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Counterfeit medicine. A threat to health. Legal situation BAES says that allowing the sale of prescription
medicines by post and telematic procedures to specific
and reviews the consequences for personal and public patients, does not mean that it is possible to dispense these
health. Furthermore, this document also provides a tool for medicines outside the official circuit and for this reason,
visual inspection to facilitate the detection of counterfeit the Court strengthens the essential role of health
medicines. professional.
It is true that the occurrence of such medicines has It is clear that the main aim of the promulgation of the
considerably increased in recent years due to the Royal Decree was to strengthen the telematic channel in
emergence of new technologies that allow the order to make it safer when dispensing medicines.
purchaser/patient buying medicines through telematics However, we should notice that only, at least in Spain,
channels. In many of these cases, the purchaser ignores the may be online dispensed non-prescription medicines of
existing rules on the sale of such products and because human use following industrial manufacturing.
both the comfort of acquiring them and the anonymity that
occurs in this purchase, he/she prefers to use this channel As regards online sale of non-prescription medicines,
without being aware that most of the time he/she is buying Spanish legislation protects the rational use of medicines,
a counterfeit medicine. It is for this reason that European establishing a series of guarantees to ensure that the supply
health authorities have tried to stop this indiscriminate and demand of medicines is done from a health public
selling enabling pharmacies legally established to sell interest facility, as in the case of the pharmacy, and with
online some medicines that before patients only could buy the performance of a skilled professional, both health and
in the pharmacy. scientifically, of medicines as pharmacists.
However, at present the society is fully linked due to The second Additional Provision and sole Transitional
the rapid expansion of the Internet phenomenon that Provision of the mentioned Royal Decree show that
provides users large amounts of information, sometimes pharmacies before starting distance selling of non-
excessive, and allows the purchase of products through the prescription medicines for human use manufactured
network. industrially through websites (20) must, firstly, have been
published a common logo on the website, and secondly be
Consequently, this outrageous commercialism has running the websites of the Spanish Agency for Medicines
caused the sale of different types of goods, including and Health Products and the competent authorities of the
medicines. This fact has led to a regularization of the Autonomous Communities.
market to try to eradicate criminal acts.
Pharmacies interested in telematics salling shall send
Moreover, in the field of European Public Health it is their notifications to the competent authorities of their
worth noting the full respect of the European authorities on autonomous region, so that the latter will be able to
the responsibilities of Member States for the organization implement their websites.
and delivery of health services, such as pharmaceutical
services. We must be aware that pharmacies are health In addition, pharmacies should inform about the
institutions (private property and public interest) (14) and beginning of their telematics activity, data on
in Spain are distributed following a demographic and pharmaceutical holder of the pharmacy that offers such a
geographical (15) criterion ensuring access to medicines to service, and the date of the beginning of the activity, web
almost the entire population (16). In Spain dominates the address and should describe the procedures for sending the
so-called "Mediterranean model" pharmacies which patient medication.
enables citizens a high degree of accessibility to
medicines. However, pharmacies that plan to provide this service
must be aware that it is a "virtual" extension thereof.
However, given the massive proliferation of illegal sale Consequently, the pharmacist must perform the legal and
of medicines (counterfeit and unauthorized) to the public ethical measures that regulate their professional work in
through Internet and with the objective of public protection the field of medicines dispension. They should also meet a
and risks' reduction, the Royal Decree 870/2013 was number of requirements described below.
approved, regulating the online selling of non-prescription
medicines (17) to the public and regulating also the Law Firstly, as we have showed in the previous parragraphs,
29/2006 of July 26 on sale of medicines for human use they can only perform this service, pharmacies which have
through websites for later publishing a single text (Royal been legally authorized prior notification of such activity
Legislative Decree 1/2015 of 24 July that approves the to the competent authority of the Autonomous Community
revised text of the law on guarantees and rational use of in which it is located. Orders are directly made to the
medicines and health products) which encompasses most pharmacy through the web address given and it can not
part of the comprehensive regulation on abovementioned offer or link to self-medication or self-diagnostic tools that
medicines. avoid the obligatory advice of the pharmacist.
On the other hand, it should be noted that in Spain the Secondly, dispensing can be only made by a
sale of medicines are also done by post (18). However, this pharmacist, prior personalized advice, located in a
fact is not similar to the one of selling medicines online. pharmacy legally established and without the involvement
The Spanish Constitutional Court allowed this type of sale of intermediaries.
(19) under strict conditions.
Thirdly, it may occur that the buyer is located in
@Real Academia Nacional de Farmacia. Spain
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