[Ip-health] KEI statement to WHO 20th Expert Committee on the Selection and Use of Essential Medicines

Thiru Balasubramaniam thiru at keionline.org
Fri Apr 17 06:51:45 PDT 2015


*KEI statement to WHO 20th Expert Committee on the Selection and Use of
Essential Medicines*

Knowledge Ecology International (KEI) will present the following statement
on 20 April 2015 to the Open Session of the 20th Expert Committee on the
Selection and Use of Essential Medicines.


Statement of Knowledge Ecology International: WHO 20th Expert Committee on
the Selection and Use of Essential Medicines, with specific focus on
expanding access to new cancer drugs, when available at affordable prices

20 April 2015

Dear members of the WHO Expert Committee and the WHO secretariat,

Thank you for providing Knowledge Ecology International (KEI) the
opportunity to address this Committee.

In April 2002, the World Health Organization (WHO) made history by its
inclusion of antiretrovirals into the WHO Essential Medicines List (EML).
In the words of then Director-General, Dr. Gro Harlem Brundtland,

*[t]he designation of ARVs as essential are vital steps in the battle
against the AIDS pandemic. They should encourage both industrialized and
developing country governments to make HIV treatment more widely available.*
*[1]* <http://keionline.org/print/2206#1b>

This week, the 20th Expert Committee is asked to consider the inclusion of
new drugs for cancer, hepatitis C (HCV) and tuberculosis (TB), and to
change the methodology for the EML.

KEI wants the WHO to create a category in the EML for products that would
be essential, if available at affordable prices. We have been making this
proposal for several years, and we elaborate on the reasons today,
highlighting the case of new drugs for cancer.

Historically, the WHO has excluded drugs to treat cancer than have been on
the market less than 15 years, and are protected by patents. The exclusion
is primarily due to the high prices for cancer drugs. It is also the case
that many of the new drugs for cancer are targeted therapies, and some,
such as imatinib or dasatinib, are useful for treat fairly small
populations. In 2014, the USA approved 10 new cancer drugs. All 10 were
super expensive. Nine of the 10 new cancer drugs were approved as orphan
drugs, for small client populations. As we learn more from genetic and big
data, the use of targeted therapies will grow.

New drugs are expensive in some parts of the world, like North America, or
in Europe, due to policies, not physics, chemistry or biology. A policy to
grant an IPR monopoly, through patents, data or other IPR mechanisms, is
designed solely to induce investments in R&D.

Countries can regulate or eliminate monopolies, and some do. India has
broken the monopoly for sorafenib, because of excessive pricing, and
several countries broke the imatinib monopoly, also over pricing concerns.

Several countries and several health and innovation experts have proposed
the elimination of monopolies for cancer drugs, and the creation of new
ways of funding and rewarding investments in the development of new cancer
drugs and diagnostics devices, relying upon combinations of grants and
large, robust inducement prizes. The innovation prize funds would be funded
by the same entities tasked with reimbursing drug purchases today.

IPR enforced monopolies, created to induce investments, are only one way to
stimulate R&D,[2] <http://keionline.org/print/2206#2b> and they are the
wrong way, when it comes to cancer drugs, particularly for developing
countries, if that means a generation of cancer patients is excluded from
the benefits of new drugs that are used in high income countries.

By creating a category in the EML for drugs (and diagnostics) that are
essential, if available at affordable prices, the WHO will send a signal to
governments and cancer patients, that they have policy options that can
provide for more equal and more fair access to new drugs.

One of our employees has stage 4 HER2+ breast cancer. She is alive today
and leading a good life because she has had several years of treatment with
trastuzumab, a drug under consideration today that is finally losing its
patent and data protection, but which has had very limited access outside
of high income countries. She has recently switched to T-DM1, a drug that
so far is very effective in prolonging her life. Why would the WHO have a
policy that effectively endorses inequality? Why would the WHO only
legitimize the grant of an access restricting monopoly on a cancer drug,
and not recognize the possibility and the benefits of the alternatives that
expand access by delinking R&D funding from the prices of drugs, or
policies to address excessive pricing in other ways, such as through the
grants of compulsory licenses?

[1] <http://keionline.org/print/2206#1>WHO takes major steps do make HIV
treatment accessible, 22 April 2002,

[2] <http://keionline.org/print/2206#2>See: 2014. James Love, Alternatives
to the Patent System that are used to Support R&D Efforts, Including both
Push and Pull Mechanisms, with a Special Focus on Innovation-Inducement
Prizes and Open Source Development Models, World Intellectual Property
Organization, CDIP/14/INF/12, September 19.

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