[Ip-health] News: Mondaq- Council of Europe Aims to Hold Medical Device Companies Accountable for Counterfeit Products

Terri Beswick Terri at haieurope.org
Tue Jan 18 09:01:51 PST 2011

Council of Europe Aims to Hold Medical Device Companies Accountable for
Counterfeit Products


13 January 2011


Article by Kathleen H. Dooley  and Joseph P. McMenamin  


In a move designed to address the public health threat posed by
increased distribution of counterfeit medical device products, the
Council of Europe Committee of Ministers (Council) has drafted a binding
international instrument that, if ratified, will impose criminal
liability on the medical device counterfeiters operating in any of
Europe's 47 member states.


For years, the Council has been concerned about the secondary channels
that create pathways for the distribution of counterfeit products,
especially those created by the Internet, the ineffectiveness of
proposed deterrents and the criminal element that has penetrated the
marketplace throughout Europe. As the Council sees it, counterfeiting
medical products and similar crimes threaten the right to life protected
by the European Convention on Human Rights and Fundamental Freedoms.


The Council's move, known as the MEDICRIME Convention, is the first
international criminal law measure that proposes to obligate member
states to criminalize activity such as the manufacturing of counterfeit
medical products; supplying, offering to supply and/or trafficking in
counterfeit medical products; falsifying documents in sales of medical
device products; and the unauthorized manufacturing or supplying of
products and marketing of non-conforming medical device products.


The MEDICRIME Convention provides for national and international
cooperation and coordination across public administration sectors, and
for preventive measures as well as protective measures for alleged
victims and witnesses. It also anticipates the creation of a monitoring
body composed of members from each member country, to oversee the
MEDICRIME Convention by the member states.


Consistent with the Convention's concerns about the global threat
presented by counterfeiting of medical products and other related
crimes, MEDICRIME applies to the 47 member countries of the Council, but
can also be recognized and ratified by non-Council countries around the
world. The Convention will be opened for signature in 2011, at a date to
be set by the Council.


Countries and organizations in other parts of the world are also
considering similar action such as the World Health Organization's
anti-counterfeiting proposal and the Anti-Counterfeiting Trade Agreement
to which the United States and nine other nations, as well as the
European Union, are expected to be signatories.


In the absence of a clear mandate with enforceable sanctions,
counterfeiting will continue to pose a global threat to patients'
well-being and safety. Whether the Convention will provide the
protection sought can be judged only after it has been enacted and in
force for some reasonable time, but it seems clear that the public
health risk justifies the attempt.



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