Legislation on Antibiotics in Latin America

Full text (in Spanish, 119 pp, PDF, 672 Kb; contents listed below, with heading translated for user orientation)

Part I: Legal Norms
- Introduction
- Content and Methods
- Legal Norms on Medications in Latin America
- Compulsive Health Registration
- Prescription, Dispensing and Supply of Medications
- Dispensing Facilities, Production and Distribution
- Control of Advertising and Promotion
- Statutes and Regulations on Antibiotics
- Drug Surveillance
- System of Compliance to Norms
- Conclusions and Recommendations
- References

Part II: Annexes
1. Norms per Country, in Chronological Order and by Website
2. Legal Drug Definitions, including Antibioltics, and and Regulatory Agency (by couhtry)
3. Health Registry for Drugs
4. Prescription, Dispensing and Supply of Medications
5. Places Authorized to Dispense, Produce and Distribute Drugs
6. Control of Drug Advertising and Promotion
7. Specific Legislation on Antibiotics
8. Controlling Compliance with Existing Norms

PAHO Antimicrobial Resistance Page

- WHO Drug Resistance Page
- WHO Pharmaceutical Products Page

Prepared in 2004 by Carlota Ríos Ruy-Pérez.
Coordinated by Mónica Bolis, Strategic Health Development Area, and
Roxane Salvatierra-González, Disease Prevention and Control Area¹

The objective of this study is to analyze existing legislation on the general topic of prescription drugs and on the specific topic of antibiotics, with the goal of evaluating its regulatory effectiveness and applicability, and to weigh the influence and repercussions of judicial measures on the causes of and solutions to the inappropriate use of antibiotics.

Antibiotics can be defined as "a substance produced by or a semisynthetic substance derived from a microorganism and able in dilute solution to inhibit or kill another microorganism." ²

The resistance of the infectious agents of certain diseases to drugs specifically used to combat them is a phenomenon confirmed by scholars who have observed the appearance of bacterial strains with susceptibility profiles highly resistant to drugs previously used. From the perspective of global public health, this resistance constitutes an increasing problem that has worsened through the misuse or abuse of antibiotic agents. This is expressed in the Declaration on Resistance to Antibiotics presented by the World Medical Association in its 48^th General Assembly held in South Africa in 1999.³

In Resolution WHA51.17 adopted by the World Health Organization (WHO) in 1998⁴, Member States were urged to do the following:

• Promote the appropriate and effective use of antibiotics with regard to cost.
• Prohibit issuing antibiotics without a prescription from a skilled health professional.
• Limit the excessive use of antibiotics in animal husbandry with regard to products destined for human consumption.
• Promulgate or strengthen legislation to impede the manufacture, sale, and distribution of counterfeit antibiotics, as well as the sale of antibiotics in parallel markets.
• Strengthen health services and their surveillance capacity, in order to obtain compliance with current legislation.

El plan estratégico de la OMS para contener la resistencia a los antibióticos, publicado en 2001, refuerza estos conceptos y encarece a los gobiernos que velen por el cumplimiento de todas las medidas recomendadas. Según los criterios de la OMS y de los peritos en el tema, los factores que han contribuido de forma importante al desarrollo del problema son: The WHO Global Strategy for Containment of Antimicrobial Resistance, published in 2001, strengthens these concepts and urges governments to ensure the implementation of the recommended measures⁴. According to WHO criteria for and to experts on the subject, the factors that have contributed importantly to the development of the problem are as follows:

• Prescriptions for antibiotics being issued by unqualified people.
• Prescriptions for antibiotics being issued either indiscriminately or excessively by qualified professionals.
• The exaggerated or incorrect use of antibiotics in hospitals.
• Self-medication and misguided perceptions on the part of poorly informed patients.
• Patient noncompliance to regimens or prescribed doses.
• Inadequate or misleading advertising and promotion.
• The sale of antibiotics in unauthorized parallel markets.
• A lack of legislation regulating the use of antibiotics and enforcing existing standards.

As a result, certain factors-not techno-scientific but rather sociocultural ones-can be observed that directly affect this problem and have been considered in studies conducted in Argentina, Brazil, Chile, Cuba, Ecuador, Mexico, and Uruguay. These studies provide evidence to prove that this problem is indeed present in the Region of the Americas. They underline, among other points, that in Latin America the lack of regulatory legislation makes it possible to distribute and sell antibiotics freely without a prescription, which subsequently makes the task of controlling this practice is especially difficult in the Region, there being no regulatory standards on antibiotics. This means that consumers can obtain them anywhere, which makes self-medication a serious problem.⁵

Latin America presents a very broad and varied spectrum with respect to drafting legislation aimed at ensuring the health of the population. Drug control, licensing for the medical and pharmaceutical professions, and scientific, technical and research activities-as well as those of those pertaining to trade-are all normative components of considerable importance within what is commonly called 'sanitary law' or 'health legislation'.

This legislation has been developed on par with the growth of both commerce and of the pharmaceutical industry. Also worth emphasizing is the influence of international organizations specializing in health, and nowadays also of international economic nuclei within the Region such as the Southern Cone Common Market (MERCOSUR), the Andean Community (CAN), and the Central American Integration System. These groups have contributed important sets of standards for various subjects concerning drugs, as well as resolutions that have been ratified by the States involved and incorporated into current legislation now in effect in each country.

¹ Our thanks to Susana Castiglione, Consultant for Health Legislation, for her contribution to this study.
²'Antibiotic'. Merriam-Webster Online Dictionary.
³ World Medical Association, Declaration on Resistance to Antibiotics. Adopted by the 48^th World Health Assembly (WHA) held in Somerset West, South Africa, in October 1996.
⁴ World Health Organization, 51^st World Health Assembly: Emerging and other communicable diseases, antimicrobial resistance (Res. WHA51.17/1998).
⁵ Sosa A, Resistencia a antibióticos en América Latina. Boston: Association for the Prudent Use of Antibiotics (APUA).