The Council of Europe has been paying great
attention to the issue of counterfeiting. A number of seminars and high level
conferences1 were dedicated to discussing this problem, the threats it poses and
possible solutions to it. Throughout these events it was stressed that the
Council of Europe should approach the problem of counterfeit pharmaceutical
products from a public health perspective and see it as a threat to public
health (and safety), thus undermining the right to life enshrined in Article 2
of the European Convention on the Protection of Human Rights and Fundamental
Freedoms. To this end the elaboration of an international legal instrument,
possibly a convention within the Council of Europe, in co-operation with other
relevant international organisations, such as the WHO, was considered advisable.
The Survey Report on Counterfeit medicines
(also known as the “Harper Report”)2 provided a comprehensive overview of the
current situation of counterfeit medicines in the territory of the Council of
Europe member states to the Partial Agreement in the Social and Public Health
Field and identified existing gaps in legislation and administrative procedures.
An important political backing to the Council
of Europe’s work against counterfeiting was provided by the Parliamentary
Assembly of the Council of Europe (PACE), which adopted a number of
Recommendations3 on this subject. One of the main messages that could be drawn
is “the rapidly rising incidence of counterfeit goods in Europe – a phenomenon
which places customers’ health and well-being at risk, erodes the markets for
legitimate producers, damages the reputation of brand names, distorts
competition, undermines employment and reduces tax income.”
In 2007, the Parliamentary Assembly submitted a
Report on the need for a Council of Europe convention on the suppression of
counterfeiting and trafficking in counterfeit goods, underlining that “traffic
in counterfeit goods is a scourge that is growing to epidemic proportions across
the wider Europe in both the range and volume of goods involved. All member
states of the Council of Europe are concerned as countries of origin, transit or
destination for counterfeit goods.” The Assembly highlighted that there is a
legal vacuum at international level and that appropriate national authorities
are either inexistent or weak and therefore underlined the need to make
provision for an international legal instrument establishing specific offences
relating to counterfeiting medicines so that counterfeiters can be arrested and
criminally prosecuted.
At the inter-governmental level, the Committee
of Experts on Pharmaceutical Questions “Ad-hoc group on counterfeit medicines”
(P-SP-PH/CMED), under the Public Health Committee (CD-P-SP) of the Partial
Agreement in the Social and Public Health Field, set up the Ad hoc Group on
Counterfeit Medicines in 2003 with the task of focusing on public health
protection and possibilities for improved co-operation of member states and
other stakeholders as regards counterfeit medicines and other forms of
pharmaceutical crime.
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