On July 12, 2017, section 5 and subsections 6(3) and 6(4) of the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) came into force. These sections amend the Food and Drugs Act to require healthcare institutions to report serious adverse drug reactions and permit the Governor in Council to make regulations that specify what this reporting will be and how it will be done. The amendments will also allow for the importation and sale of foreign drugs that have not been authorized for sale in Canada, but for which there is an urgent public health need.
Vanessa’s Law, which amended the Food and Drugs Act, came into force on November 6, 2014. While most of the act’s amendments came into force immediately, some required supporting regulations.
As we reported, the Government of Canada published draft regulations amending the Food and Drug Regulations on April 22, 2017. However, the draft regulations did not come into force at that time, as the necessary provisions in Vanessa’s Law were not yet in force.
These newly in force sections of Vanessa’s Law introduce those necessary provisions. They will allow the amendments to the Food and Drug Regulations that will (i) require healthcare institutions to report serious adverse drug reactions associated with foreign drugs sold for use regarding an urgent public health need, and (ii) permit the importation and sale of foreign drugs that have not been authorized for sale in Canada, but for which there is an urgent public health need.
This will be the first time that healthcare facilities will be required to report serious adverse drug reactions under the Food and Drugs Act. Currently, the manufacturer or importer of a drug authorized for sale in Canada is required to report. However, given that no authorization will be issued for foreign drugs imported in connection with an urgent public health need, responsibility for reporting has been shifted to healthcare institutions, which will be best placed to identify serious adverse drug reactions that may be associated with the use of these foreign drugs in Canada.