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.

[Marc Garneau, Liberal, Westmount—Ville-Marie, QC]

Thank you, Mr. Chair.

If I had one word to describe my personal experience with Bill C-393, it would be the word “agonizing”. Let me define what I mean here, because it's not often a politician will talk about an experience as being agonizing. It's agonizing in the sense that I believe so much in the high-level objective of CAMR, which is to provide much needed medicine to people who are in need of it, and I've been solicited by a huge number of people who feel passionately about it. At the same time, I have not been convinced that this particular bill will solve that problem. Your testimony today generally supports my thinking, in the sense that you have pointed out what it can do and what it can't do and what it risks causing in terms of problems and other realities.

I want to start with something you said, Ms. Downie, at the very beginning. It is that the biggest problem is the result of poverty; it's not the result of a problem with our patent law. I'd like to ask you, perhaps, to expand a little bit more on that statement.

[Brigitte Zirger, Director, Policy Bureau, Therapeutic Products Directorate, Health Products and Food Branch, Department of Health]

I'll try to do this on the fly, then.

As Ms. Downie has already mentioned, Health Canada's regulatory role within Canada's Access to Medicines Regime is three-fold.

Firstly, the department is responsible for undertaking a regulatory review of a drug submission to verify that the product meets the same requirements for safety, efficacy and quality as drugs available to Canadians.

Secondly, Health Canada is responsible for ensuring that the pharmaceutical product is distinguishable from the patented version available in Canada. This is aimed at preventing diversion or re-importation of the product.

Third, Health Canada is responsible for performing pre-export inspections to verify, among other things, the distinguishing features and the quantities to be exported. These details would be stated on the manufacturer's application for compulsory licence that is sent to the Commissioner of Patents.

Now, the products of most interest under CAMR are antiretrovirals used for the treatment of HIV/AIDS. In Canada, the vast majority of these drugs are still under patent protection, which means that Canadian generic versions have not yet been developed. This was the case with Apo-TriAvir.

I would add that submissions that are received and have been received under CAMR are taken into review immediately upon arrival and are completed well within the performance target. These reviews are undertaken with the same diligence as any domestic submission review we undertake, and that is mainly because at the end of that review, and when the patents expire, those drugs can come to Canada.

Companies, whether they are brands or generics, don't develop risk-free products. If they did, Health Canada would never have to issue a negative decision. And it is Health Canada's view that there should be no question of a double standard, nor should there be any concern that a drug leaving Canada destined for humanitarian purposes might be unsafe. Bill C-393 could put this in jeopardy. By removing the mandatory review, it is unclear what safety, efficacy, and quality standards would be applied to drugs exported from Canada under a government-issued compulsory licence.

Maintenance of quality once drugs are in that country and the trade of substandard, falsely labelled, counterfeit, and falsified medicines are serious public health problems. These pose significant challenges to developing countries, which receive drugs from many different sources, including Canada, and where the capacity of national drug regulatory agencies varies significantly. Removing Health Canada's review of drugs exported under CAMR simply moves the drug assessment to lesser-resourced agencies in developing countries or to WHO, which itself depends on regulatory agencies such as Health Canada to do the reviews.

Health Canada, its regulatory counterparts, and organizations like WHO work collaboratively to build regulatory capacity in developing countries. For example, there are quite a number of international harmonization projects, which I've named here but will skip, which focus on the development of lesser-resourced regulatory agencies.

In 2009, Health Canada replaced numerous annual ad hoc visits from these agencies with an international regulatory forum aimed at providing training. The forum is being repeated in two sessions this year and it involves some 27 participating countries. One of them is taking place next week.

We have an HIV vaccine initiative, which is a collaboration between the Government of Canada and the Bill and Melinda Gates Foundation, that is aimed at advancing the science of HIV vaccines and the prevention of mother-to-child transmission of HIV. An element of this collaboration, again, is aimed at capacity-building in the area of vaccines.

Most importantly, Health Canada works with WHO's pre-qualified program, which is actually mentioned in the bill. It aims to ensure that medicines and vaccines for high-burden diseases meet the global standards for safety, efficacy, and quality. The pre-qualified list is used by UN procurement agencies as well as by developing countries when making procurement purchases. Health Canada and many other countries undertake product reviews for this program, and it's because of this work that Apo-TriAvir was added to the pre-qualified list on the basis of Health Canada's product review.

In summary, Canada is committed to increasing access to high-quality medicines and health care in developing countries. Health Canada's role in CAMR is one aspect of this commitment, and so is Health Canada's contribution to building capacity in lesser-resourced regulatory authorities.

[Brian Masse, NDP, Windsor West, ON]

That's fine as long as the witnesses are going to stick to Bill C-393. I don't think we need to hear about other issues.

[Colette Downie]

Thank you, Rob.

I'm on to slide 5 now. I'll just back up for a second to say that Canada's patent system rewards the extensive investment that's needed to develop new, innovative products, including medicines, by giving patent holders exclusive rights to sell the results of their research for a number of years. In Canada, it's 20 years. When the patent expires, of course, others are free to sell the product, as when we see generic drug manufacturers selling copies of formerly patented medicines.

The access to medicines regime is an exception to our patent system. It allows the Canadian government to authorize someone other than the patent holder, whose property the patent is, to manufacture a patented drug or a medical service for export to a list of particularly needy countries. In recognition of the tremendous investment that's needed to develop these products, and because we want to continue to encourage companies to develop innovative new products, and medicines in particular, Canada's access to medicines regime, CAMR, was designed in a specific way to clearly define its limits, essentially.

While the process for applying for a special authorization under CAMR is actually pretty straightforward—and if the committee is interested, I could share the forms that are required, because when you see them they're actually quite straightforward—CAMR does contain some important disclosure provisions, which were designed first of all to promote transparency and prevent abuse, including the diversion of products back to Canada or to other markets where they might not actually be needed for humanitarian reasons, and, as I said, to ensure that the drugs manufactured are actually used for humanitarian and public health reasons and not for commercial purposes. Also, it's to allow the government or the Federal Court to cancel a licence if, for example, it's abused, is not used in good faith, or is used for commercial reasons. It's important to know that the regime relies on patent holders and not the government to police the use of products licensed under CAMR.

What Bill C-393 proposes to do is remove some of the important anti-diversion and transparency measures that make the regime enforceable. For example, it reduces the information that an applicant must disclose before it gets government approval—basic things such as the requirement to identify the patents involved, the name of the patent holder, the quantity shipped, where it's being shipped to; it would make the authorizations unlimited in duration and quantity; it would remove requirements to notify the patent holder when the medicine is being shipped, how much is being shipped, where it's being shipped to, and who will be handling it in transit as well; it proposes to remove requirements that licensed products have special markings, colouring, and labelling, to make them distinguishable from the patented versions available in Canada. It would significantly also narrow the ability of the government to terminate an authorization, and it eliminates the ability of a patent holder to challenge the shipment of goods, if they're for commercial purposes, in court.

What this means is that anyone could apply to the government for a licence to sell unlimited quantities of products outside Canada, and the government would be required to issue a licence on the basis of not a lot of information and without a mechanism at the back end to make sure that products are actually being shipped for commercial reasons, or to the country they're intended for.

Research and development-focused pharmaceutical companies have global reach, they have global perspective, they have flexibility about where they invest their R and D dollars, and they naturally favour jurisdictions that provide strong and predictable IP regimes. We're concerned that reducing the safeguards provided in CAMR will result in pharmaceutical companies' hesitating to invest in Canada for lack of certainty about the protection of their investments. If they believe the patented products they sell in Canada could also be sold in an unlimited way to other countries, including perhaps being diverted to relatively well-off countries like the ones I mentioned earlier, such as Mexico or Poland or Hungary, they might hesitate to invest the time, money, and resources to bring new and innovative products to Canada.

Another key concern with Bill C-393 is that it introduces a double standard: it would no longer require—it makes optional—that drugs manufactured and exported under the regime pass the Canadian health and safety review at Health Canada.

Many of these developing countries do not have the infrastructure in place to make sure that drugs they are purchasing are safe and effective. The Health Canada review process under CAMR makes sure that they receive the same level of protection as is provided to Canadians.

I'll just turn for a moment to Brigitte, who can expand a little on that point.

We're really now just getting to the end of slide 5, and on to slide 6 in a second.

[Colette Downie]

I think everyone has a copy of our deck before them...? Fantastic. That's what we'll be going through.

I'll start by thanking you for the invitation today to speak about Canada's access to medicines regime, or CAMR, as it's often called, and to speak about the possible implications of private member's Bill C-393, which proposes to significantly change this regime.

Together, my colleagues and I will be speaking about CAMR and Bill C-393. Our presentation will be divided up according to our various responsibilities, but it will, I hope, highlight the following.

First, there is the complex problem of delivering medicines to the developing world and what the Canadian government is doing about that. An access to medicines regime like CAMR, like Canada's, can't by itself solve the main problems of access to medicines, which are really the result of poverty, not patent laws.

A number of risks are associated with removing the conditions that exist in CAMR to give what would be essentially a blanket licence well beyond what would be needed to deal with some of the humanitarian problems that motivate this private member's bill. In particular, it would allow for export of almost any patented drug made in Canada for an unlimited time and to many countries that are relatively well off, like Poland, Mexico, and Brazil. There would be no policing mechanism to ensure good faith in the shipments, all of which potentially would have--at least we're concerned about it--concerns for Canadians' access to innovative new medicines and research and development jobs.

So while the proposed bill raises these risks, at the same time the government's view is that it's very unlikely to achieve its very laudable goals, which are to increase the exports of much-needed medicines to developing countries.

Following our joint presentation, all of the officials here would be happy to answer your questions.

I'll turn over the beginning of the deck to Louise Clément.

[Brian Masse, NDP, Windsor West, ON]

Thank you, Mr. Chair.

I'll be brief. I think it's important for us to talk to the witnesses who are here today.

I want to start by thanking my colleagues for continuing with the study of Bill C-393, as Judy Wasylycia-Leis, the original sponsor of the bill, has moved on. I want to thank my colleagues for living up to the commitment they made to have hearings in this committee. I do appreciate that.

I want to provide a little bit of context. I won't get into many of the details of the bill, but I will maybe talk a little bit about why the bill is important and provide a little bit of the history for members who weren't around at that time.

I was elected back in 2002. When I came to Parliament Hill, there was already a movement to have a bill or a law to deal with some of the world's poorest and developing nations to help them get access to pharmaceuticals and medicines, since the simple status quo was not acceptable.

A year later, the WTO and a series of other global endeavours led to an opportunity for Canada to be one of those countries to actually put a system in place for generic drugs to be produced in advance of patents to help those suffering from tuberculosis, malaria, HIV/AIDS, and other types of catastrophic diseases and health problems. Bill C-56 was tabled in the House of Commons, and a subsequent government tabled Bill C-9, known as Jean Chrétien's Pledge to Africa bill.

At that time, the committee had lots of hearings. We had several different panels come forward. There were really comprehensive examinations. And just so my colleagues know, I actually proposed 100 amendments to that bill at that committee, believing at the time that it was flawed. Now, that's not to say I was right, but, at the end of the day, in the House of Commons all political parties ended up agreeing unanimously to a bill.

The explicit goal of everybody in that room and in the House of Commons was to have Canada put in place a system to be able to get these drugs to children and people across the globe who are suffering. As things stand, each day around 14,000 people die of HIV or AIDS, and when children actually have HIV/AIDS, one-third die by the age of one, and one-half by the age of two. We simply have the tools necessary to correct this situation.

Only one patent has gone through this regime to date. That was to Rwanda. It's been very limited in scope. That's from Apotex. There have been generic drug companies that say they will send more drugs overseas if we fix the legislation, and that's what we're proposing to do.

Once again, I'm proud to sponsor this bill, but, at the same time, I'm ashamed of my record on this, because I voted for a bill, and we promised the world we would do something that hasn't taken place. It certainly hasn't met what people said in the House of Commons and what they said here at committee, so I want to seek solutions to fix that.

I voted for the bill even though I thought it was flawed, because we stand unanimously together, as parliamentarians, to try to make a difference. We put those things aside to see whether or not the bill would actually work and if the problems we thought would happen weren't going to take place. But the reality is that they have.

So I stand here today to once again try to correct this situation, and to work cooperatively with everyone, because I think there was honest and sincere debate from all members and all parties to actually have a country that actually has a solution for this and that contributes and shows leadership. But we have failed people on this. There's no doubt about it. People are suffering. People are dying. People are not getting treatment. We put a lot of weight behind this and we need to solve it. I think it's a moral and ethical obligation for us, and I think Canada has the tools to be, once again, a leader in this field.

I thank you again for continuing with your commitment to have this heard in the halls of this committee, and hopefully in Parliament as well.

Thank you, Mr. Chair.

[The Chair, Conservative, David Sweet]

Order, please.

Good morning, ladies and gentlemen. Bonjour à tous.

Welcome to the 37th meeting of the Standing Committee on Industry, Science and Technology, the third meeting of this session.

We have a small piece of business that I'd like to deal with.

Members have in front of them the budget for our study regarding Bill C-393. Could I have someone—

Access to Medicines Regime

[Brian Masse, NDP, Windsor West, ON]

Mr. Speaker, it is an honour for me to table a petition on Bill C-393 regarding the reform of Canada's access to medicines regime.

Fourteen thousand women, men and children die every day from infectious diseases such as tuberculosis, malaria, HIV and AIDS. This country has yet to fix Canada's access to medicines regime which was created a number of years ago, back in 2003, which still has not helped provide access to low cost medicines for those abroad. We are literally letting children, women and men suffer unnecessarily.

The petitioners call upon Canada to reverse its policy and to become a contributor to the health and well-being of those individuals as opposed to ignoring them.

Industry, Science and Technology

[Michael Chong, Conservative, Wellington—Halton Hills, ON]

Mr. Speaker, I have the honour to present, in both official languages, the second report of the Standing Committee on Industry, Science and Technology, concerning its study of Bill C-309, An Act establishing the Economic Development Agency of Canada for the Region of Northern Ontario. The committee requests an extension of 30 days to be able to properly study the bill.

I also have the honour to present, in both official languages, the third report of the Standing Committee on Industry, Science and Technology, in relation to its study of Bill C-393, An Act to amend the Patent Act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act.

The committee requests a 30-day extension in order to give the bill proper consideration and to hear all witnesses who wish to appear.

Access to Medicines Regime

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

Mr. Speaker, I am very pleased to be able to table my very last petition in the House before I leave this place after 13 years. Actually, this will be the very last time that I will say anything on the official record of the House of Commons. I cannot think of a better issue around which to do this than on the matter raised by petitioners from my constituency and across Canada, particularly from the Canadian Grandmothers for Africa organization.

The petitioners call upon this House to follow through with the support that it gave Bill C-393, my private member's bill on the access to medicines regime, to ensure that more drugs flow at costing rates to Africa and other developing nations.

Members will know that this bill was supported by the House of Commons at second reading. It has gone to committee and the petitioners implore members of the House from all parties to see the process through, to discuss this matter at committee, to call witnesses, and to ensure that we change Canada's access to medicines regime to ensure that drugs flow to countries in need and to ensure that Canada lives up to its reputation as a leader in terms of humanitarian and compassionate issues around the world.

I thank all of those who have worked so hard on this issue, especially the grandmothers across Canada. I urge the House to help me leave this as a lasting legacy for all Canadians and the world.

Business of the House

[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.

International Aid

[Joyce Murray, Liberal, Vancouver Quadra, BC]

Mr. Speaker, I am pleased to rise in the House today to present a petition that calls on Parliament to set a timetable to meet Canada's development assistance commitments, to increase Canada's foreign aid commitments to combat HIV-AIDS, tuberculosis and malaria, and to make the legislative changes necessary for Canada's access to medicines regime to facilitate immediate and sustainable lower cost generic medicines flowing to developing countries. They call on the government to support Bill C-393.

The petition is signed by residents of Vancouver Quadra. It stems from the heroic efforts of the African grandmothers who raise children orphaned by AIDS. They are supported by the efforts of over 200 grandmother groups across Canada.

Drugs and Pharmaceuticals

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

Mr. Speaker, I have three petitions. The first petition has to do with concerns from constituents and others about the 14,000 men, women and children who die every day from tuberculosis, malaria and HIV-AIDS.

The petitioners call upon this House to support Bill C-393, my private member's bill. They are pleased that it received support at second reading, and call upon this House to complete the process and ensure that it becomes law.

International Aid

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

Mr. Speaker, I am very pleased to present yet another petition that was organized by the Grandmothers to Grandmothers Campaign in support of my Bill C-393, reforms to the Canada access to medicines regime, and also generally to ensure we meet our millennium development goals.

The petitioners call upon all of us to do our part to ensure that 0.7% of our gross national product goes to development assistance internationally and that we contribute our share to the global fund to fight AIDS, TB and malaria.

I want to thank the grandmothers again for their incredible pioneering work in gathering thousands of petitions in support of Bill C-393, and in their show of courage and conviction to ensure that people around the world benefit from the resources of this rich nation.

Patent Act

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

Madam Speaker, I am pleased to table a petition that was organized by the Grandmothers for Grandmothers campaign who wanted to see Bill C-393 pass through the House to committee.

They are delighted with the results of the vote in the House last night. They urge all parliamentarians to continue working on the bill to ensure that necessary medications get to those countries that cannot otherwise afford them to deal with such horrible and deathly diseases as HIV and AIDS, tuberculosis and malaria.

On behalf of everyone in the House, I would like to thank the grandmothers again for their great work on this issue.