Post on 16-Jul-2015
SPOC model cooperation against counterfeit medicines
The institutional coordination schemes in Italy
Domenico Di Giorgio
Taipei, February 2015
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
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Direct interests:
Employment with a company x
Consultancy for a company x
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Financial interests x
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Indirect interests:
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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
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.
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.
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
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”).
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»)
Medicrime Tools: SPOC modelSingle Points of Contact
InternationalCo-operation
NetworkNational SPOC
Co-operationwith industry
SPOC forDrug RegulatoryAuthority (DRA)
• Risk Assessmentfor Public Health• National SPOC
SPOC forJustice
SPOC forPolice
SPOC forCustoms
SPOCs networking approach for national & international cooperation
SPOC
National networkformal or informal collaboration
between SPOCs at national level
InternationalCo-operation
between National SPOCs
National SPOC Role ininternational/national
co-operation;Central Reporting Point
Industry InvestigationSPOC e.g.
Qualified/ResponsiblePerson
SPOC for MedicinesRegulatory Authority(DRA)incl. Official MedicinesControl Laboratories
CompetentAuthorities for Medical Devices
SPOC forJustice
SPOC forPolice
SPOC forCustoms
Signals Public;health
professionals
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
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
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.
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.
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.
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.
IMPACT Italia TASKFORCE | 2007
Ministryof Health
LaboratoriesNatl. HealthInst. (ISS)
PoliceCarabinieri NAS
ItalianMedicines
Agency | AIFA
Officialmedicinescontrol lab(OMCL) -
Laboratoryanalysis on
suspectsamples
Track andtrace system
Distribution
Medical Devices
Cosmetics
Dietarysupplements
Legaland
investigativeactivity
on pharmaceutical
crime
Research
Clinical Trials
Registration
Post Marketing
Surveillance
Involved Stakeholders | 2013
MoH/Customoffices
Industries(Association)
Pharmacies(Association)
Health prof.(Orders)
Patients(Associations)
Official MedicinesLab
(Natl. HealthInstitute – ISS)
SpecializedPolice
(Carabinieri NAS)
Customs AgencyAnti-Fraud
Ministry ofEconomic
Development
Ministryof Health
(MoH)
ItalianMedicines
Agency | AIFA
Formal Agreements | Example
ItalianMedicines
Agency | AIFA
Ministryof EconomicDevelopment
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
Management of Inputs | 1
USMAF Industries Pharmacies Health prof. Patients
OMCLISS
Police Carabinieri NAS
Ministry ofEconomic
Development
Ministryof Health
ItalianMedicines
Agency | AIFA
ANALYSIS IMPORT/EXPORT
IPPOCRATE PROJECT
AIFA Officesinvolved:
GMPPharma
Vig.
SEIZURE50 TONS OF
APIILLEGALLYIMPORTED
SIGNALSUSPECTED
ILLEGAL IMPORT
INSPECTION AIFA, NASSAMPLING
RESULTS OF ANALYSIS
JUDICIAL AUTHORITY
Customs AgencyAnti-Fraud
1
2
3
5
4
6
7
Management of Inputs | 2
OMCLISS
Police Carabinieri NAS
Ministry ofEconomic
Development
Ministryof Health
ItalianMedicines
Agency | AIFA
VOLUNTARY WITHDRAWAL
AIFA Officesinvolved:
GMPPharma
Vig.
SIGNALSUSPECTED
ILLEGAL IMPORTSAMPLING
Customs AgencyAnti-Fraud
1
2
3
4
7
5
6
USMAF Industries Pharmacies Health prof. Patients
RESULTS OF ANALYSIS
JUDICIAL AUTHORITY
IT Activities
CYBER SPACE ILLEGAL AND FAKE E-PHARMACIESIT INTELLIGENCE WHO
Project Convey Italian Competition Authority
OMCLISS
Police Carabinieri NAS
Ministry ofEconomic
Development
Ministryof Health
ItalianMedicines
Agency | AIFA
LegitScript:BLOCKED
MORE THAN 100ILLEGAL
E-PHARMACIES
Customs AgencyAnti-Fraud
USMAF Industries Pharmacies Health prof. Patients
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.
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).
Restricted Web Area
Restricted Web Area
Access is allowed for officials identified byAIFA, USMAF, customs, ISS, NAS, with authentication username and password.
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.
“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
“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
“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.
“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.
“Food Supplements” Operation
Sex shop “Magic America” (Bologna)“GOLDEN ROOT +” Presented as stimulant2 cps, 450 mg.Price € 25,00.
Lab analysis demostrated the contamination with sildenafil and yohimbine (alkaloid).
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.
Contacts:Domenico Di Giorgio
AIFA – Italian Medicines AgencyProduct Quality Office, Director
d.digiorgio@aifa.gov.itmedicrime@aifa.gov.it