Medicines

Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines

The problem of Spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines was first addressed at the international level in 1985 at the Conference of Experts on the Rational Use of Drugs in Nairobi. The meeting recommended that WHO, together with other international and nongovernmental organizations, should study the feasibility of setting up a clearing house to collect data and to inform governments about the nature and extent of counterfeiting.

In 1988 the World Health Assembly adopted resolution WHA41.16 which requested the Director-General of WHO to initiate programmes for the prevention and detection of the export, import and smuggling of falsely labelled, counterfeited or substandard pharmaceutical preparations. Given the rapid spread of counterfeit drugs in many national distribution channels, the World Health Assembly in 1994 adopted resolution WHA47.13. This requested the Director-General of WHO to assist Member States in their efforts to ensure that available medicines were of good quality, and in combating the use of counterfeit drugs.

IMPACT

Increasing international trade of pharmaceuticals and sales via the internet has further facilitated the entry of counterfeit products into the supply chain. In 2006 this led to WHO's launch of the International Medical Products Anti-Counterfeiting Taskforce (IMPACT*).
In 2010, the 63rd World Health Assembly asked WHO to convene a time-limited and results oriented intergovernmental working group to examine:

  • WHO's role in ensuring availability of good-quality, safe, efficacious and affordable medicines
  • WHO's relationship with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT)
  • WHO's role in prevention and control of substandard/spurious/falsely-labelled/falsified/counterfeit Medical Products
  • Documents related to the Working Group of Member States meeting on Substandard/spurious/falsely-labelled/falsified/counterfeit Medical Products

The Working group made specific recommendations to the 64th World Health Assembly in May 2011. Agenda item 13.7 - document A64/16 "Report of the Working Group meeting of Member States on Substandard/spurious/falsely-labelled/falsified/counterfeit Medical Products"

  • The 65th World Health Assembly discussed the outcome of the Working Group meetings and adopted the WHA resolution (WHA65.19) which created a new Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products. The first meeting of the Member State mechanism will be held from 19 to 21 November 2012 in Buenos Aires, Argentina, and the working documents are available at the following link:
    http://apps.who.int/gb/ssffc/

For enquiries please contact: qsm@who.int

Contacts

HIS/EMP
20 Avenue Appia
1211, Geneva 27
Switzerland
Email: empinfo@who.int