Counterfeit Medicines

What are counterfeit pharmaceutical products?

Counterfeit products are illegal imitations of legitimate products that are meant to deceive buyers. They demonstrate several criteria.

  • They are deliberately and fraudulently mislabeled with respect to identity and/or source
  • They can be branded and generic
    They can include products:
    – With correct ingredient(s)
    – With wrong ingredient(s)
    – Without active ingredient(s)
    – With insufficient quantity of active ingredient(s)
    – Or with fake packaging

What are Generic Medicines?
Generic medicines are legitimate copies of patented (branded) pharmaceuticals. They can be produced after patent protection has expired or under certain flexibiities of Intellectual Property law. The same GMP and quality standards apply to generics as to branded medicines.
An issue with counterfeit medicines is that they are sometimes confused with generic medicines. Several countries have introduced legislation to control counterfeits but lack of awareness of the difference has meant that the laws have also affected the import of legitimate generic medicines. In 2009[2]Customs misunderstanding led to blocking transit of good generics through Schipol airport.[3]

[1] WHO Fact Sheet http://www.wpro.who.int/media_centre/fact_sheets/fs_20050503.htm
[2]Court ruling in Kenya a victory for access to medicines http://www.essentialdrugs.org/edrug/archive/201004/msg00036.php
[3]India may drag EU to WTO on seizure of drugs in transit http://www.essentialdrugs.org/edrug/archive/200903/msg00057.php

Controlling counterfeit medicines in South East Asia – science and collaboration
In December 2012 HAIAP News included a feature on current activities aimed at controlling counterfeit medicines in South East Asia. It highlighted the collaboration between Interpol and WHO and governments.

‘Operation Storm is unprecedented at both the national, regional and international level. This is the first time that three national agencies – Customs, the Drug Regulatory Agencies, and the Police – are working together to conduct joint operations for counterfeit pharmaceutical crimes. Also for the first time, seven Asian countries have recognized the common threat that counterfeit pharmaceuticals pose and have come together to tackle this problem. Also unprecedented, at the international level, is the cooperation among INTERPOL, WHO and WCO to fund and to coordinate operations’.

You can read the whole article here