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.

Business of the House

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

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)