Evidence of meeting #42 for Industry, Science and Technology in the 40th Parliament, 3rd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was c-393.
A recording is available from Parliament.
Director, Patent and Trade-mark Policy Directorate, Department of Industry
I'm sorry. Can you repeat the question? I apologize, but I didn't hear the front end of that question.
Conservative
Peter Braid Conservative Kitchener—Waterloo, ON
If there is an unlimited period of time during which a medication can be exported, does that dilute intellectual property rights at all?
Director, Patent and Trade-mark Policy Directorate, Department of Industry
It dilutes them less than would be the case if there were no time limit on export, because the WTO decision and CAMR in turn provide opportunities for a generic version of patented products to be made. These are protected products in Canada that will be made and sent to other countries. If there were no time limit on the manufacture of these drugs, there would be more of a concern for companies.
Conservative
Director, Patent and Trade-mark Policy Directorate, Department of Industry
I think patentees would have that concern, certainly.
Senior Counsel, Legal Services, Justice Canada, Department of Industry
If I could add to that, there is a general provision in the TRIPS article that allows for compulsory licensing in the domestic setting. It stipulates that when you allow an authorization or when you allow for compulsory licensing, you must have a feature so you can review it.
You must also have a feature that provides the patentee with an opportunity to bring forth evidence showing that the circumstances that gave rise to the issuance of a compulsory licence no longer exist and so the authority should terminate. It's a general proposition that is designed to defend the intellectual property system.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
Along that line of questioning, because it's kind of interesting, was there a reference to a time limit anywhere in the waiver?
Senior Counsel, Legal Services, Justice Canada, Department of Industry
No, but it's in article 31 of the TRIPS agreement itself. Anybody who chooses to adopt legislation implementing a waiver still is responsible for meeting its obligations under the remaining articles or paragraphs of article 31 and TRIPS, which control the use of compulsory licensing in a domestic setting.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
So by definition, I guess, if it's not actually changed in the waiver, then TRIPS still applies.
Senior Counsel, Legal Services, Justice Canada, Department of Industry
Yes, that's right.
Conservative
The Chair Conservative David Sweet
All right, members.
Seeing no other questions or debate, shall clause 9 carry? I had better get a show of hands. I see five hands. Opposed? Six hands.
(Clause 9 negatived)
(Clause 10 negatived)
(On clause 13)
If you remember, the amendment on clause 13 was withdrawn, I believe. Shall clause 13--
Mr. Lake. I'm sorry. I got ahead of myself.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
No. That's okay. I want to fully understand the ramifications of clause 13. Again, clause 13 now deals with section 21.16. I again want to come back to section 21.16, what the purpose is of section 21.16 in the first place, and maybe the rationale that goes into it, and then the effect clause 13 would have on that.
Director, Patent and Trade-mark Policy Directorate, Department of Industry
Section 21.16 of the Patent Act presently describes the obligation on the authorization holder to provide the patentee or patentees, as the case may be—and it was that case in the Apotex example—as well as the Commissioner of Patents with a copy of the agreement. So once the agreement is signed with an importing country or user to supply a particular drug to a particular country, that's the obligation that appears. Currently in the Patent Act, under section 21.16, it's an obligation to provide a copy of the contract, basically.
Clause 13 of Bill C-393 would change the section. It would eliminate the requirement that the agreement to supply include the name and the particulars of the authorized product for export, the name of the country, and the name of the drug purchaser as applicable. It would remove a number of pieces of information that would have to be provided. It's of concern because, when read with other changes in Bill C-393, it would reduce the transparency in the system.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
Mr. Masse, if I could again, there were three clauses that you thought were important enough to leave in when you struck out the other eight. What is it about this one? Why is it critical?
NDP
Brian Masse NDP Windsor West, ON
It's the time of when entering the agreement, and once again, it's the amount of information and requirements that seem to convolute the application for it. It's less of consequence now that clause 4 has been basically defeated, but to me, it's not as important as previous ones. It takes away entering into an agreement so it gives a little more flexibility for those who are making application.
I still don't believe, despite clause 4 not being changed, we still have.... I don't know where the abuse elements that seem to be suggested would take place. I don't know where they keep coming from, because they don't exist in reality. To me, it's a modest change.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
Again, on that comment about the abuse elements not actually taking place in reality, could you comment on that? As we've gone through the bill, the potential for abuse seems to be a real concern.
Director General, Marketplace Framework Policy Branch, Department of Industry
Right. I guess the way we would think about the issue is that the regime in CAMR is not enforced by the government; it's meant to be enforced by rights holders. So the transparency requirements--for example, some of the things that are dealt with in section 21.16 of the Patent Act and that clause 13 would amend--are meant to assist that private enforcement of the regime. If there's no transparency about the name of the country or the particulars of the authorized product for export, it's very difficult to then enforce those requirements should they not be respected.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
Okay.
So again, the transparency--
I'm sorry. Go ahead, Ms. Frendo.
Director, Patent and Trade-mark Policy Directorate, Department of Industry
I'm sorry. I was just simply going to add to that point that, as has been mentioned before, throughout this regime it tries to ensure that the drugs are not exported for commercial purposes.
So again, providing this kind of information as part of providing an obligation on the authorization holder to provide a copy of the agreement, when signed, to the patentee and to the importing countries, helps ensure that there is transparency, but also that there are measures in place to ensure the regime is not used for commercial purposes, which would be contrary to the objectives of the WTO decision.
Conservative
Peter Braid Conservative Kitchener—Waterloo, ON
Thank you, Mr. Chair.
Quickly cutting to the chase, then, are you saying--and I will get you to confirm--that the reason to address Mr. Masse's point that there hasn't been abuse is that there are safeguards in place, those safeguards have helped to prevent abuse, and Bill C-393 removes many of the safeguards?
Director, Patent and Trade-mark Policy Directorate, Department of Industry
Certainly, there were a number of safeguards built into the Patent Act to ensure that the regime would be used and applied in accordance with the WTO decision and the objectives by which it was implemented in Canada. Bill C-393 does remove a number of those amendments. I'm not going to go through it now that we've had various changes and amendments, but Bill C-393 does remove a number of those safeguards.
Conservative
The Chair Conservative David Sweet
Thank you.
That appears to be the end of our debate.
Shall clause 13 carry? Can I see a show of hands again, please?
(Clause 13 agreed to)
All right.
Shall the schedule as amended carry?
Mr. Lake.
Conservative
Mike Lake Conservative Edmonton—Mill Woods—Beaumont, AB
I have a quick question. Could you summarize what the changes were to all the schedules? We had four schedules that are now two, right?