IFPMA-TFDA Workshop on Couterfeit Medicines ‘Integrated Approach Against Fake Medicines’ Session 4: Collaboration within and between countries On 6th February 2015 At Taipei International Convention Center Taipei, Taiwan

1. IFPMA-TFDA Workshop on Counterfeit
Medicines- Integrated approach
against Fake Medicines
Legal framework necessary for effective
collaboration – MEDICRIME Convention
Dr Sabine WALSER, EDQM (Council of Europe)
Taipei, 6 February 2015

2. Overview
• The problem: ‘counterfeiting, falsifying, faking’ medicines…
medical product crimes
• Co-operation among / within States to fight medical
product crimes: where do we stand?
• A way forward – MEDICRIME Convention
• Co-operation is key
• Where should we go?
Sabine WALSER ©2015 EDQM, Council of Europe. All rights reserved.
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3. The problem:
‘counterfeiting, falsifying, faking’ medicines
…medical product crimes
• Crimes threatening individuals’ lives – death, health damage,
impairment working capacity / life quality
• Corruption of national healthcare systems’ integrity - wasting
public healthcare resources ↔ undermining public confidence
• Organised international crime ↔ trafficking humans, drugs,
guns, counterfeit/illegal medicines ↔ decreasing public security
• Decreasing economic development & prosperity
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4. Criminal behaviour ↔ product/system integrity
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5. co-operationamong/within States to fight
medical product crimes: where do we stand?
• No consensus about ‘terminology’ - in spite of growing concerns about
criminal behaviours and risks
• No specific legal framework currently used at international level to
prevent / fight crimes targeting all types of medical products used for
therapy / diagnosis / prevention of diseases
• Few judicial trials - poor deterrent sanctions
• Split competences / powers: enforcement (customs; police) …health
authorities –
• Internet: used by organised crime to hide origin / source of product;
distribution to unwitting users
Sabine WALSER ©2015 EDQM, Council of Europe. All rights reserved.
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6. Co-operation among/within States to fight
medical product crimes: where do we stand?
• Co-operation among authorities within a State / across regions:
• Common basic legal concepts as regards medical product
crimes? Regional/international legal framework?
• Common approaches to support co-operation as regards cross
border crimes? Pro-active/ ad-hoc information exchange
• No individual state, no region, no organisation, no sector alone
can control international medical product crimes…
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7. A Way Forward to More Effective
Co-operation among States -
MEDICRIME Convention
First international treaty criminalising intentional acts:
• Manufacturing of counterfeit medical products
• Supplying, offering to supply & trafficking in counterfeit medical
products
• Falsification of documents
• Unauthorised manufacture or supply of medicinal products or
the marketing of medical devices that do not comply with
conformity requirements (“similar crimes”) → bridging
health & criminal law
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8. MEDICRIME Convention
First international treaty to:
Prevent and combat counterfeiting of medical products & similar
crimes through legal and other measures:
• Establish criminal offences (legal definition)
• Protect victims
• Promote national & international co-operation
• Global treaty – global responses – instrument with global
vocation – open for signature by states in the world: Council of
Europe Treaty Office: http://www.conventions.coe.int/ go to,
‘The Treaty Office in a Nutshell’ (pdf)
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9. MEDICRIME Convention
Medical products:
• Medicinal products/drugs for human & veterinary use, & medical
devices, & active substances, & excipients, components &
accessories of medical devices, & trial/study medication (Art 4)
• False representation of product identity/source (‘falsified’) =
counterfeit medical product
Important: without connotation of Intellectual Property Rights (IPR)
Similar crimes (Art 8):
• Intentional manufacturing, trafficking, offering …medical products
unauthorised… or not in compliance with conformity requirements
.
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10. MEDICRIME Convention
does NOT criminalise:
• generic medical products authorised for being marketed by a
competent authority (globally)
• non-intentional breaches of quality norms, good practices /
standards in the manufacture and distribution of medical
products (→ outside of scope Art 8 ‘similar crimes’)
does NOT regulate:
• production, distribution of medical products & businesses (e.g.
internet pharmacies, brokers) where legal
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11. Cooperation is key
• Criminals build & use international networks →
production, transit, trafficking, financial transactions
• International co-operation required:
• Systematic, structured, networking approach based on
information exchange / analysis / follow-up:
• Common networking model - Council of Europe - APEC
SPOCs models compatible and widely accepted and used
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12. SPOCs networking approach for
national & international cooperation
International
co-operation
between
National
SPOCs
National SPOC
Role in
international/national
co-operation; Central
Reporting Point
Industry
Investigation
SPOC e.g.
Qualified/
Responsible
Person
SPOC for
Customs
SPOC for
Police
SPOC for
Justice
SPOC for
Medicines Regulatory
Authority (DRA) incl.
Official Medicines
Control Laboratories
•Competent
Authorities for
Medical Devices
national network
SPOC
formal or informal collaboration
among SPOCs at national level
Signals
Public; health
professionals
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13. MEDICRIME Convention Article 17
National measures of co-operation and
information exchange (1)
1. Each Party ….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….
2. …. to ensure co-operation between its competent authorities and the
commercial and industrial sectors as regards risk management
3. …respecting protection of personal data, each Party …to set up or
strengthen mechanisms:
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 prevention
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14. MEDICRIME Convention Article 17
National measures of co-operation and
information exchange (2)
b. Making available the information obtained by the health
authorities, customs, police and other competent authorities
for cooperation between them
4. Each party … that persons, units or services in charge of co-
operation and information exchange are trained for this purpose.
… adequate resources
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15. MEDICRIME Convention Article 22
International co-operation on prevention
and other administrative measures
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
The EDQM contributed to the development of the APEC SPOCs
toolkit and to the carrying out of the APEC SPOCs training on
28-29 January 2015 Clark, Philippines (APEC Chairmanship 2015)
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16. Offering MEDICRIME Convention to the
Global Community…
• 28 October 2011: opening of signature of convention – states can
join the convention; become parties
• January 2015: 23 states expressed political will to join the
convention:
Argentina, Austria, Belgium, Switzerland, Cyprus, Spain-ratified,
France, Finland, Germany, Hungary-ratified, Iceland, Italy, Luxembourg,
Liechtenstein, Moldavia-ratified, Portugal, Russian Federation, Turkey,
Ukraine-ratified
• 3 States: Israel, Morocco, Republic Guinea
• 4 States implemented the provisions into domestic law - ‘ratification’
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17. Sabine WALSER ©2015 EDQM, Council of Europe. All rights reserved.
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18. Part of the global community –
Council of Europe
• International organisation (5 May 1949) headquarters:
Strasbourg (France)
• Core values: human rights, democracy & rule of law
→ statute/expertise covering criminal & civil & social /
public health / legal instruments, policies, programmes of
activities
Pan-European membership & international relations:
• 47 member states in Europe
• Observer states: Canada, Holy See, Japan, Mexico, United States
→ Distinct from the European Union (EU)
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19. Sabine WALSER ©2015 EDQM, Council of Europe. All rights reserved.
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20. European Directorate for the Quality of
Medicines & HealthCare (EDQM)
Council of Europe
Directorate – Technical
Secretariat:
Convention on the Elaboration of
a European Pharmacopoeia
(1964) - Observers in all
regions of the world and the
EDQM share a common goal that
is promotion of good quality of
medicines and support for
authorities cooperation against
counterfeit (falsified) medical
products that put patients’ lives
at risk
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Members:
Austria, Belgium, Bosnia & Herzegovina, Bulgaria,
Croatia, Cyprus, The Czech Republic, Denmark,
Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Montenegro, Netherlands,
Norway, Poland, Portugal, Romania, Serbia,
Slovakia, Slovenia, Spain, Sweden, Switzerland,
‘The Former Yugoslav Republic of Macedonia’,
Turkey, Ukraine, United Kingdom and the European
Union.
Observers:
Albania, Algeria, Argentina, Armenia, Australia,
Azerbaijan, Belarus, Brazil, Canada, China,
Georgia, Israel, Kazakhstan, Madagascar, Malaysia,
Moldova, Morocco, Republic of Guinea, The
Russian Federation, Senegal, Singapore, South
Africa, Syria, Tunisia, The United States of America,
The Taiwan Food and Drug Administration (TFDA)
and the World Health Organisation (WHO)

21. Where should we go?
• Everyday new victims – no time to lose
• MEDICRIME Convention… first international criminal law treaty to
prevent medical product crimes threatening patients…
• Measures & legal concepts globally applicable
• MEDICRIME can enhance impact of other international criminal law
treaties that require criminalisation of acts
• Criminals are nearly perfect networkers – SPOCs networking can do
better
The MEDICRIME Convention is here –
let’s use it together!
Sabine WALSER ©2015 EDQM, Council of Europe. All rights reserved.
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22. Thank you for your attention
http://www.conventions.coe.int
www.coe.int/medicrime
www.coe.int
www.edqm.eu
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