An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act

This bill was last introduced in the 40th Parliament, 3rd Session, which ended in March 2011.

This bill was previously introduced in the 40th Parliament, 2nd Session.

Sponsor

Judy Wasylycia-Leis  NDP

Introduced as a private member’s bill. (These don’t often become law.)

Status

In committee (House), as of Dec. 2, 2009
(This bill did not become law.)

Summary

This is from the published bill. The Library of Parliament often publishes better independent summaries.

This enactment amends the Patent Act and the Food and Drugs Act to make it easier to manufacture and export pharmaceutical products to address public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics.

Elsewhere

All sorts of information on this bill is available at LEGISinfo, provided by the Library of Parliament. You can also read the full text of the bill.

Votes

March 9, 2011 Passed That Motion No. 3 be amended by deleting all the words after the words “The provisions of this Act that amend the Patent Act” and substituting the following: “shall cease to apply on the day that is the tenth anniversary of the day on which this Act comes into force unless, before that day, the application of those provisions is subject to a comprehensive review by the standing committee designated by the House of Commons for that purpose, that committee recommends that they be maintained and the House of Commons approves that recommendation.”.
Dec. 2, 2009 Passed That the Bill be now read a second time and referred to the Standing Committee on Industry, Science and Technology.

Access to MedicinesStatements By Members

March 9th, 2011 / 2:10 p.m.
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NDP

Megan Leslie NDP Halifax, NS

Mr. Speaker, women and girls continue to be affected disproportionately by HIV and AIDS in sub-Saharan Africa. Better access to life-saving medicines would greatly benefit mothers and children living with HIV and AIDS, as well as help family members, particularly grandmothers caring for their grandchildren.

Bill C-393 proposes a one-licence solution that would greatly simplify the licensing process to export lower-cost generic medicines to developing countries.

I would like to recognize the support of this bill by the strong national network of grandmothers groups which seek to build solidarity, raise awareness and mobilize support in Canada for Africa's grandmothers. These women have built a strong two-way relationship that has proven to be a powerful challenge to a pharmaceutical industry that prioritizes profits over human rights, health, social and economic justice.

I hope that the actions of these grandmothers and of all women and girls working in solidarity with each other around the world will inspire the members of this House to pass Bill C-393.

Patent ActPrivate Members' Business

March 3rd, 2011 / 5:15 p.m.
See context

Liberal

Frank Valeriote Liberal Guelph, ON

Mr. Speaker, I rise in the House this evening to speak in support of Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act.

I strongly urge all members to support the bill and the amendments put forward by my hon. colleagues from Halifax and from Windsor West, calling for a one license solution to cut the red tape currently preventing the sale of generic drugs overseas and to also restore the definition of pharmaceutical products to protect the knowledge developed by name brand drug manufacturers. Accepting these amendments will simultaneously help those in the developing world and will also protect the investment and the knowledge developed by pharmaceutical companies.

On May 14, 2004, the Martin Liberal government passed Bill C-9, An Act to amend the Patent Act and the Food and Drugs Act (The Jean Chrétien Pledge to Africa). This act established the legal framework for Canada's Access to Medicine Regime, or CAMR, which sought to balance Canada's trade and intellectual property obligations with the humanitarian objectives set out in Bill C-9 and help us honour our commitment to realize the sixth millennium development goal to combat HIV and AIDS.

Despite this act's best intentions, CAMR was unsuccessful in its objective to facilitate timely access to generic versions of patented drugs for people in the least developed or developing countries to fight HIV-AIDS, malaria, tuberculosis and other diseases. This act's complexities are blamed for the daunting inability and serious obstacles to the supply of generic drugs to fight HIV-AIDS in the developing world. As a result, drugs have only been delivered to one country on one single occasion, Rwanda.

Parliamentarians have made a number of attempts to fix the obstacles preventing the shipment of generic drugs to those who need it. Now we have another opportunity to meaningfully help those in need. The opportunity is right now. We have the chance to pass Bill C-393, which will help to clear these obstacles and reduce the complexity of the current CAMR regime, so we can begin to deliver on our pledge to improve the health of the world's poorest people. It is absolutely imperative that we do so, to stop people from dying when they could be living and to alleviate suffering when they could be blessed with an extension of their lives for their own well-being and the well-being of their entire family.

The statistics are alarming. There are more than 33 million people living with HIV-AIDS globally, 22.5 million of whom live in sub-Saharan Africa. Three-quarters of all AIDS related deaths since 2008 occurred in Africa. There are 2.3 million children infected with HIV. One in two children with HIV in the developing world dies before their second birthday. Less than 15% of the children who need treatment are getting it. More than half a million children die of AIDS every year. Every day 7,100 people become infected with AIDS.

Yet statistics themselves can be desensitizing, thrown around at random to make a point. I have a hard time conceptualizing what 2.3 million children infected with HIV really means, so I thought I would put this into perspective.

I recall a documentary called Paper Clips, where children in a middle school in Tennessee, attempting to grasp the enormity of just how big the number six million really was, gathered six million paper clips, one for each life. If we did the same and placed the clips in boxes of 100, just like the ones we have in our offices, the number of children with HIV in developing countries would equal the number of paper clips contained in 23,000 of these boxes.

Let me give the House another comparison. Thirty-three million people in the world are living with HIV-AIDS globally. That is the entire population of Canada. Imagine attempting to treat this many people in a meaningful way, with our hands tied because of ineffective and cumbersome legislation that we can now change.

Developing countries in Africa are already suffering from the government's withdrawal of foreign aid dollars, which in part resulted in our loss of a seat at the United Nations Security Council. We must not allow this ambivalence to prevail.

If we do not vote for this bill, we will wake tomorrow and we as a country will be no better able to help the 7,100 newly-infected people with HIV tomorrow. Nor will we be in a position to prevent another 7,100 people from becoming infected two days from now. Today we have to make a choice and there is only one right decision. I am voting for Bill C-393. I am voting for helping people in need and for doing what is right. I implore everyone in the House to do the same.

I am acutely aware of the way HIV-AIDS destroys the lives of people, having personally witnessed this epidemic while doing international aid work in San Pedro Sula, Honduras, the city with the highest incidents of AIDS in Central America at the time I was there. As part of my continuing international aid work in central and South America, I have helped build schools in the hope that knowledge and health education can keep children safe and help prevent the infection of HIV.

A 2008 UN report estimated that seven million cases of AIDS could be prevented in the next decade if every child received a primary education.

I am also aware of the impact that AIDS can have through my work with Anne-Marie Zajdlik and the Masai Centre for the treatment of AIDS in Guelph while on the Bracelets of Hope Campaign, where we raised over $1 million selling red and white beaded bracelets made by the women of Lesotho in southern Africa to fund AIDS treatment centres in that country.

In discussing this bill, Dr. Zajdlik said:

In the last 5 years I have treated hundreds of HIV positive children...Despite our best attempts, many, many of these children died.

In our world of unprecedented wealth, information and technology, no child should die of a preventable disease. The life saving miracle of medicine and medical technology is part of the intellectual property of the world and should be made available to all.

Prevention has to be taken seriously. This can be achieved in several ways. Building schools, improving educational programming, increasing HIV testing and treatment sites are but some. We must also facilitate the provision of antiretroviral drugs, or ARVs, that actually prevent the transmission of AIDS from a pregnant woman to her newborn. Providing these drugs will prevent infant deaths and will save hundreds of thousands of children from suffering from HIV-AIDS.

In 2009, 370,000 children were infected with HIV during the perinatal and breast-feeding period of growth. That is 370,000 children who could have been saved through the use of ARVs and other HIV-AIDS drugs that would have prevented the transmission of this virus. That is another 370,000 children who would not have grown into adulthood with the risk of passing HIV onto others.

While resources need to be devoted to preventing HIV-AIDS, we must also acknowledge that we need to do our part to help treat HIV-AIDS in the developing world until it is eradicated. That means developing the best legislation and regulatory system possible to ensure that generic and affordable medication is available for those who need it.

According to a 2010 UN report, access to antiretroviral drugs has resulted in a gain of 14.2 million life years worldwide. In Botswana, AIDS-related deaths fell from 18,000 deaths in 2002 to 9,100 deaths in 2009 as a result of antiretroviral drug use. Accordingly the rate of children orphaned by AIDS fell by 40%. This is not only a matter of life and death; it is also an enormous moral and social issue.

The House should be grateful for the efforts of the Guelph GoGo Grandmothers who have nobly and passionately worked towards the passage of this legislation. I can feel the impact that its members have had on the House. I sincerely hope its efforts have not been in vain.

If we pass this bill and embrace this noble strategy, we can prolong lives and prevent the transmission of this insidious disease. Imagine a world without AIDS, where people could live and thrive knowing that they would live to be able to provide for their loved ones and raise their children with the knowledge that they could have a child without transmitting HIV to them, a world where their energy could be spent productively contributing to their families, communities and economies.

Wishing this to be true will not make this happen. We must be intentional in our efforts to pass legislation so it will happen. I implore the members to vote with me in favour of Bill C-393 and make it happen.

Patent ActPrivate Members' Business

March 3rd, 2011 / 5:25 p.m.
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Bloc

Monique Guay Bloc Rivière-du-Nord, QC

Mr. Speaker, I am pleased to take part in this evening's debate at the report stage of Bill C-393. The purpose of this bill is to amend the Canadian Access to Medicines Regime, which was created to facilitate the development and sale of low-cost generic medicines to developing countries.

Bill C-393 was introduced in the House on May 25, 2009, by the former member for Winnipeg North so that this regime, which has been used only once so far, would be more flexible and therefore used more often. In fact, these changes were called for by the only generic pharmaceutical company to have ever used the regime. It sent a clear message that if the changes are not made, it would never use the regime again. However, we have been advised that, if Bill C-393 passes, it has promised to create and distribute a drug for the treatment of HIV infection among children in Africa.

Since we began examining the bill, the Bloc Québécois has always remained completely open and carefully studied the impact of the changes that Bill C-393 would bring to the Canadian Access to Medicines Regime. We have made it very clear from the beginning that we did not want the House of Commons to limit itself only to the study of Bill C-393. One of our biggest concerns was the importance of seeing more low-cost medicines distributed to some of the world's most needy populations.

Once again, we believe that other solutions, no doubt more consensual, could have been considered. For that to happen, Parliament would have had to clearly express its desire to reflect on this very important question without any partisan agendas. However, as he himself indicated on January 31, 2011, my colleague from Verchères—Les Patriotes was unable to convince the members of the Standing Committee on Industry, Science and Technology to take an interest in studying the regime as a whole.

How can we balance the objectives of Bill C-393 with the concerns that have been raised, such as respect for the requirements of our participation in the World Trade Organization, the need to encourage research and innovation of pharmaceutical products and respect for the altruistic spirit of the act that created the regime in 2004—the objective of which was not to create a tool to export medication for commercial purposes? We can do so simply by more closely monitoring its application to ensure that these irritants are simple concerns and not real problems. Today, the real problem is that there are entire segments of poor societies that are struggling with infectious and communicable diseases. This has reached proportions so high that it is impossible to turn a blind eye and do nothing. Today, we have the only option before us here, which is the passing of Bill C-393.

Of course, when the bill came out of committee some amendments were needed to bring out the essence of the bill. That is why the member for Halifax moved two motions that were then amended by the member for Windsor West. As we have said before, we are in favour of their adoption.

However, a third motion was moved by the member for Verchères—Les Patriotes, which is pragmatic, something that is more than necessary in this case. Since it is impossible to eliminate all of the potential irritants of passing Bill C-393 by studying the information available, without any concrete examples, we believe that we must create some examples.

Need I remind members that one single global transaction took place through Canada's access to medicines regime? This was the sale of antiretrovirals to Rwanda by Canadian company Apotex. We must experiment and use the modified regime to prove that all of the concerns were unfounded, while assuming our responsibilities as legislators and not disregarding the concerns raised by experts. This inspired my colleague from Verchères—Les Patriotes to propose this sunset clause. He wants to create a sort of pilot project.

Pilot projects are strong tools to test and evaluate programs. They must not prevent decisions from being made. On the contrary, they should make decisions easier. That is why we agree that a fundamental part of the clause proposed by the Bloc Québécois is missing, which is feedback. What will we do, as parliamentarians, at the end of the pilot project?

Motion No. 3 is silent on this issue. That is why in a few moments I will be proposing a major amendment that will require hon. members to re-evaluate the plan in order, if possible, not to interrupt a plan that has contributed significantly to making a difference in getting drugs to countries that struggle, despite poverty, to bring relief to their sick.

I also propose making another major change resulting from the fact that in this matter, as in all matters brought to our attention, we have continued to listen to the people. When we were asked why we proposed a pilot project for four years, the answer was easy. It seemed and continues to seem clear to us that at the end of that period of time we would have seen concrete results from the changes made. If, at the end of four years, nothing has happened, then we will have to admit that the officials who told us that Bill C-393 would not change anything were right. However, one argument made us stop and think. What would happen to a drug being distributed at the very moment that the four years were over?

To prevent a drug from being withheld for that reason and to truly give Parliament enough time to study this new plan with access to real examples provided by the manufacturers and exporters of these new generic drugs, and, if possible, to make permanent the changes suggested by Bill C-393 before the sunset clause takes effect, we agree with the proposal made by a stakeholder we have encountered many times, to extend the trial period from four years to ten years. Therefore, there is every reason to adopt Motions No. 1 and No. 2, and Motion No. 3, as amended, in order to allow the desired changes to the plan to be made while ensuring that the plan remains consistent with the spirit of the legislation adopted in 2004.

Therefore, seconded by the hon. member for Compton—Stanstead, I move that motion No. 3 of January 31, 2010, be amended by replacing the words following “The provisions of this Act that amend the Patent Act” with the following:

“shall cease to apply on the day that is the tenth anniversary of the day on which this Act comes into force unless, before that day, the application of those provisions is subject to a comprehensive review by the standing committee designated by the House of Commons for that purpose, that committee recommends that they be maintained and the House of Commons approves that recommendation.”

Patent ActPrivate Members' Business

March 3rd, 2011 / 5:35 p.m.
See context

NDP

Paul Dewar NDP Ottawa Centre, ON

Mr. Speaker, I want to thank my colleagues from the Bloc for that amendment. We see it as a friendly and constructive amendment.

Bill C-393 has been debated at great length in this House. We have heard the reasons for it. I would remind members of the House that this is an urgent call to help and that we are talking about 2.3 million children under the age of 15 who are infected right now with HIV. We can help those who are in need of help right now.

One in two children with HIV in the developing world dies before reaching his or her second birthday. Let us think about that. Many of us in this House have children. Fifty per cent of those who contract the virus die, not because they cannot be helped, but because we are not able to help them right now.

That is what the bill is about. It is about life and death, and this House can decide to help save lives. It is that simple.

When we look at the numbers, there is despair, but there is hope. The despair is what the virus does. The hope is what we can do in the House today. What I just saw from my colleagues in the Bloc, what I have heard from my colleagues in the Conservative Party who support the bill and what I heard from my colleagues in the Liberal Party show that the will is there. It is goodwill. It is about people living up to their principles. It is about people putting aside their partisan differences. It is about people listening to the people who need our help. We have heard those voices loud and clear, some of us who have been to Africa.

When I went to the Democratic Republic of the Congo, I saw a warehouse for medicines that could help save children and that warehouse was half empty. They want to see a supply of medicines and by passing this legislation, as amended, we can fill that warehouse to ensure those medicines get to the people who need it.

On another visit after I went to see that warehouse in the Congo a couple of years ago, was to some of the clinics where huge progress has been made to identify the HIV-AIDS virus.

However, if they do not have the medicines to help those who have been identified, then they will perish.

We are here today to look at the bill to ensure it can be amended and improve what the House passed previously.

I want to address, very directly, the amendments. If we are not able to get the one licence solution back in, as my colleagues know, then this bill is not worthy of going ahead. We cannot pretend. If the one licence solution is not put back in, the bill will not be worth the paper it is written on, and my colleagues know that.

To those who have concerns about compliance with WTO regulations, they will know it has been analyzed by experts and it is compliant. So, that argument does not hold weight. They know there are provisions and the amendments in the bill that would ensure standards are kept. We have ensured in the bill and the amendments that have been made that there are no concerns around leakage, in other words, that drugs would go to other countries. It is very precise. These drugs would go to the countries that have been put in the legislation.

We have an opportunity to put forward an innovative solution to help the millions of children who need it. We have an opportunity to improve something that this country has innovated. We have an opportunity, which excites me, to work together as parliamentarians to do something to help save lives.

I salute the people who have worked on this. I have been blessed with the opportunity to take the bill at this point. Many people have referenced my colleague from Winnipeg who started this, but it is because of every member in this House that I stand here today able to debate this bill.

Another thing happened in this place that was unusual and was welcomed. I put aside the bill I had and because of unanimity in the House, I was allowed to pick this bill up at the stage it was at. That means each party had to oblige.

I thank every member in the House for that. If members of the NDP did not get that support, we would have been unable to debate the bill. It does not matter whether members are in favour of the bill or not. I, the NDP members and the people who have worked on the bill thank each and every member of Parliament for that.

It is important to note that what we are talking about is, yes, saving lives. However, it also addresses what is happening in the world in terms of the disease itself. As we know, it is an HIV virus, which is mutating and changing, and we need medical regimes and medicines to change along with the virus. That is happening.

However, another thing is happening. As we know, countries like India have been trying since 2000 to become compliant with the WTO. They are unable to provide the same generic regimes they had in the past, so it requires innovation. We just do not have the drugs to support the people who need them now. The bill would help deal with that challenge.

For those who wonder what the bill can do, it can show the way forward to deal with not only the changes required in the regime of medicines needed, because of the change in the virus, but it will ensure that the progress made, with over five million lives saved in the last number of years, will continue. If we do not, make absolutely no mistake about it, we will potentially be going backward. Why? Because the drugs, which have worked so successfully, have to respond to the way in which the HIV virus and others are changing and mutating.

We cannot stand still. We have to continue to move ahead, and the bill is all about that. There are no concerns about WTO compliance. There are no concerns about quality controls. There are no concerns about leakage to other jurisdictions in terms of the drugs being sent somewhere else. They are in the bill and we would have oversight.

The only challenge is for the House to pass the bill, as amended. If we can do that, if we can put aside our differences, as we have before, and let our partisan shields down and ask what is the best for the people on the receiving end of these drugs, then we can show what Parliament is about. It is about working together from time to time. We have done that on a couple of occasions.

One of the proudest moments for all of us was witnessing, for instance, the apology to first nations. I will never forget that day and I hope we can do that again with this bill.

People are watching. I want to ask all of us to acknowledge the work that has been done by activists and civil society members. The grandmothers have been tireless and vigilant and have understood the importance of Canada working in solidarity with people in other countries. It is the finest example of what Canada and other activists, particularly from the coalition for HIV-AIDS, can do.

At the end of the day, it is very simple. I ask my colleagues to support the bill, as amended, so we can do what we can to help the people who need it. That is what I hope we will do. I hope next week all my colleagues will see fit to pass the bill. I look forward to them supporting it.

Patent ActPrivate Members' Business

March 3rd, 2011 / 5:45 p.m.
See context

Edmonton—Mill Woods—Beaumont Alberta

Conservative

Mike Lake ConservativeParliamentary Secretary to the Minister of Industry

Mr. Speaker, I thank my hon. colleague from the NDP for his passion on this issue, for his interest in picking this bill up. I thank all hon. colleagues in the House, regardless of how they feel about this legislation, for voting unanimously to allow the member to pick up the bill so we could continue this important debate.

Bill C-393 is drafted to deal with the many challenges associated with access to medicines in the developing world.

Before I begin, I commend the Grandmothers to Grandmothers campaign for their continued perseverance to keep this issue at the top of public debate. Although we may not agree on the legislation, I share with the grandmothers a commitment to bringing real and meaningful improvements to the health issues plaguing the people of the developing world, especially those who are most vulnerable, children and mothers.

The House of Commons Standing Committee on Industry, Science and Technology recently completed an extensive review of Bill C-393. The committee heard that Canada's Access to Medicines Regime, in its current form, enabled Canada to deliver two shipments of approximately 15 million tablets of an HIV-AIDS drug to Rwanda in 2008 and 2009.

This makes Canada the only country to have successfully exported generic versions of patented drugs to a developing country using a system like Canada's access to Medicines Regime, a significant achievement to be sure.

The committee also heard testimony that made the following point very clear. African countries depend on medicines from countries such as India, not Canada as some have suggested. The rationale is basic economics: they cost less. They cost less to produce and ship and systems are already in place that see millions of generic copies of patented drugs shipped from countries like India to the developing world.

This is why our government's primary effort to combat the shortage of drugs in the developing world has been focused on direct support to NGOs in Africa or to the global fund to fight AIDS, tuberculosis and malaria. Supporting these worthwhile initiatives is the most effective means to help those in need.

However, that is not all that our government has done. In budget 2010 the government reaffirmed its commitment to double international assistance, bringing Canada's total international assistance to approximately $5 billion

. Working with the Bill and Melinda Gates Foundation, our government is at the forefront of the effort to develop an HIV vaccine, possibly one of the greatest medical breakthroughs of our time.

The committee heard from Dr. Frank Plummer, a world-leading HIV-AIDS researcher and specialist in infectious diseases, who said that to address this issue “we need multiple mechanisms, and the Government of Canada is doing that”.

We will continue to do just that by focusing our efforts on worthwhile results-based initiatives worldwide. Our government's concerns with Bill C-393's proposal to water down Canadian patent laws are shared by members of the opposition, too.

To quote the Liberal member of Parliament for Esquimalt—Juan de Fuca, I would note the following. He says:

Patents are not an obstacle to accessing medicines in developing countries. In the words of Uganda's President Yoweri Museveni, the debate about changing patent rules for drugs is a "red herring.

The notion that patent laws stand in the way of shipping drugs to Africa is simply false.

At the conclusion of the review by the Standing Committee on Industry, Science and Technology, committee members voted to substantially amend Bill C-393.

These amendments were considered necessary by some members of the committee to ensure that the bill would both respect Canada's international trade obligations and maintain the integrity of Canada's framework for encouraging innovation and access to medicines for Canadians.

However, I still have reservations with the amended Bill C-393, which is why I cannot support it. In particular, I am concerned that, unlike the existing Access to Medicines Regime, the amended Bill C-393 does not include sufficient safeguards to ensure that drugs authorized for export are used for humanitarian purposes only and cannot be sold on the black market.

As well, the amended Bill C-393 does not have the necessary components to respect Canada's international trade obligations.

I, and I am sure other hon. members as well, am committed to improving the poor health conditions of people living in the developing world. In my opinion, the most effective way to do this is to improve the basic health infrastructure in the developing world. Low-income countries lack the trained medical staff, access to clean water, accurate diagnostic equipment, and reliable power that are crucial to improving health outcomes.

Canada needs to help these countries by continuing to support funds that assist countries to procure essential medicines, by providing technical assistance to help those countries navigate the drug procurement process and by helping to train qualified health professionals. All of this is in an effort to ensure that the primary health care needs of the world's most vulnerable citizens are being met. We need to focus on what works.

We heard before the committee that in 2003, 400,000 Africans were being treated for HIV-AIDS. In 2010, that 400,000 will grow to 5.2 million people. We need to continue to focus on what makes a difference in the lives of those people.

The testimony provided to the committee was essential to getting to the heart of Bill C-393 and its well-intentioned but flawed reform of Canada's Access to Medicines Regime. Access to health care in developing countries is a multifaceted issue. Neither Canada's Access to Medicines Regime nor the changes proposed by the bill currently before us will provide the additional health care professionals, infrastructure and other tools necessary to effectively administer life-saving drugs in Africa.

As our colleague, the member of Parliament for Esquimalt—Juan de Fuca, so succinctly stated recently:

Changing [Canada’s Access to Medicines Regime] will have no effect on the ability of [Low Income Countries] to acquire medicines and medical supplies that are beyond their means to purchase or administer in the first place.

Bill C-393 is not the answer to solving the access to medicines issue. It is for this reason that I urge members to not support Bill C-393.

Patent ActPrivate Members' Business

March 3rd, 2011 / 5:50 p.m.
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Liberal

Raymonde Folco Liberal Laval—Les Îles, QC

Mr. Speaker, unlike the hon. member across the way, I am supporting Bill C-393, which aims to correct the major issues with Canada's Access to Medicines Regime, or CAMR.

It is true that the regime is not currently operating, but reforms could change that. CAMR has provided only one drug to one country since it was created by Parliament more than six years ago. We cannot expect the regime to be used again if it is not effectively reformed.

Doctors Without Borders told the committee that it had tried many times to use the regime to get drugs to patients, but that it had given up because of pointless hurdles in the legislation. Developing countries have said that CAMR is not flexible enough, that it contains too many restrictions and that it is not compatible with their procurement processes. Only one Canadian generic drug manufacturer used the regime, and it then said that it would not use the complex process again. But it is important to note that the manufacturer publicly committed to using the regime again if it were simplified, for example, to export a long-awaited pediatric formulation of an anti-AIDS drug that is not currently available from any other source.

Canadians want Parliament to take action to fix CAMR. According to a national poll, 80% of Canadians support reforming Canada's Access to Medicines Regime to make it more workable and to help developing countries get access to more affordable life-saving medicine. So do dozens of prominent Canadians, including our former prime minister whose government enacted CAMR, and many leading Canadian organizations, including all those that recently issued an open letter on World AIDS Day to our colleagues in the House of Commons.

We need to make sure that competition makes these drugs affordable. This is critical for developing countries and has already been recognized by Canada and all the other member countries of the World Trade Organization, the WTO. The ability to procure lower-cost generic versions of expensive patented drugs is the most important factor in making it possible to treat and save the lives of 5 million HIV-positive people in low- and middle-income countries. Another 10 million people living with HIV also need these drugs. There is an urgent need for competition in order to obtain and increase access to affordable generic drugs, and this need will continue in developing countries.

At the core of Bill C-393 was, and should be, a proposal to streamline CAMR with a simplified one licence solution. This approach would eliminate the regime's current requirement for separate negotiations with patent-holding pharmaceutical companies for individual licences for each purchasing country and each order of medicines. It would also remove the requirement to determine and disclose in advance of even being able to apply for a licence to export to a single recipient country and a fixed maximum quantity of medicines. These unnecessary requirements have proven to be the major stumbling blocks to the use of CAMR.

Independent legal experts have repeatedly confirmed that the reforms in Bill C-393, including the one-licence solution, are compliant with Canada's obligations as a member of the WTO, unlike what my colleague across the floor said. This includes a world-renowned expert who appeared before the Standing Committee on Industry, Science and Technology, as well as experts brought together last year by the United Nations Development Program in order to examine Bill C-393 in relation to Canada's WTO obligations.

The proposed reforms in Bill C-393 offer value for money and its proposed changes to CAMR would cost taxpayers nothing. In fact, the one licence solution in Bill C-393 would make Canadian foreign aid more effective because limited resources could purchase more medicines and would also free up scarce resources to invest in making health systems stronger.

Scaling up access to treatment also means greater opportunities for producing and distributing good quality, Canadian made generic medicines, meaning more business and more jobs in addressing oppressing global health needs.

CAMR is not working rapidly and easily precisely because it requires one specific country and a fixed quantity of medicines to be determined and disclosed in advance before seeking a licence is even possible. It took years to get to the point of getting even one licence issued because of this. Claiming that it only took 68 days for the process to work is misleading because it ignores the entire process that was and is required. The one licence solution would streamline the process so that it can work.

Bill C-393 does not weaken measures aimed at ensuring the delivery of quality medicines to patients. The amendment to restore the one-licence solution will ensure that all medicines exported under the regime would still be reviewed by Health Canada. Furthermore, all of the regime's existing safeguards against diversion of medicines would remain unchanged.

Streamlining CAMR does not jeopardize pharmaceutical research and development, including those carried out in Canada. CAMR authorizes exports of generic versions of patented medicines to certain eligible countries only. These countries were already agreed upon by Canada and all WTO members in 2003 and are already reflected in the current CAMR, as created unanimously by Parliament in 2004. These countries represent a small portion of total global pharmaceutical sales and the profits of brand name pharmaceutical companies. Furthermore, the brand name drug companies are entitled to receive royalties on sales of generic medicines supplied to these countries under CAMR.

As for the amendment to include a sunset clause, there is no valid reason to include such a clause, which would automatically kill the crucial improvements needed for the CAMR after they have been in effect for just a few years. On the one hand, the need for more affordable medicines in developing countries could unfortunately remain a reality for many more years to come. On the other hand, it is no secret that the regime is flawed and, as a result, there is almost zero chance that it will ever be used again unless it is simplified.

So why would Parliament bother making improvements to the regime to make it more effective, only to turn around and put an expiry date on those improvements through a sunset clause, to return to the current system, which has proven untenable?

I support Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, and I invite my hon. colleagues to also vote to support it.

Patent ActPrivate Members' Business

March 3rd, 2011 / 6 p.m.
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NDP

John Rafferty NDP Thunder Bay—Rainy River, ON

Mr. Speaker, I am pleased to stand today to talk about Bill C-393. In fact, I am pleased that my friend from Ottawa Centre put his name to the bill and is giving me the opportunity to do just that.

As I listened to the various debaters today, it occurred to me there were some myths that perhaps I might have an opportunity to debunk today. I hope everyone is listening carefully as I do that.

The bill was first introduced almost two years ago in the House. The intention was to address deficiencies and limitations in Canada's access to medicines regime that have rendered it cumbersome and very user-unfriendly.

Parliament can and must deliver on its promise to people in developing countries struggling with the burden of such public health problems as AIDS, tuberculosis and malaria.

I will deal with myth number one. The myth is that Bill C-393 would weaken current safeguards aimed at ensuring medicines are not diverted and illegally resold. Critics of Bill C-393 have previously claimed that it would weaken Canada's medicines regime and the existing measures to prevent the diversion and illegal resale of medicines, or that it would allow substandard medicines to be exported to developing countries. These claims were never accurate. In any event, such objections can no longer stand since the relevant clauses were removed at committee and are no longer part of Bill C-393.

All of the requirements to disclose quantities of a medicine being shipped and to which countries are being preserved. These safeguards were already deemed satisfactory by Parliament when it first created Canada's medicines regime.

Myth number two is that Bill C-393 would remove measures to ensure the quality of medicines being supplied to developing countries. This claim is simply not true. Under Bill C-393 as it now stands, a Health Canada review would continue to be required for all drugs exported.

Myth number three is that the amendments in Bill C-393 would violate Canada's obligations under the World Trade Organization's treaty on intellectual property rights. In detailed analysis, including by some of the world's leading legal experts on the subject, have shown that this is not correct. All countries at the World Trade Organization, including Canada, have repeatedly and explicitly agreed that issuing compulsory licences on patented medicines to facilitate exports of lower priced generic medicines is entirely consistent with World Trade Organization rules.

The next myth is that Bill C-393 and the one licence solution would authorize unfair competition for brand name pharmaceutical companies. We heard my friend from Ottawa Centre and a number of other speakers today mention the one licence solution. The claim makes no sense. The proposed one licence solution would not, as some inaccurately claim, create unfair competition for brand name pharmaceutical companies.

To be clear, nothing in Bill C-393 prevents brand name pharmaceutical companies from competing to supply their patented products to developing countries. Rather, Bill C-393 simply aims to enable competition by generics to supply those eligible countries and preserves the requirement that generic manufacturers pay royalties to patent holding pharmaceutical companies in the event of any compulsory licence being issued.

Bill C-393 is about making workable something already endorsed by Parliament.

Another myth is that Canadian generic manufacturers will not be able to supply medicines at prices that are competitive with generic manufacturers elsewhere. This claim is simplistic and unfounded. The goal is not to get business for Canadian companies. The goal is to get quality medicines at the lowest possible price for as many patients in developing countries as possible. However, it makes no sense to simply assume that Canadian companies cannot compete globally because they already do.

My friend from Edmonton—Mill Woods—Beaumont was talking about the inability of countries to actually deal with the issue and to work with the drugs. That is a another myth that I will debunk.

The barrier to greater access is not the price of medicines but rather widespread poverty and inadequate health systems. The myth is that widespread poverty, inadequate health systems and not enough doctors, clinics, nurses and so on are the barriers to delivering these.

I spent almost six years living in west and southern Africa working for a Canadian aid organization and I can tell the House that there are multiple barriers to accessing medicines in the developing world which vary from country to country and even community to community. However, major progress has been made in increasing access to treatment, including by strengthening health systems. It is simply inaccurate to claim that the quality of health or physical infrastructure in some developing countries presents an insurmountable challenge to delivering affordable medicines.

For example, with determination and innovative approaches, AIDS treatment is being delivered effectively in some of the most resource limited settings imaginable. In just a few years, millions of people have been put on life-saving AIDS drugs in developing countries, thanks to both effective global investments in health systems, for example through the global fund to fight AIDS, tuberculosis and malaria, and the use of generic medicines purchased at dramatically lower prices.

Every credible organization and expert recognizes the obvious fact that the price of medicines is a key factor affecting access to those medicines and that the price of medicines prevent many patients with HIV or numerous other conditions from accessing life-saving treatments. Prices are higher when medicines are only available from brand name pharmaceutical companies that hold patents on those medicines. Instead of the word patents we could use monopolies if we wish.

Making medicines affordable, strengthening health systems and other initiatives to tackle poverty and improve health in developing countries are not mutually exclusive. Rather, they are complementary and all are necessary. All the clinics, doctors and nurses in the world will not be able to help patients if medicines are priced out of reach, and that is the bottom line, and that is why we have this bill before us today.

Patent ActPrivate Members' Business

March 3rd, 2011 / 6:10 p.m.
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NDP

Jim Maloway NDP Elmwood—Transcona, MB

Mr. Speaker, I am very pleased to be speaking once again to Bill C-393. I want to recognize Judy Wasylycia-Leis, the former member for Winnipeg North, who did a terrific job in this House for the whole 12 years she was here, particularly with respect to this bill.

It seems so typical that when we find issues like this, we always seem to be up against the Conservatives who are finding ways to oppose bills like this, seemingly always taking the side of big business and the drug companies, trying to put up roadblocks to the good work that was done by the member. Now I recognize there are a few members across the way who have supported the bill, but in a general sense, we predictably find the Conservatives supporting the corporate agenda.

I want to also thank the Bloc because it has made some amendments that actually change the bill in an extremely substantial way. Prior to this, we were looking at a five-year sunset clause. Five years is a very short period of time for something like this, particularly when we recognize how long it takes Parliament to get anything done in terms of legislation. Amending it to deal with a 10-year review seems a much more reasonable approach, and I want to thank the Bloc for that.

There are a number of issues that we can deal with on the bill. I know I do not have a lot of time, but we are talking about over 16,000 lives lost per day in the world to HIV, tuberculosis, malaria and other treatable infectious diseases, according to the Global Fund. In 2009, 33.3 million people around the world were living with HIV-AIDS; 1.8 million of them died from the infection and 260,000 of them were children. Ninety-seven per cent of the people infected with HIV-AIDS live in low- to middle-income countries. Almost 15 million people infected with these diseases were in need of antiviral drugs and only 5.2 million were treated.

It is significant that we have seen in the last three or four years, Warren Buffet and Bill Gates in the United States make a commitment while they are still alive to give away half of their $50 billion fortunes and challenging other billionaires in the United States and, I believe, even around the world to participate with them. But the foundation of Bill and Melinda Gates, supplemented by half of Warren Buffet's money, showed some very good direction. They could have picked many different causes in the world, but they chose Africa and the AIDS issue as a point to concentrate on when other groups and other governments were not interested in that. Thus I want to compliment them.

I also want to compliment all of the people who were involved in the development of this bill and getting it to this stage.

Motions in AmendmentPatent ActPrivate Members' Business

January 31st, 2011 / 11:05 a.m.
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NDP

Megan Leslie NDP Halifax, NS

Mr. Speaker, every day, over 16,000 lives are lost in the world to HIV, tuberculosis, malaria and other treatable infectious diseases, according to the Global Fund.

In 2009, 33.3 million people around the world were living with HIV-AIDS, 1.8 million of them died from the infection and 260,000 of those people were children. Ninety-seven percent of people infected with HIV-AIDS live in low to middle wealth countries, and while almost 15 million infected in these countries were in need of antiviral drugs, only 5.2 million were treated.

I am pleased to speak to Bill C-393, which would fix key flaws in Canada's Access to Medicine Regime, CAMR. I have eagerly been awaiting this opportunity because Bill C-393 is a bill that I talk about a lot with my constituents in Halifax. I get letters and phone calls about CAMR. I have been to events around Nova Scotia, like the grandmothers' event, Good Words for Africa-A Scrabble Afternoon, which is a scrabble fundraiser to raise money for HIV-AIDS and to raise awareness of Bill C-393.

I get postcards from the grandmothers to grandmothers campaign. I have received letters from the HIV-AIDS Legal Network. I am a member of the all party HIV-AIDS and TB caucus, or the HAT caucus, where I have listened to Stephen Lewis and James Orbinski talk about Bill C-393. I have received Facebook messages and tweets. I have been stopped on the streets. I have talked to students, doctors, community activists, retired politicians, health policy experts and grandmother after grandmother about this legislation. They have all said the same thing, which is to support Bill C-393 in its original form.

One letter I received was from the international NGO, OXFAM. I would like to read this letter to my colleagues in the House because it effectively communicates everything we need to know about this bill. It reads:

Dear Member of Parliament,

You have an amazing opportunity right 2at would save lives around the world, without costing Canadian taxpayers a dime.

In many places in the world, countless people are dying every day of AIDS, Tuberculosis, Malaria and a host of other diseases.

But these deaths are preventable. What these countries need is access to generic medications.

The good news is: The political will exists to ensure this access. In 2004, Parliament unanimously passed legislation creating Canada’s Access to Medicines Regime (CAMR).

The bad news is: CAMR is broken.

As the legislation functions now, generic drug manufacturers are required to negotiate with patent holders on a country-by-country and drug-by-drug basis, before they are able to distribute affordable life saving medicines. Due to this complexity and difficulty of use, CAMR has been deemed unworkable in its present form.

In more than six years, CAMR has resulted in only one order of one AIDS drug to one country.

But wait! There is more good news: Bill C-393--in its original form--would solve this problem. It contains a one-licence-solution, which would eliminate the need for separate negotiations with patent-holders for each purchasing country and each order of medicines. It would provide a more workable process to get affordable medicines for people in developing countries. And it would do all of this while meeting every one of Canada’s international legal obligations, including WTO rules.

Please commit to voting to restore the “one-licence” solution to Bill C-393.

You will be directly responsible for saving lives.

Thank you.

As I said, this is a letter that many of my colleagues in the House would have received from OXFAM. It does not get any simpler than that. As members of Parliament, as representatives of our communities, we could be directly responsible for saving lives. Or, we could all be implicated in Canada's refusal to help and watch by the sidelines as more and more people die. It is up to each and every one of us in this House to make a decision about what side of this issue we are on.

CAMR is not working now but reforms can make it work. As we have heard, CAMR has only delivered one medicine to one country since Parliament created it more than six years ago. There is no expectation that CAMR will be used again, unless it gets fixed.

Médecins sans frontières, Doctors Without Borders, testified before committee that it tried for months to make use of CAMR to get medicines for patients but, ultimately, it abandoned this effort because of unnecessary hurdles in the law. Only one generic drug manufacturer has been willing to use CAMR and said that it would not try this process again. However, it has publicly committed to using the system again if it were simplified to make a version of an AIDS drug that is needed to treat children with HIV, a drug that is not currently available from any other source.

Streamlining CAMR does not jeopardize pharmaceutical research and development, including here in Canada. CAMR only authorizes exports of generic versions of patented medicines to certain eligible countries and these countries were already agreed upon by Canada and all WTO members in 2003 and are already reflected in the current CAMR as it was created by Parliament in 2004.

These countries represent a very small portion of the total global pharmaceutical sales and profits of brand name pharmaceutical companies. Further, the brand name drug companies are entitled to receive royalties on sales of generic medicines supplied to these countries under CAMR.

Bill C-393's proposed reforms offer value for money for Canadians. These changes cost taxpayers nothing. In fact, Bill C-393's one-licence solution would make Canadian foreign aid more effective because limited resources could be used to purchase more medicines and would also free up scarce resources to invest in making health systems stronger. Scaling up access to treatment also means greater opportunities for producing and distributing good quality, Canadian-made generic medicines, meaning more business and more jobs in addressing a pressing global health need.

We are here today debating amendments that I have introduced at report stage. We have had to introduce these amendments because Conservative and Liberal members of the industry committee worked together to strip some of the most critical aspects from the CAMR legislation, like the one-licence solution.

We have heard criticism about this bill and we are willing to compromise. We are willing to work with parties to reach across the House and work together to ensure this important legislation passes. We have brought forward only two amendments in an effort to make Parliament work and get this legislation passed.

However, at the core of Bill C-393 is and should continue to be the one-licence solution. This approach would eliminate CAMR's current requirement for separate negotiations with patent-holding pharmaceutical companies for individual licences for each country and each order of medicines.

It would also remove the requirement to determine and disclose in advance of even being able to apply for a licence to export a single recipient country and a fixed maximum quantity of medicines. These unnecessary requirements have been proven to be the major stumbling blocks to the use of CAMR. The one-licence solution was removed by committee by a slim majority when it deleted clause 4 of Bill C-393 in spite of the fact that it had clear support at second reading.

Canadians want Parliament to take action on the Canadian access to medicines regime. According to a national poll, 80% of Canadians support reforming Canada's Access to Medicines Regime to make it more workable so that we can help developing countries get access to affordable and life-saving medicines. Dozens of prominent Canadians have come on board to say that this is the way we should be moving, including the former prime minister whose government enacted CAMR.

In honour of World AIDS Day, a group of prominent Canadians wrote a letter to members of Parliament asking them to support Bill C-393. Some of the signatories to this letter included: the right hon. Paul Martin, the former prime minister of Canada; Janice Alton, national co-chair, Canadian Voice of Women for Peace; Richard Bedell, medical advisor for Dignitas; Nigel Fisher, president and CEO of UNICEF; Robert Fox, executive director of Oxfam; Michael Geist, Canada Research chair of Internet and E-commerce Law at the University of Ottawa; Karen Kain, artistic director at the National Ballet of Canada; Alexa McDonough, former member of Parliament; Steve Morgan, researcher at the University of British Columbia; and David Suzuki, Companion of the Order of Canada. As members can see, there are pages and pages of signatories.

Canadians want this legislation to pass and they want all parliamentarians to work together to ensure it passes. I hope every member will stand and vote for these amendments and support Bill C-393.

Motions in AmendmentPatent ActPrivate Members' Business

January 31st, 2011 / 11:15 a.m.
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Bloc

Luc Malo Bloc Verchères—Les Patriotes, QC

Mr. Speaker, it is my turn, after the member for Halifax, to speak to Bill C-393, which would amend Canada's access to medicines regime. Before I speak directly about Motions Nos. 1 and 2 moved by the member for Halifax and Motion No. 3, which I moved, I would like to talk about the study we did in parliamentary committee.

When the parliamentary committee was studying this bill, I informed the committee chair that it would be important to take a closer look at Canada's access to medicines regime because it had been used only one time. We wondered why this regime, which was meant to provide ongoing access to medicines, particularly antiretrovirals, for African countries and all disadvantaged countries, was used only once and what kinds of changes would have to be made to it. More generally, how could we change how the different partners involved in this regime acted so that it was used more? Some witnesses told us that the regime worked, yet many people had used it only once. My colleague spoke about groups that had written to her and that came to tell us in committee that they would like to see the regime used more.

I told the committee chair that we needed to hear as many witnesses as possible and that the study needed to be broadened to include the entire regime, not just the bill that had been introduced by the former member for Winnipeg North. The study began and we heard from many witnesses. Unfortunately, I did not get the feeling that my colleagues around the table wanted to go beyond the bill and study Canada's access to medicines regime in its entirety.

When it comes down to it, all members of the House should hope that a regime put in place by Parliament in 2004 is used and that countries in need of low-cost medications have greater access to them, especially when witnesses told the committee that, in the case of antiretroviral drugs, many of these disadvantaged countries need access to second- or even third-generation drugs, which are not currently available in generic form.

This is why it was important to go beyond the bill and study the regime. However, because other members clearly refused to do so, we had to stick to Bill C-393 and study its merits, hence the analysis of the various motions before us.

As the member for Halifax mentioned, the Bloc members who sit on the committee voted in favour of all of Bill C-393's clauses, including those that referred to the one-licence solution.

Basically, when examining a bill like Bill C-393, we need to look at what it is all about and what is at the core of the bill. When we looked at Bill C-393, it was clear that its key element was the one-licence solution, which is why the hon. member for Halifax had to reintroduce that element. Motions Nos. 1 and 2 reintroduce clauses that the Bloc Québécois has already voted to support.

Now I would like to move Motion No. 3, which I had placed on the order paper on December 15, 2010, and which is in fact a sunset clause. I will not take the time to reread the motion, since the Speaker already read it when introducing the motions under consideration.

Why do we feel that a sunset clause is necessary? Quite simply, to sum everything up and to connect, in a way, all of the testimony we heard in committee. Many witnesses said they wanted to improve access to medications, that is, facilitate the sale and production of drugs in order to make them more accessible, which is what Bill C-393 is all about. Keeping this bill intact would serve to address the concerns expressed by this group of witnesses, since the sunset clause would not affect the other clauses of the bill.

Witnesses also pointed out that by changing Canada's access to medicines regime, Bill C-393 might be in violation of WTO rules. No one in the House would want to introduce or enact legislation that would violate WTO rules. In fact, Canada is calling on its trade partners around the world to comply with these very rules; we therefore would not want the legislation we are passing to violate those rules.

What is more, some fear that the changes made to the regime will simply make it a vehicle for exporting drugs on a large scale, which is inconsistent with the very spirit of this humanitarian regime. They fear that the fundamental purpose of the regime—to provide help—will be lost, and they want the regime's core purpose, namely to aid countries in need of inexpensive drugs, to be preserved.

Officials told us that nothing would change and that even amending the regime through Bill C-393 would change nothing. There need to be concrete examples and facts proving that Bill C-393 can indeed work and that the regime it is amending is an effective regime that is not breaking any rules.

The purpose of the sunset clause is simply to reassure everyone and to ensure that when the four years are up, we have solid examples and can resume the debate calmly with much more on the table than just the example of Rwanda with the current regime. Then in the House and in committee, we can base our discussions on reality, on concrete evidence and on the advances that will have been made through the changes Bill C-393 is making to Canada's access to medicines regime.

Motions in AmendmentPatent ActPrivate Members' Business

January 31st, 2011 / 11:25 a.m.
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Conservative

Mike Wallace Conservative Burlington, ON

Mr. Speaker, I want to welcome back everybody to the House after the Christmas break. I am very happy to back.

I am pleased to have the opportunity to discuss Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, and to address the motions that some of my colleagues have put forward to amend the bill at report stage. However, before I discuss Bill C-393 and the motions, I will take a few minutes to highlight Canada's commitment to improving the health conditions of people living in the developing world. This will provide important context given that the laudable goal behind Bill C-393 is to improve the access to medicines in developing countries.

I am sure I can speak for all hon. members in expressing support for this excellent humanitarian goal. However, in my opinion, the most effective way to improve the poor health conditions of people living in the developing world is not by changing Canada's Access to Medicines Regime, as Bill C-393 and other motions today propose to do, but by helping to ensure that primary health care for the world's most vulnerable citizens, the mothers and their children, are being met.

As a result, I stand proudly behind the recent announcement by Prime Minister Harper—

Motions in AmendmentPatent ActPrivate Members' Business

January 31st, 2011 / 11:25 a.m.
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Conservative

Mike Wallace Conservative Burlington, ON

Mr. Speaker, Canada will provide support to improve maternal and child health care to several developing countries as part of its five-year commitment to the Muskoka initiative. As part of this initiative, Canada will provide support to improve the nutrition and health of three million pregnant and nursing women and their children in Ethiopia.

In addition, the government will strengthen the national health system in Mozambique to develop health services for mothers and children, providing life-saving HIV treatment to 38,000 children, treating 94,000 pregnant women and preventing HIV infections, and immunizing 2.8 million children over the age of five against measles.

Canada's support will also help to strengthen maternal and neonatal health services in Bangladesh through the purchase of essential drugs and equipment; the recruiting and training of health care professionals, including 2,000 new skilled community birth attendants; the upgrading of existing treatment centres; and by helping to purchase enough oral polio vaccine for 250,000 children annually.

I will now turn to discussing my concerns with Bill C-393, followed by the motions before us today at report stage.

I would like to remind the House that this is not the first time I have stood up to speak to this bill. I spoke to it before it went to committee. I actually supported it going to committee so we could hear the discussions. I want to thank my colleague from the Bloc, who attended those meetings and provided valuable input.

In October 2010, as we all recall, Bill C-393 underwent an extensive review by the House of Commons Standing Committee on Industry, Science and Technology, a committee of which I am a member. I would like to congratulate the members of the committee for their commitment to hearing testimony from a wide array of witnesses. Among those who shared their views on the access to medicines initiative for the developing world were experts in the field of international trade and patent law, representatives of non-governmental organizations with experience working in Africa, and government officials with knowledge of the historical background and technical implications of Canada's access to medicines regime.

Through this extensive testimony, the committee was well informed of the international drug procurement framework and trade obligations within which Canada's access to medicines regime must operate.

The committee also heard that Canada's access to medicines regime is only one element of the government's plan to improve health outcomes in developing countries, and that Canada is active in supporting programs like the Muskoka initiative on maternal and child health, which will have a significant effect on improving health conditions in poor countries.

The committee also heard evidence that there is a large economic context to providing affordable health care, including drugs, to low income countries, and that poverty, not patents, is the major obstacle to health access in developing countries.

Finally, the committee heard that Canada's access to medicines regime is working in its current form. The two shipments of 15,600,000 tablets of HIV-AIDS drugs to Rwanda in 2008 and 2009, after the country made a request for the drugs, is proof that it does work. It may not work to the efficiency and effectiveness of many we have heard from, but in its present form it does work. If it is compared with the access to medicines regimes in other countries, Canada is the only country around the world that has actually been able to use the system to deliver drugs to a third world country, a country in need.

In my view, along with what my colleague from the Bloc has said, that tells me that the regimes as set up now are not working to people's satisfaction. However, that does not mean that the regime we have is not set up in a proper, legal, and effective form. Maybe we should be looking at a broader review of what we can do to make sure we provide HIV drugs to those countries in need.

At the conclusion of the committee's review, members voted to substantially amend Bill C-393. One of the changes the committee considered necessary was the removal of the clauses that would allow Canada's access to medicines regime to be used by generic companies to export any amount of any drug to almost any country, including some that are relatively well off. This is sometimes known as the one-licence solution.

It is my understanding that the committee considered the elimination of the one-licence solution and the other changes to Bill C-393 necessary to ensure that the bill respects Canada's international trade obligations and maintains the integrity of Canada's framework for encouraging innovation and to ensure access to medicines for Canadians.

My key concern with the motions before us today is that they seek to undo all of the good work of the committee and they undermine the conclusions our fellow members of Parliament reached after careful review of Bill C-393.

In addition, I have particular concerns with Motion No. 3. The motion is original, in that it proposes to implement changes to Canada's access to medicines regime on a trial basis; first, for an initial period of four years, and then for a further five years, if both Houses agree.

As I have said, during the committee's review of Bill C-393, several witnesses noted that Canada's access to medicines regime works to send drugs to developing countries in need. It is the only regime, as I have said, of its kind in the world to have had this kind of success. As a result, it is our view that Canada's access to medicines regime does not need the changes that Bill C-393 proposes on a temporary basis.

I am also concerned that allowing provisions of Bill C-393 to have a temporary effect would be harmful because it would do nothing to improve primary health in developing countries. In our government's opinion, the best way to improve primary health care is through programs such as the Muskoka initiative that actively work to improve poor health conditions in African countries.

For all of these reasons, I am of the view that none of the motions to amend Bill C-393 should be accepted today by members of Parliament and that at third reading this bill should be defeated. Canada's access to medicines regime works and does not requiring changing.

In reviewing Canada's initiatives on access to medicines, the needs of developing countries must be balanced with the needs of Canadians. In sending over 15 million tablets of HIV-AIDS drugs to Rwanda, the current access to medicines regime has demonstrated that it achieves this balance; and the regime would not be improved by Bill C-393 or the motions put forward today. Therefore, I ask my colleagues not to support the report stage motions to amend Bill C-393.

Finally, Mr. Speaker, I want to thank Elizabeth Rennie and her team of grandmothers. Grandmothers to Grandmothers has come to see me many times. I have been very clear to this organization that I think the bill needs changes and that it would not have any effect on our being able to provide the drugs the organization would seek for African countries. This was passed by all parties. I think all parties should look at what we can do to continue to provide support for those countries, but I do not think it is through changes to this regime.

Motions in AmendmentPatent ActPrivate Members' Business

January 31st, 2011 / 11:35 a.m.
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Liberal

Joyce Murray Liberal Vancouver Quadra, BC

Mr. Speaker, I am pleased to be back in the House today and would like to welcome all members back to this first day of the 2011 session.

I am also very pleased to debate this topic again. I spoke to it last in November 2009. Since then there has been considerable work done on Bill C-393, a bill that proposes to amend Canada's access to medicines regime. However, I would like to touch again on the reason this matters.

I was born in South Africa and spent much of my childhood there. I went back in 2002, and visited Soweto and people there knowing full well that 50 per cent of the people in Soweto at that time were infected with the HIV-AIDS virus. That meant that of every child born to an infected mother, one out of two was infected with the AIDS virus, and of every baby born who was infected with the virus, one out of two, or half, would not live past their second birthday. This is also a humanitarian tragedy in Africa.

I visited with a cousin who was a manager in an important industry in South Africa. I asked how the economy was doing, and he said that one of the key challenges was that with the prevalence of AIDS in South Africa, people were being trained to be managers, technicians, professionals, and workers but then leaving and dying early because of the AIDS scourge. Therefore, it is also an economic tragedy in South Africa.

In Africa approximately five million people have access to AIDS treatments comparable to what we have in Canada, but 10 million people in Africa do not. That is why the bill for CAMR was put forward in 2004 by a Liberal government to provide access to such medicines and to enable Canadian companies to export low-cost, generic drug cocktails to help lessen those tragedies.

Although the hope was that there would be a flow of royalties to Canadian companies and a flow of life-giving medication to Africans who required it, that bill just did not work. The legislation was flawed with bureaucratic and institutional barriers that made it unworkable. Essentially, only one contract was signed and implemented under that law. Therefore, Bill C-393 was put forward as a solution to address those problems and make it easier accomplish the objectives of CAMR.

There are members in the House who believe that Bill C-393 is imperfect and does not do enough to address systemic problems in providing access to affordable AIDS medication in Africa. I understand that reasonable people can sometimes disagree on the means to a common end: supporting Canadian businesses and those people in Africa who need medication for AIDS.

To those MPs, I would say that the motion for the one-licence solution that is at the core of the bill must reinstate the latter for Bill C-393 to become meaningful, and that it will help. There have been many credible witnesses before the committee who said that Bill C-393 , while perhaps not being the full solution to AIDS in Africa, would improve access to affordable AIDS medication for people who are dying without it, as well as protecting the interests of the patent owners of those medications. Let us help the Africans and support Bill C-393 and its one-licence solution.

I would like to make a few comments beyond the direct implications of the bill.

Imagine if the 10 million people in Africa currently carrying the HIV-AIDS virus and suffering and dying from AIDS were receiving the drug cocktails that turn this dreadful killer of a disease into a chronic yet manageable one, as we are doing in Canada. Imagine the well-being that would result in Africa and the economic and human implications of doing so.

Another piece that is starting to become clearer is drug cocktails. These medications prevent the transmission of AIDS. This is a very important point and an important underpinning for passing Bill C-393 with the one licence solution intact.

Drug cocktails lower the viral load of an AIDS patient to undetectable levels, which means they do not allow the disease to be transmitted. These cocktails are proving to be an almost 100% prevention mechanism. Treatment equals prevention. With access to these medicines people will no longer suffer the way they do without treatment and transmission of the disease will be prevented. If people who have contracted HIV-AIDS are fully treated, millions of others will be prevented from contracting AIDS each year. It is even more urgent that Canada support making affordable drugs available in Africa.

Unfortunately, the Conservative government is ignoring this prevention aspect of HIV-AIDS treatment. It has provided absolutely no support for pilot projects in Canada. There is a provincially funded pilot project in my province of British Columbia which seeks out AIDS sufferers who are not aware they have contracted the virus, or are incapable of managing their own treatment, so that they can be treated and the transmission of AIDS in Canada can be reduced. Six thousand people a year contract AIDS in Canada unnecessarily. With proper treatment, AIDS would no longer be transferable.

I would urge Conservative MPs to recognize the importance of AIDS medications as being not only treatment but prevention too. I would urge my colleagues to support prevention funding and projects here in Canada and abroad, which is what we are talking about with Bill C-393.

One member referred to Dr. James Orbinski, head of Doctors Without Borders. He has led this organization through some of the worst and most wrenching conflicts in Africa: Somalia, Rwanda and Darfur. Dr. Orbinski received a Nobel Prize on behalf of Doctors Without Borders. He has a great deal of credibility both as a medical professional and as someone who has worked in Africa on this issue. Dr. Orbinski commented that the possible failure of Bill C-393 with its one licence solution reinstated would be as unconscionable as leaving a room full of AIDS patients to die simply because they are poor and African.

Members on all sides of the House have big hearts. We want to see improvements in AIDS treatment in Africa and affordable medicines as part of that. I would urge all members to think about the foundational reasons of the importance that this bill go forward and soon. Lives are at risk every day that we wait.

We cannot let our brothers and sisters in Africa down. We must fix CAMR so these treatments can be provided affordably and soon. Humanity depends on it. I urge all members of Parliament to support Bill C-393 with its one licence solution.

Motions in AmendmentPatent ActPrivate Members' Business

January 31st, 2011 / 11:45 a.m.
See context

NDP

Brian Masse NDP Windsor West, ON

Mr. Speaker, I want to thank the member for Halifax for her great work on the bill. I also want to thank the members who spoke in favour of the bill. The bill is very important. Since 2003 I have been trying to get the law amended or fixed properly. It was Bill C-56 originally.

I want to impress on members that we can make a difference. We can choose to make it happen. We have proposed under Bill C-393 WTO and TRIPS agreement compliance. By that I mean that it abides by all international laws. There can be no other excuse used during this debate. If members do not believe me, they can believe the Library of Parliament's independent research which shows that what we are proposing here today is legal internationally. If we want to make a difference, we can do it now.

Back in 2004 I spoke in this chamber about the law that we passed and my fear that it was built to fail. It has failed. There has been one application. Apotex got one drug into Africa, despite the obstacles of the bill.

We told the world something. We told the world that we would help, that Canada would stand front and centre, show respect and help people. We said that we would make sure that women, men and children would get drugs that we have on our shelves and in our plants, that they could not get because of the cost. We told that to the world. We promised the world that we would lead the way. However, the way that we did it is despicable. We made a law that does not work, which others replicated, which gave an excuse. Right now people are suffering. People are dying. That does not have to happen. Not only have we chosen to turn our backs on them, but we have given them a phony law and literally slapped them in the face. Canada, the country to which I belong, has done that.

That is a shame. I have seen that over the years as a member of Parliament. I have tried to fix it four times. I feel strongly about it. I thought about that on the way to Ottawa. I used to belong to the AIDS Committee of Windsor. Before that, I had friends in Toronto who were gay, who had AIDS, who suffered. I have seen friends die, and they had medication. It is horrible to witness the disintegration of a human being, and that is in the best of circumstances.

We have an opportunity to make a difference. We continue to hear that it is a great idea and the laurels of the bill are applauded but that it cannot work. It does work, and we need to try. We need to move the bill to the next stage. It has to go to the Senate. Let those excuses resurface there and let us find solutions. As New Democrats, that is what we have done along the way.

I have a brief time to speak today, and I have two amendments that I will propose.

We have agreed to compromise continually in this process, not only with the Conservatives, but with the Liberals and now with the Bloc. There has been an attempt, one way or another, to either gut the bill or pretend that we are doing something and then say that we are doing all these other things. That is not the point. The point is this is one tool that could end the suffering of millions of people. This is one tool in the kit that Canada could use to help people.

Even if members' worst fears occur, we could bring the bill back to this chamber and fix it again. We could bring it back right away. We do not want intellectual property stolen. It will not happen with this bill, but that is one of the excuses that has been given. We have actually included the components of criticism that members have put. Even though we did not think they were warranted, we have agreed to them. Even under the worst scenario, we could bring the bill back to the chamber and fix it right away. New Democrats are prepared to participate every single day to do that. We are here today to do that.

I want to thank some people. I want to thank Richard Elliot and the grandmothers across this country, people who care for people and understand the connection, the values and principles with which this country could lead the world.

We have told them that we have a phony law that does not give them the drugs they deserve, that they could get to actually have good health and take care of other types of problems, as opposed to a solution.

There is no other excuse. The bill is WTO and TRIPS compliant. I have heard that. Witness after witness came to the committee. The same excuses were brought forward against this bill. They were not verified. At the very least, we could try with this bill. The people who are opposed to this are worried that affordable medicines will get to people rather quickly, and even more important, will get to the types of diseases that we need to get to. If that becomes a problem because it is happening too often and too fast, then we could revisit that. The excuses we have heard make no sense whatsoever.

The drug industry has blatantly said that if we do this it is going to cost us research and development and the industry will not invest in Canada. Despite the generous corporate tax cuts, despite all the grants and subsidies the industry is getting for research development and all the other incentives that have been thrown in the mix, the industry would throw the country under the bus just because a bill could pass that would, ironically, give the industry money. The pharmaceutical companies would get money for the drugs. They would get a percentage.

Again, I want to thank every member for participating in this debate. I hope that everybody thinks about this as the bill, hopefully, goes forward.

I would like to amend Motions No. 1 and 2. Mr. Speaker, I move:

That the motion proposing to restore Clause 2 of Bill C-393 be amended by replacing the definition of “pharmaceutical product” with the following:

“pharmaceutical product” means any patented product listed in Schedule 1 in, if applicable, the dosage form, the strength and the route of administration specified in that Schedule in relation to the product and any other patented product, or product manufactured through a patented process, of the pharmaceutical sector needed to address public health problems, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics, and includes active ingredients necessary for its manufacture and diagnostic kits needed for its use.

The second amendment is long, and it is also WTO and TRIPS compliant. Mr. Speaker, I move:

That the Motion proposing to restore Clause 4 of Bill C-393 be amended by replacing the text after “4.(1) Subsection 21.04(1) of the Act is replaced by the following:” with the following:

21.04 (1) Subject to subsection (3), the Commissioner shall, on the application of any person and on the payment of the prescribed fee, authorize the person to make, construct and use a patented invention solely for purposes directly related to the manufacture of the pharmaceutical product named in the application and to sell it for export to any country listed in Schedule 2.

(2) Paragraph 21.04(2)(c) of the Act is repealed.

(3) Paragraph 21.04(2)(e) and (f) of the Act are repealed.

(4) Subparagraph 21.04(3)(c)(i) and (ii) of the Act are replaced by the following:

(i) sought from the patentee or, if there is more than one, from each of the patentees, by certified or registered mail, a licence to manufacture and sell the pharmaceutical product for export to one or more of the countries listed in Schedule 2 on reasonable terms and conditions and that such efforts have not been successful; and

(ii) provided the patentee, or each of the patentees, as the case may be, by certified or registered mail, in the written request for a licence, with the information that is in all material respects identical to the information referred to in subsection (2).

(5) Paragraph 21.04(3)(d) of the Act is repealed.

(6) Section 21.04 is amended by the following after subsection (3):

(4) The solemn or statutory declaration referred to in paragraph 3(c) is not required in the case of an application to the Commissioner for an authorization to supply the product named in the application to an eligible importing country for purposes of addressing a national emergency or other circumstances of extreme urgency in that country or for purposes of public non-commercial use, but in such cases, the Commissioner shall notify the patentee or patentees of the issuance of the compulsory licence as soon as reasonably practicable after it has been issued.

That is all about compromise by the New Democrats for those who are opposed to the bill.

Motions in AmendmentPatent ActPrivate Members' Business

January 31st, 2011 / 11:55 a.m.
See context

Conservative

Kelly Block Conservative Saskatoon—Rosetown—Biggar, SK

Mr. Speaker, I echo the comments of my colleagues here this morning in welcoming everybody back. It is good to be here and to be participating in such an important debate.

I too have had many opportunities in the past number of months to meet with representatives from Grandmothers to Grandmothers in my riding and to appreciate the commitment and compassion that they come to me with in sharing their concerns for providing this kind of aid to folks in Africa. I am thankful for the opportunity to provide my views on Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act as well as on the motions to amend Bill C-393 that are being discussed today at report stage.

Given that Bill C-393 has been under discussion in Parliament since 2009, I will begin my comments with a short review of the bill's history as well as the goals of the Access to Medicines Regime, which the bill seeks to substantially revise.

Canada's Access to Medicines Regime was developed in 2005 with three key principles in mind. The first was to provide a mechanism for developing and least developed countries to access the drugs and medical devices they need to treat HIV/AIDS, malaria, tuberculosis and other public health epidemics. The second was to ensure that Canada's intellectual property regime for patents continues to respect international obligations. The third principle was to maintain the integrity of Canada's business environment and ensure that Canadians continue to have access to the latest pharmaceutical products and innovations.

In my view, years might have passed since the regime's development, but all three of these objectives are still relevant today and must be kept in mind when considering next steps on Bill C-393. I would urge my fellow members of Parliament to also keep in mind that Canada's Access to Medicines Regime is the only one of its kind worldwide to have successfully authorized an export of drugs to a country in need. Thanks to the regime, in 2008 and 2009 over 15 million tablets of an HIV/AIDS drug were successfully delivered to Rwanda. This demonstrates that Canada's Access to Medicines Regime works as it was intended to support public health objectives.

As we may recall, Bill C-393 recently underwent an extensive review by members of the Standing Committee on Industry, Science and Technology. During this review, the committee heard from a wide array of witnesses, including technical experts in the government, representatives of several non-governmental organizations focused on HIV/AIDS initiatives, members of the pharmaceutical industry and concerned citizens. This extensive testimony thoroughly informed the committee about the health challenges facing people living in the developing world, which go beyond the issue of drug patent protection.

It is my understanding that after this extensive testimony was carefully reviewed by members of the House of Commons standing committee, the committee decided to eliminate many of the proposed changes in Bill C-393. In particular, it voted to remove clauses from the bill that would have expanded the definition of an eligible product for export under Canada's Access to Medicines Regime to any drug, and that would have allowed the regime to export any amount of any drug to almost any country for an unlimited period of time. This is sometimes referred to as “the one-licence solution”.

The trouble with this is that if the one-licence approach is applied to Canada's Access to Medicines Regime, it would allow drugs to be sent to high-income countries like Singapore, obviously counter to the original principles of the regime.

Business of the House

March 3rd, 2010 / 4:15 p.m.
See context

Liberal

The Speaker Liberal Peter Milliken

I would like to make a statement concerning private members' business. Standing Order 86.1 states that all items of private members' business originating in the House of Commons that have been listed on the order paper during the previous session shall be deemed to have been considered and approved at all stages completed at the time of prorogation.

In practical terms, this means that notwithstanding prorogation, the list for the consideration of private members' business established at the beginning of the 40th Parliament shall continue for the duration of this Parliament.

All items will keep the same number as in the first and second sessions of the 40th Parliament. More specifically, all bills and motions standing on the list of items outside the order of precedence shall continue to stand. Bills that had met the notice requirement and were printed in the order paper, but had not yet been introduced, will be republished on the order paper under the heading “Introduction of Private Members' Bills”. Bills that had not yet been published on the order paper need to be re-certified by the office of the Law Clerk and Parliamentary Counsel and be resubmitted for publication on the notice paper.

All items in the order of precedence are deemed to have been considered and approved at all stages completed at the time of prorogation. Thus, they shall stand, if necessary, on the order paper in the same place or, as the case may be, referred to the appropriate committee or sent to the Senate.

At prorogation, there were 11 private members' bills originating in the House of Commons adopted at second reading and referred to the appropriate committee. Therefore, pursuant to Standing Order 86.1: Bill C-290, An Act to amend the Income Tax Act (tax credit for loss of retirement income), is deemed referred to the Standing Committee on Finance.

Bill C-300, An Act respecting Corporate Accountability for the Activities of Mining, Oil or Gas in Developing Countries, is deemed referred to the Standing Committee on Foreign Affairs and International Development.

Bill C-304, An Act to ensure secure, adequate, accessible and affordable housing for Canadians, is deemed referred to the Standing Committee on Human Resources, Skills and Social Development and the Status of Persons with Disabilities.

Bill C-308, An Act to amend the Employment Insurance Act (improvement of the employment insurance system), is deemed referred to the Standing Committee on Human Resources, Skills and Social Development and the Status of Persons with Disabilities.

Bill C-309, An Act establishing the Economic Development Agency of Canada for the Region of Northern Ontario, is deemed referred to the Standing Committee on Industry, Science and Technology.

Bill C-310, An Act to Provide Certain Rights to Air Passengers, is deemed referred to the Standing Committee on Transport, Infrastructure and Communities.

Bill C-391, An Act to amend the Criminal Code and the Firearms Act (repeal of long-gun registry), is deemed referred to the Standing Committee on Public Safety and National Security.

Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, is deemed referred to the Standing Committee on Industry, Science and Technology.

Bill C-395, An Act to amend the Employment Insurance Act (labour dispute), is deemed referred to the Standing Committee on Human Resources, Skills and Social Development and the Status of Persons with Disabilities.

Bill C-442, An Act to establish a National Holocaust Monument, is deemed referred to the Standing Committee on Transport, Infrastructure and Communities.

Bill C-464, An Act to amend the Criminal Code (justification for detention in custody), is deemed referred to the Standing Committee on Justice and Human Rights.

Pursuant to Standing Order 97, committees will be required to report on these reinstated private members’ bills within 60 sitting days of this statement.

In addition, one private members’ bill originating in the House of Commons had been read the third time and passed. Therefore, pursuant to Standing Order 86.1, the following bill is deemed adopted at all stages and passed by the House.

Bill C-268, An Act to amend the Criminal Code (minimum sentence for offences involving trafficking of persons under the age of eighteen years). Accordingly, a message will be sent to the Senate to inform it that this House has adopted this bill.

As they are no longer members of this House, all the items standing in the name of Ms. Dawn Black, Mr. Bill Casey and Mr. Paul Crête will be dropped from the order paper.

Consideration of Private Members’ Business will start on Friday, March 5, 2010.

To conclude, hon. members will find at their desks an explanatory note recapitulating these remarks. I trust that these measures will assist the House in understanding how private members' business will be conducted in the third session. In addition, the table can answer any questions members may have.

Access to Medicines RegimeStatements By Members

November 27th, 2009 / 11:10 a.m.
See context

NDP

Judy Wasylycia-Leis NDP Winnipeg North, MB

Mr. Speaker, night has already fallen in much of Africa. Another day has passed and another 14,000 people have died needlessly from infectious diseases for which medicine is readily available, just not for them.

It is mostly grandmothers who care for the dying and who are left to piece together the shattered lives that remain. They tell us through the Grandmothers to Grandmothers Campaign, Canadian women devoting incredible energy in solidarity with their African sisters, that Canada's access to medicines regime, which was supposed to make more drugs available, is not working.

UNICEF, Oxfam, Canadian Crossroads International, Results Canada and the Canadian HIV/AIDS Legal Network all agree and have called for the changes set out in my private member's Bill C-393. I urge all members to vote for this bill to ensure that we fix Canada's access to medicines regime and get Canadian drugs moving to save lives.

Patent ActPrivate Members' Business

November 27th, 2009 / 1:20 p.m.
See context

Liberal

Bernard Patry Liberal Pierrefonds—Dollard, QC

Mr. Speaker, I am pleased to rise in this House today to add my remarks with respect to Bill C-393.

I will try to make myself as clear as possible. I firmly believe that a nation as well off as Canada has to do everything in its power to facilitate access to and distribution of medicines in countries that are suffering terribly from the crippling impact of diseases like HIV/AIDS, malaria and tuberculosis.

That is why a Liberal government—needless to say—introduced legislation to establish Canada's access to medicines regime, otherwise known as CAMR.

That piece of legislation was passed unanimously by Parliament because it reflected our Canadian values, and the compassion Canadians have for those less fortunate in particular.

As we know, Rwanda was the first and only country to test CAMR by importing HIV/AIDS drugs from the Canadian generic drug manufacturer APOTEX.

We also know that three separate pharmaceutical companies holding the appropriate Canadian patents answered the call and authorized APOTEX to manufacture and deliver the requested product without having to pay any royalties. Incidentally, I should point out that these three companies recently reiterated their offer, again, royalty free.

After receiving the authorization, it took Apotex about one year to manufacture and ship the product and an additional year to ship the remaining amount permitted under the licence.

The fact that it was the only application of CAMR in Canada, and that no other country with a similar system has ever provided generic drugs to developing countries, leads us to the following question: why is CAMR not used more?

Unfortunately, rather than carrying out an in-depth analysis of the problem, some have concluded that the problem was that the legislation, although well intentioned, had shortcomings and that amending it would make it easier to apply. This resulted in Bill C-393, which puts forward the solution of a single licence system.

If we look at the facts surrounding the shipment of generic drugs to Rwanda, we see that the patent-holding pharmaceutical companies reacted very quickly when they were contacted. From beginning to end, the mandatory licensing process took 68 days.

I am pointing this out because it is extremely important to establish whether the licensing process caused the undue delay in shipping the drugs to their destination.

From what I have just outlined, it does not seem that the CAMR legislation, in its current form, is the cause. It seems that the problem lies elsewhere.

Why did it take one year to send the first shipment if the CAMR legislation was not at issue? It is important that we be fully aware of this fact given that we are attempting to determine the true causes of the problem.

Much has been made of the issue of intellectual property rights. Some claim that the pharmaceutical companies are hiding behind our international obligations under the WTO agreement on trade-related intellectual property rights, known by the acronym TRIPS, in order to hold back the flow of generic drugs.

Recognizing intellectual property rights is crucial for the future discovery of drugs that will save lives. If we do not protect intellectual property rights, we will deprive ourselves of key research, not only in the pharmaceutical sector but in all sectors driven by research. This will have extremely negative consequences for Canada.

Dozens of new drugs to treat HIV, malaria and similar illnesses are currently being tested. Related research is absolutely critical and is being carried out by patent drug manufacturers.

In testimony he gave on October 20 before the Senate Committee on Banking, Trade and Commerce about a similar bill, Bill S-232, a lawyer for the pharmaceutical industry said that the amendments proposed in Bills S-232 and C-393 are not in keeping with Canada's international trade obligations regarding intellectual property.

Are we going to ignore that conclusion? That said, let us focus on some of the known causes of the current problem.

More than 90% of the 319 drugs on the list of essential drugs for developing countries are not patented. Less than 10% are patented. It is important to understand that.

A recent study of 65 countries by Dr. Amir Attaran, a biologist and lawyer with the University of Ottawa, found that the main barrier to access to drugs in developing countries is not the granting of a single patent licence, but poverty. Yes poverty, always poverty.

Let us look at some other realities.

If we look at the necessary drugs that reach developing countries, we see that most of them come from countries like India, China and South Africa. Why not Canada? Certainly not because of the CAMR. It is because these drugs are available for less than what Canadian generic drug manufacturers charge, which is higher because of our higher labour costs.

This is certainly one of the reasons why developing countries do not turn to Canada for drugs under the CAMR. They have cheaper options.

The challenge at present is not the supply of drugs. The supply is there. But how are we going to deal with the very real challenge posed by the fact that recipient countries lack the infrastructure to make a proper diagnosis and to deliver, distribute, administer and store drugs?

We need to turn to organizations such as Health Partners International Canada, which have extensive experience in the field in managing the distribution of drugs in developing countries that have very little infrastructure.

I firmly believe that we can work productively with these organizations to get drugs to where they are needed. I also believe that this is a much better way to achieve our objectives than what Bill C-393 offers.

According to Margaret Chan, WHO Director-General, “Health systems are the tap root for better health. All the donated drugs in the world will not do any good without an infrastructure for their delivery.”

This bill offers no solutions to the problem of drug distribution infrastructure. It should have proposed the following measures: the creation of partnerships between the private sector and NGOs, which have a lot of experience in this area, to ensure effective drug distribution; and accountability and transparency of the access to medicines regime and distribution. This bill leaves out some important requirements in this area, which could make it easier for drugs to be diverted to recipients other than the developing nations they are meant for.

Health Partners International Canada has also recommended that the government take all reasonable measures to ensure that drugs from Canadian suppliers are not diverted from their intended recipients.

The problem of counterfeit and poor quality drugs will only get worse if Canada's Access to Medicines Regime is amended as set out in Bill C-393.

Therefore I call upon my colleagues in the House to clearly focus on the problems before us and send developing countries the drugs they desperately need, but also help those countries improve their infrastructure.

This bill makes no mention of the many different aspects of poverty, but rather talks about one licence. Instead of being a disposable, limited-time measure, agreeing to one licence would eliminate the voluntary licence step in agreements on trade-related aspects of intellectual property rights, or TRIPS, within the WTO.

I believe that intellectual property rights are essential in our society, and this bill offers no guarantee that those rights will be protected. In conclusion, I cannot support Bill C-393.

Patent ActPrivate Members' Business

November 27th, 2009 / 1:30 p.m.
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NDP

Glenn Thibeault NDP Sudbury, ON

Mr. Speaker, I am extremely proud to stand today to support the legislation brought forward by my colleague from Winnipeg North.

Bill C-393 would, as the bill's summary states, amend the Patent Act and the Food and Drugs Act to make it easier to manufacture and export pharmaceutical products to address public health problems afflicting many developing and least developed countries, especially those resulting from HIV-AIDS, tuberculosis, malaria and other epidemics.

This is an extremely worthwhile bill and I would encourage all members of Parliament, regardless of their party, to come together to ensure that the bill passes into law.

Every day, 14,000 people around the world die from preventable diseases. Eight thousand people die each day from HIV-AIDS because they lack access to antiretroviral drugs. Half of the 2.3 million children with HIV in the developing world will not live to see their second birthdays. Morally, this is simply unacceptable.

These deaths destroy families and communities, undermine economic growth and leave thousands of children orphaned. According to the World Health Organization, two billion people cannot get or cannot afford drugs that could have a massive impact on their standards of living.

Research by Polaris shows that 93% of Canadians think it is important to help people in developing countries who need medicines to treat or prevent diseases such as HIV-AIDS, tuberculosis and malaria. The same study shows that a majority of Canadians do not believe the federal government is doing enough to help developing countries by making medication to treat these diseases more affordable. The intention of this bill is to correct this.

The current Canada's Access to Medicines Regime, introduced in 2004, which I remind the House was supported by all parties, was a good start. Competition from generic manufacturers has allowed the price of AIDS medications to fall by 95% in some developing nations, but this legislation only allows generic drugs to be sold to countries explicitly named in the legislation. Companies producing generic drugs must also apply for a special licence for each order of drugs for each country they will supply.

In fact, the total number of licences issued to Canadian companies that produce generic drugs is one. That is right. In five years, only one Canadian company has managed to jump all the hurdles to get Canadian access to the medicine regime's licence, and it has done so just once.

This shipment was sent out in two parts to Rwanda in September 2008 and then again September 2009. That company has come out and said that it will not go through the process again unless it is reformed significantly. There is simply too much red tape. Although the final stage of approval only takes two weeks, this ignores the months of negotiations required to get to the point of submitting an application. Now is the time to improve upon this regime.

The changes proposed in Bill C-393 would mean that companies producing generic drugs would need to obtain just one licence for each medicine they intended to produce. This licence would allow the company to produce multiple orders for as many eligible developing countries as needed, without the need to apply for a new licence for each drug order.

I understand some people are worried that changes to the current regime would undermine Canadian pharmaceutical companies and that this in turn would mean they would stop their research and developmental activities, but this is not the case. This bill would not alter the current provisions, which means brand name companies still receive royalties on the drugs they have patented and brand name companies are still able to compete against generic brands in developing nations.

The bill would also not alter the anti-diversion measures that ensure that generic drugs are distinguished from branded drugs so they cannot be sold elsewhere. In fact, Bill C-393 is completely in line with intellectual property rights, both here in Canada and at the World Trade Organization.

In 2003, the World Trade Organization explicitly stated that developed countries should have more flexible policies to promote access to drugs for people in developing states. These changes will cost the taxpayer nothing and will actually stimulate the Canadian pharmaceutical industry. As companies in Canada ship more orders to developing nations, they will be able to sustain jobs and increase exports from Canada.

Even though this bill is first and foremost a humanitarian issue, there are clearly good economic reasons to reform Canada's access to medicines regime. Implementing this bill is a win-win situation. Developing nations will gain access to much needed drugs and Canadian companies can continue to grow.

I would also like to point out that these changes will not eliminate the review of the safety and quality of the drugs that will be available to developing nations. Drugs will still need to be reviewed by Health Canada, the importing country's government, or by the World Health Organization. The bill will only avoid the duplication of the review processes, meaning that drugs can get to the people who need them and get there faster.

In the one case where drugs were shipped under Canada's access to medicines regime, the company manufacturing the drug spent seven months undergoing a Health Canada review, only for that review to be repeated and duplicated at the World Health Organization. That adds a significant delay to getting the drugs approved. By streamlining the process, we can eliminate any duplication and make sure that these drugs get to the people who need them as quickly as possible.

Some people have suggested that voluntary programs, that is, programs where brand name pharmaceutical companies voluntarily ship drugs to developing countries, mean that no new legislation is required. These voluntary programs are laudable and we should congratulate the companies that have undertaken these efforts, but I do not believe they offer a credible alternative to this legislation.

Put simply, far too few drugs are produced and shipped through these programs to help everyone in the developing world who needs access to them. This legislation would increase the amount of drugs available to people living in developing states and it would also mean that generic brand drugs can reach the countries where they are most needed.

I would like to remind the House that next year, when Canada hosts both the G8 and G20 meetings, we have a real opportunity to shape the global agenda in many areas, including how to deal with the aftermath of the global economic slowdown and how to cope with climate change. These are the things that we can talk about. The best way to shape this agenda is to enact domestic legislation such as this bill, which shows that Canada is ready to lead by example. However, we have to act now.

We have a moral duty to do the right thing and I urge all parliamentarians to support Bill C-393.

Patent ActPrivate Members' Business

November 27th, 2009 / 1:40 p.m.
See context

Edmonton—Mill Woods—Beaumont Alberta

Conservative

Mike Lake ConservativeParliamentary Secretary to the Minister of Industry

Mr. Speaker, I am pleased to have the opportunity to address Bill C-393, which aims to modify certain fundamental aspects of Canada's access to medicines regime.

In 2004 members of Parliament and senators from all parties unanimously supported legislation introduced by the Liberal government of the day to establish this regime by amending the Patent Act and the Food and Drugs Act.

Canada's access to medicines regime's stated purpose is to improve access to lower cost Canadian-made generic versions of patented drugs and medical devices to address public health problems in developing countries. It was designed to achieve this humanitarian objective while respecting Canada's international trade obligations and maintaining the integrity of Canada's patent system.

The public health problems that gave rise to Canada's access to medicines regime in 2004 continue to exist today. This government remains committed to supporting this initiative.

I, and I am sure other members of the House, view it as a key component of Canada's long-term comprehensive approach to addressing serious public health problems that affect many developing and least developed countries, such as HIV/AIDS, tuberculosis, malaria and other epidemics.

In addition to Canada's access to medicines regime, this approach includes significant contributions from the Government of Canada to other global mechanisms and alliances, which have come into existence in recent years and have become leading instruments for procuring lower cost drugs to respond to the needs of developing and least developed countries.

For example, the government has contributed more than $500 million to the global fund to fight AIDS, tuberculosis and malaria. It has also pledged another $450 million to the fund over the next three years. In addition, the government is working with the Bill and Melinda Gates Foundation to fund the development of HIV/AIDS vaccination.

While the government's commitment to addressing public health problems in the developing world and to Canada's access to medicines regime is unwavering, there are concerns with Bill C-393's proposed modifications to the regime's legislative framework.

This is because the bill, if passed by Parliament, would result in the elimination of many of the key operational elements of Canada's access to medicines regime in order to adopt a very broad, one-licence approach that could have serious negative implications for continued pharmaceutical investment and growth in Canada.

In addition, many of the bill's proposed legislative changes may not be in keeping with the spirit of the World Trade Organization decision on which Canada's access to medicines regime is based. Canada's access to medicines regime was the result of years of intensive international negotiations by Canada and other developed and developing country members of the World Trade Organization to find a means to export needed medicines from countries with pharmaceutical manufacturing capacity to countries with little or no such capacity.

In August 2003 this process concluded when all of the World Trade Organization members reached a landmark decision. They agreed to waive two of the patent obligations in the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights in order to improve access to the patented drugs and medical devices needed to address public health problems in developing and least developed countries, such as HIV/AIDS, tuberculosis, malaria and other epidemics.

Canada's access to medicines regime was developed to implement this decision domestically. Canada's regime is one of nine regimes in existence that have implemented the World Trade Organization decision, but it is the only one to have successfully authorized an export of needed drugs to a developing countries. This important event occurred on September 24, 2008, when the Canadian drug manufacturer Apotex Inc. sent approximately seven million tablets of an HIV/AIDS therapy to Rwanda.

In 2007 the government completed a statutory review of the regime. As part of that process, it reviewed all public input on Canada's access to medicines regime. That input included extensive written submissions received in response to a 2006 consultation paper on the regime. It included expert testimony heard at hearings by the House of Commons Standing Committee on Industry, Science and Technology in April 2007, as well as input from developing countries in a workshop organized by non-governmental organizations.

In December 2007 the Minister of Industry tabled in Parliament a report on the results of the statutory review. The report concluded that insufficient evidence had accumulated to warrant making changes to the regime at that juncture. This conclusion remains valid today, since the case for making legislative or regulatory changes to Canada's access to medicines regime has still not been made.

The fact that Canada is the only country to date to see drugs shipped to a country in need under its access to medicines regime demonstrates that our system does work. However, for Canada's access to medicines regime to be used again, another country in need must inform the World Trade Organization of its intent to import lower cost versions of patented pharmaceutical products under the terms of the August 2003 decision.

The government continues to encourage developing and least developed countries to use the system and it hopes that such a notification happens. In the meantime, however, the government will continue to support Canada's access to medicines while fighting diseases and helping improve public health conditions in the developing world through other initiatives in its long-term comprehensive strategy on access to medicines.

Before I conclude, I would like to thank those who have advocated so tirelessly on this issue. In particular, I would like to acknowledge the hard work of the grandmothers to grandmothers campaign, which has continued to raise awareness and mobilize support for this bill.

Although we may disagree on the effects of the proposed modifications in Bill C-393 on the legislative framework of Canada's access to medicines regime, we can certainly agree on the need to address public health in the developing world. The grandmothers have shown true commitment to this cause and I believe their efforts deserve recognition.

With that said, the reasons I have outlined here today prevent me from voting in favour of this bill.

Patent ActPrivate Members' Business

November 27th, 2009 / 1:45 p.m.
See context

Liberal

Joyce Murray Liberal Vancouver Quadra, BC

Mr. Speaker, I am pleased to speak in support of Bill C-393 today. The bill would amend a bill passed in 2004, which was known at the time as the “Jean Chrétien pledge to Africa act”. I would like the listeners to keep in mind that objective.

The original bill created what is now known as Canada's Access to Medicines Regime. The stated purpose of this law was to help get more affordable generic medicines to patients in developing countries for public health needs, including HIV-AIDS, tuberculosis and other epidemic diseases, a very worthy objective, indeed.

This legislation was brought in by a Liberal government and, as the member opposite has just noted, was passed with unanimous support from all political parties in May, 2004, reflecting Canadians' beliefs and the empathy that Canadians feel for those who are in need.

I want to get on record as saying that this is a humanitarian, non-partisan issue that relates to the health and safety of those less fortunate in developing countries.

A country as lucky as Canada has the responsibility to do everything in its power to facilitate the access and distribution of medicines to those countries that are suffering from the devastating effects of diseases such as HIV.

On a personal level, I immigrated to Canada from South Africa at a young age. I went back in the 2000s and met people who were struggling with this terrible affliction. I am very concerned about compassionate assistance to help the AIDS epidemic.

The amendments in Bill C-393 are supported by a wide variety of organizations, including the Canadian Grandmothers to Grandmothers Campaign, which is an organization of women working to support the courageous South African grannies who are looking after those children who have been orphaned by the AIDS scourge.

Another point of context is that these amendments to the Canada's Access to Medicines Regime come at a time when the Conservative Government of the day has reduced by half the number of the poorest African countries that are being supported by CIDA on its priority list. With these cuts, alternative means of support for these countries is badly needed.

There are problems with the current Canada's Access to Medicines Regime. Despite the fact that the member opposite just celebrated CAMR, and I appreciate his positive statements about this Liberal initiative, it is not a successful regime. It is not working. In fact, in more than four years, only one country, Rwanda, and one Canadian generic manufacturer has used the regime for a single shipment of a single AIDS drug. That is not my definition of success.

Issuing one licence to export only one drug to only one country in almost five years since the law has passed tells us that there is something missing and something else is needed. It is not the expeditious solution for which parliamentarians and WTO members were looking.

The fact is no developing countries, other than Rwanda, have come forward or shown any interest to utilize CAMR in order to get much needed medicines for their citizens. Nor has any country sought to use laws comparable to this that have been passed in other countries. Therefore, this tells us that this law needs to be fixed.

A comprehensive access to medicines regime is needed more than ever. According to a joint UN program on HIV, more than 2.3 million children under the age of 15 are infected with AIDS, most of whom are living in developing countries. Without treatment, an estimated one-third of infants infected with HIV will die before reaching the age of one and half will die before reaching the age of two.

If the need for medicines is so critical, which clearly it is, what is preventing these developing countries from coming forward to utilize the Canada's Access to Medicines Regime? Simply put, the regime puts up unnecessary barriers and red tape.

The major concern I have heard in regard to the existing legislation is that the processes and requirements in place may be unnecessarily complex. As a result, they are dissuading the developing countries and generic pharmaceutical companies from stepping forward, utilizing the legislation and bringing forward the solutions for which everyone is looking.

There are many other difficulties to overcome following the delivery of medication to a developing country. We know that at times there are inadequately developed infrastructure, untrained medical staff, unregulated distribution of the drug and disorganized administration. These are all legitimate challenges on the ground.

However, in terms of this legislation, the question in Canada is actually simply. How can we make Canada's Access to Medicine Regime as simple, straightforward and risk-free as possible for the developing countries, for the generic pharmaceutical companies to use, while maintaining fairness for brand name drug providers? This amendment does that.

I will just speak a bit more about the barriers the existing legislation presents.

Under the current regime, the process for a generic drug manufacturer in Canada to get a compulsory licence to supply developing countries does not reflect the very procedures the developing countries typically go through when procuring medicines.

As the regime stands now, the law contains over 100 clauses that are required to be met. Clearly, that is shown to be a barrier. There are simply too many hurdles that developing countries have to jump over before they can place and receive an order. In thinking about the bill, it is important that we remember that in these developing countries the doctors, nurses and volunteers, and not the lawyers, are ordering these drugs.

Criticism levied against these proposed reforms mainly focus on how they will negatively impact the patented pharmaceutical industry, but the fact is their drugs are simply too expensive to be purchased at their current price and they have not taken the action necessary to get affordable medicines to developing countries.

Nothing in these amendments nor in CAMR itself prevents brand name pharmaceutical companies from competing to supply their patented products to developing countries and under these amendments, royalties would still be based on the sales of the generic product and would flow to the pharmaceutical company.

What is being proposed in Bill C-393? I will take a moment to read into the record parts of a letter I received from a group in my riding of Vancouver Quadra. It is from the UBC Medical Undergraduate Society, signed by Mattias Berg, the president. He speaks about Bill C-393, proposing a simplified one-licence solution. He says:

This approach, widely recommended by multiple humanitarian organizations including Médecins Sans Frontières...would cut through most of the red tape that prevents CAMR from being used to its full potential.

He goes on to add:

As concerned Canadians and future physicians, we are asking you to please support this bill and help save the lives of millions of children and patients in the developing world.

A compulsory licence will require that the generic manufacturer pay a royalty to the company that holds that patent and royalties would still be based on the sales of the generic product to the developing country, as in the existing CAMR formula. If the legislation is reformed, Canada's largest generic pharmaceutical company has committed publicly that it will make a desperately needed three-in-one AIDS drug that is suited for children in developing countries. This is all about that.

As we know, very few children in these countries have access to medicines to combat HIV, and they suffer unnecessarily. This is a human tragedy which we are trying to address. By streamlining the access to medicines regime, we would not create any additional costs to Canadian taxpayers. In fact, it requires the government to spend no additional funds.

Nobody claims that Canada's access to medicine regime, either in its existing form or in an amended version, would provide a complete solution. Barriers to accessing medicines in the developing world will continue. However, Canadians right across the country want to say that they are doing our part to help fight sickness and poverty around the world. It is part of our humanness to want to help.

This amended legislation is a policy tool that has the potential to put into action the desire of Canadians to help those less fortunate and help facilitate developing countries to gain access to affordable and timely treatment. For both compassionate and pragmatic reasons, the bill deserves Parliament's support and I hope the members will provide it.

Patent ActPrivate Members' Business

November 27th, 2009 / 2:05 p.m.
See context

Conservative

Mike Wallace Conservative Burlington, ON

Mr. Speaker, if you give me a notice that I have a minute left, I will wrap it up.

It is my honour to stand here with this opportunity to address Bill C-393, which seeks to make substantial operational changes to the legislative framework for Canada's access to medicines regime under the Patent Act and under the Food and Drugs Act.

While I and I am sure other hon. members in the House are committed to improving access to medicines in the developing world via Canada's access to medicines regime and other initiatives, I have some strong reservations about Bill C-393 and its proposed revisions.

However, let me begin today with some background on Canada's access to medicines regime. The stated purpose of the regime is to increase access to lower-cost, Canadian-made generic versions of patented pharmaceutical products needed to address public health problems in developing and least-developed countries. The development of Canada's access to medicines regime was a landmark event as there was no other international precedent at the time.

Thus, in crafting the regime, the government focused on three important objectives: first, to increase access to patented drugs and medical devices in the developing world; second, to continue to respect Canada's international trade obligations; and third, to maintain the integrity of our domestic patent system for pharmaceuticals.

In 2004, the then-Liberal government introduced legislation to establish the regime by amending the Patent Act and the Food and Drugs Act. Shortly thereafter, Bill C-9 received royal assent with the unanimous support of all parties on both sides of the House and the Senate.

I will now turn to discuss some of the problematic elements of Bill C-393 that propose to alter the scope of eligible drugs for export under the regime, and the health and safety review that these pharmaceutical products go under.

First, I am concerned that Bill C-393 seeks to eliminate the list of pre-approved products for export in Canada's access to medicines regime. While some critics of the regime allege that the list makes CAMR too rigid and inflexible, it does serve an important and practical purpose. Specifically, the list of pre-approved products for export minimizes the discretionary elements of the regime and, as a result, expedites the decision making process. It also provides prospective users with the assurance that, assuming all other statutory requirements are met, an application for authorization under the regime will be used by the commissioner of patents.

Second, I am concerned about the proposed changes in the drug review process in Bill C-393. If passed, these changes would significantly alter the level of domestic oversight regarding the safety and quality of the products exported under CAMR. This is because Bill C-393 suggests, among other things, to make the existing mandatory Health Canada review optional.

Further, it suggests allowing the export of eligible products under Canada's access to medicines regime to be made on the basis of a review by a foreign regulatory authority. Such an abeyance of Health Canada's review would not be permitted for drugs and medical devices destined for the Canadian market.

In addition, during the statutory review of the regime in 2007, developing countries and generic drug manufacturers expressed strong approval of the very drug review that Bill C-393 seeks to remove. These potential users of CAMR went on record as saying that Health Canada's review was a useful mechanism for ensuring that products sent to the developing world under this system were safe and of high quality.

Some critics of Canada's access to medicines regime state that the Health Canada drug review is unnecessary and allege that it duplicates the World Health Organization's pre-qualification process for listing pharmaceutical products that are eventually purchased by international aid agencies and developing and least-developed countries without appropriate regulatory capacities. However, I do not agree with them.

Health Canada has a long-lasting and excellent relationship with the World Health Organization in this regard, both in undertaking reviews for the international organization's pre-qualification program, and in working with the World Health Organization and other initiatives to build regulatory health and safety capacity in developing and least developed countries.

Furthermore, since Health Canada's reviews are accepted by the World Health Organization for an alternate listing process, Canada's domestic drug reviews are not duplicated. The alternate listing process, which is an abbreviated process for listing drugs to the pre-qualified program, is available for drugs reviewed by Health Canada, the United States Food and Drug Administration and the European Medicines Agency.

I would like to conclude by reiterating that while the government remains committed to Canada's access to medicines regime and a broader, long-term approach to fighting public health diseases in the developing world, it opposes Bill C-393 and its proposed changes to the regime.

In my opinion, several of the changes to the Patent Act and the Food and Drugs Act raise concerns about the potential impact on the effective operation of CAMR. Many of these changes also do not support the humanitarian objective of improving access to safe medicines for the developing world.

Finally, there is little evidence that Bill C-393's proposed amendments will make a meaningful difference in the volume and frequency of exports under Canada's access to medicines regime.

To date, Canada's compulsory licensing and export regime is the only one of its kind worldwide to have successfully authorized and exported drugs to a country in need.

For all of these reasons, I urge hon. members in the House not to support Bill C-393. I do want to say in closing, however, that I do appreciate the efforts of the member for Winnipeg North in this matter. I have had a number of meetings in my riding with citizens who are deeply concerned that this regime is not working, but this bill does not meet their needs, based on our review of how it has been laid out. However, I do appreciate the member bringing this to the attention of the House of Commons.

Patent ActPrivate Members' Business

June 12th, 2009 / 1:30 p.m.
See context

NDP

Judy Wasylycia-Leis NDP Winnipeg North, MB

moved that Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, be read the second time and referred to a committee.

Mr. Speaker, it is a real privilege for me today to begin to speak to a bill that has been the product of so many hours of work by community activists and NGOs right across this country and around world. I am pleased to speak today to Bill C-393, which is an act to amend the Patent Act and to ensure that we can flow drugs for international humanitarian purposes.

Our day to day work in this place clearly impacts upon every aspect of Canadian lives, but rarely are we, as members of Parliament, presented with so clear and direct an opportunity to save lives. We know that 14,000 people a day die from infectious disease, such as HIV-AIDS, tuberculosis and malaria, and that these deaths are preventable because they can be treated with medicines that are on the market today. The dimensions of this crisis are almost impossible to comprehend, with the personal cost to victims' health, the cost to their families, the plight of those left as orphans, and the strain on grandparents thrust into the role of providers.

There are 33.2 million people living with HIV worldwide, 22.5 million, or 68%, live in sub-Saharan Africa. In 2007, 2.1 million adults and children died of AIDS, and 76% of them, or 1.6 million, were in sub-Saharan Africa alone. An estimated 2.1 million children under 15 were living with HIV worldwide in that same year, and again, nearly 90% were in sub-Saharan Africa. Some 13 million children have been orphaned by HIV-AIDS in sub-Saharan Africa, and it is now estimated that by the year 2010, as many as 20 million children will have been orphaned by AIDS worldwide.

Finally, without treatment, an estimated one-third of infants infected with HIV will die before reaching the age of one. Half will die before the age of two.

Tuberculosis patients and malaria sufferers are also losing their lives for lack of available medicines, medicines that are on the market today. Five thousand people die from tuberculosis every day, while more than one million people die each year from severe malaria, a disease relatively easy to treat with proper drugs.

This is mind-boggling when we think about it. It is a crisis that no Canadian wants to turn his or her back on. Everyone in this country wants to see Canada do its job and carry out its responsibilities on such a serious life and death situation.

Canadians were very proud when Parliament took action quickly five years ago, following the landmark decision by the World Trade Organization in 2003. It allowed more prosperous nations, like Canada, to offer humanitarian medical support to developing nations.

Canadians were very proud when Parliament unanimously passed reforms to the Patent Act in 2004, called Canada's Access to Medicines Regime, otherwise known as CAMR. That regime was created to provide a framework to use a system of compulsory licensing to allow generic drug companies to produce cheaper versions of the latest most effective drugs to treat infectious diseases even though they were still under patent.

However, we all became disillusioned. Canadians right across this country were very disappointed when we actually came to realize that this medicines regime produced practically no results.

Since that time, four years ago, when we passed the legislation unanimously in the House, there has been only one compulsory licence completed under that legislation. Last September, the first and only shipment went out. It was a shipment of 7 million Apo-TriAvir tablets, shipped to Rwanda by Apotex, Canada's largest generic drug manufacturer. That was an important shipment. It will help 21,000 people. However, given the statistics I just mentioned, it is a drop in the bucket. That has been the only shipment.

There is obviously something wrong with the legislation. I am here today to try to fix it. The burden of drug costs for the world's lowest-income nations has intensified. Despite the efforts of those like my former colleague, the hon. Alexa McDonough, Canada and other prosperous nations are shamefully not on track to meet our commitments to the United Nations millennium development goals, such as reaching 0.7% of GNP in international assistance by the year 2015, increasing our efforts toward the global fund, reducing child and maternal death, and reducing HIV-AIDS.

Other G8 commitments to reduce poverty have not lived up to their hype. As a final blow, the world is now in the midst of an economic crisis of unprecedented proportions. Within their own borders, the devastating loss of large numbers of productive adults to infectious disease has further compounded the already difficult road to economic security and stability. Countries are obviously even less able to cope with high drug costs for their citizens. I am sure that members of Parliament realize that Canadians will not tolerate us carrying on with a dysfunctional drug system that keeps cheaper drugs from getting to where they are needed.

Former UN special envoy for HIV-AIDS in Africa and respected Canadian Stephen Lewis has been at this for years, tirelessly. He has never given up trying to reduce the incidents of HIV-AIDS in Africa and elsewhere, and has never stopped pushing and prodding us to find solutions. He, like all of us, is concerned about the inaction under the legislation we passed five years ago. He said:

Delaying action is inexcusable when the path forward is so clear: streamline CAMR, get affordable medicines to those who are dying for them, save thousands of lives, particularly those of children with HIV. Every day counts,

Stephen Lewis is right. Every day counts. Canadian generic drug maker Apotex has made a priority of clearing up the mess. It has committed to making a low-cost version of an important pediatric AIDS medication as soon as this access to medicines regime is made workable. I want to remind members that, in sub-Saharan Africa, half of all the children born with HIV died before reaching their second birthday.

This type of drug, which is so needed, is not currently being made. If we could only change the rules, it would happen and it would improve the treatment of these children tremendously. Peggy Edwards, co-chair of the national advocacy committee of the grandmothers to grandmothers campaign, echoes the call for CAMR reform. She says:

Right now, African grandmothers are carrying the burden of caring for children orphaned by AIDS and dying of AIDS without appropriate medicines. Streamlining CAMR and getting affordable medicines to children with HIV would ease that burden considerably.

That is very well said. Let me also quote Richard Elliott, who is the executive director of the Canadian HIV/AIDS Legal Network. I should mention that his organization has studied this process more than anyone and knows it inside and out. He says:

The current system just doesn’t work...The need is enormous, but CAMR just isn’t user-friendly in its current form.

That is why, in Bill C-393, I have drawn on the legal network's expertise and that of others knowledgeable of the strengths and weaknesses of the current CAMR system to come up with a workable proposal for change. It is a proposal that will get these drugs into production and to the children and adults who have been waiting for them for far too long.

Bill C-393 proposes critical changes to Canada's access to medicines regime. Let me mention a few of them.

It provides for a one licence system to replace the need for single applications for every drug, for every amount of drug produced, and for every country which is seeking medications. That is important.

It gets rid of the narrow list of eligible drugs in order that new medicines can be incorporated at the earliest possible time.

It gets rid of the two-year time limit on compulsory licences with only one reapplication allowed.

It lives up to our international trade agreements while dumping the CAMR's requirements that exceed WTO demands.

Finally, it discourages unnecessary legal action by allowing generic producers to correct minor errors within a limited time.

The reforms we are proposing today in the bill have been supported by many, including 37 humanitarian and health organizations in Canada. They have said so in their submissions to government. That we are here today aware of the problems with CAMR and with solutions to offer to resolve these problems is due to the ongoing effort of so many individuals and organizations.

I want to particularly thank the Canadian HIV/AIDS Legal Network, Results Canada, Stephen Lewis Foundation and Oxfam Canada. I would particularly like to mention the incredible work of the Grandmothers to Grandmothers Campaign that now has more than 200 groups spread across Canada working tirelessly to raise awareness and rally support for these grandparents struggling for their own and their families' survival in sub-Saharan Africa in the wake of their children's premature deaths from HIV-AIDS. In Winnipeg, the group is named Grands 'n' More Winnipeg and I have been helped by discussions and information from Linda Watson, Irene Rempel, Enid Butler, Nancy Cosway and Shelley Coombes.

This spring, the grandmothers, as they have become known around this place, and I am wearing the pin that they have given to us all, brought petitions with more than 32,000 signatures to Parliament. We all had the privilege of presenting some of those petitions.

I want to cite the work of a present colleague of mine who formerly worked on this issue. The member for Windsor West was active on this file when Parliament first passed this bill a number of years ago.

In presenting the bill, I feel a great sense of responsibility. Normally, I have had the responsibility in this place to speak for my constituents in Winnipeg North. That responsibility is daunting in itself.

Today, I am speaking to this bill for millions of women, men and children who have a right to health, a right to life, just as we do, but who through circumstances of birth find themselves faced with serious conditions and diseases in countries unable to afford them the help they and their families need because of economic limitations.

As I have said, the challenges are unimaginable, but the spirit of the struggle is strong. We have a choice today, whether to break down a barrier that is denying them a future or to stay with the status quo and extinguish that spirit. I urge members to choose the former.

Patent ActPrivate Members' Business

June 12th, 2009 / 1:50 p.m.
See context

Liberal

Marc Garneau Liberal Westmount—Ville-Marie, QC

Mr. Speaker, I would like to begin by saying that I truly believe that as a country, we must do everything we can to help people in developing countries get access to much-needed medicines. Such a humanitarian initiative must be supported, because we all know that many people are suffering in poorer parts of the world.

Having said that, I personally do not believe that we can achieve that goal by changing the law associated with Canada's Access to Medicines Regime. Allow me to explain.

Canada's Access to Medicines Regime, or CAMR, came into force in May 2005, following the adoption by Parliament of Bill C-9. CAMR's purpose was to put in place a low-cost generic drug-based mechanism to deliver lifesaving medications to countries which could not otherwise afford them. The purpose was laudable and remains laudable, and the bill passed with the consent of all parties.

As an amendment to the Patent Act, CAMR allows generic drug companies to obtain the compulsory licence to manufacture patented pharmaceutical products and to export those products to developing countries that do not have internal capacity to manufacture products required to address public health problems.

If one looks at the flow of generic medicines to developing countries since the implementation of CAMR, one can only cite one example of such a transfer from Canada, and that was to Rwanda.

Similar legislation to CAMR implemented in other countries has also not resulted in the flow of generic medicines to developing countries.

The reasons for this situation are complicated, but they have nothing to do with the difficulty of complying with the current legislation, as the bill before us today suggests. The amendments proposed in Bill C-393 will not make things better, because the main challenges involved in getting medicines to the people who need them have nothing to do with the flaws in the current legislation.

The balance that was established in the legislative process through amendments to the Patent Act and the Food and Drugs Act was deemed appropriate by the review conducted in 2007 by Industry Canada in collaboration with Health Canada, CIDA and DFAIT.

Although critics of CAMR have said that the law is too complicated, it is worth noting that Douglas Clark, the former director of Patent Policy at Industry Canada, has stated that this criticism is not credible.

In fact, the reasons why CAMR does not work as we had hoped have to do with real problems in the field, in the countries that need these medicines. They have to do with access to properly trained medical staff, whether they be doctors or nurses. They have to do with clean water supply, refrigeration facilities, accurate diagnosis, secure infrastructure for distributing the medicines and so on. In short, they have to do with poverty and the need to make developing countries aware of CAMR. Those are the real challenges.

It is not the process itself of requesting the medicine. That process is uncomplicated, even with its checks and balances that ensure compliance with international obligations under the WTO TRIPS agreement, the agreement on trade-related intellectual property rights.

Canada does have obligations related to TRIPS and it is important to respect them. The World Trade Organization's agreement on trade-related intellectual property rights, to which Canada is a signatory, generally prohibits countries from engaging in compulsory licensing for purposes of export.

Canada and other WTO member countries are authorized to adopt regimes like CAMR only as a result of an agreement reached between WTO member countries in August 2003, which waives the restriction that compulsory licensing can only be used for their domestic markets. This waiver sets out strict and limited conditions under which Canada and other exporting WTO members may grant compulsory licences to manufacture and export pharmaceutical products for humanitarian purposes.

It is important to remember that Canada is only one of many nations that have implemented the waiver as part of their domestic legal regimes. CAMR appropriately uses this waiver as the basic framework for Canada's regime. The waiver is also used by other nations as the basis for their domestic law equivalence of CAMR.

The changes to CAMR proposed by Bill C-393 would eliminate all references to the TRIPS agreement and waiver and would eliminate most of the elements of CAMR that help Canada to comply with the applicable conditions governing the issuance of compulsory licences.

The amendments proposed to CAMR in the bill would render the regime non-complied with Canada's WTO obligations as established in the TRIPS agreement and waiver.

Key deficiencies in the proposed amendments, from the standpoint of WTO compliance, include the fact that TRIPS requires the applicant for licence to seek a voluntary licence from the patent owner.

Bill C-393 would repeal the provision of CAMR that requires the prospective licensee to seek from the patentee a voluntary licence to manufacture and sell pharmaceutical products for export. This is inconsistent with the spirit of the waiver, which is intended, where feasible, to encourage voluntary agreements rather than impose compulsory licences.

TRIPS requires that the scope and duration of the licence must be limited to the purpose for which it is authorized. The bill would repeal all limitations on the scope and duration of the compulsory licence, theoretically granting a perpetual and unlimited legal right.

TRIPS requires that a licence should be terminated if and when the circumstances that lead to its issuance cease to exist or are unlikely to recur. Under Bill C-393, absent an application by a patent owner, a licence would only terminate if relinquished by the licensee.

TRIPS requires that the patent owner be paid adequate compensation in the circumstances of each case. Bill C-393 would repeal the CAMR provision that allows the patent owner to seek a higher royalty than the formula established by CAMR, if warranted.

The waiver applies only to pharmaceutical products needed to address public health problems. Bill C-393 would repeal schedule 1 of CAMR, which is the list of eligible products, and would not put in place any limitation on the patented pharmaceutical products for which a compulsory licence may be granted.

The waiver requires all importing WTO members to make a notification to the WTO, specifying the name and quantity of needed pharmaceutical products. Importing members, which are not least-developed countries, must also establish that they do not have the manufacturing capability to produce the pharmaceutical product. Bill C-393 would not require any notification or copy of the notification submitted by an importing country regarding its need for a pharmaceutical product or setting out the quantity required or speaking to manufacturing capacity.

The waiver states that exporting members, like Canada, can only authorize manufacture and export of that amount of product necessary to meet the needs of the importing member and states that all of the product must be exported to that importing member, as opposed to other members or countries. Bill C-393 places no limits on the amounts of product that may be manufactured under the compulsory licence and would permit unlimited quantities of the product to be exported to any eligible importing country regardless of their need.

The issues noted above are only the most obvious problems of Bill C-393 to comply with Canada's international obligations. It is clear that if this bill were to become law, Canada would be in default of its international trade treaty obligations under the TRIPS agreement.

Canada is a well-intentioned country that wishes to provide much needed assistance to countries in need of medicines to prevent or combat diseases such as tuberculosis, malaria, HIV-AIDS and other epidemics. That is why Parliament voted for Bill C-9, the original CAMR legislation. In other words, our intentions were and remain honourable.

In the intervening years, however, we have come to the conclusion that what we had intended, a flow of generic drugs to countries in need, is not happening. We are all in agreement on this point, however, there is a different interpretation as to why CAMR is failing.

There are many things that Canada can and should do through CIDA, and that is where Canada should focus its efforts. That will enable Canada's Access to Medicines Regime, which is part of the solution, to do everything it is supposed to do.

Patent ActPrivate Members' Business

June 12th, 2009 / 2 p.m.
See context

Conservative

Dave Van Kesteren Conservative Chatham-Kent—Essex, ON

Mr. Speaker, I am pleased to have the opportunity to address Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act, which aims to modify certain fundamental aspects of Canada's Access to Medicines Regime.

Canada's Access to Medicines Regime's stated purpose is to improve access to lower cost, Canadian-made generic versions of patented drugs and medical devices to address public health problems in developing countries. It was designed to achieve this humanitarian objective, while respecting Canada's international trade obligations and maintaining the integrity of Canada's patent system.

Members of the House view Canada's Access to Medicines Regime as a key component of Canada's long-term approach to addressing serious public health problems that affect many developing and least developed countries, such as HIV-AIDS, tuberculosis, malaria and other epidemics. In addition to Canada's Access to Medicines Regime, this approach includes significant contributions from the Government of Canada to other global mechanisms and alliances which have come into existence in recent years and have become leading instruments for procuring lower cost drugs to respond to the needs of developing and least developed countries.

For example, the government has contributed more than $500 million to the global fund to fight AIDS, tuberculosis and malaria. It has also pledged another $450 million to the fund over the next three years. In addition, the government is working with the Bill & Melinda Gates Foundation to fund the development on an HIV-AIDS vaccination.

The government has serious concerns with Bill C-393's proposed modification to the regime's legislative framework. If passed by Parliament, the bill will result in the elimination of many of the key operational elements in Canada's Access to Medicines Regime in order to adopt a very broad, one-licence approach. This could have serious negative implications for continued pharmaceutical investment and growth in Canada. In addition, many of the bill's proposed legislative changes may not be in keeping with the spirit of the World Trade Organization decision on which Canada's Access to Medicines Regime is based.

This decision was the result of years of intensive international negotiations by members of the World Trade Organization. Those negotiations sought a solution to international patent obligations that impeded the export of critical medicines from countries with pharmaceutical manufacturing capabilities to countries without.

In August 2003, WTO members reached a landmark decision. They agreed to waive two of the patent obligations in the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights, known as TRIPS, in order to improve access to patented drugs and medical devices needed to address public health problems in developing and least developed countries.

Canada's regime is one of the nine regimes in existence to have implemented the World Trade Organization decision, but it is the only one to have successfully authorized the export of drugs to a developing country. This important event occurred on September 24, 2008, when a Canadian drug manufacturer, Apotex Inc., sent approximately seven million tablets of HIV-AIDS therapy to Rwanda.

In 2007 the government completed a statutory review of the regime as part of this process. It reviewed all public input in Canada's Access to Medicines Regime. That input included the extensive written submissions received in response to a 2006 consultation paper on the regime, expert testimony heard at separate hearings by the House of Commons Standing Committee on Industry, Science and Technology in April 2007, and I was a part of that committee, as well as input from developing countries at a workshop organized by non-governmental organizations.

In December 2007 the Minister of Industry tabled a report on the results of the statutory review in Parliament. The report concluded that insufficient evidence was accumulated to warrant making changes to the regime at that juncture.

This conclusion remains valid today, since the case for making legislative or regulatory changes to Canada's Access to Medicines Regime has still not been made. The fact that Canada is the only country today to see drugs shipped to a country in need under its access to medicines regime demonstrates that our system does work.

However, for Canada's Access to Medicines Regime to be used again, another country in need must inform the World Trade Organization of its intent to import lower-cost versions of patented pharmaceutical products under the terms of the August 2003 WTO decision.

The government has and continues to encourage developing and least developed countries to use the system and hopes that such a notification happens. In the meantime, however, it will continue to support Canada's access to medicines, while fighting diseases and helping improve public health conditions in the developing world through other initiatives in the government's long-term comprehensive strategy on access to medicines.

It is for these reasons that I urge all hon. members of this House not to support Bill C-393.

Patent ActPrivate Members' Business

June 12th, 2009 / 2:05 p.m.
See context

Bloc

Nicolas Dufour Bloc Repentigny, QC

Mr. Speaker, the Bloc Québécois acknowledges the need for immediate action to ensure that low-cost medications are sent to low-income countries.

As the Canadian HIV/AIDS Legal Network has said, the numbers speak for themselves. In 2007, the United Nations estimated that 33 million people were living with HIV/AIDS, including 2.5 million children. More than 8,000 people die every day from HIV/AIDS in the world.

The Bloc Québécois is aware of the different challenges surrounding research and development, of the problem with intellectual property on patents, of the need to pursue scientific research, and of the difficulty in balancing this with accessibility of low-cost medications in low-income countries. The Bloc also recognizes Canada's international obligations regarding the protection of intellectual property and the balance between accessibility and scientific research on this subject. As the Bloc Québécois has said many times, we must have another look at the Patent Act and Canada's access to medicines regime, now that law has been applied and the first medications sent to an African country.

It is more clear than ever that we need to act quickly. We must call together the various stakeholders to determine the advantages and disadvantages of Canada's access to medicines regime, and to come up with ideas to improve the current regime. We have a number of questions about the current effectiveness of this regime and its first application. Did it achieve the goal of bringing medications to the people? What were the relationships between the suppliers of the low-cost medications and the receiving country? Did the country have the necessary infrastructure to help sick people obtain the medication? Did the medication have the desired effect? How did negotiations work between the companies producing name-brand and generic medications?

The Bloc Québécois believes it is important to review Canada's access to medicines regime and the Patent Act, and to conduct in-depth follow-ups on the first application. Only after evaluating each step of the regime will we be able to determine how to improve it.

The Bloc Québécois is in favour of sending Bill C-393 to committee. We recognize that there are some provisions in the current regime that are keeping it from working properly. The committee will be able to carry out an in-depth analysis of how this legislation was applied on the ground for the first time.

However, the Bloc Québécois already has several concerns about the details of relaxing the requirements in relation to the current system, namely, expanding the list of countries, eliminating the wait time, Canada's commitments regarding intellectual property and how this bill will affect those commitments, the fact that brand name pharmaceutical companies are losing their oversight on agreements, the balance between intellectual property, the humanitarian aspect of the system, and the commercial aspect, which is more significant in Bill C-393 than in the current system.

Obviously, this bill raises many questions. The Bloc Québécois believes, however, that urgent action is required on this issue and that a study of Bill C-393 would be an excellent forum to begin discussions on potential ways to make the current system more flexible. Bearing in mind that a certain balance must achieved between the commercial and humanitarian aspects, the Bloc Québécois will definitely propose several amendments to this bill.

The World Health Organization, the Joint United Nations Programme on HIV/AIDS and UNICEF produced a report in 2008 entitled Towards universal access: Scaling up priority HIV/AIDS interventions in the health sector. That report reveals that access to anti-retroviral treatment for advanced HIV/AIDS improved between 2006 and 2007 in low-income and moderate-income countries. At the end of 2007, nearly 3 million people were being treated, that is, nearly 950,000 more people than in 2006, which is 31% of the 9.7 million people requiring anti-retroviral therapy.

Since 2001, the number of people receiving anti-retroviral therapy has increased 15-fold, from under 200,000 to 3 million, including 2 million people in Africa.

The greatest increase in treatment rates was in sub-Saharan Africa. That seems encouraging, but the fact remains that less than a third of the people who need treatment are receiving it. Some 2.5 million people were infected that same year, while fewer than 1 million new patients began receiving treatment.

There have been other improvements as well. Some 33% of HIV-positive pregnant women in those same countries received antiretroviral medications to prevent transmission of the disease to their child. Only 10% of pregnant women had access to that treatment in 2004. Once again, there has been a substantial improvement, but two-thirds of HIV-positive pregnant women still do not have access to these drugs.

With respect to children, nearly 200,000 of them had access to treatment in 2007, compared to 127,000 in 2006 and 75,000 in 2005. However, less than 5% of children have access to pediatric AIDS treatment, the kind of treatment specially developed for them. Treatment for children can cost up to eight times more than treatment for adults.

Every day, there are nearly 1,800 new cases of HIV infection in children under the age of 15, mainly as a result of mother to child transmission. In addition, every day, 1,400 children under 15 die from AIDS-related illnesses. More than 6,000 young people between the ages of 15 and 24 are infected with HIV. After more than 20 years of effort, less than 10% of pregnant women have access to services to prevent them from transmitting HIV to their newborn. Less than 10% of the children who are orphaned or made vulnerable by AIDS receive public assistance or have access to support services. Less than one-third of young women between 15 and 24 in sub-Saharan Africa really understand how to avoid the disease.

In the fall of 2008, Apotex, a generic drug company, began delivering triple combination anti-AIDS pills to Rwanda, and the contract calls for 21,000 people to be treated over two years. This is the first initiative of its kind in the world. Other countries have laws that allow low-cost drugs to be sent to developing countries, but none has shipped any yet.

According to patent drug companies, authorization to use their products was given very quickly, within two months, which proves the efficiency of the program. In terms of generic drugs, and more specifically Apotex, there are too many restrictions and the effort is not worth it. Apotex has stated that it would not want to repeat the experience in the current conditions.

Let us take a look at the background. At the end of the 1990s, charitable organizations initiated an awareness campaign. Pharmaceutical patents were deemed to be one of the main obstacles to drug access. Developing countries called on the World Trade Organization to relax intellectual property rules. Others considered corruption and insufficient infrastructure, in African countries in particular, to be the main obstacle.

In November 2001, in Doha, WTO members unanimously accepted that pharmaceutical patents were one of the main obstacles to access to drugs. In August 2003, WTO members agreed to allow developed countries to export low-cost drugs to developing countries. On August 30, 2003, WTO members agreed to make legal changes to certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights that seemed to prevent poor countries from importing pharmaceuticals.

I am told that I have only one minute remaining and so I will say that the Bloc Québécois supports some of the principles contained in Bill C-393. As I mentioned at the very beginning, we have a number of questions. Therefore, we would like this bill to be sent to a committee for more in-depth study. And, as I mentioned, the Bloc will propose a number of amendments to ensure that the bill will respect not only the industry but above all the charitable organizations that work primarily in Africa in order to ensure that we do all we can to fight AIDS.

Patent ActPrivate Members' Business

June 12th, 2009 / 2:15 p.m.
See context

Conservative

Blaine Calkins Conservative Wetaskiwin, AB

Mr. Speaker, I am pleased to have the opportunity today to address Bill C-393, which seeks to make substantial operational changes to the legislative framework for Canada's access to medicines regime under the Patent Act and for the Food and Drugs Act.

While I and other hon. members of the House are committed to improving access to medicines in the developing world via Canada's access to medicines regime and other initiatives, I have some strong reservations about Bill C-393 and its proposed changes. However, let me begin with some background on Canada's access to medicines regime.

The stated purpose of the regime is to increase access to lower-cost, Canadian-made generic versions of patented pharmaceutical products needed to address public health problems in developing and least-developed countries.

The development of Canada's access to medicines regime was a landmark event, as there was no other international precedent at that particular time. Thus, in crafting the regime, the government focused on three important objectives: first, to increase access to patented drugs and medical devices in the developing world; second, to continue to respect Canada's international trade obligations; and third, to maintain the integrity of our domestic patent system for pharmaceuticals.

In 2004, the then Liberal government introduced legislation to establish this regime by amending the Patent Act and the Food and Drugs Act. Shortly thereafter, Bill C-9 received royal assent with the unanimous support of all parties in both the House and the Senate.

I will now turn to discussing some of the problematic elements of Bill C-393 that propose to alter the scope of eligible drugs for export under the regime and the health and safety review of these pharmaceutical products.

First, I am concerned that Bill C-393 seeks to eliminate the list of pre-approved products for export in Canada's access to medicines regime. While some critics of the regime allege that the list makes Canada's access to medicines regime too rigid and inflexible, it does serve an important and practical purpose. Specifically, the list of pre-approved products for export minimizes the discretionary elements of the regime, and as a result, expedites the decision-making process. It also provides prospective users with the assurance that, assuming all other statutory requirements are met, an application for authorization under the regime will be issued by the Commissioner of Patents.

Second, I am concerned about the proposed changes to the drug review process in Bill C-393. If passed, these changes would significantly alter the level of domestic oversight regarding the safety, efficacy and quality of products exported under Canada's access to medicines regime. This is because Bill C-393 suggests, among other things, making the existing mandatory Health Canada review an option. Further, it suggests allowing the export of eligible products under Canada's access to medicines regime to be made on the basis of a review by a foreign regulatory authority.

Such an abeyance of Health Canada's review would not be permitted for drugs and medical devices destined for the Canadian domestic market. In addition, during the statutory review of the regime in 2007, developing countries and generic drug manufacturers expressed strong approval for the very drug review that Bill C-393 seeks to remove. These potential users of Canada's access to medicines regime went on the record as stating that Health Canada's review was a useful mechanism for ensuring that products sent to the developing world under the system are safe, efficacious and of high quality.

Some critics of Canada's access to medicines regime state that the Health Canada drug review is unnecessary and allege that it duplicates the World Health Organization's pre-qualification process for listing pharmaceutical products that are eventually purchased by international aid agencies in developing and least-developed countries without appropriate regulatory capacities.

However, I do not agree with them. Health Canada has a long-standing and excellent relationship with the World Health Organization in this regard, both in undertaking reviews for the international organization's pre-qualification program and in working with the World Health Organization on other initiatives to build regulatory health and safety capacity in the developing and least-developed countries.

Furthermore, since Health Canada's reviews are accepted by the World Health Organization for its alternate listings process, Canada's domestic drug reviews are not duplicative. The alternate listings process, which is an abbreviated process for listing drugs to the pre-qualified program, is available for drugs reviewed by Health Canada, the United States Food and Drug Administration and the European Medicines Agency.

I would like to conclude by reiterating that while the government remains committed to Canada's access to medicines regime and a broader long-term approach to fighting public health issues in the developing world, we simply oppose Bill C-393 and its proposed changes to the regime.

In my opinion, several of these changes to the Patent Act and the Food and Drugs Act raise concerns about their potential impact on the effective operation of Canada's Access to Medicines Regime. Many of these changes also do not support the humanitarian objective of improving access to safe and efficacious medicines in the developing world.

Finally, there is little evidence that the proposed amendments in Bill C-393 will make a meaningful difference in the volume and frequency of export under Canada's access to medicines regime. To date, Canada's compulsory licensing for export regime is the only one of its kind worldwide to have successfully authorized an exported drug to a country in need. This demonstrates that Canada's Access to Medicines Regime can and does, currently work.

For those reasons, I urge all hon. members in the House not to support Bill C-393 not because the intention is not good, but the bill is simply flawed.

Patent ActRoutine Proceedings

May 25th, 2009 / 3:10 p.m.
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NDP

Judy Wasylycia-Leis NDP Winnipeg North, MB

moved for leave to introduce Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act.

Mr. Speaker, I am very honoured to introduce this bill in the House today. It would amend the Patent Act as a remedy to the serious flaws within Canada's access to medicines regime that was passed in this place unanimously in May 2004.

That initiative was intended to be a meaningful humanitarian tool to flow lifesaving medicines to the world's poorest nations at affordable below patent prices. The built-in problems have resulted not in a flow but a trickle and there has been only one successful application. Meanwhile, many people, thousands of men, women and children, suffer needlessly without getting access to the treatments that are available.

This bill is here with the help of the Canadian HIV/AIDS Legal Network and with the support of Canadian Grandmothers for Africa, Grands 'n' More Winnipeg, the Stephen Lewis Foundation, Doctors Without Borders, Results Canada, and many other organizations.

I recommend this bill because it offers members amendments to the act that would streamline the process and get urgently needed drugs to HIV and AIDS patients as soon as possible.

(Motions deemed adopted, bill read the first time and printed)