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How can we stem the tide of counterfeit medicines?

24/06/2015

How can we stem the tide of counterfeit medicines?

In 2011, the World Health Organization (WHO) estimated that 10% of the medicines sold around the world were counterfeit.

While its scale is difficult to quantify accurately, the counterfeiting of medicines is a growing phenomenon. According to the American Center for Medicine in the Public Interest, the traffic in pirated medicines increased by 90% between 2005 and 2010. In France, medicines were the primary sector affected by counterfeiting in 2013.

However, the main problem with counterfeit medicines is that they are a significant risk to public health: they can result in serious consequences for patients’ health and may even cause death.

 

  1. Counterfeit medicines, a complex problem

 

  1. What is a counterfeit medicine?

In general, counterfeiting consists in reproducing or imitating something without having the right to do so and giving the impression that the copy is an authentic product. The WHO defines counterfeit medicines as being “medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source.”

Falsified medicines can imitate, in every way, the packaging, appearance, brands, logos, and leaflets of authentic medicines and can mimic the batch numbers, expiry dates and all forms of identification of these medicines, in particular the shapes and colors of the tablets or capsules. Sold without any permit issued by a health authority, they may or may not contain the active ingredient, they may contain an insufficient or incorrect amount of the active ingredient, they may contain a different active ingredient, or sometimes they may even contain a toxic product. For these reasons, they are dangerous.

While this scourge is having a particularly adverse effect on developing countries, where up to 30% of medicines are counterfeit, it is by no means unknown in the developed countries, which have witnessed growth in the market for counterfeit medicines with the arrival of sales on the Internet. Thus, according to the WHO, 50% of the medicines purchased from Internet sites that conceal their physical address are likely to be counterfeit.

 

  1. Significant risks to patients’ health

Counterfeiting and falsification of medicines pose a serious risk to public health by virtue of the content of these medicines, which may be dangerous and not only cause numerous medical complications, but also lack the active ingredients and so fail to treat the diseases for which they are intended. Thus, the use of counterfeit medicines can result in ineffective treatments, a long-term increase in resistance to medicines, and even the death of patients. The WHO highlights these risks by quoting the case of counterfeit antimalarial drugs that do not contain sufficient active ingredients and which contribute to the increasing resistance to the disease vis-à-vis the treatment. More generally, the use of counterfeit medicines can create a net reversal in the fight against the spread of diseases such as AIDS or tuberculosis, to the extent that they do not treat the patients and thus they fail to limit the propagation of diseases.

 

  1. How can we combat counterfeiting?

A number of mechanisms are being deployed in the fight against the growing phenomenon of counterfeit medicines:

– developing special technologies during the production of medicines in order to safeguard the manufacture of products, rendering the products unique, identifiable, and impossible to replicate accurately;

– taking direct action against the points of sale of counterfeit medicines, on the Internet in particular;

– developing and improving the techniques of identification and analysis of counterfeit medicines;

– promoting awareness among the general public of the dangers associated with the use of counterfeit medicines and directing them toward points of sale for medicines that are protected and approved by the health authorities.

 

  1. The ways in which Servier is combating counterfeit medicines

Over the past decade, Servier has been deploying a number of measures in the fight against counterfeit medicines and for dealing with any warnings applied to its products: the creation of an organization dedicated to this subject, to the use of technological innovations, and to participation in various programs combating counterfeit medicines.

 

  1. Internal and cross-departmental organization

An operational group comprising every department at Servier that is participating in the fight against counterfeiting was set up in 2004. It has at its disposal resources for organizing this fight internally and between the various departments.

Servier has a PHARMA\SOP to complement internal resources for combating counterfeiting. An SOP (Standard Operating Procedure) “a security procedure that describes how to confront a threat and the action to be taken in order to reduce the risk. It describes the steps to
follow in order to reduce the possibility of an accident occurring and, if it does occur,
the action to be taken in order to limit the consequences of such an accident”». In conjunction with the Servier PHARMA\SOP, it is the Brand Names Department, attached to the Legal Department, that deals directly with any suspicions of counterfeiting and is responsible for verifying whether or not a warning has been confirmed. Each country employs a local falsification manager who is responsible for gathering the information required for each notified warning in order to facilitate the work involved in verification.

Servier has also developed a network of contacts around the world in order to conduct sampling operations. They purchase Servier medicines in pharmacies so as to detect the possible presence of counterfeit medicines in a particular market. This sampling procedure is initiated as soon as cases of counterfeiting are discovered in a given country. The aim of this initiative is to increase the level of information gathering and to notify the health authorities as soon as possible of the threat to a particular market.

 

  1. Technological innovations

Technologie Servier (TES) and, in particular, the Spectroscopy and Chemometrics Department, have refined cutting-edge analysis techniques to determine whether or not a specific medicine is authentic. If a case of falsification is confirmed, TES conducts in-depth analyses to identify the components of the counterfeit product. This analytical process identifies both the associated risk and is also able to compare the counterfeit products in order to identify their common features.

The Securistamp program

For a number of years, Servier has also been implementing the Securistamp program which, in particular, was used to examine 7000 Servier products in China and in Russia during 2014, at wholesale outlets as well as pharmacies. This program is also being deployed in the Ukraine and in Vietnam.

It consists of a coded digital authenticator printed on every type of packaging (boxes, leaflets, and blister packs) and is in the form of a coded digital image. The technology employed is encrypted data embedded in a digital tag. Capable of being read by an iPhone fitted with a lens or by an office scanner, this tool is able to determine in less than one minute whether or not the scanned packaging is authentic.

 

Le système SecuriStamp

Innovative, quick and easy to use, the Securistamp system provides an immediate check on the origin of the medicine, thus contributing to protection of the patient.

 

  1. Programs involving the fight against counterfeit medicines

In addition to its internal organization and the use of cutting-edge technological innovations, Servier is actively involved in a network of organizations engaged in the fight against counterfeit medicines, such as the Pharmaceutical Security Institute, the Association for Safe Online Pharmacy, the EFPIA Anti-counterfeiting Working Group, and the IPM Platform.

Pharmaceutical Security Institute (PSI)

The Pharmaceutical Security Institute is a nonprofit-making organization whose objectives are the protection of public health, sharing information about the counterfeiting of medicines, and promoting legal action by the competent authorities. Comprising 28 pharmaceutical laboratories, the PSI enables Servier to assess the status of the threat in different countries and to be informed about changes in the operating methods of the counterfeiters.

ASOP (Association for Safe Online Pharmacies)

Servier is also an observer member of the Alliance for Safe Online Pharmacy (ASOP). ASOP EU, the European branch of the Alliance, aims to make the online purchase of medicines more secure in those countries in which online sales are permitted by law.

EFPIA Anti-counterfeiting working group.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents the pharmaceuticals industry in Europe.  Servier is a member of the Anti-counterfeiting Working Group of the l’EFPIA.

Interface Public Member of the World Customs Organization

Finally, Servier is in contact as often as possible with the authorities in numerous countries (customs authorities, health agencies, police, etc.) in order, in particular, to undertake awareness assignments.

In a similar spirit of collaboration with national authorities, Sevier is participating in the Interface Public Member (IPM) Platform developed by the World Customs Organization. By providing information about its products and its export channels, Servier is enabling customs authorities in the 87 member nations of the program to identify suspect products more effectively.

 

III. European and international measures designed to combat the online sale of counterfeit medicines

According to the WHO, 50% of the medicines purchased from Internet sites that conceal their physical address are counterfeit. In order to combat this phenomenon, the public authorities have either developed a series of operations, such as Pangea, or have put in place a system for verifying the legitimacy of online pharmacies.

 

  1. Operation Pangea

Operation Pangea is a typical example of the action taken by international public authorities in order to combat the illicit sale of medicines on the Internet. Coordinated, in particular, by Interpol and the World Customs Organization, it comprises numerous national authorities involved in the fight against counterfeiting, together with regulatory health authorities, the police, and the private sector, including Servier.

Launched in 2008, Operation Pangea is one week of annual action against the online sale of counterfeit products and illicit medicines. Its primary purpose is to educate the general public by highlighting the dangers of purchasing medicines online. Specifically, these actions are directed toward three fundamental factors that apply to the online sale of counterfeit medicines: the providers of access to the Internet, the online payment systems, and the delivery services.

In 2015, Operation Pangea included 115 countries; it was able to confiscate 20 million illicit and counterfeit medicines and to close down 2414 Internet sites.

 

  1. The common logo of the European Union for the online sale of medicines

With effect from 1st July 2015, authorized online sales websites must also display, on every page of the site that deals with the marketing of medicines, the logo common to every Member State of the European Union.

By clicking on the common European logo for selling medicines online, patients will be able to verify whether the site from which they are purchasing their medicines is included in the list of websites authorized for the electronic marketing of medicines. The list of websites authorized to sell medicines online will also be available from the health authorities in each country.

The common logo of the European Union for the online sale of medicines

 

CONCLUSION

While the counterfeiting of medicines is a very real scourge and rapidly expanding, it is the responsibility of everyone involved in the health care sector to do all in their power to resist the spread of these products and their use by patients.

Servier is directly involved in the fight against counterfeiting by deploying numerous internal and external resources to prevent falsification and to improve the detection of counterfeit products. Servier is also a member of several working groups engaged in the fight against counterfeiting, in order to promote public/private cooperation, since only cooperation between laboratories on the one hand and health, customs, and police authorities on the other hand can combat the proliferation of counterfeit medicines throughout the world.

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