Information Note of the World Intellectual Property Organization (WIPO) for the United Nations Secretary-General’s High-Level Panel on Access to Medicines and the Expert Advisory Group
This paper summarizes the critical, cross-cutting impact that strengthened pharmaceutical production capabilities in Africa can make to improved access to innovation on the continent. Industry has an important role to play across a number of the different models that have been proposed to the High-Level Panel. We believe that a strong pharmaceutical industry able to produce quality-assured, innovative products, whether under license or within a different intellectual property paradigm, is vital if Africa is to benefit from access to new innovations addressing pandemic diseases and emerging health priorities.
WHO, UNIDO and other partners are working with African organizations and Governments to build capacity and address the multiple barriers to developing industry.
Background note prepared by the Secretariat of the World Trade Organization (WTO). This note is prepared only as a background resource to support the work of the High Level Panel, based on the practical experience of the WTO Secretariat in capacity building and policy dialogue relating to public health matters.
This submission briefly presents some relevant WHO experience in access to medicines, cooperation between international agencies, and a number of projects WHO is currently implementing to foster the development of health products that address priority health needs. This submission leaves out many other aspects of WHO’s work and experience that are relevant to access to medicines in general, as we understand that these are outside the mandate of the HLP.
United Nations Secretary-General, Ban Ki-moon, on 19 November 2015, announced the appointment of the United Nations Secretary-General’s High-Level Panel on Access to Medicines (‘the High-Level Panel’). The formation of the High-Level Panel is in line with the ambitions of UN Member States as articulated in the 2030 Development Agenda and in support of attaining Sustainable Development Goal 3, to ensure healthy lives and promote the well-being of all. It builds on the findings and recommendations of the Global Commission on HIV and the Law.
Recognising the interdependence of health and development and in line with the recently adopted 2030 Agenda for Development and the Sustainable Development Goals, the United Nations Secretary General has convened a High-Level Panel on Access to Medicines.The High-Level Panel and its Expert Advisory Group has estabished a document that outlines the Terms of Reference.
The United Nations Office of the High Commissioner of Human Rights identifies the human rights involved in the High-Level Panel's mandate to "review and assess proposals and recommend solutions for remedying the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health in the context of health technologies." This paper outlines the intellectual property and trade law questions which are of relevance to the Panel’s inquiry and to propose perspectives that may be of use in considering solutions.
BACKGROUND PAPER: International legal norms: the right to health and the justifiable rights of inventors
The challenge before the United Nations Secretary-General’s High-Level Panel on Access to Medicines (‘the Panel’) is to “make recommendations that: (a) remedy the policy incoherence between international human rights law and trade rules in the context of access to health technologies; and (b) achieve a better balance of the justifiable rights of inventors, the right to health and sustainable development." This background document has been prepared in an effort to provide more information on the legal meanings and relative weight of ‘rights of inventors’ and the ‘right to health’.It provides an overview of the provisions of international law relating to access to medicines and other health technologies, and to intellectual property (IP), in the domains of both human rights law and trade law.
BACKGROUND PAPER: Existing and Prior Work, Initiatives and Proposals to Improve Innovation and Access to Health Technologies
The United Nations Secretary-General’s High Level Panel on Access to Medicines (‘the Panel’) is not the first body that has been established to address the innovation of, and access to, health technologies. The global record is replete with initiatives of both large and small scale. Some of these initiatives have aimed, as the High-Level Panel will, at strengthening the coherence of relevant laws and policies which underpin health technologies innovation and access, while other initiatives have attempted to address discreet gaps which emerge in either innovation or access – or both – for specific types of technologies or disease, or particular demographic groups of end-users. This paper offers an overview of these various initiatives.
A civil society declaration on the UN Secretary-General’s High-Level Panel on Access to Medicines.
Synthesis Report of the Secretary-General On the Post-2015 Agenda - “We recognize that people are at the centre of sustainable development and, in this regard, we strive for a world that is just, equitable and inclusive, and we commit to work together to promote sustained and inclusive economic growth, social development and environmental protection and thereby to benefit all.” Rio+20 Outcome Document, The Future We Want
Public Health Innovation and Intellectual Property Rights: REPORT OF THE COMMISSION ON INTELLECTUAL PROPERTY RIGHTS, INNOVATION AND PUBLIC HEALTH
In May 2003, WHO Member States agreed at the World Health Assembly to set up a time-limited body to consider the relationship between intellectual property rights, innovation and public health.
The operative part of the text of the resolution establishing the Commission (WHA56.27) reads as follows: “…collect data and proposals from the 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…”
The Commission was established by the Director-General of WHO in February 2004. The Commission was supported by a small Secretariat in WHO under the overall direction of Dr Tomris Türmen, representative of the Director-General. Dr Charles Clift was Secretary of the Commission.
The Global Commission on HIV and the Law comprised a panel of eminent persons who interrogated the relationship between legal responses, human rights and HIV. The Commission advocated for evidence and human rights based legal environments for effective and efficient HIV responses. “HIV and the Law: Risks, Rights & Health” is the Global Commission on HIV and the Law’s flagship publication. Released in July 2012, the report presents public health, human rights and legal analysis and makes recommendations for law and policy makers, civil society, development partners and private sector actors involved in crafting a sustainable global response to HIV. Chapter 6 of the report, Medicines For Whom? Intellectual Property Law and the Global Fight for Treatment contained a number of recommendations relevant to the issues being addressed by the High-Level Panel. [Chapter 6 from page 76].
by Mohammed El Said & Amy Kapczynski
This paper identifies and describes the most critical TRIPS (Trade-Related Aspects of Intellectual Property) flexibilities and describes the barriers to their widespread use, as well as developments undermining their continued availability. We also offer conclusions and policy recommendations based upon our analysis. While TRIPS does formally offer certain flexibilities to developing countries, in practice, the complexity and administrative burdens associated with these flexibilities imposes a substantial toll on health in developing countries. More than 15 years after the adoption of the TRIPS Agreement, it is time for a reassessment of its impact, and for consideration of a binding amendment or instrument that could protect access to medicines for the global poor. At a minimum, much more must be done to support the use of TRIPS flexibilities in developing countries, as we describe in our conclusion.
The Millennium Development Goals recognise the crucial importance of reducing poverty and hunger, improving health and education, and ensuring environmental sustainability. The international community has set itself the target of reducing the proportion of people in poverty by half by 2015, along with associated specific targets for improving health and education and environmental sustainability.
It is our task to consider whether and how intellectual property rights (IPRs) could play a role in helping the world meet these targets – in particular by reducing poverty, helping to combat disease, improving the health of mothers and children, enhancing access to education and contributing to sustainable development. It is also our task to consider whether and how they present obstacles to meeting those targets and, if so, how those obstacles can be removed.