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ANALES?DE?LA?REAL?ACADEMIA?NACIONAL?DE?FARMACIA?
ISSN (Online) 1697-4298
Counterfeit medicine. A threat to health. Legal situation
Title in Spanish: El medicamento falsificado. Una amenaza para la salud. Situación legal
Carlos del Castillo Rodríguez1,*, María Jesús Lozano Estevan
1Facultad de Farmacia, Universidad Complutense de Madrid
ABSTRACT: The existence of substandard, spurious,
falsely labelled, falsified and counterfeit (SSFFC)
medical products is an unacceptable risk to public
health, becoming an emerging problem in recent years.
However, we should be aware that the phenomenon of
counterfeiting is not a novelty since such practice
coexists with human beings since time immemorial. In
the present work we will do a partial analysis of
counterfeiting situation from a legislative point of view
and will analyze how various legal and non-legal
instruments have been used trying to resolve this issue
in the European context.
*Corresponding Author: carlcast@ucm.es
Received: November 20, 2015 Accepted: December 14, 2015
1. INTRODUCTION
Medicines are medical products subject to state
intervention in all their phases (1), being multi-
dimensional products (2). According to Valverde (3):
“there must be a need of moving towards a free global
movement of medicines taking into account the specific
problems of developing countries”. The legal regulation of
medicines can not be understood without a detailed
regulation of persons, both natural and legal persons
involved in the circulation and supply of medicines (4).
Nowadays, worldwide, there is an irregular supply of
medicines. This activity is a great threat that has to be
controlled by the public administration as guarantor of
citizens' rights.
We should understand that the movement of counterfeit
medicines is an emerging problem in both developed and
developing countries. Although in Spain the distribution
chain is secure, health authorities should be alert to the
emergence of possible counterfeit medicines, especially
sold online through websites. The community pharmacist
occupies the best position to exercise pharmacovigilance
and detection activities of counterfeit medicines since at
present there is a large number of consumption in
developed countries due to the population's feeling of
insecurity.
Although health authorities in developed countries had
proved the existence of spurious/falsely-labelled/falsified/
and counterfeit medicines, they thought they could only be
@Real Academia Nacional de Farmacia. Spain
Article
analesranf.com
RESUMEN: La existencia de medicamentos
falsificados es una realidad. Se trata de un problema
emergente en los últimos años. Sin embargo, hemos de
ser conscientes que el fenómeno de la falsificación no es
un hecho novedoso ya que tal práctica convive con el
ser humano desde tiempos pretéritos. En el siguiente
texto se realizará un análisis parcial de la situación de
los mismos desde su punto de vista legislativo y se
analizará cómo se han utilizado diversas herramientas
jurídicas y no jurídicas para intentar solventar esta
problemática existente a nivel comunitario.
An Real Acad Farm Vol. 81, Nº 4 (2015), pp. 329-333
Language of Manuscript: English
purchased by users via Internet. There was no evidence
that might be found in legal distribution channels, at least
in the European Union.
However, in 2007, the British health authorities
detected more than two million doses of Zyprexa
imported, nearly half of them were acquired by patients.
This medicine did not contain the doses indicated in its
fact sheet (5).
For this reason, and given the health alert that occurred,
it was decided to regulate/change urgently issues related to
distribution and import of medicines in the European
Union in order to ensure proper distribution channel of the
medicines
2. SITUATION OF COUNTERFEIT MEDICINES IN
SPAIN
After the need of promulgation of Royal Decree
1/2015, of July 24, amending law of guarantees and
rational use of medicines and health products (6), it has
been set a clear and necessary definition of counterfeit
medicine. The metioned Act defines counterfeit medicine
as: “Medicines that are deliberately and fraudulently
mislabelled with respect to:
1. º Its identity, including packaging and labeling,
name or composition in regard to any of its components,
including excipients and the dosage of those ingredients;
2. ° its source, including the manufacturer, country of
manufacturing, country of origin and the holder of the
marketing authorization; or,
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