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
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Similar to Session 4: Domenico Di Giorgio AIFA Italy / SPOC model cooperation against counterfeit medicines, The institutional coordination schemes in Italy
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Session 4: Domenico Di Giorgio AIFA Italy / SPOC model cooperation against counterfeit medicines, The institutional coordination schemes in Italy
1. SPOC model cooperation against
counterfeit medicines
The institutional coordination schemes in
Italy
Domenico Di Giorgio
Taipei, February 2015
2. Public Declaration of transparency/interests*
The view and opinions expressed in the following PowerPoint slides are
those of the individual presenter and should not be attributed to AIFA
Interests in pharmaceutical industry NO Currently Last 2 years
More than 2 years
but less than 5
years ago
More than 5 years
ago
(optional)
Direct interests:
Employment with a company x
Consultancy for a company x
Strategic advisory role for a company x
Financial interests x
Ownership of a patent x
Indirect interests:
Principal investigator x
Investigator x
Individual’s Institution/Organisation receives a grant or
other funding
x
*Domenico Di Giorgio, in accordance with the Conflict of Interest Regulations approved by AIFA Board of Directors (26.01.2012) and published on the Official Journal of 20.03.2012
according to 0044 EMA/513078/2010 on the handling of the conflicts of interest for scientific committee members and experts
N.B. I am not receiving any compensation
3. Moving from IPR and GMP laws to…
Public Health orientation
EU Directive 2011/62:
(EU Parliament and Council) amending Dir. 2001/83/
EC as regards the prevention of the entry into the legal
supply chain of medicinal products which are falsified
in relation to their identity, history or source.
CoE MEDICRIME Convention:
Convention of the Council of Europe on counterfeiting
of medical products and similar crimes involving
threats to public health.
4. Cooperation is the key
EU Directive 2011/62:
(25) Art. 118c. Member States, in applying this
Directive, shall take the necessary measures to
ensure cooperation between competent authorities for
medicinal products and customs authorities.
CoE MEDICRIME Convention: e.g.
Art. 17 – National measures of co-operation and
information exchange.
Art. 22 – International co-operation on prevention and
other administrative measures.
5. Framework
In Italy the phenomenon of pharmaceutical counterfeiting has a low
incidence in the legal distribution network (pharmacies, authorized stores),
but it is growing in the illegal ones (Internet, sex shops, food supplement
stores), due to the involvement of international organised crime.
• The establishment (in 2007) of a collaborative network was a priority for
the Italian Medicines Agency
• Partnership via the national anticounterfeiting task-force IMPACT ITALIA
helped to solve many cases
6. Medicrime Convention
First international treaty bridging health & criminal law, by criminalising
• intentional manufacturing of counterfeit (fraudulent/falsified) medical
products;
• supplying, offering to supply & trafficking in counterfeit medical products;
• falsification of documents;
• unauthorised manufacturing or supplying of medicinal products or
marketing of medical devices that do not comply with conformity
requirements (“similar crimes”).
7. Medicrime Convention
MEDICRIME Convention is a basis for enhancing international response to
organised crime:
• Art. 5 - 8 – Offences («substantive law»)
• Art. 12 - Sanctions and measures
• Art. 13 - Aggravating circumstances «…committed
in the framework of a criminal organisation…; use
of mass media…»
• Art. 15 – Criminal proceedings
• Art. 16 – Criminal investigation
• Art. 17 – National measures of cooperation &
information exchange «(S)POCs – cooperation
within a state»)
• Art. 18 – Preventive measures
• Art. 19 – Protection of victims
• Art. 21 – International cooperation on criminal
matters (seizure, confiscation, extradition, mutual
legal assistance)
• Art. 22 – International cooperation on prevention
& other administrative measures («National SPOC
for cooperation between states»)
8. Medicrime Tools: SPOC model
Single Points of Contact
International
Co-operation
Network
National SPOC
Co-operation
with industry
SPOC for
Drug Regulatory
Authority (DRA)
• Risk Assessment
for Public Health
• National SPOC
SPOC for
Justice
SPOC for
Police
SPOC for
Customs
9. SPOCs networking approach for
national & international cooperation
SPOC
National network
formal or informal collaboration
between SPOCs at national level
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 Medicines
Regulatory Authority
(DRA)
incl. Official Medicines
Control Laboratories
Competent
Authorities for
Medical Devices
SPOC for
Justice
SPOC for
Police
SPOC for
Customs
Signals
Public;
health
professionals
10. Basic elements SPOC networking across regions
and national borders
National Network among Single Points of Contact (“SPOCs”) of the
competent health, medicines/device regulatory, customs, police, and judicial
authorities within a state.
Goal:
• Information collection, reports
• Operational management of a signal within area of responsibility of the
competent authority (optional)
• Collaboration-assistance in prevention/management of risks and unlawful
actions
11. Basic elements SPOC networking across regions
and national borders
Structure:
Single Points of Contacts (SPOCs) individuals/units 7/7 24 365; databases
Function:
handling signals; reporting; sharing information; training; awareness
programs
Medicines – devices regulatory authority SPOC:
health risk assessment
Skills:
familiar with relevant legislation in the field/access to expertise
12. Basic elements SPOC networking across regions
and national borders
• Within each state there should be a SPOC for each of the several agencies
that play a role in medical products safety; however one SPOC should be
designated as the lead agency contact, or National SPOC.
• There should be a list of persons that are the designated single points
of contact in each State, preferably regions (a list of the agency SPOCs
within a APEC economy) and either each state/region should maintain an
inventory of the lead contact (National SPOC) for own state/region.
13. Basic elements SPOC networking across regions
and national borders
• There should be one person (National SPOC) designated as the single
point of contact who will be the primary communicator for that State with
other States world wide/within the region.
• Within each State there needs to be SPOC interaction and involvement
with the following entities (through a variety of relationships which are
country specific) customs, police, regulatory authority, judiciary and
marketing authority holder.
14. Basic elements SPOC networking across regions
and national borders
• SPOCs have an important role across the borders especially within States/
regional/at international levels and both in regard to urgent circumstances
(life threatening), finding the source of the problem and routine such as
monitoring goods’ flow/customs data.
• The National SPOC and agency SPOCs should be designated by sufficiently
high levels, ministries and senior official by own authority to ensure they
have the authority to communicate with and garner the necessary actions
from/among various departments and ministries.
15. A SPOC example: IMPACT Italia
IMPACT Italia summarizes all key features of the SPOC model.
• IMPACT Italia, the national anticounterfeiting Task force, has been
established in 2007 to combact counterfeit medical products.
• IMPACT Italia Secretariat is composed, since the establishment of the
working group on counterfeit prevention, by four branches of the Italian
public administration.
16. IMPACT Italia TASKFORCE | 2007
Ministry
of Health
Laboratories
Natl. Health
Inst. (ISS)
Police
Carabinieri NAS
Italian
Medicines
Agency | AIFA
Official
medicines
control lab
(OMCL) -
Laboratory
analysis on
suspect
samples
Track and
trace system
Distribution
Medical Devices
Cosmetics
Dietary
supplements
Legal
and
investigative
activity
on
pharmaceutical
crime
Research
Clinical Trials
Registration
Post Marketing
Surveillance
17. Involved Stakeholders | 2013
MoH/Custom
offices
Industries
(Association)
Pharmacies
(Association)
Health prof.
(Orders)
Patients
(Associations)
Official Medicines
Lab
(Natl. Health
Institute – ISS)
Specialized
Police
(Carabinieri NAS)
Customs Agency
Anti-Fraud
Ministry of
Economic
Development
Ministry
of Health
(MoH)
Italian
Medicines
Agency | AIFA
18. Formal Agreements | Example
Italian
Medicines
Agency | AIFA
Ministry
of Economic
Development
2 Memoranda of understanding with the Directorate
general for the fight against counterfeiting to support
AIFA activities:
March 2010, support for the publication of the book
“Counterfeit medicines. Facts and Practical advice”
December 2010, support for the following activities:
• IT Intelligence project about e-pharmacies
• Webinar for operators training
• Communication
• Handbook for operator
19. Management of Inputs | 1
USMAF Industries Pharmacies Health prof. Patients
OMCL
ISS
Police
Carabinieri NAS
Ministry of
Economic
Development
Ministry
of Health
Italian
Medicines
Agency | AIFA
ANALYSIS
IMPORT/EXPORT
IPPOCRATE
PROJECT
AIFA Offices
involved:
GMP
Pharma
Vig.
SEIZURE
50 TONS OF
API
ILLEGALLY
IMPORTED
SIGNAL
SUSPECTED
ILLEGAL IMPORT
INSPECTION
AIFA, NAS
SAMPLING
RESULTS
OF ANALYSIS
JUDICIAL AUTHORITY
Customs Agency
Anti-Fraud
1
2
3
5
4
6
7
20. Management of Inputs | 2
OMCL
ISS
Police
Carabinieri NAS
Ministry of
Economic
Development
Ministry
of Health
Italian
Medicines
Agency | AIFA
VOLUNTARY WITHDRAWAL
AIFA Offices
involved:
GMP
Pharma
Vig.
SIGNAL
SUSPECTED
ILLEGAL IMPORT
SAMPLING
Customs Agency
Anti-Fraud
1
2
3
4
7
5
6
USMAF Industries Pharmacies Health prof. Patients
RESULTS
OF ANALYSIS
JUDICIAL AUTHORITY
21. IT Activities
CYBER SPACE ILLEGAL AND FAKE E-PHARMACIES
IT INTELLIGENCE WHO
Project Convey Italian Competition Authority
OMCL
ISS
Police
Carabinieri NAS
Ministry of
Economic
Development
Ministry
of Health
Italian
Medicines
Agency | AIFA
LegitScript:
BLOCKED
MORE
THAN 100
ILLEGAL
E-PHARMACIES
Customs Agency
Anti-Fraud
USMAF Industries Pharmacies Health prof. Patients
22. International Network
Single Points of Contact (SPOCs) model:
the national points may relate to the international ones, sharing inputs and
investigative data via:
• Council of Europe (AIFA)
• Working Group of EU Enforcement Officers (NAS, AIFA)
• Official Medicines Control Laboratories (OMCL)
• WHO-IMPACT (AIFA, MoH)
• Permanent Forum on International Pharmaceutical Crime (NAS)
Cooperation with private agencies (as LegitScript or PSI – Pharm. Security
Institute) is also considered.
23. Evolution Of The Cooperation
Single Points of Contact (SPOCs) model:
From bodies/structures towards a collaborative working approach.
Single Points of Contact (SPOCs): from enforcement model, mainly reactive
activities to multisectorial information - communication analysis - follow
up of lessons learnt, to Community of Practice (CoP) - social sciences
model, learning context.
Evolution fostered through training and community tools (web based).
25. Restricted Web Area
Access is allowed for officials identified by
AIFA, USMAF, customs, ISS, NAS, with
authentication username and password.
26. Restricted Web Area
When a new document (e.g. case study,
report, legislation dossier, blacklist, alert,
newsletter…) is published, the system
automatically generates an e-mail to all users.
27. “Food Supplements” Operation
In the framework of the agreement on “measures to apply in case of
infringement or conflict with legislation”, signed in December 2011 between
Ministry of Health and AIFA, the parties have planned and performed in
March 2012 a control operation on the market.
The operation was conducted in March in 5 different cities:
• Milan
• Trento
• Bologna
• Florence
• Rome
28. “Food Supplements” Operation
The AIFA Counterfeit Prevention Unit organized a web training in order to
encourage the involvement of Carabinieri NAS and to explain some relevant
aspects:
• Legal dietary supplements and legislation
• Fake dietary supplements and the recent cases
• Operating procedures
29. “Food Supplements” Operation
The Unit has prepared two documents:
• a list of illegal products, mostly fake supplements that contain derivatives
of active pharmaceutical ingredients, reported from European Agencies;
• a guide on the requirements of legal supplements.
During the day was created a point of contact for information about
products, with the help of experts in the sector.
30. “Food Supplements” Operation
• Every joint team checked the offer of at least five non pharmaceutical
shops (EG sex shops, dietary supplements shops).
• 22 of the suspect products were sampled and analyzed by the Italian
OMCL (National Institute of Health); 4 of them were classified as “illegal
medicines”.
• Police forces followed up to the results of the operation with seizures and
investigations.
31. “Food Supplements” Operation
Sex shop “Magic America” (Bologna)
“GOLDEN ROOT +”
Presented as stimulant
2 cps, 450 mg.
Price € 25,00.
Lab analysis demostrated the contamination with sildenafil and yohimbine
(alkaloid).
32. Conclusions
• The establishment of collaborative networking methods (an informal
task-force, to be better formalized and “branded” after a 1-2 years pilot
phase) is a priority.
• Adhere to basic SPOCs networking approaches to avoid barriers to
international cooperation
• Best Practice: APEC/ Europe SPOCs basic approaches which are
fully compatible
• Start working on practical projects where the final goals are clear and
the respective competences fully recpected: EG joint training sessions,
publications, exchange of information via restricted channels.
• Keep in developing tools (EG investigation models) involving all partners:
cooperation create an added value.
33. Contacts:
Domenico Di Giorgio
AIFA – Italian Medicines Agency
Product Quality Office, Director
d.digiorgio@aifa.gov.it
medicrime@aifa.gov.it