Bill C-393 (Historical)

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

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

Patent Act

[The Deputy Speaker, Conservative, Andrew Scheer]

The House will now proceed to the taking of the deferred recorded division of the motion at second reading stage of Bill C-393 under private members' business.

The House resumed from November 27 consideration of the motion 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.

World AIDS Day

[Chris Charlton, NDP, Hamilton Mountain, ON]

Mr. Speaker, in this place which so often generates more heat than light, I want to pay tribute to the thousands of Canadians who act where government fails. One area where this is painfully obvious is in our response to HIV-AIDS.

Organizations such as the Hamilton AIDS Network are doing incredible work in preventing HIV transmission, and recognizing and responding to the stigma and challenges posed by HIV-AIDS. But, instead of partnering with NGOs on their essential programs, the government is forcing them to do more with less.

The same is true for the Grandmothers to Grandmothers Campaign that was launched by the Stephen Lewis Foundation. Volunteers are dedicating themselves to ensuring that whether one lives or dies with HIV is not determined by one's race, gender or citizenship.

The government could so easily support these efforts by passing the NDP's Bill C-393, but instead, it puts the needs of big pharma ahead of the need to win the battle against AIDS in the global human family.

On this World AIDS Day, I want to salute the Hamilton AIDS Network and the Grandmothers of Steel for their compassion and commitment. I want to challenge the government to support their efforts with resources instead of just rhetoric.

Access to Medicines Regime

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Mr. Speaker, I am pleased to table another petition. The signatures were gathered by grandmothers speaking out for grandmothers in Africa across this nation.

They are very concerned about the status of legislation before the House, which will come to a vote on Wednesday. They urge all members to support private member's Bill C-393. They urge all of us to make the necessary changes to Canada's access to medicines regime, and ensure that the commitments we made to the poorest nations of the world are kept.

Patent Act

[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.

[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.

[Mike Lake, Conservative, Parliamentary 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.

[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.

[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.

The House resumed from June 12 consideration of the motion 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.

Access to Medicines Regime

[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.

Drugs and Pharmaceuticals

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Madam Speaker, I am very pleased to present yet another petition from Canadians who want to see changes to the Canadian access to medicine regime, so we can return to that noble goal of sending drugs as quickly and as cheaply as possible to sub-Saharan Africa and other countries.

The petitioners call upon the House to support my private member's bill, Bill C-393, a bill which is also similar to the one in the Senate being debated today, Bill S-232, a bill which just heard representation from experts showing, in fact, how nothing in these two bills contravenes the World Trade Organization, and is totally in compliance with everything we stand for in this country.

They call upon Parliament to help ensure access to affordable medicines wherever they are needed throughout the world as quickly as possible.

International Aid

[Judy Wasylycia-Leis, NDP, Winnipeg North, MB]

Madam Speaker, I am honoured to table a petition regarding Canada's access to medicines regime.

The petitioners call upon Parliament to support my private member's bill, Bill C-393, that proposes changes to this regime to make it possible for generic drugs to flow more effectively, efficiently and quickly to countries in need, especially in sub-Saharan Africa.

They want this to happen because 14,000 people die every day from diseases, such as HIV-AIDS, tuberculosis and malaria, diseases that are preventable if these countries were to have access to medicines that we take for granted in this country.

Grandmothers for Africa

[Denise Savoie, NDP, Victoria, BC]

Mr. Speaker, this past weekend I greeted Grandmothers for Africa as they pedalled into Victoria ending a 280-kilometre fundraising ride.

These remarkable women are recipients of the Rosemary Brown Award for Women for their tireless work in solidarity with grandmothers in Africa.

So today I rise to support the grandmothers' campaign to unblock Canada's access to medicines regime and get affordable generic drugs moving to the world's most vulnerable people.

This week, the second half of the first and only shipment under this legislation is leaving Canada for Rwanda, and the generic provider has said that it will be the last shipment unless the regime is amended.

My colleague, the member for Winnipeg North, has introduced Bill C-393 to remedy the regime's flaws. I urge all members to think like a grandmother and support this bill.

Patent Act

[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.