150128 APEC Clark SPOCs

State of Play: Implementation of SPOCs –
European Directorate for the Quality of
Medicines & HealthCare (EDQM)/Council of
Europe
APEC Life Sciences Innovation Forum (LSIF) Training Program on Medical
Product Integrity and Supply Chain Security
Establishment of Global Single Point of Contact Systems-
28 January 2015, Clark (Angeles City), the Philippines
Dr François-Xavier Lery, EDQM/Council of Europe

Council of Europe
Inter-governmental
organisation
Core values:
• human rights
• pluralist democracy
• rule of law
Distinct from European Union
Dr François-Xavier Lery © 2015 EDQM, Council of Europe. All rights reserved.

European Directorate for the Quality of
Medicines & HealthCare (EDQM)
Council of Europe
Directorate
Convention on the
Elaboration of a
European
Pharmacopoeia
(1964)

Council of Europe/EDQM
Specific platform for cooperation against counterfeit/falsified
medical products:
• Human Rights & Rule of Law
• Minimising public health risks posed by counterfeit medical
products & similar crimes
Supported at the level of the EDQM by:
Committee of Experts on Minimising public health risks posed by
counterfeit medical products & similar crimes (expert & policy-
making levels): CD-P-PH/CMED

CD-P-PH/CMED
Support of promotion and application of the MEDICRIME
convention by a comprehensive & integrated approach:
• Support for the development of specific legislation
• Multisectorial cooperation (EDQM training platform) &
intelligence building→ SPOCs
• Public health protection: awareness, risk communication,
identification of health damage in patients

Drafted & presented: 2nd Workshop 22-23 May 2013, Seoul:
EDQM, Lead, APEC RHSC Roadmap Working Group SPOC; inspired by Council of Europe SPOCs Model
International
Co-operation
between
National
SPOCs
National SPOC
Role in international and
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
between SPOCs at national level
Signals
Public; health
professionals
Overview: APEC SPOCs Tool Kit (1)

Overview of APEC SPOCs Tool Kit (2)
→ Scope: Medical products produced, marketed, advertised
outside the regulatory control of the competent
authorities (WHO SSFFC): criminal investigations on
counterfeit/falsified medical products
→ Public health protection should be a priority
→ Cooperative approach:
• A. National SPOC (one per state/economy)
• B. SPOCs within competent authorities (a SPOC per competent
authority in each state/economy)
• Industry Investigation SPOC liaison/cooperation with A.,B.

A. National SPOC – Central Reporting Point in one
state/economy
→ Centralises information held by competent authorities
within one state/economy about medical products
produced, marketed, advertised outside the regulatory
control of the competent authorities
→ Information is disseminated to National SPOCs of other
states/economies for international cooperation

B. SPOCs -police, customs, health authorities incl.
official laboratories, judiciary- within one
state/economy
→ Regular/systematic networking: law, agreement-based or
informal
→ Operational management: « signals » (suspect cases) or
confirmed cases
→ National authorities to decide on modes of investigation

APEC–EDQM/Council of Europe common goals
(SPOCs) – common approaches (1)
APEC LSIF Anti-counterfeit Medicines Action Plan Components –
Council of Europe Model for a Network between SPOCs:
1. ...Cooperation within each APEC economy/states (regulators, customs,
law enforcement, judicial and industry) critical…
2. APEC economies/states to work together to collect data on counterfeit
medicines
3. APEC economies/states to coordinate legislation, penalties for
prosecuting criminals counterfeiting medicines posing a threat to public
health; bypassing regulatory control

→ Council of Europe SPOCs model: adopted June 2007
→ European Union Regulatory Authorities (Working Party
Enforcement Officers): endorsed September 2007
→ Permanent Forum International Pharmaceutical Crime;
tabled at WHO IMPACT endorsed December 2007 for
international use
→ APEC Anti-counterfeit Medicines Action Plan: endorsed
September 2010 (SPOCs: see previous slide)

→ Legal provisions for national/international cooperation
among competent authorities: Council of Europe
MEDICRIME Convention, international treaty: opened
October 2011 for states to join
→ 2nd APEC LSIF Action Plan Workshop Seoul (Korea) May
2013: supported APEC SPOC Tool Kit
→ Agreed: development of National SPOC (within 12 months
of APEC LSF and RHSC endorsement)

State of Play: Implementation of SPOCs
EDQM basic training
Aims:
→ raise awareness
→ foster co-operation
→ share knowledge & best
practices – SPOCs model
→ in national teams
(medical products regulators
+ police + customs)
Activities:
→ delivery of training to nominees of
authorities
→ trainers: delegates of Council of
Europe bodies;
→ “train the trainers” approach:
subsequent roll-out
→ evaluation: trainees’ feed-back –
consideration in further basic/
advanced level training
→ follow up: immediately;
impact 3 and 6 months after training

State of Play: Implementation of SPOCs
EDQM basic training
Results: 2007 – ongoing
National teams of 40 states in Europe; 6 States (Africa; South-America):
200 officials
EDQM training platform
Establishing/maintaining a network of SPOCs:
Aims:
Nomination/appointment/designation by national authorities:
National SPOCs, authority SPOCs within 47 member states of Council of
Europe

EDQM SPOC network
Activities:
National competent authorities notified (S)POCs or equivalents to the
EDQM (2013)
Results:
National SPOCs, authority SPOCs (100):
Regulatory, police, customs authorities;
contact details, competencies, validity of authorisation
EDQM to maintain list (based on procedure)

EDQM Advanced level SPOCs training
Aim:
→ Knowledge, skills: to establish a SPOCs network and to co-operate across
the region
→ Use of practical tools for SPOCs co-operation
→ Forum for exchange of expertise and experience
Activities development:
→ Tracking sheets
→ Signal management procedures
→ Tools for information exchange
Results: 2012 - ongoing
National teams of 12 states (Europe); 4 States (Africa): 90 officials

EDQM KnowX database
Knowledge database: inventory of experiences with confirmed
cases
Aim:
→ Platform for officials from competent authorities to build knowledge and
intelligence (restricted access)
→ Help SPOCs report and share information
→ Use/access for SPOCs/equivalent officials: under participating authorities’
control
Activities:
→ EDQM: technical development and host of the database
Results:
→ Database launched: March 2014

Legal provisions:
Interagency cooperation (S)POCs
Convention on the counterfeiting of medical products and
similar crimes involving threats to public health (Council of
Europe international treaty; treaty series 211): MEDICRIME
Goal:
→ Prevent and combat above acts through a harmonised international legal
framework, perspective of public health protection
Objectives:
→ Protection of public health through criminalising acts threatening patient
health
→ Patient protection
→ Promotion of cooperation among competent health and law enforcement
authorities within each state + on international level

Legal provisions:
Interagency cooperation (S)POCs
MEDICRIME
Specific provisions supporting cooperation among authorities:
→ Art 17. National measures of coordination, collaboration and information
exchange:
• … to ensure that national competent authorities exchange information and
cooperate to prevent and combat…through points of contact
• …receiving and collecting data
→ Art 22. International co-operation on prevention and other administrative
measures:
• …designate a national contact point …transmitting and receiving requests
for information and/or cooperation with the fight against counterfeiting of
medical products and similar crimes involving threats to public health….

Follow-up
Upon LIF and RHC endorsement of SPOCs toolkit (2013):
→ APEC economies: status update of development of a SPOC system within
their economy
→ APEC Gap analysis: a) operational SPOCs, b) SPOCs in development,
c) planned SPOC development, d) no planned SPOCs
→ Establishment of APEC SPOC database – assistance offered:
• INTERPOL (May 2013 SPOC workshop);
• EDQM (CoE) particularly in APEC economies that are Council of Europe
members, observers and observers European Pharmacopoeia Commission
• Complementing SPOCs in Europe
→ Planning a follow-up SPOC APEC workshop during 2015:
• expertise from APEC economies with operational SPOCs, WHO, EDQM and
Interpol.

Conclusion
 Networking across borders only effective if based on
common concepts, understanding and working methods:
harmonised SPOCs approach – APEC 1/3/21, international
community
 EDQM (Council of Europe) welcomes global international
cooperation
 Criminals are networkers – let’s do better!

Thank-you for your attention!
For more information: www.coe.int; www.edqm.eu
22

150128 APEC Clark SPOCs

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