When the new regulations come into force, a Canadian company operating nationally will first have to conduct efficacy tests. That will cost it thousands of dollars. As Mr. Parker said earlier, those tests are very costly, and waiting times for results are from 3 to 12 months.
Then it will have to prepare a file and submit it to Health Canada. It will also incur further costs of $10,000 to $12,000 to open the file.
Lastly, the company will have to wait 9 to 12 months for Canadian authorities to process the file. In all, the process will take 12 to 24 months, and the company will have spent $10,000 to $12,000, not including research and development costs.
In the meantime, for the same product in the United States, a company will file an expedited administrative application, pay $3,500 USD and receive approval for its product within three months. That's possible when the American regulatory file is deemed in order.
Our view is that we should wait before allowing an American file to be submitted in Canada; in other words, we should waive the 12‑ to 24-month period imposed under the new regulations for every Canadian company. We think it will take two to five years for Health Canada to complete the entire process.
There are precedents for this. When the natural and non-prescription health products directorate was created, it took seven years to process applications. Now, five years after the Safe Food for Canadians Regulations came into force, we're still issuing establishment licences. That's not what was planned.
We don't mean to attack the Health Canada people, but it is what it is. Implementation delays are always longer and more complicated than anticipated. That's the situation we have to face.