House of Commons Hansard #90 of the 38th Parliament, 1st Session. (The original version is on Parliament's site.) The word of the day was rcmp.


Civil Marriage ActGovernment Orders

4:50 p.m.

The Deputy Speaker

The chief government whip has asked that this vote be delayed until 5:29 p.m. tomorrow.

Patent ActGovernment Orders

May 3rd, 2005 / 4:55 p.m.

Westmount—Ville-Marie Québec


Lucienne Robillard Liberalfor the Minister of Industry

moved the second reading of, and concurrence in, amendments made by the Senate to Bill C-29, an act to amend the Patent Act.

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4:55 p.m.

Chatham-Kent—Essex Ontario


Jerry Pickard LiberalParliamentary Secretary to the Minister of Industry

Mr. Speaker, as hon. colleagues will recall, Bill C-29 proposes remedial technical amendments to both the Patent Act and the Jean Chrétien Pledge to Africa.

The Jean Chrétien Pledge to Africa, which received royal assent on May 14, 2004, implements an August 30, 2003, decision of the World Trade Organization allowing developed countries such as Canada to adopt legislation authorizing the production of low cost generic versions of patent medicines for export to least developed and developing countries unable to produce their own.

Those who are familiar with the Jean Chrétien Pledge to Africa may recall that the legislation contained four schedules, which are to be annexed into the Patent Act. Schedule 1 sets out various pharmaceutical products which are eligible for the export licences under the regime and schedules 2, 3 and 4 set out various classes of the least developed and developing countries which would be eligible for these products.

However, because of an oversight in the drafting of these various schedules, they became divorced from the enacting clause, with the result that there is no legal authority by which to annex them to the Patent Act. If this oversight were not fixed, the Jean Chrétien Pledge to Africa could still come into force but there would be no products eligible for export and no countries to send them to.

In other words, unless the schedules are properly annexed, the Patent Act and the Jean Chrétien Pledge to Africa cannot be made operational. This oversight, although fundamental from a policy perspective, is a simple technical one from the legal perspective and it lends itself to the simple technical, albeit legislative, solution. The amendment setting forth that solution was introduced and adopted during the examination of Bill C-29 by the committee at the other place.

As a result, the text of the bill now before us differs from the one that appeared before the House in two very minor but critically important ways. First, new section 2.1 provides that the Patent Act shall be amended by adding schedules 1 to 4 of the Jean Chrétien Pledge to Africa to the end of the legislation, that is, after section 103. Second, new subsection 3(1) provides that both of the provisions in Bill C-29 that deal with the Jean Chrétien Pledge to Africa would come into force on the same day as the latter instrument.

I should add that the oversight that gave rise to the need for these changes was discovered only very recently and not in sufficient time to bring forward the necessary amendments while Bill C-29 was initially under examination in this House.

In fairness to the government on this point, it will be recalled that the Jean Chrétien Pledge to Africa received royal assent only three months after it was introduced in the House in the last Parliament. That was a very busy period during which there were a number of amendments made to the bill by all parties.

Quite simply, no one involved with this legislation, from the legislative drafters and the stakeholders who were intimately involved to the members of Parliament examining the bill in committee, caught the technical oversight. Even Carswell's 2005 edition of the Patent Act overlooked it.

While the version of Bill C-29 which we are considering today differs marginally from the one seen and approved in this House earlier, the underlying technical remedial objectives remain the same. I encourage my colleagues to join me in supporting Bill C-29 as amended by the other place so that it may enjoy the swift passage that characterized the progress of the Jean Chrétien Pledge to Africa through both Houses during the last Parliament.

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5 p.m.


Paul Crête Bloc Rivière-Du-Loup—Montmagny, QC

Mr. Speaker, I listened with great interest to what my colleague had to say .

I would like to remind the people listening to us that last year, at about this same time, the bill was very urgent. It absolutely had to be passed and all the parties worked together on passing it.

Last fall we made technical amendments that should have been made earlier. Now we have another delay, thanks to what a Senate committee has done, with recommendations that may be justified in the end.

However, the government and even all the parties have been criticized somewhat in the papers this week about the fact that a law that was leading edge a year ago is still not in effect. This is not something frivolous. This is about major health problems in very poor countries, developing countries. We are speaking about people with an urgent need for the medicines to be made available.

I would like to ask my colleague how he can explain why it has taken such a long time before—finally I hope—passing the bill, making no more amendments and allowing it to come into effect.

In the comments made by the newspapers this week, people from the generic drug industry said, among other things, that there were some aspects that discouraged putting the law into effect.

There were also some amendments proposed in the Senate. Public servants explained a bit of the reasons for this delay to us.

In the end, however, we are in a situation where we wonder, if the same tragic situation had arisen here in Canada, would we have taken so long to deal with it?

It is important for the government to tell us why it took so long to add to what already existed last year and what had already been introduced as a bill. It will be remembered that we were on the eve of an election call. We went through several stages very quickly, thinking we were doing the right thing. What we have before us now is the same bill, or the same bill slightly modified, as we know. Can anyone explain why it took so long?

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5 p.m.


Jerry Pickard Liberal Chatham-Kent—Essex, ON

Mr. Speaker, I want to thank my colleague and all colleagues in the House for trying to move this forward as expeditiously as possible.

There is no question that sometimes fundamental mistakes can be made. In this case, a drafting error was made. In order to ensure that there was no loss of time, we put those amendments forward in the Senate, had them adopted, and then brought them back to the House at the first opportunity.

We have tried to move the bill forward as quickly as possible without delay. That is why we are back in the House today, looking for the kind of support and the goodwill that we have had from Parliament over this issue.

My colleague from the Bloc asked a very good question. We have attempted to move this as quickly as we can, without delay, by reaching out to the Senate to get the approval of that amendment. We have brought it back to get the approval of the House of Commons, rather than delaying the issue from moving forward.

I believe we are now in a position where we can enact the bill quickly with the amendments before the House. We can look at a technical drafting problem where the schedules were not put into the bill. In a perfect world, that would have been done. In this case, our drafters missed it and everyone who examined the bill missed it. I believe that even all opposition parties that had an opportunity to examine the bill missed it.

However, the goodwill and good spirit of all of my colleagues in the House and all of my colleagues in committee has been very much appreciated. Everyone has worked to ensure the bill goes forward and I do appreciate that.

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5:05 p.m.


Réal Ménard Bloc Hochelaga, QC

Mr. Speaker, I add my voice to that of other members to congratulate all the parliamentarians in this House who have worked on making this bill the best and the most perfect bill possible.

Admittedly, this is a highly humanitarian bill. In the past, our examination of drug costs and issues related to research and development has tended to cause division between the parties.

I believe that the current Minister of Human Resources and Skills Development was the Minister of Industry at the time when this bill was referred to the committee. The committee achieved a perfect consensus, which should also be reflected in the allocation for the Summer Career Placements Program this year. But that is for another debate. Without digressing, I would like to plead in favour of the status quo, if the minister gets my drift.

That having been said, I have three short questions for my hon. colleague. First, could he remind the House of the degree of cooperation that was anticipated in connection with this GMO issue? I know that there were expectations concerning the bill in that respect. Second, could he remind us of the difference between compulsory licensing and the current system? Third, could he remind us of the importance of schedule I, which lists the countries which will be allowed to bid and to which the shipping of medicine will be allowed? I think it would be helpful, for the benefit of our fellow citizens, if he could read this list.

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5:05 p.m.


Jerry Pickard Liberal Chatham-Kent—Essex, ON

Mr. Speaker, I would say that your comments are well appreciated. I believe there has been cooperation among all parties in the House. You in particular along with the--

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5:05 p.m.

The Deputy Speaker

Order. The parliamentary secretary should address his comments through the Chair rather than specifying a specific member of Parliament.

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5:05 p.m.


Jerry Pickard Liberal Chatham-Kent—Essex, ON

Mr. Speaker, I thought that “you” could be considered as plural or singular. It is not a specific member of Parliament. “You” could well be the whole Bloc Québécois. I think your English is good enough to understand that, but just to correct you, so you will remember in the future.

Everyone has cooperated extremely well and I am pleased with that. The question about the annex lists, we have four schedules as I mentioned. One schedule points out the drugs that could be included under the bill. All drugs that could be included are in one of the schedules in that annex. The other list includes different countries. There are three lists of different levels of countries to which those drugs can be sent. Those are specifically laid out as well. I understand that those would be available to everyone in the House and all Canadians who wish to get those annexes.

We have a system in place where drug companies and others can go forward, produce those generic drugs, and ensure that they go to the required countries, so countries could receive those at much less cost if we look at the general cost of patent medicines.

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5:05 p.m.


James Rajotte Conservative Edmonton—Leduc, AB

Mr. Speaker, I want to ask the parliamentary secretary how the progress is going in terms of actually preparing and how many medicines we can expect perhaps in the years ahead to be used for least developed nations for HIV-AIDS, TB and malaria? What is the government's plan with respect to helping with the medical infrastructure and everything else that is needed in order to ensure that these medicines are used effectively? I would appreciate if he could bring the House up to date on that.

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5:10 p.m.


Jerry Pickard Liberal Chatham-Kent—Essex, ON

Mr. Speaker, it is my understanding that those drugs that are primarily used for certain outbreaks or certain problems that come about, and it could be malaria, HIV-AIDS or whatever, would be added to schedules and those schedules would then be able to move forward.

At this point in time there is a schedule set forth for certain drugs. This is not a broad spectrum of every drug being put on the scale. It is for those that are dealing with specific problems that we see abroad and richer countries like Canada can help. They cannot manufacture those drugs on their own.

In order to forecast what would be added to those schedules in the future, we would have to look at a broader picture of where those problems would come from and what drugs would be applicable. Then there would have to be amendments to those annexes in order to implement any of that. Again, it would have to come back to an amendment to the schedules in order to change any further drugs that would go on those lists.

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5:10 p.m.


James Rajotte Conservative Edmonton—Leduc, AB

Mr. Speaker, it is a pleasure to rise today to again discuss this bill. As members of the House know, we have seen this bill many times and in many forms. It is a bill which members of all parties can take some pride. We worked together on an issue as serious as this in terms of trying to get cheaper medicines into least developed nations by amending the Patent Act.

For the parliamentary secretary's information, I was asking more about the infrastructure that is helping to ensure that these medicines get to the people who need them and that they do the most good when they get there.

A lot of the people from the non-governmental organizations, like Médecins Sans Frontières, the global AIDS fund, Oxfam and others, came before us and said it is one thing to allow for cheaper medicines, but it is another thing to ensure that the system is in place. We have the physicians and nurses, but we should also ensure that people are taking these medicines with an adequate diet, a clean water supply, and know how to take the medicines properly. If they do not take them properly, it can act in the exact opposite way and make them immune to treatment. I encourage the government to ensure that through CIDA and other departments, agencies and organizations it continues to work with the NGOs to ensure that the medicines actually arrive and do some good.

When this bill was introduced in the past Parliament, every opposition party was willing to pass this legislation in one day. Unfortunately, it has taken the government four times to get this legislation right. That reveals a lot about this Parliament and the last Parliament. In fact, there were people in all parties who through goodwill have tried to move forward on this issue. It says something about the government. It brought the bill forward and reintroduced amendments in committee. Now it has reintroduced amendments again to its own piece of legislation which had unanimous opposition support from the first day it was introduced.

It should be pointed out to the Canadian people that there are parties like the Conservative Party that are very willing to work with all other parties on issues of concern to Canadians. I certainly commend my colleagues from the Bloc Québécois and the NDP who worked on this issue. I know they put a lot of effort into this as well. To be fair, the current Minister of Labour and Housing was quite instrumental in committee in trying to shepherd some of these amendments.

I want to give a brief overview of this issue. It is about trying to enable generic manufacturers to manufacture medicines, which are still under the 20 year patent protection, at lower cost, so a lot of the individuals in the least developed nations will be able to reduce the cost in terms of what they actually pay for these medicines. It is important because it allows generic manufacturers to step in not only from Canada but from other nations.

We should also recognize the efforts that a lot of the brand name manufacturers have made. I had the opportunity to visit the headquarters of GSK, GlaxoSmithKline, in the United Kingdom. One of the things it talked about was river disease in Africa. I believe it has dealt with about 20 million people and has been able to combat that disease. Its goal is to eradicate it within about 20 years. We should recognize its efforts, as well as Merck Frosst's efforts in Botswana. This is an issue which people and companies of goodwill can certainly have an impact on.

We supported Bill C-29 and the Jean Chrétien pledge to Africa act in the last Parliament and we support these amendments. We hope that this bill will finally be passed and become law. The Conservative Party is showing an awful lot of goodwill by putting up one speaker and ensuring the bill goes through in an hour to an hour and a half of debate.

I encourage the government to work with the NGOs to ensure that the infrastructure is in place. I encourage it to keep an accounting and then report to Canadians on what progress has been made.

I was trying to make another point to the parliamentary secretary. The government should keep track of how much medicine actually goes to these nations under this legislation so that we can be accountable to Canadians. We should be able to tell them in 2006, 2007, and in subsequent years that under legislation which was enacted in 2005, how many people were helped, how much medicine was produced, and how much money went globally to fight the horrific challenging diseases of tuberculosis, malaria and HIV-AIDS.

We in the Conservative Party support these amendments. We support the goal of this legislation. We would like to see it succeed.

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5:15 p.m.


Paul Crête Bloc Rivière-Du-Loup—Montmagny, QC

Mr. Speaker, that was an interesting speech, which reminds us of the work accomplished in this regard to date. However, I agree with my colleague. To some extent, it is somewhat disgraceful for it to have taken another year for the bill to pass.

In my colleague's opinion, is this the result of administrative delays or something else? Sometimes, we can slow down the process or see that a bill is not rushed through, because people are constantly telling us that rushing legislation through is not necessary.

Were there not such representations? In his opinion, is this not simply evidence of how slow the legislative process—the stages involved in passing bills—is and is this not also partially the result of having rushed this bill through last year, before the election call? Are these two realities not lessons for the future? First, there was an additional delay because things were done too quickly and therefore not properly. Second, things slowed down significantly over the past year for amendments which, ultimately, have proved to be insignificant or, in any case, which could have taken less time.

I want to know what my colleague thinks about this.

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5:15 p.m.


James Rajotte Conservative Edmonton—Leduc, AB

Mr. Speaker, my friend in the Bloc Québécois is absolutely correct. This legislation was introduced in the final period of Jean Chrétien's administration. He professed a great deal of interest in trying to help nations in Africa and other least developed nations.

When this legislation was introduced our House leader, the current member for West Vancouver--Sunshine Coast--Sea to Sky Country, approached the Bloc Québécois and the NDP and there was agreement among all opposition parties to pass it in one day. Interestingly, the government said no. This was government legislation and the opposition was willing to pass it in one day, yet the government would not agree. It said there were problems with the legislation.

The member asked me if it was an administrative problem or a question of other issues or just normal delay in the House. I am trying to be fair and diplomatic, but it was a question of government incompetence. The government could not put together a piece of legislation right from the beginning. I believe other parties would agree that it was a question of government incompetence. It is ironic because the government is fond of saying the opposition does not want to make Parliament work. Bill C-29 has shown the exact opposite. Members of the opposition were willing to work with the government to make this work.

My colleague from Windsor and the Bloc member who asked the question worked hard at committee to get Bill C-29 through committee as soon as possible. It came back to the House with amendments. The government forgot to include a schedule so it has to be amended again.

I have spoken to this legislation about five times in the House and have said essentially the same thing. We support it and we want it to go through as quickly as possible.

The government should be ashamed at how long it has taken to get this legislation through. It should do its job henceforward. However, there may be a new government sooner rather than later that would ensure that people in the least developed nations would get the medicine they need. There would be no incompetence that would hold up a good piece of legislation such as this bill.

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5:20 p.m.


Brian Masse NDP Windsor West, ON

Mr. Speaker, the member has worked very efficiently on this file.

It is important to reinforce his comments that at committee there was a great difference between where his party was and where mine was when this bill was first introduced to us. We spent a lot of time bridging that gap.

I had over 100 amendments to this piece of legislation. Members of the opposition worked very hard to condense the legislation to be accommodating and to at least be open to significant changes that had to come. The original draft of the legislation was significantly different. We had to go through a very difficult time in committee to change the legislation to make it work.

The government members claimed the other day that if we worked with them and made sure that we were diligent, they would get this bill passed. We are not doing our jobs. People across the world are suffering from tuberculosis, HIV and other diseases and we are not providing medications because of the incompetence in handling this file.

I would ask the hon. member to revisit that period when as opposition members we heard promises from the government that it would move the legislation expeditiously through the whole system, through committee and into what we have done today. Does he think this is a black mark on Canada? I think it is.

In 2003 when the legislation was originally conceptualized, we were to fast-track it to make sure we could do our part for others. We have not seen that. Not a single pill has gone to anyone who needs it because of the incompetence of the government. There is suffering that could be ended today. I would like the member to reiterate what we did on our side.

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5:20 p.m.


James Rajotte Conservative Edmonton—Leduc, AB

Mr. Speaker, in fairness, I should say that my colleague in the NDP worked very hard at committee. He is correct in the sense that often the Conservatives and the NDP do not agree, probably 90% of the time. However, on this issue he listened to what I said and I listened to what he said. A lot of the amendments he brought forward, I supported. Members from the Bloc brought forward amendments.

It is interesting, and the member will recall, that at committee the Bloc members had their amendments ready. The NDP members had their amendments ready. We had our amendments ready. Even some Liberal members had their amendments ready, but the government did not. We were told that the Prime Minister had taken an interest in the file and he was changing some of the amendments, so we had to put off committee meetings. We had to agree unanimously that we would not meet on a given day but that we would meet the following week. We had to cancel the meeting again because we had to wait for the amendments from the government to its own legislation. It was astounding.

We should compliment the staff of the committee and all members, who really worked hard. We worked day and night to get our amendments ready. Then we waited for two weeks for the government to prepare its amendments.

It shows how ironic the charge is that somehow Parliament does not work because of the opposition when the work on this bill shows the exact opposite.

The hon. member talked about Canada's lead role on this issue. The point of the bill was to take the lead on the issue. It is embarrassing that it has taken so long to get this piece of legislation through the House.

When the two ministers presented the bill at committee for the first time, I asked the simple question of how much the outlay of money was through CIDA and other organizations to shepherd the movement of medicines to these nations. The answer we got was that they did not know, that they were not dealing with that now. That should have been part and parcel of it from the very beginning.

I have very dear friends who have moved to Canada from that area of the world. They have said to me that the tsunami was tragic. It was the worst and the best: the worst in terms of how nature dealt a devastating blow to millions of people, but it showed the best of the human spirit in terms of the response.

That is what this should be about. This tragedy is 10 times the size of the tsunami and we should have 10 times the human response to the tragedy. The government should have taken the lead on this issue and shown the rest of the world how generous Canadians are in that endeavour. Unfortunately, it has not done so, but we certainly hope it will in the future.

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5:25 p.m.


Paul Crête Bloc Rivière-Du-Loup—Montmagny, QC

Mr. Speaker, I am pleased to be able to speak today about this bill.

As I was saying previously, this bill was under consideration several times last year. There was a desire at first to ensure that the entire issue of intellectual property rights over drugs did not limit their availability in the poorest countries in the world, those that need them. We wanted these countries to have access to drugs without having to pay exorbitant prices like those we often see in our society. Imagine what this would mean for the poorest countries in the world.

The Government of Canada was congratulated on having taken the initiative to pass a bill of this kind. Since that time, unfortunately, the bill has been lost in a huge administrative and legislative maze. It will be remembered that the bill was passed about this time last year. Then, when the House resumed after the election, technical amendments had to be made to fix certain errors or add certain provisions that had not been foreseen. The bill was then sent to the Senate, which has now proposed two new amendments to correct it.

During this time, certain justified remarks have been made in the newspapers. I will simple quote Mr. Tony Parmar of Doctors Without Borders in an article seen this week, on May 2 to be exact:

“We're still in a waiting game”, said Tony Parmar of Doctors Without Borders, who was hoping that the countries hit by AIDS, malaria and other treatable diseases would benefit from the passage of this bill.

These illnesses can and need to be treated as quickly as possible.

We obviously welcome the fact that we will finally have a bill that helps to cover this kind of situation. We hope that the process will be quicker for medical infrastructure assistance, so that the bill will be efficient.

The witnesses at committee, especially the NGOs, including Doctors Without Borders and other stakeholders of this kind, told us clearly that we should not confine ourselves to making the drugs available—something we have not yet succeeded in doing. We have thought for nearly a year that the bill would finally be passed in its definitive form. Now there is an opportunity to do so.

At the same time, the necessary assistance must be available. If the drugs are not taken properly, if the proper dose is not taken, if the instructions are not followed, if there is no appropriate medical support, the desired result will not be achieved. It is equally important that medical resources be among those made available to international aid. This is why we must support the bill before us.

The two proposed amendments to the bill are technical in nature. One of them will allow a representative of the Senate to sit on the committee in question, and the other is similar. Neither changes the substance of the bill but they remind us of the unacceptable international situation. Thousands of people are dying because they lack access to affordable drugs of acceptable quality. This may be one of the points on which we ought to be coming down hardest on the international community.

Initially, we realized that the general rules concerning intellectual property would never allow an adequate supply. This is what gave rise to the desire to create an exception so that the WTO rules could be applied differently to give the poorest countries access to these drugs. No satisfactory response has yet been forthcoming. Very few countries in the world have followed up on the matter or have proposed legislation or regulations in the appropriate way to meet this urgent need.

Right here in Canada, a year after introducing such a bill, and having patted ourselves on the back for being the first in the world to do so, we are still dragging our feet as far as the necessary administrative amendments are concerned.

Let us hope that this will be the last time, and that once this bill is passed we will have the opportunity to put the appropriate mechanisms in place in the short term.

Mr. Speaker, I see that the time allotted to me will be limited by the end of business. I would like to have some indication from you as to whether I should continue at some later time.

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5:30 p.m.

The Speaker

The hon. member for Montmagny—L'Islet—Kamouraska—Rivière-du-Loup will indeed have 15 minutes to complete his remarks next time this bill comes before the House.

It being 5:30 p.m. the House will now proceed to the consideration of private members' business as listed on today's Order Paper.

The House resumed from February 9 consideration of the motion that Bill C-274, an act to amend the Patent Act, be read the second time and referred to a committee.

Patent ActPrivate Members' Business

5:30 p.m.


Derek Lee Liberal Scarborough—Rouge River, ON

Mr. Speaker, I am pleased to engage in debate on this private member's initiative. We always congratulate each other for our private members' initiatives and I applaud the member on this one. In the end, I find that I am not able to support it and I will try to explain why in the few minutes that are available to me.

As has been stated a number of times, Canada's drug patent policy seeks to benefit effective patent enforcement for new and innovative drugs on the one hand, with the timely market entry of their lower priced generic alternatives on the other.

The current manner in which that balance was realized was established in 1993 with the enactment of Bill C-91. That bill introduced into the Patent Act what is commonly called the early working exception as well as the enabling authority for the NOC regulations, which sounds a little technical but that is what they are called, and which Bill C-274, which we are looking at here today, proposes to repeal.

I should confirm as well for the record that I conspicuously voted against Bill C-91 when it was proposed at the time. Since then there has been a massage of the provisions in the regulations and the balance, which I referred to earlier, has been created, although in my view that balance is still not effective. However to remove the whole regulations without putting something else back into place would not achieve the public interest purposes that I seek.

In the pharmaceutical industry the early working exception does allow generic companies to work or develop a patented product while in the process of applying for Health Canada approval to sell that product on the market. Generic drug companies are therefore able to complete the regulatory approval process during the lifetime of the patent and be in a position to enter the market as soon as the patent expires.

The NOC regulations were conceived in order to prevent generic copies of patented drugs from going to market in breach of the patent. They do so by linking Health Canada's ability to approve generic drugs to the patent status of the brand name drug that the generic is seeking to copy. If passed, as I said, Bill C-274 would undermine our attempt to provide balance and would strip the patent holder from what they argue is the most effective means of protecting their patent.

There has been a significant debate over the last while in intellectual property circles about how we regulate pharmaceuticals in this way. Rising concern has been expressed about the balance between fostering innovation and the availability of generic drugs. Many countries have made adjustments to their laws in order to optimize that balance between innovation and access to affordable medicines. For instance, in 2003 the United States introduced reforms to its so-called Hatch-Waxman rules which are similar in many respects to the NOC regulations we maintain here.

Here in Canada, recent court decisions have enabled patent holder drug companies to list new patents on Health Canada's patent register on the basis of just inconsequential changes to the original drug product. The listing of these additional patents, which in the industry is sometimes called evergreening, has resulted in repeat litigation between innovative and generic companies and, in some instances, the unwarranted delay of generic market entry, and I regret that evergreening.

The process appears costly and not in the public interest. Some observers have suggested that we put in place a once only procedure whereby the patent holder could not evergreen after an NOC application began. There would only be one 24 month stay triggered by the generic company's NOC application.

To address these problems, the government recently proposed some regulatory amendments designed to readjust that balance between the enforcement of the intellectual property rights of the patent holder and encouraging the generic entry. The amendments are directed to both the NOC regulations and other intellectual property instruments, including what is called data protection under the food and drug regulations.

These amendments were pre-published in part I of the Canada Gazette on December 11 last and pre-publication was followed by a 75 day consultation period, during which the pharmaceutical industry and other interested parties could submit their comments. The government is currently reviewing those comments.

In my view, the government should include in the new regulation package, however it wishes to put it in, the new “once only” 24 month stay so generic companies will know where they stand and they will not have to face this repeated evergreening, this artificial device now apparently relied on by the patent holding companies.

By restoring the balance to the NOC regulations and shoring up the data provisions in the food and drug regulations, the government's proposed regulatory amendments, and the one I have just proposed here and which other members may propose, would provide greater overall stability and predictability to our intellectual property environment for pharmaceuticals.

These new changes would attract new medical therapies to Canada, encourage real improvements to existing drugs and ensure more timely competition in the marketplace.

While I salute the hon. member's interest in this issue, I am confident that the amendments that have been described in my remarks will better address the concerns that motivated the tabling of the bill in the first place and avoid the wild west scenario that might evolve in the event there were a complete revocation of these regulations as the bill proposes.

Patent ActPrivate Members' Business

5:35 p.m.


Rob Merrifield Conservative Yellowhead, AB

Mr. Speaker, it is a pleasure to add my voice to the debate on this important legislation. I commend my hon. colleague for bringing Bill C-274 forward.

I believe he has good intentions with regard to why this legislation is important and why he is bringing it forward to this House. I believe he is looking at the cost of pharmaceuticals in this country. We know pharmaceuticals are the number one driver of costs in our health care system. If we look out into the 21st century as far as we can determine it will continue to be that way. Perhaps it will even expand as we move forward.

Pharmaceuticals do a tremendous job for Canadians. They are well received and well used. In fact, we actually have to change the paradigm around pharmaceuticals in this country. Instead of understanding or thinking that there is a pill for every problem, we have to start understanding that every pill does have a problem because of what we are seeing with the adverse events with some of the pharmaceuticals on our marketplace today.

How do the pharmaceuticals get on to the market and are the proper rules in place to allow them there? This is part of the debate that has to go on in Canada. However the legislation actually talks about the evergreening or the battle between the generics and the brand name pharmaceuticals.

I think it is fair to have this debate and to actually raise the awareness of the people of Canada about this issue and what is happening. Bill C-274 would repeal the patent medicine notice of compliance regulations and reduce the patent protection of 20 years down some. As my colleague mentioned, the regulation was enacted in 1993. It was called Bill C-91 and it was introduced by the Conservative government.

I would like to read into the record the Conservative Party policy as it was adopted in March in Montreal.

The Conservative Party believes that Canada's pharmaceuticals legislation must strike a balance between encouraging the development of new drugs, and ensuring that those drugs are available to Canadians at affordable prices. We believe that part of this balance is achieved through adhering to the international standard of 20 years patent protection for pharmaceuticals.

To reduce that would not strike the balance. I believe it would disrupt the balance. It would actually drive investment out of Canada and not be in the best interest of the Canadian population, the pharmaceutical industrial or Canadian health care as a whole.

We support the laws and regulations that respect property rights. We encourage research and development into new drugs by brand name companies. We also support regulations that would allow generic manufacturers to offer similar medications through lower prices in a reasonable time.

What I think we are talking about is the balance between what the brand name pharmaceuticals are doing with regard to research and development, and then the generics that come along after the 20 year patent has expired capitalizing on the drug by duplicating it at a cheaper price and selling it to Canadians at a lower price. The generic manufacturers can realize their profits at that time.

It is a balance between encouraging development and investment into new technologies, as well as at the lowest price possible.We want to strike that balance and hold that balance.

Therefore we support the regulation of drug prices through the Patented Medicines Prices Review Board. This is unique to Canada. It is much different than in the United States. The prices review board sets our prices for brand name pharmaceuticals at a balance between seven other international countries so that we are not high or low but we make sure that the top price does not go above the median of those seven countries.

Because of that we have actually quite reasonable prices for pharmaceuticals in Canada. It has caused some problems because those prices are quite a bit lower than our nearest trading partner which is the United States. Consequently, Internet pharmacies are popping up which is causing considerable concern on both sides of the border.

Our prices are artificially set low, going into a marketplace that does not have a regulated pricing regime and therefore the brand name pharmaceuticals are being pumped in. It is not really comparing apples to apples from that perspective. It is a long complex issue, but it is an issue that I do not have time to address here. However, I want to bring it forward because it has implications with regard to the pricing of pharmaceuticals in Canada.

The bill does not seek to strike a balance. It seeks to tip the balance on to the generic side. Generic companies also are doing a very good job in Canada. They do great work, and some wonderful companies are adding to the prosperity of Canadians with jobs. We want to appreciate what they do at the same time.

This is a complex issue. I had an opportunity to sit in the industry committee when it was debating this issue last year. The debate becomes very complex. As one goes through the debate, one has to appreciate both sides, understand them and get a handle on it. The debate was would evergreening happen, or would the generics take advantage of laws of the land and try to capitalize on what happened in patent law or would the brand names try to capitalize and hold off generics unjustifiably to try to steal an extra two, three or four years under patent law.

My question to the industry officials who were there at the time was this. Did generic firms ever try to compromise the 20 years and bring their products on to the marketplace ahead of the 20 year window of patent protection? The response I received astounded me. In fact, it was not did they ever. It was they could not remember one product ever developed in Canada that was not attempted by the generic firms.

When we see this happening, we have to ask ourselves, in light of what the mover of this bill is trying to do in getting rid of evergreening, if this is legitimate. If a product is allowed on the market ahead of the 20 year period, if it is challenged in litigation and law to recoup of the costs and if the brand names win in court, they would never be able to recoup the costs of what they lost because of market share from the court case.

Therefore, we have a serious situation if the bill goes through the way it is. I believe it would drive the brand name pharmaceuticals out of the country. What do they do for the country? It is roughly $1 billion per year in research and development in Canada. They hire well educated Canadians and they provide well paying, stimulating employment for those Canadians. They produce some amazing drugs. That is probably the best benefit we can get from the pharmaceutical industry in Canada. I believe they will continue to do that.

The Conservative Party wants more than that from them. We want more investment because I believe they are falling behind on some of their investment. We want more well paying jobs. We want more knowledge based jobs. We want more new drugs developed in Canada. Therefore, we have to set up an environment that ensures they have assurance from governments that they will respect their 20 year patent law.

Therefore, I would like to read again another piece of our policy from the March convention which talks about research and development and innovation. It states:

The Conservative Party recognizes the importance of health sciences research in enhancing the health of Canadians and as a dynamic economic sector in its own right.

Research and development in Canada has done that. It is important for us to continue to protect that and to ensure a stable situation for our pharmaceuticals so we not only have very good products, but we have them at a very cheap rate as well, and Canadians can be proud.

Incidentally, our brand name pharmaceuticals in Canada are 50% to 80% cheaper than they are in the United States. On the generic side, that is not true. The generics are cheaper in the United States than they are in Canada.

I am please to have contributed to the debate on this issue, but I cannot support the bill.

Patent ActPrivate Members' Business

5:45 p.m.


Réal Ménard Bloc Hochelaga, QC

Mr. Speaker, I am pleased to rise to speak to a bill that proposes to totally eliminate linkage regulations. My neo-Bolshevik friends introduced this bill.

It has a certain merit. However, with all due respect, it lacks subtlety. It is reasonable to question the balance that must always be sought between innovative and generic industries.

It would be difficult, however, to say that linkage regulations have to abolished completely. We must not lose sight of the historical context. Until the Conservatives under Brian Mulroney changed the Patent Act, Canada had a system of compulsory licenses. In other words, a company manufacturing and marketing a drug obtained an exclusive license. With the payment of a royalty to the company, the drug could be copied.

For years, because this system of compulsory licensing in return for a royalty—royalty was the word at the time—was in effect, it was felt that Canada performed poorly in the area of research and development.

Obviously, if it is possible and relatively easy to copy a drug, that does not provide not much of an incentive for the biomedical industry to make investments.

These investments grew over the years. I saw the figures last year. Between the marketing phase and the research phase, from the moment the molecule is isolated to the moment the drug is available for consumption, it can easily take 10 to 12 years. We are talking about an investment cycle involving several million dollars.

Following a royal commission, Canada decided it wanted to change its system, at least in terms of drugs. When the Conservatives under Brian Mulroney came into power in 1984, they changed the law a few years later.

Now, it is no longer a compulsory licensing system, but an exclusivity system. In other words, to be a patent holder you have to submit an application to Health Canada and Industry Canada through the Canadian Intellectual Property Office. Then you get exclusivity, not from the date the patent is obtained—which was the case with the former legislation—but when the Conservatives passed their Bill C-91, exclusivity was granted for 20 years from the date the application is submitted to Health Canada and the Canadian Intellectual Property Office. Note that this is not market exclusivity for 20 years, since two or three years can go by before a patent is granted.

The Bloc Québécois cannot support the bill as it now stands. We have a large caucus in the Bloc Québécois, this great force of national liberation, this leading political force in Quebec that is here to stay, as everyone knows, if that is the wish of our fellow citizens. The Bloc Québécois cannot support the bill as it now stands. Why? Because we cannot agree to put all these innovative industries on an equal footing. We cannot say that marketing a patent, for example, for a washing machine or a dryer is the same as marketing a drug patent. There need to be guarantees for infringement protection. That is what the linkage regulations are for.

The linkage regulations are not perfect. I am even prepared to acknowledge that the innovative industries have engaged in delinquent behaviour, by extending patents that had expired. I believe what our colleague from the NDP was trying to say was that the industry used provisions in the linkage regulations, themselves established under the Patent Act. These provisions provided an opportunity, when there was an allegation of infringement, to automatically get an injunction for up to 24 months.

This mechanism is indeed questionable. I have statistics showing that between 1998 and 2003, there were almost 80 cases brought before the courts concerning notices of allegation. In two cases out of three, the generic companies won, which means the notices of allegation were not founded. It is true that in the past innovative companies used the linkage regulations not to protect themselves from infringement, but to extend their patents. This is unacceptable, as this was not the intention of the legislator.

We acknowledge that there are major investments that need protecting. The bulk of pharmaceutical research facilities are located in Montreal, not necessarily in Hochelaga—Maisonneuve, but more in West Island. These investments must be protected. Yet at the same time it is not acceptable to tolerate patents being perpetuated by claim mechanisms.

It must be acknowledged that the government has recently modified the regulations in order to protect us somewhat against that, in order to make use of the linkage regulations less easy, less automatic, less immediate, not to protect against infringement but rather against evergreening.

The Bloc Québécois, believing that this balance must exist between the generic and innovative drug industries, cannot support questionable practices which lead to evergreening.

That said, we do not feel that the solution proposed by the NDP, that is total abolition of regulations, is reasonable. Unfortunately, my neo-socialist friends sometimes let themselves get carried away with solutions that are a touch excessive. Fortunately, the Bloc Québécois, in all circumstances, provides that balance between what is desirable and what is feasible. I believe the Bloc Québécois worked very hard in committee to ensure that the linkage regulations are maintained, but used wisely.

Still, we must recognize that it may take 10 years from the time a molecule is isolated to the time a drug is available to consumers, and this can represent investments of up to $800 or $900 million. This money is not coming from the unions or workers or governments, but rather from the private sector. I do not want to shock my socialist friends but, in our system, it is normal to expect a return on an investment.

We do not tolerate abuses. We want a balanced policy and I believe that repealing the regulations in their entirety is unreasonable.

In closing, I want to say that, in the future, we will need to monitor drugs without any real therapeutic benefits. The Patented Medicine Prices Review Board refers to three classes of drugs: classes 1, 2 and 3. I believe that we must work with the pharmaceutical industry to ensure that new drugs coming onto the market and for which Health Canada issues an advisory have real therapeutic benefits. I agree with the NDP that, in the past, things have been somewhat lax and drugs with no new therapeutic benefits were marketed.

According to our estimates, this has contributed to a 50% increase in the cost of drugs.

Mr. Speaker, I sense your impatience. There is no medicine for that. The only cure is for me to sit down and give the floor to someone else.

Patent ActPrivate Members' Business

5:55 p.m.


Pat Martin NDP Winnipeg Centre, MB

Mr. Speaker, I am thankful for the opportunity to enter into the debate on Bill C-274. I would like to begin by paying tribute to my colleague from Windsor West, who is the sponsor of this important piece of legislation, and to recognize the contribution he has made to this debate. It is safe to say that among those of us here he has become known as somewhat of a champion on this issue of providing accessible, affordable, necessary pharmaceutical products to the Canadian public within the confines and parameters of a fair system, but one that provides access to necessary drugs without bankrupting the system.

I should point out that Bill C-274 relates to access to less costly pharmaceutical products. What could be more poignant, timely or topical as we all wrestle with the problem of our health care system and the difficulty in providing these basic needs to Canadians. We know that the quickest growing aspect of our health care system is the exorbitant prices that we are paying for necessary life-saving drugs.

I begin by simply recognizing how important the job is that my colleague from Windsor West has done in bringing this important issue to the House of Commons today.

This bill has been stripped down to its most lean form. One could sum it up by simply saying that the bill seeks to repeal the patented medicines notice of compliance regulations. We argue that Canada's notice of compliance regulations regime fosters an anti-competitive behaviour among drug manufacturers. It is antithetical to what needs to be done in our pharmaceutical industry, in that it does not encourage research and development and innovation. It means that Canadians, governments, hospitals and benefit providers are paying more for drugs than would be necessary if a fair system were in place.

After careful consideration of this issue, my colleague from Windsor West has arrived at the conclusion that the single most effective thing he could do to enable more Canadians to get the drugs they need at affordable prices is to repeal the regime known now as the patented medicines notice of compliance regulations.

It would be helpful to look at a bit of the history. From the 1920s to the 1980s our government played a key role in limiting market monopolies on pharmaceutical products. In the interests of access and competition, our government played an interventionist role to limit and restrict the possibility of monopolies. The regulations that we talk about took their first form relatively recently, in 1993, in a bill which I think we can all remember, the infamous Bill C-91, billed as the biggest corporate giveaway. The biggest corporate sellout in Canadian history was Bill C-91. We remember it with great regret as a turning point in the health of our health care system.

Compulsory licensing, I should explain, allowed a non-patent holder to compete with lower priced versions. The compulsory licence issue was done away with in Bill C-91. This is one of the most dangerous elements. People sounded the alarm. I remember the NDP passionately fighting against Bill C-91 at the time. The debates were very public and high profile.

It seemed that pressure from the Canada-U.S. Free Trade Agreement in 1988 and then subsequently NAFTA in 1994 exerted enormous pressures that radically altered the way Canada dealt with pharmaceutical patents.

The compulsory licensing aspect was one of the changes. In fact a federal commission of inquiry in 1985 concluded that the use of compulsory licensing had saved hundreds of millions of dollars in the health care system at the time, had no adverse impact on the research and development of pharmaceutical products, or on the multinational drug companies regarding investment in research and development. It was found and held to be true in 1985 that government intervention in the form of compulsory licensing of real competition was saving money.

That reason and logic was thrown out the window in those days in the rush to implement the free trade agreement. Whoever negotiated these things on behalf of Canada I have always maintained should be dragged into the streets and shot because they really did sell us down the road. The names of the chief negotiators of the free trade agreement and NAFTA should live in infamy in Canadian history for what they did to us. We remember now the impact of NAFTA and the free trade agreement radically altering the way Canada deals with pharmaceutical patents.

If another federal commission of inquiry were held today, it would likely find the exact inverse of the 1985 findings. This radical shift in government policy that my colleague from Windsor West is trying to address has undermined the possibility of government to retain some element of control over pharmaceutical pricing to ensure that Canadians have access to affordable pharmaceuticals at the pharmacy counter and in our public health care system.

There is a contradiction in that there is a gap we cannot even span between the stated purpose of these notice of compliance regulations and the actual results of them. In actual fact the purpose of the NOC regulations was to protect patent rights, et cetera. Rather than protecting legitimate patent rights, these NOC regulations have actually incorporated and caused an abuse of litigation options and in fact of people extending, artificially some would add, the patent protection for a period longer than the 20 years, which we argue is already very generous.

I see I am running out time, so I will simply cite some of the key issues that others may not have touched on. One is evergreening, which implies the perpetual renewal of patents with small or insignificant changes or modifications to an existing drug. This is a bastardization of the patent protection that was agreed to under international guidelines and in our bilateral trade agreement with the United States. It is being abused widely. I will give an example.

In 2003, 103 patents were added to the patent registry by brand name companies but there were only 16 actual new substances approved. In other words, these patents were being listed based on a change in the colour of the pill, based on a change in the recommended dosage. The tiniest, most insignificant excuses are being used to provide a monopoly on these drugs, where companies can charge the highest possible amount without worrying about generic competition. This is what is killing us, figuratively and literally in some cases, because Canadians cannot afford the drugs they need because we are shackled by these monopolistic biases built into the system.

My colleague has tried to address this by eliminating the notice of compliance regulations within the drug patent review mechanism. I commend my colleague from Windsor West for being bold enough to bring this initiative before the House of Commons on behalf of Canadians who deserve access to life-saving drugs. If that means standing up to big pharma now and then, we are not afraid to do it. We are not going to sit and listen to apologists for big pharma justify the rip-off of the system in the form of billions of dollars. We are being fleeced by big pharma. My colleague from Windsor West and the NDP caucus are trying to address that. We should all stand up and support my colleague's bill today.

Patent ActPrivate Members' Business

6:05 p.m.

Pickering—Scarborough East Ontario


Dan McTeague LiberalParliamentary Secretary to the Minister of Foreign Affairs

Mr. Speaker, let me begin by suggesting that I will be supporting in principle Bill C-274 in the name of the member of Parliament for Windsor West. I have worked tirelessly with the member over the years, as I have with the member for Scarborough—Rouge River and a number of other members on what has been obviously one of the most neglected areas of our health care policy.

We have heard some very interesting speeches by members of Parliament from all sides of the House on this issue. Most will not support, apparently, the initiative that is being taken here. We certainly need to update our thinking about drug patents in this country and of course, since 1993, what has been the ultimate benefit for Canadians.

We can talk about innovative drugs and how important it is to keep the price of our health care system down. We can look at a number of other initiatives and PR perspectives that have been given. It is important for us to understand that when it comes to the so-called balance that has been discussed, we need to give to the House a reality check that Canadians spent almost $22 billion in drugs last year, up substantially from the year before. Much of that balance, quite apart from the cost to consumers and the cost to various drug plans and other drug insurers, has also meant investments in research and development.

We know that when a drug is qualifying for its approval it must go through a very rigorous test. The test is a requirement that the companies must engage in as part of their research and development. What we have seen recently, and I think this has been made very clear by the Patented Medicine Prices Review Board and others, is that in fact the research and development is often advertising. In fact research and development is what they are required to do to conduct clinical trials, not the vaunted, wonderful R and D that would happen, that we thought would take place many years ago, but instead, what they have to do, the bare bones. Even at that we saw last year that the 11% requirement was not met. It is now down near 9%.

Let us put this into perspective. Several members have talked about the regulations as they relate to new drug submissions, as they relate to the requirement to fulfill certain obligations. We heard from other members concerning certain drugs that were abused. In fact, almost every drug that was nearing or ending its patent was subject to automatic injunctions which allowed the patent holder to basically make a claim of infringement without even having to prove it, because of a bizarre, arcane, draconian system. It basically forced the generic which was lawfully attempting to reproduce the drug at the end of expiry into a legal morass which went on for years.

In the case of Losec, it should have come off in 1999. Losec is an ulcer drug which costs Canadian consumers over $425 million a year. Those are real figures that cannot be simply dismissed. Of course the overall costs to our health care system came in the form of private corporations, provinces and other corporations which had to pay for this ultimately.

I suggested at the time that it was important for us, and we know we had a pitch battle in the industry committee of which I was vice-chair, where members suddenly walked in out of nowhere, knowing it all. Of course we never had the full study that we thought we should have had, but it did click with the industry department. I know that what they proposed here in terms of its recent regulatory package to deal with the retroactive claims or what they call evergreening took place sometime in November or December. To date we have no definitive answer as to where that is going.

My guess is that while it may take out the most egregious forms of automatic injunctions or this draconian system of being able to claim retroactively one's submission for a new drug, it seems to me that it will not do what has been done in the only other jurisdiction which had this system, the United States. There, the President of the United States proactively said, “I will not allow you to frivolously cause another stay or to go and get another patent extension or bring these matters before the courts and tie them up while making tons and tons of money”. Instead, the United States went with one stay .

The United States, of course, receives not only the benefit of having the infrastructure of the drug industry, it also has some of the greatest lobbyists to Congress. If Congress could accept that as a limitation, why is it so difficult for this House of Commons and our industry department to get it right?

I am exasperated as any member of Parliament here. I am glad that members of Parliament raise the issue of cross-border drugs, and that we have this terrible thing that is happening, but that, in many respects, beguiles and, of course in my view, denies the real game that has been played here with prescription drugs to the detriment of Canadians.

I know the position of the Liberal Party in 1993. I campaigned on that position. I defeated a member of Parliament who cheerfully brought this thing through. It hurt seniors and Canadians and today I am true to what I said in 1992 and 1993 when that bill was wrong. It needs a rewrite.

There is no doubt in my mind that section 511 prevents, for example, paclitaxel, which is a very important drug for women as it relates to cancer. It was a drug created by the United States department of health. Officials found it through a little coniferous tree known as a yew. They found the product and were able to extract the serum but could not patent it because they were a government agency. They gave it at the time to Bristol-Myers Squibb. BMS then took the product, patented it, and then released it several years later because it thought it was not effective. A little tiny company in St. Catharines, Ontario, which is saving millions of dollars and a lot of lives, decided to pick this product up only to find that BMS out of nowhere showed up and reclaimed the patent.

There is something terribly wrong with a company being able to not invest a penny in that kind of patent product, to get rid of it, to abandon it only to get it back when some other small innovative company, which happens to also be a very important company, loses the opportunity. In my view, our regulations do not provide any balance. They in fact destroy the balance and unevenly put the burden on consumers against those who want to innovate and those who want to create new products.

I am very pleased to see the Bloc Québécois finally recognizing this issue. I am very pleased to see that there is certainly a change in terms of the approach that people are taking, that people count, and that there has to be a restoration of balance.

However, I want to make it very clear that if we want to make this legislation successful, meaningful, and build on what we are doing in other initiatives, including the Chrétien relief package for Africa which I initiated through my caucus in 2001 working with Médecins Sans Frontières and Oxfam, the last thing we should be doing is giving ourselves, with respect to the drug patents regime, a bum rap.

It is very important that we understand that the fragility of the system, as it relates to the overall cost for drugs and being able to increase innovation while not completely dumping on our generic industry, is the position to which we have to continue to look forward.

As the rest of the world is busying its way to find new opportunities for its generic industries, Canada has had a policy which in my view has been very detrimental to generics. I can only conclude that if it is so important for us to have a drug patents regime, where a company can come in and create all sorts of innovation in another country and not even have the courtesy of packaging those new drugs in this country, we have been sold a bill of goods.

It is extremely important that members of Parliament get their minds around this and speak to the department and industry officials because it is also not true to suggest that there is some kind of a balance between innovation and generics. We should also consider the balance between health care and industrial outcomes. In my view, health care has not been properly treated. If anything, it has been seen only from a commercial end and I do not think Canadians would generally agree with that.

It is important for us to understand the intentions of the bill. If we cannot change forcefully these regulations, then there is no other option but to rewrite them. I believe that is the right approach and it is an approach whose time unfortunately has come. I would ask that all parties who are involved with this, who may be lobbied on this question, take into consideration the overall impacts on our economy and on the bottom line for Canadians, particularly Canadians between the ages of 18 and 64 who often have no drug plans.

I am not asking the drug industry to not be given something that it clearly deserves, but it is important for us to understand that when it comes to sustaining economic outcomes for Canadians, it is important that Canadians have an opportunity to understand that these regulations must also serve the general and common interests of this country. I believe that they do not. I believe they need to be reformulated and if they cannot be reformulated, this member's bill must be allowed to pass.

Patent ActPrivate Members' Business

6:15 p.m.


Alan Tonks Liberal York South—Weston, ON

Mr. Speaker, I am pleased to take part in this debate on Bill C-274. I would like to congratulate the member for Windsor West who, in putting forward the bill, seeks to exclude certain medicines from the scope of the regulation-making power set out in subsection 55.2(4) of the Patent Act and to repeal the patent medicines notice of compliance regulations.

Members on both sides have spoken with great eloquence and a huge amount of insight into the manner in which the whole pharmaceutical industry operates. Many people have criticized the regulations because they are special rules that only exist in the pharmaceutical industry.

I would put forward the opinion that when one considers the amount of risk associated with pharmaceutical research and development, and society's vital need for the best available medicines at a reasonable price there is a compelling rationale to have special rules in place with respect to this industry.

In no other industry are the stakes as high. The quality of life of people not only in this country but throughout the world is dependent on investment in this particular site. This can only be achieved by an architecture of legal and enforceable rules that would ensure a certain degree of predictability in this particular industry. This is precisely why these regulations are in place. They provide an enforcement mechanism that is time limited, effective, and tailored to the particular features of the industry.

It has been pointed out very eloquently and in a very informed manner that there are problems and shortcomings with respect to the present regulations. However, they are predictable and they are what we have in place at this time. Under these regulations, patent disputes are addressed concurrently with the health and safety review process, and the majority of cases are resolved within a reasonable timeframe.

The enforcement mechanism of the 24 month stay is clear, predictable, and minimizes market disruption. It gives patentees the certainty that the generic competitor will not be able to market its product until infringement issues have been addressed.

The stay also serves as a convenient clock for judges to render a timely decision. The process under the regulations is less expensive and faster than traditional patent infringement litigation, which I am sure my learned colleague would agree is extremely expensive.

Repealing these regulations could be expected to have a number of detrimental consequences. It would necessitate much more costly and protracted patent enforcement litigation. It would also seriously undermine the ability of these companies to compete with their counterparts in other jurisdictions for research and development capital.

While there have been problems with excessive litigation between innovative and generic companies on certain drugs protected by multiple patents, I do not believe the bill provides an appropriately measured solution.

Industry Canada, with the assistance of Health Canada, has completed an exhaustive review of patent listing behaviour and litigation outcomes, and concluded that while the fundamentals of the regime are sound, a number of recent court decisions have enabled more aggressive patent enforcement practices on the part of generic drug companies.

The amendments in the regulations will reaffirm the strict rules for listing patents on Health Canada's patent register and will clarify when generic companies must address listed patents. This will ease Health Canada's administrative burden, cut down on litigation, and accelerate the market entry of generic versions of patented innovative drugs. As a whole, these amendments will bring greater stability and predictability to the intellectual property environment for pharmaceuticals by introducing firmer lower and upper boundaries to the market exclusivity of innovative drugs.

In contrast, the radical measures that have been proposed in this bill would forsake any semblance of balance, undermine R and D investment, and lead to instability and unpredictability in the marketplace. As I said, while the hon. member for Windsor West may have the best and most well intentioned desire in tabling the bill, its objectives will be counterproductive and would be better served by the government's current regulatory initiative.