UNSG High-Level Panel Releases Report on Improving Access to Medicines

22 September 2016

A new report by a panel convened by the UN Secretary-General on improving access to medicines and health technologies has drawn significant interest in the week since it was released, along with questions about next steps in this field.

The publication, known formally as “The High-Level Panel on Access to Medicines Report: Promoting Innovation and Access to Health Technologies,” was formally released on 14 September, bringing to a close a nearly year-long process launched by UN Secretary-General Ban Ki-moon in November 2015.

The report was commissioned as part of a broader recognition of the strong relationship between health and development, which is also referred to in the UN Sustainable Development Goals (SDGs) adopted in September 2015. The third SDG is focused specifically on good health and well-being, and outlines a series of related targets to meet this goal.

Addressing policy incoherence

The goal of the report was to attempt to reconcile “the policy incoherence between the justifiable rights of inventors, international human rights law, trade rules, and public health in the context of health technologies,” according to the panel’s terms of reference.

This same policy incoherence, the panel noted, has limited “access and the right to health” to a large portion of the world’s population.

The publication elaborates on policy recommendations to improve access to medicines for communicable and non-communicable diseases, both in developed and developing countries. The analysis covers the interlinkages – and potential gaps or inconsistencies – in the relevant human rights, trade, intellectual property rights, and public health frameworks and policies.

Overarching messages

The report calls upon all stakeholders, especially governments, to take concrete steps aimed at filling the gap when the necessary market incentives are lacking. Specifically, the report suggests taking steps that would “delink” research and development (R&D) costs from prices, arguing that such actions are essential when trying to develop, for example, innovative approaches to emerging infectious diseases, such as the Ebola and Zika viruses.

“No one expected either virus to leave its endemic borders or spread so rapidly. Consequently, no vaccines were developed,” the report says. In turn, the lack of prior funding for developing Ebola therapies and point-of-care diagnostics proved devastating when the disease outbreak was at its full force in 2014, with the virus ultimately killing over 11,000 people.

The report also calls for government action in fostering additional health-related investment, such as in medical R&D. This investment could be structured in a similar fashion to foreign aid commitments, where a percentage of national GDP is committed annually.

Another recommendation suggests requiring more transparency from the pharmaceutical industry. This could involve having manufacturers and distributors disclose their R&D costs, as well as those incurred in production, marketing, and distribution.

The report suggests taking advantage of the flexibilities offered by the TRIPS Agreement, as reinforced by the 2001 Doha Declaration. Article 27 of the TRIPS Agreement, which deals with patentable subject matter, is also cited as a relevant consideration, given the importance of ensuring that patentability is only possible when innovation is indeed genuine.

The report also addresses another area of the TRIPS Agreement, specifically the terms regarding compulsory licenses under Article 31 of TRIPS. The panel states that some governments might not be currently exercising this right, in an attempt to avoid industry backlash.

Any government or industry action that is tantamount to undermining TRIPS-provided flexibilities must therefore be avoided, according to the panel. Ways to address this could include reporting any “undue political or commercial pressure” during one of the WTO’s trade policy review exercises.

The report also addresses how intellectual property rights are dealt with in free trade agreements negotiated among countries – and warns against including “TRIPS-plus” provisions in such accords. “These provisions may impede access to health technologies, including those requiring governments to ease standards of patentability, drug regulatory authorities to link marketing approval to the absence of any claimed patent, and the requiring of test data exclusivity instead of test data protection, to list a few,” the report says.

The publication therefore stresses that any trade deal must avoid including terms that could hinder policies “that guarantee the right to health for all.”

According to Professor Frederick Abbott, member of the Expert Advisory Group that provided assistance to the High Level Panel, the report can be broken down in three key messages.

Firstly, Abbott told Bridges, “new models of innovation that do not rely on funding through high market prices of medicines are needed.” The second and third key points, he continued, involved how to tackle market distortions and some of the challenges in the current intellectual property framework.

“In order to address distortions in the market for medicines, all governments must maintain the flexibility to use the measures they find appropriate to overcome them, and should not bargain away or be forced to leave these flexibilities unused. Objection by a minority of HLP members regarding interpretation provides ongoing evidence that the TRIPS Agreement can and does remain an obstacle to addressing critical access to medicines issues,” he said in summarising these last two points.

Initial reactions

The much-anticipated release of the report drew swift reactions from media outlets and stakeholders alike, with some welcoming the report’s efforts and objectives, while others raised questions as to its focus and scope.

On the industry side, some pharmaceutical companies have already expressed concerns over the focus of the report, with some representatives telling the Financial Times that the panel should have directed its work toward the lack of proper infrastructure. They cited examples such as the need for temperature-controlled vehicles and warehouses, which could improve the storage and transport of medicines in order to guarantee effective distribution.

The US Chamber of Commerce issued its own reactions upon the report’s release, similarly questioning the focus of the UN panel report. According to the US business federation, the publication did not cover the “real culprits that stand between patients and care” – specifically, tariffs and taxes levied on imported medicines, along with weak healthcare infrastructure that impedes effective distribution.

“The irony is that by singling out patents, this report has attacked the innovative systems that have actually produced thousands of cures and saved millions of lives,” said the US Chamber of Commerce, warning that the report’s recommendations could hurt the private sector’s ability to develop ground-breaking new treatments.

Meanwhile, some civil society groups have argued that the report should have gone even further in its recommendations, rather than focusing so much on market failures. One suggestion raised by some NGOs would be to put forward some solutions that they say would be relatively quick to implement, such as automatic compulsory licensing on essential medicines.

“We applaud the Panel’s most proactive recommendation, which calls for the negotiation of a binding international medical research and development convention that would increase and coordinate governments’ investments in R&D and delink the costs of R&D from end prices,” said Health GAP in a statement.

The group disagreed, however, with some of the other points in the report, such as the suggestion that TRIPS flexibilities provided a sufficient framework for resolving the access to medicines issue.

Nevertheless, many stakeholders have also acknowledged the report’s relevance in bringing to the fore various sensitive issues – such as access to affordable medicines, transparency of R&D costs and prices, and public return on R&D commissioned by the public sector – and encouraging more discussion and action.

ICTSD reporting; “Poorer countries need rapid access to generic drugs, UN says,” FINANCIAL TIMES, 14 September 2016.

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