Mr. Speaker, I am pleased to speak to Bill C-9, the humanitarian bill. It is certainly important for all caucuses to support the legislation because the need for access to medicines has been recognized internationally. It is important that Canada participates and sets an example for the world, although it does remain to be seen whether we will have set a good example. I will have more on that later.
Every day a countless number of people die in the developing world of diseases for which there are cures, diseases such as tuberculosis, malaria and pneumonia, simply because of a lack of access to medicines most often due to the high cost of pharmaceutical products.
Although there is yet no cure for the HIV-AIDS pandemic, there are drugs to ameliorate it. In Africa alone, every day 6,000 people die of AIDS, while 11,000 more contract the disease.
I think we would all agree that Stephen Lewis, the Canadian special envoy on this at the United Nations, has done more not only in Canada but around the world to raise this issue and to force us to realize it than any other human being alive.
On health, education and security, any initiative to improve in these areas will have many different components, and this bill seeks to address one of those core components, namely the access to medicines.
Improved health is linked to increased school attendance for children and their ability to do well while at school. As we all know, education is a lifelong process and has a lifelong impact on an individual's well-being and economic productivity.
We have heard lots of talk about security in recent days. In fact, the Prime Minister is talking about that very subject this afternoon in Washington. I firmly believe one of the most important ways that we can make our world more secure is through improving the health of the people in that world because it leads them to participate more fully in the social, economic and cultural events and aspects of their countries and their home communities.
Many studies show the devastating economic impact of infectious diseases such as malaria and the AIDS pandemic. The World Health Organization's recent commission on macroeconomics and health stated:
The evidence confirms that countries with the weakest conditions of health and education have a much harder time achieving sustained growth than do countries with better conditions of health and education.
There is no surprise there.
On the international process over the past several years, the background to this legislation is that when it is passed, Bill C-9 will be among the first pieces of legislation of its kind in the world, the end product of several years of negotiations on the international stage. It goes back to November 2001 at the WTO Doha round on intellectual property rights. The declaration affirmed that countries have the right to protect public health and improve access to affordable medicines, including through compulsory licensing of pharmaceutical products.
This international acknowledgement was incredibly important because, although many countries officially recognized the need for a better balance between intellectual property rights and human rights, the need for a north-south sharing of technologies and knowledge, the reality of intellectual property rights made the practicalities of that sharing difficult, which meant that little of substance was actually being done.
The WTO agreement last August is the practical solution to the principles agreed to at Doha and was historic in that it gave World Trade Organization members the right to export to developing countries those generic medicines still under patent without fear of trade retaliation and it acknowledged the importance and urgency of so doing.
On the competition aspects of the bill, because of intellectual property rights, patent holder or innovator companies have monopolies on their drug products in this country for a period of 20 years, which the health critic for the Bloc Québécois was explaining very well a few moments ago. That 20 year patent protection rule varies from country to country around the world.
In developing new drug products there is often many years of research and development and patent holders obviously must recoup their costs and these costs, particularly for new experimental drugs such as those used in HIV-AIDS, are often far too high for developing countries and NGOs delivering health services in those developing countries to meet the need and demand for the products.
As a result, many patent holders have entered into agreements with countries and specific programs to provide their drugs at lower prices or at no cost at all but those efforts have been insufficient to meet the demand.
Increasing competition, by allowing generic producers to enter the market earlier, is seen as crucial to ensuring that those needing treatment have access to those medicines as required. Increasing competition increases supply and decreases prices, and both of these are needed for developing countries in order for them to be able to meet the urgent health care needs of their people.
On the international obligation front, Canada has many international obligations in this area, including having recognized since 1945 the right to health as a fundamental right, the UN's special session on HIV-AIDS to make, in an urgent manner, every effort to increase the standard of treatment for people suffering from HIV-AIDS, including the prevention and treatment of opportunistic infections.
It is important to ensure that as parliamentarians we fully respect and reflect Canada's obligations to taking this important step toward the full realization of the human right to health, including the promotion of access to affordable medicines for all.
My colleague, the member for Windsor West, who has worked very hard and tirelessly on this legislation, presented both at committee and here at report stage several other pharmaceutical products that can be of use to developing countries. An amendment was made to include an important fixed dose drug for the treatment of tuberculosis and that was passed at report stage and, I am happy to say, is included in the bill.
Unfortunately, two other drug products that he had proposed were rejected at report stage. One of them is on the World Health Organization's pre-qualified list of drugs for HIV-AIDS and the other is currently indicated for pneumonia, which is the leading killer of children in the developing world under the age of five. This drug is also being studied for possible anti-tuberculosis use.
I sincerely hope that the Minister of Health and the Minister of Industry will together move quickly to receive advice on those two products and include them on a future schedule of drugs.
We first saw Bill C-9 as Bill C-56, which was introduced last November but died on the Order Paper when the House of Commons prorogued on December 12. It was reintroduced in its initial form on February 12 but the government proposed many changes following that.
Testimony was given at committee from a variety of groups, and while all witnesses appearing made it clear that they were supportive of the initiative, many problems with the bill that were identified by those expert witnesses. They included the first right of refusal, which would have allowed the patent holder, the pharmaceutical companies, to scoop a contract negotiated by a potential generic producer. This would drive up the cost of the eventual drug.
With regard to the schedule, testimony on this aspect was clear. It was felt that there should be no schedule of drugs. It was felt by the overwhelming majority of witnesses that this would be flawed at the outset and that having a schedule, regardless of how flexible it may be intended to be, would add another unnecessary step in the process of getting drugs to the developing world. The reason for that is that if the drug is not listed on the schedule there would have to be a process to first, get it on the schedule, and then get it to where it was needed.
Respected organizations, such as Doctors Without Borders, testified that the language did not allow for the participation of non-governmental organizations. It was felt that the wording would not allow them to participate because NGOs do not consider themselves as agents of any government and they play a crucial role in many developing countries in providing health care services, including access to medicines.
Many witnesses also presented testimony about the need to expand the schedules of eligible countries. In its original form only WTO member developing countries and least developed countries were eligible, while many witnesses testified that there was no requirement by international trade rules to exclude those several dozen other developing countries, such as Vietnam, Iran and Iraq, countries which also face substantial health issues that we see regularly on our television sets and that could be better addressed if they had access to medicines at affordable cost.
I want to turn now to the major problems that we see in the bill. Over 100 amendments that were submitted by my colleague, the member for Windsor West would have done several things, including eliminating the first right of refusal, extending the list of eligible countries and drug products and, lastly, clarifying the language around the participation of non-government organizations.
After the committee hearings, the government took more than a month to present its amendments to the bill. It made substantial amendments, including eliminating the first right of refusal, allowing for other developing countries to apply through diplomatic channels to be eligible to participate and to allow NGOs to participate. Although some of these changes presented further additional problems that may affect the workability of the bill, myself, the member for Windsor West and my colleagues in the New Democratic Party caucus are supportive of the majority of those proposed amendments.
We did raise at committee the new concerns around the increased opportunities for legal battles between patent and generic drug companies that could seriously impact how this bill will actually work in reality, the unnecessary requirement that developing countries wishing to be added to the list of eligible countries are required to be added specifically with reference to a particular drug product and it is unclear what process has to be followed after that.
My colleague from Windsor West was pleased to have the support of the committee and wanted it recognized on several amendments, including those to ensure that humanitarian concerns be considered the first determination if the Federal Court is required under the appropriate section as to whether a royalty rate has been established according to the formula that will be prescribed in the regulations.
The section on page 12 of the bill now reads:
The Federal Court may make an order...taking into account
(a) the humanitarian and non-commercial reasons underlying the issuance of the authorization;
(b) the economic value of the use of the invention or inventions to the country or WTO Member
We can see the importance of reversing those two clauses.
Another amendment ensures that there is a minimum of a 30 day waiting period that a potential generic producer must observe to apply for a voluntary licence from the patent holder before applying to the Commissioner of Patents for a compulsory licence.
The third amendment was a language change to ensure that the minister be required to establish an advisory committee to advise on the inclusion of further drug products in schedule 1.
There are some continuing problems that have been identified and the first that remains is on the scheduling. As the House has heard before, there is a consensus that the presence of a schedule at all provides further inflexibility in ensuring that countries have access to the drugs that they require.
A list by its nature is exclusionary because it does not include all possibilities and the negotiations that led to the historic WTO waiver last August examined and rejected the idea of creating a list.
Under Bill C-9, if a country wants a drug that is already approved for use and sale here in Canada, it will have to start a process to get that drug included before a generic producer could apply for a voluntary or compulsory licence to supply the country with that medication.
We presented at committee and in the House amendments to improve the schedule, and we will continue to monitor the impact of the existence of the schedule on the workability of the bill.
The second major problem that remains, in our opinion, is that NGOs in countries where they are legally entitled to purchase and distribute pharmaceutical products to contract directly with generic suppliers in Canada. Again, NGOs play a crucial role in many developing countries in their broader health care programs, including purchasing and distributing of essential medicines, and this barrier is a major cause of concern around the workability of this bill.
The third major problem stems from those amendments the government proposed at committee stage to replace the first right of refusal. The new legislation, as amended, now includes opportunities for patent holders to take generic products to the federal court about the royalty rate and the price of the product. Over the past decade there have been at least 300 cases brought against generic producers in federal court and court battles can be lengthy and costly, as we all know. Given that the price generic producers can charge is now to be regulated by a fixed and flexible cap, there is concern that they may not be able to participate to increase supply on the variety of products that might have been possible without these new sections and without the first right of refusal clauses. Generic producers will have significant outlay of cost to increase their own research and development and operational costs to get into this business of increasing supply, and with the price cap there may be a serious disincentive for generic producers to participate.
Problems, as I have tried to indicate, do remain with the bill, but it is in the best interests of the people who the bill is intended to assist for us to give the regime a try and to pass the legislation quickly.
Canada has made numerous international commitments, which I and my colleagues in the New Democratic Party caucus support, to help address the pandemic of HIV-AIDS and other diseases like tuberculosis and malaria. While we continue to be critical of some government action, or better said, inaction, in some of these areas, if Bill C-9 actually works to increase pharmaceutical products through competition, then it will be an important tool and broader strategies to improve health in countries across the world.
We have gone through the process of hearing expert witnesses, amending legislation and exchanging ideas on how we think the bill should work. However there was a definite mindset and will be in all parties, including my own, to ensure that we deal with the bill as quickly as possible to ensure that we at least try to get cheaper pharmaceutical drugs on the market.
We in the NDP will continue to watch and monitor how the bill works and whether it provides enough incentive for generic producers to actually get into the business of producing cheaper versions of drugs for export to developing countries, the role and efficacy of the advisory committee and the schedule of drugs.
Just before I take my seat, I was interested to hear that this bill has been named the Jean Chrétien bill. While I do not wish to take anything away from the former prime minister and I know his interest in Africa, there will be very few Canadians who will think that this should be related to Jean Chrétien. It should be known as the Stephen Lewis bill. It was Stephen Lewis who brought this to the attention of Canadians and, indeed, people around the world and it is important that it be recognized at this time.