E-DRUG: New Guatemalan Decree Hinders Access to Medicines
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[crossposted with thanks from IP-HEALTH; WB]
10 July, 2003
Guatemala City, July 10th, 2003 - The international medical humanitarian
organization M�decins Sans Fronti�res (MSF) warns that a decree passed by
the Guatemalan government in April this year seriously jeopardizes access to
life-saving medicines for the most vulnerable people in Guatemala.
67.000 Guatemalan people, 4.800 of them children, are living with HIV/AIDS.
Since antiretrovirals (ARVs) are not protected by patents in the country,
MSF has been able to use generic ARVs in its programs in Guatemala and
subsequently has been able to buy drugs more than 75-99% cheaper than the
government.
On April 15th 2003, the Guatemalan Industrial Property (IP) Law was
modified: the Congress passed Decree 9-2003, which gives originator
pharmaceutical companies five years of market exclusivity in the country
starting from the registration of the originator drug in Guatemala. The
decree bans the drug regulatory agency use of originators' product data,
which is necessary to give the equivalent generic version marketing
approval. This drastic change in Guatemalan law will prevent generic drugs
from being registered even when there are no patents on those drugs. This
five-year exclusivity does not exist in any IPR legislation in Latin
America.
"The decree is bad news for poor people living with HIV/AIDS in Guatemala,"
says Luis Villa, Head of the MSF mission in Guatemala. "Because of the new
decree, registration of generics like the ones we use will be delayed and
patients outside the MSF project will not be able to benefit from these
cheaper alternatives. Five years can be a question of life and death for
people living with HIV/AIDS," Villa says.
Decree 9-2003 creates an unnecessary barrier to accessing cheaper medicines.
"This is particularly alarming since ARVs are not under patent in Guatemala
and importing and using generic drugs has therefore been unlimited," says
Cailin Morrison, legal expert of the MSF Campaign for Essential Medicines.
"The WTO TRIPS Agreement does not require countries to provide such market
exclusivity to originator companies, and there is no reason for countries to
be doing this."
MSF urges the Guatemalan Congress to repeal Decree 9-2003, which would
abolish data exclusivity, thus promoting generic competition and improving
access to assured quality medicines. For too many people living with
HIV/AIDS and other diseases in Guatemala, medicines have been a luxury.
There is only one thing that has brought down the prices of ARVs in Central
America, and that is the introduction of generic competition. The Guatemalan
government must uphold its commitment made in Doha to protect public health
over commercial interest.
In Guatemala, MSF teams provide medical care for people with HIV/AIDS and
Chagas, as well as primary health care and other services for vulnerable
populations. MSF is present in Guatemala since 1988.
[Rachel Cohen
MSF-USA
rachel.cohen@newyork.msf.org]