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Healthy Skepticism Library item: 10319

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Vacca Gonzalez CP, Fitzgerald JF, Bermudez JA.
[Defining generic drugs: an end or a means? Analysis of regulations in 14 countries in the Region of the Americas].
Rev Panam Salud Publica 2006 Nov; 20:(5):314-23
http://www.ingentaconnect.com/content/paho/pajph/2006/00000020/00000005/art00004?token=00511e6139098649c25d2f3f7b2f27375f2a72752d705e437a63736a423147355d7d766a44532e567


Abstract:

OBJECTIVES: To characterize current regulatory practices and trends relating to competing medications in 14 Latin American and Caribbean countries.

METHODS: Between July 2004 and April 2005 we collected information on national regulations and policies that established or contained a definition of “generic drug” and related terms in 14 Latin American and Caribbean countries: Argentina, Barbados, Bolivia, Brazil, Colombia, Costa Rica, Ecuador, Guatemala, Mexico, Nicaragua, Panama, Paraguay, Peru, and Venezuela. We also compiled information on the incentives to register and produce competing medications, promotion of the use of International Nonproprietary Names (INNs) for pharmaceutical substances, the regulation of bioequivalence studies, and the replacement of prescription medications with less expensive alternatives.

RESULTS: We noted three patterns in the regulations: (1) countries that encourage financial support for competing medications, extensively promote the use of INNs, and place no restrictions on the replacement of innovative (proprietary) medications with competing products (Argentina, Colombia, Costa Rica, Ecuador, and Paraguay); (2) countries with policies aimed at showing therapeutic equivalence, which limits substitutions to approved products from a list of authorized competing medications that must be prescribed by their INN and must use distinctive labeling (Brazil, Mexico, Panama, and Venezuela); and (3) countries at a beginning stage in the process of regulation (Barbados, Bolivia, Guatemala, Nicaragua, and Peru). This variety leads to difficulties in characterizing pharmaceutical markets, and can lead to misleading categorizations.

CONCLUSIONS: Efforts to harmonize policies should consider the possible relationship among definitions adopted in different countries, the development of national pharmaceutical markets, and national policies to stimulate competition.

Keywords:
DRUG INDUSTRY; DRUGS; GENERIC; DRUG AND NARCOTIC CONTROL; AMERICAS Publication Types: English Abstract MeSH Terms: Barbados Drugs, Generic/standards* Latin America Terminology Substances: Drugs, Generic


Notes:

Spanish.

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909