Thiru Balasubramaniam

Thiru Balasubramaniam

[Reposted from] As mentioned in a previous piece, the trilateral report by the secretariats of the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and the World Trade Organization (WTO), Promoting Access to Medical Technologies and Innovation: Intersections between public health, intellectual property and trade, covers a lot of ground including but not limited to: 1) the global burden of disease and global health risks, 2) health and human rights, 3) access to essential medicines: an indicator for the fulfillment of the right to health, 4) public health, innovation and access in the WHO, 5) intellectual property systems, 6) competition policy, 7) free trade agreements, 8) the current R&D landscape, 9) new approaches to innovation for neglected diseases, 10) WHO Expert Groups on R&D Financing, 11) generic medicines policies, price controls and reference pricing, 12) pre-grant and post-grant review procedures and 13) review of IP provisions in recent FTAs.

At the launch of the report, a Geneva-based diplomat drew KEI’s attention to the report’s treatment of human rights, particularly in the context of the right to health. The diplomat noted that the report’s references to the obligations to safeguard the right to health in the context of public health and trade rules would have been unthinkable 10 years ago. This pieces endeavors to contextualize the report’s treatment of human rights within WHO discussions on de-linkage and the R&D treaty which seek to secure “an enhanced and sustainable basis for needs-driven, essential health research and development” (WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property).

Chapter II A(1) deals with the human rights dimension in relation to trade rules and intellectual property. In particular, the trilateral report references to the obligations to safeguard the right to health in the context of public health and trade rules would have been unthinkable 10 years ago. The report presents the human rights framework as an “important mechanism to further the public health policy goals of ensuring and improving access to medicines for those who are most in need” in light of the double burden of infectious and noncommunicable diseases faced by low and middle-income countries (Page 40).

On the WHO Constitution’s inextricable link to the right to health, the report states:

The human rights dimension has provided an important legal and policy vantage point for consideration of public health and pharmaceutical issues. International human rights law defined under customary international law and international human rights treaties create binding obligations on member states. The WHO Constitution was the first international instrument to state that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition” (see Preamble). The right to health is a central element of the international human rights system. It is part of the Universal Declaration on Human Rights, adopted in 1948, the 1966 International Covenant on Economic, Social and Cultural Rights (ICESCR), as well as of regional
human rights instruments and many national constitutions. By 2009, 135 countries had incorporated aspects of the right to health in their national constitutions (Perehudoff, 2008; Hogerzeil and Mirza, 2011). It also constitutes the basis for the overall objective of the WHO – laid out in Article 1 – which is “the attainment by all peoples of the highest possible level of health”. The Declaration of Alma-Ata, adopted in 1978,provided a more global perspective on tackling the inequities in access to health care systems in general linking the social
dimension of achieving the highest attainable level of health and access to essential medicines. (Pages 40-41)

Perhaps the most surprising portion of the report’s language on human rights is contained in the following passage which states:

“In the context of neglected diseases where innovation in medical technologies has not kept with the needs of developing countries, the right to health includes an obligation for states to promote R&D of new medical technologies.”

This human rights dimension should be at the forefront current discussions at the WHO to “secure an enhanced and sustainable basis for needs-driven, essential health research and development relevant to diseases that disproportionately affect developing countries” (Global Strategy and Plan of Action on Public Heath, Innovation and Intellectual Property)

In its treatment of these WHO discussions, we note the trilateral reports’s emphasis of the de-linkage concept.. The report described de-linkage in the following manner:

One important concept that evolved from this discussion is the concept of delinking price of the final product from the costs of R&D. This concept is based on the fact that patents allow developers to recoup the costs and make profits by charging a price in excess of the costs of production. This way of financing R&D is viewed as constituting a barrier to access to medicines in countries where populations pay out of their own pockets for medicines and thus cannot afford to pay high prices. The principle of delinking is based on the premise that costs and risks associated with R&D should be rewarded, and incentives for R&D provided, other thanthrough the price of the product (Page 116).

The trilateral report notes that the core recommendation of the WHO Consultative Expert Working Group on R&D Financing,

“recommended that WHO member states negotiate a global convention or a treaty under the auspices of Article 19 of the WHO Constitution. The proposed convention would be aimed at providing effective financing and coordination mechanisms to promote R&D.”

In light of the trilateral report’s contention that right to health includes the obligation for states to promote R&D of new medical technologies, countries should further analyze and examine the de-linkage and R&D treaty concept in discussions on the right to health, trade rules and innovation and access.

However, the report does leave the reader unsatisfied in one aspect. As this reports examines the intersection of health, trade rules and intellectual property, it invites the question as to whether the current R&D system, predicated upon international trade rules, is subject to the right to health. Perhaps this was a bridge too far for the secretariats of WHO, WIPO and WTO.