Enforcement and Technical Solutions
Pierre DELVAL, Founder & Executive director of the WAITO Foundation
To fight the increasingly complex criminal methodologies of local and international
organized crime, the State has no option but to apply a policy of prevention and
deterrence against fraudulent act as counterfeiting, based on technical systems that
are inseparable from criminal proceedings.
This governmental approach enables to:

Protect consumers and patients more effectively against health risks,

Systematically crack down on dangerous fraudulent act that are sustainably
established on national or regional area,

Complete the IPR arsenal, giving new alternative tools to restrictive legal
approach,

Generate additional revenues by gradually eliminating unfair competition, reestablishing patient trust and re-launching damaged industry sectors and
public health economy.
In this context, Waito foundation is hoping a concrete and real return of State
intervention following numerous scandals on fake medicines. However, this
intervention should use new “standard-based” forms of protection, in a globalized
context:

Moving beyond the principle of precaution, the State should, as of now, have a
say about medicines and health product, and intensify its actions on all
products concerned by consumer safety and public health, in particular by
means of inspection and secure tracking and tracing regime.
From now on WAITO’s fundamental reflection addresses the criminal effectiveness in
the fight against pharmaceutical crime – not in terms of IPR (which is now
demonstrating its limitations) but in terms of the use of the principle of authority
marking – particularly concerning the protection of patients and governmental
stability.
Using authority marking is a sovereign right, in the same way as minting notes or
applying a state seal or revenue stamp. When applied on a sensitive product
requiring State’s protection and when used for its authentication and secure track
and trace abilities, authority marking becomes a unique repressive potential in terms
of criminal law and it can be used by all nation States, subject to respect some
conditions:

Adapting the concept of authority marking in the local penal code and make it
applicable by each enforcement.
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
Respecting basic criterias of the quite new standard ISO 12931 titled
“Performance criteria for authentication solutions used to combat
counterfeiting of material goods”.

Developing a governmental platform in charge of official marketing
authorization. This platform has to have also delegation from State to stamp
authority marking on imported medicines and local production.
This measure allows, among other benefits, the criminal enforcement of forgery,
aggravated deception and willful harm to other’s lives.
The technical-legal arsenal dedicated to authority markings thus becomes a powerful
legal argument particularly dissuasive against organized crime and local mafias. This
marking can also serve as a compliancy tool

An indispensable stage in insuring patient safety.
So, globalization harbours its hopes and dangers, today reinforced by successive
economical crises and speculation. The evident progress achieved also sheds light
on new criminal profiles. In a context of global chaos, where organized crime as a
matter of course reached a prime position, offences such as pharmaceutical crime
including counterfeit have now a direct impact on health and safety of citizens, but
also on political and economical stability of a country. Access for all - patients,
distributors, public or private chemists and public authorities alike – to the guarantee
of innocuousness, the authentication and secure track and trace of medicines and
health products become a fundamental criterion in governmental strategies.
In any case, WAITO is pushing this option with States, by considering that it is the
only one who will allow to put concretely obstacle to the criminal threats of the local,
regional and international mafias. Several countries will soon adopt this approach
within modern governance, focusing more specifically on the conformity of origin,
technical conformity, valorization of local production and fight against fraud –
particularly in pharmaceutical products. Others will follow this new tendency in
various sectors, making available to consumers the right to buy better or to treat
themselves in a safe way.
However, a legal tool alone will not bring an end to the manufacturing and distribution
of illegal medicines. Political will be indispensable to the application of laws and the
establishment of an effective and coordinated system of control and secure tracking
and tracing regime. Countries should, then, strive to be innovative in fighting this
dangerous traffic even more vigorously and with a broader political scope,
encompassing the fight against corruption, fiscal protection, consumer safety,
criminal law as well as other existing legal weapons. This State policy must be
implemented with both ambition and determination, to eventually become an obstacle
to the dangers of counterfeiting-crime© as Medicrime that currently is in full
expansion.
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