Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes interfere with widespread access to medicines by creating monopolies that maintain medicines prices well beyond the reach of those who need them.

The magnitude of the AIDS crisis in the late nineties brought this to the public’s attention when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis — 8,000 people dying daily — the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of quality generic HIV medicines and a steady scale-up in access to those medicines. This has allowed nearly 13 million people1 to lead longer, healthier lives. However, trends in international intellectual property law could impact many of the policy tools used to scale up HIV treatment.

Developments in global health and specifically access to medicines policies are now at an important juncture. Impressive progress has been made in access to medicines for HIV and many lessons can be learned from that experience. But it is important to examine whether those lessons can be applied for other diseases. Today’s pharmaceutical patent regime affects almost all medicines developed since 1995 in most countries. The high prices of new medicines, such as for cancer, tuberculosis and hepatitis C, cause huge access challenges globally, in both developed and developing countries. These new global challenges pose the question of whether the public health approaches to medicines patents developed in response to the HIV/AIDS crisis are exclusive to HIV or whether they can be applied more broadly.

This book provides a history of the parallel developments in global public health and international patent laws: detailing the current situation, how we got here, and how we can move forward to best protect the future of medical innovation as well as the lives that will depend on it.



TABLE OF CONTENTS

 

INTRODUCTION

Why patents matter to patients

How the HIV pandemic changed everything

Timeline of events related to access to medicines and intellectual propertyENDING GLOBAL DIVERSITY IN PATENT LAWS: 1. THE TRIPS AGREEMENT

Globalising the patent regimes of wealthy nations

Health at the centre of trade talks from Geneva to Seattle and Doha

Concern grows at the World Health Organization

NGOs advocate for health primacy over patents

Negotiations on TRIPS and public health at the WTO, 1999–2001

2. TURNING THE TIDE: THE WTO DOHA DECLARATION ON TRIPS & PUBLIC HEALTH

The WTO Doha Declaration on TRIPS and Public Health

Provisions of the Doha Declaration: Paragraphs 1–5 and 7

Generic production or importation in least-developed countries

Compulsory licensing for export (“Paragraph 6 system”)

Paragraph 6 of Paragraph 6: The regional waiver

India: A model of Paragraph 6 implementation

3. PRIVATE PATENTS AND PUBLIC HEALTH: FROM DECLARATION TO APPLICATION: THE PRACTICAL USE OF THE DOHA DECLARATION SINCE 2001

Implementing Doha: Compulsory licences, government use, and waivers for LDCs

Compulsory licensing and government use

Paragraph 7 of the Doha Declaration, also known as the ‘LDC pharmaceutical waiver’ or ‘Paragraph 7 mechanism’

Use of Doha flexibilities: Examining the numbers

Results: Compulsory licences granted by a government or government authority

Results: Instances of government use since 2001

Results: Use of the LDC pharmaceutical waiver (Paragraph 7 mechanism)

Observations

Results: Trends in the use of TRIPS flexibilities

Conclusions

The use of the Doha Declaration beyond HIV/AIDS

Compulsory licences on cancer medicines in Thailand

Effects on export trade and foreign direct investment

Compulsory licences on medicines in India

Compulsory licences on hepatitis C medicines in Europe

The ‘almost compulsory licences’

A move towards voluntary licensing: Creating a patent pool

The Medicines Patent Pool

4. CLOSING THE POLICY SPACE: TRADE AGREEMENTS AND TRIPS-PLUS MEASURES

TRIPS and its built-in flexibility

Trade agreements closing in on TRIPS flexibilities

The Trans Pacific Partnership Agreement

Merits of the multilateral system

Patentability criteria and the evergreening of patents

Patent oppositions

5. THE NEW FRONTIERS: PATENTS AND TREATMENT FOR CANCER, HEPATITIS C, AND OTHER DISEASES

Introduction

Patented essential medicines: The 2015 EML

HIV, affordability, and the EML

The challenges of hepatitis C, cancer, and biosimilars

Hepatitis C

Cancer: A leading cause of death and unsustainably high prices

The imatinib (Glivec) case

A growing call from doctors for more reasonable pricing

The case of biological medicines

Medicines prices are everyone’s problem now

Conclusions: New medicines, new urgencies in addressing the drug price and access divide

6. FIXING THE BROKEN R&D SYSTEM: ENSURING ESSENTIAL INNOVATION AND ACCESS TO MEDICINES FOR ALL

The crisis in innovation and access: Missing essential medicines

Paediatric HIV and the struggle to incentivize all medicines for children

Why there is under-investment in certain classes of medicines

Missing medicines are also a problem in wealthy nations

Market failure spurs vulnerability to microbial resistance

Not-for-profit essential drug development: Pioneering new innovation models

High prices do not necessarily indicate essential innovation

Changing the R&D system: Policy changes and challenges to date

Intellectual property issues

Lack of understanding of how much drug development costs

Delinkage models: A way forward

7. RESTORING THE BALANCE: ACCESS TO ESSENTIAL MEDICINES IN A POST-TRIPS WORLD

Will a public health approach to IP beyond HIV be possible?

ANNEXES

NOTES AND REFERENCES

LIST OF BOXES, FIGURES AND TABLES