The National Agency for Health Inspection, Regulation, and Monitoring (ARCSA), has recently issued a regulation relating to the control of counterfeit, adulterated, and altered products in Ecuador. ‘Adulterated’ products are defined through the regulation as those that have had their characteristics changed knowingly in some way, whereas ‘altered’ products are those products whose characteristics are altered unwittingly.
The key points of the regulation are as follows:
1) Those responsible for establishments that manufacture, pack, store, export, import, donate, distribute, transport, commercialize, sell or dispense products for human use or consumption and subject to ARCSA control, are also responsible for preventative measures in respect of counterfeiting, adulteration and alteration of products.
2) The appropriate technician for such establishments is also responsible for:
- Confirming the authenticity of its products prior to distribution and commercialization
- The control of inventories so as to avoid products being diverted to non-authorized establishments. In addition, in the event of theft of products, this must be notified to ARCSA with corresponding supporting documentation
3) Said establishments must also have capabilities to trace their products once they enter circulation, to enable identification and withdrawal of counterfeit, altered and adulterated products.
4) It is the responsibility of the general public to report instances of suspected counterfeiting, and to cooperate with ARCSA if requested.
5) ARCSA is the entity responsible for the development of strategies for the control and monitoring of such products, in particular it has the following responsibilities:
- Receive and verify in a timely manner complaints regarding such products
- Carry out periodical inspections at the establishments previously detailed
- Coordinate with the relevant institutions in respect of mechanisms for obtaining samples and their subsequent analysis
- Coordinate with relevant institutions with regard to the mechanisms necessary for the seizure and destruction of products found to be counterfeit, altered or adulterated
- Coordinate campaigns for educating the population in general with regard to such products
- Publish notices with regards to such products, through its webpage and other media
- Exchange relevant information at an international level
As can be seen, the burden for fighting counterfeits in Ecuador is threefold; ARCSA, manufacturers and distributors and the like, and to a lesser extent, the general public. The burden also seems to somewhat weighted towards the establishments themselves, although it is unclear exactly how the regulations will work in practice, or how vigorously they will be enforced and the sanctions for non-compliance. Nevertheless, regulation in an area that is a growing problem in Ecuador is to be welcomed.
8th August 2016