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
[2]Court ruling in Kenya a victory for access to medicines
[3]India may drag EU to WTO on seizure of drugs in transit

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

Falsified and Sub-standard Medicines: Danger of Death  – Unusual in the industrialized countries   – Commonplace in developing countries
Jacques Pinel was a pharmacist working with MSF.  He devoted his career with MSF to improving the supply and use of quality essential medicines. He had almost completed this publication when he died in 2015.

Jacques’ close co-workers and companions therefore decided to finish the document in Jacques’ spirit so as to make it available to as many people as possible. The outcome of this process had been  made public in French in August 2016, and it is has now been translated in English.

The first chapter is devoted to explaining a few basic notions for a better understanding of the topic of medicines, their quality and their legal and regulatory environment.
The second chapter explains how a medicine can be of poor quality and the distinction to be made between falsified (counterfeit or frankly “fake” medicines) and “sub-standard” medicines.

The third chapter examines how the upheavals in the way the world is politically organized and the evolution of the international market have affected the quality of medicines available to the world.

And finally, chapter four explains what measures must be taken to improve the situation for the most deprived countries and the essential role played by the World Health Organization (WHO) with its Pre-qualification Programme.

Jacques was a fervent supporter of this WHO Pre-qualification Programme. He hoped that the responsibility of the Pre-qualification Programme -initially targeting the antiretrovirals, TB-medicines and the artemisinin-combined therapies-would be widened to include all the medicines on the WHO Model List of Essential Medicines.

You can download the publication here