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

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*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