Bill C-393 (Historical)

An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act

This enactment amends the Patent Act and the Food and Drugs Act to make it easier to manufacture and export pharmaceutical products to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.

[Mona Frendo]

Not alone, no. Clause 9, on section 21.09, of Bill C-393 and clause 10, on section 21.12, of Bill C-393 would also delete the renewal and that duration of the export, so--

[Mike Wallace, Conservative, Burlington, ON]

I will speak to that point.

My question is for the bureaucratic expert we have here in front of us today. If clause 2 is completely defeated, what was just mentioned by Mr. Lake as one of the issues that we're having problems with.... Would that then bring back the CAMR definitions that are already in there, in legislation that is already passed and is law and has been used? That would then eliminate that opportunity that Bill C-393 is trying to do in terms of the renewal aspects. So if clause 2 is completely defeated, the issue about renewal will not be an issue any more because we're using the CAMR definitions, which require a renewal.... That's where I'm getting....

I understand what Mr. Garneau was trying to do. I understand that he didn't try to put the definitions back in. The suggestion is to get rid of the whole clause altogether. I want to know what the ramifications are. One of the issues we've heard about at committee from all stakeholders was whether we want that renewal piece back in or not. It is an issue. Is it added back in if clause 2 is deleted?

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

In fairness, I sometimes find this process confusing, too, and it is tough sometimes when we're looking at Bill C-393. You see what is replacing what was taken out, but you don't see what was actually taken out. That's sometimes the problem that causes confusion.

In this case, Bill C-393 takes out all the references I was talking about, but we don't see that in Bill C-393 itself. I think that's what you're speaking about in terms of the confusion, Mr. Garneau.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

If it's important for the interpretation for the rest of Bill C-393, as the experts seem to suggest, then it's an oversight on my part. My intent was to go to the “pharmaceutical product” definition. I have to admit that I did not realize that we'd left hanging some definitions here that might be important.

If they're really required for the rest of the act, which they appear to be, it would be good to bring them back in, although they weren't there with the current proposal.

[Brian Masse, NDP, Windsor West, ON]

Why don't we just delete clause 2 of Bill C-393 and restore the current system?

[Mike Lake, Conservative, Edmonton—Mill Woods—Beaumont, AB]

Mr. Garneau referred to the other definitions that are in section 21.02 of the act that is being amended here. To be clear, the other definitions in the Patent Act that are struck out by clause 2 of Bill C-393 are references to “General Council”, “General Council Decision”, “TRIPS Agreement”, “TRIPS Council”, and “WTO”.

Now Mr. Garneau, I'm not sure if it's the Liberal position to wipe out all references in the Patent Act to “General Council”, “General Council Decision” “TRIPS Council”, and “WTO”, but that's the effect of clause 2 of Bill C-393.

Mr. Garneau's amendment changes the definition of “pharmaceutical product”, but it doesn't address the wiping out of all of the references to WTO, TRIPS Council, TRIPS agreement, and all of those things. Is that correct?

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

This is one of the disadvantages of being an engineer instead of a lawyer. My intent was not to get rid of other definitions. I only see two definitions in Bill C-393. I wasn't aware of the existence.... I have to admit that I didn't pick up on all these other definitions. I have no problems with those other definitions being brought into here, if it will help the situation. My intent was to define “pharmaceutical product”.

[Mona Frendo]

I'll answer that question by listing the definitions that are currently in CAMR. There are definitions for: “authorization”, “General Council”, “General Council Decision”, “patented product”, “pharmaceutical product”, “TRIPS Agreement”, “TRIPS Council”, and “WTO”. Bill C-393 would delete all of those definitions except for the definition of “authorization” and “pharmaceutical product”. And, as I heard Mr. Garneau say, he would choose to revise the definition for “pharmaceutical product” put forward in Bill C-393.

On the issue of the other definitions, “patented product”, for example, is referred to in the definition of “pharmaceutical product”. If you delete the definition of “patented product”, you are creating potential uncertainty in the definition of “pharmaceutical product” that Mr. Garneau has proposed.

In terms of deleting the definition of “WTO”, I just did a quick search of the provisions, and that term is referred to in subparagraph 21.13(d)(ii) and paragraphs 21.14(g) and 21.14(f), so there would be implications in other sections of the act. That word is referenced in other parts.

“General Council Decision” is referred to in at least one other place that I could find quickly, and that is subsection 21.17(2).

There would be implications if you delete a number of these definitions and only leave “authorization” and “pharmaceutical product”. You're going to have carry-through implications for other provisions in the bill.

[Luc Malo, Bloc, Verchères—Les Patriotes, QC]

Mr. Chairman, if we reconsider our decision to pass clause 12 as amended by LIB-4 and we pass this amendment to the definitions in clause 2 of the bill, it will no longer be possible to add any definitions if there is a need to do so.

Earlier, I asked the officials who are here with us what definitions are needed in order to understand the Patent Act. Bill C-393 is obviously going to amend that Act, and we will be removing all the definitions that currently appear there if we pass clause 2 as amended, or even if we pass it as it appears in the bill.

So, I'd like to reformulate my question and ask it again. We are currently debating clause 2. What definitions are needed in order to understand the Act, whether or not it is amended by Bill C-393?

[Mike MacPherson]

Bill C-393 appears to be including a definition for the term “pharmaceutical product”. It states that it is the same definition as “section 2 of the Food and Drugs Act. If we go to section 2 of the Food and Drugs Act, we have “drug”, which is what this would be referring to, and there is a complete definition there of what a “drug” is. Mr. Garneau's amendment would replace that with a straight reference to section 1 of the Patent Act, which would now be the first section of Bill C-393.

[Mike MacPherson]

It appears that Bill C-393 is defining “pharmaceutical product” according to section 2 of the Food and Drugs Act, and the amendment is replacing that definition with a reference to schedule 1 of Bill C-393, which is actually the old schedule 1 of the Patent Act.

[Mona Frendo]

I was only going to add that I think it is because clause 2 of Bill C-393 states, “Section 21.02 of the Act is replaced by the following”, and there are two definitions after that. One is for “authorization” and one is for “pharmaceutical product”. So the understanding was that when the Liberal amendment was put forward it was to deal with those two definitions and not--

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

I don't know whether there is simply an error in the amendment, because the intent was simply to… In the previous amendment, we established a new list of products that is now part and parcel of Bill C-393. The intent was simply to include a definition that would be consistent with the criteria used to draft such a list, which is now the new list # 1 in the document. It was simply to have a definition of “pharmaceutical product” that would be consistent with the criteria used for the new list that is now in the bill.

[Rob Sutherland-Brown, Senior Counsel, Legal Services, Justice Canada, Department of Industry]

It's all very complex and interrelated, but essentially, the original CAMR legislation, Bill C-9, made reference to things like the WTO waiver decision. To do that, a number of the definitions were technical; WTO is used, so there's a definition of WTO to tell you what the World Trade Organization is.

For “General Council” and which General Council, it tells you that. But it also, importantly, tells you about the “Decision”, which is referred to throughout the legislation as somebody importing or exporting in conformity with the authorization.

For “patented product”, again, it's a technical definition to tell you what it means. It's defined in terms of infringement. That's what this is about. It's about authorizing otherwise unauthorized users to infringe.

So these play both a definitional and a drafting role throughout the original legislation. Those references have been removed in Bill C-393, so they may or may not have much impact on Bill C-393 itself, but they do have an impact on the overall schema, in the sense that it loses the tie to the WTO agreements, both the main agreement and the TRIPS, the trade-related aspects of intellectual property agreement.

[Mona Frendo]

Clause 2 as it was put forward in Bill C-393 would have deleted the reference to schedule 1 and would have expanded the scope of eligible products for export under Canada's access to medicines regime to any drug as defined under section 2 of the Food and Drugs Act. That would have been the impact of clause 2 of Bill C-393. It would also have changed the definition of authorization under Canada's access to medicines regime to delete a reference that's currently in the act and that talks about a renewal system.

So together with other clauses in Bill C-393, it would have had the impact of removing any limits on the duration of an export authorization in CAMR. That would have been the impact of Bill C-393's clause 2.

In terms of the Liberal amendments, it does not affect Bill C-393's proposed changes to the definition of authorization, hence the issues with regard to no limits on duration continue. It also does not reinsert other definitions that were deleted by Bill C-393.

Currently the act defines things like “General Council Decision”, which is the WTO decision on which CAMR was based, and the meaning of “patented product”. There are a number of other technical definitions that, together with other elements of the regime, add clarity and help define what in fact the purpose of this regime is.