Legal Framework: Counterfeit Medicines.

AIFA and the actions against drugs counterfeiting

Marcello Chiavoni

Zagreb, November 2014

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

N.B. < I am not receiving any compensation>

*Marcello Chiavoni, 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

Interests in pharmaceutical industry NO Currently Last 2 years

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Direct interests:

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Indirect interests:

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PHENOMENON

The problem of falsified and illegal medicines has

registred in the last years a growing trend, which is

partially traceable back to the explosion of illegal e-

pharmacies on the Internet.

The worldwide dimensions phenomenon were

demonstrated by many recent cases.

Any medicinal product with a false representation of:

(a) its identity, including its packaging and labelling, its

name or its composition as regards any of the

ingredients including excipients and the strength of those

ingredients;

(b) its source, including its manufacturer, its country of

manufacturing, its country of origin or its marketing

authorisation holder; or

(c) its history, including the records and documents

relating to the distribution channels used.

[Directive 2011/62/EU]

FALSIFIED MEDICINES

FEATURES

Absence of active ingredient

Different active ingredients and different dosage from

what in the label

Dangerous or contaminated ingredients

These different types of products have in common the

low quality; we cannot establish who’s the manufacturer,

with what kind of ingredients and manufacturing

processes they were made.

In Italy the incidence of the problem is lower, in

comparison with other UE Member States or third

countries, due to the preventive and counteracting

initiatives such as the track and trace system in use for

the medicines, to the authorisation and monitoring

processes in use for imported medicines and, moreover,

to the collaboration among many institutions and to the

control of police forces in the field.

THE PHENOMENON IN ITALY

THE PHENOMENON IN ITALY

As far as legal medicines are concerned, such as the

ones dispensed by health care facilities or purchased in

pharmacies and parapharmacies, the distribution

network is safe. In recent years we never registered

cases of illegal and/or counterfeit products in the legal

chains. The danger is represented by the illegal

distribution channels, such as the online pharmacies.

IMPACT ITALIA

Customs Agency

Anti-Fraud

Ministry of Economic

Development

Italian Medicines

Agency|AIFA

Police Carabinieri

NAS

OMCL

ISS

Ministry

of Health

USMAF

Industries

Pharmacies

Health prof.

Patients

LEGAL CONSUMPTIONS

Products for erectile disfunctions (Cialis, Viagra, Levitra) Sold packages (2009) 4.154.125

Sold packages (2010) 4.375.038

Sold packages (2011) 4.754.477

MEDICINES FOR CENTRAL NERVOUS SYSTEM

2009 2010 + 5.2 % (spending)

+ 3.4 % (consumptions)

ANTIDEPRESSANTS

2002 2010 + 6.7% (yearly variation)

The first three medicines prescribed (per amount):

Paroxetin | Escitalopram | Sertralin

Among the prescribed active ingredients (not

reimbursed), benzodiazepines are at the first place for

spending and consumption (17.2% of the total amount

of not reimbursed medicines).

LEGAL CONSUMPTIONS

The web monitoring project promoted by AIFA (August

2011) shows that the active ingredients most frequently

offered on the Internet are:

Gabapentin

Serotonin

Escitalopram

Citalopram

Sertralin

INTERNET ILLEGAL OFFER

COMMUNICATION

Enforcement Training Regulation

COUNTERACTING ACTIVITIES

REGULATION

Directive 2011/62/EU

Enforces preventive and counteracting activities for the

protection of the legal distribution/manufacturing sector.

MediCrime Convention (CoE)

The first binding criminal law international instrument on

counterfeiting of medical products and similar crimes

involving threats to public health.

ENFORCEMENT

PANGEA IV | 2011

50.000 seized units (counterfeit/illegal medicines)

PANGEA V | 2012

30.000 seized units (counterfeit/illegal medicines)

DIETARY SUPPLEMENTS| 2012

Medicines sold as “dietary supplements” or “natural

products” in in non pharmaceutical shops

E-PHARMACIES

100 illegal websites shut down

through 3 operative procedures

TRAINING 43 countries (CoE);

200 officials trained in ad hoc courses (CoE);

8 publications;

500 Italian officers involved (health authorities, police,

customs).

E-PHARMACIES

Starting from the assessment of illegality, based on the

current regulations (D.lgs 219/2006, Consumer Code or

other laws regulating the advertising in the

pharmaceutical sector), it is possibile to act against illegal

website, by targeting:

Registrants

Hosts

Ise Providers

Webmasters

ENFORCEMENT IN ITALY

Counterfeiting prevention task-force (Art. 142 bis)

Intersectoral cooperation between health authorities

(AIFA; MoH), Customs, Police (Art. 142 quater)

Conference of Stakeholders on illegal e-pharmacies

(Art. 142 quinquies)

INTERNATIONAL PUBLICATIONS

CONTACTS

Marcello Chiavoni

Pharmacist

Anti-Counterfeiting Unit, AIFA

m.chiavoni@aifa.gov.it

www.aifa.gov.it