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


State of Play: Implementation of SPOCs – 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)


State of Play: Implementation of SPOCs – 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


State of Play: Implementation of SPOCs – 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


http://www.coe.int/

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150128 APEC Clark SPOCs

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