Transcript Presentation

Special 301 and Access to
Medicines:
The Case of Guatemala
Ellen R. Shaffer PhD MPH, Joe Brenner MA
Center for Policy Analysis on Trade and
Health (CPATH)
www.cpath.org
October 2010
Crisis in Access to Medicines
in Guatemala
“No hay dinero,” Jakelin Johana Cucyan
Sosa, a Guatemalan woman living with HIV.
Deepening crisis for sick Guatemalans.
US- Central American Free Trade
Agreement (CAFTA) and Special 301 have
pushed the cost of medicine out of their
reach.
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Access to Medicines Reduced for
People Living With HIV/AIDS
Sosa is one of an estimated 59,000 people
in Guatemala living with HIV
Guatemalans are one-sixth of Central
America’s HIV infected population. (USAID)
Cost of managing HIV/AIDS for Sosa and
for other women and families in Guatemala
has increased dramatically since CAFTA
and as a result of Special 301.
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CPATH Case Study - Guatemala
3 Questions to Determine:
1. Whether CAFTA IP rules are limiting
access to generic and lower price
medicines in Guatemala.
2. The influence of data exclusivity on
pricing in Guatemala.
3. The price implications of introducing data
protected drugs to the market, and
conferring data protected status to drugs
already offered in Guatemala.
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Case Study – Methodology
Identified several drugs used for
conditions that are common causes of
morbidity and mortality, and also for
HIV/AIDS.
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Tug of War
Data Protection in Guatemala
TRIPS (WTO)
Protects data against unfair
commercial use
Guate 1999
DE, exceptions for access
Guate 2000
15 years DE
Guate 2003
5 years DE
Guate 2004
DE repealed
Guate 2005
5 years DE
CAFTA 2006
5 years DE
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Data Exclusivity
77 brand-name drugs have data
protection for either 5 or 15 years,
including 5 protease inhibitors for
HIV/AIDS
DE 15 years: Kaletra – HIV/AIDS
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Case Study Finding
Compared prices for a sample of 5- and 15-year
data protected drugs with non-data protected
drugs listed on the Open Contract, for statins,
insulins, antibiotics, oncology drugs, and
protease inhibitors.
Data-protected drugs are significantly more
expensive compared to non-protected drugs in
the same therapeutic class.
Health Affairs, 28, no. 5 (2009): w957-w968
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Case Study Finding (continued)
Examples:
Data protected Insulin Lantus costs 846%
more than isophane insulin
Data protected anti-fungal Vfend costs
810% more than the non-data protected
amphotericin B
Data protected intravenous antibiotic
Invanz costs 342% more than the nondata protected meropenem (Meronem).
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Medicines $ vs. Lives
Drug
DataProtected
No DP
Diff:
Cost
Diff:
Lives
Insulin
$50
$5
846%
9
Antibiotics
(IM)
$85
$10
810%
7
Antibiotics
(IV)
$58
$17
342%
2
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Guatemala’s Ministry of Health –
Strategies to Lower Drug Costs
Donors such as PAHO and the Clinton
Fund have offered HIV/AIDS medicines at
lower prices.
Guatemala’s Decree 16-2003 permitted
waiving import taxes on AIDS drugs and
other benefits.
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Special 301 Submission PhRMA Responds (2008)
“…Ministry of Economy’s failure to act
upon proposals developed by the Ministry
of Health..
“…Guatemala has not corrected the tax
discrimination caused by Decree 16-2003
against R&D products that has been in
force for more than four years.”
“PhRMA members recommend that
Guatemala remain on the Watch List in
2008…”
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Result: Guatemala on
Special 301 Watch List for 2008
Implication: Guatemala could be
penalized with U.S. trade sanctions
for non-compliance
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Guatemala Gets the Message
2009 - Ministry of Health instructed to
purchase HIV/AIDS drugs directly from
brand-name originator drug companies at
full price.
Drug purchases from PAHO and the
Clinton Fund, which offered lower prices,
cut off.
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Prices for HIV/AIDS
Drugs Increase Sharply
In 2009, prices increased in some cases by a factor of 13, forcing
the Ministry of Health to sharply curtail the medicines and services it
was able to provide. [CPATH]
In Jan. – March, 2010, Guatemala bought (ARVs) at elevated prices
in the local market. This resulted in a loss of $3 million and put the
lives of hundreds of people at risk, due to delayed delivery by local
providers. [Agua Buena]
The rapid growth in the number of people receiving antiretroviral
therapy is challenging the country’s ability to sustain its treatment
program. [UNGASS]
UNGASS Report – Guatemala, 2010. Available at : http://data.unaids.org/pub/Report/2010/guatemala_2010_country_progress_report_en.pdf
Agua Buena: Comparison of ARV prices in 9 countries in Central and South America (2006). Available at:
http://www.aguabuena.org/articulos/regional20061027.php
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301 Effect on HIV/AIDS Drugs
Prices ($US) Vs. Lives, 2010 (Agua Buena)
Medicine
Efavirenz 600mg
Local
PAHO
Diff $
Diff
LIVES
306
49
$257
5
Lopinavirritonavir
200/50mg
1497
420
$1070
2
Abacavir 300mg
2858
190 $2668
Tenofovir 300mg
205
78
$127
2
Didanosina 100
mg
806
89
$717
8
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16
Impact on Access
Jakelin Johana Cucyan Sosa manages her
illness, and is caregiver for her husband, who is
also HIV positive and bedridden.
She cares for her two daughters, Frida 11, and
Sabrina, 7.
She had received free treatment though Hogar
Marco Antonio Clinic, a small,donations-based
clinic.
Unable to get funding for the suddenly more
expensive drugs, Sosa’s healthcare facility lost
the ability to provide adequate treatment.
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Crisis Deepens
Lack of treatment causes demand for
2nd-line and 3rd line drugs, often
unavailable in Guatemala
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CAFTA and Special 301Medicine More Expensive
CAFTA grants greater monopoly rights to
brand name pharmaceutical companies
Special 301 List makes medicines more
expensive and less available for women
and families in Guatemala
Local distributors also benefit: JI Cohen
was chosen even when bids more costly
than competitors [Agua Buena]
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Civil Society Response
Media and health professionals are critical
The Global Fund has demanded that purchases
be made through transparent and efficient
mechanisms, such as the PAHO Strategic Fund
or the Global Fund’s Voluntary Pooled
Procurement (VPP). However, this restriction
only applies to purchases made with Global
Fund resources, which means that unless an
effective system of oversight is put into place,
there still exists the possibility of “tossing public
money out the window”.
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Policy Recommendations
1.
Remove Guatemala from the Special 301 List.
2.
Ensure that Special 301 is not used to promote TRIPSplus restrictions on access to medicines.
3.
Adopt a policy guideline banning USTR from using
Special 301 to punish nations which take regulatory action
to promote public health and access to medicines.
4.
Prioritize public health in U.S. trade policy. Include health
experts and advocates in all levels of trade policy
development, effective immediately.
5.
Indicate support for Guatemala’s Decree 16-2003, and the
Guatemalan government’s legal authority and obligation
to purchase medicines at the most affordable price in
order to treat the largest number of people.
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Protect Global Health
Center for Policy Analysis on Trade and
Health (CPATH)
Ellen R. Shaffer
Joseph Brenner
www.cpath.org
[email protected]
Phone: 415-922-6204
Fax:
415-885-4091
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