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]

That subsection states that the Commissioner of Patents “shall...authorize the person to make, construct and use a patented invention solely for the purposes directly related to the manufacture of the pharmaceutical product named in the application”.

So it ties the authorization to a specific product named in the application. It also ties it to a particular country that would be listed in schedules 2 to 4 of the Patent Act—to the original three country lists also named in the application.

So there are two critical parts of subsection 21.04(1): that the product has to named in the application and that the country has to be named in the application. The authorization is tied to those two elements.

Clause 4 of Bill C-393 would significantly alter this authorization by the Commissioner of Patents. It would allow the Commissioner of Patents to authorize any person to manufacture more than one pharmaceutical product under the Patent Act and sell it for export to more than one country. It would also eliminate the requirements that the product be named in the application and that the country be named in the application. Again, it unties the process. It adopts what was referred to previously in this committee as a one licence solution.

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

Yes, Mr. Chair. In fact, Lib-1.5 and Lib-1.6 do the same as Lib-1.3 and Lib-1.4. They clarify that we're now dealing with schedule 2, that list of countries that used to be “the Schedule” in Bill C-393 but has now become schedule 2. It's really just a minor clarification.

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

Yes, Mr. Chair.

This amendment is an amendment to clause 13 of Bill C-393. It's to restore the existing paragraph 21.16(1)(a) because it's connected to the restoration of the existing application process in accordance with amendment Lib-2, which deleted, as you know, subclause 4(2). That's essentially what it is. It's related to clause 4, but it is in clause 13.

[Rob Sutherland-Brown]

There are a number of elements in Bill C-393. As I think I said last Thursday, this is very intricate: A goes to B to go to C, etc., so you have to follow the thread through the fabric, so to speak. But yes, I think that's a fair comment.

Some of the anti-abuse provisions that were in the Patent Act are removed by the proposals in Bill C-393. If you remove those anti-diversion or anti-abuse provisions, then you are in a very difficult situation if you try to enforce the limitations of the waiver agreement and the scheme for exporting drugs under compulsory licence.

Thank you, Mr. Chair.

[Rob Sutherland-Brown]

I think that's a fair comment. The non-commercial character of the scheme was something that was set out in what is referred to as the chairman's statement, and that, by definition of the General Council decision in the Patent Act, was incorporated into the Canadian legislation because we thought it was an important element of the whole scheme that was created at the WTO.

So it is an important element and it runs through our legislation as it exists prior to Bill C-393. It's reflected in the provisions whereby the Federal Court can review an authorization to see whether, at the price the drug is being exported, it is for a non-commercial purpose or at a commercial price as opposed to a “humanitarian price”. It was an important element in the scheme, yes.

[Mona Frendo]

I'll try to answer that.

Paragraph 21.03(1)(a) of the Patent Act, which has been struck out—but then effectively some sort of mechanism has been reinserted—is the process of amending schedule 1, the list of drugs for export. Paragraphs 21.03(1)(b) to (d) and subsection 21.03(2) of the Patent Act—that's basically the rest of section 21.03—have also been effectively removed. Those paragraphs and the subsection describe the processes and requirements for adding and removing a country from what were schedules 2 and 3 of the Patent Act, those lists of countries Mr. Sutherland-Brown was referring to that had various requirements for using the WTO waiver as per the international rules.

What clause 3 of Bill C-393 would do is, for these lists of countries, effectively modify that process so that only two factors—and there were many more in the Patent Act—could be taken into consideration for adding or removing an eligible country from the new schedule. This would significantly limit the ability to amend that list and take action.

I can give you a couple of examples of what clause 3 would eliminate, if that would help.

[Colette Downie]

As it stands without the amendments that are proposed--just as clause 3 stands--or as the amendments are proposed to clause 3 in Bill C-393: is that the question?

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

As I understand it, Mr. Chair, this is really just to correct the fact that in Bill C-393 for the moment they refer to “the Schedule” because there is only one schedule. Now there are two schedules. This is to correct where it says “the Schedule” to say “Schedule 2”.

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

On Thursday, we adopted the fourth Liberal amendment, which restores to the bill the process related to Schedule 1, where it lists the medications that can be sent. I thought there was no provision in the current bill, Bill C-393, stating who could add medications to the list or remove them from it. So it was important to clarify that; otherwise, there would have been a gap in the bill.

Do I understand correctly?

[Mona Frendo, Director, Patent and Trade-mark Policy Directorate, Department of Industry]

Clause 3 of Bill C-393 would remove the process that's currently in the Patent Act for adding or removing products from schedule 1, the list of eligible drugs for export under Canada's access to medicines regime. That process currently involves the Governor in Council making changes to the list based on the recommendations of the ministers: the Minister of Industry and the Minister of Health.

It would do a number of other things as well. It would collapse into one what are currently three schedules of countries in the Patent Act. This is all under Bill C-393. It would limit the process of amending to that list of countries, which was referred to as “the Schedule” in Bill C-393. That's basically what clause 3 of Bill C-393 would do.

As I understand Liberal amendment 1.2, it would reinsert the process for amending schedule 1, the list of eligible products for export under the Patent Act, because as a result of Liberal amendment 4 and Liberal amendment 2, which was withdrawn, schedule 1 has been reinserted into the Patent Act. That whole process of adding or removing to schedule 1 has been reinserted into the text of the Patent Act as a result of Liberal amendment 1.2.

I would say that there is no change to what is I guess now schedule 2, this list of countries, and the process of amending that schedule. That is not referred to in either Bill C-393 or in the Liberal amendments as far as I can see, but I'll have to check. It may be in further amendments.

[Mike MacPherson]

Liberal-5 from the past meeting had the effect of leaving in the original schedule 1 of the Patent Act, and the schedule in Bill C-393 would then become schedule 2. So most of the amendments--1.3 to 1.6--just correct references to schedule 2. I believe that Liberal-1.2 reinstates the minister's power to add drugs to the list, the schedule, but the officials at the back would be in a better position to speak to that.

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

Thank you, Mr. Chair.

As you remember and as all of the members will recall, at the last meeting on Thursday, I had put forward what's called the old amendment Lib-1. It had created a certain amount of confusion, not only with some of the experts, but also with me.

Just to summarize, my intention had been to reinstate schedule 1 of medications that are in the Patent Act, to bring it into Bill C-393, and also to establish that any medications that would be used under CAMR had to have Health Canada approval.

Well, I didn't realize there were a number of other definitions that had been removed in Bill C-393 that were really required to be reinstated because they were called up, notably the definition of “patented product”, “WTO”, and things like that. It's also to make sure, as I said, that medications allowed under CAMR would meet Health Canada approval.

I got together with the legislative assistant on Thursday afternoon, which gave rise to a number of alternate amendments called Lib-1.1 through to Lib-1.6. That's really the new part of it, what is being introduced here this morning, which I believe will rectify the problems that were identified last Thursday afternoon.

Thank you, Mr. Chair.

Canada Consumer Product Safety Act

[Megan Leslie, NDP, Halifax, NS]

Mr. Speaker, I am pleased to rise today to speak to this bill, because it means that it is one step closer to becoming law.

The NDP has advocated for consumer protection for years. Judy Wasylycia-Leis, my former colleague, the former member for Winnipeg North, has been on this file for years, advocating for stronger consumer protection. I know that our leader has raised it with the Prime Minister, and in the 40th Parliament, this session, the member for Sudbury has been a strong advocate for changes to consumer protection laws that would actually result in protection for consumers.

As we have heard a few times in this House, the previous legislation is 40 years old. It is time for a change. It is time to catch up and modernize. All parties are in agreement that this legislation is desperately needed.

However, that does not necessarily ensure that product safety is going to be ensured in Canada. This legislation is going to need to be enforced in order for it be effective. As the member for Elmwood—Transcona has said, there are serious questions about whether or not enforcement is actually going to happen and whether or not sufficient resources are going to be put into this bill.

This is a good bill. I am proud to support it. Our party is proud to support it. I am proud that it is going to the other place and may soon get royal assent. We are hopeful that it will be soon. However, we need to stop and think critically about whether this bill is just a shell being carried into effect for show, or whether it will actually provide protection for consumers.

There are a number of reasons to think that the government might abdicate its responsibility on this bill, should it be passed through the other place. The reason is this: despite the fact that the legislation is their own, and despite their repeated statements that this legislation is important to them, the Conservatives have dragged their feet. There is no other way of putting this. They have dragged their feet in introducing this legislation to the session. Previously, they prorogued Parliament and killed similar legislation, not once but twice. There was significant delay in getting this to first and second reading.

Now we are rushing it through. I think that is fair. We know what is in this bill. It has been to committee before. We have debated it before. However, it has taken a long time for us to get to this point.

Even though we are at third reading now, we have to ask why has this process has taken so long. Why has the government not acted quickly on this legislation, when there have been many opportunities to do so? I think it demonstrates a level of unwillingness to emphasize the safety of Canadians. It is disconcerting that so much time and energy, resources and effort, were put into trying to eliminate the gun registry, while product safety was put on the back burner.

The member for Portage—Lisgar is driving around in a minivan saying “End the registry”. In fact, that minivan was idling outside of Confederation Building the other day, so clearly they do not care about the environment either. There is no minivan saying “protect consumers”. There are no flyers going into other ridings, no radio or TV ads saying that we should protect consumers. All we get is foot-dragging.

Over the last month, we have received alarming reports about Health Canada's failure to warn parents about the risks of cadmium in children's jewellery. Health Canada testing showed unacceptable cadmium levels much earlier than we had previously known. Some of the products that they tested had cadmium levels of 93%, and yet the government delayed letting Canadians know about this. This is children's jewellery, and we all know what children do with small objects. It goes right in the mouth.

Health Canada has actually stated that cadmium is more toxic than lead. Testing that revealed unacceptable cadmium levels occurred in the 2009-10 testing cycle. But that was not the first time it was discovered. The previous testing cycle also revealed unacceptable cadmium levels. Health Canada advisories until now have not mentioned any of these test results. It is hard to imagine. These tests were on children's jewellery.

Our children were at danger of ingesting cadmium from these products because of the government's lack of transparency on testing and a lack of public education on cadmium's dangers. This is just plain wrong. It is irresponsible. I cannot understand why the government would not have mentioned these test results, especially when there was a 93% level in some products containing cadmium. The risks were inherently clear.

How can we trust the government to be the guardians of public safety under this new regime that Bill C-36 offers, when it failed to warn the public that its own tests were revealing cadmium in children's products?

The bill is good, but it is going to require significant resources in order to be effective. It is going to require an adequate number of inspectors and a team that is able to respond effectively to product safety concerns. They will have to respond in such a way that every Canadian will be kept safe from dangerous products.

It goes without saying that the government has done poorly on similar files, like food inspection. We should be questioning the Conservatives' willingness to fund product safety protections adequately. So it is a step forward, but without teeth. Without the systems in place to carry out the intended functions, it is going to be a colossal failure.

We will see the government trumpet the bill's passage and send a message to Canadians that their products are safe, but this message needs to be backed up with funding. It needs to be backed up with resources. Otherwise, we will be giving Canadians a false sense of security.

I stand here representing the voices of consumers from coast to coast to coast. I thank the government for finally bringing in this legislation, and I ask that they commit the resources to enforce it. Otherwise, the bill will be meaningless. I desperately hope that two, five, or ten years from now we are not lamenting a failure to act and saying “I told you so”.

I was reading the newspaper today and there was a quote by James Orbinski. It was not about this bill. It was about the access to medicines regime, Bill C-393. It was brought forward by my former colleague, Judy Wasylycia-Leis, but is now being handled by my colleague from Windsor West. Bill C-393, if passed, would facilitate selling developing countries generic drugs still under patent. It would fix the 2005 regime that was created by the Martin government. The bill should be supported by all members who believe in justice and fairness.

James Orbinski is the co-founder of Dignitas and a world-renowned health activist. In referring to Bill C393, he inadvertently said something related to Bill C-36: “Right now CAMR is a rhetorical success and a practical failure. Bill C-393 is an effort to make CAMR a practical success”. I read that and thought of Bill C-36. We must not let it become a rhetorical success but a practical failure. We need to ensure that there are resources in place.

I talked about justice and fairness. The bill should also raise levels of justice and fairness for low-income Canadians. It goes without saying that dangerous products touch the lives of socio-economically disadvantaged Canadians proportionately more than the rest of society. Cheap products rely on cheaper manufacturing processes, and these products are wreaking havoc on the lives of people who cannot afford better choices. These people are poorly positioned to deal with health consequences or with wages lost due to taking time off from work to care for themselves or their loved ones.

I believe strongly that product safety should not just be the prerogative of the rich. This issue goes to the heart of the equality principles held by Canadians, and product safety legislation should play a central role in moving toward economic justice in our country.

I would like to touch on an issue that I do not think has been raised in the House very often. Sometimes when I am out in the community I am approached by people who say that they have problems with Bill C-36. They see some constitutional issues they would like to see addressed; they are worried about the constitutionality of this legislation.

Recently, the member for Sudbury raised this constitutionality issue with lawyers who appeared at committee, asking whether we had to worry about this. According to the lawyers, there were no constitutional problems with this bill, nothing really to worry about.

The last time around, when this bill was called Bill C-6, it made it through the House and was then sent to the other place. When senators considered the bill at committee, the Public Interest Advocacy Centre made a presentation on this specific issue. It is not only important for members of the House to understand some of the constitutional issues that were raised, but also some thorough analysis would show, that we really do not need to worry about.

For background, the Public Interest Advocacy Centre is a non-profit organization that was established in 1976. Its mandate is to enable the representation of ordinary and vulnerable consumers when decisions are made concerning the important products and services they obtain. Of course, they are a natural organization to turn to when we consider product safety, whether it is legislation, regulation or action.

PIAC made a formal written presentation to the senate committee and I will read from the memorandum it submitted. I reads:

It is particularly disheartening to find the oppositional posture to this Bill presented as a matter of protection of the civil rights of business and property owners engaged in the sale and distribution of the consumer products that are the subject matter of this bill. Such individuals are amply protected by the provisions in the Canadian Charter of Human Rights and possible civil remedies for government behaviour that exceeds the ambit of its protective statutory mandate. Monetary loss, embarrassment and hurt feelings are regrettable, but nonetheless compensable in the event of improper government conduct.

On the other hand, harm caused to public health and citizen livelihood may only be imperfectly remedied. What will be the explanation given to a parent grieving the loss or permanent injury of a child caused by the use of a product irresponsibly brought to market, when the reason is the lack of, or delay in application, of proper enforcement tools by the responsible authority caused by these amendments? There is no guarantee that even an inadequate remedy of compensation may be available in the event of a breach of health and safety requirements that is of such widespread effect that it is ultimately financially ruinous of the supplier.

The rights of defendants in circumstances where criminal and/or quasi-criminal related behaviour may be involved are important, particularly in relation to the consequences that may be visited upon a defendant. But it is decidedly inappropriate to expose innocent Canadian consumers to potentially negligent market behaviour because of the fear that government inspectors may lack either the appropriate motive or skills of enforcement. It is a grievous misallocation of the Senate's legislative superintendence to cater to the misplaced fears of a few over the real health and safety concerns of the many potentially at risk. PIAC urges the Senate to reject the amendments of the committee and adopt Bill C-6 without change.

Michael Janigan, the executive director of PIAC, has his name at the bottom of the memo. That is a good positioning of the two sides that we have to balance here. We need to look out for the consumer protection of Canadians. We need to ensure that people can rely on the fact that their products are safe. It is absolutely imperative. I think he did a great job of showing the balance that has to be struck between the two and where, ultimately, how justice would bring us to the one side.

It is a great summary of the constitutional arguments and I really do support the perspective of PIAC. Thanks should be extended to PIAC for getting involved in this issue and contributing to the discussion in the other place.

I am strongly supportive of Bill C-36. It is an excellent framework. We need to move forward after 40 years of old legislation that is not modern. Ultimately, we cannot make this a rhetorical success but a practical failure. We need to ensure that the government puts adequate resources behind this bill to ensure it is a success for all Canadians.

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

Thank you very much.

Earlier, I asked a question about Mr. Masse's proposal. Could you please comment on it and give us your view of the potential consequences of striking these clauses from Bill C-393, as proposed by Mr. Masse? I obviously realize that time is short and that we are dealing with a very complex issue.

[Rob Sutherland-Brown]

I can't speak to the WTO negotiations because that was a very long multi-year process, but certainly when the WTO member states were trying to find a way to make compulsory licensing work in jurisdictions that had no pharmaceutical manufacturing capacity, there were a number of things that concerned them, and that was if you allowed jurisdictions with the capacity to manufacture without any constraint, this would eviscerate the patent system around the world. They said, okay, people who have a need to issue a compulsory licence but don't have local manufacturers can request products from the WTO and jurisdictions with capacity can then issue a compulsory licence domestically. The request from the putative importer to the WTO had to name the product involved and the quantum that they needed to treat their local health problems.

That was a critical element of the WTO agreement and it's a critical element of the Canadian implementing legislation that tried to put the system in place. The same is true, I guess, with the names of the importers, because what happens in the international drug markets is that a lot of product gets diverted. It seems critical that this kind of information be available about compulsorily licensed products, so that the patentees and the granting nations can control how the product is used, that in fact it gets to the destination that's intended.

It took a lot of negotiation here domestically when we were doing the legislation, because as Bill C-393 shows, there are a lot of interest groups that have ideas about what the perfect system would be. I think that in the course of developing the initial CAMR legislation, Canada was concerned that it remain compliant with its WTO obligations or that it didn't create a scheme that would go beyond the scope of the TRIPS waivers decisions. It's a long process, both domestically and internationally.