HANDBOOK FOR PARLIAMENTARIANS

The Council of Europe Convention on the
Counterfeiting of Medical Products and
Similar Crimes involving Threats to Public Health
(MEDICRIME Convention, CETS No. 211)
Council of Europe
French edition:
Manuel à l’usage des parlementaires –
Convention du Conseil de l’Europe
sur la contrefaçon des produits
médicaux et les infractions similaires
menaçant la santé publique
(STCE no 211, Convention MÉDICRIME)
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© Council of Europe, November 2015
Printed at the Council of Europe
Document prepared by Dr Ilise
L. Feitshans, expert consultant, in
co-operation with expert consultants
Mr Hugo Bonar, Prof. Asier Urruela
Mora and Mr Bart Wijnberg, and the
Secretariat of the Committee on
Social Affairs, Health and Sustainable
Development of the Parliamentary
Assembly, the European Directorate
for the Quality of Medicines
& HealthCare (EDQM) and the Criminal
Law Division of the Directorate
General Human Rights and Rule
of Law of the Council of Europe.
Secretariat of the Committee
on Social Affairs, Health and
Sustainable Development
Parliamentary Assembly
of the Council of Europe,
F-67075 Strasbourg Cedex
Tel: +33 (0)3 90 21 49 03
Fax: +33 (0)3 90 21 56 49
http://assembly.coe.int
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Contents
I. THE COUNCIL OF EUROPE AND THE PARLIAMENTARY ASSEMBLY 5
II. FOREWORD BY THE PRESIDENT OF THE PARLIAMENTARY ASSEMBLY 7
III. OVERVIEW 9
A. The problem of counterfeiting of medical products and similar crimes 9
B. Introduction and objectives of the handbook 13
C. Role of parliamentarians 15
1. Fact-finding 15
2. Public awareness campaigns 15
3. Steps towards the ratification of the MEDICRIME Convention 16
4. Implementation of protections to safeguard public health 16
D. Background 17
1. Scope of the global health problem posed by counterfeiting 19
2. Health as a human right: the Council of Europe mission 20
3. Patient, consumer and victim perspective 21
E. National activities among Council of Europe member states 21
F. The dearth of international standards 23
G. The involvement of international organisations in the fight against
counterfeiting of medical products and similar crimes 24
1. WHO Surveillance and Rapid Alert System for SSFFC Medical Products 24
2. The World Customs Organization 26
3. Interpol’s response to counterfeit medicine 26
4. Europol 27
IV. THE COUNCIL OF EUROPE MEDICRIME CONVENTION 29
A. Purposes of the convention 30
B. Non-discrimination principle 31
C. Definitions 32
D. Preventive measures 37
1. Specialised prevention authorities and co-ordinating bodies 37
2. Protective measures and assistance to victims 39
3. Measures aimed at the general public: outreach and awareness
to prevent counterfeiting 39
E. Interventions 40
1. International co-operation in criminal matters 41
2. International co-operation on prevention and other administrative
measures 41
Handbook for parliamentarians ► Page 4
F. Criminalisation of acts 43
1. General overview 44
2. Key provisions 45
3. Integration with existing procedural law 48
G. Jurisdictional requirements for initiating proceedings and punishing offences 49
H. Corporate liability 51
I. Sanctions 51
J. Aggravating circumstances 52
K. International recidivism 53
L. Follow-up mechanism – Committee of the Parties 55
1. Composition 55
2. Functions 55
M. Relationship with other international instruments 56
N. Amendments to the convention 56
O. Final clauses 56
V. POSTFACE BY THE DEPUTY SECRETARY GENERAL OF THE COUNCIL
OF EUROPE 57
APPENDIX I – Council of Europe Convention on the Counterfeiting of Medical
Products and Similar Crimes (MEDICRIME Convention) 59
APPENDIX II – Table of signatures and ratifications
of the MEDICRIME Convention (CETS No. 211) 81
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I. The Council of Europe
and the Parliamentary
Assembly
The Council of Europe is the continent’s oldest political organisation. Founded
in 1949, it has 47 member states, representing more than 820 million Europeans,
and five observer states (Canada, the Holy See, Japan, Mexico and the United
States of America).
The main aims of the Organisation are:
–– protecting human rights, parliamentary democracy and the rule of law
in all member states;
–– developing continent-wide agreements to harmonise member states’
social and legal practices;
–– promoting awareness of a European identity and greater unity based
on shared values that transcend different cultures.
Since the fall of the Berlin Wall, its main purpose has been to act as a political
anchor and human rights watchdog for all the democracies in greater Europe;
assist them in carrying out and consolidating political, legal and constitutional
reform; and facilitate the exchange of good practice in areas such as human
rights, local democracy, education, culture and the environment.
The protection of public health has long been a key element of the work carried
out by the Council of Europe. Its conventions on bioethics, the safety of blood
products and organ transplantation are widely considered as authoritative
by regulatory authorities and health-care professionals within and outside
Europe. The Convention on the Elaboration of a European Pharmacopoeia
(ETS No. 50), serviced by the Council of Europe’s European Directorate for the
Quality of Medicines & HealthCare (EDQM), provides quality standards for the
ingredients and the production of medicines. These standards are binding for
38 signatories in Europe, including the European Union, and are a recognised
reference for its 27 observers all around the world, including the World Health
Organization (WHO).
Handbook for parliamentarians ► Page 6
The Council of Europe has its permanent headquarters in Strasbourg, France.
By statute, it has two constituent organs: the Committee of Ministers composed
of the ministers for foreign affairs of the member states, and the Parliamentary
Assembly (PACE), comprising delegations from the 47 national parliaments.
The 648 men and women who make up the Council of Europe Parliamentary
Assembly (http://assembly.coe.int) come together four times a year to debate
topical issues and common challenges, request action from Europe’s governments
and hold those governments accountable for their acts. They speak
on behalf of more than 820 million Europeans whom they represent on any
subject they choose, and Europe’s governments – represented in the Council
of Europe by the Committee of Ministers – are obliged to reply to them. They
are greater Europe’s democratic conscience.
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II. Foreword
by the President
of the Parliamentary
Assembly
Fake medicines are an outrage. Creating or selling drugs that turn out to be
useless – or, worse, directly damaging to our health – can hasten death and
prolong or aggravate serious illness. To deliberately cause suffering of this kind
for crude profit, especially when the actual root of the problem may never
be known, is – literally – a sickening act which strikes at the roots of human
decency, saps mutual trust and fundamentally damages society in many ways.
In addition to the harm they cause to human health, counterfeit medicines
have an economic cost: they drain resources from already hard-pressed public
health systems and add to the burden of global disease. And the bad news is
that, as far as we can tell, there are more and more of them.
As parliamentarians, we have a responsibility to do everything we can to
protect our citizens by stopping this insidious new form of crime. We can pass
laws which oblige genuine medical products to be fully and robustly licensed,
throughout the chain of production. We can insist that producing, selling or
facilitating “bad medicine” are serious crimes in our countries, with strong
penalties that are strictly enforced. We can help each other’s law-enforcement
agencies to pursue and bring to justice the perpetrators of these crimes,
wherever in the world they may hide.
The Council of Europe’s MEDICRIME Convention – first proposed by the
Parliamentary Assembly and signed in Moscow in 2011 after years of negotiation
by government experts – is a global instrument which will do all that and
more. Filling a gap in international law, it is on course to become the world’s
strongest weapon in the fight against the counterfeiting of medical products
and similar crimes.
Handbook for parliamentarians ► Page 8
Some 24 states have so far signed the convention – including countries beyond
the Council of Europe area, such as Guinea, Israel and Morocco. I welcome the
recent ratification by Guinea. This will allow the convention to enter into force
on 1 January 2016 and to begin doing its vital work.
This handbook explains the MEDICRIME Convention in simple language, spells
out clearly what it does, how it can help and what we as parliamentarians can
do to make it a reality.
Its clauses may be dry, but they will save lives. By ensuring it enters into force
in your country, and by encouraging its full implementation, you can play an
important part in saving those lives.
As President of the Parliamentary Assembly of the Council of Europe, I urge
national authorities to ratify this important convention without delay. Health
and life cannot wait.
Anne Brasseur
President of the Parliamentary Assembly
of the Council of Europe
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III. Overview
“Counterfeiting of medical products and similar crimes violate the
right to life as enshrined in the Convention for the Protection of
Human Rights and Fundamental Freedoms, as these criminal and
dangerous conducts effectively deny patients the necessary medical
treatment and may often be harmful to their health, sometimes even
leading to the death of the patient or consumer.”
Explanatory report to the Council of Europe MEDICRIME
Convention1
A. The problem of counterfeiting of medical products
and similar crimes
Counterfeiting medical products threatens the health of individuals and
the integrity of health-care systems at the global level. This crucial problem,
which requires a co-ordinated international response, is addressed by the
Council of Europe Convention on the Counterfeiting of Medical Products and
Similar Crimes involving Threats to Public Health (the MEDICRIME Convention)
(CETS No. 211).2
The need for action is obvious: US$75 billion dollars in global value per year in
counterfeit medicines for human use;3 more than US$250 billion in lost revenue
in counterfeiting products in general;4 untold administrative costs for investigation
and prosecution; physical and emotional harm to countless victims;
increased long-term economic cost due to a greater global disease burden.
1. Explanatory report to the Council of Europe Convention on the Counterfeiting of Medical
Products and Similar Crimes involving Threats to Public Health, paragraph 3.
2. Council of Europe Convention on the Counterfeiting of Medical Products and Similar
Crimes involving Threats to Public Health, Moscow, 28.X.2011.
3. Interpol, Pharmaceutical Crime Sub-Directorate, “Pharmaceutical Crime and Organised
Criminal Groups. An analysis of the involvement of organised criminal groups in pharmaceutical
crime since 2008”, 2014.
4. OECD, “The Economic Impact of Counterfeiting”, 1998.
Handbook for parliamentarians ► Page 10
Counterfeiting is a global phenomenon that grows significantly each year, as
improved technology in all areas of the supply chain enhances the ability of
criminals to manufacture, transport and deliver dangerous counterfeit medical
products to customers, while many customers are unaware that they have
not paid for the real thing. Fraudulent or deceptive practices and counterfeit
medicines have garnered high-profile media attention because of several
key cases, causing untold anguish to patients and their families who must
worry about the impact of these medicines. This in turn undermines public
trust in health authorities and health-care systems, and thus in the integrity
of government protection of public health.5
In response to the growing market for counterfeit medicines, and the subsequent
danger to public security from manufacturing, supplying, trafficking
in counterfeits and even providing false documentation of medical products
that are made to appear legitimate, the Council of Europe has successfully
drawn up the first international, legally binding treaty against the criminal
act of counterfeiting medical products and similar crimes involving threats to
public health. Opened for signature in Moscow, at a high-level conference on
28 October 2011, following a wide consensus among the member states, to
date (October 2015), the MEDICRIME Convention has been signed by 24 states.6
With five ratifications so far, the convention has the requisite support to enter
into force on 1 January 2016.
Law plays an important role in regulating conditions that can lead to injury. But
there is little that can be done to prevent harm in circumstances where there
is no law. This is why it was so important for this convention to be developed
and for the Council of Europe’s work against counterfeiting to receive political
backing. This support was provided by the Parliamentary Assembly of the
Council of Europe (PACE), which adopted a number of recommendations7
on this subject. PACE challenged the image of counterfeiting as a harmless
activity and called upon Council of Europe member states “to improve
data collection on the linkage between counterfeited goods and injuries
or deaths, in particular as regards products such as pharmaceuticals” and
5. Interpol, Pharmaceutical Crime Sub-Directorate, op. cit.; Explanatory report to the MEDICRIME
Convention, paragraph 4.
6. The text of the convention was corrected in accordance with the Committee of Ministers’ decision
in September 2012 (1151st meeting of the Ministers’ Deputies, 18-19 September 2012).
7. Recommendation 1673 (2004) on counterfeiting: problems and solutions; Recommendation
1793 (2007) on the need for a Council of Europe convention on the suppression of
counterfeiting and trafficking in counterfeit goods; Recommendation 1794 (2007) on
the quality of medicines in Europe.
III. Overview ► Page 11
emphasised 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”.8
At the intergovernmental level, the multidisciplinary Ad hoc Group on
Counterfeit Medicines, established in 2003, dealt with aspects of public
health protection and possibilities for improved co-operation of member
states and other stakeholders as regards counterfeit medical products: it
carried out a survey to identify the gaps in legislation and administrative procedures9
and held several seminars and conferences.10 In 2008, the European
Committee on Crime Problems (CDPC) agreed on the importance of combating
counterfeit pharmaceutical products and stressed that the Council
of Europe’s work could bring much added value to the initiatives of other
international and regional organisations in combating the counterfeiting
of medicines and other health-care products. It approved the terms of
reference of the Group of Specialists on Counterfeit Pharmaceuticals and
entrusted an ad hoc committee on counterfeiting of medical products and
similar crimes, with the task of preparing a report that could be included in a
possible international, legally binding instrument to fight crime concerning
counterfeit pharmaceutical products (the final report). The CDPC agreed that
the highest priority should be given to criminal law aspects of the problem
by strengthening international co-operation in preventing any activity that
jeopardises public health. The CDPC stressed the need for the specialist group
to take into account existing national legislation of member states in this field
as well as other work being carried out at the international level, in particular
by the European Union and WHO.
Ultimately these efforts produced a text that emphasises international cooperation
among governments and international law-enforcement authorities,
and international collaboration among transdisciplinary groups of experts, to
refine the understanding of the impact on public health and develop robust
8. Recommendation 1673 (2004); Recommendation 1793 (2007); Recommendation 1794
(2007).
9. Harper J. and Gellie B. (2006), Counterfeit Medicines – Survey Report, Council of Europe
Publishing, Strasbourg. The “Harper Report” exposes differences that exist in national
legislations concerning criminalising counterfeiting of medical products.
10. Seminar “Counteract the Counterfeiters – limiting the risks of counterfeit medicines to public
health in Europe by adequate measures and mechanisms”, Strasbourg, 21-23 September
2005; International Conference “Europe against Counterfeit Medicines”, Moscow,
23-24 October 2006.
Handbook for parliamentarians ► Page 12
models for testing and detecting counterfeit pharmaceuticals and medical
devices. It provides a strong message to encourage member states to engage in
awareness campaigns to alert the public, health-care professionals and industry
stakeholders to the dangers of pharmaceutical and health-care product crimes,
with particular emphasis on Internet sales. The resulting MEDICRIME Convention
covers legitimate medical products including generic medicines and medical
devices, regardless of whether they are protected under intellectual property
legislation. To cover offences including illicitly distributed medicines that
otherwise are not included in the concept of counterfeiting, the MEDICRIME
Convention has introduced the concept of “similar crimes involving threats to
public health” (Article 8). Such medicines are legitimately produced for certain
markets but fraudulently diverted, often by organised crime elements, out of
the legitimate supply chain and from the essential safety and quality controls
which maintain their integrity. The MEDICRIME Convention also covers the
counterfeiting of veterinary medicines: there is a growing black market in
counterfeit veterinary medicines, affecting the lives of pets as well as the quality
of food for human consumption in the food chain, and also threatening
human health directly if veterinary diseases bypass species barriers.11 The risk
of injury and death from counterfeit medical products and similar crimes is
thus comprehensively addressed by the MEDICRIME Convention.
Member states are affected by the threat of these crimes whether they are a
state of destination, transit or origin. No member state or any part of the world
is exempt from this truly international crime. While it may be global in nature,
it has a domestic impact. The extent of counterfeiting of medical products
in Council of Europe member states or globally is not easily calculable from
the public health perspective, due to the challenges posed by injuries not
being directly linked to their cause: victims’ injuries and deaths are usually
recorded according to their underlying ailments and do not reflect the impact
of counterfeit medical products.
The absence of a cohesive worldwide legal instrument establishing the counterfeiting
of medical products and similar acts as crimes under international
law has impeded efforts to prevent the entry of counterfeit medicines into
the legitimate supply chain. The criminalisation of the counterfeiting of medical
products has also been inadequately addressed within many nations.12
The MEDICRIME Convention represents a first legislative attempt to create a
11. For example, a falsified poultry vaccine led to the avian flu, thus endangering human
health.
12. The Falsified Medicines Directive of the EU is not, in fact, a criminal law instrument.
III. Overview ► Page 13
comprehensive international criminal law instrument to provide for a system
to prevent public health threats from criminal activities, support the victims
and prevent and detect crimes involving medical products. This is achieved
by creating and implementing a workable multi-jurisdictional framework
addressing counterfeiting and falsification of medical products and similar
crimes involving threats to public health. This convention criminalises counterfeit,
falsified and illegally supplied medical products, so that now there is
a new juridical basis for criminal enforcement to protect the integrity of the
legitimate supply chain for medicines and medical devices.
The MEDICRIME Convention is the first international treaty or agreement
specifically establishing the counterfeiting of medical products, falsification
of documents and similar acts as international crimes, without regard to the
status of similar activities under domestic national laws.13 Instead of piecemeal
attacks under domestic laws that may or may not include criminal penalties
along with their potential civil liability for documented impact on public health,
the convention seeks to impose legal order over counterfeiting chaos. Never
before has international law had the criminal jurisdiction to halt and punish
crimes involving medical products that threaten to harm large populations
of the general public.
B. Introduction and objectives of the handbook
This handbook is designed to promote greater awareness among parliamentarians
concerning all forms of counterfeiting of medical products and similar
crimes. Significantly, this handbook is a vital tool for parliamentarians who wish
to encourage member states to sign, ratify and implement the MEDICRIME
Convention, the Council of Europe’s main instrument to combat the counterfeiting
of medical products and similar crimes, with a view to stopping such
crimes in order to protect public health.
Driven by the urgency of this public health issue, Council of Europe member
states wished to extend their co-operation under the convention to nonmember
states. This approach can promote a juridical consensus and provide
a justification for each state to apply their authority under the auspices of the
MEDICRIME Convention, and provide a rationale for them to join existing efforts
by the International Criminal Police Organization (ICPO/Interpol), Europol,
13. For example, with regard to patent and trademark laws. The protection of intellectual
property rights lies outside the scope of the MEDICRIME Convention, which is drafted
from a human rights and public health perspective.
Handbook for parliamentarians ► Page 14
the World Customs Organization (WCO), the United Nations Office on Drugs
and Crime (UNODC) and the WHO Substandard/Spurious/Falsely-labelled/
Falsified/Counterfeit (SSFFC) member state mechanism including its Rapid
Alert System for surveillance.
Despite their ongoing efforts, international organisations involved in fighting
the counterfeiting of medical products currently lack critical enforcement
authority to take on this specific problem as a matter of international criminal
law. Their programmes operate in separate spheres, sometimes under the
auspices of their general powers but without specific legal authority regarding
these crimes. The time has come, however, to provide a juridical basis for
intervention.
The MEDICRIME Convention therefore represents an important step in the
creation of criminal law that will facilitate transnational co-operation to arrest
a global problem.
This handbook for parliamentarians falls within the context of the parliamentary
dimension of the Council of Europe’s will to criminalise the counterfeiting of
medical products and similar crimes involving threats to public health. The
objectives of this handbook include:
1. Explaining the MEDICRIME Convention’s purposes and language in a
manner that is accessible to parliamentarians and their constituents across
the member states of the Council of Europe and beyond.
2. Encouraging ratification of the convention based on such understanding
of the purposes, its impact and the public health protections it intends
to provide by making the counterfeiting of medical products and similar acts
involving threats to public health crimes under international law.
3. Enabling parliamentarians and their home legislatures to engage in
programmes for awareness raising to reassure the law-abiding, general public.
4. Encouraging home nations to proactively co-operate with international
law-enforcement efforts.
5. Encouraging international collaboration by experts to develop the
benchmarks, analytical methods and related enforcement tools that can recognise
counterfeit medical products once such products enter the market,
so that evidence will exist when prosecuting the people who profit from the
manufacturing, distribution and transport of counterfeit medical products.
III. Overview ► Page 15
The MEDICRIME Convention may be described as both a comprehensive
and proactive legal instrument. It contributes to the fight against this global
public health threat from a unified, international perspective, encouraging
international co-operation by enforcement authorities, while also requiring
international collaboration by experts to bolster state-of-the-art methods
that can detect counterfeit medical products. Presently, there is inadequate
jurisdiction to support efforts among international organisations and treatybased
organisations which take action but suffer from the absence of justification
in international criminal law. The convention has an added value that
lies in its multidisciplinary approach. It aims to prevent the counterfeiting of
medical products by developing international collaboration between a wide
variety of specialists in various disciplines, in order to combat the problem
at its source using a wide range of tools. International co-operation and collaboration
by experts are therefore a linchpin for controlling the traffic and
monitoring the long-term effects of these threats to public health, at all stages
of the supply chain.
C. Role of parliamentarians
Parliamentarians can play a vital role in efforts to combat this global phenomenon
by:
–– promoting signature and ratification of the MEDICRIME Convention;
–– encouraging their national legislatures and enforcement administrations
to implement the MEDICRIME Convention requirements.
The following are some activities that could be undertaken by parliamentarians.
1. Fact-finding
–– initiate relevant parliamentary enquiries.
2. Public awareness campaigns
–– formally request their respective governments to hold public hearings
that address specific questions about the spread, prevention and public
health impact of these crimes;
–– engage their respective legislature, enforcement authorities and executive
branch in a public awareness campaign offering tools at the local and
national levels (this handbook, USB flash drives containing legislative
texts and campaign material on the subject).
Handbook for parliamentarians ► Page 16
3. Steps towards the ratification of the MEDICRIME Convention
–– strengthen existing domestic legislation;
–– organise debates at national level (within their parliaments), and at
regional and local levels (in their respective constituencies), regarding
methods to prevent and stop these crimes, while respecting respect civil
liberties and other human rights;
–– initiate open discourse with the general public (articles in the press,
social media, public forum events in community centres and schools).
4. Implementation of protections to safeguard public health
–– establish a specific follow-up committee (or sub-committee, or
parliamentary group) within the national parliament;
–– exchange information and expertise with other parliamentarians to stop
trafficking in counterfeit, falsified or deliberately sub-standard medicines;
–– establish bilateral partnerships at national and international levels
(professional associations, non-governmental organisations (NGOs),
the European Union, Europol, Interpol, WHO, the United Nations, the
Inter-Parliamentary Union (IPU),WCO, UNODC, the Heads of Medicines
Agencies Working Group of Enforcement Officers (HMA WGEO), the
Permanent Forum on International Pharmaceutical Crime (PFIPC)) and
across Council of Europe member States to:
— contribute to the development of national strategies and programmes
aimed at instituting criminal liability for crimes covered by the
MEDICRIME Convention;
— enable their staff to provide technical/legal assistance to states which
so request;
— ensure compliance of national legislation with international
commitments in the field, in particular the MEDICRIME Convention;
— revise and strengthen national legislation, including by establishing
a database to register the impact on, and the subsequent needs
of, victims of counterfeit medical products, including the ones for
veterinary use;
— adopt legislation that is consistent across European countries and
beyond, with a view to achieving greater harmonisation, which will
advance enforcement efforts;
III. Overview ► Page 17
— appropriate sufficient funding for resources that combat counterfeiting
of medical products, the falsification of documents accompanying
medical products and similar crimes;
— establish national data-collection systems to help identify vulnerable
groups and the consumers who are likely to fall prey to these medicines
and medical devices, and follow-up with higher scrutiny of health
care for victims;
— establish confidential and anonymous hotlines and other support
services so that anyone can report an incident of medical counterfeiting,
falsified documents or similar crimes covered by the convention;
— support increased oversight and quality surveillance for all licensed
medicines throughout the world.
The MEDICRIME Convention is very special because it enables states parties
to create a follow-up mechanism in order to ensure effective implementation
of these provisions. By creating working groups and encouraging international
co-operation for enforcement and international collaboration for the
definition, surveillance and long-term understanding of the disease burden
caused by these crimes, the convention will also inevitably raise the general
public’s awareness of national law. We urge your participation and welcome
your enthusiastic use of this handbook.
D. Background
The sale and subsequent use of counterfeit medicines and medical devices
(and of products from similar crimes involving threats to public health) are
ubiquitous. These products are made using components from unregulated
sources, resulting in risky medicines and medical devices that present an
undisputed danger to life and health.
This global public health problem has profound short and long-term consequences
for physical health, psychological development and psychosocial
well-being. In addition, the fear of having taken deliberately counterfeit
(falsified) medicines causes untold emotional anguish for patients and their
loved ones alike, thus undermining public trust in all health care, even when
using legitimate products from authorised suppliers. It may be surprising that
counterfeit medical products are not yet subject to international criminal law.
Even though these products may be illegal in some states, it is not internationally
agreed that they are illegal. Hence there is no violation of criminal law,
until the MEDICRIME Convention enters into force.
Handbook for parliamentarians ► Page 18
A costly threat to the integrity of global public health
A primary trend in many member countries is the increased use of illicit, socalled
“online pharmacies”, operated by both informal networks and organised
criminal groups.
Large amounts of money are involved in these types of transnational criminal
enterprises: one illicit online pharmacy network, which was dismantled by US
authorities in 2011, made US$55 million during its two years of operations.14
A 2008 European Commission working document15 estimated the costs incurred
to the EU from falsified medicines until 2020 as follows: hospitalisations as a
consequence of treatment using counterfeit medicines, €1.8-22 billion and
avoidable medical treatment at primary health-care doctors, €93 million to
1.1 billion. There is also the unnecessary suffering caused to the patients,
which is not quantifiable, but very damaging indeed.
Are law-enforcement authorities’ hands tied by the organised networks that
conduct these dangerous activities?
Is there something that governments can do by working together?
A global public health problem requires an international solution
Protecting public health, an offshoot of a government’s duty towards citizens
that is derived from the core value of protecting the right to life, has long
been a key element of the work carried out by the Council of Europe. Council
of Europe conventions are respected for their wide influence that extends
“… way beyond its Member States’ perimeter”.16
Injury prevention specialists recognise that injury is best controlled by eliminating
and/or minimising opportunities for exposure to harm, which can be
achieved by creating strategies at national and international levels. Furthermore,
the World Health Assembly Executive Board has continuous reporting regarding
this problem, and has “decided that a study to increase understanding
and knowledge on the links between accessibility and affordability and their
14. Interpol, Pharmaceutical Crime Sub-Directorate, op. cit.
15. Commission Staff Working Document accompanying document to the proposal for a
Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain
of medicinal products which are falsified, 2008.
16. Statement by Mr Ferit Hohxa, Permanent Representative of Albania to the United Nations,
on “Cooperation between United Nations and Regional Organizations” 53rd meeting of
the 67th General Assembly (Plenary), GA/11326,12 December 2012, New York.
III. Overview ► Page 19
impact on the emergence of substandard/spurious/falsely-labelled/falsified/
counterfeit medical products (SSFFC) and to recommend strategies to
minimise their impact will be included on the next provisional list of activities
for consideration by the fourth meeting of the Member State mechanism”.17
Treaties, such as the European Convention on Human Rights (ETS No. 5), the
European Convention on Mutual Assistance in Criminal Matters (ETS No. 30)
and the Convention on Cybercrime (ETS No. 185), are well-established global
benchmarks and have been incorporated into national, European Union
and international laws. Council of Europe guidance documents concerning
bioethics, safety of blood products and organ transplantation are the source
of respected standards, applied by regulatory authorities and health-care
professionals worldwide. The Convention on the Elaboration of a European
Pharmacopoeia, for example, serviced by the Council of Europe’s European
Directorate for the Quality of Medicines & HealthCare, provides quality standards
for the ingredients and production of medicines. These standards are
binding for 37 signatory states in Europe and the European Union, and are a
respected reference for its 27 observers all around the world, including WHO.
The certification process under the auspices of EDQM is a potential repository
for the reporting of counterfeit drugs and medical devices and the testing of
their contents.
In light of this juridical context, it is natural for the Council of Europe to lead
the international movement to criminalise counterfeit medical products.
The Committee of Ministers of the Council of Europe relied upon the juridical
foundations expressed in its preamble when it adopted the MEDICRIME
Convention in December 2010. Noting other relevant international legal instruments
and programmes, especially within WHO and by the European Union,
as well as in the forum of the G8, it was clear that there were no obstacles to
having the Council of Europe fill this void in international criminal law.
1. Scope of the global health problem posed by counterfeiting
The EU has acknowledged the need to simultaneously protect consumers and
safeguard intellectual assets so that creativity and innovation can continue
to be major drivers of growth. Europol’s Serious and Organised Crime Threat
Assessment (SOCTA) has issued a report describing cases involving commodity
17. World Health Organization, Report by the Director-General. Agenda item 8, report of the
third meeting of the member state mechanism on SSFFC medical products, 68th World
Health Assembly A68/33 Provisional agenda item 17.3, 20 March 2015.
Handbook for parliamentarians ► Page 20
counterfeiting in violation of health, safety and food regulations and the sale
of sub-standard goods. It has designated this issue as a new priority area in the
EU policy cycle 2014-17. Cases are often extremely complex, involving many
different jurisdictions, sometimes crossing borders through easily removed
websites on the Internet or connecting counterfeiters to unsuspecting buyers
via social media. For example, their report cites Peter Gillespie, a chartered
accountant and pharmaceutical distributor, who imported 72 000 packs of counterfeit
medicinal products, which is more than 2 million doses. Approximately
one third of these shipments involved medicines for serious conditions such
as prostate cancer, heart problems and schizophrenia.18
To combat these operations, in 2014 WHO implemented the Surveillance and
Rapid Alert System for SSFFC Medical Products. The system is operational
throughout the European region and functions in affiliation with other WHO
regional offices. WHO sets forth four basic conditions19 for individuals, communities
and societies to attain optimal levels of safety. But efforts are hampered by
the lack of criminal law jurisdiction to enforce protections, and by rapid changes
in technology for counterfeiting and anonymous distribution via the Internet.
2. Health as a human right: the Council of Europe mission
Rights are not favours or gifts, and society cannot survive without protecting
the human right to health, the linchpin right of access to preventive health
care and the right to medical treatment, as enshrined in different Council of
Europe and international treaties. Thus, protecting the right to health through
the proactive enforcement of laws that protect public health is an integral part
of fostering the well-being of society as a whole.
Crimes involving medical products are a complex problem that destroys consumer
and prescribers’ choices through deceptive and criminal acts of third parties.
Regulatory models have been developed to promote the implementation
18. Europol and the Office for Harmonization in the Internal Market, 2015 Situation
Report on Counterfeiting in the European Union, at www.europol.europa.eu/
content/2015-situation-report-counterfeiting-european-union.
19. 1) a climate of social cohesion and peace as well as of equity protecting human rights
and freedoms, at a family, local, national or international level 2) the prevention and
control of injuries and other consequences or harms caused by accidents; 3) the respect
of the values and the physical, material and psychological integrity of the individuals; and
4) the provision of effective preventive, control and rehabilitation measures to ensure
the presence of the three previous conditions. Québec WHO Collaborating Centre for
Safety Promotion and Injury Prevention, Activity Report January 2002-June 2003, at
www.inspq.qc.ca/pdf/publications/261-ReportOMS2002-2003Eng.pdf.
III. Overview ► Page 21
of safety measures to control known risks of injuries in the workplace, public
spaces, the environment and in fixed infrastructures such as health-care delivery
systems. Using established knowledge about control systems to implement
protection can therefore reduce injury or prevent certain problems. It may be
possible, through international collaboration between experts in the fields of
health-care, law enforcement and legislation, to construct a model regulatory
apparatus that will detect dangerous activities before counterfeit (falsified)
and illegally supplied medicines and medical devices enter the supply chain
and reach their markets.
3. Patient, consumer and victim perspective
The convention is a unique tool that allows for states to prosecute upon proven
evidence of these acts, without requiring the victim to file charges (this role
belongs to the state prosecutor; the victim has a standing in criminal procedure).
It is very difficult to prove the causal relation between consumption
of a drug and damage to health, but the convention determines criminalisation
based on the risks, even without harm occurring. The international collaboration
provision of the MEDICRIME Convention offers a good start in this
respect. There is a range of variables that may influence the level of harm to
an individual from a counterfeit medical product, and this convention is the
first step towards redress for people who have been harmed and the national
health-care systems that pay to provide care for them and which may not
have the necessary means.
E. National activities among Council of Europe member states
Alexander Prokopiev, member of the Russian Duma, garnered international
attention by discussing, in the Russian press, amendments to the Russian
Code of Administrative Offences and the Criminal Code that tighten the
controls over pharmaceutical production and introduce criminal penalties for
documented harm.20 Citing weak criminal penalties as a major cause of the
mounting crisis in counterfeit products, this member of the Russian Duma
would like such acts to be considered crimes that pose a direct threat to the
life of individuals. Since producing legitimate medicines nonetheless requires
precision technology that is not immune to mistakes, the parliamentarian
was quick to note the importance of exonerating legitimate manufacturers
in case of unintended errors.
20. Interview with member of the Duma committee on health, 12 May 2015.
Handbook for parliamentarians ► Page 22
In 2011, the French medicines and health-care products regulatory authority
(ANSM) withdrew PIP (Poly Implant Prothese) breast implants from the
market. These medical devices contained materials that were unsuitable for
humans, and which had not been declared in the product’s documentation.
Thousands of women in Europe and on other continents suffered health
complications, and some of them have sought help through their national
health-care systems.21
In September 2014, law-enforcement authorities from Austria, Belgium, Cyprus,
France, Hungary, Slovakia, Spain and the United Kingdom, supported by
Europol, joined in a simultaneous operation to stop the distribution of counterfeit
prescription-only medicines in the European Union. Authorities seized
several million pills with an estimated value well in excess of €10 million, a
large amount of cash and several vehicles, and froze more than €7.5 million in
bank accounts and assets. The investigation began in September 2012, thanks
to intelligence leads provided by Spanish authorities. Eurojust assisted with
the creation of a common strategy, including the establishment of a joint
investigation team from Spain, Austria, France and the UK, and which was supported
by authorities in Cyprus, Hungary and Slovakia. Over the course of the
investigation, more than 300 000 tablets with an estimated value of €2 million
were seized in Austria, but authorities believe that amount represents only one
fifth of the total transactions in that country. Significant financial transactions
relating to the sale of counterfeit and unlicensed medicines were uncovered in
both France (payments totalling €9 million over three years) and the UK (more
than €12 million in transactions). In Spain, counterfeit goods worth more than
€1.5 million were seized and three people were arrested.22
Since 2008, Interpol has co-ordinated Pangea, targeting medicines sold illicitly
online. Their 2014 campaign led to the removal of more than 19 000 adverts for
medicines on social media platforms and the closure of over 10 600 websites.
The public health threat and the economic dimensions of this phenomenon
cannot be understated.23
21. Kleijssen J. and Keitel S., “The Council of Europe MEDICRIME Convention: protecting the
patient from counterfeit/falsified medical products, a pre-requisite for safe healthcare”,
May 2014, www.coe.int/fr/web/human-rights-rule-of-law/article-jk-2014-04-03.
22. Eurojust, Press release (2014) “Fake medecines targeted”, at http://www.eurojust.europa.
eu/press/PressReleases/Pages/2014/2014-09-01.aspx.
23. http://www.interpol.int/Crime-areas/Pharmaceutical-crime/Operations/Operation-Pangea.
III. Overview ► Page 23
F. The dearth of international standards
The MEDICRIME Convention represents a path-breaking first step towards
solving these potentially devastating threats to public health throughout
Europe and the world.
Due to the globalisation of commerce in general, and the organised crossborder
networks for the manufacture, transport and distribution of counterfeit
and illicitly supplied medical products, the solution to this global health problem
must include a unified governmental response under international law.
Without specific language to provide jurisdiction for stopping these activities,
current prevention efforts have been piecemeal at best and cannot outstrip
the massive influx of illicitly supplied medicines and devices into the public
health delivery system unless there is a firm basis for treating acts involving
medical products as international crimes.
The 20th session of the UN Commission on Crime Prevention and Criminal
Justice (CCPCJ)24 adopted resolution 20/6 “Countering fraudulent medicines, in
particular their trafficking”, due to concern about the involvement of organised
crime in the trafficking of fraudulent medicines. Resolution 20/6 highlights
the potential utility of the United Nations Convention against Transnational
Organized Crime (UNTOC) for which UNODC is the guardian, in re-enforcing
international co-operation in the fight against trafficking, under provisions
for mutual legal assistance, extradition and the seizing, freezing and forfeiture
of the instrumentalities and proceeds of crime. Resolution 20/6 contains nine
action points.25 Paragraph 8 requests that UNODC, in co-operation with other
United Nations bodies and international organisations, such as the International
Narcotics Control Board (INCB), WHO, the WCO and Interpol, assist member
states in capacity building by using the experiences, technical expertise and
resources of each organisation in order to create a co-ordinated effort to dismantle
organised criminal networks engaged in all stages of distribution and
trafficking. It must be recognised, however, that resolutions lack the force of
a treaty or convention governing international criminal laws.
24. Technical Conference of Experts on the Trafficking in Fraudulent Medicines,
14-15 February 2013 in Vienna; Report on the 20th session of the Commission on Crime
Prevention and Criminal Justice (CCPCJ); Resolution 20/6: English and French international
law enforcement action against fake medicines, The Hague, The Netherlands, 1
September 2014.
25. www.unodc.org/documents/organized-crime/FM/Resolution_20_EN.pdf.
Handbook for parliamentarians ► Page 24
Within the European Union, the European Falsified Medicines Directive (FMD),
a regulatory instrument, is intended to protect the integrity of authorised
medicinal products within the legitimate supply chain. But, FMD is a regulatory
approach covering – within the EU – medicinal products for human use, and
is not focused on the criminal law perspective. By contrast, the MEDICRIME
Convention aims to criminalise acts that interfere with legal medical products
for humans and animals, and includes both the trafficking and the criminal
acts involved in the distribution of products such as adulterated materials,
fraudulent components and falsified documentation to patients and healthcare
systems.
Although laudable and sometimes fruitful, existing efforts by international
organisations have no plain language that defines the counterfeiting and
falsification of medicines and medical devices as criminal activity under international
law. Unless there is a firm basis for treating the activities discussed in
the MEDICRIME Convention as crimes under international law, those existing
efforts will be unable to stem the tide of these harmful activities. Bringing
criminals to justice, from the standpoint of procedure, because it codifies the
juridical concept of the counterfeiting of medical products and similar crimes
where there has previously been no international criminal law, and from the
point of view of substance, by defining the acts that cause harm, therefore
represents a major step towards establishing jurisdiction over these acts as
criminal activity under international law.
G. The involvement of international organisations
in the fight against counterfeiting of medical products
and similar crimes
Here are some examples of efforts by international organisations that have
taken an expansive view of their jurisdiction to tackle the global public health
challenge and to prevent and arrest transnational counterfeiting activities
that are dangerous to public health but are not considered as “crimes” under
current international law.
1. WHO Surveillance and Rapid Alert System
for SSFFC Medical Products
WHO found that the manufacturing, distribution and sale of SSFFC medical
products is an international issue threatening the health of citizens and
public confidence in medicines. WHO Executive Board recommendations for
III. Overview ► Page 25
detailed approaches to pharmacovigilance, though not treaty based and not
law, provide a springboard for discussion of detailed methods to protect the
integrity of medicines everywhere, because the procedures set forth in their
recommendations are the product of international collaboration by experts.26
Officially recognising that vigilance is necessary to protect global trust in
health-care delivery systems, WHO initiated a project specifically focused on
creating a global reporting and alert system for SSFFC products with followup.
The WHO Surveillance and Rapid Alert System for SSFFC Medical Products
provides a form that can be sent to a designated WHO email address to alert
the network about the discovery of an SSFFC product. Photographs, laboratory
reports, recall notices or other documents can also be sent as attachments.
When the Rapid Alert Form is received, the information automatically
populates a WHO database. The originator will receive email confirmation
and follow-up contact by email or telephone from WHO within 24 hours in
cases where adverse reactions in patients are reported, or 72 hours if there
are no adverse reactions. The reporting form is available in several languages.
Workshops are held to increase member states participation and capacity
building for handling, communication and prevention of incidents involving
SSFFC products, including development of specialised laboratories for quality
assurance and forensic testing. Detailed statistical analysis of reported incidents
are conducted by WHO analysts who will publish reports concerning
the scope, scale, extent and harm caused by SSFFC products. The success of
this programme requires international collaboration among experts from
WHO member states and national medicines regulatory authorities (NMRAs)
to create an effective global surveillance system and a database of reliable,
validated and accurate data. NMRAs play a critical role as the frontline for data
collection, submitting information to WHO in order to assist in the development
of new strategies to reduce these products.27 Under the WHO system,
NMRAs are trained to report incidents involving SSFFC products through the
use of the WHO Rapid Alert Form.
26. World Health Organization, Executive Board, Recommendations for health authorities
to detect and deal with actions, activities and behaviours that result in SSFFC medical
products, November 2014.
27. From 27 to 29 May 2014, WHO offered training for implementing the surveillance and rapid
alert system for SSFFC products. Hosted by the Ministry of Health of Turkey and Medicines
and Medical Device Agency, 48 experts from 19 countries of the WHO European Region
included pharmaceutical inspectorates, pharmacovigilance departments, quality control
laboratories and enforcement.
Handbook for parliamentarians ► Page 26
2. The World Customs Organization
Established in 1952, the Customs Co-operation Council (now the World Customs
Organization) is an independent intergovernmental body whose mission is
to enhance the effectiveness and efficiency of customs administrations. WCO
represents 179 customs administrations across the globe that collectively
process approximately 98% of world trade.28 As the global centre for customs
expertise, the WCO is the only international organisation with competence
in customs matters and can rightly call itself the voice of the international
customs community. The WCO’s governing body – the Council – relies on the
competence and skills of a secretariat and a range of technical and advisory
committees to accomplish its mission. The secretariat comprises over 100
international officials, technical experts and support staff of various nationalities.
As a forum for dialogue and exchange of experiences between national
customs delegates, the WCO offers its members a range of conventions and
other international instruments, as well as technical assistance and training
services provided either directly by the secretariat, or with its participation.
The secretariat also actively supports its members in their efforts to modernise
and build capacity within their national customs administrations. WCO endeavours
to combat fraudulent activities are also recognised internationally. The
partnership approach championed by the WCO is one of the keys to building
bridges between customs administrations and their partners.
3. Interpol’s response to counterfeit medicine
According to Interpol, organised criminal networks are attracted to the huge
profits made from counterfeit medicines. An Interpol analytical report published
in 2014,29 asserts that counterfeiters operate in networks across national borders
using components from different sources and using major routes of global commerce
to import, export, manufacture, distribute and sell counterfeit medicines.
According to Interpol, global action is vital in order to identify, investigate and
prosecute the perpetrators of these activities, even though there is no present
international consensus that such actions are a crime under international law.
Despite this void in international criminal law, Interpol is tracking medical
counterfeiting and similar crimes in three main ways:
–– co-ordinating operations in the field to dismantle transnational criminal
networks;
28. www.wcoomd.org.
29. Interpol, Pharmaceutical Crime Sub-Directorate, op.cit.
III. Overview ► Page 27
–– delivering training and capacity-building programmes for agencies
involved in the fight against crimes concerning medical products;
–– building partnerships with stakeholders across a variety of sectors.
It should be noted, however, that Interpol is neither a regulatory agency nor a
treaty-generating international organisation. Therefore it can track the problem
of medical counterfeiting but it cannot deploy its full range of resources
and powers as it does to stop activities that are recognised as a crime under
international law. The Council of Europe MEDICRIME Convention therefore
provides an essential element for arriving at the criminalisation of harmful
acts that would otherwise be without redress under international law.
4. Europol
The European Union has acknowledged the need to protect consumers and
safeguard intellectual assets simultaneously, to ensure that creativity and
innovation continue to be major drivers of growth. Europol supports and
strengthens action by competent authorities to co-operate mutually in preventing
and combating organised crime, terrorism and other forms of serious
crime affecting two or more member states. In March 2013, Europol Focal
Point “COPY’s”30 mandate to investigate counterfeit products was expanded
to include sub-standard and dangerous goods. Europol’s 2013 SOCTA evaluation
identified counterfeit goods violating health, safety and food regulations
and sub-standard goods as a recommended priority crime areas in the
2014-17 EU Policy Cycle.
30. Focal Points are teams formed by specialists and analysts supporting member states’
operations related to specific areas of crime that are included in the 6 April 2009 Council
Decision establishing the European Police Office (Europol)”.

► Page 29
IV. The Council of Europe
MEDICRIME Convention
The MEDICRIME Convention sets forth a path-breaking new approach to
tackling the major global public health threat of counterfeiting of medical
products and similar crimes.
For the first time in international law, the Council of Europe offers a workable
framework for national and international co-operation between the competent
legal, health, police and customs authorities, the effective prosecution of crime
and the protection of victims. It brings together the field of criminal law, as
the mechanism to achieve the specific purpose of protection, and the field of
public health as the beneficiary, in a single instrument. Thus the MEDICRIME
Convention represents the most advanced and comprehensive instrument at
the international level for averting the public health crisis that could arise if
counterfeiting of medical products and similar crimes were left unchecked.
This convention clearly recognises that international co-operation among
states is key to solving this problem in order to protect public health. It aims
to achieve this by creating a workable strategy for prevention, detection and
response, including prosecution, to these types of crimes all while taking into
account the impact on victims.
Protecting public health, by combating counterfeiting of medical
products and similar crimes
Existing informal mechanisms do not provide a legal basis to establish counterfeiting
of medical products and similar acts as crimes under international
law from a public health perspective. The MEDICRIME Convention therefore
represents the first time an international treaty defines and criminalises the
counterfeiting of medical products that undermines public confidence in the
safety, efficacy and quality of medical products and the ability of the state to
guarantee a sufficient level of confidence in its health-care system.
Handbook for parliamentarians ► Page 30
Equally important, the convention covers all medical products (Article 3),
regardless of whether they are protected under intellectual property rights
or are generics. This is because counterfeiters do not discriminate between
innovative and generic medical products and counterfeiting of either type
constitutes a danger to public health. The convention facilitates international
co-operation among legal, law-enforcement and health authorities as well as
harmonisation of procedures for detection, inspection, reporting and followup
in the event of negative health consequences. These measures include but
are not limited to product recall, the prohibition of confiscated medicines,
active substances, medical devices and their parts and materials, storage
of evidence and destruction of dangerous counterfeit materials. Lastly, the
convention establishes an international agenda that will make use of existing
monitoring mechanisms.
No safe havens for criminals
One major added value of the MEDICRIME Convention, from a practical
enforcement perspective, may be its codification of “common language”, which
creates transborder pathways for co-operation. This will make it harder for
counterfeiters to benefit from “legal gaps” – there will be no safe havens for
counterfeiters within the realm of the Council of Europe and the co-operating
states also bound by the convention. At the same time, the convention protects
the integrity of the larger public health system.
A. Purposes of the convention
The duty of governments to protect public health is a long-established principle
of law. Globalisation has made the transfer of goods and technology easy, but
until the advent of the MEDICRIME Convention there was no international
criminal law limiting transborder trade in counterfeit medical products and
no formalised international co-operation to punish such acts while taking
into account the perspective of public health. Despite the threat of harm to
the general public, each state was compelled to rely on its own resources and
the limited reach of its criminal jurisdiction with uneven consistency and variable
results, and with only informal co-operation from foreign enforcement
authorities or international policing organisations.
Therefore, the MEDICRIME Convention endeavours:
–– to prevent and combat counterfeiting of medical products and similar
crimes thereby protecting the rights of consumers to the integrity of
IV. The Council of Europe MEDICRIME Convention ► Page 31
their medicines and maintaining trust in the health-care system, thus
helping governments to fulfil their obligation to protect public health;
–– to protect the rights of victims of the counterfeiting of medical products
and similar crimes;
–– to provide a basis under international criminal law for national and
international co-operation to fight this phenomenon, which, according to
Interpol, is sometimes linked to money laundering and organised crime;
–– to promote international collaboration that will produce robust
procedures to aid detection, data collection, monitoring, follow-up,
reporting and notification to authorities, consumers, stakeholders and
the general public;
–– to provide a platform to ensure the uniform criminalisation of dangerous
acts across states parties, the co-ordination of law enforcement to detect
the crime, report the crime to the relevant enforcement authorities and
notify public health officials who in turn can alert the general public in
case of emergency; ultimately, this will also prevent illness that inevitably
burdens national health-care resources.
B. Non-discrimination principle
The convention prohibits all types of discrimination when implementing its
provisions. The list of grounds for discrimination is based on those listed in
Article 14 of the European Convention on Human Rights, and its Protocol No. 12,
and also includes other grounds. Specifically, in applying the convention it
is prohibited to discriminate against individuals based on sex, race, colour,
language, age, religion, political or any other opinion, national or social origin,
association with a national minority, property, birth, sexual orientation, state
of health, disability or other status.
Protection against discrimination is important when implementing measures
to safeguard the rights of victims, because illness and disability in nature does
discriminate and refuses to respect international borders. The ever-increasing
data on health disparities linked to race, age or sex is poorly understood,
but it remains true that the impact of counterfeiting of medical products
and similar crimes may differ based on a victim’s overall health status, race,
age or sex, or whether they have an underlying disability that is unrelated
to the counterfeit medical product. It is reasonably foreseeable that specific
counterfeit products will have different effects across sub-populations, due
to individual variability or genetic differences (such as adverse reactions or
Handbook for parliamentarians ► Page 32
a patient’s genetically inherited condition). For example, in 2008, medicines
containing contaminated heparin, a blood-thinning medicine essential in the
treatment of several life-threatening conditions, were associated with serious
injuries and deaths.31 Many of those who died were also being treated for
other medical conditions.
C. Definitions
The MEDICRIME Convention uses the term “counterfeit” in the sense of “a false
representation as regards identity and/or source” (Article 4.j).32 Jurisdiction
therefore extends beyond the final products that reach end users in the supply
chain, to include the active substances and excipients that go into the
manufacture of medicines and parts and materials specifically used to create
counterfeit medical devices.
The term “medical product” is used in the convention to include both medicines
(medicinal products)33 and medical devices.
“Medicinal product” is defined (Article 4.b) as:
“i. any substance or combination of substances presented as having properties
for treating or preventing disease in humans or animals;
ii. any substance or combination of substances which may be used in or
administered to human beings or animals either with a view to restoring,
correcting or modifying physiological functions by exerting a pharmacological,
immunological or metabolic action, or to making a medical
diagnosis;”
31. FDA, Postmarket Drug Safety Information for Patients and Providers
(2015), Information on Heparin, at www.fda.gov/Drugs/DrugSafety/
PostmarketDrugSafetyInformationforPatientsandProviders/UCM112597.
32. This definition is similar in wording and has the same meaning as the EU Falsified Medicines
Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011, at
http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf. The
EU Directive refers to the term as falsified whereas the MEDICRIME Convention refers to
the term as counterfeit. As both have the same meaning they are used in this handbook
interchangeably, but the term counterfeit is preferred.
33. The term medicinal product is the same as used in the EU Directive 2004/27, for human use
and Directive 2004/28 for veterinary use, but the convention combines these to provide a
single medicinal product definition. It also adds investigational medicinal products under this
combined heading but does not define this latter term. The term investigational medicinal
product is, however, defined in EU Directive 2001/20/EC of the European Parliament and
of the Council of 4 April 2001.
IV. The Council of Europe MEDICRIME Convention ► Page 33
The terms “active substance” and “excipient”, which are components of the
finished dosage medicinal product, are defined separately.34
Article 4.e states that “medical device” shall mean “any instrument, apparatus,
appliance, software, material or other article, whether used alone or in combination,
including the software, designated by its manufacturer to be used
specifically for diagnostic and/or therapeutic purposes and necessary for its
proper application, designated by the manufacturer to be used for human
beings for the purpose of:
i. diagnosis, prevention, monitoring, treatment or alleviation of disease;
ii. diagnosis, monitoring, treatment, alleviation of or compensation for an
injury or handicap;
iii. investigation, replacement or modification of the anatomy or of a physiological
process;
iv. control of conception;
and which does not achieve its principal intended action in or on the human
body by pharmacological, immunological or metabolic means, but which may
be assisted in its function by such means”.
The terms “parts and materials” and “accessories” are used in relation to medical
devices and are also separately defined.35
The very broad term “document”, as defined in Article 4.h, covers “any document
related to a medical product, an active substance, an excipient, a part,
a material or an accessory, including the packaging, labelling instructions for
use, certificate of origin or any other certificate accompanying it, or otherwise
directly associated with the manufacturing and/or distribution thereof”.
34. “Excipient” means any substance that is not an active substance or a finished medicinal
product, but is part of the composition of a medical product for human or veterinary
use and essential for the integrity of the finished product. “Active substance” means any
substance or mixture of substances that is designated to be used in the manufacture of a
medicinal product, and that, when used in the production of a medicinal product, becomes
an active ingredient of the medicinal product. (Articles 4.c and 4.d).
35. “Parts and materials” mean all parts and materials constructed and designated to be used
for medical devices and that are essential for the integrity thereof, (Article 4.g). For example,
this could be a screw or mechanical joint specifically designated for a hip replacement.
“Accessory” means an article which, whilst not being a medical device, is designated
specifically by its manufacturer to be used together with a medical device to enable it to
be used in accordance with the use of a medical device intended by the manufacturer of
the medical device. For example, this could be software used to run a medical device.
Handbook for parliamentarians ► Page 34
The legislatively developed term “trafficking” is not defined in the convention,
but is used in a manner that is consistent with UN texts.36
Article 4.k reaffirms the important duty of a state to protect the public health
of its citizens, stating “the term ‘victim’ shall mean any natural person suffering
adverse physical or psychological effects as a result of having used a counterfeit
medical product or a medical product manufactured, supplied or placed on
the market without authorisation or without being in compliance with the
conformity requirements as described in Article 8”. Victims have, among others
(see Articles 19 and 20 of this convention), the right to access to information
relevant to their case and which is necessary for the protection of their health,
but the convention respects existing national laws and procedural criminal
rules, as well as national laws governing civil liability for such acts.
A major argument favouring ratification is that medicinal products which are
unhealthy for animals may have an impact on the health and well-being of
humans. Animals in the food chain must be healthy in order to ensure protection
of people in daily life. Article 4 uses the phrase “preventing disease in
humans or animals” and covers “medicines for human and veterinary use”. The
rationale for including medicines for veterinary use under this convention is
that deliberately compromised medicines may directly affect public health
through the food chain, and indirectly where disease is transmitted from animals
to humans as a consequence of inefficacious veterinary medicines. The
drafters of the convention have had the forethought to include non-human
consumption of medicines in the scope of their definitions, ensuring a comprehensive
system so that no subsequent international treaty or convention
is required to target the presence of counterfeit medicines in the food chain.
Criminalisation of counterfeiting and related acts
The MEDICRIME Convention obliges parties to establish as criminal offences
the intentional commission of the acts defined in Articles 5 to 8:
–– manufacturing of counterfeit medical products;
–– supplying, offering to supply (including brokering), and trafficking in
counterfeit medical products;
–– falsification of documents;
36. Such as the United Nations Single Convention on Narcotic Drugs (1961), the United Nations
Convention on Psychotropic Substances (1971), the United Nations Convention Against
Transnational Organized Crime and its Protocols (2000), the United Nations Firearms
Protocol, and the Council of Europe Convention on Action against Trafficking in Human
Beings (CETS No. 197, 2005).
IV. The Council of Europe MEDICRIME Convention ► Page 35
–– similar crimes involving threats to public health, in so far as such activity
is not covered by Articles 5, 6 and 7. These include, in particular:
“a. the manufacturing, the keeping in stock for supply, importing, exporting,
supplying, offering to supply or placing on the market of:
i. medicinal products without authorisation where such authorisation
is required under the domestic law of the Party; or
ii. medical devices without being in compliance with the conformity
requirements, where such conformity is required under the domestic
law of the Party;
b. the commercial use of original documents outside their intended
use within the legal medical product supply chain, as specified by the
domestic law of the Party.”
Examples of offences covered by Articles 5, 6 and 7 are outlined below to illustrate
the breadth of risk for patients, and the profit that can be made by white-collar
criminals, as well as by organised crime. They also illustrate that, increasingly,
lifesaving medicines rather than “lifestyle” medicines are being counterfeited and
trafficked. Of particular relevance to the offences described in the MEDICRIME
Convention is the reality that each instance is likely to involve two or three of the
offences established in Articles 5, 6 and 7, and possibly in some cases, Article 8.
Italian organised criminal elements are suspected to have been involved in
the 2014 theft, counterfeiting and trafficking of Herceptin®,37 a medicine for
the treatment of cancer. Once stolen, the medicines were channelled through
an authorised Italian wholesaler to fictitious wholesalers in Hungary, Romania,
Latvia and Italy. They were then tampered with and falsified, so much so that
in some cases no active ingredient remained. The counterfeit Herceptin® was
then put on the market in other countries (Austria, Finland, Germany, Sweden
and the UK) for dispensing to patients. This was a very lucrative crime as one
vial costs, for example, over £400 in the UK.
Avastin®, a high-priced medicine used for the treatment of cancer, was trafficked
by Richard Taylor from Europe to the US, and sold directly by Montana
Health Care Solutions and Rocky Ventures to US medical clinics. This involved
both the diverted authentic as well as counterfeit versions of Avastin®. Some
of the Avastin® did not contain any active substance, to the detriment of the
37. IRACM (2014), “Herceptin traffic in Europe: Organized crime at the heart of the investigation”, at
www.iracm.com/en/2014/05/europe-herceptin-traffic-organized-crime-at-the-heart-ofthe-
investigation/.
Handbook for parliamentarians ► Page 36
cancer patients. Richard Taylor was finally sentenced to 18 months in prison
and a fine of US$800 000.38
Other lifesaving medicines that have been counterfeited and trafficked39 include
Truvada®, Viread®, Combivir® and Viramune®, all indicated for the treatment of HIV.
Counterfeit versions of these treatments have been found on the markets of several
European countries since 2009. The trade in counterfeit lifesaving medicines, such
as Casodex® for the treatment of prostate cancer, Zyprexa® for the treatment of
psychosis and Plavix® for the treatment of cardiovascular disease, was the subject
of a multi-state investigation centred on the UK, which began in 2007.40
Adulteration with different active substances is common in the illegal manufacturing
industry and supply market, due to the use of the same machinery to
make various products involving the use of different active substances. This has
been common in the production of counterfeit erectile dysfunction medicines
where multiple active ingredients have been found during analysis.41 In 2012,
over 100 patients of a Pakistani medical clinic were reported to have died as a
result of the adulteration of Isotab®, a cardiac medication, with pyrimethamine
which is used for the treatment of malaria. The resulting product contained over
14 times the recommended dosage of pyrimethamine for malarial patients.42
Veterinary medicinal products are equally vulnerable. Questions were raised in
one UK prosecution43 as to the impact of counterfeit veterinary medicines on
the global epidemic of antibiotic resistance. Counterfeit anti-inflammatories,
pain medication, sedatives and antibiotics, with a value of £6 million, were
sold by a couple living in France, and operating from Belgium and the UK, to
4 000 customers in the farming and veterinary professions up to 2011. The
products had been imported from Asia.
38. Roth J. (2013), “Counterfeit Drugs: Prosecuting the Profiteers, Protecting the Public Health”,
FDA Voice, At http://blogs.fda.gov/fdavoice/index.php/tag/misbranded/.
39. Partnership for SafeMedicines.org, “Counterfeit HIV Medication: Profitable for Criminals but
Dangerous for Patients”, at www.safemedicines.org/counterfeit-hiv-medication-profitablefor-
criminals-but-dangerous-for-patients.html.
40. Jessop N. (2012) “Stepping up the fight against counterfeits”, PharmTech.com, 24 (3), at
www.pharmtech.com/stepping-fight-against-counterfeits.
41. Campbell N., et al. (2013), “Adulteration of purported herbal and natural sexual performance
enhancement dietary supplements with synthetic phosphodiesterase type 5 inhibitors”,
J Sex Med, 10(7), 184209, PubMed.gov. at www.ncbi.nlm.nih.gov/pubmed/23634714.
42. Khan S.M. (2012), “Medicine adulterated with large amounts of anti-malarial:
Sharif”, The Express Tribune, at http://tribune.com.pk/story/330278/
medicine-adulterated-with-large-amounts-of-anti-malarial-sharif/.
43. McKenna M. (2011), “Are counterfeit drugs driving antibiotic resistance?”, Wired, at
www.wired.com/2011/08/counterfeit-driving-resistance/.
IV. The Council of Europe MEDICRIME Convention ► Page 37
Medical devices are also vulnerable to being counterfeited. The recent PIP
breast implant scandal44 affecting many European countries resulted in
industrial-grade silicone being used in human-grade implants.
D. Preventive measures
A good reporting system is one of the best approaches to combating the
counterfeiting of medical products and similar crimes, because it can collect
data and alert officials to potential problems before harm occurs. Article 18 of
the MEDICRIME Convention offers preventive measures that attack this global
health problem in several important ways.
It requires measures for the establishment of quality and safety requirements
for medical products as well as a safe distribution system and measures to
prevent the illegal supply of counterfeit medical products. The 28 member
states of the EU that are members of the Council of Europe already have this
type of regulatory system established under the directives covering medical
products, as described in this convention, but some non-EU member states
may not. By establishing regulation and good practice standards there will
be a safer and a more guaranteed system of medical product supply within
and among all states bound by the MEDICRIME Convention.
Article 18 also includes provisions for training all authorities involved and for
awareness-raising campaigns aimed at populations affected by the counterfeiting
of medical products and similar crimes.45 Without these measures, it
would be easier for offenders to commit the crimes described in Articles 5 to
8 of this convention without the fear of sanction and thus contribute to the
detriment of public health.
1. Specialised prevention authorities and co-ordinating bodies
Reporting suspected counterfeit medical products, falsification
of documents or similar crimes
Health professionals are key players in the process of detecting and reporting
suspected counterfeit medical products, but they do not have the authority
44. Jones B. (2012), “Breast implant scandal: What went wrong?”, CNN, at http://edition.cnn.
com/2012/01/27/world/europe/pip-breast-implant-scandal-explained/index.html.
45. The Interpol co-ordinated “Operation Pangea” includes this concept in order to raise
awareness among the consuming public, at www.fda.gov/NewsEvents/Newsroom/
PressAnnouncements/ucm322492.htm; at http://interpolnoticeremoval.com/tag/mpcpc/.
Handbook for parliamentarians ► Page 38
to act independently. Article 17 of the convention calls on states to ensure
that their legislatures create enforcement networks with partners among all
types of competent authorities, including health authorities, customs and
police, so they may exchange information and co-operate in accordance
with domestic law. Article 17 also encourages these competent authorities
to co-operate with industry and trade sectors on risk management in regards
to the counterfeiting of medical products and similar crimes involving threats
to public health. The text therefore opens the way for a highly sophisticated
national infrastructure which allows public health officials and others to work
together in order to detect, report, measure and counteract counterfeiting
and similar crimes.
Consequently, the MEDICRIME Convention creates an opportunity for states to
support the work of global health policy makers, such as the Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
(PIC/S) Rapid Alert Scheme46 and the WHO47 strategic approach to this global
health problem as outlined in guidelines from the Executive Board of WHO,
which reports to the World Health Assembly (WHA).48,49 There is no need
46. PIC/S (2015), Procedure for handling rapid alerts and recalls arising from quality defects
(PI 013-3) at www.picscheme.org/publication.php?id=17.
47. In November 2014, the WHO Executive Board determined that its in-house monitoring mechanism
should review procedures to detect, report and follow up SSFFC issues using the WHO
Rapid Alert System which is designed to offer patients and consumers a validated basis to
develop collaboration strategies for reducing the incidence of SSFFC products, by identifying
the vulnerabilities in supply chains, measuring the harm caused and facilitating the more
efficient exchange of information between countries. WHO Executive Board guidelines are
consistent with the international collaboration provisions of the MEDICRIME Convention.
48. WHO guidelines, “it is advisable to have the sample, if possible, attached to a report form
on the suspected SSFFC medical products containing as much pertinent data as possible,
including but not limited to: identification and description of the problem, contact details
for the person or entity reporting the problem, product name (International Non-proprietary
Name and brand name, if any), batch, manufacturing date, expiry date, manufacturer or
marketing authorization holder (hereinafter MAH), location/source where the product
was acquired (online, authorized or unauthorized establishment), and description of any
adverse events due to the use”.
49. It should be noted that both PIC/S and WHO’s Member State Mechanism (MSM) on SSFFC
concern medical products, but do not include medical devices, parts, materials or accessories,
and are focused on the protection of health through recording effects of medical
products adversely affecting health. The MEDICRIME Convention’s focus is different in that
it uses criminal law to address offending behaviours in relation to medical products, active
substances, excipients, parts, materials and accessories.
IV. The Council of Europe MEDICRIME Convention ► Page 39
to re-invent the wheel to convey information about these offences.50 WHO
activities already in place51 can serve to rebut potential arguments against
ratification such as “we don’t have the money and infrastructure to set up
data collection to combat such crimes”: rather, states or the Committee of the
Parties can tailor the existing system to meet specific needs.
2. Protective measures and assistance to victims
The MEDICRIME Convention does not alter existing methods of recovering
damages using civil liability. Instead, Article 19 of the convention reaffirms
victims’ right to compensation from the perpetrators, while also granting
them the opportunity for assistance in their recovery process and requiring
that they have access to information about their case, when necessary for the
protection of their health. Ratifying states also undertake to promote the role
of such rights in their national legislatures.
Article 20 ensures, among other rights, that victims have standing to complain
at criminal proceedings, in a manner consistent with the procedural rules of
domestic law, and to have access to the information regarding their complaint,
possible charges, the general progress of the investigation or proceedings, and
their role therein as well as the outcome of their cases. This is a key provision
because, while not expressly being provided for by the convention, it may
enable victims to obtain additional information on the harm that has been
done to them as relevant to their health (Article 19). At the same time, the
provision of the right of victims to access information promotes institutional
accountability and governmental transparency.
3. Measures aimed at the general public: outreach
and awareness to prevent counterfeiting
Communication with the general public is an essential tool for preventing
crime, however this is often neglected when estimating the costs for any
programme targeting criminal activity.
50. WHO’s SSFFC includes sub-standard products which are not included in the MEDICRIME
Convention, as sub-standard is a breach of good manufacturing practice standards and
not an intentional activity to counterfeit a medical product or a similar crime. Substandard
products are not counterfeit, unless made intentionally sub-standard under Article 5 of
the convention.
51. WHO recommendations for health authorities to detect and deal with actions, activities
and behaviours that result in substandard/spurious/falsely-labelled/falsified/counterfeit
medical products IV.1.2. Testing in quality-control laboratories.
Handbook for parliamentarians ► Page 40
And yet outreach to the public is one of the least expensive approaches to
crime prevention, with the added value that it reassures the public that states
have taken a proactive interest in protecting their right to health by defending
the integrity of health care.
The MEDICRIME Convention encourages the participation of the private sector
and civil society, including the media. The media clearly have an important
role to play in educating the general public and in realistically addressing the
issue through documentaries and television films on the risks posed by the
counterfeiting of medical products and similar crimes. Other players active
in the field include NGOs and the voluntary sector, also covered by the term
“civil society”, whose work must be acknowledged and built upon. States are
invited to encourage these secondary projects and programmes aimed at
preventing counterfeiting of medical products and similar crimes.
The convention invites states to adopt a range of measures, within national
and local plans, using a multidisciplinary approach to prevention, along with
efficient co-ordination across jurisdictions.
Some possible approaches include:
–– co-ordination between the education and health sectors, law-enforcement
and licencing authorities;
–– establishing infrastructure for the detection of counterfeit medicines, with
a view to enacting criminal laws against counterfeiting in each country;
–– establishing mechanisms for data collection, in collaboration with
civil society, for detecting and evaluating the crimes covered by the
convention, with due respect for the requirements of personal data
protection;
–– encouraging co-operation between competent state authorities, civil
society and the criminal prosecution apparatus to curb this danger to
public health.
E. Interventions
Concerned countries already participate on an ad hoc basis in several key
international programmes set up by Interpol52 and Europol, but the absence
of a juridical basis for enforcement undermines the ability to fully exploit these
52. Interpol operations on pharmaceutical crime at www.interpol.int/Crime-areas/
Pharmaceutical-crime/Operations/Operation-Mamba.
IV. The Council of Europe MEDICRIME Convention ► Page 41
resources. The MEDICRIME Convention fills this void. It provides a legal basis
for successful programmes that prevent, stop and punish offences established
under the MEDICRIME Convention.
Article 22 of the MEDICRIME Convention promotes international collaboration
among states to organise surveillance measures for the quality and integrity of
medical products in commerce, and to co-operate on protecting and providing
assistance to victims. To do so, the convention obliges states parties to designate
national contact points (without prejudice to the internal reporting systems
of the parties) for the exchange of information. Thus, monitoring occurs at
two levels: at the national level, by encouraging laws that are consistent across
ratifying nations, and at the international level, through sharing information.
1. International co-operation in criminal matters
The MEDICRIME Convention offers an important example of a practical approach
to intervention because it allows for subsequent extradition treaties regarding
the offences established in the convention. Article 21, paragraph 2, obliges
states to “co-operate to the widest extent possible in pursuance of the relevant
applicable international, regional and bilateral treaties on extradition and
mutual legal assistance in criminal matters concerning the offences established
in accordance with this Convention”. This effort can provide a legal basis for the
efforts already undertaken by states in conjunction with other organisations,
such as Interpol, Europol and WHO. This provision also offers a new opportunity
to harmonise existing treaties and conventions regarding extradition, in
the event that a transnational offence is committed and causes harm in one
country but is not, until the ratification of the MEDICRIME Convention, illegal
in the perpetrator’s home state.
2. International co-operation on prevention
and other administrative measures
Although criminal law is invaluable as a tool to punish perpetrators and their
agents, other administrative measures (particularly, of a preventive nature)
are necessary in order to counter the risks posed by counterfeiting of medical
products and similar crimes. It is important to use both types of measures.
Article 18 of the MEDICRIME Convention promotes consistency across infrastructures,
by encouraging governments to, among other requirements for
ensuring safety and quality in the manufacturing and distribution of medical
Handbook for parliamentarians ► Page 42
products, engage in a campaign informing the general public about the crimes
covered by the convention and the competent authorities which fight these
offences.
As stated in Article 22, paragraph 2, “the Parties shall, without prejudice to their
internal reporting systems, designate a national contact point which shall be
responsible for transmitting and receiving requests for information and/or
co-operation in connection with the fight against counterfeiting of medical
products and similar crimes involving threats to public health”. For example,
by encouraging international co-operation among states,53 it should become
easier, at all stages in the supply chain, for national authorities to prevent, trap
and arrest perpetrators of offences established by states under the MEDICRIME
Convention.54 Because illegitimate copies of medicines do not have quality,
safety and efficacy guarantees from competent authorities, the prevention portions
of the MEDICRIME Convention that facilitate international collaboration
and the creation of robust systems to detect and report counterfeit medical
products are important for protecting public health.
The MEDICRIME Convention will enable enforcement agencies, police, customs
and health regulatory authorities to build on and benefit from communication,
collection of samples for verification, risk evaluation by competent authorities
and the health sector and a communication strategy for disseminating the
information to the public. WHO, for example, accepts reports received inperson,
by post mail, telephone or email. Reports and samples sent to WHO
are then systematically recorded and communicated to stakeholders including
enforcement, public health officials and the general public. Reporting at
the international level involves contacting national focal points. According to
WHO, follow-up after appropriate investigation by competent authorities may
53. Council of Europe Ad hoc Group on Counterfeit Medicines (2007), “A model for a network of
Single Points of Contact (SPOCs) to combat counterfeit medical products”, EDQM, at www.
edqm.eu/medias/fichiers/Model_for_a_Network_and_Single_Points_of_Contacts_SPOCs.pdf.
54. Relevant precedent exists such as the WHO Executive Committee guidelines, which are
not law, but which provide a useful starting point: “A. … 1. Establish and convene an MSM
working group comprised of experts from Member States to: (i) draft recommendations
to strengthen NRRAs in their prevention, detection and response to SSFFC medical products,
including on criteria for risk classification and assessment prioritization of cases of
SSFFC medical products; (ii) develop training material for NRRAs in hard and soft copy,
multilingual, virtual and face to face formats focused on the prevention, detection and
response to SSFFC medical products. B. Create a focal point network for the exchange of
information and consultation at large among Member States and establish an on-going
virtual exchange forum”.
IV. The Council of Europe MEDICRIME Convention ► Page 43
include the recall and destruction of hazardous medicines,55 while sharing
information with counterparts in other states and with patients or their families.
Non-EU member states of the Council of Europe and other states considering
the implementation of the convention could choose to seek guidance
from the EU directives on human and veterinary medicines, clinical trials
and medical devices, or from the WHO Executive Board guidelines as a basis
for international co-operation by specialised bodies for implementing the
inspections along the distribution chain, noting compliance history and best
practices for prevention. For example, WHO collects data about: (a) verification
of current good manufacturing and distribution practices in the supply chain
from starting materials to finished dosage medical product; (b) verification of
the origin and destination for each transfer of possession; (c) post marketing
surveillance and co-ordination with regulatory agencies; (d) identification
and investigation of activities and behaviours that result in SSFFC medical
products; (e) collection of samples for verification, or analysis and (f ) recalls
of SSFFC medical products.56 By increasing prevention through international
co-operation, the MEDICRIME Convention can provide a legal basis to existing
efforts under WHO guidelines and open communication channels with health
professionals, patients and consumers.57
F. Criminalisation of acts
The MEDICRIME Convention obliges parties to establish as offences, when
committed intentionally, the manufacturing, supplying, offering to supply
and trafficking of counterfeit medical products, active substances, excipients,
parts, materials or accessories, the falsification of documents and other similar
crimes involving threats to public health.
The convention does not target unintended breaches of good practices by
manufacturers authorised to manufacture or distribute medical products,
where such authorisation is required by domestic law. As noted by Jan Kleijssen
55. WHO’s Member State Mechanism (MSM) has described such medicines, which do not
include medical devices, parts, materials or accessories, as SSFFC (Substandard/spurious/
falsely-labelled/falsified/counterfeit) rather than as counterfeit or falsified. At http://apps.
who.int/gb/SSFFC/pdf_files/WG1b/A_MSM_WG1_2-en.pdf.
56. World Health Organization, Executive Board, Recommendations for health authorities
to detect and deal with actions, activities and behaviours that result in SSFFC medical
products, November 2014.
57. http://apps.who.int/gb/ebwha/pdf_files/EB136/B136_29-en.pdf.
Handbook for parliamentarians ► Page 44
and Susanne Keitel: “The Convention does not criminalise honest medicine
manufacturers.”58
Similar crimes involving threats to public health
Global trafficking has made it necessary for the MEDICRIME Convention to
take an expansive view of “threats to public health,” and obliges the parties
to take the necessary legislative and other measures to also establish similar
crimes (as mentioned above) as offences under its domestic law, when they
are committed intentionally.
These crimes, committed throughout the world,59 affect a wide range of
medicinal products, including those indicated for blood pressure, cancer,
sedatives, antidepressants, hormone replacement therapies and cholesterol,
but also medical devices, such as needles, condoms and dental equipment,
including X-Ray machines.60,61
Wherever authentic medical products have been diverted from their intended
market, as in the offences envisaged by Article 8, they often also involve the trafficking
of counterfeit medical products as envisaged by Articles 5 and 6, as well
as the use of falsified documentation as envisaged by Article 7 of the convention.
1. General overview
Due to the fact that many counterfeit medical products are manufactured in
a first country for marketing in one or more state(s) and then diverted from
the state of intended destination to a third state, detection and prosecution
may be challenging. By specifically targeting the manufacture, trafficking
and sale of medical products outside the scope of regulatory systems, the
MEDICRIME Convention may stop threats to public health that undermine
public confidence in the system. It is difficult for states to co-operate on
58. Kleijssen J. and Keitel S., “The Council of Europe MEDICRIME Convention: protecting
the patient from counterfeit/falsified medical products – a pre-requisite for safe
healthcare”, May 2014.
59. Singh J. (2008), “Phase out the Fakes”, Medicaldevice-network.com. at www.medicaldevicenetwork.
com/features/feature1811/.
60. MHRA Press release (2015), “UK leads the way with £15.8 million seizure in global operation
targeting counterfeit and unlicensed medicines and devices”, at www.gov.uk/government/
news/uk-leads-the-way-with-158-million-seizure-in-global-operation-targeting-counterfeitand-
unlicensed-medicines-and-devices.
61. Interpol (2015) Operation Pangea VIII, at www.interpol.int/en/Crime-areas/
Pharmaceutical-crime/Partnerships.
IV. The Council of Europe MEDICRIME Convention ► Page 45
matters such as extradition and mutual legal assistance because national laws
regarding the definition and punishment of the type of offences covered by
the MEDICRIME Convention vary between states. Extradition for offences, as
established under the convention, may be impossible unless the states are
parties to the MEDICRIME Convention.
Throughout the substantive criminal law chapter of the MEDICRIME Convention,
parties undertake to establish as offences in their domestic laws each act
targeted by the various provisions. There is limited scope for each state or
the European Union, at the time of signature or when depositing its instrument
of ratification, to declare to the Secretary General of the Council of
Europe a reservation where that is provided for, such as in Articles 5.1, 6 and
7 as regards excipients, parts and materials, and for 5.2 as regards excipients.
Reservations may also be entered in the same circumstances in Article 9.2 as
regards Articles 7 and 8 and, in Articles 10.1.d and 10.2 as regards jurisdiction.
These possible reservations notwithstanding, the list of prohibited acts and
consequent offences applies equally to all cited medical products.
As regards Articles 5 to 7 of the MEDICRIME Convention, it should be noted
that the mere possession of counterfeit medical products, active substances,
excipients, parts, materials and accessories or falsified documents is not
specifically criminalised under the convention. However, possession of such
items with an intent to commit any of the criminal acts set out in Articles 5
and 6 could be considered – when not included in the concept of “keeping
in stock” related to “trafficking” of Article 6 – as an attempt under Article 9.
The MEDICRIME Convention does not specifically require criminalising the
possession of equipment that could be used to commit the criminal acts set
out in Articles 5, 6 and 7, since it would in practice often prove difficult to
establish a sufficiently strong link between the mere possession of equipment
that could theoretically be used for such criminal activity and the actual activities
of counterfeiting, supplying and trafficking in counterfeits, as well as the
falsification of documents. However, such equipment may, of course, play an
important role as evidence, if that link can be established. Finally, possession
of equipment could also be considered as an attempt (under Article 9), if a
criminal intention can be demonstrated.
2. Key provisions
Articles 5 to 8 of the MEDICRIME Convention list intentional conduct that is
considered to be so inherently dangerous to public health that those articles
Handbook for parliamentarians ► Page 46
apply even without actual physical or psychological damage to victims. As
the right to life is protected by Article 2 of the European Convention on
Human Rights, it follows that public health is a protected collective right.
The manufacturing of counterfeit medical products creates a health risk, but
until these products are consumed or used they are unlikely to cause actual
harm. For this reason alone it would be futile to suggest that actual harm
needs to be proven when an offender manufactures a counterfeit medical
product or falsifies or uses a falsified document.62 That risk comes to fruition
when the patient consumes the finished dosage form of a medicinal product
or is treated with the medical device. Too often, due to delayed detection of
harm or to another underlying medical condition, it can be difficult to prove
a nexus of actual harm in many cases.63 Although “adulteration” has not been
specifically defined in Article 4 of this convention, the concept of adulteration
involves reducing the quality of a product by changing its ingredients at the
manufacturing stage. Supplying, offering to supply or trafficking in adulterated
medical products are defined as criminal offences in the convention.
People who are agents of a corporation engaging in such illegal activity are
also criminals under this convention.
Significantly, the criminal law in the MEDICRIME Convention punishes people
who are not in possession of the illegal goods in question, but who provide
a link in the distribution chain, under Article 6, for supplying or offering “to
supply, or trafficking …counterfeit medical products, active substances,
excipients, parts, materials and accessories”. The terms “supplying” and “offering
to supply” are not specifically defined, but were intended by the drafters
to include brokering, procuring, selling, donating or offering for free as well
as promoting these products through advertising. Note that “offering to
supply”64 is a separate criminal act distinguished from an “attempt to supply”,
62. Interpol, Pharmaceutical Crime Sub-Directorate, op. cit. Actual harm would not have
occurred to the patients in the medical clinic if the medicinal product adulterated with
Pyrimethamine had not been dispensed to patients, but the threat existed once the product
had been manufactured. Having been dispensed, over 100 patients died. It took significant
investigation to determine which medicinal product actually caused the deaths as more
than one was initially suspected as being the cause.
63. The case of dinitrophenol (DNP) weight loss product is an example where the post mortem
can show that the death was consistent with the actions of 2,4-dinitrophenol, but a death
from an Erectile Dysfunction (ED) medicine would present itself as a cardiac event and
might not be connected with the ED medication unless prompted by external information.
NHS choices (2013), “Warning issued over deadly DNP ‘diet drug’”, at www.nhs.uk/
news/2013/09September/Pages/Warnings-issued-over-deadly-DNP-diet-drug.aspx.
64. Offering to supply can often be found on online auction sites.
IV. The Council of Europe MEDICRIME Convention ► Page 47
under Article 9. A person may thus engage in the criminal act of making an
“offer to supply” without actually having those products in their possession.
This conduct differs from “attempt to supply”, when the supplier does possess
counterfeit medical products, but does not complete the criminalised act.
MEDICRIME Convention Article 7 on the falsification of documents covers the
act of producing a false document from scratch, as well as unlawfully amending
or changing a document with regard to its content or its appearance so that
a person reading the document is deceived into believing that the medical
product, active substance, excipient, part, material or accessory which the
document accompanies is legitimate,65 and not counterfeit or the subject of
a criminal conduct as described in Article 8, paragraph a.
MEDICRIME Convention Article 8 on similar crimes involving threats to public
health includes certain offences that are considered to be similar to counterfeiting
of medical products, as they pose an equally serious threat to public
health, but are nevertheless clearly distinct from that conduct by the fact that
the medical products subject to Article 8, paragraph a, are not counterfeited.
In fact, these products are intentionally manufactured, kept in stock for supply,
imported, exported, supplied, offered for supply, or placed on the market
without authorisation (medicines) or without being in compliance with the
conformity requirements (medical devices) as laid down in the domestic law
of the parties.
An example of the offences set out in Article 8, paragraph a, is the well-attested
existence of a sprawling black market for medicines for hormonal treatment
produced without authorisation – which are used for doping for athletes and
by others who want to artificially enhance their physical performance.66 The
abuse of these unauthorised medicines can lead to bodily injury and death,
and their uncontrolled circulation constitutes in itself a significant threat to
public health. Another example is the otherwise legitimate manufacturing of
a medicine, which criminals then divert through the black market with a view
65. Herceptin®, a medicinal product used in the treatment of cancer, was stolen in
Italy and was placed on markets in Austria, Finland, Germany, Sweden and the UK.
Other countries were involved in the distribution chain of this diversion and counterfeiting
and the perpetrators used falsified documentation to get the product
onto the market in other countries. Palmer E. (2014), “EMA warns Herceptin vials stolen
in Italy spreading through EU”, FiercePharma at www.fiercepharma.com/story/
ema-warns-herceptin-vials-stolen-italy-spreading-through-eu/2014-04-16.
66. IFPMA, “2 Fields 1 Goal, Protecting the integrity of science and sport” at www.ifpma.org/
ethics/doping-in-sport.html.
Handbook for parliamentarians ► Page 48
to unauthorised supplying. It is a fact that legitimate anabolic steroids used
for medical purposes are also sold on the black market to athletes and other
people who wish to enhance their physical performance.67
In addition to the offences enumerated in Article 8.a, Article 8.b obliges parties
to establish as an offence “the commercial use of original documents outside
their intended use within the legal medical product supply chain, as specified
by the domestic law of the Party”. This provision is intended to target the
intentional abuse of original documents for criminal purposes related to the
acts set out in Article 8. a, for example, to cover up the fact that a medicine
has been manufactured without authorisation by pairing the unauthorised
product with original documents intended for another – authorised – medicine.
The commercial use of documents outside the legal medical product supply
chain without criminal intent, such as the legitimate selling and/or buying of
waste papers (such as unused packaging) for recycling purposes is obviously
not covered by the provision.
3. Integration with existing procedural law
The Council of Europe already has a wide set of standards in relation to judicial
co-operation in criminal matters. For example, the European Convention on
Extradition (ETS No. 24) and its protocols (ETS Nos. 86 and 98), the European
Convention on Mutual Assistance in Criminal Matters (ETS No. 30) and its
protocols (ETS Nos. 99 and 182), and the Council of Europe Convention on
Laundering, Search, Seizure and Confiscation of the Proceeds from Crime and
on the Financing of Terrorism (CETS No. 198) constitute transversal instruments
that can be applied to many different offences.
In Article 17 the convention sets forth several principles to govern international
co-operation:
–– the parties shall remove obstacles to the rapid circulation of information
and evidence and co-operate in order to prevent or stop activities
criminalised by the convention;
–– the parties shall enable international co-operation for enforcement
actions;
67. “Brian Wainstein fights extradition on steroid charges”, 2013, Steroid.com at www.steroid.
com/blog/Brian-Wainstein-Fights-Extradition-on-Steroid-Charges.php. Brian Wainstein had
been prosecuted in Ireland and convicted and sentenced to two years’ imprisonment for
the 2003 distribution of anabolic steroids, at http://juicedmuscle.com/jmblog/content/
genxxl-axio-syntrop-biogen-and-their-offspring.
IV. The Council of Europe MEDICRIME Convention ► Page 49
–– the parties shall promote international collaboration to refine the state
of the art of detection.
In sum, the MEDICRIME Convention therefore clearly addresses the present
lacunae in public health protection and quality control of medicines and fills
an important void in the realm of international criminal law. The practical effect
of these criminal law provisions, not written into the text of the document, is
that ratification of the MEDICRIME Convention also offers states a modicum of
control over transnational corporations that can leapfrog across jurisdictions
in search of favourable laws and economic conditions. Thus, regulation in
states that have agreed to multi-jurisdictional protections against offences in
accordance with the MEDICRIME Convention may provide another important
tool to check egregious conduct by bad actors in those nations.
G. Jurisdictional requirements for initiating proceedings
and punishing offences
Article 10 of the MEDICRIME Convention facilitates international co-operation
for enforcement against this global threat to public health by taking a broad
view of the jurisdiction of parties under this convention. It does this in two
ways: first it establishes in Article 10, paragraphs 1, 2 and 3, a broad view of
situations where a state party can exert its jurisdiction in relation to offences
established under this convention (basis of jurisdiction: territoriality principle,
nationality principle, passive personality principle, persons having their habitual
residence in the territory of the party, aut dedere, aut judicare (extradite or
prosecute)). Secondly, Article 10, paragraph 5, establishes a concrete system of
co-operation between parties (“where more than one Party claims jurisdiction
over an alleged offence established in accordance with this Convention, the
Parties concerned shall consult, where appropriate, with a view to determining
the most appropriate jurisdiction for prosecution”). Article 10 requires
parties to expand their legislative reach, if necessary, in order to comply with
these terms.
The MEDICRIME Convention uses plain language that respects long-established
principles of international law:
–– the territoriality principle: each party is required to punish offences
committed on its territory, as well as on ships flying its flag or aircraft
registered under its laws;
–– the nationality principle: each party is required to punish offences
committed by its nationals abroad;
Handbook for parliamentarians ► Page 50
–– the passive personality principle: each party is required to punish offences
committed against its nationals abroad;
–– the principle of attachment of the perpetrator or victim to the state
where the person concerned has his/her habitual residence;
–– the principle of aut dedere, aut judicare.
However, according to Article 10, paragraph 4, each state or the European Union
may, at the time of signature or when depositing its instrument of ratification,
acceptance or approval, by a declaration addressed to the Secretary General
of the Council of Europe, declare that it reserves the right not to apply, or to
apply only in specific cases or conditions, the jurisdiction rules laid down in
Article 10, paragraph 1.d (offence committed abroad by its national or a person
habitually residing in its territory), and paragraph 2 of this article (offence
committed abroad when the victim is a national or a person habitually residing
in the territory of the party).
This means that, if a state already has extraterritorial criminal law provisions,
those provisions may apply to offences established in the MEDICRIME
Convention: there is no need for new provisions.
The convention does provide for jurisdiction over any offence established
in accordance with the MEDICRIME Convention when an alleged offender is
present in the territory of one party and cannot be extradited to another party
because of his or her nationality. The convention preserves the right of each
state party to preserve its jurisdiction over criminal acts in its own territory
under its domestic law.
States parties undertake to introduce legislation to conform to these provisions,
thereby promoting harmonisation of domestic laws in the field. The
MEDICRIME Convention lists circumstances whereby the parties agree to
establish jurisdiction over and punish criminal acts such as:
“Article 5 – Manufacturing of counterfeits
1. Each Party shall take the necessary legislative and other measures to
establish as offences under its domestic law, the intentional manufacturing
of counterfeit medical products, active substances, excipients, parts,
materials and accessories.”
The same language has been accepted in subsequent articles: Article 6 –
Supplying, offering to supply and trafficking in counterfeits; Article 7 – Falsification
of documents; Article 8 – Similar crimes involving threats to public health.
IV. The Council of Europe MEDICRIME Convention ► Page 51
H. Corporate liability
Significantly, the MEDICRIME Convention holds accountable with corporate
liability – in accordance with the domestic law of the parties – legal persons,
such as corporations, that engage in offences established in accordance
with the MEDICRIME Convention. This is an important provision because it
extends the scope of the substantive criminal law provisions contained in
the convention beyond the activities of people into the realm of organised
activities and organised crime when committed by legal persons. The states
parties also commit to fill the void in their existing domestic laws so that such
offences established in accordance with the convention cannot be committed
by corporations within their jurisdiction. Subject to the legal principles of the
party, the liability of a legal person may be criminal, civil or administrative.
The convention obliges the states parties to introduce into their domestic law
corporate liability for offences established in accordance with the MEDICRIME
Convention. Therefore, this provision promotes harmonisation and consistency
among all parties to the convention and indirectly generates a rationale for
consistent provisions regarding criminalisation of offences established in
accordance with the convention worldwide.
I. Sanctions
The convention obliges the parties to introduce “effective, proportionate and
dissuasive sanctions, including criminal or non-criminal monetary sanctions”,
taking account of the seriousness of the offence. In the case of individuals
committing an offence, these sanctions may entail deprivation of liberty and
even extradition. Legal persons are also subject to effective, proportionate
and dissuasive sanctions, including criminal and non-criminal monetary sanctions,
and may be subject to other measures, such as temporary or permanent
disqualification from exercising commercial activity, placement under judicial
supervision, or a judicial winding-up order.
Additionally, the MEDICRIME Convention requires parties to ensure that
measures can be taken concerning the seizure and confiscation of certain
documents, goods and the proceeds derived from offences. In addition, the
convention allows for the destruction of medical products that have been
produced as a result of an offence established under the convention.
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J. Aggravating circumstances
Article 13 requires parties to ensure that certain circumstances (mentioned in
letters a to f) may be taken into consideration as aggravating circumstances in
the determination of the sanction for offences established in this convention.
By the use of the phrase “may be taken into consideration”, the ad hoc committee
highlights that the convention places an obligation on parties to ensure
that these aggravating circumstances are available for judges to consider
when sentencing offenders, although there is no obligation on judges to
apply them. The reference to “in conformity with the relevant provisions of
national law” is intended to reflect the fact that the various legal systems in
Europe have different approaches to aggravating circumstances and therefore
the convention permits parties to retain their fundamental legal concepts.
The first aggravating circumstance (a), is where the offence caused the death
of, or damage to the physical or mental health of, the victim. Given the inherent
difficulties in linking the consumption of a medicine or the use of a medical
device directly with the occurrence of a death, the ad hoc committee considered
that in such cases, it should be up to the national courts of the states parties
to assess the causal link between acts criminalised under the convention and
any death or injury sustained as a result thereof.
The second aggravating circumstance (b), is where the offence was committed
by persons abusing the confidence placed in them in their professional
capacity. This category of persons obviously includes health-care professionals,
but the application of the aggravating circumstance is not restricted to them.
The third aggravating circumstance (c), is where the offence was committed by
persons abusing the confidence placed in them as manufacturers or suppliers.
The fourth aggravating circumstance (d), is where the offences of supplying and
offering to supply are committed through the use of large-scale distribution,
including through information technology systems. The use of information
systems, including the Internet, for supplying counterfeit medicines and the
supply (and offering to supply thereof) without authorisation is one of the
most worrying and serious aspects of counterfeiting of medical products and
similar crimes today. Given the immense reach of the Internet, counterfeit,
and hence dangerous, medical products are now being spread all over the
world at an alarming rate, At the same time, due to problems of jurisdiction, it
has become increasingly difficult to apprehend the criminals behind various
IV. The Council of Europe MEDICRIME Convention ► Page 53
Internet sites, offering cheap (and therefore mostly counterfeit) medicines or
other medical products.
The fifth aggravating circumstance (e) is where the offence involved a criminal
organisation. The convention does not define “criminal organisation”. In applying
this provision, however, parties may take their cue from other international
instruments which define the concept. For example, Article 2(a) of the United
Nations Convention against Transnational Organized Crime defines “organised
criminal group” as “a structured group of three or more persons, existing for a
period of time and acting in concert with the aim of committing one or more
serious crimes or offences established in accordance with this Convention,
in order to obtain, directly or indirectly, a financial or other material benefit”.
Recommendation Rec(2001)11 of the Committee of Ministers to member
states concerning guiding principles on the fight against organised crime
and the EU Council Framework Decision 2008/841/JHA of 24 October 2008
on the fight against organised crime give very similar definitions of “organised
criminal group” and “criminal organisation”.
The sixth aggravating circumstance (f), applies when the perpetrator has previously
been convicted of offences of the same nature as those established
under the convention. By including this provision, the convention signals the
need to make a concerted effort to combat recidivism in the low risk/high gain
area of counterfeiting of medical products and similar crimes.
K. International recidivism
Counterfeiting of medical products and similar crimes are more often than not
perpetrated transnationally by criminal organisations or by individuals, some
of whom may have been tried and convicted in more than one country. At
the domestic level, many legal systems provide for a different, often harsher,
penalty where someone has previous convictions. In general, only conviction
by a that same national court counts as a previous conviction. Traditionally,
previous convictions by foreign courts were not taken into account on the
grounds that criminal law is a national matter and that there can be differences
of national law, and also because of a degree of suspicion of decisions
by foreign courts.
Such arguments have less force today in that the internationalisation of criminal
law standards, in response to the internationalisation of crime, has prompted
the harmonisation of different countries’ laws. In addition, in the space of
a few decades, countries have adopted instruments such as the European
Handbook for parliamentarians ► Page 54
Convention on Human Rights, whose implementation has helped build a
solid foundation of common guarantees that inspire greater confidence in
the justice systems of all the participating states.
On the basis of these considerations, the principle of international recidivism
has been established in a number of international legal instruments.
Under Article 36, paragraph 2 (iii) of the Single Convention on Narcotic Drugs
of 30 March 1961, for example, foreign convictions have to be taken into
account for the purpose of establishing recidivism, subject to each party’s
constitutional provisions, legal system and national law. Under Article 1 of
the Council Framework Decision of 6 December 2001 amending Framework
Decision 2000/383/JHA on increasing protection by criminal penalties and
other sanctions against counterfeiting in connection with the introduction
of the Euro, European Union member states must recognise as establishing
habitual criminality final decisions handed down in another member state for
the counterfeiting of currency.
The fact remains that at the international level there is no standard concept
of recidivism and the laws of some countries do not have the concept at all.
The fact that foreign convictions are not always brought to the courts’ notice
for sentencing purposes is an additional practical difficulty. However, in the
framework of the European Union, Article 3 of the Council Framework Decision
2008/675/JHA of 24 July 2008 on taking account of convictions in the Member
States of the European Union in the course of new criminal proceedings has
established in a general way – without limitation to specific offences – the
obligation of taking into account a previous conviction handed down in
another (EU member) state.
Therefore Article 14 of the MEDICRIME Convention provides for the possibility
to take into account final sentences passed by another party in the determination
of a sentence. To comply with the provision, parties may establish in
their domestic law that previous convictions by foreign courts are to result
in a harsher penalty. They may also provide that, under their general powers
to assess the individual’s circumstances when setting the sentence, courts
should take those convictions into account. This possibility must also include
the principle that the offender should not be treated less favourably than if
the previous conviction had been a national one.
This provision does not place any positive obligation on courts or prosecution
services to take steps to find out whether persons being prosecuted have
received final sentences from another party’s courts. It should nevertheless be
IV. The Council of Europe MEDICRIME Convention ► Page 55
noted that, under Article 13 of the European Convention on Mutual Assistance
in Criminal Matters, a party’s judicial authorities may request from another
party extracts from and information relating to judicial records, if needed in a
criminal matter. In the framework of the European Union, the issues related to
the exchange of information contained in criminal records between member
states are regulated in two legal acts, namely Council Decision 2005/876/JHA of
21 November 2005 on the exchange of information extracted from the criminal
record and Council Framework Decision 2009/315/JHA of 26 February 2009
on the organisation and content of the exchange of information extracted
from the criminal record between member States.
L. Follow-up mechanism – Committee of the Parties
1. Composition
The convention provides for a follow-up mechanism to ensure its effective
implementation in the form of the Committee of the Parties. This mechanism
is based on a balanced composition of representatives of states parties to the
convention, plus representatives of the Parliamentary Assembly of the Council
of Europe, the CDPC and other relevant Council of Europe intergovernmental
or scientific committees, “in order to contribute to a multisectoral and multidisciplinary
approach” (Article 24.1). Representatives of international bodies,
of relevant official bodies of the parties or of civil society may be appointed
to the Committee of the Parties as observers (Articles 24.3, 24.4 and 24.5).
2. Functions
The Committee of the Parties shall monitor the implementation of the convention.
In addition to the traditional follow-up competences, the Committee of
the Parties has three main functions:
–– to facilitate the effective use and implementation of the convention,
including the identification of any problems;
–– to express an opinion on any question concerning the application of
the convention, including by making specific recommendations to the
parties in this respect;
–– to facilitate the collection, analysis and sharing of information, experience
and good practice between states to reinforce their capacities and
improve their policies in this field.
Handbook for parliamentarians ► Page 56
M. Relationship with other international instruments
The terms of the MEDICRIME Convention do not affect the rights and obligations
arising from the provisions of other multilateral or bilateral treaties, or
instruments on matters governed by this convention. The parties may conclude
bilateral or multilateral agreements and any other international instruments
on the matters dealt with in the convention, provided they do not derogate
from the convention.
N. Amendments to the convention
The parties may propose amendments to the provisions of the convention.
Proposed amendments must be communicated to all Council of Europe
member states, all signatories, all parties, the European Union and any state
invited to sign or accede to the convention. The CDPC will draft an opinion on
the proposed amendment, which will then be submitted to the Committee
of Ministers. After considering the proposal and opinion, the Committee of
Ministers must consult all parties and obtain unanimous acceptance before
deciding whether to adopt the amendment.
O. Final clauses
The convention is open for signature by the member states of the Council of
Europe, the non-member states which have participated in its elaboration
(Israel) or enjoy observer status with the Council of Europe (Holy See, Japan,
Mexico, the United States of America and Canada) and the European Union.
The Committee of Ministers may invite any non-member state of the Council
of Europe to accede to the convention after having obtained the unanimous
agreement of the other states/European Union having expressed their consent
to be bound by this convention. When appropriate, the parties to the convention
may specify the territory or territories to which it will apply.
► Page 57
V. Postface
by the Deputy Secretary
General of the Council
of Europe
In recent years, occurrences of counterfeiting of medical products and similar
crimes have increased worldwide. These crimes endanger public health, and
affect patients and their confidence in the legal marketplace.
Even more profitable than drug trafficking, this new form of crime has an
undeniable advantage for criminals: they go largely unpunished or receive
only mild sanctions. Even when states take strict measures to regulate the
production and distribution of medical products and devices, these measures
often prove insufficient, especially when criminal networks find gaps in
national legislations allowing them to make substantial profits at the expense
of people’s lives and health. The MEDICRIME Convention was drafted to protect
vulnerable patients and their right to safe access to medicines of appropriate
quality, and to fight against organised crime. As the first and only international
treaty dealing with this problem, the convention aims at prosecuting the
counterfeiting of medical products and similar crimes, protecting the rights
of victims and promoting national and international co-operation.
Organised criminal groups use the Internet to sell counterfeited medical products
globally, and their profits fund other activities linked to organised crime.
No state is spared this scourge. It is therefore essential that countries around
the world urgently address this problem. Concerned by this global challenge,
the Committee of Ministers agreed that this convention should be universal.
The large number of states that have expressed their willingness to be bound
by the MEDICRIME Convention shows that more and more governments
recognise the severity of the problem. The convention provides a clear legal
basis for harmonising provisions and good practices in this field. It lays the
foundation for national and international co-operation between legal, lawenforcement
and health authorities, in particular through multidisciplinary
co-operation within the networks of focal points established by the convention
among competent authorities.
Handbook for parliamentarians ► Page 58
The number of victims grows every day. The MEDICRIME Convention, along
with all measures taken by the Council of Europe and other international
organisations, has a large impact on all states’ efforts to eradicate these criminal
networks that endanger public health.
Therefore, I welcome this handbook, which I am sure will prove extremely
useful for parliamentarians when promoting the MEDICRIME Convention.
Gabriella Battaini-Dragoni
Deputy Secretary General
of the Council of Europe
► Page 59
Appendix I
Council of Europe Convention on the Counterfeiting
of Medical Products and Similar Crimes
(MEDICRIME Convention)68
Council of Europe Treaty Series – No. 211
Moscow, 28.X.2011
Preamble
The member States of the Council of Europe and the other
signatories to this Convention,
Considering that the aim of the Council of Europe is to achieve a
greater unity between its members;
Noting that the counterfeiting of medical products and similar
crimes by their very nature seriously endanger public health;
Recalling the Action Plan adopted at the Third Summit of Heads of
State and Government of the Council of Europe (Warsaw, 16-17 May
2005), which recommends the development of measures to
strengthen the security of European citizens;
Bearing in mind the Universal Declaration of Human Rights,
proclaimed by the United Nations General Assembly on 10 December
1948, the Convention for the Protection of Human Rights and
Fundamental Freedoms (1950, ETS No. 5), the European Social
Charter (1961, ETS No. 35), the Convention on the Elaboration of a
European Pharmacopoeia (1964, ETS No. 50) and its Protocol (1989,
ETS No. 134), the Convention for the Protection of Human Rights and
Dignity of the Human Being with regard to the Application of Biology
and Medicine: Convention on Human Rights and Biomedicine (1997,
ETS No. 164) and the Additional Protocols thereto (1998, ETS No. 168,
2002, ETS No.186, 2005, CETS No. 195, 2008, CETS No. 203) and the
Convention on Cybercrime (2001, ETS No. 185);
68. Text corrected in accordance with the Committee of Ministers’ decision (1151st meeting
of the Ministers’ Deputies, 18-19 September 2012).
Handbook for parliamentarians ► Page 60
Also bearing in mind the other relevant work of the Council of
Europe, particularly the decisions of the Committee of Ministers
and work of the Parliamentary Assembly, notably Resolution
AP(2001)2 concerning the pharmacist’s role in the framework of
health security, the replies adopted by the Committee of Ministers
on 6 April 2005 and on 26 September 2007, concerning respectively,
Parliamentary Assembly Recommendations 1673 (2004) on
“Counterfeiting: problems and solutions” and 1794 (2007) on the
“Quality of medicines in Europe”, as well as relevant programmes
conducted by the Council of Europe;
Having due regard to other relevant international legal instruments
and programmes, conducted notably by the World Health
Organisation, in particular the work of the group IMPACT, and by
the European Union, as well as in the forum of the G8;
Determined to contribute effectively to the attainment of the
common goal of combating crime involving counterfeiting of
medical products and similar crimes involving threats to public
health, by introducing notably new offences and penal sanctions
relative to these offences;
Considering that the purpose of this Convention is to prevent and
combat threats to public health, giving effect to the provisions of
the Convention concerning substantive criminal law should be
carried out taking into account its purpose and the principle of
proportionality;
Considering that this Convention does not seek to address issues
concerning intellectual property rights;
Taking into account the need to prepare a comprehensive
international instrument which is centred on the aspects linked
to prevention, protection of victims and criminal law in combating
all forms of counterfeiting of medical products and similar crimes
involving threats to public health, and which sets up a specific
follow-up mechanism;
Recognising that, to efficiently combat the global threat posed by
the counterfeiting of medical products and similar crimes, close
international co-operation between Council of Europe member
States and non-member States alike should be encouraged,
Appendix I ► Page 61
Have agreed as follows:
Chapter I – Object and purpose, principle of non-discrimination,
scope, definitions
Article 1 – Object and purpose
1 The purpose of this Convention is to prevent and combat threats
to public health by:
a providing for the criminalisation of certain acts;
b protecting the rights of victims of the offences established
under this Convention;
c promoting national and international co-operation.
2 In order to ensure effective implementation of its provisions by the
Parties, this Convention sets up a specific follow-up mechanism.
Article 2 – Principle of non-discrimination
The implementation of the provisions of this Convention by the
Parties, in particular the enjoyment of measures to protect the
rights of victims, shall be secured without discrimination on any
ground such as sex, race, colour, language, age, religion, political
or any other opinion, national or social origin, association with
a national minority, property, birth, sexual orientation, state of
health, disability or other status.
Article 3 – Scope
This Convention concerns medical products whether they are
protected under intellectual property rights or not, or whether they
are generic or not, including accessories designated to be used
together with medical devices, as well as the active substances,
excipients, parts and materials designated to be used in the
production of medical products.
Article 4 – Definitions
For the purposes of this Convention:
a the term “medical product” shall mean medicinal products
and medical devices;
Handbook for parliamentarians ► Page 62
b the term “medicinal product” shall mean medicines for human
and veterinary use, which may be:
i any substance or combination of substances presented
as having properties for treating or preventing disease
in humans or animals;
ii any substance or combination of substances which
may be used in or administered to human beings or
animals either with a view to restoring, correcting
or modifying physiological functions by exerting a
pharmacological, immunological or metabolic action,
or to making a medical diagnosis;
iii an investigational medicinal product;
c the term “active substance” shall mean any substance or
mixture of substances that is designated to be used in the
manufacture of a medicinal product, and that, when used in
the production of a medicinal product, becomes an active
ingredient of the medicinal product;
d the term “excipient” shall mean any substance that is not
an active substance or a finished medicinal product, but is
part of the composition of a medicinal product for human or
veterinary use and essential for the integrity of the finished
product;
e the term “medical device” shall mean any instrument,
apparatus, appliance, software, material or other article,
whether used alone or in combination, including the software,
designated by its manufacturer to be used specifically for
diagnostic and/or therapeutic purposes and necessary for
its proper application, designated by the manufacturer to
be used for human beings for the purpose of:
i diagnosis, prevention, monitoring, treatment or
alleviation of disease;
ii diagnosis, monitoring, treatment, alleviation of or
compensation for an injury or handicap;
iii investigation, replacement or modification of the
anatomy or of a physiological process;
iv control of conception;
Appendix I ► Page 63
and which does not achieve its principal intended action in or on
the human body by pharmacological, immunological or metabolic
means, but which may be assisted in its function by such means;
f the term “accessory” shall mean an article which whilst
not being a medical device is designated specifically by its
manufacturer to be used together with a medical device to
enable it to be used in accordance with the use of the medical
device intended by the manufacturer of the medical device;
g the terms “parts” and “materials” shall mean all parts and
materials constructed and designated to be used for medical
devices and that are essential for the integrity thereof;
h the term “document” shall mean any document related to a
medical product, an active substance, an excipient, a part, a
material or an accessory, including the packaging, labeling,
instructions for use, certificate of origin or any other certificate
accompanying it, or otherwise directly associated with the
manufacturing and/or distribution thereof;
i the term “manufacturing” shall mean:
i as regards a medicinal product, any part of the process
of producing the medicinal product, or an active
substance or an excipient of such a product, or of
bringing the medicinal product, active substance or
excipient to its final state;
ii as regards a medical device, any part of the process
of producing the medical device, as well as parts or
materials of such a device, including designing the
device, the parts or materials, or of bringing the medical
device, the parts or materials to their final state;
iii as regards an accessory, any part of the process of
producing the accessory, including designing the
accessory, or of bringing the accessory to its final state;
j the term “counterfeit” shall mean a false representation as
regards identity and/or source;
k the term “victim” shall mean any natural person suffering
adverse physical or psychological effects as a result of having
used a counterfeit medical product or a medical product
manufactured, supplied or placed on the market without
authorisation or without being in compliance with the
conformity requirements as described in Article 8.
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Chapter II – Substantive criminal law
Article 5 – Manufacturing of counterfeits
1 Each Party shall take the necessary legislative and other measures
to establish as offences under its domestic law, the intentional
manufacturing of counterfeit medical products, active substances,
excipients, parts, materials and accessories.
2 As regards medicinal products and, as appropriate, medical devices,
active substances and excipients, paragraph 1 shall also apply to
any adulteration thereof.
3 Each State or the European Union may, at the time of signature or
when depositing its instrument of ratification, acceptance or approval,
by a declaration addressed to the Secretary General of the Council
of Europe, declare that it reserves the right not to apply, or to apply
only in specific cases or conditions, paragraph 1, as regards excipients,
parts and materials, and paragraph 2, as regards excipients.
Article 6 – Supplying, offering to supply,
and trafficking in counterfeits
1 Each Party shall take the necessary legislative and other measures
to establish as offences under its domestic law, when committed
intentionally, the supplying or the offering to supply, including
brokering, the trafficking, including keeping in stock, importing
and exporting of counterfeit medical products, active substances,
excipients, parts, materials and accessories.
2 Each State or the European Union may, at the time of signature
or when depositing its instrument of ratification, acceptance or
approval, by a declaration addressed to the Secretary General
of the Council of Europe, declare that it reserves the right not to
apply, or to apply only in specific cases or conditions, paragraph 1,
as regards excipients, parts and materials.
Article 7 – Falsification of documents
1 Each Party shall take the necessary legislative and other measures
to establish as offences under its domestic law the making of
false documents or the act of tampering with documents, when
committed intentionally.
Appendix I ► Page 65
2 Each State or the European Union may, at the time of signature
or when depositing its instrument of ratification, acceptance or
approval, by a declaration addressed to the Secretary General
of the Council of Europe, declare that it reserves the right not to
apply, or to apply only in specific cases or conditions, paragraph 1,
as regards documents related to excipients, parts and materials.
Article 8 – Similar crimes involving threats
to public health
Each Party shall take the necessary legislative and other measures
to establish as offences under its domestic law, when committed
intentionally, in so far as such an activity is not covered by Articles 5,
6 and 7:
a the manufacturing, the keeping in stock for supply, importing,
exporting, supplying, offering to supply or placing on the
market of:
i medicinal products without authorisation where such
authorisation is required under the domestic law of
the Party; or
ii medical devices without being in compliance with the
conformity requirements, where such conformity is
required under the domestic law of the Party;
b the commercial use of original documents outside their
intended use within the legal medical product supply chain,
as specified by the domestic law of the Party.
Article 9 – Aiding or abetting and attempt
1 Each Party shall take the necessary legislative and other measures
to establish as offences when committed intentionally, aiding or
abetting the commission of any of the offences established in
accordance with this Convention.
2 Each Party shall take the necessary legislative and other measures
to establish as an offence the intentional attempt to commit any
of the offences established in accordance with this Convention.
3 Each State or the European Union may, at the time of signature
or when depositing its instrument of ratification, acceptance or
Handbook for parliamentarians ► Page 66
approval, by a declaration addressed to the Secretary General
of the Council of Europe, declare that it reserves the right not to
apply, or to apply only in specific cases or conditions, paragraph
2 to offences established in accordance with Articles 7 and 8.
Article 10 – Jurisdiction
1 Each Party shall take the necessary legislative and other measures
to establish jurisdiction over any offence established in accordance
with this Convention, when the offence is committed:
a in its territory; or
b on board a ship flying the flag of that Party; or
c on board an aircraft registered under the laws of that Party;
or
d by one of its nationals or by a person habitually residing in
its territory.
2 Each Party shall take the necessary legislative and other measures
to establish jurisdiction over any offence established in accordance
with this Convention, when the victim of the offence is one of its
nationals or a person habitually resident in its territory.
3 Each Party shall take the necessary legislative and other measures
to establish jurisdiction over any offence established in accordance
with this Convention, when the alleged offender is present in its
territory and cannot be extradited to another Party because of his
or her nationality.
4 Each State or the European Union may, at the time of signature
or when depositing its instrument of ratification, acceptance or
approval, by a declaration addressed to the Secretary General of the
Council of Europe, declare that it reserves the right not to apply, or
to apply only in specific cases or conditions, the jurisdiction rules
laid down in paragraph 1, sub-paragraph d, and paragraph 2 of
this article.
5 Where more than one Party claims jurisdiction over an alleged
offence established in accordance with this Convention, the
Parties concerned shall consult, where appropriate, with a view
to determining the most appropriate jurisdiction for prosecution.
Appendix I ► Page 67
6 Without prejudice to the general rules of international law, this
Convention shall not exclude any criminal jurisdiction exercised
by a Party in accordance with its domestic law.
Article 11 – Corporate liability
1 Each Party shall take the necessary legislative and other measures to
ensure that legal persons can be held liable for offences established
in accordance with this Convention, when committed for their
benefit by any natural person, acting either individually or as part
of an organ of the legal person, who has a leading position within
it based on:
a a power of representation of the legal person;
b an authority to take decisions on behalf of the legal person;
c an authority to exercise control within the legal person.
2 Apart from the cases provided for in paragraph 1, each Party shall
take the necessary legislative and other measures to ensure that
a legal person can be held liable where the lack of supervision or
control by a natural person referred to in paragraph 1 has made
possible the commission of an offence established in accordance
with this Convention for the benefit of that legal person by a natural
person acting under its authority.
3 Subject to the legal principles of the Party, the liability of a legal
person may be criminal, civil or administrative.
4 Such liability shall be without prejudice to the criminal liability of
the natural persons who have committed the offence.
Article 12 – Sanctions and measures
1 Each Party shall take the necessary legislative and other measures
to ensure that the offences established in accordance with this
Convention are punishable by effective, proportionate and dissuasive
sanctions, including criminal or non-criminal monetary sanctions,
taking account of their seriousness. These sanctions shall include,
for offences established in accordance with Articles 5 and 6, when
committed by natural persons, penalties involving deprivation of
liberty that may give rise to extradition.
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2 Each Party shall take the necessary legislative and other measures
to ensure that legal persons held liable in accordance with Article 11
are subject to effective, proportionate and dissuasive sanctions,
including criminal or non-criminal monetary sanctions, and may
include other measures, such as:
a temporary or permanent disqualification from exercising
commercial activity;
b placing under judicial supervision;
c a judicial winding-up order.
3 Each Party shall take the necessary legislative and other measures
to:
a permit seizure and confiscation of:
i medical products, active substances, excipients,
parts, materials and accessories, as well as goods,
documents and other instrumentalities used to
commit the offences established in accordance with
this Convention or to facilitate their commission;
ii proceeds of these offences, or property whose value
corresponds to such proceeds;
b permit the destruction of confiscated medical products, active
substances, excipients, parts, materials and accessories that are
the subject of an offence established under this Convention;
c take any other appropriate measures in response to an offence,
in order to prevent future offences.
Article 13 – Aggravating circumstances
Each Party shall take the necessary legislative and other measures
to ensure that the following circumstances, in so far as they do not
already form part of the constituent elements of the offence, may,
in conformity with the relevant provisions of domestic law, be taken
into consideration as aggravating circumstances in determining
the sanctions in relation to the offences established in accordance
with this Convention:
a the offence caused the death of, or damage to the physical
or mental health of, the victim;
Appendix I ► Page 69
b the offence was committed by persons abusing the confidence
placed in them in their capacity as professionals;
c the offence was committed by persons abusing the confidence
placed in them as manufacturers as well as suppliers;
d the offences of supplying and offering to supply were
committed having resort to means of large scale distribution,
such as information systems, including the Internet;
e the offence was committed in the framework of a criminal
organisation;
f the perpetrator has previously been convicted of offences
of the same nature.
Article 14 – Previous convictions
Each Party shall take the necessary legislative and other measures
to provide for the possibility to take into account final sentences
passed by another Party in relation to the offences of the same
nature when determining the sanctions.
Chapter III – Investigation, prosecution and procedural law
Article 15 – Initiation and continuation of proceedings
Each Party shall take the necessary legislative and other measures
to ensure that investigations or prosecution of offences established
in accordance with this Convention should not be subordinate to
a complaint and that the proceedings may continue even if the
complaint is withdrawn.
Article 16 – Criminal investigations
1 Each Party shall take the necessary measures to ensure that persons,
units or services in charge of criminal investigations are specialised
in the field of combating counterfeiting of medical products and
similar crimes involving threats to public health or that persons are
trained for this purpose, including financial investigations. Such
units or services shall have adequate resources.
2 Each Party shall take the necessary legislative and other measures, in
conformity with the principles of its domestic law, to ensure effective
criminal investigation and prosecution of offences established in
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accordance with this Convention, allowing, where appropriate, for
the possibility for its competent authorities of carrying out financial
investigations, of covert operations, controlled delivery and other
special investigative techniques.
Chapter IV – Co-operation of authorities and information exchange
Article 17 – National measures of co-operation
and information exchange
1 Each Party shall take the necessary legislative and other measures
to ensure that representatives of health authorities, customs,
police and other competent authorities exchange information and
co-operate in accordance with domestic law in order to prevent
and combat effectively the counterfeiting of medical products and
similar crimes involving threats to public health.
2 Each Party shall endeavour to ensure co-operation between its
competent authorities and the commercial and industrial sectors
as regards risk management of counterfeit medical products and
similar crimes involving threats to public health.
3 With due respect for the requirements of the protection of personal
data, each Party shall take the necessary legislative and other
measures to set up or strengthen mechanisms for:
a receiving and collecting information and data, including
through contact points, at national or local levels and in
collaboration with private sector and civil society, for the
purpose of preventing and combating the counterfeiting
of medical products and similar crimes involving threats to
public health;
b making available the information and data obtained by the
health authorities, customs, police and other competent
authorities for the co-operation between them.
4 Each Party shall take the necessary measures to ensure that
persons, units or services in charge of co-operation and information
exchange are trained for this purpose. Such units or services shall
have adequate resources.
Appendix I ► Page 71
Chapter V – Measures for prevention
Article 18 – Preventive measures
1 Each Party shall take the necessary legislative and other measures to
establish the quality and safety requirements of medical products.
2 Each Party shall take the necessary legislative and other measures
to ensure the safe distribution of medical products.
3 With the aim of preventing counterfeiting of medical products,
active substances, excipients, parts, materials and accessories, each
Party shall take the necessary measures to provide, inter alia, for:
a training of healthcare professionals, providers, police and
customs authorities, as well as relevant regulatory authorities;
b the promotion of awareness-raising campaigns addressed to
the general public providing information about counterfeit
medical products;
c the prevention of illegal supplying of counterfeit medical
products, active substances, excipients, parts, materials and
accessories.
Chapter VI – Measures for protection
Article 19 – Protection of victims
Each Party shall take the necessary legislative and other measures
to protect the rights and interests of victims, in particular by:
a ensuring that victims have access to information relevant to
their case and which is necessary for the protection of their
health;
b assisting victims in their physical, psychological and social
recovery;
c providing, in its domestic law, for the right of victims to
compensation from the perpetrators.
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Article 20 – The standing of victims in criminal
investigations and proceedings
1 Each Party shall take the necessary legislative and other measures
to protect the rights and interests of victims at all stages of criminal
investigations and proceedings, in particular by:
a informing them of their rights and the services at their disposal
and, unless they do not wish to receive such information, the
follow-up given to their complaint, the possible charges, the
general progress of the investigation or proceedings, and
their role therein as well as the outcome of their cases;
b enabling them, in a manner consistent with the procedural
rules of domestic law, to be heard, to supply evidence and
to choose the means of having their views, needs and
concerns presented, directly or through an intermediary,
and considered;
c providing them with appropriate support services so that
their rights and interests are duly presented and taken into
account;
d providing effective measures for their safety, as well as that of
their families and witnesses on their behalf, from intimidation
and retaliation.
2 Each Party shall ensure that victims have access, as from their first
contact with the competent authorities, to information on relevant
judicial and administrative proceedings.
3 Each Party shall ensure that victims have access, provided free of
charge where warranted, to legal aid when it is possible for them
to have the status of parties to criminal proceedings.
4 Each Party shall take the necessary legislative and other measures
to ensure that victims of an offence established in accordance
with this Convention committed in the territory of a Party other
than the one where they reside can make a complaint before the
competent authorities of their State of residence.
5 Each Party shall provide, by means of legislative or other measures,
in accordance with the conditions provided for by its domestic law,
the possibility for groups, foundations, associations or governmental
or non-governmental organisations, to assist and/or support the
Appendix I ► Page 73
victims with their consent during criminal proceedings concerning
the offences established in accordance with this Convention.
Chapter VII – International co-operation
Article 21 – International co-operation in criminal matters
1 The Parties shall co-operate with each other, in accordance with the
provisions of this Convention and in pursuance of relevant applicable
international and regional instruments and arrangements agreed
on the basis of uniform or reciprocal legislation and their domestic
law, to the widest extent possible, for the purpose of investigations
or proceedings concerning the offences established in accordance
with this Convention, including seizure and confiscation.
2 The Parties shall co-operate to the widest extent possible in
pursuance of the relevant applicable international, regional and
bilateral treaties on extradition and mutual legal assistance in
criminal matters concerning the offences established in accordance
with this Convention.
3 If a Party that makes extradition or mutual legal assistance in
criminal matters conditional on the existence of a treaty receives
a request for extradition or legal assistance in criminal matters
from a Party with which it has no such a treaty, it may, acting in
full compliance with its obligations under international law and
subject to the conditions provided for by the domestic law of the
requested Party, consider this Convention as the legal basis for
extradition or mutual legal assistance in criminal matters in respect
of the offences established in accordance with this Convention.
Article 22 – International co-operation
on prevention and other administrative measures
1 The Parties shall co-operate on protecting and providing assistance
to victims.
2 The Parties shall, without prejudice to their internal reporting systems,
designate a national contact point which shall be responsible for
transmitting and receiving requests for information and/or co-operation
in connection with the fight against counterfeiting of medical products
and similar crimes involving threats to public health.
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3 Each Party shall endeavour to integrate, where appropriate,
prevention and combating of the counterfeiting of medical products
and similar crimes involving threats to public health into assistance
or development programmes provided for the benefit of third
States.
Chapter VIII – Follow-up mechanism
Article 23 – Committee of the Parties
1 The Committee of the Parties shall be composed of representatives
of the Parties to the Convention.
2 The Committee of the Parties shall be convened by the Secretary
General of the Council of Europe. Its first meeting shall be held within
a period of one year following the entry into force of this Convention
for the tenth signatory having ratified it. It shall subsequently meet
whenever at least one third of the Parties or the Secretary General
so requests.
3 The Committee of the Parties shall adopt its own rules of procedure.
4 The Committee of the Parties shall be assisted by the Secretariat
of the Council of Europe in carrying out its functions.
5 A contracting Party which is not a member of the Council of Europe
shall contribute to the financing of the Committee of the Parties
in a manner to be decided by the Committee of Ministers upon
consultation of that Party.
Article 24 – Other representatives
1 The Parliamentary Assembly of the Council of Europe, the European
Committee on Crime Problems (CDPC), as well as other relevant
Council of Europe intergovernmental or scientific committees,
shall each appoint a representative to the Committee of the Parties
in order to contribute to a multisectoral and multidisciplinary
approach.
2 The Committee of Ministers may invite other Council of Europe
bodies to appoint a representative to the Committee of the Parties
after consulting them.
Appendix I ► Page 75
3 Representatives of relevant international bodies may be admitted as
observers to the Committee of the Parties following the procedure
established by the relevant rules of the Council of Europe.
4 Representatives of relevant official bodies of the Parties may be
admitted as observers to the Committee of the Parties following
the procedure established by the relevant rules of the Council of
Europe.
5 Representatives of civil society, and in particular non-governmental
organisations, may be admitted as observers to the Committee of
the Parties following the procedure established by the relevant
rules of the Council of Europe.
6 In the appointment of representatives under paragraphs 2 to 5,
a balanced representation of the different sectors and disciplines
shall be ensured.
7 Representatives appointed under paragraphs 1 to 5 above shall
participate in meetings of the Committee of the Parties without
the right to vote.
Article 25 – Functions of the Committee of the Parties
1 The Committee of the Parties shall monitor the implementation
of this Convention. The rules of procedure of the Committee
of the Parties shall determine the procedure for evaluating the
implementation of this Convention, using a multisectoral and
multidisciplinary approach.
2 The Committee of the Parties shall also facilitate the collection,
analysis and exchange of information, experience and good
practice between States to improve their capacity to prevent and
combat the counterfeiting of medical products and similar crimes
involving threats to public health. The Committee may avail itself
of the expertise of other relevant Council of Europe committees
and bodies.
3 Furthermore, the Committee of the Parties shall, where appropriate:
a facilitate the effective use and implementation of this
Convention, including the identification of any problems
and the effects of any declaration or reservation made under
this Convention;
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b express an opinion on any question concerning the application
of this Convention and facilitate the exchange of information
on significant legal, policy or technological developments;
c make specific recommendations to Parties concerning the
implementation of this Convention.
4 The European Committee on Crime Problems (CDPC) shall be
kept periodically informed regarding the activities mentioned in
paragraphs 1, 2 and 3 of this article.
Chapter IX – Relationship with other international instruments
Article 26 – Relationship with other international
instruments
1 This Convention shall not affect the rights and obligations arising
from the provisions of other international instruments to which
Parties to the present Convention are Parties or shall become
Parties and which contain provisions on matters governed by this
Convention.
2 The Parties to the Convention may conclude bilateral or multilateral
agreements with one another on the matters dealt with in this
Convention, for purposes of supplementing or strengthening its
provisions or facilitating the application of the principles embodied
in it.
Chapter X – Amendments to the Convention
Article 27 – Amendments
1 Any proposal for an amendment to this Convention presented
by a Party shall be communicated to the Secretary General of the
Council of Europe and forwarded by him or her to the Parties, the
member States of the Council of Europe, non-member States having
participated in the elaboration of this Convention or enjoying
observer status with the Council of Europe, the European Union,
and any State having been invited to sign this Convention.
2 Any amendment proposed by a Party shall be communicated to the
European Committee on Crime Problems (CDPC) and other relevant
Appendix I ► Page 77
Council of Europe intergovernmental or scientific committees,
which shall submit to the Committee of the Parties their opinions
on that proposed amendment.
3 The Committee of Ministers, having considered the proposed
amendment and the opinion submitted by the Committee of the
Parties, may adopt the amendment.
4 The text of any amendment adopted by the Committee of Ministers
in accordance with paragraph 3 of this article shall be forwarded
to the Parties for acceptance.
5 Any amendment adopted in accordance with paragraph 3 of this
article shall enter into force on the first day of the month following
the expiration of a period of one month after the date on which
all Parties have informed the Secretary General that they have
accepted it.
Chapter XI – Final clauses
Article 28 – Signature and entry into force
1 This Convention shall be open for signature by the member States
of the Council of Europe, the European Union and the non-member
States which have participated in its elaboration or enjoy observer
status with the Council of Europe. It shall also be open for signature
by any other non-member State of the Council of Europe upon
invitation by the Committee of Ministers. The decision to invite a
non-member State to sign the Convention shall be taken by the
majority provided for in Article 20.d of the Statute of the Council
of Europe, and by unanimous vote of the representatives of the
Contracting States entitled to sit on the Committee of Ministers.
This decision shall be taken after having obtained the unanimous
agreement of the other States/European Union having expressed
their consent to be bound by this Convention.
2 This Convention is subject to ratification, acceptance or approval.
Instruments of ratification, acceptance or approval shall be deposited
with the Secretary General of the Council of Europe.
3 This Convention shall enter into force on the first day of the month
following the expiration of a period of three months after the
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date on which five signatories, including at least three member
States of the Council of Europe, have expressed their consent to
be bound by the Convention in accordance with the provisions
of the preceding paragraph.
4 In respect of any State or the European Union, which subsequently
expresses its consent to be bound by the Convention, it shall enter
into force on the first day of the month following the expiration
of a period of three months after the date of the deposit of its
instrument of ratification, acceptance or approval.
Article 29 – Territorial application
1 Any State or the European Union may, at the time of signature
or when depositing its instrument of ratification, acceptance or
approval, specify the territory or territories to which this Convention
shall apply.
2 Any Party may, at any later date, by a declaration addressed to the
Secretary General of the Council of Europe, extend the application
of this Convention to any other territory specified in the declaration
and for whose international relations it is responsible or on whose
behalf it is authorised to give undertakings. In respect of such
territory, the Convention shall enter into force on the first day of the
month following the expiration of a period of three months after
the date of receipt of such declaration by the Secretary General.
3 Any declaration made under the two preceding paragraphs
may, in respect of any territory specified in such declaration, be
withdrawn by a notification addressed to the Secretary General of
the Council of Europe. The withdrawal shall become effective on
the first day of the month following the expiration of a period of
three months after the date of receipt of such notification by the
Secretary General.
Article 30 – Reservations
1 No reservation may be made in respect of any provision of this
Convention, with the exception of the reservations expressly
established.
Appendix I ► Page 79
2 Each Party which has made a reservation may, at any time, withdraw
it entirely or partially by a notification addressed to the Secretary
General of the Council of Europe. The withdrawal shall take effect
from the date of the receipt of such notification by the Secretary
General.
Article 31 – Friendly settlement
The Committee of the Parties will follow in close co-operation
with the European Committee on Crime Problems (CDPC) and
other relevant Council of Europe intergovernmental or scientific
committees the application of this Convention and facilitate,
when necessary, the friendly settlement of all difficulties related
to its application.
Article 32 – Denunciation
1 Any Party may, at any time, denounce this Convention by means
of a notification addressed to the Secretary General of the Council
of Europe.
2 Such denunciation shall become effective on the first day of the
month following the expiration of a period of three months after
the date of receipt of the notification by the Secretary General.
Article 33 – Notification
The Secretary General of the Council of Europe shall notify the
Parties, the member States of the Council of Europe, the nonmember
States having participated in the elaboration of this
Convention or enjoying observer status with the Council of Europe,
the European Union, and any State having been invited to sign
this Convention in accordance with the provisions of Article 28, of:
a any signature;
b the deposit of any instrument of ratification, acceptance or
approval;
c any date of entry into force of this Convention in accordance
with Article 28;
d any amendment adopted in accordance with Article 27 and
the date on which such an amendment enters into force;
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e any reservation made under Articles 5, 6, 7, 9 and 10 and
any withdrawal of a reservation made in accordance with
Article 30;
f any denunciation made in pursuance of the provisions of
Article 32;
g any other act, notification or communication relating to this
Convention.
In witness whereof the undersigned, being duly authorised thereto,
have signed this Convention.
Done in Moscow, this 28th day of October 2011, in English and in
French, both texts being equally authentic, in a single copy which
shall be deposited in the archives of the Council of Europe. The
Secretary General of the Council of Europe shall transmit certified
copies to each member State of the Council of Europe, to the
non-member States which have participated in the elaboration
of this Convention or enjoy observer status with the Council of
Europe, to the European Union and to any State invited to sign
this Convention.
► Page 81
Appendix II
Table of signatures and ratifications
of the MEDICRIME Convention (CETS No. 211)
Treaty open for signature by the member States, the non-member States which
have participated in its elaboration and by the European Union, and for accession
by other non-member States
Opening for signature
Place: Lanzarote
Date: 28.10.2011
Entry into force
Conditions: 5 Ratifications
including at least 3 member States
of the Council of Europe
Date: : 1/1/2016
Status as of 13/11/2015
Member States of the Council of Europe
States Signature Ratification
Albania
Andorra
Armenia 20/09/2012
Austria 28/10/2011
Azerbaijan
Belgium 24/07/2012
Bosnia and Herzegovina
Bulgaria
Croatia 03/09/2015
Cyprus 28/10/2011
Czech Republic
Denmark 12/01/2012
Estonia
Finland 28/10/2011
Handbook for parliamentarians ► Page 82
States Signature Ratification
France 28/10/2011
Georgia
Germany 28/10/2011
Greece
Hungary 26/09/2013 09/01/2014
Iceland 28/10/2011
Ireland
Italy 28/10/2011
Latvia
Liechtenstein 04/11/2011
Lithuania
Luxembourg 22/12/2011
Malta
Moldova 20/09/2012 14/08/2014
Monaco
Montenegro
Netherlands
Norway
Poland
Portugal 28/10/2011
Romania
Russia 28/10/2011
San Marino
Serbia
Slovakia
Slovenia
Spain 08/10/2012 05/08/2013
Sweden
Switzerland 28/10/2011
The former Yugoslav Republic of Macedonia
Appendix II ► Page 83
States Signature Ratification
Turkey 29/06/2012
Ukraine 28/10/2011 20/08/2012
United Kingdom
Non-member States of the Council of Europe
States Signature Ratification
Belarus
Burkina Faso
Canada
Guinea 10/10/2012 24/09/2015
Holy See
Israel 28/10/2011
Japan
Mexico
Morocco 13/12/2012
United States of America
International Organisations
Organisations Signature Ratification
European Union
Total number of signatures not followed by ratifications: 19
Total number of ratifications/accessions: 5
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