In any business, honourable member, you require certainty and predictability over a three- to five-year horizon. Introducing a drug in Canada requires investments in clinical trials. It requires more than just getting a Health Canada approval.
What has happened with the PMPRB regulations is that they have impacted upon the predictability and the certainty of the business model, which is to ensure that beyond just introducing a product, we can ensure that the product supports clinical research on an ongoing basis and supports some of the kinds of initiatives, from a health system perspective, that we've spoken about and supports patient needs for the long term.