WHA70 agenda item 13.6 Member State mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products
Delivered by Cyntia Genolet, Manager, Regulatory and Health Policy
Progress toward health improvement will not be achievable without a consistent and constant fight against falsified medicines. Falsified medicines deliberately and deceitfully attempt to pass themselves off as genuine approved medicines. They represent a serious threat to patients, and undermine the full spectrum of legitimate medicines both patented and generic medicines, and exist in all therapeutic areas.
Falsified medicines are a public health threat which knows no border. They are sold in the streets and open markets but also penetrate the legitimate supply chain and less regulated markets like the Internet. No country is immune to this danger.
Initiatives to fight this scourge are increasing, but success will be achieved only through collective action building on each actor’s expertise and strength. IFPMA commends the fifth recommendation of the Mechanism review report which encourages the engagement of additional actors, including manufacturers. As a partner in global health, IFPMA plays its part, in particular as a member of Fight the Fakes, a campaign of over 30 leading public health organizations that coordinate their efforts to speak up against falsified medicines.
The lack of a globally approved definition is a key hindrance to strong coordinated action. IFPMA therefore welcomes the consensus found by the WHO mechanism members in accepting the use of the term “falsified” for the purposes of work within the Member State mechanism. Reaching this consensus is an important step forward.
This agreement is in line with IFPMA’s position: as stated in our 2010 “Ten Principles”, patents have nothing to do with falsified medicines. Efforts to tackle falsified versions of genuine approved medicines must not be confused with patent infringement disputes.
The WHO has a key global coordination role to play in the fight against falsified medicines by ensuring that all aspects of this problem are adequately addressed at international level.