[Ip-health] The Wire: US’s Inconsistent Policies on Pharma Could Compromise Global Access to Medication

Thiru Balasubramaniam thiru at keionline.org
Tue Oct 11 03:12:50 PDT 2016


US’s Inconsistent Policies on Pharma Could Compromise Global Access to


A recently released UN report highlights international “policy incoherence”
on medication, but the US has denounced its findings, signalling its
unwillingness to institute reforms.

Following public outcry against increases in drug prices, most notably by
US presidential candidate Hillary Clinton, the high cost of medication has
taken centre stage in the US. The country’s recent response to a UN report
on access to medication brings to light its somewhat contradictory position
on medication.

The report, released last month, was met with disappointment and rancour –
mostly from the US and some sections of the pharmaceutical industry. While
civil society groups have largely been welcoming of the report, some groups
thought the panel could have been more ambitious in its recommendations. In
particular they felt the panel could have laid stronger emphasis on
bolstering countries’ commitments to rectifying the issue of compulsory
licensing of drugs. Additionally, the panel could have further strengthened
its language on human rights issues discussed in the report.

While the US has painted itself into a corner on its position on access to
medicines, it is not the only country pushing for higher patent protection
for its drugs. For instance, Switzerland has also pushed for stronger
protection. But what specifically makes the US’s position so untenable is
its own desire for cheaper drugs at home, particularly given the context of
current domestic policy debates.

Issues with UN panel

UN Secretary General Ban Ki-Moon constituted the UN High Level Panel on
Access to Medicines in November 2015 “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”. The panel
comprised former heads of state, academics, treatment activists, civil
servants and representatives from the pharmaceutical industry, including
both generic and branded drug companies.

The panel conducted two public hearings in the course of its consultations
over the past year – in London andSouth Africa – and received over 180
different submissions from governments, industry representatives, civil
society groups, academics and intergovernmental organisations.

Over the past few months, the US has made concerted efforts to display its
opposition, including raising questions on the very premise of the panel.

Winnie Byanyima, executive director of Oxfam International and one of the
members of the panel, said in an email, “The US government and the
pharmaceutical industry have made their opposition to the high level panel
and the resulting report clear from the outset. They are closely aligned in
their fight to maintain a status quo that puts profits before people and
has led to a dramatic rise in the cost of new medicines across the globe.”

In its submission to the panel earlier this year, the US government said
that “the narrowly-focused mandate of the Panel was flawed” and that the
panel could not address the inter-related issues that are barring access to
safe, effective and affordable medicines.

Pressure from Big Pharma

In February this year, several pharma associations, including the
Biotechnology Innovation Organization, National Association of
Manufacturers, National Foreign Trade Council, Pharmaceutical Research and
Manufacturers of America (PhRMA), the US Chamber of Commerce and the US
Council for International Business (USCIB) wrote to Orrin Hatch, an
American senator from Utah, alerting him to“the lack of transparency
regarding the selection of the panel members and experts, the limited scope
of inquiry…”

Hatch is the chairman of the senate finance committee and is widely seen as
an ally of the pharma industry. So strong are the ties that in April this
year, the senate finance committee also allegedly try to pressure Colombia
in its efforts to grant a compulsory license on the Novartis cancer drug

The associations urged Hatch to “work with the administration to support an
effective interagency approach to safeguard innovation at multilateral
institutions.” They cited “a positive precedent” set by the coordination
between the US state department, office of the US trade representative and
the US commerce department at the December 2015 UN Framework Convention on
Climate Change (UNFCCC) negotiations held in Paris: “In Paris technical and
IP (intellectual property) experts from different parts of the
administration worked together to secure a final UNFCCC text that does not
mention IP and thus removes uncertainty that could have discouraged
continued investments by US companies in clean technology.”

On the other hand, civil society groups took active steps to seek answers
from the US administration. In July this year, more than 50 civil society
organisations wrote to the US secretary of state John Kerry asking him to
explain whether the use of pressure on issues related to the access to
medicines is consistent with the US’s policies and priorities. They
expressed their concerns over the public statements made by state
department representatives regarding the mandate, composition and work of
the panel, including the US’s official submission to the UN panel.

Responding to queries sent over email, the state department said that it
has responded to this letter and that the US intellectual property rights
office met with some representatives from civil society on September 22 to
discuss issues raised in their letter. “The incoming letter does not
address the so-called ‘pressure exerted by the State Department on the
High-Level Panel’ and this is simply incorrect,” a spokesperson from the
state department said.

Contradictory policies

When the report was released last month, the US government denied the
existence of any “policy incoherence” in its domestic policies and
denounced the report as “fundamentally flawed” in a statement to the press.
This policy incoherence between granting monopolies to drug companies and
the people’s access to medication was one of the key issues that the UN
panel was tasked to investigate.

Civil society organisations such as Knowledge Ecology International (KEI)
rebutted the US government’s denial, pointing out the inconsistencies in US
policy. James Love from KEI, who spoke to this reporter on the sidelines of
the WTO Public Forum held in Geneva last week, said, “US government
officials insist that no policy incoherence exists between R&D [research
and development] incentives based upon high drug prices and access to the

Love also pointed out inconsistencies in the US government’s stand on
different medication-related issues being considered by the UN right now.
He drew attention to the recently endorsed draft on antimicrobial
resistance (AMR), which came about as a result of a high level meeting of
the UN General Assembly and was released a week after the UN report on drug
prices. “The US position on the high level panel was not consistent with
the position on the same issue in the same fora in the same week, in the
context of antibiotic drugs,” Love said.

Notably, section 10 (c) in the declaration on AMR states “…we acknowledge
the importance of delinking the cost of investment in research and
development on antimicrobial resistance from the price and volume of sales
so as to facilitate equitable and affordable access to new medicines,
diagnostic tools, vaccines….”

Critics also allege that the US’s domestic policies on access to medicines
contradict its international stand on the issue.

Judit Rius, the US manager and legal policy advisor for Médecins Sans
Frontières’s Access campaign said, “There is a disconnect between what the
US says domestically and what it says internationally on the access to

She drew attention to a recent article by US President Barrack Obama in the
Journal of American Medical Association. In the article, Obama touched upon
the challenges arising from the fact that the pharma industry opposes any
changes to current US drug policy. “We need to continue to tackle special
interest dollars in politics,” he wrote in reference to the domestic
healthcare system.

Love said, “Drug prices are a huge issue within the US and the notion that
high prices don’t interfere with access is absurd. We don’t want the US
Department of State to block work on de-linkage. We need to move away from
monopolies and high prices, while preserving or expanding incentives for
new drug development. This is what de-linkage is about, finding a way to
eliminate the conflict between R&D incentives and access”.

UN panel’s recommendations

Among the panel’s most significant recommendations is that “governments and
the private sector must refrain from explicit or implicit threats, tactics
or strategies that undermine the right of the WTO Members to use TRIPS [the
agreement on Trade Related Intellectual Property Rights] flexibilities”.
The panel said that undue political or commercial pressure, including
punitive measures against offending members, should be reported to the WTO
secretariat and its members.

Ruth Dreifuss, co-chair of the panel and a former president of Switzerland,
said in Geneva last week, “With this report, we wanted to find out if we
can build on the big hope that was promised at the time of the Doha
Declaration in 2001. Were countries able to use the flexibilities in the
TRIPS agreement? Unfortunately the evolution did not happen as we had
anticipated”. Dreifuss was referring to clause in the Doha Declaration that
affirmed that the TRIPS agreement “can and should be interpreted and
implemented in a manner supportive of WTO members’ right to protect public
health and, in particular, to promote access to medicines for all”.

In the past, the US and Switzerland have pushed for rights to file
complaints against some countries over the loss of trade ‘benefits’ under
TRIPS, although their IPR laws are consistent with international

Additionally, concerned about the the UN report’s take on human rights
issues, the US made efforts to weaken the report’s language, according to
some sources who did not wish to be named.

Speaking to this reporter later, Dreifuss denied the presence of any
external pressures on the panel. “But there were good dynamics from within
the panel,” she said.

Earlier in the year, the UN Human Rights Council passed a resolution on the
access to medicines. At the time, Australia, the EU, Japan, Switzerland and
the US had said that human rights cannot have primacy on international
trade and investment regimes.

On this, Dreifuss said, “Even if all international treaties are equally
binding, the implementation of fundamental human rights must take
precedence over trade and investment agreements.”

The panel’s recommendations attempt to address all of these issues. Daniela
Bagozzi, spokesperson for the Essential Medicines and Health Products
Department at WHO said in an email, “The panel recommends negotiating a
binding UN R&D convention that would delink the costs of R&D from the price
of medicines. This is in line with the recommendations of WHO’s
Consultative Expert Working Group on Research and Development: Financing
and Coordination. However, this proposal has not gained much support among
WHO member states over the past years. It thus remains to be seen whether
this proposal will be endorsed by governments this time.” She said that the
WHO is working on a fair pricing forum for 2017, to bring together all key
actors and try to reach an agreement on pricing strategies to make
medicines more affordable and expand access.

In India, although the UN report has been welcomed, concerns remain about
how the country will respond to likely US pressure on the matter.

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