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]

Clause 4 of Bill C-393 would change the system of authorization that is currently in CAMR to a particular country and to a production of a particular drug. It would change this completely. It would allow the Commissioner of Patents to authorize any person to manufacture more than one pharmaceutical product and sell it for export to more than country. That would be a significant change. It would also eliminate the requirements that the manufacturer of the pharmaceutical product and the importing country be named in the application.

That's what Bill C-393 proposes to do in clause 4. It would also delete a number of the specifics that would have to be named by the generic manufacturer and the potential applicant under CAMR when applying to the Commissioner of Patents for an authorization.

Again, it's what I was mentioning earlier: the name of the product, the prescribed information about the product, the maximum quantity to be exported and sold, the name of the patentees, and the name of the importing country. It would delete that at the legislative level in the Patent Act.

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

Thank you, Mr. Chairman.

I'm sure you would acknowledge that Mr. Garneau followed the proper process before presenting his amendments. They were submitted in advance so that members could review them. Now you have just talked about the clauses you would like to have removed from Bill C-393. Considering how little time we have left, it would be rather difficult to examine that suggestion properly. In terms of what you just said, I would like to hear from officials as to how they interpret this.

Considering how little time we have left, I am really just wondering if it will be possible to arrive at an informed opinion regarding Mr. Masse's suggestion.

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

I would just like to ask Mr. Masse for clarification. He seemed to be saying he is prepared to amend that clause of Bill C-393.

Could you explain once again which clauses that are affected by subclause 4(2) that you would be willing to retain under the current Act?

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

Could I ask the officials to comment on the amendment? What impact would the amendment have on Bill C-393? What might it fix and what might it not fix?

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

Mr. Chairman, we can certainly dispose of the amendment and clause 2, or pass them, but either way, we are creating a problem. We have to resolve that problem before we can decide whether we want to accept or reject both the amendment and the clause.

We previously passed a schedule identifying which drugs could be sold in accordance with the Patent Act. However, Bill C-393 does not tell us either who or how that schedule could be amended.

My proposing a new definition of “pharmaceutical products”, Mr. Garneau was trying to identify the ideal mechanism whereby drugs could be added or removed from Schedule 1.

Department officials are saying that in terms of how as pharmaceutical products are currently defined, the mechanism is not sufficiently clear, refined and detailed. Before going any further, I think we have to find a way to fix this. If we just create problems by trying to dispose of the amendment and the clause too quickly, as framers of the legislation, we will not have done our job properly. I think that is what we should do, because that is what we're here for, Mr. Chairman.

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

It certainly is very complicated. If we need this mechanism, if we want the medications to be Health Canada approved, what do we have to change in Bill C-393 to achieve that objective?

[Rob Sutherland-Brown]

Thank you, Chairman.

It's hard to know where to begin. As you have noted, this is very complex and very interrelated, and that's the way legislation is usually crafted, so that when it's presented in the House the interconnections between (a) and (b) and (c), etc., are clear.

But the question is, if you stay with the definition of “pharmaceutical product” that is in Bill C-393 now, that is defined by reference to the Food and Drugs Act, and the Food and Drugs Act definition of “drug” is everything in the world: any substance that can be used as a medicine, not only for humans but also for animals. It also includes disinfectants for cleaning kitchen surfaces and stuff like that.

So there is no need to amend if you stay with that. If you introduce the prospect of a Minister of Health or a Minister of Industry joint recommendation, they have to recommend to somebody. In the existing legislation--Bill C-9 or the Patent Act--it is the Governor in Council who makes amendments to the schedules that are in that act and does so on the recommendation of the appropriate ministers. In the case of a drug, that recommendation is given by both the Minister of Health and the Minister of Industry. Amendments to the other country schedules are done on the recommendation of the ministers for industry, international affairs, and CIDA, and I think for international trade as well.

The original legislation, the Patent Act, that purports to be amended by Bill C-393 has a mechanism that's built in for amendments to all those things and the circumstances that have to be met. If you use the definition that's proposed in amendment Lib-1, there is no mechanism left in the act, because Bill C-393 gets rid of all those mechanisms for amending. So it may say “on the recommendation of a minister”, but there is no mechanism in the legislation to permit it.

It's very intricate and very interrelated.

[Mona Frendo]

The simple answer is no. If you revert to the pharmaceutical product definition that is in the Patent Act currently, there is no reference to any ability to add to that list on the recommendation of the Minister of Industry and the Minister of Health. That ability is found in section 21.03 of the Patent Act currently.

Clause 3 of Bill C-393 proposes to eliminate that section of the Patent Act. Therefore, if you revert to the definition of pharmaceutical product that is in the Patent Act without also considering the changes to clause 3 of Bill C-393, you will not have an amending ability for schedule 1.

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

That is not what I understood to be the correct interpretation. Departmental officials said that, based on the current wording of Bill C-393, if we do not add that drugs listed in Schedule 1 must be recommended by the Minister or another entity, in fact, we don't really know how drugs could be added or what process would have to be followed to add them to the schedule.

Now Mr. Masse is saying that he is going to remove a certain number of clauses from Bill C-393, so that there will not longer be an issue as to who would be authorized to add products to Schedule 1, and so as to ensure that this will in fact be done based on the recommendation from the Minister of Health.

I simply want to be sure that if we revert to the definitions as they currently appear in section 21.02 of the Act—and if Bill C-393 is subsequently passed—there will be some mechanism whereby we could actually identify the individual or entity authorized to add products to Schedule 1.

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

In looking at Mr. Garneau's amendment and then at the existing Patent Act, what this appears to be doing is simply reinstating the wording from the existing Patent Act. It talks about reinserting the words “patented product listed in Schedule 1...if applicable, the dosage form, the strength and the route of administration specified in that Schedule in relation to the product”.

But for some reason—and I guess this is what we're trying to figure out, Mr. Garneau--you're reinstating the old definition for pharmaceutical product, except for one little exception. You're adding the words “on the recommendation of the Minister and the Minister of Health”. Those words are found in the existing Patent Act in paragraph 21.03(1)(a).

I'm just wondering why you've mixed two clauses that have both been removed under Bill C-393 and have reinserted them under the definition of pharmaceutical product. I'm wanting an idea of what the rationale is there.

[Mona Frendo]

If I understand what Liberal amendment 5 does, it restores Bill C-393's schedule of countries; it restores schedule 1 of the Patent Act, which currently lists the drugs that are eligible for export under CAMR, and it references Bill C-393's list of countries as schedule 2. That would not affect other clauses of Bill C-393 that eliminate the possibility of adding to schedule 1, for example.

So schedule 1 is currently— There are x number of products on that schedule and currently there is a process under the Patent Act on the recommendation of the Ministers of Industry and Health to add to that list to respond to countries' needs. That would no longer exist as a result of one of Bill C-393's proposed changes to CAMR.

[Mona Frendo]

Yes, in the sense that.... Section 21.03 of the Patent Act currently refers to schedule 1, the list of drugs, and the process for adding to those drugs on the recommendation of the Minister of Industry and the Minister of Health. Bill C-393 would delete not only schedule 1, but the process for amending that schedule.

So the reference that is in your definition, Mr. Garneau, to “on the recommendation of the Minister of Industry and the Minister of Health”, would not exist under Bill C-393.

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

That's a good question. I'm told that under the current legislation, in order for a product to be licensed, it has to be approved by Health Canada.

Under Bill C-393, without Schedule 1, products requiring approval could apparently be approved by someone other than Health Canada, in particular by the countries importing those drugs. My intention was to ensure that only drugs approved by Health Canada would be eligible. What we want to do is ensure that these products are all reviewed by Health Canada before being shipped to other countries.

If section 21.02 is reinstated, as opposed to clause 2 here, there is no mention of Health Canada in the definition of “pharmaceutical product”. But is it covered in other parts of the act--that it limits products to being Health Canada products approved by the Minister of Health?

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

We are currently discussing potentially deleting clause 2 of Bill C-393 and restoring section 21.02, as drafted in the current Act, and thereby bringing all the definitions back in. However, Mr. Garneau's intention, in amending the definition of “pharmaceutical product” through amendment LIB-1, was to ensure that it would be appropriate, given the amendments we have just passed, and thereby to amend the schedules.

I'm just wondering whether, by retaining the definitions as they appear in the current Act, the definition of “pharmaceutical product” will still be comprehensible and correct.

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

Thanks again, Mr. Chairman, for giving me the floor. I would like to ask our legislative clerk for clarification.

Mr. Garneau's goal was to only amend the definition of the term “pharmaceutical product” in order to make it consistent with those clauses that are amended by amendments LIB-4, LIB-5 and LIB-6, and specifically amendment LIB-5.

Once clause 2 has been completely deleted from Bill C-393, will the definition of “pharmaceutical product” still be adequate considering the amendments we have just passed?