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Section: Guatemala
Published: May 2004

Current State of Anti-Retroviral Access in Guatemala

By Bill Latham
Asociación Agua Buena

May 2004This report summarizes the current state of anti-retroviral (ARV) access in Guatemala and examines the potential impact of the Global Fund donation in coming years. Because the price of ARVs has a significant impact on access, the report compares prices paid by Médecins Sans Frontières (MSF) and the public health system, and discusses Guatemalan laws related to generic ARVs. 

"No Waiting List" Yet Thousands Lack Access

 Thanks to the efforts of MSF, Guatemala has reached a milestone of sorts in which there is "no waiting list" for PLWAs who need highly active anti-retroviral therapy (HAART). As MSF staff are quick to point out, however, that does not mean everyone who needs HAART is receiving it.In February 2004, MSF provided the following breakdown of ARV access in the country's clinics:











Ministry of Health










Hospice San José





Clínica Familiar Luís Angel García



(included in Ministry total)







*IGSS: Guatemalan Social Security Institute. A semi-autonomous agency providing health care to public employees and workers from participating private companies. See discussion below.Ministry of Health: Responsible for AIDS clinic in the Roosevelt National Hospital and assists clinic in San Juan de Dios National Hospital, through its National Aids Program (PNS).Hospice San José: NGO serving as both hospice and orphanage.

Clínica Familiar Luís Angel García: Partnership of NGO and Ministry of Health, in the San Juan de Diós National Hospital. Physicians' salaries paid by ministry, staff costs and some medicines provided by private sources.

Another 22 adults from Guatemala's armed forces are treated in the Hospital Militar, according to hospital physician Dr. Rodolfo Diaz, making the national total 2,596 as of February this year.  Between IGSS and MSF, at least 200 more people have begun receiving HAART since February, for a current total of about 2,800 who have access to ARVs. MSF currently provides ARVs at four locations: Coatepeque, Puerto Barrios and two clinics (Roosevelt National Hospital and MSF's own clinic, Yaloc) in Guatemala City.  People who appear at the national hospitals and need ARVs are referred to MSF, which is committed to providing treatment to anyone who needs it."We will give medicines to whoever needs them until Global Fund starts," said Sylvie Pouit, director of MSF-France in Guatemala. Despite this encouraging development, everyone who is working in AIDS in Guatemala agrees there are thousands more people who need treatment but are not receiving it.Dr. Ruben Mayorga, advocacy director of Oasis, believes an additional 3,500 to 5,000 people need treatment.  "Less than half of people who have symptoms will get tested," Mayorga said.  "Many will not be diagnosed.  Of the remainder, maybe 50% don't know where to get treatment. Treatment is given passively.  There is no aggressive campaign to tell people treatment is available because we don't have enough medicines."Sylvie Pouit said at least four factors prevent people from seeking therapy:  1) lack of HIV testing; 2) failure to diagnose the disease; 3) discrimination in health centers; and 4) failure to inform the public about where to seek treatment. In MSF's Yaloc Clinic, 60% of new patients were diagnosed as WHO Stage 4 and 36% were Stage 3, clearly indicating late diagnosis. Both Mayorga and Pouit note that, at this moment, most HIV tests in Guatemala are not free.  Tests at San Juan de Dios Hospital and Aprofam cost $7.50, while those at Proyecto Vida, which hosts MSF's Coatepeque clinic, cost $3.75, and tests at the Roosevelt Hospital are $5.00. Tests for pregnant women and children are free in the Roosevelt Hospital. MSF does not do HIV testing.Carlos Serrano, a coordinator with the PLWA group Gente Positiva, said there is no political will in Guatemala to provide medicines. Regarding access to ARVs in existing clinics, he said distance limits access for many people. "If they don't live with 50 kilometers of the medicine supplier, many are effectively without access," he said, noting that transportation costs are frequently an obstacle, as is the need for PLWAs to make constant visits to treatment centers in Coatepeque or Guatemala City.Based on epidemiological models, the National AIDS Program (PNS) estimates that 75,600 people had been infected with HIV through the end of 2003, and that 18,000 of those have died.  Dr. Sergio Aguilar of PNS believes 4,600 people will die of AIDS this year, and that the country will see 5,680 new AIDS cases in 2004.  He believes the sub-registry of  HIV/AIDS cases is extremely high, perhaps over 70%, and that 6,000 to 8,000 people are currently living with AIDS and need ARV treatment in Guatemala. As noted above, only 2,800 of these people currently have access to therapy.

 An Estimate Based on IGSS Data

 Because the Guatemalan Social Security Institute (IGSS) has historically treated many more PLWAs than any other group in Guatemala, and because it is more likely to identify the disease at an earlier stage than national hospitals, its data can be used as a rough check on the above estimates.  Several important demographic factors have to be kept in mind.IGSS services are roughly divided into three categories: Accidental Injury, Illnesses (Enfermedad Común) and Maternity.  HIV/AIDS is treated through Enfermedad Común, at the IGSS hospital in Zone 7 of Guatemala City. Dr. Paúl Chinchilla Santos, head of the epidemiology department at IGSS, estimates that, between IGSS affiliates and their dependents, about 15% of Guatemala's population has access to Enfermedad Común's services, and thus to HIV/AIDS treatment.Through January 2003, IGSS affiliates from only 11 of Guatemala's 22 departments received coverage for illnesses. That coverage was expanded to all but three departments (El Progreso, Santa Rosa and El Petén) in 2003. As of 2002, the number of IGSS affiliates in all departments was 953,052 and more than half, 587,075, were from the department of Guatemala. Another significant factor concerns wives of affiliates. Per IGSS regulations, Enfermedad Común services are provided to wives of workers in all departments except the department of Guatemala.  Women from Guatemala, if infected with HIV and pregnant, would receive AZT prophylaxis through the IGSS maternity unit, but would then be referred to national hospitals for treatment.  IGSS covers children without congenital illnesses through 5 years of age. A child who is infected with HIV at birth would be covered through the age of 15.In 2002, IGSS registered 223 new adult AIDS cases and 75 new pediatric cases. If one ignores the caveats above and simply assumes that IGSS covers 15% of the national population, these numbers suggest that, on a national level, there were at least 1,490 new adult AIDS cases in and 500 pediatric cases, or a total of 1,990 new cases in 2002.  In the first three months of 2004, IGSS registered a total of 129 new cases, suggesting a national rate of 3,440 new AIDS cases this year. While these calculations are simplistic, they do provide an independent estimate for new AIDS cases in Guatemala and corroborate the view that thousands of Guatemalans currently need ARVs but are not receiving them.

Global Fund: How Much Relief and When?

 In October 2003, the United National Global Fund approved a two-year grant for Guatemala's AIDS program, amounting to $8,423,806.72.  For reasons discussed below, the grant contract has not yet been signed and Global Fund programs have still not begun in the country.

The Global Fund proposal would provide ARV access for the following number of people:







Number of PLWAs with access to ARV therapy






 Dr. Mayorga notes that the number of PLWAs who could be treated are based on drug costs of $980 per patient per year.  If generics could be used, the number of people treated would be at least doubled.  MSF is currently conducting trials with Triamune (d4T+3TC+nevirapine), which significantly lowers costs to about $35 per patient per month, or $420 per year. Its current first-line therapies of AZT-3TC-Sustiva and D4T-3TC-Sustiva cost $602 and $500 per year, respectively.  MSF purchases generic AZT, D4T and 3TC from an Indian supplier, but obtains Sustiva from Merck. For these same therapies, the Guatemalan government pays about $1340 and $1560 per year.According to Carlos Serrano of Gente Positiva, the Global Fund will be treating about 75% fewer people if generic medicines can not be used.While the Global Fund donation will certainly improve ARV access, the number of PLWAs who gain access is much lower than the number of new AIDS cases appearing in Guatemala. Furthermore, some of the money may be needed to absorb patients treated in other centers.  MSF, which is committed to supplying ARVs to all new patients who need them in 2004 and to maintaining therapy for everyone who has begun it, hopes to begin scaling back its programs in 2005.  Chus Valverde, of MSF-Spain, said the organization hopes to begin placing its patients in Global Fund programs within the next year and a half.A firm date has still not been established for when Global Fund programs will begin. Guatemala, like many other countries, had hoped to designate the United Nations Development Program (UNDP) as the Principal Recipient (PR) of the donated funds.  The PR's responsibilities in each country include managing the funds and assuring that project objectives are being met.  Although other countries had used the UNDP as their PR,  the Global Fund recently ruled that the PR must be a local institution, forcing Guatemala's Country Coordinating Mechanism (CCM) to search out another agency to administer the funds.  That decision, which has not yet been made, must be approved by the Global Fund before the contract is signed.According to Dr. Mayorga, who serves on the CCM, 11 organizations have applied through a bidding process to administer funds. "We could have a primary recipient by June," he said.  "If everything goes very well, money would arrive by September."Annie Salazar of the National Aids Program is less optimistic.  She believes the contract will not be signed before September and that the most optimistic date to begin Global Fund programs would be January 2005.  The mechanism by which Global Fund money would be used to purchase ARVs has still not been worked out.

Generics Debate in Congress and Price Gouging on the Open Market

In 2003, the Guatemalan Congress enacted legislation, commonly known as Decree 9-2003, that effectively banned the registry and sale of new generic medicines in the country.

The law gives pharmaceutical companies five years of market exclusivity for newly registered drugs and prohibits the drug regulatory agency from using any confidential product data submitted in the approval process. Without using that data, the agency can not evaluate an equivalent generic version for registration and marketing approval. According to MSF, the law prevents generic drugs from being registered, even when there are no patents on those drugs.Any company wishing to sell the drug after five years must obtain the permission of, or enter a licensing agreement with, the original registrar. Because no time limit is established, the law essentially provides perpetual intellectual property rights protection to anyone first registering a drug compound for sale in Guatemala. So far eight drugs, none of them ARVs, have been registered since 9-2003 was enacted, and two more are pending.Under Decree 9-2003, a new product is defined as "any pharmaceutical product that has not been previously authorized for sale in Guatemla" and a new chemical is defined as "any active ingredient, chemical compound or molecule that has not been previously evaluated by the competent health authority in Guatemala for purposes of registration". Under Decree 9-2003, the mere act of registering a drug conveys intellectual property rights, based on the single criterion of whether the drug has been previously sold or registered locally.  A drug patented 100 years ago elsewhere in the world could conceivably enjoy perpetual, local protection if it had not previously been sold or registered in the country!The Ministry of Health, IGSS, MSF, Conferencia Episcopal, Landivar University, other NGOs and some pharmaceutical companies are backing a congressional proposal, introduced in April this year, to overturn 9-2003.  According to Luis Villa, general coordinator of MSF-Spain, the proposed legislation would modify existing Guatemalan law to bring it into compliance with World Trade Organization rules, including those governing data exclusivity and protection of confidential test data.The new legislation is opposed by the GANA political party of President Oscar Berger, a result, Villa believes, of U.S. pressure. Indeed, a recent Special 301 Watch List report from the United States Trade Representative warns that "legislation was introduced in April 2004 to revoke data exclusivity. If revocation were to occur, this would be a major step backwards in terms of fulfilling the TRIPS obligation to protect confidential test data, as well as one of the key intellectual property obligations in the recently concluded CAFTA . . . The United States will monitor this situation very closely."While patented inventions receive only 17 years of protection in the U.S., a newly registered drug in Guatemala effectively has perpetual protection. "The U.S. is trying to impose measures that don't even exist in its own country on an impoverished nation,” Villa said. "It's a moral question."For Annie Salazar, director of the National AIDS Program, the bottom line couldn't be simpler.  "The Ministry has to be able to buy the most effective drug, based on norms and protocols in the country, at the lowest price, while meeting standards of quality," she said.The stakes for AIDS care in Guatemala are enormous.  The PNS estimates the government could save 60% on ARVs if allowed to purchase generics.  "With our resources, we're going to be spending everything on medicines,"  Salazar noted. "We're currently spending 50% of our budget on medicines, viral loads and CD4 tests.  Most of the remainder goes to administration. I have nothing left for prevention."Dr. Rodolfo Diaz, of the army's hospital, expressed similar concerns. "Our budget is being cut and we need more funds to continue," he said.Generics aside, the government also pays far more for single-source drugs than NGOs pay on the open market.  In 2003, for example, IGSS spent about a third of its $6.7 million ARV budget on just one drug, Roche's Nelfinivir.  Under the government's procurement rules, a list of all drugs is submitted for open bidding at the end of each year.  Prices submitted by drug companies in the "open contract" then prevail for the next full calendar year at IGSS, the Ministry of Health and the Military Hospital.  The price Roche set for Nelfinivir in 2003 was $2.40 per 250 mg tablet to the government. MSF was able to negotiate a much lower price for the same drug, which it purchases from Roche for just $0.86 per tablet.  In January 2004, Roche lowered its open contract price to $1.44, still about 70% more than MSF pays.


 1. Approximately 2,800 people currently have access to ARVs in Guatemala. 2. An estimated 3,500 to 5,000 people living with AIDS lack ARV access.  Between 3,400 and 5,700 new AIDS cases are expected in 2004, the majority of which will not be diagnosed. 3. AIDS cases are under-reported due to lack of testing, improper diagnosis, discrimination, and failure to inform the public about availability of ARVs. Under-reporting may be as high as 70%.4. Global Fund programs are not expected to begin before late 2004 or early 2005.5. The Global Fund donation will provide ARVs to a relatively small percentage of new AIDS cases, especially if generic medicines can not be used.6. Legislation has been introduced in the Guatemalan Congress to repeal Decree 9-2003, a law that effectively bans the registry or sale of generic medicines, while maintaining compliance with WTO rules.  The legislation is opposed by the United States. 7. The Health Ministry, Military Hospital and IGSS could save more than 60% on ARVs if allowed to purchase generic medicines. The government pays far more for single-source drugs than NGOs who purchase them from the same suppliers. 

*Bill Latham 
AIDS Medicines for Guatemala  
Tel: 502-232-3882

**Asociacion Agua BuenaSan José, Costa RicaRichard Stern, DirectorTel/Fax:

Guillermo Murillo


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