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Finance committee  It's important to state that we do not want to create less of a safety or evidentiary standard. It may be that you do the same amount of work. It's just that we don't have old regulations from the 1960s governing, for example, a drug that's very advanced. We're seeing right now,

May 6th, 2019Committee meeting

David Lee

Finance committee  Biologics right now are scheduled. They're regulated well in our regulations for the drugs. For the most part, companies will keep going through that pathway. For example, some of the stem cell research and advanced cell work that we're seeing done in hospitals may not, with th

May 6th, 2019Committee meeting

David Lee

Finance committee  Certainly from the Health Canada side, part of the reason we rationalize this pathway is, very much to your point, that in hospitals we're seeing more and more abilities to fabricate products right at bedside; you'll genetically inform a cell and put it in a patient. You're right

May 6th, 2019Committee meeting

David Lee

Finance committee  We will take that back, Mr. Chair. Thank you.

May 6th, 2019Committee meeting

David Lee

Finance committee  Actually schedule G is structured to eliminate randomness so that it instructs the minister to focus on certain things when scheduling. Right now many companies can fit their filings in either the device side or the drug side, but more and more as you're seeing different manufa

May 6th, 2019Committee meeting

David Lee

Finance committee  It's created through this enactment. It's empty so far. We have been consulting a great deal with innovation hubs in Montreal, Toronto, Vancouver, across the country, which are really bringing very advanced health products. It's exciting for patients, but to see which ones will g

May 6th, 2019Committee meeting

David Lee

Finance committee  Exactly, so when a hospital is adopting, for example, brand new genetic therapies, they are not waiting for five years for us to make a regulation. These are happening in our cancer centres now, and so to really get that flexibility has been the aim of this instrument.

May 6th, 2019Committee meeting

David Lee

Finance committee  This is not done through application. It is a power available to the minister. But having said that, our branch has been conducting a foresight exercise in consultation with companies, with other international regulators, because we're all wrestling with the same technologies com

May 6th, 2019Committee meeting

David Lee

Finance committee  No, we've prevented that because, again, these are pretty rigorous criminal prohibitions so you really don't want to shuttle one for the other. It's just where something can be more than one, you're settling on one of the pathways.

May 6th, 2019Committee meeting

David Lee

Finance committee  We did spend a lot of time in the drafting room on that, Mr. Chair. You needed something to identify the product before it was classified as a drug or a food, so “thing” was really chosen to be malleable enough that it could be all three. Chewing gum, for example, is a thing tha

May 6th, 2019Committee meeting

David Lee

Finance committee  Mr. Chair, the CFIA was sort of involved in the discussions here, and this was really to align.... You're correct that many instruments apply to foods. The Food and Drugs Act is on the safety side and then you have the Safe Food for Canadians Act. These are to line up the powers

May 6th, 2019Committee meeting

David Lee

Finance committee  Basically there are four definitions at the act level: food, drug, cosmetic and device. Especially with the newer technology, we're seeing blurring across the lines. If you think of yourself as a start-up company and you're getting ready to go through the device regulations, whi

May 6th, 2019Committee meeting

David Lee

Finance committee  Thank you, Mr. Chair. Subdivision C would amend the Food and Drugs Act to optimize patient safety, but to enable innovation. Clause 164 would introduce a more organized way to determine classification. Right now, products can fall under more than one definition, such as a food

May 6th, 2019Committee meeting

David Lee

Health committee  I will acknowledge that this is a complex area. For that reason, we are working with experts who can try to tell us what is possible in that space. Again, the intent of the policy is to make sure that there is not a promotional activity that is promoting unhealthy food to somebod

April 25th, 2018Committee meeting

David Lee

Health committee  My understanding is no, but I will turn to my colleague Hasan to explain.

April 25th, 2018Committee meeting

David Lee