The Medicrime Convention: Combating Pharmaceutical Crimes through European Criminal Law and beyond

Date01 September 2016
Published date01 September 2016
DOI10.1177/203228441600700308
Subject MatterArticle
350 Intersentia
THE MEDICRIME CONVENTION
Combating Pharmaceutical Crimes through
European Criminal Law and Beyond
S N*
ABSTRACT
e falsi cation of medicinal products represents a signi cant public health threat and
has rapidly turned into a global criminal phenomenon. Pharmaceutical crimes are
considered an emerging categor y of transnational organised crime and have progres sively
become cyber-enabled crimes.  e international community has called for a stronger
and more e ective response, but the international legal framework has long remained
substantially inadequate at both European and international levels. Against this
background, 1January 2016 marked a signi cant milestone in the  ght against falsi ed
medicines with the entry into force of the Counc il of Europe MEDICRIME Convention.
e Convention is the  rst binding European criminal law instrument to oblige States
Parties to criminalise the fal si cation of medical products and similar o ences posing
serious threats to public health. It represents a landmark tool which will pave the way
for harmonised criminal leg islation and enhanced international coope ration in criminal
matters at pan-European level and beyond .
Keywords: falsi ed/counterfeit medicines; MEDICRIME Convention; pharmaceutical
crimes; public hea lth; transnational organised cr ime
* Associate Profes sor of International L aw, Director of the ‘Observat ory on Human Right s: Bioethics,
Health, Env ironment’, School of Law, University of Sale rno, Italy; snegri@u nisa.it.
e MEDICRIME C onvention
New Journal of Eu ropean Crimina l Law, Vol. 7, Issue 3, 2016 351
1. THE FALSIFICATION OF MEDICINAL PRODUCTS:
AGLOBAL CRIMINAL PHENOMENON POSING
ASERIOUS THREAT TO PUBLIC HEALTH
e fa lsi cation of medicinal products represents a signi cant public health th reat
and has rapidly become a global cr iminal phenomenon.1
Falsi ed medicines raise serious concerns about patient safety because t hey are
not equivalent in quality, safety and e cacy to their genuine counterparts. In fact,
they may contain ingredients of low quality or in the wrong doses; they may be
deliberately and fraudulently misla belled with respect to their identity or source; t hey
may have fake packaging, t he wrong ingredients, or low levels of the active ingred ients.
As such, they may result in therapeutic failures, adverse side e ects (like a llergic
reactions, drug resi stance, intoxication) and even death.
Both pate nt-protected and gene ric medicines , as well as t he active subst ances and
excipients of which they are made, have increasingly been the object of illega l
activities of falsi cation and counterfeiting. International organisations and
pharmaceutical companies report that this crime is on the rise around the globe.
Moreo ver, count erfeit ing te chniq ues have become ever mor e sophi sticat ed, ma king it
harder to identify fake products and more di cult to combat the risk that they may
enter into the legal supply chain and engender potentia lly disastrous e ects on public
health.
e magnitude of the problem and the di culty to assess its real scale are
particula rly alarming. Falsi ed med icines have been reported to occur worldwide a nd
no country can rea lly consider itself immune f rom the risk that these products may
reach patients and consumers.  e actua l extent varies from country to country a nd
depends on an array of factors, i ncluding inadequate legal frameworks and pena lties;
ine ective controls of manufacturing, import and distribution of medical products;
ine ective collaboration among bodies and institutions involved in regulation,
control, investigation and prosecution, such a s health authorities, police, cu stoms and
the judiciary; ine ective collaboration and exchange of information between t he
public and the private sector; i nsu cient international cooperation.2 While very low
in developed countries (less than 1% of market value),
3 the incidence of this
1 Since the focus of this a rticle is on the protection of publ ic health, the term “fa lsi cat ion” is to be
preferred to “counterfeit ing”. In fact, whi le falsi e d medicines are fa ke medicines desi gned to
mimic real med icines, counterfeit medicines a re, strictly speak ing, medicines that do not comply
with intellectual property rights or that infringe trademark law. However, both falsi cation and
counterfeitin g are illegal and a mount to “pharmaceutica l crimes”.
2 See Council of Europe, C ounterfeit me dicines, Survey report by Jonathan Harper and Bertrand
Gellie, Str asbourg, 20 06; WHO, Counter feit medical prod ucts, Report by the Secretariat, Doc.
A61/16, 7April 2008.
3 WHO, Medicines: spurious/falsely-labelled/falsi ed/counterfeit (SFFC) medicines, Fact sheet no.
275, May 2012.

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