We're over time.
Evidence of meeting #34 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site.) The winning word was clause.
A recording is available from Parliament.
Evidence of meeting #34 for Health in the 41st Parliament, 2nd Session. (The original version is on Parliament’s site.) The winning word was clause.
A recording is available from Parliament.
9:20 a.m.
Conservative
June 12th, 2014 / 9:20 a.m.
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
Thank you, Mr. Chair.
Mr. Robinson, my understanding is that in the act there's no current way to protect the minister from potential lawsuits. For example, if the minister were to recall a drug pre-emptively, believing that its distribution were detrimental to the health of Canadians and then it were discovered that the drug was safe for distribution, the minister and the government could be sued for loss of product sales during the duration of the recall. Is that your understanding?
9:20 a.m.
Vice-President, Government Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
I'll defer to my colleague, Mr. McIntosh, who has a much more detailed knowledge of that aspect of the act.
9:20 a.m.
Keith McIntosh Senior Director, Scientific and Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
I believe it is correct that there is no specific immunity provided to the minister in that regard.
9:20 a.m.
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
Do you feel that perhaps limits the minister's resolve to act in the best interest of Canadians?
9:20 a.m.
Senior Director, Scientific and Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
I think our system generally provides ministers great discretion in delivering their mandate for enabling legislation, and I think any citizen or corporation would want to have the ability to have a judicial review for actions that were unnecessary, but certainly—
9:20 a.m.
Senior Director, Scientific and Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
—I think the bar in Canada is quite high to demonstrate that in the courts.
9:20 a.m.
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
Okay. So the minister would be protected if it were in good faith, or would he or she still be sued?
9:20 a.m.
Senior Director, Scientific and Regulatory Affairs, Canada's Research-Based Pharmaceutical Companies (Rx & D)
I believe so.
9:20 a.m.
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
I'd like to turn to you, Ms. Abbey.
You've raised a fascinating subject. Let me see if I understand. Are you saying that these products should not be reused in any circumstances, or that if they are reused, they should be reprocessed here in Canada under federal government oversight?
9:20 a.m.
Executive Director, Reuse of Single-Use Devices Task Force, MEDEC - Canada’s Medical Technology Companies
We need the regulatory oversight in Canada. The position of the MEDEC members is that it's difficult for us to tell a hospital what or what not to do. They're doing it in an effort to save money. The gap right now is that nobody is looking at these devices from a safety, efficacy, and quality standpoint, which is what we're asking for. Other jurisdictions have taken that step and have called these reprocessing companies “manufacturers”.
9:20 a.m.
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
You seem to be saying that when they create these products, there has been research done and the manufacturer has established that these should not be reprocessed under any conditions. Yet you're saying that they can be reprocessed as long as it's being done in Canada in federally regulated companies. There's a bit of a contradiction there.
9:20 a.m.
Executive Director, Reuse of Single-Use Devices Task Force, MEDEC - Canada’s Medical Technology Companies
I agree. The term “reprocessed single-use device” actually doesn't often make sense. The reality is that an original equipment manufacturer, at the point where they are starting to think about a new device, goes through a rigorous exercise of how to design it, how to develop it, and how to validate it. That leads to licensing. As for the point at which they are looking at what materials, how the device is going to be used, and what sort of durability there is, that whole exercise is a pretty rigorous one.
The fact is that we now have reprocessing companies that are regulated in the United States and think they can now, through their proprietary technology and expertise, take a single-use device and reprocess it. Our view is that we should be asking them to prove it. Right now, Health Canada—
9:20 a.m.
Executive Director, Reuse of Single-Use Devices Task Force, MEDEC - Canada’s Medical Technology Companies
Yes, prove it to the government in the same way that original equipment manufacturers need to prove what their devices are.
9:20 a.m.
Liberal
Francis Scarpaleggia Liberal Lac-Saint-Louis, QC
It's interesting. Why has the government not acted on this? You mentioned an Auditor General's report from 2004. We still haven't gotten to the point where the federal government is regulating drug compounders in this. So really, why are there these gaps? In your view, why hasn't the government acted?
9:25 a.m.
Executive Director, Reuse of Single-Use Devices Task Force, MEDEC - Canada’s Medical Technology Companies
I think that initially when they first concluded they didn't have the authority, it was a challenge because most of the reprocessing was being done in-house by hospital staff—
9:25 a.m.
Liberal
9:25 a.m.
Executive Director, Reuse of Single-Use Devices Task Force, MEDEC - Canada’s Medical Technology Companies
I agree, but to regulate hospital staff would be very difficult with the federal-provincial jurisdiction.
9:25 a.m.
Executive Director, Reuse of Single-Use Devices Task Force, MEDEC - Canada’s Medical Technology Companies
The fact that these reprocessing companies are now doing the vast majority of the work makes it much easier.
