You are correct that in 2012 the Minister of Health announced that Canada was going to proceed with the development of an orphan drug framework for Canada. We advanced a significant amount of work under that project. Most notable was the enactment of Bill C-17, Vanessa's law, which gave the regulator under the Food and Drugs Act many more powers that would be useful, especially in the rare disease space.
At that time we also considered going forward with a specific set of regulations. We decided on a change of course in this respect. We had conversations and dialogue with our international regulatory partners on some of the challenges they face because they had specific legislation for orphan drugs. We ultimately decided not to proceed with specific regulations, but through a regulatory review of drugs and devices initiative, we incorporated new processes and new pathways that could be very valuable for the approval of orphan drugs and also for some other products.