| dc.description.abstract | Counterfeiting of medicines is a global phenomenon which can be examined and
defined from a dual perspective: the protection of public health and the protection
of intellectual property rights. From the first point of view, the falsification of a
medicine is the deliberate and intentional adulteration of the identity, composition
or source of a medicine and can cause serious damage to the health of those who
take it. From the second point of view, counterfeiting means violation of intellectual
property rights, such as trademarks and patents, relating to a medicine, and is
mainly relevant for the legal consequences of such violation.
Being a globally relevant phenomenon, it is necessary establish a multilevel
protection. In fact, the Convention on the counterfeiting of medicinal products and
similar offenses of the Council of Europe (so-called Medicrime Convention) of
2011 and the Directive 2011/62/EU on falsified medicines are dedicated to the
falsification of medicines.
The MEDICRIME Convention imposes on the States Parties the obligation to
criminalize the conducts of production and distribution of falsified medicines, as
well as “similar crimes”, instrumental conducts which are also dangerous to public
health.
The European Directive imposes, with the integration of Implementing
Regulations, a traceability system for medicines, by means of the provision of a
unique identification code and compliance with good manufacturing practices of
the active substances. To complete the system outlined by the Directive, the
provisions regarding online pharmacies are fundamental, which are increasingly
replacing physical ones. The provision of a common logo, which through a series
of hypertext links refers to the subjects who have authorized the remote selling and
to the list of pharmacies to which the same authorization has been granted, also
allows the last link in the chain, the consumers, to be able to distinguish the subjects
legally engaged in the online sale of medicines, from the so-called rogue and fake
e-pharmacies. The control of the distribution chain is also accompanied by the
provision of sanctions, thus placing itself in parallel with the Medicrime
Convention.
Rules on counterfeiting of pharmaceutical products are then found in the TRIPs
Agreement annexed to the Treaty establishing the WTO.
The TRIPs Agreement provides for minimum rules on counterfeiting, trademarks
and patents, emphasizing the necessary coordination between companies, customs
and judicial authorities.
Public and private law profiles, therefore, are juxtaposed until they almost intersect
in the name of a general collective interest: guaranteeing the achievement of the
highest possible standard of health through the expansion of the audience of
subjects who have access to genuine, safe, effective and quality medicines. [edited by Author] | it_IT |
