Legal Framework: Counterfeit Medicines.

Transcription

1 Legal Framework: Counterfeit Medicines. AIFA and the actions against drugs counterfeiting Marcello Chiavoni Zagreb, November 2014

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 Direct interests: 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) Employment with a company Consultancy for a company Strategic advisory role for a company Financial interests Ownership of a patent X X X X X Indirect interests: Principal investigator Investigator Individual s Institution/Organisation receives a grant or other funding X X X *Marcello Chiavoni, in accordance with the Conflict of Interest Regulations approved by AIFA Board of Directors ( ) and published on the Official Journal of 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 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.

4 FALSIFIED MEDICINES 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]

5 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.

6 THE PHENOMENON IN ITALY 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.

7 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.

8 IMPACT ITALIA Italian Medicines Agency AIFA Police Carabinieri NAS OMCL ISS Ministry of Health Customs Agency Anti-Fraud Ministry of Economic Development USMAF Industries Pharmacies Health prof. Patients

9 LEGAL CONSUMPTIONS Products for erectile disfunctions (Cialis, Viagra, Levitra) Sold packages (2009) Sold packages (2010) Sold packages (2011)

10 LEGAL CONSUMPTIONS MEDICINES FOR CENTRAL NERVOUS SYSTEM % (spending) % (consumptions) ANTIDEPRESSANTS % (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).

11 INTERNET ILLEGAL OFFER 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

12 COUNTERACTING ACTIVITIES Regulation Enforcement Training COMMUNICATION

13 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.

14 ENFORCEMENT PANGEA IV seized units (counterfeit/illegal medicines) PANGEA V 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

15 TRAINING 43 countries (CoE); 200 officials trained in ad hoc courses (CoE); 8 publications; 500 Italian officers involved (health authorities, police, customs).

16 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

17 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)

18 INTERNATIONAL PUBLICATIONS

19 CONTACTS Marcello Chiavoni Pharmacist Anti-Counterfeiting Unit, AIFA