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Falsified, illegal and stolen medicines

AIFA pays particular attention to the issue of counterfeit medicines.

The most used definition of counterfeit medicines is the one developed by WHO:” …a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source..”

The phenomenon presents an increasing trend and it involves developed and developing countries. It concerns brand name drugs and generic drugs, life saving medicines and lifestyle products. We can distinguish different types of counterfeiting, since counterfeit products may include products

  • with the correct ingredients or
  • with the wrong ingredients,
  • without active ingredients,
  • with insufficient active ingredients or
  • with fake packaging.  

All of these types have in common the poor quality, since the production does not respect the rules of good manufacturing and good distribution practice established worldwide.

Counterfeiting is an underground phenomenon and data are merely indicative. According to most reliable estimates the proportion of counterfeit medicines on the global market would be around 7% with peaks as high as 50% in some Asian and African countries.

An unpublished survey of EU member states revealed that in the last five years there have been 27 known counterfeit medicines cases in the legitimate supply chain and 170 in the illegitimate supply chain.

AIFA's commitment to combat the phenomenon is due to certain activities:

IMPACT ITALIA

Is the Italian task-force that involves the main institutions working to combat counterfeit medicines: Aifa, Istituto Superiore di Sanità, Carabinieri NAS and Ministry of Health. It also includes representatives from other administrations (Ministry for Economical Development, Ministry of Internal Affairs, Customs) and actively cooperates with private stakeholders.

The task-force is the reference point for all issues related to counterfeiting.

Priority goals of the task-force:

  • definitions of flow of information
  • writing and approval of standard operating procedures (SOPs) for investigators
  • writing of guidelines for the training of the field investigators and health professionals
  • production of centralised online information and training systems
  • technical support to the action of international institutions such as WHO and the Council of Europe (CoE)

Last October the task-force took part in the operation “PANGEA III”, an international “Internet week of action” focused on anticounterfeiting, that involved 45 countries.
The monitoring activities took place between 5 and 12 October 2010, under the coordination of INTERPOL, IMPACT (International Medical Products Anticounterfeiting Taskforce) and World Customs Organization.
At a national level, the activity was conducted through the taskforce IMPACT Italia by AIFA, Italian Customs Agency and Carabinieri NAS.

During the operation about 140 postal packages were inspected, with a total seizure of 10.000 units (tablets, capsules and vials) illegally imported in Italy; the samples were sent to the Italian National Health Institute, as IMPACT Italia participants, for the due lab analysis.
The results confirmed the growing online demand for products as sexual disfunction drugs, slimming medicines, antidepressants.

PANGEA IV, scheduled for late 2011, is currently under preparation: AIFA has already formally joined the project.

International cooperation

In recent years the AIFA has actively participated to many international initiatives, as for instance:

  • the international conference  of Rome, 2006, “Combating counterfeiting drugs”, co-organized by AIFA, WHO and the German Ministry of Health;
  • the IMPACT meeting (2006) which defined  the “terms of reference” of the WHO task-force: AIFA is currently the Acting executive secretariat of the taskforce (since September 2010);
  • the European Parlament Conference “Making patient safety a priority”, Bruxelles, September 2009;
  • the Conference “Preparing the practical implementation of the council of Europe convention on counterfeiting of medical products and similar crimes involving threats to public health (MediCrime Convention)”, Basel, April 2010.

Since 2008 the AIFA holds the Presidency of two of the four technical Committees of the Council of Europe/EDQM concerning pharmaceutical issues: the “Committee of experts on minimising public health risks posed by counterfeiting of medical products and related crimes (D. Di Giorgio chairs it since 2008, and was re-elected in June 2011) and the “ European Committee on Pharmaceuticals and Pharmaceutical Care”.
 
AIFA also actively participated in the definition of two important regulatory instruments aimed at redefining the anti-counterfeiting activities framework: the Council of Europe “MediCrime Convention” and the amendment to European Directive 2001/83.

The MediCrime Convention will introduce specific criminal sanctions against medicines counterfeiting: after 3 years of negotiations, the Convention was open to signature (October 2011), and it is planned to be adopted by the 47 Member States of the Council of Europe, and also by some “Observers”, during 2012.

The amendment of the rules for the pharmaceutical sector defined in European Directive 2001/83  was published in July 2011, as EU Directive 2011/62: the regulation has led to introduction of some basic elements:

  • a definition of falsified products to products in which even one of the elements has been falsified: packaging, label, composition, country of origin, distribution channels. The new definition clearly states that unintentional quality defects cannot be considered as counterfeit products.
  • the definiton of actors and operators (eg, the brokers) involved in activities as the sale or the purchase of medicinal products, which duties were absent in the current regulation: brokers are distinguished from wholesale distributors, since their activity, consisting in negotiating independently or on behalf of other legal or natural person, does not imply physical handling or possession of the goods;
  • a strengthening of controls on Active Pharmaceutical Ingredients compliance to the principles and guidelines of Good Manufacturing;
  • control of goods in transit through Customs: Member States shall take the necessary measures in order to prevent that medicinal products that are introduced in the European Union but are not intended to be placed on the market of the Union enter into circulation, if there is sufficient ground to suspect that these products are falsified;
  • rules and principles for the sales of medicines at a distance to the public: the natural or legal person or the body provided for by national law offering medicinal products for sale at a distance is authorized or entitled to supply medicinal products to the public, also at a distance, according to national legislation where that person or body is established. The medicinal products offered for sale at a distance comply to the national legislation of the Member States of destination; a common logo shall be established that is recognisable throughout the Union, while allowing for the identification of the Member State where the person or body offering medicinal products for sale at distance is established.

E-pharmacies

Italian law prohibits e-pharmacies but can not prevent Italian customers from buying from foreign e-pharmacies.

AIFA and IMPACT Italia activities are focused on the study of the Internet as distribution channel for counterfeit medicines: some examples of the ongoing activities are the sampling project from suspect sites (a cooperation between AIFA, ISS and NAS), that led to further studies: a characterization of the available online offer; an IT study aimed at better defining the three different types of e-pharmacies (legal, illegal and fake), with the goal of preparing a black list of sites devoted to computer fraud; and a study on the use of social networks as a promotional channel for illegal pharmacies.

Thefts of medicines

The phenomenon and the Database on thefts

The criminal activity is alarmingly growing in our Country: in 2013 many cases of thefts from Italian hospitals and robberies against trucks have been reported. In order to share and analyse data and information on the phenomenon AIFA along with Farmindustria, ASSO-RAM and Carabinieri NAS, and with the support of the Ministry of Health, set up a database on thefts, an archive constantly updated with data shared by the over thirty companies participating in the project.
The Database, hosted and managed by AIFA, is available online to authorized users (member companies and police forces). It aims at gathering and organising in a structured way all available information on cases concerning theft of medicines, in order to let police forces (e.g. Carabinieri NAS) analyze and acquire useful data to rebuild origins and structure of illegal trafficking and to define targeted measures to fight the phenomenon.
To join the initiative, please send a request at medicrime@aifa.gov.it.

A practical example of uses of the database is offered by the recent investigation on the "Herceptin” case – an hospital-use-only medicine indicated for the treatment of breast or gastric cancer stolen from Italian hospitals, manipulated and/or falsified, and subsequently reintroduced through false documentation in the distribution chain of other European countries.

The case started from an alert sent by an English wholesaler to AIFA in March 2014, concerning anomalies found on some packages of Herceptin purchased through the Italian operator FARMACEUTICA INTERNAZIONALE Srl and headed to Germany. AIFA and Carabinieri NAS started a series of investigations and in-depth analysis that have revealed the involvement of other medicinal products in the illegal trafficking of drugs and, at the same time, a number of unauthorised European operators.

Rapid Alert, Non Urgent Information (NUI) and AIFA updates

This section will host all the documents, insights and updates on cases involving thefts of medicines, published and disseminated by AIFA or other foreign Regulatory Authorities, and any measures implemented to protect the public health.

Stolen medicines

This section makes available information of medicinal products stolen in Italy. The aim is to provide useful and timely updates to all operators in order to intercept any "suspect offers," potentially related to illegal activities.

Alert

The investigations carried out during the "Herceptin" case highlighted the importance of a system of exchange and sharing of information between all operators in the pharmaceutical and healthcare fields, in order to timely plan appropriate interventions and prevention strategies.

AIFA calls, therefore, all healthcare structures in Italy to report at medicrime@aifa.gov.it any case of theft of medicines and any other useful information in this regard, aiming at supplementing the particulars reported by the member companies with those of the hospitals, in order to make it possible, in a short time, the sharing and spreading of information about high risk medicines, as allegedly aim of trafficking, both at national and European level. The ultimate goal is to prevent patients from being administered ineffective therapies.

Training

Several training initiatives on the issue of counterfeiting and the importation of illegal drugs have been organized and promoted by AIFA.
The peculiarities of the phenomenon requests for ad hoc training for professionals who daily face the problem.

AIFA PC Unit, in collaboration with the administrations involved in IMPACT Italia, has launched a series of pilot e-learning initiatives since 2010, that allowed the development in 2011 of a first series of online events attended by customs and police officers.
The first series consisted of four webinars, each devoted to specific issues, with the participations of teachers from different administrations as AIFA, ISS, NAS, Customs, Ministry of the health and Ministry of Economic Development.

The objectives of the project was to support operators in their prevention activitiesthrough the delivery of reliable and useful informations on key aspects, as for instance:

  • Customs and pharmaceutical laws on importation, at national and international level
  • Medicines, compostion, pharmaceutical forms and active pharmaceutical ingredients
  • Characteristics of different types of health products like medical devices, cosmetics, dietary supplements, herbal products and  regulatory issues for the different sectors
  • Recent case studies and the borderline situations

AIFA works on training project also a an international level: in 2009 UPC hosted the international training course “Best practices to combat counterfeiting of medicines and to protect public health”, organized in collaboration with CoE, which involved a total of 40 trainees, from different administrations of 8 different countries. Training course was aimed at increasing participants’ awareness and showing areas for and means of improved co-operation.
The international section of the course was followed by a national edition, attended by 40 officials from different Italian administrations.
In January 2010 and May 2011 AIFA supported CoE/EDQM in the organizations of two international courses on “Best practices to combat counterfeiting of medicines and to protect public health”, hosted by the Portuguese and Norwegian DRAs; the courses were dedicated to police, customs and DRA operators from areas considered at risk, such as Portuguese speaking countries in Africa and South America. 

Communication

In Autumn 2009 Aifa cooperated with Ministry of Health, Nas and Iss in launching a communication compaign, “Attento!”, targeted on patients.

Messages have been disseminated through:

  • a poster and a leaflets distributed to 75.000 Italian pharmacies
  • the official Impact Italia website (www.impactitalia.gov.it) designed to optimize communication between patients and institutions

The objectives of the campaign were:

  • to inform the public about the health risks;
  • to provide the patiens with the essential information to evaluate whether a drug is counterfeit;
  • to discourage the patient from buying medicines from illegal channels

The evaluation of the results of the campaign will led to more informative initiatives.

 

Foto di Domenico Di Giorgio

Inspection and Certification Department

Head of office: Domenico Di Giorgio
E-mail: d.digiorgio@aifa.gov.it

 

Foto di Domenico Di Giorgio

Product Quality and Pharmaceutical Crime Counteracting

Head of office (ad interim): Domenico Di Giorgio
E-mail: d.digiorgio@aifa.gov.it

Data aggiornamento: February 2017
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