Mr. Speaker, it is a great pleasure for me to take part in this debate on Bill C-9. As I was saying yesterday, I do so with the belief that, to some extent, we are contributing not only to the north-south dialogue, but we are clearly making history, since this bill was passed unanimously and therefore received extremely strong and continuous support from all parties.
As members know, all the parties committed to working together to ensure speedy passage of the bill, in hopes that the other place will do likewise. However, we know this is another matter entirely.
Bill C-9 addresses the important issue of the contribution of companies manufacturing pharmaceutical products. My caucus colleagues know that, for about ten years now, I have taken an interest in the actions of drug companies, both the generic products industry and the innovative drug industry. I am extremely proud to say that I do not think I have ever been too critical, as the member for Verchères—Les-Patriotes knows.
Today, I would be remiss if I did not pay tribute to the innovative drug industry, which has assumed its responsibilities. Let us take a closer look at this issue.
In 1989, the Conservatives, under Brian Mulroney, ended the compulsory licensing program. In other words, it was possible, before Bill C-22, which became Bill C-91 under the Conservatives, to obtain a licence from a company with a monopoly. This licence was granted to a generic drug company, which had to pay royalties to be able to produce and reproduce the drug.
We must not forget that, back then, the term of a patent was ten years. What is a patent? I think that the President of the Privy Council has doubtless thought about this. A patent is important because it is a social contract. The President of the Privy Council will agree with me that it is a social contract by which society gives exclusive right to the protection and production of an invention or pharmaceutical product.
Furthermore, 18 months after the patent is filed, a full description of the invention is made public. There are, however, three criteria that must also be met. There are three criteria for patentability, at least in Canada.
First, the invention must be new. A search is conducted worldwide, not just in North America. The Commissioner of Patents conducts an international search to ensure that it is a new invention.
Second, the invention must show ingenuity.
Third, the invention should be useful.
If these three conditions are met, a patent is granted, and it provides trade exclusivity and complete protection. Copying the invention or chemical process is against the law, and there can be counterfeit charges. This is an extremely strict system.
In matters of copyright, we have case law and judicial mechanisms, since extremely important trade issues underlie the whole concept of copyright.
In 1989, the Conservatives did away with compulsory licensing. From then on, Canada was in line with what was being done in other countries. That was very important for Montreal, since the biotechnology industry is concentrated there. The Conservatives set the patent protection at 20 years, once the patent has been granted by the commissioner and the three conditions—new, useful and not obvious—have been met. Patent protection is then provided.
However, when Bills C-22 and C-91 were enacted, they also had provisions forbidding the export of drugs. It was illegal to export drugs, and sanctions could be imposed.
Since 1989, another factor has been added, and this is intellectual property rights. Governments signed what has been called the TRIPS agreement.
Moreover, two years ago a bill was passed to harmonize all Canadian patents. Some were still in the 10-year system, others 20. There was a challenge by the U.S. under the TRIPS agreement, and the mandatory arbitration went against Canada.
A noteworthy point about the WTO is that the relative clout of the countries has no importance. There are dispute settlement mechanisms in place that allow a country like Costa Rica to win out over the United States. Canada lost and so it has to harmonize all of its patents to the 20-year period.
Today we have a bill before us that will make it possible to export drugs, but not to export them just anywhere, just to designated importing countries listed in the schedule to the bill. Basically, these are the developing countries.
The list was incomplete in the first version of the bill, and the Minister of Industry has revised it. To all intents and purposes, the countries able to import drugs fall into the category classified as developing countries.
How will this be possible? Countries wishing to obtain drugs issue a call for tenders on a web site, so the competition is international, of course. Canadian companies will be competing with others in the U.S. and Europe.
When a company wants to compete in order to supply drugs to a third world country, there are two things in the bill that govern this. First, generic companies will be able to obtain the contract. Initially the bill contained what was termed the right of first refusal. This meant that companies holding a patent could, even if the contract had been negotiated by the generic companies, be the first supplier because they were the patent holders.
All of the international cooperative bodies criticized this bill, from Development and Peace to Doctors without Borders. All those involved in delivering humanitarian aid said that this was impossible, that if this right of first refusal were maintained there would be a dissuasive effect on the generic companies which might want to negotiate contracts.
At least in this one instance, though far from a regular occurrence, the government did heed the stakeholders in committee, and the right of first refusal was done away with.
The supply of drugs is not a trivial issue. Just think that, every year, 10 million children die from diseases relating to malnutrition which could have been avoided. Every year, one million people, most of them children under the age of five, die of malaria. Every day, over 8,000 people in the world die of AIDS. We know that the HIV-AIDS epidemic is concentrated in certain parts of the world, particularly in African countries.
Why are these figures important? Because, for each of the diseases that I mentioned, there is a drug available. However, if this drug is not accessible at a lower cost to countries that are facing these epidemics, we will not be able to fight these epidemics.
Even if Canada, through cooperation agencies such as CIDA, allocated $100 million per year for the development of third world countries, if the nationals of these countries are not themselves active, productive and healthy citizens who can make a commitment to help build and improve their country and their economy, these developing countries have a major problem on their hands.
We need legislation that will allow third world countries to have access to drugs at a lower cost. The way drugs are being produced—and that includes the factory price and the distribution to retailers—it is clear that the system is not competitive.
Of course, in Canada, the Patented Medicine Prices Review Board was established when the Conservatives passed Bill C-91. The board is a quasi-judicial tribunal. Let me give an example. When Merck Frosst produces a drug, the Patented Medicine Prices Review Board monitors the situation to ensure that, once the drug leaves the factory and is distributed to wholesalers and retailers, the price charged is not prohibitive or exorbitant. We have a price index to determine if prices are excessive. If they are, the Patented Medicine Prices Review Board may ask the company to refund the overcharged amount. Such a measure has been taken in a number of cases.
When it comes to exporting drugs from Canada, the Patented Medicine Prices Review Board has no jurisdiction. It was up to the international community to amend agreements on intellectual property rights and trade in order to make these drugs accessible at a better price, a cheaper price. This raised a number of issues.
I think that everyone in this House understands how this works. A voluntary licence is issued by the patent holder. If the latter refuses to issue the licence, the patent commissioner may issue an order. The agreement amended in August 2003 does not require the patent holder to transfer their drug.
A royalty of roughly 2% of the commercial value of the product has to be paid out. This is not a donation. Companies that hold the patents will receive royalties for the person or company that obtained this voluntary licence. If there is disagreement on the royalty or the terms of the licence transfer—which initially has to be voluntary—the patent commissioner can be asked to rule and the licence, which was to be voluntary, will become mandatory.
Concerns were raised during the work at committee on how NGOs fit into this. For example, there is Doctors Without Borders, and Development and Peace, which are Canadian NGOs working in third world countries. Some NGOs, if not all, would have liked to be able to negotiate directly with the manufacturer. Obviously, thought needed to be given to this. There was a risk of interfering in national sovereignty.
Governments are subject to international law. In major international conventions, government means something. One of the first conventions provided a definition of sovereignty. That word simply rolls off my tongue. Sovereignty was defined in 1934 at Montevideo. It was said that a government has five characteristics: a functioning government; a permanent population, of course; control over a territory, which is increasingly being described as a defined territory; the capacity to recognize citizenship; and, of course, international relations.
Once a government or administration is in office, it is responsible for the delivery of health care. I understand the industry minister has amended the bill to ensure not that NGOs can directly negotiate with the manufacturers but that they can be involved in the negotiations since they have the ultimate responsibility for service delivery. That is one of the responsibilities governments have.
Parliamentarians also wanted to ensure that the additional pharmaceuticals needed to supply third world countries are manufactured in a manner that distinguishes them from the products sold on the domestic market. Under the bill, pharmaceuticals for export would be differentiated through different colours and different labels.
This is an extremely humane and responsible piece of legislation. I want to say a few words about the companies grouped under Rx&D. I remember having breakfast at the parliamentary restaurant with representatives of that organization, along with our industry critic, the hon. member for Kamouraska—Rivière-du-Loup—Témiscouata—Les Basques, and also, of course, our international trade critic, the hon. member for Verchères—Les-Patriotes. The hon. member for Trois-Rivières, who has a long-standing interest in the third world, also joined us. I even recall that he asked very relevant questions. He was most interested in Africa.
We understand, of course, that pharmaceuticals would not only be exported to Africa. They could also be exported to Central and South America. However, I remember how much emphasis the member for Trois-Rivières put on Africa.
We wanted to ensure that the member companies of Rx&D would co-operate. It is clear that if the companies had not been interested in issuing voluntary licences, we would have found ourselves in a very embarrassing situation. Various arbitration mechanisms would have led to compulsory licensing. The commissioner of patents would have had to intervene and it is clear that it would have caused undue delay.
I must say that the innovative companies have behaved very responsibly in this matter. I hope that this sense of responsibility is reflected in the various domestic debates we shall have.
Perhaps I could take a few moments to talk about what is going on in Canada with respect to the price of pharmaceuticals, even though I know this is about the international level. Members are aware that it is the largest expense in all health care systems. In fact, each year in Canada, a total of $120 billion is spent on health. The fastest growing budgetary item in that area is the cost of drugs; the hon. member Abitibi—Baie-James—Nunavik knows this because he has sat on various regional health boards.
I had proposed a number of solutions to my caucus, in order to fight the rising cost of pharmaceuticals. In fact, the cost of medicine is rising at a faster rate than costs in the health care system in general. On average, health care costs in Canada, in each province, are rising by 5% per year, but the cost of medicine is rising more than that.
I shall conclude by saying that we are going to support the speedy passage of Bill C-9, because it is a good bill for third world countries, for our international obligations, and for the north-south dialogue.
I salute the innovative companies that have shouldered their responsibilities. I congratulate all members of this House—in particular, the hon. member for Kamouraska—Rivière-du-Loup—Témiscouata—Les Basques—who have worked very hard in committee. I hope the other place will enjoy the same kind of energy that has characterized this House's work on Bill C-9.