The WHO “Red Book” on Access to Medicines and Intellectual Property – 20 Years Later
About the book: The publication in 1998 by the WHO’s Essential Drugs Department of the document “Globalization and Access to Drugs: Implications of the WTO/TRIPS Agreement” marked a point in time in the movement to ensure access to essential medicines for all. The publication, often referred to as ‘the WHO red book’, marked the beginning of an international policy process to address the issue of innovation and access to essential medicines. It triggered a series of reactions from the pharmaceutical industry, the US Government and the WTO, reproaching WHO for stepping out of its role. In light of these attacks, the then Director General of WHO decided to send the document to be revised by three independent academics specializing in intellectual property. The letters and documents criticizing the WHO publication as well as the review by the three international experts are reproduced in this book.
Some Critical Issues Related to Access to Medicines and Intellectual Property
About the book: The international debate and negotiations over access to medicines in the last ten years have been one of the most important moments in the recent history of public health. This debate is taking place in UN specialized agencies like WHO, UNDP, UNCTAD, UNAIDS, WIPO, WTO, the Commission of Human Rights, NGOs working on health, philanthropic foundations, and the pharmaceutical industry. This book is a collection of papers by the South Centre between 2011 and 2014 on the deliberations and negotiations in the World Health Organization (WHO) on access to medicines and their relationship with other actors dealing with international trade and intellectual property regimes.
Author: Germán Velásquez is the Special Adviser for Health and Development at the South Centre, Geneva, Switzerland
Derechos de Propiedad Intelectual, Investigación y Desarrollo, Derechos Humanos y Acceso a Medicamentos: Bibliografía Seleccionada y Anotada
Descripción:
El Centro del Sur ha preparado esta bibliografía seleccionada y anotada para asistir a los países en desarrollo en la implementación de políticas y reglamentaciones en materia de PI de manera coherente con los objetivos de desarrollo y los principios de salud pública. El creciente volumen de literatura que se está produciendo en torno al tema de PI, I+D, derechos humanos y acceso a medicamentos en los últimos cinco años puede ayudar a los países a encontrar las oportunidades y el espacio de maniobra para proteger a los ciudadanos de los países en desarrollo del medio insano que han generado las nuevas normas del comercio internacional.
Autores: Germán Velásquez, Carlos M. Correa, Xavier Seuba
IPR, R&D, Human Rights and Access to Medicines: An Annotated and Selected Bibliography
About the Book: The South Centre seeks to provide the appropriate technical assistance and country support to developing countries, within a comprehensive and coherent national IP Strategy, to promote the implementation of the TRIPS Agreement that is consistent with the protection of public health and promotion of access to medicines. To this end, the South Centre has prepared this selected and annotated bibliography to assist developing countries to implement IP policies and regulations consistent with development goals and public health principles.
Authors: Germán Velásquez, Carlos Correa and Xavier Seuba
Food Security and Access and Benefit-Sharing for Genetic Resources for Food and Agriculture
About the book: A study prepared for the UN FAO (Food and Agriculture Organisation) on whether, and how, national and regional laws, guidelines and other arrangements on access to genetic resources and benefit-sharing (ABS) may impact upon agriculture and food security.
Authors: Gurdial Singh Nijar, Gan Pei Fern, Lee Yin Harn and Chan Hui Yun
The Right to Development, Small Island Developing States and the SAMOA Pathway
In 2015, the United Nations community reached agreements on updating the financing for development mechanisms, Agenda 2030 and an updated climate change regime. The SAMOA pathway is an important resource and an input to these efforts. (more…)
South Centre Statement to the Open-Ended Meeting of WHO Member States: Follow-up of the report of the Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG)
At the open-ended meeting of WHO Member States on the follow-up of the report of the CEWG, the South Centre called for concrete discussions to start negotiations on a binding legal instrument on R&D financing and coordination. (more…)
The Bolar Exception: Legislative Models and Drafting Options
The basic principle of patent law is that once the term of a patent has expired, the protected subject matter becomes a part of the public domain. Hence, it can be freely used, including for commercial purposes, without the interference by the former patent owner. This allows competitors to enter the market immediately after such expiry, eventually leading to lower prices for consumers and welfare gains. (more…)
Implementing Pro-Competitive Criteria for the Examination of Pharmaceutical Patents
This document discusses criteria for implementing the patentability requirements in relation to patent applications covering products and processes, as well as the use of pharmaceutical products. The adoption of rigorous criteria with this purpose is important for four main reasons. (more…)
The grant of patents and the exorbitant cost of “lifesaving” drugs
By Germán Velásquez
The important relationship between the examination of patents carried out by national patent offices and the right of citizens to access to medicines hasn’t always been well understood. Too often these are viewed as unrelated functions or responsibilities of the state. And the reason is clear: patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators. This is the case when patent policy is implemented in isolation from, rather than guided by, public health policy. (more…)
Guidelines on Patentability and Access to Medicines
The important relationship between the examination of patents carried out by national patent offices and the right of citizens to access to medicines hasn’t always been well-understood. Too often these are viewed as to unrelated functions or responsibilities of the State . And the reason is clear: Patentability requirements are not defined by patent offices, but frequently by the courts, tribunals, legislation or treaty negotiators. (more…)
South Centre Calls on the WTO TRIPS Council to Support Access to Medicines and Technological Advancement for the Least Developed Countries
The South Centre fully supports the Least Developed Countries’ (LDC) request for an extension of the transition period granted to LDCs under Article 66.1 of the World Trade Organization’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) in respect of pharmaceutical products for as long as a WTO member remains an LDC, and the waiver from obligations under Articles 70.8 and 70.9 of the TRIPS Agreement. (more…)
About the book: The publication in 1998 by the WHO’s Essential Drugs Department of the document “Globalization and Access to Drugs: Implications of the WTO/TRIPS Agreement” marked a point in time in the movement to ensure access to essential medicines for all. The publication, often referred to as ‘the WHO red book’, marked the beginning of an international policy process to address the issue of innovation and access to essential medicines. It triggered a series of reactions from the pharmaceutical industry, the US Government and the WTO, reproaching WHO for stepping out of its role. In light of these attacks, the then Director General of WHO decided to send the document to be revised by three independent academics specializing in intellectual property. The letters and documents criticizing the WHO publication as well as the review by the three international experts are reproduced in this book.
