GEPADES

Promoting Access to Medical Technologies and Innovation

Intersections between public health, intellectual property and trade

World Health Organization (WHO), World Intellectual Property Organization (WIPO)

and World Trade Organization (WTO) – 2012

Available online PDF file [251p.] at: http://bit.ly/U5QM4o

“…..Medical technologies — medicines, vaccines and medical devices – are essential for public health. Access to essential medicines and the lack of research to address neglected diseases have been a major concern for many years. More recently, the focus of health policy debate has broadened to consider how to promote innovation and how to ensure equitable access to all vital medical technologies.

Today’s health policy‑makers need a clear understanding both of the innovation processes that lead to new technologies and of the ways in which these technologies are disseminated in health systems. This study captures a broad range of experience and data in dealing with the interplay between intellectual property, trade rules and the dynamics of access to, and innovation in, medical technologies.

The study is intended to inform ongoing technical cooperation activities undertaken by the three organizations and to support policy discussions. Based on many years of field experience in technical cooperation, the study has been prepared to serve the needs of policy‑makers who seek a comprehensive presentation of the full range of issues, as well as lawmakers, government officials, delegates to international organizations, non‑governmental organizations and researchers….”
Content

Executive summary
I. Medical technologies: the fundamentals

A. Public health and medical technologies: the imperative for international cooperation

1. Policy coherence

2. Scope of the study

3. The need for this study

4. The timing of the study

5. Who should read this study?

B. The cooperating agencies: the WHO, WIPO and the WTO

1. World Health Organization

2. World Intellectual Property Organization

3. World Trade Organization

4. Trilateral cooperation

5. Other international key stakeholders

C. The global burden of disease and global health risks

1. Defining the need

2. Trends and projections: major cause groups contributing to the total disease burden

3. Global health risks

D. Factors shaping public health policy 30

1. Seeking effective outcomes within a complex policy environment

2. Transforming policy intersections: from boundaries to synergies

3. Building stronger links between local, national and global levels

4. The empirical challenge: an accessible base for policy

II. The policy context for action on innovation and access

A. Public health policy

1. Health and human rights

2. Access to essential medicines: an indicator for the fulfilment of the right to health

3. Universal access and the UN Millennium Development Goals

4. Public health, innovation and access in the WHO

5. National health policies and health systems

6. Regulation of medical technologies

B. Intellectual property, trade and other policy dimensions

C. economics of innovation and access to medical technologies

D. Traditional knowledge and traditional medicine

1. Traditional medicine knowledge systems

2. Traditional medical knowledge in international health and IP policy

3. Traditional medicines regulation

4. Concerns about misappropriation of traditional medicines

5. New approaches to IP protection of traditional medical knowledge

III. Medical technologies: the innovation dimension

A. Historical pattern of medical R&D

B. The current R&D landscape

C. Overcoming market failure: the challenge of neglected diseases

D. Intellectual property rights in the innovation cycle

E. sharing of influenza viruses and access to vaccines and other benefits

IV. Medical technologies: the access dimension

A. Access to medical technologies: the context

B. Health systems-related determinants of access

C. IP-related determinants of access

D. Other trade-related determinants for improving access 191
Annex I. Overview of international key stakeholders

A. International organizations

B. Other international key stakeholders
Annex II. Special compulsory licences for export of medicines
Bibliography