Frequently Asked Questions

1. What is the report of the Commission on Intellectual Property Rights, Innovation and Public Health?

It is the first report of its kind, mandated by the World Health Organization (WHO), and produced by an independent Commission. It analyses the relationships between intellectual property rights, innovation and public health, mobilizing the available evidence and analysis and the perspectives of different stakeholders. It makes recommendations aimed to promote innovation (i.e. new diagnostics, vaccines and medicines) relevant to the needs of sick people in developing countries, and the accessibility of health-care products in developing countries. The report was formally handed to the Director-General of WHO on 3rd April, when it was published on the Commission’s web site and hard copies made available. The report will first be considered by an intergovernmental working group of WHO's Executive Board on 28 April, and then by WHO's 192 Member States at the Fifty-ninth World Health Assembly to be held on 22-27 May 2006.

2. How and when was the Commission created?

The Director-General of WHO established the Commission in February 2004. The first meeting of the Commission was in April 2004, and the last meeting in January 2006. The Commission's origin lies in resolution WHA56.27 which was adopted at the Fifty-sixth World Health Assembly in May 2003. The resolution requested WHO "to establish the terms of reference for an appropriate time-limited body to collect data and proposals from different actors involved and produce an analysis of intellectual property rights, innovation and public health, including the question of appropriate funding and incentive mechanisms for the creation of new medicines and other products against diseases that disproportionately affect developing countries..."

3. What were the Commission's terms of reference?

The Commission was asked to submit a final report with concrete proposals to WHO's Executive Board. Its detailed terms of reference were to:

• Summarize the existing evidence on the prevalence of diseases of public health importance with an emphasis on those that particularly affect poor people and their social and economic impact;

• Review the volume and distribution of existing research, development and innovation efforts directed at these diseases;

• Consider the importance and effectiveness of intellectual property regimes and other incentive and funding mechanisms in stimulating research and the creation of new medicines and other products against these diseases;

• Analyse proposals for improvements to the current incentive and funding regimes, including intellectual property rights, designed to stimulate the creation of new medicines and other products, and facilitate access to them;

• Produce concrete proposals for action by national and international stakeholders.

4. How did the Commission do its work?

The Director-General of WHO established the Commission in February 2004. The first meeting of the Commission was in April 2004, and the last meeting in January 2006.

The initial part of the Commission’s work consisted of a process of consultation with stakeholders, the gathering of evidence and the commissioning of studies.

The Commission held meetings with stakeholders in Washington, DC, Ottawa, Mexico City, New Delhi, Rio de Janeiro, Brasilia, Brussels, Johannesburg and Pretoria.

The Commission organized a series of workshops and an open forum at WHO in Geneva in early summer 2005. Its web site, and the associated electronic discussion forum, proved a useful means of stimulating constructive debate and dialogue. It also received nearly 50 submissions from individuals and organizations.

22 studies were commissioned to inform itself about the existing state of knowledge on the subject, and to generate some new evidence.

More details of its activities, records of its meetings and consultations, and the studies and submissions can be found on this website.

5. What does the report consist of?

The report contains six chapters.

Chapter 1 contains an overview of the disease burden and the issues to be covered by the report.

Chapter 2 covers the discovery stage in product development.

Chapter 3 discusses the development stage.

Chapter 4 deals with the delivery stage.

Chapter 5 considers policies to improve innovative capacity in developing countries.

Chapter 6 concludes and considers the need to move towards a better-financed and more sustainable system for promoting innovation directed at diseases that disproportionately affect developing countries.

6. What does the report say?

Intellectual property rights are a general incentive provided by governments to promote innovation in all fields. In respect of public health, they are embedded in a set of other incentives which influence the pattern of innovation. They need to be looked at as part of a bigger picture.

In particular, because the market demand for diagnostics, vaccines and medicines needed to address health problems mainly affecting developing countries is small and uncertain, the incentive effect of intellectual property rights may be limited or non-existent.

Because intellectual property rights may not be an effective incentive in this area, there is a need for other incentives and financial mechanisms to be put in place and for collaborative efforts between different stakeholders.

Without access to the products of innovation, there can be no public health benefits. Defining the conditions by which products can be accessed is therefore an important aspect of the report.

There has been significant progress in recent years, in particular initiatives taken by different stakeholders to promote innovation in health-care products e.g. increased funding by foundations and the formation of public-private partnerships for product development.

This momentum for change is welcome but is insufficient.

More needs to be done. There are unsettled and debated issues in intellectual property for example the effectiveness of the recent amendment to TRIPS in increasing access to medicines in countries without manufacturing capacity, the impact of data exclusivity laws and the impact of intellectual property provisions in bilateral trade agreements.

And there is a need to ensure enhanced financing on a sustainable basis of innovation and access and promote synergy between the different partners.

Ultimately it is a responsibility that governments must accept if these objectives are to be achieved.

It is appropriate that WHO should now take the lead in promoting a more sustainable and better-funded effort and addressing unresolved issues.

WHO should accordingly develop a Global Plan of Action to secure enhanced and sustainable funding for developing and making accessible products to address diseases that disproportionately affect developing countries.

7. Was there consensus on the report?

All members of the Commission played a part to the very end in shaping this report. Inevitably there were compromises which reflected the different strands of opinion present in the Commission. It is no surprise, given that members of the Commission exercise diverse responsibilities in different fields (the pharmaceutical industry, public–private partnerships, government departments, research institutions, regulatory authorities, and medicine), that some would have preferred different emphases or analyses at particular points.

Nevertheless, all the Commission accepted the report as a solid contribution towards continued international dialogue, and progress towards the objectives for which the Commission was established. However some Commissioners have recorded their observations on the report and its conclusions in an Annex to the report, and have also provided commentaries which are available on the report page of the Commission website.

8. What are the next steps?

The Commission, established as a time-limited body, has now finished its work with the completion of its report.

The next steps are for the WHO's 192 Member States. First, an intergovernmental working group of the WHO Executive Board will meet on 28 April in Geneva to discuss the report of the Commission, and an accompanying draft resolution. Following that, the report and the draft resolution will be presented to the World Health Assembly when it meets from 22 -29 May. The Assembly will decide which steps WHO should then take to follow-up the implications of the report.