Name of Lead Author: Iris Isabel López
It has been reported in the communications media, during the time of intermittent shortages, Guatemala had the most expensive ARV [antiretroviral treatment] of all countries in the region due to the intellectual property of antiretroviral drugs. Since 2007, I have supported Guatemala in seeking antiretroviral treatment for persons with HIV, with the support of Aid for Aids, we have succeeded in mitigating the need in the three treatment plans. Intellectual property protection of drug molecules such as lopinavir/ritonavir has been a constant struggle, because it has been used for some 2000 patients, including 81 pregnant women 205 children for the presentation of Kaletra. This makes it necessary to invoke the human rights of life and health, and with the support of the World Fund, it was possible to purchase and supply the drug until 2015. According to comparative studies, [if?] acquired through local purchasing the cost would be $128.00, if acquired with the Revolving Fund its cost would be $80.00, through the World Fund $60.00, and if generic drugs were used their cost would be approximately $34.00. The Constitutionality Court is currently protecting a drug distribution company by prohibiting the entry of generic drugs, and these are beneficial since they meet the criteria of the World Health Organization [for] biosafety, bioequivalence, quality and lowest cost; this latter criteria affords greater coverage with lower investment, thus ensuring quality of life. Guatemalan law favors International Law with regard to Human Rights, and therefore the right to life and health must be considered critical in the acquisition of drugs, particularly because, if one is living with HIV, there are other degenerative diseases requiring treatment that are not covered by the Guatemalan government.
Corruption in Guatemala has affected the Public Health system, violating Human Rights.
Articles 93 to 95 of the Political Constitution of Guatemala recognize the Right to Health. “Right to health. The enjoyment of health is a fundamental human right, with no discrimination whatsoever.”
Article 94.- State obligation for health and social assistance. The State shall seek to ensure the health and social assistance of all inhabitants. Through its institutions, it shall promote relevant actions for prevention, promotion, recovery, rehabilitation, coordination and complementary actions to obtain for them more complete physical, mental and social wellbeing.
Article 95.- Health, a public good. The health of the Nation’s inhabitants is a public good. All persons and institutions are required to seek to maintain and restore it.
And Article 98.- Community participation in health programs. Communities have the right and duty to participate actively in planning, executing and assessing health programs. This guarantees and forces organized civil society to actively participate in the quest for the common good.
With regard to access to retroviral drugs, there are four distinct scenarios:
1. Acquisition of antiretroviral drugs and the law that has been amended to be able to make hospital admittance [internación] purchases, since the law violated and prevented purchase by the OPS [Organization of Pan-American States]/WHO Strategic Fund.
2. Registration of drugs with intellectual property, from their development molecule, to the detriment of individuals with HIV, one example [being] Lopinavir/Rotonavir and Kaletra in the case of childhood HIV.
3. Third-line antiretroviral treatment methods which, over three years, have benefited from international donations from Aid for Aids and Aids Healthcare Foundation
4. Support to protects and benefit specific healthcare businesses that sell pharmaceutical products at exorbitant prices, and that seek to prevent the use of lower-cost generic drugs. Acquisition of antiretroviral drugs and the law that has been amended to allow for hospital admittance purchases, since the law violated and prevented purchase by the OPS/WHO.
1. Generic drugs, especially antiretrovirals, are acquired by the OPS Revolving Fund, under Guatemalan law drugs must be purchased in accordance with the requirements of the State Contracting Law (Decree 57-92), and must be posted to the Government Acquisitions and Contracting System (GUATECOMPRAS).
In previous years this process was limited to the acquisition of antiretrovirals and other drugs distributed by the Ministry of Public Health and Social Assistance to the low-income population to address the morbidity rates from which they suffer.
From 2012 to 2014 it became necessary to include the amendment to Article 5 revising Articles 22 and 25 of Decree 57-92, but in order to avoid being reminded each year of its inclusion; Instrument 09-2015 issued by the Congress of the Republic of Guatemala that contains revisions to said State Contracting Law Decree 57-92 (Article 25 adds Article 54 bis Reverse Auction): “b) The Ministry of Public Health and Social Assistance and the Guatemalan Social Security Institute may directly acquire vaccines, antiretroviral drugs, family planning methods, pharmaceuticals, micro-nutrients, surgical and laboratory supplies, with the support of international agreements or treaties entered into with the following agencies: The Pan-American Health Office/ World Health Organization (OPS/WHO); agencies of the United Nations System, the World Fund; 1 United Nations Population Fund (UNPF), or by regional negotiation of prices carried out by the Office of the Executive Secretary of the Council of Ministers of Health of Central America and the Dominican Republic (COMISCA). Execution of these negotiations will be subject to the terms of the signed contractual instruments.”
Still pending is development of the regulation and its regulation, which shall be the responsibility of the Ministry of Public Health and Social Assistance, which seeks the option for hospital admittance purchases with the lowest cost and greatest coverage, and thus more individuals will be able to acquire quality drugs.
Registration of drugs with intellectual property, from their development molecule, to the detriment of individuals with HIV, one example [being] Lopinavir/Rotonavir and Kaletra in the case of childhood HIV.
There is the precedent of a pharmaceutical firm that, for ten years, enforced the intellectual property of a manufactured Lopinavir/Ritonavir molecule, including the pediatric drug known as Kaletra, this directly affected individuals with HIV receiving this treatment, because of its expense, and at a certain point, despite arguing with them to protect human rights to life and health, they threatened prohibit entry of the drugs and to file international claim against the Guatemalan government. UNOPS tried to mediate with the pharmaceutical and despite the harm to persons with HIV due to their not receiving the drugs on time, they were insensitive as they were protecting their private interests.
An attempt was made to correct this situation through the Legal Office of the Public Health and Social Assistance Ministry, the HIV Subsidy of the World Fund for AIDS, Tuberculosis and Malaria Project, and the Multisectoral National Commission of Organizations Seeking and Working to Prevent STD/HIV/AIDS (CONASIDA), based on and invoking human rights, which prevail over domestic human rights law in Guatemala.
The drug Lopinavir/Ritonavir is used in the treatment of HIV, the action mechanisms consists of inhibiting protease, a protein that plays an important role in the virus’ life cycle, particularly in its replication phase. Lopinavir itself breaks down rapidly in the organism, and the goal of combining it with Ritonavir is to slow down this process and increase the amount of time lopinavir remains in the bloodstream.
On September 15, 2000, the United States Food and Drug Administration (FDA) approved Lopinavir/Ritonavir in capsule and liquid form for use with other antiretrovirals in the treatment of infection by HIV in adults and children over 6 months of age. Lopinavir/Ritonavir in tablet form was approved by the FDA on October 28, 2005.
Guatemala’s indication is for treatment of infection by HIV; in this country there are two pharmaceutical forms registered by Abbott: 1) Tablets (Lopinavir 200 mg + Ritonavir 50 mg) and 2) oral solution (Lopinavir 80 mg + Ritonavir 20 mg). The treatment guides published by the Ministry of Public Health and Social Assistance in 2010 consider it a first-line treatment for pregnant women and second-line with the treatment failure of a first-line system; it is also considered first line only when neither Efavirenz nor Nevirapina can be used for some reason, in combination with Zidovudina and Lamivudina, the antiretrovirals of choice to initiate ARV treatment.
We note that the purchase cost of brand name drugs in Guatemala is considered high despite the fact that the majority are acquired through the Pan-American Health Organization (OPS/OMS) Strategic Fund; the main reasons for this are the extension and protection of invention patents and test data in favor of the pharmaceutical houses. An example of these are the drugs Lopinavir/ritonavir (ALUVIA) and Emtricitabina + tenofovir (TRUVADA)
To this end, the Ministry of Public Health and Social Assistance has raised the need to provide high-quality and low-price drugs, and thus it published Ministerial Agreement 472-2012 (August 13, 2012) declaring the drug Lopinavir/Ritonavir as being of high therapeutic interest and without any interest in its sale and marketing.
The Ministry of Public Health and Social Assistance of the Republic of Guatemala is the main recipient of the so-called intensification subsidy of HIV-AIDS Prevention and Treatment Activities in Vulnerable Groups and Priority Areas of Guatemala, financed by the World Fund; through this donation, and with the express approval of the Global Fund, it will acquire the generic version of the drug Lopinavir/Ritonavir.
To this end, UNOPS will act as Purchasing Agent to support the government of Guatemala in the process of acquiring said drug so as to guarantee the treatment of 1,652 patients, including pregnant women, and to rescue patients through the supply, provision and timely distribution to other beneficiaries of the STD, HIV and AIDS Program, who use the drug to contribute to maintaining adequate treatment coverage.
UNOPS has been officially requested to undertake the acquisition of an initial batch of 11,071 bottles of generic Lopinavir/Ritonavir. The specified content of each bottle is 120 tablets and each tablet has a certified concentration of 200/50 mg of the active ingredient Lopinavir/Ritonavir. In a separate document, the Ministry of Public Health and Social Assistance has provided the technical specifications to UNOPS and has requested that the shipping and billing documents be accompanied by the original quality certificate of the production batch or batches; a single photocopy of the good manufacturing practices certificate issued by the regulatory authority of the country of origin; and a single photocopy of the certificate for the free marketing of pharmaceutical products (OPS/OMS type) with documents in addition to those required for importation, given the high therapeutic interest.
The importation of generic Lopinavir/Ritonavir will allow for the purchase of greater quantities of product compared to the purchase of brand-name drugs, which in relation to the price are equivalent to double the cost. This affords a better distribution of resources for the purchase of other antiretrovirals and thus guarantees the timely supply of inputs and improved access to treatment in Guatemala.
The generic version of this product is expected to be received in May of 2013; the drug is expected to clear customs with no problems whatsoever, and we are awaiting a possible response that the pharmaceutical company Abbott might take at this time in order to prevent admittance of this product to the country.
Attached is the table showing product prices in generic and brand name versions. Total purchases for one year of this product fluctuates between 21,000 and 26,000 bottles per year.
Product Type Price per Bottle
The intellectual property expired in 2015 and it is necessary to ensure acquisition of antiretroviral therapy at standardized prices, since Guatemala purchases the treatments at the highest cost of any country of the region; Lidice López Tocón performed a study entitled “Tell me where you live and I will tell you the price of your treatment,” this analysis afforded a comparison of the costs of various drugs..
Third-line antiretroviral treatment methods which, over three years have benefited from international donations from Aid For Aids and Aids Healthcare Foundation
The problems of intermittent shortages in Guatemala that Aid for Aids has endured have specifically involved first-, second- and third-line plans. The pharmaceutical resistance of the drugs, whether due to interruption or prolonged use, necessarily requires undertaking third-generation monitoring, known as genotype.
In 2012 greater support was requested for a minor, who ended up being a direct beneficiary of Aid for Aids, who sent the third-line drugs, which have been beneficial and result in a very good quality of life. Upon completing the processing of the minor, there was already a list of 19 additional patients, most of them minors; the purchase of treatments through OPS requires an average of six months to receive the drugs in this country, and therefore it was necessary to request help and urgently offer them the treatments.
In 2013 and 2014, because the number of patients increased, they were unable to make timely projections and requested a search for donations of drugs; Aids Healthcare Foundation also offered third-line treatments.
The Guatemalan Social Security Institute (IGSS) has violated Human Rights and Decree 27-2000 [of the] General Plan for Combating the Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Syndrome (AIDS) and the Promotion, Protection and Defense of Human Rights in the presence of HIV/AIDS, which are covered by the Guatemalan Social Security Institute (IGSS) for the receipt of said benefits, with no restrictions whatsoever on this right. Due to the chronic nature of HIV/AIDS infection, said benefits will be for life. However, they have transferred to HIV patients with MARAVIROC structure, known as the latest generation.
MARAVIROC is a drug that does not appear on the list of antiretroviral drugs acquired through the OPS/OMS Strategic Fund, and therefore it is necessary for the Public Health Ministry to acquire it through local purchases in amounts totaling over $1,280.00 US dollars per month per patient, the sad thing in the transfer of the HIV patients is that they do not maintain a clinical history with the criteria for supporting said treatment, and therefore at least one genotype is considered necessary, a recount of T CD4 lymphocytes and Viral Load, which could provide guidance as to whether another drug from another plan might work without harming the patient’s compliance and treatment.
Complete treatment cannot be denied to any person wanting it, but it is indeed necessary that the Antiretroviral and Opportunistic Infections Treatment Guide in Guatemala be standardized, which offers antiretroviral treatment combinations by plan.
Individuals with HIV were covered for guaranteeing antiretroviral treatment by both the Guatemalan Social Security Institute and the national cohort served by the Ministry of Public Health Social Assistance, due to the existence of corruption at the various levels, including Public Health.
Appeal protecting and benefiting specific health businesses that sell pharmaceutical products at high prices, with a view to preventing the use of lower-cost generic drugs.
Another situation of concern was the Appeal filed by J. I. Cohen, which was declared as having merit by the Honorable Magistrates of the Constitutionality Court on November 17, 2015.
The appeal filed by J. I. Cohen, S.A. (1569-2015 of 11/17/2015) benefits the interest of distributors of pharmaceutical products who ignore people’s wellbeing; it has been widely rejected by Guatemalan civil society, including the public health authorities, they have not declared it as without merit [sic].
Recently, in the first week of January 2016, in written media a PAID AD has been circulating stating: “J. I. Cohen, S.A. CLARIFIES the decision of the Constitutionality Court dated November 17, 2015, identified in the case 1569-2015, it applies [to] approximately 6% of registered products in Guatemala, as they do are not included within the Pharmacopeias (Article 19, Governing Agreement 712-99).
The Pharmacopeias contain thousands of active ingredients, which are the basis for the manufacture of generics registered in Guatemala, they are NOT subject to the decision of November 17 and therefore they are NOT required to present toxicological or clinical studies, since in basing their manufacture on the standards appearing in said pharmacopeias, the toxicological and clinical studies carried out by the innovator support their safety and efficacy. For the estimated 6% of products to which the Constitutionality Court decision applies, there are other treatment options and alternatives such as generic drugs forming part of the remaining 94% as they are already included in the pharmacopeias. Therefore, the entire population has and will continue to have access to safe and effective generic drugs of proven quality. Protecting the business of a minority of products that have not demonstrated their safety and efficacy not only endangers the population’s right to life and health, but also places at risk the basis of the order of all society by breaking the state of law. Guatemala, January 2016.”
In the case of persons with opportunistic infections caused by histoplasmosis, who were treated at San Juan de Dios Hospital, several persons with HIV died because they required the drug known as Anfotericine B, a drug for hospital use, approximately 13 patients required using it, the treatment per patient was 14 bottles with a value of $7.88 US dollars per bottles; however, when the hospital wanted to purchase it, the cost the local distributors offered was $131.40 dollars and they also added that it was scarce. In this case it may be evidenced that because of the drug’s high price and scarcity, the hospital was unable to offer patients adequate treatment, this situation cost lives and the case was brought to the Human Rights Prosecutor.
We are indignant at seeing how the judges protect the interests of specific healthcare businesses and there is a clear trampling of human rights, particularly the right to health and the right to life. In view of the above, it is inferred that there have both been violations of the rights of persons living with HIV, and that the very political constitution of the Republic of Guatemala has been violated.
Bibliography and References
Political Constitution of the Republic of Guatemala.
Universal Declaration of Human Rights
State Contracting Act Decree 57-92
Decree 09-2015 of the Congress of the Republic of Guatemala
State Procurement and Contracting System
Ministerial Agreement 472-2012
Study “Tell me where you live and I will tell you how much your treatment costs” by Lidice López T.
Appeal 1569-2015 in favor of J. I. Cohen