28.07.2014 |

LOGFILE No. 02/2014 - Fight against counterfeit medicines - GMP News: CFDA

Fight against counterfeit medicines

An excerpt from the GMP MANUAL

by Dr. Stephan Schwarze - Bayer Pharma AG, Germany

Introduction

In the age of globalisation and the World Wide Web (Internet) counterfeit medicines have grown to become a serious challenge. Not only growth markets, but also all other markets are affected globally. This problem is a matter of grave concern to manufacturers of branded and generic products alike, parallel importers and wholesalers, brokers, and all others involved in the distribution chain of medicinal products.

Therefore, as part of an effective risk management system, particularly with regard to mitigating the risks associated with medicinal products, both pharmaceutical companies and other participants in the supply chain of medicinal products will have to adequately address this topic1.

Counterfeiting of high-quality goods in general and of medicinal products in particular is not a new phenomenon. Countless examples have been documented throughout history. In contrast to other luxury goods, concerning which a buyer is often aware that a counterfeit is involved and is willing to tolerate it, counterfeit medicines are frequently purchased with the buyer erroneously assuming that the goods are genuine. Up to now, no impairments to the health of those purchasing counterfeit luxury products have been publicised. However, counterfeit medicines always harbour an acute health hazard for patients who take or apply them; the expected effect can fail to set in or there could just as likely be undesirable side effects or even symptoms of poisoning. Impurities that can be found in counterfeit medicines also put the patient at risk.

Regardless of what type of counterfeit medicine is involved, there is always a health hazard for the patient. This is the main reason and motivation for actions to be taken against counterfeit medicines. Economic aspects and liability issues provide additional reasons for taking action against counterfeiting of medicinal products.

The fight against counterfeiting of medicinal products can be compared with a risk insurance policy: The investment made reduces the risk of negative impact in the event of a loss. However, the loss cannot be completely prevented by this means; instead, the probability of its occurrence and the impact and extent of the damage can be limited. After all, fight against counterfeiting of medicinal products is part of quality risk management.

Definition

There is no globally uniform definition of the term counterfeit medicine, even though the World Health Organization (WHO) proposed a definition as early as 1992. Therefore, there are no available verifiable statistics, nor are there any findings governed by a uniform counting mechanism that would provide insight into the extent and scope of the counterfeiting of medicinal products worldwide. For this reason, all statistics on this topic should be viewed with caution.

Counterfeit Medicine 
According to the WHO definition, a counterfeit medicine is “a medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and 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”.

The term counterfeit medicine is frequently used in connection with the infringement of intellectual property rights or trade mark rights and is defined within this context. In order to place the emphasis more clearly on the hazards to patients, in 2006, for the first time the WHO IMPACT (WHO International Medical Products Anti-Counterfeiting Task Force) deliberated on changing the definition to include “false representation of …” 2, which similarly found its way into the MediCrime Convention of the European Council. The term Falsified Medicine was ultimately coined in the European Union and is also found in the EU Falsified Medicines Directive.

Thus, a falsified medicine is defined as a medicinal product with false information on

  • the identity, including that of its packaging, its labelling, its designation or its composition in relation to one or more of its components, including excipients and the content of these components,
  • the origin, including that of the manufacturer, the country of manufacture, the country of origin and the holder of the marketing authorisation or the owner of the approval or
  • the distribution channels described in records and documentation.

The WHO, on the other hand, decided after a long, contentious debate to conduct future discussions on the basis of a collective term (SFFC – spurious/falsely-labelled/falsified/ counterfeit medical products)3.

  • Spurious/falsely-labelled/falsified/ counterfeit (SFFC) medicines are medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source.
  • Use of SFFC medicines can result in treatment failure or even death.
  • Public confidence in health systems may be eroded following use and/or detection of SFFC medicines.
  • Both branded and generic products are subject to counterfeiting.
  • All kinds of medicines have been counterfeited, from medicines for the treatment of life-threatening conditions to inexpensive generic versions of painkillers and antihistamines.
  • SFFC medicines may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient or too much active ingredient, or with fake packaging.

Extent and scope of counterfeit medicines

The absence of a globally uniform definition makes it difficult to assess the extent and scope of the counterfeiting of medicinal products. Apart from that, the criminal nature of this phenomenon hampers its quantitative measurability. It lies within the nature of criminal activities that they are not subject to controls. This can also be referred to as a sort of “unreported” criminality, the scope of which only becomes apparent when (state) surveillance activities are intensified.

However, based on facts gathered up to now, it can certainly be assumed that counterfeits of medicinal products

  • represent a global menace,
  • are steadily and increasingly on the rise,
  • have a widely varying regional distribution and
  • increasingly involve life-saving medicines.

In recent years there has been a general, steadily growing number of notifications of counterfeit medicines (for example, see the statistics of the Pharmaceutical Security Institute4). These notifications generally relate to all parts of the world. However, the nature and extent of such notifications appear to differ greatly. While counterfeit medicines reach consumers and patients in industrialised nations primarily through the illegal(!) Internet market, in other regions the legal supply chain is directly involved. In the past, it was primarily medicinal products in areas of specific indications, such as what is referred to as lifestyle aspects, that were affected (for example: substances for treating erectile dysfunction (PDE5 inhibitors) or alopecia, medicinal products that promote weight reduction, etc.). Meanwhile, life-saving medicines (such as antibiotics, anti-malarial or cancer treatment drugs) are increasingly becoming the objects of counterfeiting.

Organising the fight against counterfeit medicines

Counterfeiting of medicinal products is a complex phenomenon that cannot be contained by simple means. Such phenomena require a comprehensive, holistic approach if the various aspects involved are to be addressed adequately and feasibly.

On the basis of works by the University of St. Gallen (Switzerland), suitable means to serve this purpose would include a control loop consisting of the elements of monitoring, building up knowledge, prevention and reaction as well as the core element of continuous learning (see Figure 1).Image

Fig. 1: Model – control loop for fight against counterfeit medicines (Staake T., Fleich E.: Countering Counterfeit Trade. Springer Verlag, Berlin-Heidelberg, 2088, pp. 48ff)

Within a company, managing the fight against counterfeit medicines is often initially structured along the lines of a matrix organisation. Individual topics and subtopics are dealt with by the relevant area specialists. An expert or one of the area specialists assumes leadership as “primus inter pares”. The leadership function frequently resides in company security, the legal department or in the area of quality assurance. The continuous exchange of information is established by regular meetings of an interdepartmental team and by modern working aids for the common use of information and data.

Companies that have already been dealing intensively with the topic for some time have also been observed transferring the initially set up matrix organisation to a dedicated department with the appropriate resources, which is then further supported as needed by the area specialists. A key factor for success, independently of the type of organisation, resides in the visible and explicit support by company management in warding off counterfeit medicines, for instance in the form of a sponsor on a higher hierarchical level.

1 Schwarze S.: Organization of Counterfeit Protection Management.; In: Pharmazeutische Industrie. Editio Cantor Verlag, Aulendorf,, 71, No. 5, 2009, pp. 799–802

2 IMPACT Secretariat at AIFA, Editors: IMPACT – The handbook. 2011, p. 51

3 WHO: New global mechanism to combat Substandard/Spurious/Falselylabelled/Falsified/Counterfeit medical products

4 Pharmaceutical Security Institute – Counterfeit Situation – Internet Trends

Author:

Dr. Stephan Schwarzt
Bayer Pharma AG, Germany

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