Bill C-9 (Historical)

An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa)

Patent Act

[Aileen Carroll, Liberal, Minister for International Cooperation]

Mr. Speaker, it is a pleasure to rise in the House today in support of Bill C-9. This is groundbreaking legislation that clearly demonstrates what can be accomplished when we focus on what truly matters: humanity and compassion.

Today with the Canada and Jean Chrétien pledge to Africa act, we are sending a message to the community of nations. When confronted with misery and tragedy, Canadians do not look away.

We do not close our eyes to the sufferings of others and we do not throw up our hands in despair, we act. Diseases such as HIV-AIDS, tuberculosis and malaria are taking a terrible toll on the developing world. They accounted for almost a quarter of the global death toll last year.

However, numbers alone cannot begin to convey the full impact of these diseases on the political, economic and social structures in developing countries. Eighty percent of those dying from AIDS are between the ages of 20 and 50. It is anticipated that by the end of this decade, there could be more than 44 million AIDS orphans.

As a result, we face a potential demographic crisis where the most productive members of society can no longer raise their families and contribute to their communities.

The world's poorest countries cannot effectively fight poverty if their teachers, students, health care workers and business people are debilitated by disease. Simply put, we face the breakdown of families, community life and ultimately societies at large. Yet many of the diseases plaguing poverty stricken countries are largely treatable.

In the developed world, for example, the use of combination chemotherapy with anti-retroviral agents makes HIV-AIDS a chronic but a manageable disease. In the developing world, however, these drugs are largely unavailable. Only about 5% of those who require anti-retroviral agents are getting them and the same is true for other essential drugs. This is a great injustice and one that must be addressed.

As Canadians, we need to get involved. We need to work hand in hand with other nations to help lift the death sentence that HIV-AIDS and other diseases have literally imposed on millions of men, women and children across the planet. Fortunately, the situation, while dire, is not without hope.

After many years of sounding the alarm, the tireless efforts of a committed few are awaking the rest of the world to this grim reality. As Stephen Lewis, the United Nations Secretary General's Special Envoy on HIV-AIDS in Africa has noted, “there is a new momentum”. We are seeing a renewed commitment and engagement by those in the developed world.

I believe that Bill C-9 is a big step toward strengthening Canada's commitment on this issue.

This legislation responds to a decision by the World Trade Organization to override certain provisions of the agreement on the aspects of intellectual property rights as they relate to trade.

The decision is intended to permit the export, under certain conditions, of licensed versions of patented pharmaceutical products to countries that cannot manufacture their own.

I should point out that the WTO does not require its members to enact any particular measures. No one has ever said that Canada must get involved. Nevertheless, our collective conscience says we must do so. This is a moral imperative and a pressing need to act, and to act quickly.

We sincerely hope that our leadership on this issue will encourage other countries to follow our example.

Bill C-9 is based on a balance of interests. On one side, there are the great humanitarian objectives, to send vital pharmaceuticals to developing countries. On the other side, we must protect the integrity of our intellectual property system and ensure that we respect our international obligations in this matter.

We must not forget the importance of intellectual property rights, such as those protected by patents. After all, such protection stimulates continued progress in medicine, progress for the good of every one of us.

The government is persuaded that this bill reconciles these two imperatives and establishes a practical system to permit appropriate medicines to reach the people who need them.

At the same time, we recognize that access to less expensive generic versions of medications alone is not enough. Without well trained health care workers and adequate infrastructure, developing countries will unable to reverse the spread of these diseases.

That is why in addition to moving forward on Bill C-9, Canada continues to help developing nations build their capacity in their health care systems. By moving on these two fronts at once, increasing access to drugs and strengthening health care systems, Canada is working very hard to enable poor countries to scale up the treatments.

Canada is the first country to adopt this kind of legislation. Other countries are sure to follow our lead.

When I was in Washington last weekend for the spring meetings of the World Bank and the IMF, ministers from other countries commended Canada for the bill. They asked me for details so they could replicate it in their own countries. By having been the first country to come out of the gate and by having been the first country to bring forward this very important legislation, indeed we are imposing a certain onus, and it is an onus I intend to speak of in whatever international venue I find myself.

Because the world is watching, we have to get this right.

Thanks to a wide range of contributors, I believe we have achieved this.

I will take this opportunity to thank the members of the Standing Committee on Industry, Science and Technology and the many people who took the time to send in their comments and to appear before the committee.

The list of such intervenors is quite long and includes representatives of the patent medicine sector, the generic drug sector, and many non-governmental organizations, such as Doctors without Borders and Oxfam.

I applaud the commitment each one of them has made to this humanitarian initiative. Because of their efforts, in large part, the bill has been amended and very much improved.

Let me outline very briefly how the new regime proposed by Bill C-9 will work. The regime proposes a number of schedules that set out the pharmaceutical products and the countries to which the bill applies. Where any such country identifies a need for one of these products in order to respond to a public health problem, the country may approach a Canadian generic drug manufacturer to negotiate a supply agreement. I should add that these schedules are very inclusive and can be speedily amended to add countries or to add pharmaceutical products to respond to changing demands.

A supply agreement can be concluded at any time. The only obligation on the generic drug company is that before applying to the Canadian Intellectual Property Office for an export licence, it must first approach the brand name company holding the patents for that product to see whether the latter is willing to accord a voluntary licence on reasonable terms and conditions. If the brand name company is unwilling to do so, the generic company is free to proceed with its application for a licence and, assuming the requisite health, safety and administrative conditions are met, a licence will be issued and the product can be exported.

Finally, the regime also includes a number of safeguards to ensure the export of high quality products that will be provided directly to the people who need them.

Bill C-9 is good legislation. It proposes a fair and workable regime. This speaks volumes for Canada and Canadians and reflects a compassion that will soon benefit those in need of our help. I encourage the members of this House from all parties to lend their support to Bill C-9. Together, we can send a clear message to the millions of men, women and children in the developing world. It is a message of hope and compassion. It is a message that says Canada cares.

Mr. Speaker, I am noting your body language and I am wondering if I have run out of time. If I have, in that case I will conclude my remarks.

[Judy Sgro, Liberal, for the Minister of Industry and Minister responsible for the Economic Development Agency of Canada for the Regions of Quebec]

moved that Bill C-9, an act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa), be read the third time and passed.

[The Acting Speaker (Mr. Bélair)]

It being 5:30 p.m., the House will now proceed to the taking of the deferred recorded division at the report stage of Bill C-9.

Call in the members.

And the bells having run:

[James Rajotte, Canadian Alliance, Edmonton Southwest, AB]

Mr. Speaker, on behalf of the Conservative Party, I want to add a few words to this discussion on the second group of motions to Bill C-9, which deal mainly with adding medicines.

In particular, I want to address the issue of why we will not be supporting the motions put forward by my hon. friend from the NDP. I will reiterate what the government member said. The member for Windsor West did an excellent job at committee, a real tribute to his constituents.

However, there is something we should keep in mind. Many people before us at committee expressed concern about adding medicines. Let us look at the bill. Proposed section 21.03 of the bill reads:

The Governor in Council may, by order,

(a) on the recommendation of the Minister [of Industry] and the Minister of Health, amend Schedule 1

(i) by adding the name of any patented product that may be used to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics and, if the Governor in Council considers it appropriate to do so, by adding one or more of the following in respect of the patented product, namely, a dosage form, a strength and a route of administration--

This section really addresses the concern about whether we can add medicines. Perhaps in the future these two medicines may be added, but we do not know at this time. Our party feels that the people who make these decisions should make them within the parameters of this act itself, looking at the massive public health problems afflicting certain nations specifically with regard to HIV-AIDS, TB and malaria. We have to look at it within that umbrella and I really do think that we need to rely on our Department of Health here in Canada to guide us in these matters; that is certainly why we are making the decision we are. Obviously we are open to amending the schedule and adding other medications if that is the desire in the future.

In terms of the advisory council, our party made the motion to ensure that there is parliamentary input into the formation of this council, so that is a welcome addition as well.

I just wanted to add those few explanatory words for my hon. friend. This is why we in the Conservative Party will not be supporting Motions Nos. 14 and 18. We will support the addition to the list of all the other medicines that the government and the Department of Health have okayed and recommended.

[Brian Masse, NDP, Windsor West, ON]

Madam Speaker, I sometimes stumble through some of the medicine names which can be tongue twisters and very difficult to pronounce.

I am pleased to have a second opportunity to speak to the bill, in particular to the motions in Group No. 2 that we are referencing here, a specific series of drugs that have been introduced.

I want to first and foremost commend the committee work, as we have heard from several members. The fact that it is coming forward this way is because the committee agreed at that time to review things and make sure that Health Canada could review some of my amendments which could then be introduced at report stage. That is to the credit of the committee, the flexibility that evolved out of that, to ensure that we were doing the right thing.

Hopefully this group of amendments will provide additional resources to assist people around the world who are suffering with different types of conditions. The premise of the bill is to ensure that a distribution of generic drugs at a lower cost can get out to people who really need them. This is why we are doing this at this particular time.

These amendments are representative of a series of amendments that I proposed at the clause by clause stage. These are drugs to which Health Canada raised no objection. I thank those officials for their advice and assistance in my preparation of the list of motions on drug products. They were very professional and courteous, and made sure they were open for questions, especially given the tight timeframes under which we were working. They were very good in terms of getting back to me and my staff. It is important to recognize the work of the Health Canada officials.

Those officials have also circulated a copy of their recommendations to me, which I hope has been of use. Because of the way schedule 1 is worded, members will note that for some of the amendments, like that of amprenavir, it is simply the addition of a capsule formula but the amendment had to read to replace the whole line. It was a procedural issue but I hope the clarification is useful and once again provides for no other obstructions in getting those types of medicines to people who really need them.

This series of drugs presented here are indicated for a variety of different illnesses that affect the developing world, quite tragically. There are solutions and that is what some of these drugs can do, providing the right infrastructures for not only the countries themselves but also the humanitarian groups that are assisting them.

The amendment for amprenavir, Motion No. 12; delavirdine, Motion No. 15; lamivudine, Motion No. 17; and zalcitabine, Motion No. 19, are simple technical additions to include either the capsule or tablet formulation that is not currently in Bill C-9. All of these drugs are indicated for use in the treatment of HIV. We know from a number of speakers how many individuals across the developing worlds are suffering from HIV, and these drugs will provide some additional opportunities for them.

The amendment on ceftriaxone, Motion No. 13, simply adds the 500 milligram dosage to what already exists in schedule 1. It provides another opportunity for a specific case, if it is deemed necessary, for those wishing to assist.

The first of the new drug products which I propose to include is clarithromycin, Motion No.. 14. It is used to treat an AIDS-related infection called mycobacterium avium complex and also has other more general anti-infection uses.

As members of the House may be aware, the World Health Organization, in its attempts to facilitate quality, effective and safe HIV-AIDS, tuberculosis and malaria drugs, regularly updates what are referred to as “pre-qualified” drugs. Essentially it means that international experts appointed by the World Health Organization examine products submitted by companies around the world and assess whether they meet World Health Organization standards of quality, safety and efficacy.

Clarithromycin is on the WHO's pre-qualified list of HIV-AIDS drugs. Therefore it is one that has been vetted through the international process and we feel that that is a good reason to support it. It also apparently is a very expensive drug and, therefore, including it in the bill, which has the ultimate aim of providing access to medicines through cheaper generic versions, especially for the treatment of HIV-AIDS, tuberculosis and malaria, would make the bill even more able to achieve its aims. That is a benefit and a credit to the bill.

The second new drug that I have proposed is the fixed dose combination drug of isoniazid, pyrazinamide and rifampin, Motion No. 16. This combination of the three drugs is an anti-tuberculosis agent that is used for short course treatments of pulmonary tuberculosis in the initial phase.

According to Stop TB, tuberculosis infects one in three people worldwide. Between two million and three million die each year of this curable disease. This combination drug, also known as rifater, is also an expensive drug and could be very advantageous and important in the treatment of tuberculosis, which would, like clarithromycin, meet the aims of the bill.

The third of the new drug products I propose to introduce is moxifloxacin hydrochloride, Motion No. 18. Moxifloxacin is officially indicated for the treatment of what is called community acquired pneumonia, which simply means pneumonia acquired through regular contact as opposed to the complications from HIV-AIDS or a disease like that.

According to the Centre for Disease Control in Atlanta, approximately 5% to 10% of all children under five years old in developing countries develop pneumonia each year and acute respiratory infections like pneumonia cause approximately two million deaths among children under five each year and are the leading cause of death in that age group. In addition to children, approximately 100 of every 100,000 adults are affected yearly and the elderly are at particular risk according to WHO information. I feel the moxifloxacin should be included because of its potential to help treat people affected with pneumonia.

I believe that all these drugs are useful to have available as options to countries wishing to participate. My intent here, of course, is not to indicate that they should be used by anybody but I believe they should be available as options. However those people will decide.

As I mentioned and as the committee heard, there is consensus that the presence of a schedule at all provides further inflexibility in ensuring that countries have access to the drugs that they need. A list by its nature is exclusionary because it does not include all possibilities. If a country wants a drug that is already approved for use and sale here in Canada on the patent register, et cetera, it will still have to start a process for the drug to be included before a generic producer could apply for a voluntary or compulsory licence to supply the country with that drug. It is a bit of a barrier and it is one of the concerns we have with the bill.

I will quote from the testimony of our committee hearings by the representative of Médecins sans frontières about schedule 1:

So our proposal for that is simply to remove the schedule. Neither TRIPS nor the Doha declaration saw any list of medicines, and in fact developing countries fought very hard that there was no such list. It was a big point of discussion during those negotiations.

That is why we believe the list is something that the bill would be better without.

The government representatives have repeatedly testified that the presence of the schedule is intended as a guide and that it is meant to be flexible. I hope the members will consider supporting these amendments, particularly those that would introduce new eligible drugs important for the treatment of HIV-AIDS, tuberculosis and pneumonia to show that schedule 1 of this bill will be flexible as the government has claimed it will be. I am sure that they will be because there has been a lot of goodwill about the bill.

I commend all the parties that were a part of it. In fact, people across Canada are probably wondering why for the first time in a long time members are not shouting back and forth at different points but the fact is that we actually are talking about something that is very beneficial. We may still have differences of opinion about the bill but there is a great consensus for moving it forward rather quickly and also improving it where there are items of consensus. I think that is important to recognize.

These groups of amendments are intended to improve the bill and I hope they will receive the support they merit because they are important for many people throughout the world.

[Brian Masse, NDP, Windsor West, ON]

moved:

Motion No. 12

That Bill C-9, in Schedule 1, be amended by replacing “amprenavir” and the dosage forms, the strengths and the routes of administration specified in that Schedule in relation to the product with the following:

“amprenavir tablet, 150 mg; capsule, 50 mg or 150 mg; oral solution, 15 mg/mL”

Motion No. 13

That Bill C-9, in Schedule 1, be amended by replacing “ceftriaxone” and the dosage forms, the strengths and the routes of administration specified in that Schedule in relation to the product with the following:

“ceftriaxone injection, 500 mg (as sodium); powder for injection, 250 mg (as sodium salt) in vial”

Motion No. 14

That Bill C-9, in Schedule 1, be amended by adding the following in alphbetical order:

“clarithromycin tablet, 500 mg; tablet extended release, 500 mg; powder for oral solution, 125 mg or 250 mg”

Motion No. 15

That Bill C-9, in Schedule 1, be amended by replacing “delavirdine” and the dosage forms, the strengths and the routes of administration specified in that Schedule in relation to the product with the following:

“delavirdine capsule or tablet, 100 mg (as mesylate)”

Motion No. 16

That Bill C-9, in Schedule 1, be amended by adding the following in alphabetical order:

“isoniazid + pyrazinamide + rifampin tablet, 50 mg + 300 mg + 120 mg”

Motion No. 17

That Bill C-9, in Schedule 1, be amended by replacing “lamivudine (3TC)” and the dosage forms, the strengths and the routes of administration specified in that Schedule in relation to the product with the following:

“lamivudine (3TC) capsule or tablet, 150 mg; oral solution 50 mg/5 mL”

Motion No. 18

That Bill C-9, in Schedule 1, be amended by adding the following in alphabetical order:

“moxifloxacin hydrochloride tablet, 400 mg; intravenous solution, 400 mg/250 mL”

Motion No. 19

That Bill C-9, in Schedule 1, be amended by replacing “zalcitabine” and the dosage forms, the strengths and the routes of administration specified in that Schedule in relation to the product with the following:

“zalcitabine capsule or tablet, 0.375 mg or 0.750 mg”

Motion No. 20

That Bill C-9, in Schedule 2, be amended by adding the following, in alphabetical order:

“Timor-Leste

Timor-Leste”

[Marlene Jennings, Liberal, Notre-Dame-de-Grâce—Lachine, QC]

Madam Speaker, I am very pleased to take part in the debate on Bill C-9 at report stage.

As my colleagues from the opposition and the government have already mentioned repeatedly, this bill stems from a historic act. In fact, it is becoming a model for the rest of the world, should they be interested in adopting similar legislation.

I am very proud of the work done by all the members of the Standing Committee on Industry, Science and Technology during the hearings that allowed us to hear evidence from all interested parties, including experts and NGOs that work in developing countries.

We heard a large range of views, but everyone agreed that, first, we need this legislation and, second, the act should be strengthened to ensure that all interested parties that have a work expertise and a desire to work in developing countries can do so and have access to affordable drugs.

Although I am chair of the committee, I was unable to participate actively during many of its hearings because at the same time I am vice-chair of the public accounts committee. As everyone knows, the public accounts committee has been sitting three to four times more than a committee normally sits per week. We were sitting on this whole sponsorship issue, scandal, whatever one wants to call it, when the House was adjourned.

I can assure everyone in the House, and every Canadian, that each night I received the blues, the transcripts of everything that the committee heard. I went through them so I was very aware of what the committee members who were at the sessions were hearing.

I read the briefs that were tabled before the committee by all the different groups. I received a lot of correspondence from ordinary Canadians, pharmaceutical companies, the innovative Rx companies and generic companies. Members can name it, and I heard from them and I took notice of what they had to say.

I want to speak specifically to Motion No. 2 which was presented at report stage by my colleague from Windsor West who is with the NDP. The aim of the motion is to overturn a decision of the committee on a subamendment that I had brought to committee. What was the subamendment? I would like to read out the entire proposed paragraph and then show what Motion No. 2 would do, and explain why I do not support Motion No. 2. Proposed paragraph 21.04(2)(f) currently reads:

the name of the governmental person or entity, or the person or entity permitted by the government of the importing country, to which the product is to be sold, and prescribed information, if any, concerning that person or entity; and

It then goes on to other proposed paragraphs.

With Motion No. 2 that the member from Windsor West would hope that the House adopt, and which I hope the House does not adopt, it would remove all the section that says, “permitted by the government of the importing country”. To remove that would mean that the persons or entities could contract with generic companies in Canada who would receive licences in order to buy medication and bring it into a developing country, or a least developed country, without the knowledge of that government.

I think that the Canadian government, with the active assistance of all members on that committee, and all parties, worked hard to ensure that NGOs would have a strong role to play in ensuring that this legislation is effective when it rolls out and begins to work, and that it will actually assist the work that NGOs do in the developing world, and in the least developed countries.

I think that the legislation is fantastic. It is historic and it does not require Motion No. 2 because at its core, and I am sure that if the member had thought about it, if one were to remove that link between the government of the importing country, it would basically become Eurocentric.

It would mean that the government did not know what was best. The government of the importing country is not responsible for having policies or an infrastructure in place for public health or at least a policy to ensure that public health and infrastructure are in place.

We must work with the NGO community, governmental agencies of other countries, and multilateral agencies that we have put in place. When I say we, I mean the world. However, to remove that link, in my view, is to say that the governments of the importing countries do not have a role to play in elaborating and implementing their own public health policies and their own public health infrastructure, and that we in the developed world and industrialized world know what is best for them. We would therefore not need to treat directly with them; we could simply bypass them. I cannot agree with that and I am sure the member for Windsor West, if he thought about it, would rethink his motion.

I wish to conclude by saying that this is a wonderful bill, notwithstanding Motion No. 2, and Motions Nos. 14 and 18, which the parliamentary secretary addressed most ably by explaining that there were technical problems with those two.

Each member of the industry committee and all of the support staff from the House of Commons who assisted this committee in doing its work deserve a real applause from all Canadians because it was Parliament, the House of Commons, at its best. We were at our best during the work of that committee. I hope that when we vote on these motions and when we vote on the bill at report stage that we will again show our best to Canadians and the world.

[Larry Bagnell, Liberal, Parliamentary Secretary to the Minister of Indian Affairs and Northern Development]

Madam Speaker, I rise on a point of order. There have been consultations and if you were to seek it you would find unanimous consent to modify the English version of Motion No. 7 so that it reads as follows. I move:

That Bill C-9, in Clause 1, be amended by replacing line 29 on page 11 with the following:

“(3) The commissioner shall post

[Réal Ménard, Bloc, Hochelaga—Maisonneuve, QC]

Madam Speaker, I am pleased to speak to Bill C-9, particularly because I feel this is a historic moment. In fact, it is not every day that parliamentarians agree to act with diligence and speed. It is a historic moment because the members of the Standing Committee on Industry, Science and Technology have worked very hard, entirely without partisanship, and also because it is an important contribution to the north-south dialogue.

The bill before us at report stage is a legacy from the previous prime minister, who must be recognized. It is first and foremost an extremely significant contribution to the advancement of the north-south dialogue.

What will happen if the bill is passed? Canada had rejected the compulsory licensing program. Before the Conservative government amended the Patent Act, it was possible, indeed compulsory, to obtain a licence, not only for the approval of a drug but also for its sale and marketing. In 1989, the licence system was terminated. Once a patent holder has been recognized by the commissioner, there is a 20-year period of exclusivity. Nevertheless, this period did not permit the export of pharmaceuticals to the third world.

The bill before us suspends this process. It proposes that we re-establish—and I think it is important to say this—the licensing system, for exports to a specific list of countries. What is the situation now? It means that it will be possible for generic companies to negotiate contracts to supply designated developing or third-world countries.

I understand that in its original form Bill C-9 contained a much more restrictive list. The government, responding to the arguments of various NGOs, decided to expand the list. That deserves to be recognized.

This, then, is the situation. A generic company will be able to satisfy or fill an order from a government on the list of eligible countries. What is known as the right of first refusal has been set aside. This right applied to situations in which a generic company could have negotiated a supply contract with a third-world country, but would have had to give up the contract to the initial patent holder. The NGOs were worried, saying that this would be dissuasive, that it was not the kind of practice or legislation that would encourage generic companies to negotiate to supply the designated countries.

Under the amendments introduced by the government, the right of first refusal will not only no longer exist, but the innovative companies will not be required to reveal their contracts before they are signed, even when there is still a patent holder.

Second, generic drug companies must still obtain a licence, at first on a voluntary basis. If a licence is denied, the Commissioner of Patents will decide and it will become a compulsory licence.

So clearly, the fundamental mechanism underlying the bill is a schedule designating countries eligible to import pharmaceutical products. Generic drug companies will be able to ensure adequate supply, but they will first have to obtain a compulsory licence. It must be noted that, out of respect for our international obligations, companies granting the licence, initially voluntary, will receive royalties. There is a formula for calculating these royalties. They should be the equivalent of 2% of the product's commercial value.

But an index has been provided that takes into consideration the United Nations' human poverty index, so that the allowable royalties for the patent holder could be less than 2%, which is also an extremely positive amendment for third world countries.

Some witnesses and some NGOs, as the member for Notre-Dame-de-Grâce—Lachine knows, asked for the right to contract directly with the manufacturer and the importing country. I believe that it would be a mistake for the government to give in to this demand.

I understand that some amendments to the legislation ensure that the identified entity can be an NGO, but the government, at all times, must be involved in the negotiations. This is normal, first because the subjects of international law, the ones with international sovereignty, are naturally governments. Second, those who will dispense and organize care, ultimately, are still governments. They are the ones responsible for this plan to provide public health.

I am pleased with what we have accomplished and with the increased role being given NGOs.

It is particularly vital to adopt this bill with diligence because of the three realities that must be kept in mind. Every year, 10 million children die of diseases relating to malnutrition which could have been avoided. As well, every year one million people, most of them children under the age of five, die of malaria. Every day, 8,000 people in the world die of HIV-AIDS.

The bill we are preparing to adopt with this splendid parliamentary unanimity that is being promised, must give particular precedence to HIV-AIDS. As hon. members are aware, HIV-AIDS is a terrible reality on certain continents, Africa in particular. When it was first discovered in the 1980s, here in Quebec, in Montreal, people had no idea of the extent to which this disease was going to ravage all of humanity. Resistant strains have developed in some of the African countries, and these require urgent attention.

If it were not for this bill we are preparing to adopt, whole segments of the population would not have access to anti-retrovirals. As hon. members may know, there is a resistant strain in Africa that differs from the HIV/AIDS we are familiar with in North America. It is our duty to do something about this, as a rich country, one with great wealth, even if ours is not a perfect country and we have our own problems relating to the supply of these drugs. Yet our reality as a country, in Quebec and in Canada, bears no relation to the realities in the third world, Africa in particular.

My colleagues in caucus know I have sometimes been critical of the innovative companies. I do not think I have ever been overly critical, but I have sometimes been harsh on them and I must now thank them for their maturity and compassion in agreeing fairly readily to grant voluntary licensing rights. Once the bill is adopted, we will be ready to move.

There are, of course, provisions in the bill so that, if there is no agreement on the royalty to be paid once the voluntary licence has been applied for, it will fall to the Commissioner of Patents to set the amount.

With the member for Kamouraska—Rivière-du-Loup—Témiscouata—Les Basques, we met with the innovative companies, which are of course a very important industrial sector for Quebec, particularly the Montreal area.

I will stop there, since my time is up. It is my hope that this bill will be passed as promptly as possible, and I congratulate all the members of the parliamentary committee.

[Joe Fontana, Liberal, Parliamentary Secretary to the Prime Minister (Science and Small Business)]

Madam Speaker, let me begin by saying that I think this is Canada's finest hour, and also Parliament's finest hour, because my colleagues who have spoken before me have all indicated how all political parties have been able to come together in the committee to bring forward at report stage this bill that has practically unanimous approval.

I thank my colleagues on the committee who have worked so hard to get it to this point. They realize, as the government realizes, that this is Canada, and that we will be the first country in the world to put forward legislation and hopefully implement it as quickly as possible so that the drugs can get to the people who are dying.

I want to say to the people who sometimes watch this place that Parliament does some fine work and committees do some fine work, and this most important piece of legislation is in fact an indication of how Parliament and all political parties, when there is a national consensus to move forward, can in fact do so.

In this House we debate many bills that have a profound impact on the day to day lives of Canadians. Rarely, though, do we have an opportunity to debate a bill with such potentially far reaching benefits for the world at large. This is the type of legislation of which Canadians rightly can be proud.

Through Bill C-9, we reaffirm our compassion and our commitment to being a leader in the international community. It seems that every day we in the developed world are beset with fresh and disturbing statistics on the scope and extent of public health problems affecting much of the developing world. These facts and figures are very nearly beyond comprehension. Nowhere is this more true than with the AIDS and HIV pandemic.

HIV-AIDS has torn apart families and has caused untold suffering in some of the poorest parts of the world. According to the World Health Organization, an estimated 40 million people are now living with HIV-AIDS, with 95% of them living in developing countries. An additional 14,000 infections occur each and every day. Last year alone, the disease claimed roughly three million lives worldwide.

HIV infection also fuels other epidemics of global concern, most notably tuberculosis, which has become the leading cause of death not only among people living with HIV but also among their HIV negative family members and contacts. One-third of the world's population is now infected with TB bacillus, with more than eight million people developing the active disease and two million dying each and every year.

As my hon. colleagues have already indicated, the situation is not without hope. We are seeing a renewed commitment and engagement around the world to address this global catastrophe. In June 2001, for example, the international community witnessed the creation of the UN's global fund to fight HIV-AIDS, tuberculosis and malaria.

In September 2003, we saw the launch of the World Health Organization's “three by five” strategy, which aims to provide three million people in developing countries with AIDS treatment by the end of 2005. As well, organizations such as the Clinton Foundation, an international AIDS trust, are raising awareness in North America and around the world. This is encouraging, but more needs to be done. That is why we must lead with our support for Bill C-9.

Again I want to thank the committee members. I know we are debating the technical amendments that may be required to make this bill even better, but let me set out in context what this bill really does.

As we know, the World Trade Organization, which is concerned with agreements on trade related aspects of intellectual property rights, otherwise known as TRIPS, set out these international rules relating to trade in intellectual property matters. TRIPS has traditionally placed a strong emphasis on the protection of private property rights. However, these are the provisions that allow members to adopt measures necessary to safeguard public health and promote the public interest.

Of particular relevance is article 31. This is the article that expressly allows members to override the rights of patent holders by licensing the use of a patented invention to a third party if it is necessary to respond to domestic public health emergencies. That is precisely what Bill C-9 does and that is precisely what some of the amendments need to do.

Not only did the committee members work together, we heard from a number of witnesses. We heard from the brand companies, the generic companies and the NGOs. All of us in this place came together with the five departments of this government to work together and come up with a workable bill. All of us in this place know that bills and regulations sometimes can be cumbersome, but with everyone's help, we have a great bill.

I can say that the brand companies in Canada are already delivering drugs to the poorest countries in the world. The generic companies in Canada also want to do that. The NGOs, which are part of the lifeblood of delivering assistance to the people of the world, have to be complimented and acknowledged, because without their human infrastructure and their actual delivery of the medicines, the people would not get them. The NGOs are of incredible value to the system. I applaud them for giving us their inspiration and for showing us the way toward a great bill.

I want to talk specifically about the amendments that the member for Windsor West has brought forward. I want to assure the member that the government amendment in the first instance wanted to ensure that NGOs would not be precluded from helping to address the needs of those people, but we know that this is a country to country arrangement. While another amendment came forward to further clarify the NGO role as it relates the importing country, I want to reassure the member. I heard what he had to say.

We cannot be supportive of reverting back. After all, the committee listened to the information, had a debate and, at the end of the day, decided to change the wording. I want to assure the member that in no way does the subamendment take away the opportunity for NGOs to play a meaningful part. Yes, it needs to be a country to country arrangement. Yes, the NGOs obviously will need to have the approval of the importing country. We all know that. That is what is required under the WTO. But in no way do we believe that the subamendment, which was passed and is now part of the bill, will make it impossible for NGOs to play the meaningful part that the member really advocated for very well at committee. We are very supportive of what we had already changed. This particular amendment by the member for Windsor West unfortunately flies in the face of what the committee did, and that was to decide which amendment was better. Again, I want to acknowledge his great contribution although we cannot support his amendment.

We are also talking about Motions Nos. 14 and 18. Again I want to applaud the member for Windsor West. Through a number of different amendments, which we have just accepted, he has added to the list certain drugs and their prescribed dosages. I want to thank him as well as other members of committee and members of the House who saw that these medicines could be added to the list. He brought them to our attention and we decided to move very quickly and add them to the schedule.

While we cannot support Motions No. 14 and 18, because there are some technical and health issues that need to be cleared up, and while I know that the intent was to deal with tuberculosis, I think we have to be very careful. We have to look to our experts for advice because these drugs have not yet been approved in Canada. We cannot move them into the schedule until such time as they have been approved.

I can reassure the member and the House that Motions Nos. 14 and 18 dealing those two drugs will be moved to the advisory committee as quickly as possible. I think that with some expert insight we can move them along as quickly as possible, but I think the House should be respectful of those professions that know more than some of us do with regard to medicines and their impact.

Let me reassure members that even though we cannot support Motions Nos. 14 and 18, those two drugs will be moved on to the advisory committee as quickly as possible and hopefully we will be able to put them on the schedule.

[Deepak Obhrai, Canadian Alliance, Calgary East, AB]

Madam Speaker, it is a pleasure to speak to Bill C-9, an act to amend the Patent Act and the Food and Drugs Act.

This subject is very close to my heart because I come from that part of the world where the bill will have a major impact, the continent of Africa, where I grew up and where I went to school. To see the devastation that is taking place on that continent is very shocking and of immediate concern.

Time after time there has been mention of the major impact on the economy over there. My family still lives in that part of the world. I have on many occasions visited that part of the world. I have had first-hand experience of the devastation that is taking place in Africa as well as the economic impact. It falls upon us to see what we can do.

As a compassionate country, we have been directing foreign aid to that part of the world. It is becoming very clear that no matter how much money we are spending in that part of the world, if we do not tackle this scourge head on, the money that we are pouring into Africa will be wasted because people are dying, the economy is being affected and they need our help.

I am very happy that Canada took the lead when it brought the bill forward. When the bill was first proposed by the government, although I am on the opposition side, I commended the government for bringing forward this vision. We were the first ones to come out and support this initiative. As a matter of fact the Conservative Party was willing to pass this legislation in a single day in November so that we could address this issue.

I am happy to say that changes have been made. People in the field who were working with AIDS victims were concerned with what was wrong with the bill. Amendments that were brought forward in the committee will address many of those issues.

The issue is that in that part of the world, people cannot afford the drugs. When there is such severe poverty, when putting food on the table is an issue, how could the people fight that scourge on that continent?

I was there in November last year. I attended one of the AIDS clinics in Nairobi. I grew up in that city. About 25 years ago no one was suffering from AIDS. There was not the scourge of AIDS. It hit home when I went back there after 25 years and saw the devastating impact in the place where I grew up.

I went into the slums. I went into a grandmother's home. She was taking care of her two little grandchildren because both her daughters had died of AIDS. She herself had absolutely no idea what would happen to the children when she died.

On the streets of Africa the number of orphans is increasing. There are other severe social problems that go along with the breakup of families in that society which have to be addressed.

The priority now, and rightly so, is to ensure that cheap drugs are available. The good news is that they are available. It was only the rules and regulations that we had put in place that did not make it possible to reach out to these people.

Indeed, Bill C-9 is one of those bills that will go down in history as one that went out to help people, as a bill that Canada initiated to help people. Three months ago I was in Europe talking to Irish and Dutch parliamentarians on a Canada-European Union parliamentary visit. They were extremely proud of the Irish and Dutch governments and the assistance through ODA that they were giving to people around the world. Every time we have talked, they have dwelled on this. It was with great pride on my part that I showed Bill C-9 to them and told them that this was what was required, that their governments must look at Bill C-9 and must make sure that their own pharmaceutical companies would follow Bill C-9.

I told them that if they are really interested in spending money to help people in poor countries, then they must look at this legislation to see how they can help, because, as I have stated, the devastation is so severe that effective foreign aid delivery will not be there. I must say that I am pleased to be standing in this Parliament and to be in this country that has taken such a strong initiative to help where this devastation hits the hardest.

As we continue with this process, right now we are focusing on sub-Sahara, and of course this bill also talks about the other two diseases, not only AIDS but malaria and TB. Having grown up in that country, I have been a victim of malaria. Anybody who goes there is bound to be a victim of malaria. One cannot escape malaria living in that part of the world. I have had it too. To fight it, one needs strength and one needs medicine, cheap medicine. Again, this bill will address that issue to make sure that the scourge of malaria is fought in that part of the world and that drugs are affordable for the people in the villages of Africa and Latin America and wherever people cannot afford them.

As part and parcel of Canada's overall strategy of assistance through ODA to this part of the world, this bill fits extremely well into the whole picture of helping these countries, so it is with great pleasure that I say we will be supporting the bill.

[Brian Masse, NDP, Windsor West, ON]

Madam Speaker, it is a privilege to speak to Bill C-9 and specifically to some of the amendments in the first group.

I would like to tackle specifically one clause, a motion that we have submitted which I believe is important and will make the bill better. I am concerned it will not pass. I want to outline the reasons for moving that particular amendment.

First I want to thank my staff in Ottawa and in Windsor for the hard work they have done, in particular the Ottawa staff for the research that went into the bill. I thank the volunteers as well. I would also like to thank Stephen Lewis for his leadership on this initiative abroad. It simply makes another mark for Canada, that I hope will be successful.

The NDP is committed to ensuring that this very important humanitarian bill is passed as quickly as possible. A very important issue unfortunately has not been dealt with appropriately in the bill which could compromise its effectiveness.

As we all know, the bill was first introduced last November and after prorogation was reintroduced on resumption of Parliament in February of this year.

One of the chief points of contention with the bill was the issue of non-governmental organizations being able to contract directly with Canadian generics to purchase medicines for their programs in eligible developing countries.

During the weeks of testimony that the industry committee heard, a variety of NGOs, including Doctors Without Borders and Canadian HIV/AIDS Legal Network, testified about the importance of NGOs being able to produce lower cost pharmaceutical products directly, among other issues. I would like to thank them for all the work they have been doing abroad and also on this bill. I look forward to their achievements in the future. There are fine, capable people in those organizations.

NGOs testified that although the government intended to include NGOs, the language in the first version of Bill C-9 which identified governments and “agents” of governments as being eligible importers, the NGOs did not feel that this language adequately assured them of access to lower cost pharmaceuticals. It was inappropriate language terminology that hurt them.

Upon reflection of the various issues that were raised during committee testimony, the government proposed substantial changes to Bill C-9. It proposed removing the first right of refusal removal and opening the list of eligible importing countries to include many more developing countries. Of importance to consideration of this amendment, it changed the language about how NGOs could be involved. I commend those achievements, but unfortunately, they are changing it back again.

In its proposed amendments during clause by clause, the government put forward language in section 21.04 to remove the restriction of government or “agent of government” and replace it with “person or entity to which the product is to be sold”. The Canadian HIV/AIDS Legal Network issued a statement in support of that particular change saying it would allow NGOs to procure medicines from generic producers, assuming the NGO was legally entitled to import and distribute in the country where it was operating. This was a very progressive, important step by the government.

The difficulty with the issue is the following. No one was ever requesting that an NGO be allowed to contract directly with generic producers without the legal authority to do so in the eligible importing country. NGOs regularly receive their appropriate legal authority within whatever country they are operating to allow them to distribute medicines through their particular programs.

The more open language “a person or entity legally entitled to import and distribute”, however, was changed through a subamendment at the committee. I recognize that my colleague who presented the subamendment was attempting to clarify the language in the bill, but whether purposely or inadvertently, the language as it now stands would again prevent NGOs from participating. That is why I put forth the amendment at this stage to ensure that the language remained inclusive of NGOs.

The language in section 21.04(2)(f), lines 36 to 41 in particular, on page 6 of the bill reprinted as amended at committee, has been changed to “governmental person or entity or person or entity permitted by the government of the importing country”. This is problematic because it does not allow NGOs to contract directly. That is how they feel about the bill at this particular time. It is one of the challenges that we are going to see in the field.

The problem is that many countries, including Canada, do not necessarily provide the legal authority to procure and distribute pharmaceutical products through the government. In fact the best reference point is our own system. Here in Canada we have a commissioner of patents. Although created by an act of parliament and is part of the larger government structure, it is the commissioner of patents, not the government, who decides who is issued a compulsory licence to allow the sale and distribution of a particular pharmaceutical product. If a person obtains a compulsory licence under Canadian law from the commissioner of patents, there is nothing else the person needs in order to have the legal right to deal with that patented product in accordance with the terms and conditions of the actual licence.

It is the same in many countries around the world that also have positions of commissioners of patents. In other countries, such as South Africa, compulsory licences are issued through the courts and the legal system, not through the government.

Why is this language in its current form so problematic?

Let us assume for example that Doctors Without Borders in South Africa wants to import an anti-retroviral drug used in HIV-AIDS treatment for their programs in that country. A generic version could mean thousands of dollars in savings per year per patient. Under the current language of Bill C-9, Doctors Without Borders would have to first apply to get a compulsory licence and then, because of our law, would have to get some kind of authorization from the South African government to buy the anti-retroviral drug to use for their patients.

There is no process for that authorization in the South African government at the moment because it has a commissioner of patents that issues compulsory licences and a person or entity is not required under South African law to get anything other than a compulsory licence. That is the obstacle.

The bill is intended to be humanitarian in nature. As the minister stated in her opening comments to the committee, it is important that we have a bill that ensures that the regime not be abused, but that it also provides for the actual intervention of the drugs on the actual streets of the nations that need those types of support and supplies.

If we maintain the language around who a generic producer is able to contract with, in order to contract, NGOs would be required not only to obtain the compulsory licence, but also to get some kind of governmental authority; some kind of governmental authority that NGOs are not required to get by the laws of the country in which they are operating. It creates a circle. This circle is what is causing the NGOs to have problems and why we have this amendment.

Whatever process the eligible importing country has identified for issuing compulsory licences, whether it be through a commissioner of patents, through the courts or some other agency mandated by the government, should be enough of a legal requirement to allow NGOs to contract with generic producers. This is similar to our system here.

Again, I am not proposing that NGOs should be able to contract directly where they are not legally entitled to according to the laws of the country in which they are operating. I am simply proposing that we ensure that the language of our bill does not create further steps and barriers in the process of getting these much needed drugs to the people who need them, through the government or other person or entity legally entitled to do so.

Countries already have legislation regulating what drug products are approved for sale and use in their country. A compulsory licence would only be issued in cases where a drug is patented in that country and approved for sale and use.

There may be occasions where a country wishes to import a drug that is patented here in Canada but is not patented there. In that case no compulsory licence would be necessary by NGOs or other persons or entities wishing to distribute that pharmaceutical product, but it would still have to be approved for use and distribution, again by the importing countries under their own rules and regulations.

It is like it is here in Canada. There is Health Canada's process of determining safety of drugs and Industry Canada's process of placing products on the patent register and determining whether compulsory licences can be used.

Again, this amendment seeks not to change any of that, but seeks instead to respect the rules that are already in place in whichever importing country tries to participate under the regime that Bill C-9 would create. The change in language would ensure that there is no confusion between patent holder, generic producer, importing country, or NGO about whether a person or entity is eligible. Confusion can lead to legal battles and I know members on all sides of the House, as well as stakeholders, want to avoid that possibility.

We as parliamentarians should be respecting the sovereign process of legally issuing compulsory licences to NGOs or other organizations or persons for using patented pharmaceutical products within their own borders. We as Canadian parliamentarians do not need to tell other parliamentarians and representatives of other countries how they should do their job. We as Canadian parliamentarians cannot undermine the potential for success of this bill by including language that simply is not necessary and creates more burdens for the NGOs attempting to provide much needed health care services and governments that are dealing with health emergencies.

My amendment is simple. It proposes to return the language from what was passed at committee on a subamendment to the language proposed by the government in its own amendments to its own bill. The NGOs welcomed the government's language, as did the NDP, but we have not welcomed the new language that was passed at committee. This amendment does not propose to do anything but keep the process within established legal grounds and ensure that no additional barriers are placed in the way of NGOs attempting to deliver their humanitarian programs.

It simply boils down to this at the end. We felt that the government did a good job of listening to the NGOs and also to the witnesses at committee to deal with this problem and deal with an appropriate change from the first to the second draft. That is very important because they did change a number of different things. I commend the government for that.

Unfortunately, the subamendment, we believe, will create problems for the bill. That is why we would like to see this amendment pass. It would open up a better process for NGOs and those countries to be able to make sure that the humanitarian efforts of this bill are realized. At the end of the day, that is what all of us in Parliament want.

We want a bold initiative that is going to actually create opportunities for people who are sick and suffering, where health standards and impoverishment prevent people from achieving their fullest potential and cause death. We want to provide assistance with cheaper drugs to treat those illnesses.

That will not only make Canada a stronger nation, it will also provide for peace and security in the world.

[Aileen Carroll, Liberal, Minister for International Cooperation]

Mr. Speaker, I am delighted to speak in the House this afternoon on the subject of Bill C-9, the Jean Chrétien pledge to Africa act. As we know, the bill has been in committee and there have been a number of amendments. The bill will be coming back to the House for third reading very shortly.

The bill is the Government of Canada's response to the agreement reached at the WTO called the TRIPS agreement. It was an acknowledgement on the part of all the members of the WTO that drugs are desperately needed in Africa and other developing countries to assist them in dealing with the pandemic of HIV-AIDS, malaria, TB, and all of the diseases that are rampant there, and to make those drugs available at a price that people in developing countries could afford.

As one of the members of the WTO, Canada joined with our colleagues in signing the TRIPS agreement. That agreement puts an onus on all members within their own countries to bring forward domestic legislation that will have as its objective the distribution, production and availability of drugs for the diseases that I have just described.

In order to meet that onus, our legislation will meet changes requisite in the Food and Drugs Act, Intellectual Property Law Improvement Act, and the Patent Act.

I am proud of this bill and I do not have to apologize for that. I am proud of my government that we are the very first member of the WTO to bring this legislation forward. It was quite a task. We engaged the pharmaceutical industry in Canada and the generic drug companies. We joined in our consultation process with the non-governmental organizations. The work was the product of five departments of government coming forward to engage in the process and that, in and of itself, I think was quite an undertaking and accomplishment.

The legislation meets the requirements of TRIPS. I tend sometimes to be overly technical, but I want to give people the benefit of the background of this legislation. It reflects the moral imperative that Canada recognizes is ours to do all that we can to make those medical treatments available to the millions of people who are suffering from these diseases.

We have brought the legislation forward. It will return to the House once the process is complete in committee. As the Minister for International Cooperation, I have just returned from meetings at the World Bank over the weekend at the development committee and prior to that not long ago from meetings at the OECD, the DAC committee. Both of those are very prestigious and influential committees, where donor countries joined together in developing the best strategies to deliver aid effectively to the poor of this world.

I took advantage of both those venues to share the information with all of the donor countries, to tell them about this innovative piece of legislation, and to brag somewhat in spite of the reputation that Canadians must always maintain to be modest and unassuming. We have a lot to brag about and I did that, but I did it with a purpose. The purpose was to put a real onus on other member countries that have signed the TRIPS agreement to follow the precedent that Canada has set.

Until one country comes forward and does exactly that, these kinds of agreements can sometimes linger in a hiatus situation that would be beneficial to no one. Canada has come forward and has received accolades from our NGO communities worldwide, as well as the domestic community.

We have heard very favourable responses from leaders in civil society. I am pleased that people such as Bono and others have given great approbation to Canada for having shown the leadership to come forward and be the first out of the gate with this legislation.

It was a very important consultative process. There was a commitment on the part of the pharmaceuticals, the generics, the NGOs and these five departments to work out legislation that did not just meet the bar of that agreement, but in effect, went above the bar.

Canada has exceeded the bar in one dimension by including in this legislation, not just the countries that are members of the WTO but countries who meet the criteria as established by the DAC committee. It would include all countries that are officially recognized recipients of ODA, official development assistance.

We have broadened, right at the beginning with our legislation, the number of countries who will benefit from this, and who will now be able to access drugs at a price that they are able to afford. This drug bill, the Jean Chrétien pledge to Africa, therefore becomes an integral piece, if I can speak strictly as the Minister for International Cooperation in Canada, this drug bill, of our strategies to assist people in the developing nations.

We are working to greatly enhance the capabilities of countries with their health services in all that is required to assist them in developing a capacity that they are slowly accomplishing. Obviously, it is uneven. The growth in capacity is stronger in some countries than others. The availability of drugs, that is an incredibly important part of their battle against diseases that are the scourges I have described, becomes a very important part of an overall holistic approach.

As the Minister for Cooperation, it became and remained, and still is a major priority for us as one of the five departments who came forward here. It was a very broadly based consultative system. It allowed Canadians to come forward wearing every hat that pertained to the development of the bill. It allowed them to come to committee to engage parliamentarians on that committee, convey changes they felt needed to be made, and to convey their approval of the strength of that bill giving excellent wisdom to us as we all moved together to enact this incredibly important and timely piece of legislation.

That speaks well for the process. It speaks well for the important role of the committee. The committee was enhanced by the enabling of the members of that committee through the recent approaches the government has undertaken under the leadership of the Prime Minister to address democratic deficit. It enabled people to work together and produce legislation of this tremendous import.

We have dealt with some of the issues that originally were not roadblocks, but I would describe as hurdles, and we have overcome them. With regard to voluntary licensing, the amendments eliminate the requirement that patent holders be given the right of first refusal and that was vital. When we initially came forward, we heard a lot of concern and really to be fair, criticism not just concern, on that right of first refusal.

We have come together with our stakeholders, made the changes and eliminated that requirement. In so doing, again, it produces a piece of legislation that says to the world, this is where Canada has come from, this is what we have come out of the gate with on the TRIP agreement, and this is exactly the model that will be there to emulate.

We have included two lists in the regulations, lists of countries that will be able to benefit from this legislation and lists of the drugs that will be available as a result. Both form a beginning and are not engraved in stone for all time, but we had to begin somewhere and we have done that.

I look forward to speaking in a more formalized fashion at third reading.

[Joe Fontana, Liberal, Parliamentary Secretary to the Prime Minister (Science and Small Business)]

moved:

Motion No. 4

That Bill C-9, in Clause 1, be amended by replacing line 23 on page 7 with the following:

“at least thirty days before filing the applica-”

Motion No. 5

That Bill C-9, in Clause 1, be amended by replacing, in the French version, lines 26 and 27 on page 7 with the following:

“l'OMC mentionné dans la demande, et ce à des conditions raisonnables et sans succès,”

Motion No. 6

That Bill C-9, in Clause 1, be amended by replacing lines 21 to 25 on page 11 with the following:

“its label and packaging, as required by regulations made under the Food and Drugs Act, as well as information identifying every known party that will be handling the product while it is in transit from Canada to the country or WTO Member to which it is to be exported.”

Motion No. 7

That Bill C-9, in Clause 1, be amended by replacing line 29 on page 11 with the following:

“(3) The Commissioner shall,”

Motion No. 8

That Bill C-9, in Clause 1, be amended by replacing line 34 on page 11 with the following:

“(4) The Commissioner shall,”

Motion No. 9

That Bill C-9, in Clause 1, be amended by replacing lines 1 to 3 on page 12 with the following:

“quantity to be exported, as well as every known party that will be handling the product while it is in transit from Canada to the country or WTO Member to which it is to be exported:”

Motion No. 10

That Bill C-9, in Clause 1, be amended by replacing lines 42 to 45 on page 15 with the following:

“authorized to be manufactured and sold, which agreement must incorporate information that is in all material respects identical to the information referred to in paragraphs 21.04(2)(a), (b), (e) and”

Motion No. 11

That Bill C-9, in Clause 1, be amended by replacing line 9 on page 18 with the following:

“Health shall establish, within three years after the day this section comes into force, an”

[Brian Masse, NDP, Windsor West, ON]

moved:

Motion No. 2

That Bill C-9, in Clause 1, be amended by replacing lines 36 to 38 on page 6 with the following:

“(f) the name of the person or entity to”

Motion No. 3

That Bill C-9, in Clause 1, be amended by replacing line 23 on page 7 with the following:

“at least fifteen days before filing the applica-”