[Ip-health] Letter from 56 non-profits and experts to Secretary of State John Kerry on pressure on global access to medicines initiatives

Andrew S. Goldman andrew.goldman at keionline.org
Thu Jul 21 08:35:29 PDT 2016

Yesterday over 50 U.S.-based and international NGOs and experts sent a
letter to Secretary of State John Kerry to explain evidence that the State
Department recently pressured the United Nations Secretary-General's
High-Level Panel on Access to Medicines, and the governments of Colombia
and India against taking action to improve access to affordable medicines.

The letter itself and a press release sent by KEI and Public Citizen is
available here: http://keionline.org/node/2616

The text of the letter follows:

July 20, 2016

The Honorable Secretary of State John F. Kerry
U.S. Department of State
2201 C Street, N.W.
Washington, D.C. 20520

Dear Secretary Kerry:

We are writing to express our concern about recent statements made by
representatives of the State Department on issues regarding intellectual
property (IP) and access to medicines in various settings, including
proceedings in Colombia, several important United Nations fora, and in

*Colombia & Cancer Treatments*

In May 2016, leaked memos from the Colombian Embassy suggested that the
United States Trade Representative and others in the United States
government and Congress have pressured the government of Colombia not to
increase affordable access to imatinib, a leukemia drug marketed by Swiss
company Novartis under the brand names Gleevec or Glivec.  The drug has
generated over $47 billion in global sales for Novartis and already faces
generic competition in the United States. The Novartis price for the drug
in Colombia per patient is approximately twice the Colombian gross national
income (GNI) per capita.

The government of Colombia has been asked by Colombian civil society
organizations to issue a compulsory license on the patents, in compliance
with the World Trade Organization’s (WTO) Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS), in order to remove
barriers to generic competition and to foster affordable access to this
lifesaving drug.

The Colombian Embassy was sufficiently alarmed by the pressure from the
United States to twice remark that it was concerned that proceeding with
the compulsory license would put at risk the $450 million committed for
President Obama’s initiative to support the Colombian peace process, Paz

More recently, following a public announcement on June 9 by the Minister of
Health that he would proceed with a public interest declaration to lower
the price of the drug — only one of a series of enumerated steps toward a
compulsory license under Colombian law — news outlets aired footage of
United States Ambassador to Colombia Kevin Whittaker publicly stating that
it is very important for the Colombian government to consult with the
United States on this decision.

The declaration by the Minister was the result of over a year and a half of
national consultations, and follows Novartis’s complete rejection of
efforts by the Colombian Ministry of Health to negotiate a more affordable

We were surprised and dismayed by Ambassador Whittaker’s remarks, which
were interpreted, in Colombia and elsewhere, as unwanted interference with
a domestic dispute over the price of a drug sold by the Swiss corporation.
The United States State Department should not interfere with the government
of Colombia’s efforts to increase access to affordable medicines. Colombia
is under no obligation to consult the United States on a decision to use
its national law, when its actions are consistent with trade agreements
binding both the United States and Colombia.

*United Nations (UN) Secretary General’s (SG) High-Level Panel on Access to

In November 2015, UN Secretary General Ban Ki-Moon announced the convening
of a High-Level Panel on Access to Medicines (HLP) “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 call for submissions for consideration of the HLP to inform its report
welcomed participation from a wide array of organizations from a diverse
collection of sectors including governments, industry, civil society,
academia, and intergovernmental organizations. The panel itself consists of
former heads of state, academics, generics and brand-name pharmaceutical
industry leaders, treatment activists, civil servants and more.

We are troubled by public statements from United States State Department
representatives regarding the mandate, composition and work of the HLP,
including in its official submission to the panel, labeling it as
possessing a “critical flaw.” The U.S. submission went so far as to
question the very premise of the panel, namely that a conflict exists
between “the rights of inventors, international human rights law, trade
rules, and public health.” Such a sentiment is out of touch with the
reality faced every day by patients in developing countries around the
world and here in the United States faced with rising drug prices and lack
of innovation for critical medical needs, such as antibiotic resistance and

In June 2016, the U.S. Mission to the United Nations criticized the HLP
again in its statement at the UN High Level Meeting on Ending AIDS. The
U.S. Mission cited amongst its concerns “the Panel’s narrowly-defined
mandate, the non-transparent manner in which it was constituted, and the
presumption of a policy incoherence.”

We are deeply disappointed that the U.S. has expressed these views.  Most
disturbing was the fact that the U.S. mission questioned the notion of
policy incoherence. This incoherence is both straightforward and important.
Policies that lead to higher prices create barriers for access. If
governments rely upon high prices to fund innovation, then they have to
accept limited and unequal access to new medicines, as well as no
innovation when high prices through sales are not an option to recover R&D
costs. In what sense does the Department of State see that as coherent and
good policy?

The work of the UN HLP on Access to Medicines to advance conversations to
remedy this policy incoherence is vital. The challenges caused by high
prices of medicines and lack of innovation are not a developing country
concern only and should become a global priority, as the G7/G20 and the UN
is increasingly recognizing through the search for strategies to better
respond to antimicrobial resistance.


We are concerned about the growing evidence that the United States
continues to place pressure on the Government of India to adopt policies
that result in higher drug prices and the elimination of production sources
of affordable generic drugs. These pressures including attacks on India’s
use of compulsory licensing of patents on drugs that are not affordable,
and efforts to change India’s law on the granting of patents that expand,
extend and “evergreen” drug monopolies.

The U.S. State Department has played an active role in this pressure: the
U.S. Embassy in New Delhi regularly provides a forum for industry
representatives to address Indian policymakers and stakeholders, works with
the U.S. Patent and Trademark Office’s Intellectual Property Rights
Attachés to coordinate pressure on key officials, and delivers speeches
designed to publicly push the Indian government to adopt restrictive IP
policies. The Embassy also readily misinterprets requirements in the TRIPS
agreement related to the protection of test data to argue that India should
implement test data exclusivity measures.

India’s patent laws are compliant with the obligations and public health
safeguards in the TRIPS Agreement. Even without the U.S. pressure, the WTO
rules are severe and have limited the supply of affordable generic versions
of most new drugs. The pressure from the U.S. seeks to go even further in
limiting the supply of affordable generic medicines by preventing India
from using provisions in its national law that facilitate expedited generic
competition, including through the use of compulsory licenses. While these
provisions are consistent with WTO rules, they are opposed by large
pharmaceutical companies that seek to expand monopolies and raise drug
prices worldwide.

Any policies or practices that India adopts to expand patent rights on
medicines, restrict the use of compulsory licensing or other exceptions to
patent rights, or introduce new exclusivity rules for data would have
dramatic and negative implications for people across the globe that
desperately need access to affordable life-saving medicines, including many
global health programs funded by the United States government, such as the
U.S. President's Emergency Plan for AIDS Relief (PEPFAR). Moreover, the
same maximalist IP policies that the U.S. is promoting abroad are resulting
in a growing and unsustainable crisis of unaffordable medicine prices right
here in the United States.

We request that State Department refrains from further pressuring countries
and the UN Secretary General High Level Panel on Access to Medicines.

We take note of the official U.S. government position as stated in the
United States Trade Representative 2016 Special 301 Report, that “the
United States respects a trading partner’s right to protect public health
and, in particular, to promote access to medicines for all,” and “the
United States respects its trading partners’ rights to grant compulsory
licenses in a manner consistent with the provisions of the TRIPS
Agreement.” We contend that the incidents described in this letter
contravene this U.S. government policy.

We await your written response to this letter (a) detailing whether the
State Department sees these incidents as coherent with U.S. government
policy; and (b) clarifying State Department commitments and position on the
right of governments to use TRIPS flexibilities to protect public health
and access to medicines. Please address how the State Department will
prevent recurrences of this conduct in the future, including any guidance
that might be provided to U.S. government personnel.

We are available for a meeting at your earliest convenience to discuss
these issues in greater detail and ensure policy coherence and fulfillment
of international commitments with State Department interventions.


African Services Committee
Alianza LAC-Global por el Acceso a Medicamentos
All-Ukrainian Network of People Living with HIV/AIDS
American Federation of Labor and Congress of Industrial Organizations
American Medical Student Association
The Berne Declaration
BUKO Pharma-Kampagne
Canadian HIV/AIDS Legal Network
Cancer Families for Affordable Medicine
Catholics in Alliance for the Common Good
Center for Policy Analysis on Trade and Health (CPATH)
Center for Study of Responsive Law
Centro de Información de Medicamentos de la Universidad de Colombia (CIMUN)
Comité de Veeduría y Cooperación en Salud (CVCS)
Comunicación Positiva
Prof. Carlos Correa
Essential Information
Foundation for Integrative AIDS Research
Fundación IFARMA
Health Action International (HAI)
Health Global Access Project (Health GAP)
Initiative for Medicines, Access & Knowledge (I-MAK)
Interfaith Center on Corporate Responsibility (ICCR)
International Human Rights Clinic, University of Chicago Law School
Just Foreign Policy
Karisma Foundation
Knowledge Ecology International
La Conferencia Episcopal de Colombia
Latin America Working Group (LAWG)
LWC Policy Consulting
Maryknoll Office for Global Concerns
Médecins Sans Frontières/ Doctors Without Borders (MSF USA)
Medicines Law & Policy
Mesa de ONGs con Trabajo en VIH/SIDA
Misión Salud
Dr. Suerie Moon
National Physicians Alliance
NETWORK Lobby for Catholic Social Justice
Observatorio del Medicamento de la Federación Médica Colombiana (OBSERVAMED)
Pax Christi International
Positive Malaysian Treatment Access & Advocacy Group (MTAAG+)
Prescription Justice Action Group
Presbyterian Church (USA)
Public Citizen
Prof. Susan Sell, George Washington University
Dr. Matthew Rimmer, Queensland University of Technology
Student Global Access Campaign (SGAC)
Union for Affordable Cancer Treatment
United Church of Christ, Justice and Witness Ministries
Universities Allied for Essential Medicines (UAEM)
Dr. Germán Velásquez, Former Director of the WHO Secretariat on Public
health, Innovation and Intellectual property
Washington Office on Latin America (WOLA)
Yale Global Health Justice Partnership
Young Professionals Chronic Disease Network
Prof. Peter K. Yu

Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670

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