Counterfeit medicines is a growing problem. Several products are concerned in all therapeutic areas, whether for princeps medicines or for generic medicines.

These falsified medicines pass themselves off as real products and copy the packaging, trade dress, trade marks, logos, leaflets of authentic medicines as well as forms and colours of authentic pills or tablets. They use the same batch number, expiration date and other identification items as the authentic products. However, they are manufactured and sold without any marketing authorization of any health authority.

They may contain active ingredients in lower doses or wrong doses, or contain no active ingredient or another active ingredient and sometimes toxic ingredients. They cause a health risk because they have never been assessed by a health authority and are often manufactured in very poor and uncontrolled conditions. They are particularly difficult to identify.

In summary, they look like authentic products but they contain uncontrolled components and, by their nature, they pose a health threat.

This trade in fake medicines is controlled by international criminal networks and no region in the world is spared. Countries where distribution networks for medicines are less controlled are more vulnerable because fake medicines are more easily distributed to patients.

However, developed countries are not spared, in particular when patients buy medicines over the internet from unauthorized websites.

What are “falsified medicines” ?

The EU Directive 2011/62/EU of 8 june 2011, amending Directive 2001/83/EC, gives the following definition of “falsified medicines”:

Any medicinal product with a false representation of:

  1. its identity, including its packaging and labeling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
  2. its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorization holder; or
  3. its history, including the records and documents relating to the distribution channels used.

This definition does not include unintentional quality defects and is without prejudice to infringements of intellectual property rights.
http://ec.europa.eu/

To view examples of falsified medicines, please find the link to the World Health Organization.
http://www.who.int/

Why are falsified medicines dangerous ?

  • They do not treat the relevant pathologies because they do not contain active ingredients or because they contain active ingredients with wrong doses.
  • Even worse, they may contain toxic ingredients.
  • They increase resistance to medicines when they contain lower doses of active ingredients.
  • They are manufactured, stored and transported from one country to another without authorization and without quality control.

 

Les Laboratoires Servier’s fight against falsified medicines.

Les Laboratoires Servier’s detection measures.

We have organized our anti-counterfeiting strategy by developing detection measures allowing us to identify markets presenting risks.

In addition to a specific internal process to analyze and to follow suspicious cases, we have developed a number of tools, including:

  • To protect our products in order to detect and remotely authenticate products: the SECURISTAMP program on the most vulnerable markets.
  • To analyze suspicious products with dedicated people and through harmonized methods on our various production sites, so that we may quickly respond to each suspicious case. Please see below “What types of analyses do we use to determine whether a medicine is falsified”.

Further, we actively take part in the IPM (Interface Public Member) platform, which has been developed by the World Customs Organization. Through this platform, we provide information on our products and their trading routes to allow Customs to identify suspicious products. Customs then ask us to analyze samples so that they may seize the products if they are falsified.

Finally, we conduct samplings by proceeding with buying our own medicines within pharmacies, when falsified products are detected in a country, with the aim of multiplying detection tools and to inform Health Authorities.

Les Laboratoires Servier is also a member of associations and several working groups on anti-counterfeiting, to develop cooperation with public authorities but also with other pharmaceutical companies.

Cooperation at the same time with other pharmaceutical companies and with public authorities, including health authorities and law enforcement agencies, is crucial to the fight against these criminal networks.

Les Laboratoires Servier is a member of:

PSI (Pharmaceutical Security Institute).
The Pharmaceutical Security Institute is a not-for-profit, membership organization dedicated to:
Protecting the Public Health
Sharing Information on the Counterfeiting of Pharmaceuticals
Initiating Enforcement Actions through the Appropriate Authorities
28 pharmaceutical companies are member of PSI.
http://www.psi-inc.org/index.cfm

ASOP (Association for Safe Online Pharmacies).
ASOP EU has been established with the objective of making buying medicines online safer, in countries where it is permitted by Law.
ASOP EU is an informal, independent multi-stakeholder coalition. ASOP EU consists of various groups: patient organisations, healthcare providers, pharmacists, pharmaceutical companies, distributors, wholesalers, parallel traders, and online interme¬diaries, such as logistics and postal companies, ISPs and platforms, search engines, and financial service providers that transact payments.
http://www.asop.eu/

EFPIA anti-counterfeiting working group.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceutical industry operating in Europe. Les Laboratoires Servier is a member of EFPIA’ anti-counterfeiting working group.
http://www.efpia.eu/blog/

 

Why are information campaigns important ?

Patients are victims of these criminal networks.

It is crucial to be informed on threats posed by falsified medicines.

Several information campaigns have been launched on this topic.

We invite you to watch the campaign Fight the Fake

 

How LES LABORATOIRES SERVIER chose to reinforce the protection of their products with SECURISTAMP program.

LES LABORATOIRES SERVIER set up a printed digital encoded image on all elements of packaging of some of their products (boxes, leaflets and blisters).

The implemented technology is the encoding data embedded into a digital tag.

Any attempt to falsify a product is detected by scanning.

The image can be read with an iPhone equipped with a lens or with an office scanner.
These facilities are connected to a database on the web and allow to find out in less than a minute if the tested packaging is authentic.

This system is innovating, rapid and simple to use.
It allows to obtain an immediate confirmation and thus contributes to the protection of patient.

A risk analysis led to deploy this security tool on 11 products in 4 countries (Russia, China, Ukraine and Vietnam).

In Russia and in China, collaborators make regular product verification, either at wholesalers or in pharmacies. In 2013, more than 16 000 controls were carried out.

 

SERVIER.COM WEBSITE

Servier does not sell its medicines online.

The number of web sites selling prescriptions drugs without proper authorization is increasing. Because these sales are not regulated in many countries or because many websites do not comply with regulations when they exist, the safety and authenticity of the medicines offered for sale on these websites cannot be guaranteed. Servier, out of concern for the health and well-being of its patients, opposes the unauthorized or illegal sale and importation drugs via the Internet.

Patients should purchase medicines only from properly licensed pharmacies.

In more than 50% of cases, medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit, according to the World Health Organization.

Link: http://www.who.int/

The report “The Counterfeiting Superhighway” (EAASM) found that 62% of medicines bought online were either substandard or counterfeit.

Link: http://www.eaasm.eu/

Please check the legal and regulatory requirements in your country for online sales of medicines.

We invite you to visit the website of the regulatory agency of your country.

We provide below links to some regulatory agencies:

ANSM: http://ansm.sante.fr/

MHRA: http://www.mhra.gov.uk/

Santé Canada/ Health Canada: http://www.hc-sc.gc.ca/

FDA: http://www.fda.gov/

 

The European Commission has established a logo that will allow patients to identify authorized online pharmacies in the European Union.

This logo will be compulsory from 1 July 2015.

 

Pangea operation: an example of an initiative to fight the illegal sale of medicines online

Interpol coordinates an annual operation against illegal sales of medicines online, called operation Pangea.

Operation Pangea is an international week of action tackling the online sale of counterfeit and illicit medicines and highlighting the dangers of buying medicines online. Coordinated by INTERPOL, the annual operation brings together customs, health regulators, national police and the private sector from countries around the world.”

Link: http://www.interpol.int/

Pangea VII (13-20 may 2014) has resulted in:

  • 9.4 million illicit and fake pills confiscated
  • Estimated value : USD 36 million
  • More than 10,600 websites shut down
  • Some 543,00 packages inspected by regulators and customs authorities, of which around 20,000 were confiscated
  • Some 213 individuals are currently under investigation or under arrest for a range of offences

Link: http://www.interpol.int/fr/Crime-areas/Pharmaceutical-crime/Operations/Operation Pangea