Ellen 't Hoen – Private Patents and Public Health

PRIVATE PATENTS AND PUBLIC HEALTH
Changing intellectual property rules for access to medicines
 
Ellen F.M. ’t Hoen LLM,
 
AMB : Diemen, 2016
 
(ISBN 97890 79700 851, 181 pages, paper, € 45.00)
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Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World  Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many.
 
The AIDS crisis in the late nineties brought access to medicines challenges 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 low-priced generic HIV medicines.
 
But now, high prices of new medicines — for example, for cancer, tuberculosis and hepatitis C — are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises.
 
This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.
 
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Ellen ’t Hoen, LLM, is a public health advocate with over 30 years of experience working in pharmaceutical and intellectual property policy. She was the head of advocacy at Médecins Sans Frontières’ Access to Essential Medicines Campaign for over a decade. In 2009, she joined the innovative public health financing organisation, UNITAID, based at the World Health Organization, to establish the Medicines Patent Pool for HIV medicines. Managing Intellectual Property named her one of the 50 most influential people in intellectual property in the world in 2005, 2006, 2010 and 2011. She is a member of the World Health Organization Expert Advisory Panel on Drug Policies and Management and a researcher at the University Medical Centre at the University of Groningen. She is the author of the book, The Global Politics of Pharmaceutical Monopoly Power: Drug patents, access, innovation and the application of the WTO Doha Declaration on TRIPS and Public Health (2009), and has published widely on health and intellectual property subjects in medical and legal journals.
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“Ellen ’t Hoen is a towering figure in the movement for access to medicines, and this book represents an outstanding, sorely-needed, impressively comprehensive overview of the dysfunctional system which creates deadly monopolies on essential, life-saving drugs. Truly indispensable.”
 
(Dylan Mohan Gray, Director of internationally-acclaimed 2013 film on access to medicines, Fire in the Blood)
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“This is the definitive account of one of the most important social justice struggles of our times — by someone who not only knows it, but helped make it. Accessible, accurate and up-to-date, this book is a must-read for anyone interested in health policy, global justice, or global governance.”
 
(Amy Kapczynski, Professor of Law at Yale Law School and Faculty Director of the Global Health Justice Partnership)
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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 property
 
 

1. ENDING GLOBAL DIVERSITY IN PATENT LAWS: 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
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INTRODUCTION
 
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.
 
This book is an update of an earlier account that was published in 2009: The Politics of Pharmaceutical Monopoly Power: Drug Patents, Access, Innovation and the Application of the WTO Doha Declaration on TRIPS and Public Health. (AMB 2009, isbn 9789079700066)
 
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