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3. ° its history, including records and documents in
relation with the distribution channels used."
This problem is by no means trivial. The existence of
counterfeit medicines is not new. There is plenty of
historical data (7) demonstrating the use of these
medicines since time immemorial. It is true that this
problem has lived with human beings from almost its
origin, but the most significant rise has occurred in the last our point of view, considering the Spanish legal system,
forty years when population started to consume medicines,
most of time, almost everyday.
For this important reason, several European institutions
enacted different guidelines that were transposed into
Spanish law in relation to our Constitution in the field of
health protection, preventing the entry of these medicines
into the legal distribution channel. The European
Commission noticed the growing dimension of this
problem and, during the first months of 2008, made an
inquiry about the key ideas to better protect patients
against the risk of counterfeit medicines publishing in
December 2008 a proposal amending Directive
2001/83/EC as regards the prevention of the entry into the
legal supply system of medical products which are
falsified in relation to their identity, history or source.
The Commission made a proposal to amend
pharmaceutical legislation (8) against counterfeit
medicines in order to prevent the spread of these through
the legal supply system. For this, the Commission
introduced additional guidelines related to products, in
particular on safety features for medicines subject to
prescription; new rules regarding distribution and import
of medicines and active pharmaceutical ingredients
(API's); and rules regarding the quality of manufacturing
and the authenticity of the mentioned API's.
On the other hand, it should be noted the importance of
Directive 2011/62/EU (9) amending Directive 2001/83/EC
(10) that established a European code relating to medical
products for human use, as regards the prevention of the
entry of counterfeit medicines in the legal supply system.
This new European directive had as its main purpose to
stop the massive emergence of counterfeit medicines in the
European Union in both illegal, in most cases, and legal
(11) channels including a definition of counterfeit
medicine and making in-depth analysis on rational use of
medicines and their distribution within the Union
European in order to prevent the proliferation of
counterfeit medicines.
However, we should be aware of the existence of other
"non-legislative" weapons that enable the eradication of
this phenomenon at least in Spain and, consequently, on
many occasions, in the European Union. From our point of
view, health workforce education is the most essential
component for health promotion in most constitutions
worldwide.
It is desirable to emphasize the importance of health
workforce education in connection with counterfeit
medicines. The health workforce education is defined by
the World Health Organization as "a set of information and
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Carlos del Castillo Rodríguez, María Jesús Lozano Estevan
education activities that encourage people to enjoy good
health, to know how to attain it, to do everything as
possible individually and collectively in order to maintain
health and to ask for help if needed."
Furthermore, this definition could be extended, from
specifically to Law 44/2003, of 21 November, on Health
Profession (12) Planning which highlights the educational
role that health professionals should have with their
patients.
We have abovementioned the existence of several
initiatives both from a legislative and non-legislative point
of view used by authorities and health professionals to try
to partially eradicate the proliferation and development of
the problem of counterfeit medicines both in legal and
illegal distribution channels.
The aim of this work is not to describe in detail the
methods and initiatives of combating the rapid rise;
however, we would like to show some of them due to the
importance they have had in the possible modification of
both Spanish and EU regulation.
The first initiative we would like to emphasize is the
National Strategic Plan 2012-2015 for medicines
coordinated by the Spanish Medicine Agency's and Health
Products. This initial strategy was articulated as a response
from all sectors involved in order to shield the
pharmaceutical channel against attempts to introduce
counterfeit medicines.
After the term of the previous strategy (2008-2011) and
after the approval of Directive 2011/62/EU, a new overall
Strategic Plan, with the same principles as the previous
strategy, was designed; however, this new one raised new
performances based on the changes in recent years in order
to strengthen their effectiveness. The main objective is to
protect the health of patients preventing them from
consuming counterfeit medicines.
Secondly, we would like to indicate that group
IMPACT (The International Medical Product Anti-
Counterfeiting Task Force) published a document entitled
“Anti- counterfeit Technologies for the Protection of
Medicines”. This work shows the various technologies
available to, to the extent possible, try to alleviate the
proliferation of counterfeit medicines (13).
Finally, and from a more global perspective, we
highlight the publication in 2014 of the document entitled
National Guidelines for Pharmacists by the International
Pharmaceutical Federation (FIP) in order to combat
counterfeit medicines and provide member institutions a
plan to facilitate the development of a national guideline
for pharmacists on counterfeit medicines (already done, as
stated above, in Spain both in 2007-2011 and 2011-2015).
In the first part of the mentioned guideline different
definitions of counterfeit medicines and their extension to
counterfeit medical devices are reviewed; and it also
includes an analysis of the extent of the problem from an
international perspective. Then, the document provides a
list of thirty-two medicines most likely to be adulterated,
@Real Academia Nacional de Farmacia. Spain