The UN Secretary-General’s High-Level Panel on Access to Medicines (“Panel”) released its final report (“Report”) last month on the issue of promoting innovation and access to health technologies. It comes close on the heels of the UN Human Rights Council Resolution on Access to Medicines (see our post on it here) and echoes most of the sentiments expressed in the Resolution. The Report itself states that it builds on the “previous and existing work in the field of health technology innovation and access”. Nevertheless, the Report is notable for its no-holds barred approach towards issues such as the need for delinking the price of medicines from their R&D costs, concluding an R&D Convention for delinking, meeting heads on the aggressive stance adopted by U.S. towards nations trying to utilise TRIPS flexibilities, enabling an expedient compulsory licensing regime, among other things. As expected, the Report has already generated opposition from pharma industry. The US Department of State also has criticised the Report labelling it as “fundamentally flawed” and working under a pre conceived notion of policy incoherence between IP rights, trade liberalisation and human rights.
Background
The Panel consisted of 15 members, drawn from various backgrounds having a bearing on the health sector and was supported by an Expert Advisory Group. India marked its presence through Yusuf Hameid, the non-executive director of Cipla. The mandate given to the Panel, formed on November 19, 2015, by UN Secretary General was 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.”
Highlights
The Report is broken down into four chapters with specific recommendations at the end of each one. The first one titled ‘Health Technology Innovation and Access’, identifies the main barriers to access to health. The chapter starts off by noting that despite the tremendous advancements made in the field of medical innovation during the last few decades, a number of unmet health needs remains due to factors like high costs, inadequate R&D investment, among others. As regards inadequate R&D investment, Report notes that it is often a result of the apprehension that investments for certain diseases/ medicines will not be profitable. It specifically points out the cases of antibiotic resistance, Neglected Tropical Diseases (“NTDs”) and outbreak of infectious diseases like Zika virus and Ebola to drive home this point. Thus, despite the public private and product development partnerships in recent years, there is still need for increasing investment by the public sector if we are to effectively bring out delinking of costs, states the Report.
The most significant observation of the chapter though is in regard to the impact of policy incoherencies in enabling access. The Report observes that as a result of policies related to trade, intellectual property, health and human rights developing at different points in history and with different objectives, policy incoherencies have crept in with the efflux of time. Moreover, even in the absence of such incoherencies, the tendency of nations to prioritise the implementation of IP laws ignoring the flexibilities available therein has impeded access. The Report is particularly severe on the tactics adopted by wealthier nations, who have time and again arm twisted the poorer nations into forgoing the TRIPS flexibilities, thus reducing the possibility of enabling access.
The second chapter addresses the impact of intellectual property laws on access. Of special interest is a suggestion, which came up within the Panel to implement a system of compulsory licensing that is “effectively automatic by way of its predictability and implementation, provided the requirements under Article 31 are met.” Although the suggestion was not adopted ultimately, the Panel nevertheless urged that the “national laws be drafted in a way that facilitates the prompt and expedient use of a compulsory license or government use for non-commercial purposes of a patent, including criteria to determine the remuneration of the right holder.” Reference is also made to the “Paragraph 6 decision”, which had attempted to provide countries with scant biomedical manufacturing capacity the benefit of compulsory licensing. The Report laments the non-application of this exception and the failure by WTO members to incorporate the decision as an amendment to TRIPS till date. While ruing the inability of countries to use the TRIPS flexibilities, the Report also cautions against the emerging trend in the use of TRIPS- plus provisions in trade agreements, like TPP.
The third chapter though has garnered all the media attention as it focuses on the need to come up with new incentives for R&D of health technologies. The Report notes that the current market mechanism will not be able to provide adequate incentives in cases like anti-microbial resistance, and new models in the form of transaction taxes would have to be introduced to meet the emerging challenges. Apart from suggesting the need to delink R&D costs from end product prices, it also recommends the drafting of a binding R&D convention that would enable delinking. The final chapter is devoted to suggesting measures to improve governance, accountability and transparency at the levels of governments, multilateral organisations and private sector, which could usher in these recommendations and keep track of their progress.
Conclusion
More than two years ago, Swaraj had blogged about the decision of World Health Assembly to give WHO the mandate create a pool fund that will enable delinking of prices from R&D costs. The post also had a reference to a £10 million prize, which was awarded to anti-biotic research. Two years hence, these themes on innovative funding mechanisms and anti- microbial resistance have been repeated in the Panel Report. The palpable change though has been the growing number of health crises being added to the list. While some of the ideas may be repeated, the Report is noteworthy for calling out the pressure tactics of countries like US. Also, the relevance of such a Report seems to be at an all-time high, given that even the wealthier nations may be struggling to manage the burgeoning drug prices and are planning to cut down on health coverage rather than the looking for ways to cut down the prices. Thus, even if some of the ideas in the Report may have divided public and industry opinion, the larger point about the need for developing new models to overcome barriers to access still holds good.
(Image from here)