UN Releases Report on Access to Medicines
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.
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.
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.
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 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.