[Ip-health] KEI Intervention at SCP20 on Patents and Health

Claire Cassedy claire.cassedy at keionline.org
Tue Jan 28 06:47:01 PST 2014


KEI Intervention at SCP20 on Patents and Health

Submitted by Thiru on 28. January 2014 - 5:45

28 January 2014

Thank you Chair.

As the SCP considers the relationship between patents and health, it is
timely and relevant to reflect on the recent statement made by Marijn
Dekkers, the CEO of the pharmaceutical company Bayer on December 3rd, 2013.
The drug company is in the middle of a dispute in India over the pricing of
the cancer drug Nexavar. Bayer set the price of Nexavar at $65 thousand
dollars per year in India, and in response, the India government granted a
compulsory license. Competition from two generic drug companies led to a 97
percent decrease in the price of this drug. Dekkers described the
compulsory license as "essentially theft," and then went on to say, "We did
not develop this medicine for Indians. We developed it for western patients
who can afford it."

In setting the price on a drug for a deadly disease like cancer, Bayer
determined that the company was better off excluding nearly all patients in
India. This is why governments need to have the authority to break patent
monopolies -- to protect health and, "in particular, to promote access to
medicines for all," an obligation of the 2001 Doha Declaration on the TRIPS
Agreement and public health.

During roughly the same period, Merck and a number of other large drug and
medical device companies proposed an extensive public relations and
lobbying campaign to undermine patent reform in South Africa. Also during
the same period, Gilead received US FDA approval for an important new drug
that can cure hepatitis C, and announced it would charge $1,000 per pill,
and a total of $84,000 for a course of treatment.

Concerns about patents and health are not only a developing country issue.

Since 2011, drug companies have registered a record number of new cancer
drugs with the US FDA. Most of the new cancer drugs are priced at more than
$60,000 per year. More than 10 are priced at more than $100,000 year, and
some are nearly $400,000. Doctors, reimbursement authorities, patients and
employers in high income countries like the United States are shocked at
these aggressive prices, and are struggling to control costs and protect

Greece and Spain are considering the use of compulsory licenses on patents
for super expensive cancer drugs.

Germany, the United States, Belgium, Canada and France have all issued or
considered compulsory licenses of patents on medical devices and

In considering the work program on health and patents, the SCP needs to
identify specific activities that are relevant to the challenges
governments face, including those with aging populations, budget deficits
and escalating healthcare costs.

The African Group and the Development Agenda Group have proposed a series
of studies, meetings, research projects and technical assistance activities
which collectively strengthen the ability of states to negotiate and manage
some of the challenges directly relating to patents and health.

Some government delegations at seem intent on blocking any work that could
weak drug company monopolies. This is wrong -- wrong for developing
countries, and also wrong for countries with developed economies.

The US proposal (SCP/17/11) at the SCP, first made in 2011, is basically a
defense of the worst abuses of the patent system in the field of health --
even as courts in the United States have issued compulsory licenses on at
least four medical devices in recent years and recently abolished patents
on certain gene patents. In addition, the Congress has created an automatic
compulsory licensing program for undisclosed patents on biologic drugs as
part of the Affordable Care Act.

The United States should abandon its proposal, and delegates should
negotiate a work program using as its starting point the Africa Group/DAG

If the patent system is going to survive and thrive, it will have to be
seen as an instrument to benefit society, and not as a weapon of mass
destruction. Reforms that moderate the worst abuses of the patent system
are good for the patent system, because these reforms protect the patent
system's legitimacy and role in promoting social welfare.

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