Health committee  I think this is what Dr. Stewart was talking about. Yes, absolutely, there is the opportunity for patients to continue on treatment after the clinical trial. That's through an extension protocol or an open label type of situation. However, it is all dependent on the manufacturer being willing to continue to provide.

Health committee  I would just add that we are working very aggressively with the list of drugs that are on special access, especially for the rare diseases, to bring those into some kind of authorized state. In working with the companies, it's a matter of would it take to get them to file for approval of a product in Canada.

Health committee  I can certainly comment on the fact that we treat every drug for a rare disease uniquely. We meet with the manufacturer of that drug and we go over what kind of data they have available, what kind of data they are capable of getting, what kind of data may have been generated elsewhere in the world.

Health committee  Dr. Stewart will answer that.

Health committee  Yes.

Health committee  Did you want to add...?

Health committee  Thank you very much.

Health committee  We don't have any specific regulations.

Health committee  In countries that have legislation, they have a number of things to encourage development. Some provide tax incentives for development. Some provide extended market exclusivity periods. There are also provisions for medications to be eligible for accelerated review, which we already have in Canada.

Health committee  Thank you for your question. Our mission as Health Canada is to provide availability of safe, effective and high-quality medications. That is applicable both to the rare disease community as well as the disease community at large.

Health committee  Thank you for your question. It is correct that we are not seeing that every medication which goes to the U.S. or Europe is coming to Canada at the same time. There are two issues: first of all, getting the medication here, and also getting it at the same time as those other countries.

Health committee  We are in dialogue with the pharmaceutical industry as to why there is still a difference in times of filing. They give us a number of reasons. They find it difficult sometimes to work with more than one regulator at the same time, so we are trying through international co-operation and work sharing to minimize that obstacle.

Health committee  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.

Health committee  The consultations that were promised and that were on our website were consultations on upcoming regulations. We were no longer going to proceed with regulations, so we removed that reference to an upcoming consultation. We now have a full landing page on Canada.ca on our regulatory approach for orphan drugs.

Health committee  Yes.