DEFINITION OF THE FAKE DRUGS

Drugs and health products are not like other consumer goods, and their counterfeits are not like other counterfeits. Every day they kill and threaten the lives of a significant amount of abused patients around the world, fooled by false appearances.

Obviously, this multiplicity of definitions and terminology – sometimes varying from one country to another – contributes to the lack of clarity around the problem and its global understanding. European citizens mainly use the term “counterfeiting”, or more recently the term “falsification” while Americans more readily use the terms “false” or “fake”.

Before defining the different terms of counterfeiting, we must understand the world of the medicine and its definitions.

What is a medicine?

According to the WHO Drug Dictionary Enhanced and the European Directive 65/65, the definition of a medicine is “any substance or combination of substances presented for treating or preventing disease in human beings or animals”. “Any substance or combination of substances which may be administered to human beings or animals with the intent of making a medical diagnosis or restoring, correcting or modifying physiological functions in human beings (…) is likewise considered as a medicinal product».

Similarly, a pharmaceutical specialty is defined as “any ready-prepared medicinal product placed on the market under a special name and under a particular conditioning”.

Finally, the European Directive provides that “No medicinal product may be placed on the market of a Member State unless a marketing authorization has been issued by the competent authorities of that Member State, etc.”

What is a health product?

In addition to medicines, they include all “products destined to enhancing human health and products for cosmetic purposes”: the active ingredients for pharmaceutical use, devices for medical and in vitro diagnostics, biological products and biopharmaceuticals (blood components, organs, tissues, cells and products of human or animal origin, therapeutic genetic and cellular products, other therapeutic products), cosmetic products….

What is counterfeiting?

Counterfeiting is the act of copying a piece of work (literary, artistic or industrial) in violation of the author’s or inventor’s rights and often to the prejudice of the consumer. In the case of consumer goods, counterfeiting is therefore a fraudulent copy (which can be identical to the original) associated with the will to deceive: the purpose of the counterfeiter is to create confusion between the original product (victim of the forgery) and the fake copy he proposes. The counterfeiter thus seeks to usurp the reputation and image of a brand, a product or an individual without the owner’s knowledge.

In some cases, the consumer is duped, but in some cases consumers can become complicit to counterfeiting when they knowingly buy a fake.

In the case of medication, the patient is cheated because he ignores that the product purchased may be fake, and so dangerous for his health.

What is a counterfeit drug?

Several additional definitions have been given by official agencies.

According to the WHO, “a counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to its identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct or wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”

IMPACT

At its annual meeting in Hammamet, in Tunisia, in December 2008, the IMPACT group (International Medical Products Anti-Counterfeiting Task force), whose secretariat is hosted by the WHO, broadened the definition of counterfeit medical products:
“The term counterfeit medical product describes a product with a false representation of its identity or its source. This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products. “Counterfeits may include products with correct ingredients/components or with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients or with fake packaging.”

The Council of Europe and Medicrime

The Council of Europe’s “Medicrime” agreement, defines the term “counterfeit” as “a false representation with regard to identity and/or source”.

What is a falsified medicine?

Forgery is the « voluntarily action to alter a substance or any other element with the intent of misleading”. When dealing with the risks to public health, the term “forgery” will be preferred to that of “counterfeiting” (“counterfeiting” has a legal connotation, indicating a violation of intellectual property rights).

It defines falsified drugs as any drug with a false presentation of at least one of the following characteristics:

– “Its identity, including its packaging and labelling, its name or its composition with regards to any of the ingredients, including excipients, and the strength of those ingredients;

– Its source, including its manufacturer, its country of manufacture, its country of origin or of its marketing authorization holder; or

– Its history, including records and documents relating to the distribution channels used.
This definition does not include unintentional quality defects and is without prejudice to intellectual property rights violations”.

– Its history, including records and documents relating to the distribution channels used.

This definition does not include unintentional quality defects and is without prejudice to intellectual property rights violations”.

The National Agency for Food and Drug Administration and Control (NAFDAC)

Some countries’ health agencies also have their own definition, for example, that of the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria:

According to that country’s Decree; (Article 12 c. C-34-counterfeit medical products, forged and unhealthy food),

A counterfeit drug is defined as:

a) “any drug product which is not what it purports to be; or

b) any drug or drug product which is so colored, coated, powdered or polished so that its risks are concealed or which is made to appear to be better or of greater therapeutic value than it really is, or which is not labelled in the prescribed manner or for which the label or container or anything accompanying the drug bears any statement, design, or device which is false or misleading; or

c) any drug or drug product for which the container is so made, formed or filled as to be misleading; or

d) any drug product for which the label does not bear adequate directions for use such as warnings about the product’s use or the dangers of use by children or in wrong doses or durations. Any drug product which is not registered by the NAFDAC in accordance with the provisions of the food, drugs and related products decree.

What is a “substandard medicine” or “non-compliant drug”?

There is no legal definition for sub-standard drugs (also called “out-of-specification” products, OOS). These are genuine medicines produced by manufacturers authorized by the national medicine regulatory authority but which do not meet the quality specifications set for them by national standards. Normally, each medicine that a manufacturer produces has to comply with quality standards and specifications. These are reviewed and assessed by the national regulatory authority before the product is approved for commercialization (Marketing authorization or AMM). The term “non-compliant” means that the drug partially deviates from the specifications set by the registration authority and/or from the best manufacturing practices in force in the country of registration. On the market, these sub-standard or non-compliant drugs can be badly dosed or mislabeled and pose many real problems for public health.

What is a fake medicine?

There is no proper definition of “fake medicine.” The term is occasionally employed, and is used in the “Cotonou Appeal” of the Jacques Chirac Foundation. A fake medicine is a drug that is not what it claims to be and is intended to mislead the consumer.

What is a generic drug?

Generic drugs are authorized copies of an original drug (princeps). These copies are permitted by law as soon as the patent protecting the active principle of the reference drug falls into the public domain i.e. 20 years after the patent filing date – not the date of introduction into the market (sometimes there are several years between the two dates). However, authorization is not given in the case of an SPC extension of the patent (supplementary protection certificate for a maximum duration of 5 years after the initial expiry date).

Even though they are not totally identical to the originals, generic drugs have the same qualitative and quantitative composition in active ingredients, the same pharmaceutical form and the same bioavailability in the body as the branded reference drug.

Generic drugs are regulated, controlled and subjected to marketing authorization (AMM). Therefore they are not a problem for public health.

However, generic drugs can also fall victim to counterfeiting.