 1972

The Three Drug Combination: Potent Cocktail

A Life-saving Offer

Success Story

The Road Ahead




Systemic Failure of Regulation: The Political Economy
of Pharmaceutical and Bulk Drug Manufacturing

The Regulation of Industrial Pollution

Structure and Methodology

Structures of the Value Chains in the Rural Economy

Pathways of Pollution in the Dairy Industry

Regulatory Checks on Pathways in Value Chains

Final Observations




TRIPS Flexibilities and Access to Patented Medicines
in India

Use of Trips Flexibilities

Exemptions from Patentability

Future Options




India’s Free Trade Agreements: Implications for
Access to Medicines in India and the Global South

Introduction

TRIPS Compliance: Using the Doha Declaration

in India

India’s FTA Negotiations: An Overview

FTAs and Access to Medicines: Key Concerns

Intellectual Property Provisions

Investment (or Investor Protection) Measures

Regulatory Harmonization



Government of India’s Position

FTAs, TRIPS and the Right to Health

Conclusion




At any Price? Boehringer Ingelheim, Bayer
HealthCare and Baxter in India

The Examined Companies

How Good are the Drugs Supplied by these Companies?

What about Access?

Drug Treatment in the NGO, Private and Public Sectors

Research and Patents

Marketing and Business Behaviour

Conclusion




Trends and Prospects for India as a Global Generic
Player

Introduction

Regulatory Status of India in World Generics

Markets

India’s Bilateral Trade in Pharmaceutical Products

Outlook for the Indian Pharmaceutical Industry

TRIPS and the Future of the Indian Pharmaceutical

Industry

Conclusion




The Indian Patent Law and Access to Antiretroviral
Drugs in Sub-Saharan Africa

TRIPS and Public Health

Compulsory Licensing

Parallel Imports

The Scope of Patentability

Indian Patent Law

African Patent Laws

The Impact of the Patent Status in India on Access

in Sub-Saharan Africa

Lacking Access to Patented Radical Innovative

Antiretrovirals

Patents Matter




Accessing Medicines in Developing Economies
Intersection between IPRs and Competition Law

Refusal to Licence Pharmaceutical Patents in

South Africa

Some Considerations

Abbott’s Withdrawal of Medicine Registration

Applications in Thailand

Exclusive Distribution and the High Prices of

Medicines in Vietnam

Indian Perspective

Concluding Remarks




The Politics of AIDS Treatment in Brazil
Introduction

The Strategy of Local Generic Production

Challenges to the Sustainability of an Inclusive AIDS

Treatment Policy

Restricting Patent Rights to Reduce ARV Costs

Conclusions




Financing Pharmaceutical Research and
Development: Alternatives to the Patent System

Problems with the Patent System

Alternative Mechanisms for Financing R&D

Conclusion




Post-script

Glossary