E-DRUG: Free trade agreements threatening access to essential drugs
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["Free" trade is not good for access to medicines, as found by MSF in Peru.
For links to the English and Spanish versions of the report "Access
to Medicines at Risk Across the Globe: What to Watch Out
for in Free Trade Agreements in the United States", see
English: http://www.accessmed-msf.org/documents/ftabriefingenglish.pdf
Spanish: http://www.accessmed-msf.org/documents/ftabriefingspanish.pdf
WB]
For Immediate Release
Contact Kevin Phelan at +1-212-655-3763 or +1-646-201-8230
Free Trade Agreement Will Put Access to Life-Saving Medicines in Peru and
Region at Risk:
New Report Warns that US Trade Negotiations Are Threatening Access to
Medicines Worldwide
New York/Lima, Peru, May 14, 2004 – Intellectual property proposals being
negotiated in a free trade agreement between the United States, Peru, and
other Andean countries could severely restrict access to essential
medicines for millions of people in Peru and other parts of the Andean
region according to the international medical humanitarian organization
Doctors Without Borders/Medecins Sans Frontieres (MSF). MSF warns that the
negotiations being launched next week are part of a US strategy to span the
globe with bilateral and regional free trade agreements that undermine
international consensus reached at the World Trade Organization (WTO) about
the appropriate balance between the protection of private intellectual
property and the protection of public health. These agreements will make it
impossible for dozens of countries to uphold their right and obligation to
ensure access to affordable medicines for their populations.
In a new report released by MSF today entitled “Access to Medicines at
Risk
Across the Globe: What to Watch Out for in Free Trade Agreements with the
United States,” the organization argues that in existing agreements, Such
as those already finalized with Central American countries, Chile, Morocco,
and Singapore. the US has consistently pushed through intellectual property
provisions that will delay or even block generic competition – the only
proven means of reducing the prices of medicines. The report issues a
warning about these provisions not only to the Andean countries set to
begin negotiations next week (Colombia, Ecuador, Peru, and eventually
Bolivia), but also Panama, Thailand, five southern African countries, and
34 Latin American and Caribbean countries currently negotiating a Free
Trade Area of the Americas (FTAA).
For Peru, the impact of such agreements on access to medicines is clear.
Thanks to previous legislation that did not allow for pharmaceutical
patents, a number of generic medicines exist, including antiretrovirals for
people with HIV/AIDS. This market competition has forced the price of
first-line AIDS medicines down to as little as $408 per person per year,
compared to $4,300 per person per year for brand-name drugs.
“There are 76,000 Peruvians living with HIV/AIDS today, and hundreds and
thousands more with other life-threatening diseases. Their lives depend on
the availability of affordable medicines,” said Cedric Martin, head of
mission for MSF in Peru, where the organization provides medical care for
people living with HIV/AIDS in the slums of Lima and in the city’s
Lurichango prison. “Every day, people with HIV/AIDS are dying in Peru,
and
the only hope for access to treatment is through affordable medicines. If
the US gets its way, every new medicine brought to the market for AIDS and
other illnesses will be unaffordable for individual patients and the health
system in general.”
One of the most dangerous provisions that the US is pushing in free trade
agreements is a new “patent policing” role assigned to national drug
regulatory authorities. Normally, it is up to patent holders to ensure
their patents are enforced. The US government is also urging drug
regulators to block access to generic medicines by insisting that they
grant a five-year patent-like monopoly for drugs that are not patented by
the original manufacturer, and by preventing the registration of generic
versions of patented drugs, effectively rendering useless compulsory
licensing, one of the most important safeguards WTO intellectual property
rules [see technical note below for additional information].
Successful disease control programs will depend on future access to
affordable generic drugs. “If generic antiretrovirals were not available,
treating AIDS in Peru would cost ten times more,” continued Mr. Martin.
“At such a price access to medicines for the majority will be
impossible.”
How US trade policy aims to block access to generics: technical note on
proposed intellectual property provisions commonly proposed by the US in
free trade agreements and their potential impact on access to medicines in
Peru
Restrictions through Patents:
o Patent Extensions: Peru could be required to provide extensions on
patent-terms, beyond the 20-year monopoly period already required.
o Patents on “New Uses”: The US is seeking provisions that would
allow
companies to apply for a new patent for each “new use” of a product.
Under
this provision, a drug that is currently used to treat AIDS could receive a
new 20-year patent monopoly if it were found to be effective against
cancer. Legislation previously enacted by the Andean region explicitly
excluded new uses from their patent law, however this law would have to be
repealed if the agreement between the US, Peru and other Andean countries
included a provision on “new use” patents.
Restrictions through Registration:
o Linking Market Authorization to Patent Status: This provision would
bar the registration of a generic drug if a patented version has already
been registered. As a result, Peru’s drug regulatory authority will
become
an enforcer of patents on medicines.
o Data Exclusivity: The US is aggressively seeking 5-10 years of
exclusive protection over pharmaceutical test data needed to approve
medicines for use in a country, which means that in the absence of a patent
there would be a patent-like barrier to the registration and use of generic
medicines. The Andean region previously adopted legislation that included
data exclusivity, however this legislation was repealed when the negative
impact on access to medicines was recognized. The agreement between the
US, Peru, and other Andean countries would undo this pro-public health
change in legislation.
o Both provisions related to drug registration could have the
especially harmful effect of blocking compulsory licenses. Even if Peru
were to issue a compulsory license to overcome a patent barrier for a
life-saving medicine, these provisions could block the registration of the
drug for use in Peru, rendering the compulsory license useless.
Links to “Access to Medicines at Risk Across the Globe: What to Watch Out
for in Free Trade Agreements in the United States”
English: http://www.accessmed-msf.org/documents/ftabriefingenglish.pdf
Spanish: http://www.accessmed-msf.org/documents/ftabriefingspanish.pdf
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Rachel M. Cohen
U.S. Director, Campaign for Access to Essential Medicines
Doctors Without Borders/Médecins Sans Frontières (MSF)
333 Seventh Avenue, 2nd Floor * New York, NY * 10001-5004 * USA
Tel: +1-212-655-3762
Mobile: +1-917-331-9077
Fax: +1-212-679-7016
E-mail: rachel.cohen@newyork.msf.org
http://www.doctorswithoutborders.org/
http://www.accessmed-msf.org/
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