Literature Review

Commission on Intellectual Property Rights
Integrating Intellectual Property Rights and Development Policy

WIPO WTO TRIPS
London September 2002
The Commission was established primarily to consider how to integrate intellectual property rights into development policy. The report outlines recommendations on how development objectives can be integrated into development policy at the national and international level. The Commission believes that IPRs are here to stay and the next step for developing countries is to adapt them to suit each context.
Read more about the Commission and the report

Health Research and Development
The Lancet Volume 359
June 22, 2002
Drug Development for neglected diseases: a deficient market and a public-health policy failure.
Patrice Trouiller, Piero Olloaro, Els Torreele, James Orbinski, Richard Laing, Nathan Ford

The authors address the issue that there are few effective, safe, and affordable pharmaceuticals to control infectious diseases. These diseases cause high mortality and morbidity among poor people in the developing world. The authors reviewed the outcomes of research and development in pharmaceuticals in the past 25 years. They discovered that of the 1393 new chemical entities marketed between 1975 and 1999, only 16 were for tropical diseases and tuberculosis.
Read the article

The Washington Post
Friday, August 22, 2003
Solving the Drug Dilemma
John Evans, Professor Economics, Northwestern University

The escalating costs of pharmaceuticals means that public policy must now address the two conflicting social goals of making drugs affordable and stimulating the advance of medical technology. Professor Evans offers a solution, a two part pricing model that rewards innovation and ensures lower costs to the consumer.

New Scientist
June 14, 2003 p 29
Medicines without barriers
Tim Hubbard and Jamie Love
The article argues that the current international patent system does not promote the development of new drugs. The patent system is an inefficient way of purchasing R&D. The authors call for the development of a new trade framework that works for the public good.

Le Monde Diplomatique
July 2003
Drugs should be a common good; Unhealthy Profits
German Velasquez

Rising costs of pharmaceuticals already a problem for developing countries. Developed countries are also realizing they cannot support the rising costs of drugs. The costs of drugs has increasingly been influenced by TRIPS. Calls for research to serve real needs and not market opportunities. Calls for new solutions instead of attacking pharmaceutical companies.

An agenda for research and development
Meeting on the role of generics and local industry in attaining the Millennium Development Goals in pharmaceuticals and vaccines.
June 24-25, 2003
James Love (CPTech) Tim Hubbard (Welcome Trust Sanger Institute)
Paper offers a policy framework about how R&D should be financed when high prices to poor consumers during a patent term is an unacceptable outcome.

A Better Trade Framework to Support Innovation in Medical Technologies
Workshop on Economic Issues Related to Access to HIV/AIDS Care in Developed Countries.
May 27, 2003
James Love

Outlines a new trade framework which ensures that countries funded R&D in sufficient levels and allowed experimentation in business models. It is an alternative to the TWO TRIPS agreement but works either independently or together with TRIPS. It is designed to support the entire health sector.

Nature Volume 424
July 10, 2003
Drive for patent-free innovation gathers pace
Declan Butler

Reports on how a group of top scientists and economists are asking the World Intellectual Property Organization to promote open models of innovation that do not rely on patents. WIPO spokesperson agreed and indicated a meeting should be set up to discuss open source in intellectual property.

Washington Post
August 16, 2003
The quiet war over open source
Jonathan Krim

Reports on Microsoft lobbyists who responded quickly to the article in Nature magazine July 10, 2003. Lobbyists from Microsoft funded trade groups objected to the suggestion that overly broad or restrictive intellectual property rights could stunt technological innovation and economic growth. Lobbyists also tried to stop the WIPO meeting to discuss open source.

The Global Alliance for TB Drug Development
October 2001
The Economics of TB Drug Development. New data for new research.
Published by Rockefeller Foundation

No new class of anti-TB drug has been developed in the past 30 years. R&D for new drugs has suffered from the pharmaceutical industry’s perceived lack of need and sufficient market. This report outlines potential market for new anti-TB drugs, cost of drug development, return on investment and options for funding and conducting drug development.

Expert Report JL-RND
Evidence regarding research and development investments in innovative and non-innovative medicines.
September 22, 2003
James Love, CPTech

This report reviews evidence of the costs of private sector drug development, the nature of private R&D flows and offers alternatives for governments.

MSF/DND Working Group paper
Paying for healthcare R&D: Carrots and sticks.
January 2001
James Love, CPTech

This paper explores mechanisms for governments and donors to enhance R&D efforts.

Public Private Sector Partnerships (PPPs)
Product Development Public Private Partnerships for Diseases of Poverty [pdf 1.3mb]
Robert G. Ridley (Control and Click to follow link)
UNICEF/ UNDP/ World Bank/ WHO Special Programme for Research and Training in Tropical Diseases
IPPH Meeting, London, 15 - 16th April 2004
Research and Development
Innovation and Stagnation: Challenge and Opportunity on the Critical Path to New Medical Technologies [pdf 245kb]
US Department of Health and Human Services
Food and Drug Administration
March 2004

Working paper on priority infectious diseases requiring additional R&D [pdf 196kb]
WHO/ IFPMA
WHO/ Industry Drug Development Working Group
July 2001
General
Report of the Commission of Macroeconomics and Health [pdf 776kb]
Chapter index
Commission on Macroeconomics and Health
World Health Organization
Geneva, 2001

Integrating Intellectual Property Rights and Development Policy (Chapter index)
UK Commission on Intellectual Property Rights
London, September 2002

WTO Agreements and Public Health [pdf 788kb]
World Health Organization/ World Trade Organization
Geneva, 2002
Declaration on the TRIPS agreement and public health [pdf 9kb]
WTO Ministerial Conference
Fourth Session
Doha, 9 - 14 November 2001

IPR, Innovation, Human Rights and Access to Drugs [pdf 801kb]
Department of Essential Drugs and Medicines Policy
World Health Organization
Geneva, 2003

Documentation Center, WHO Essential Drugs and Medicines Policy
A selected listing of publications and documents.
http://www.who.int/medicines/library/edm_general/edm-2001-3/edm-2001_3.doc
GET PERMISSION FROM WHO TO HAVE THIS LINK.

The European and developing countries clinical trials partnership (ECDTP) Concept document
June 20, 2002
To develop a European and development countries partnership for clinical trials and new interventions against poverty-related diseases.
EDCTP Steering Committee Meeting

The EDCTP’s goal is to develop new interventions against HIV/AIDS, TB and malaria through a long term partnership between Europe and developing countries. This paper outlines their strategies to address this issue as well as a brief background on the EDCTP.

The Lancet, Volume 360
November 2, 2002
The pharmaceutical industry as an informant
Joe Collier, Ike Iheanacho

The pharmaceutical industry spends more time and resources on generation, dissemination and collation of medical information than it does on production of medicines. Most of this information is protected by regulations about intellectual property rights. Only a small portion is shared with the public. However, this makes the business of information generation inefficient and threatens patient’s interests.

The Lancet, Volume 360
November 9, 2002
The pharmaceutical industry as a political player
John Abraham

The extent of the pharmaceutical industry’s influence over drug regulation at the expense of other interested parties means that the current regulation system needs to be more robust. A regulatory system that protects the public from drugs that are unsafe, ineffective or unnecessary is essential.

The Lancet, Volume 360
November 16, 2002
The pharmaceutical industry as a medicines provider
David Henry, Joel Lexchin

Rising drugs prices means that other options for drug patents need to be considered. Better access to essential drugs may be achieved through voluntary licensing arrangements between pharmaceutical companies and manufacturers in developing countries.

The Lancet, Volume 360
November 23, 2003
Accountability of the pharmaceutical industry
MN Graham Dukes

The pharmaceutical industry is accountable to shareholders and society, however the industry has developed practices that do not consider society, including excessive or inappropriate pricing of drugs. In order to influence multinationals corporations governments must work with voluntary organizations that represent society’s public health interests.

ISDB (International Society of Drug Bulletins) Declaration on therapeutic advance in the use of medicines
Paris, November 2001
Working Group

ISDB promotes the use of good quality independent information about drugs and therapeutics to health professionals and the public. This declaration outlines what constitutes a genuine therapeutic advance as considered from the viewpoints of patients and the society.

Changing patterns of pharmaceutical innovation
May 2002
A research report by the National Institute for Health Care Management, Research and Educational Foundation (NIHCM).

Outlines the disparity between spending on drugs and clinical value. A large increase in spending is attributed to line extensions providing no significant clinical improvement over older medications. In 85% of cases these product line extensions do not provide significant improvement over currently marketed therapies.

The crisis of neglected diseases developing treatments and ensuring access
March 2002
Drugs for neglected diseases working group. Medicines Sans Frontiers (MSF).

The Drugs for Neglected Diseases (DND) Working Group, a multidisciplinary, independent group experts established by Medicines Sans Frontiers in 1999. This paper outlines four research themes and the findings of the DND. The four areas are essential R&D agenda and advocacy, capacity building and technology transfer, legal and regulatory affairs, finance and access. The paper offers solutions and alternatives for each section. The DND working group is one of three MSF pillars.

High level group on innovation and provision of medicines
May 2002
G10 Medicines Report

Business and pharmaceutical industry oriented. Concerned with European market share and perceived US lead in innovation. Recommendations are more to do with responding to concerns about US pharmaceutical industry and how to grow EU share of market. Public health not really addressed.

Priority Medicines for the citizens of Europe and the world
September 2003
Dutch Presidency of the European Union
July-December 2004

Project proposal calls for the preparation of a research agenda on public health grounds. An agenda that would take into consideration a careful and transparent process of prioritization of treatment needs and the appropriate use of public funds for R&D.

Sustaining access to medicines in Europe: The coming crisis
November 2001
Health Action International (HAI) Europe

The problem of access to essential medicines is seen as a crucial issue for developing countries, however evidence shows that access is a growing problem in developed countries as well. HAI Europe held a seminar with International Medico to discuss the issues. The seminar reports are summarized in this document.

Beyond Philanthropy: the pharmaceutical industry, corporate social responsibility and the developing world
2002, Oxfam, VSO and Save the Children

Report assesses corporate social responsibility of pharmaceutical companies. It challenges the pharmaceutical industry to improve its efforts to tackle the health crisis affecting children and adults in developing countries. Outlines policies responsible companies should have on access to treatment which include pricing, patents, joint public private partnerships, R&D and appropriate use of drugs.

Also read the Bellagio Series on Development and Intellectual Property Policy, The Rockefeller Foundation. http://www.rockfound.org

Trends in drug patenting. Ediciones Corregidor
Buenos Aires, 2001
Carlos M. Correa

The report examines specific cases of drugs where based on the technical considerations illustrate types of patenting that potentially divert patents from their real purpose – to encourage and reward a genuinely inventive effort.

Global Principles for Better Health Care: A guide for policymakers
December 2002
A report for the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), prepared by the National Economic Research Associates.

The Guide is aimed at policy makers who are facing health care system reform. It helps to identify issues and uses others’ experiences as examples. It outlines principles for successful health reform.

Please also see the WHO Department of Essential Drugs and Medicines Policy for a more comprehensive list of publications and documents relating to essential drugs and medicines policy.