Lead Author: Ann Blackwood
Organization: Unites States Department of State
Country: USA

Submission

United States submission of views on the UN High-Level Panel on Access to Medicines

 The challenge of providing adequate access to safe, effective, affordable, life-saving medicines is one that all countries share. The United States government shares the United Nations (UN) Secretary General’s concern and interest in finding solutions to address this issue and appreciates this opportunity to provide input into the UN Secretary General’s High-Level Panel on Access to Medicines.

This opportunity to provide substantive input is the first and only opportunity for UN Member States and occurs well alter the establishment of the High-Level Panel and the determination of its mandate. The Panel’s narrowly-focused mandate leads us to believe the Panel’s work may inevitably reach a narrow set of conclusions that would be unlikely to highlight win-win outcomes to facilitate access to medicines and would not adequately address this complex issue. Because of this critical flaw and other issues outlined below related to the scope, processes, transparency, and participation, the United States strongly recommends that the UN Secretary General reconsider the Panel’s work and work with interested Member States in that reconsideration to address the above concerns,

The High-Level Panel’s mandate is too narrow to address the many and often inter-related barriers to access to safe, effective, and affordable medicines. The World Health Organization (WHO) identifies four main factors contributing to access to medicines: l) the rational selection and use of medicines,  2) affordable prices,  3) sustainable financing, and 4) reliable health and supply systems.  None of these factors are being directly studied by the Panel. With regard to affordable pricing of medicines, the WHO has identified numerous considerations, including pricing and procurement policies, taxes, markups and tariffs, and other national policies (or lack thereof) that ultimately result in higher costs for consumers and for health systems.2 In fact, even common, essential, off-patent medicines often do not achieve their intended health impact due to supply and manufacturing issues.

For example, the United Nations Commission on Life Saving Commodities suggests that access to and appropriate use of 13 essential commodity types can save the lives of an estimated 6 million women and children by 2017. A parallel effort by the WHO to address shortages of medicines has recognized the importance of evolving beyond singular, vertical approaches to strategies that embrace strengthening the entire health system. It the Panel’s mandate ignores these important factors, its work will be of dubious utility.

 The Panel has been tasked with examining only two pieces of the larger puzzle, and will be doing so in isolation, pursuant to terms of reference which are based on a description of the problem stated in a way that suggests predetermined outcomes. The United States is concerned that by conducting such a narrow review, the report issued by the Panel may be imbalanced and of limited use, or even counterproductive in building consensus among stakeholders and national governments.

We question the premise that the rights of inventors, international human rights law, trade rules, and public health are "misaligned.” Nearly all UN and other international documents recognize positive contributions of international trade to public health. Promoting innovation for life-saving medicines is critical to providing improved treatments for today’s diseases, and new treatments for tomorrow’s. The international trading system further spurs the diffusion of medicines around the world contributing to improved public health outcomes for populations that may not otherwise have access to life-saving drugs. The mandate of the Panel risks addressing alleged “misalignment” without being able to take into account the value or relative contribution of each of the pillars mentioned.

 The process being followed by the Panel is insufficiently transparent to judge to what extent it is using data and individual country circumstances to reach conclusions in the very limited time available. The creation and operation of the High-Level Panel has occurred almost entirely without UN Member State involvement or input. Furthermore, contrary to the calls for the involvement of all relevant UN agencies in initiatives within their mandates, neither the World Health Organization (WHO), World Trade Organization (WTO), nor World Intellectual Property Organization (WIPO) were consulted prior to the Panel’s establishment. This calls into question the ability of the panel to consider all relevant factors, the huge volume of policies approved by these organizations, and data and information available on access issues. At the same time, the Panel’s work overlaps with efforts taking place in these forums, including the WHO’s Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property, and WTO agreements, negotiations and other work on trade-related matters.

Further concerns regarding the High-Level Panel include the lack of sufficient time for the solicitation and development of data (including engagement with governments and stakeholders) and the lack of variety of expertise in the composition of the Panel.

 In sum, the United States believes that the issue of access to medicines is important for global health and for all countries. We would strongly advise the United Nations Secretary General to reconsider the Panel’s work and to work with interested Member States, in recognition of the complex nature of this issue, and the need to incorporate all relevant factors into a meaningful analysis of why people in low and middle income countries do not have the access to medicines that we all believe is desirable and necessary. We question whether the current mandate, and the process for the work of the Panel, are appropriate to produce recommendations that will have this impact.

 Thank you for your consideration of these comments. 

Bibliography and REferences

' http://www. who. int/trade/gIossary/story002/en/

See also the WHO-WTO-WIPO study "Promoting Access to Medical Technologies and innovation” pages 144—201, available at: https://www. wto.org/english/rese/booksp e/’pamtiwho v'Po»*toweb13 e.pd