Mr. Speaker, I am pleased to rise to speak to a bill that proposes to totally eliminate linkage regulations. My neo-Bolshevik friends introduced this bill.
It has a certain merit. However, with all due respect, it lacks subtlety. It is reasonable to question the balance that must always be sought between innovative and generic industries.
It would be difficult, however, to say that linkage regulations have to abolished completely. We must not lose sight of the historical context. Until the Conservatives under Brian Mulroney changed the Patent Act, Canada had a system of compulsory licenses. In other words, a company manufacturing and marketing a drug obtained an exclusive license. With the payment of a royalty to the company, the drug could be copied.
For years, because this system of compulsory licensing in return for a royalty—royalty was the word at the time—was in effect, it was felt that Canada performed poorly in the area of research and development.
Obviously, if it is possible and relatively easy to copy a drug, that does not provide not much of an incentive for the biomedical industry to make investments.
These investments grew over the years. I saw the figures last year. Between the marketing phase and the research phase, from the moment the molecule is isolated to the moment the drug is available for consumption, it can easily take 10 to 12 years. We are talking about an investment cycle involving several million dollars.
Following a royal commission, Canada decided it wanted to change its system, at least in terms of drugs. When the Conservatives under Brian Mulroney came into power in 1984, they changed the law a few years later.
Now, it is no longer a compulsory licensing system, but an exclusivity system. In other words, to be a patent holder you have to submit an application to Health Canada and Industry Canada through the Canadian Intellectual Property Office. Then you get exclusivity, not from the date the patent is obtained—which was the case with the former legislation—but when the Conservatives passed their Bill C-91, exclusivity was granted for 20 years from the date the application is submitted to Health Canada and the Canadian Intellectual Property Office. Note that this is not market exclusivity for 20 years, since two or three years can go by before a patent is granted.
The Bloc Québécois cannot support the bill as it now stands. We have a large caucus in the Bloc Québécois, this great force of national liberation, this leading political force in Quebec that is here to stay, as everyone knows, if that is the wish of our fellow citizens. The Bloc Québécois cannot support the bill as it now stands. Why? Because we cannot agree to put all these innovative industries on an equal footing. We cannot say that marketing a patent, for example, for a washing machine or a dryer is the same as marketing a drug patent. There need to be guarantees for infringement protection. That is what the linkage regulations are for.
The linkage regulations are not perfect. I am even prepared to acknowledge that the innovative industries have engaged in delinquent behaviour, by extending patents that had expired. I believe what our colleague from the NDP was trying to say was that the industry used provisions in the linkage regulations, themselves established under the Patent Act. These provisions provided an opportunity, when there was an allegation of infringement, to automatically get an injunction for up to 24 months.
This mechanism is indeed questionable. I have statistics showing that between 1998 and 2003, there were almost 80 cases brought before the courts concerning notices of allegation. In two cases out of three, the generic companies won, which means the notices of allegation were not founded. It is true that in the past innovative companies used the linkage regulations not to protect themselves from infringement, but to extend their patents. This is unacceptable, as this was not the intention of the legislator.
We acknowledge that there are major investments that need protecting. The bulk of pharmaceutical research facilities are located in Montreal, not necessarily in Hochelaga—Maisonneuve, but more in West Island. These investments must be protected. Yet at the same time it is not acceptable to tolerate patents being perpetuated by claim mechanisms.
It must be acknowledged that the government has recently modified the regulations in order to protect us somewhat against that, in order to make use of the linkage regulations less easy, less automatic, less immediate, not to protect against infringement but rather against evergreening.
The Bloc Québécois, believing that this balance must exist between the generic and innovative drug industries, cannot support questionable practices which lead to evergreening.
That said, we do not feel that the solution proposed by the NDP, that is total abolition of regulations, is reasonable. Unfortunately, my neo-socialist friends sometimes let themselves get carried away with solutions that are a touch excessive. Fortunately, the Bloc Québécois, in all circumstances, provides that balance between what is desirable and what is feasible. I believe the Bloc Québécois worked very hard in committee to ensure that the linkage regulations are maintained, but used wisely.
Still, we must recognize that it may take 10 years from the time a molecule is isolated to the time a drug is available to consumers, and this can represent investments of up to $800 or $900 million. This money is not coming from the unions or workers or governments, but rather from the private sector. I do not want to shock my socialist friends but, in our system, it is normal to expect a return on an investment.
We do not tolerate abuses. We want a balanced policy and I believe that repealing the regulations in their entirety is unreasonable.
In closing, I want to say that, in the future, we will need to monitor drugs without any real therapeutic benefits. The Patented Medicine Prices Review Board refers to three classes of drugs: classes 1, 2 and 3. I believe that we must work with the pharmaceutical industry to ensure that new drugs coming onto the market and for which Health Canada issues an advisory have real therapeutic benefits. I agree with the NDP that, in the past, things have been somewhat lax and drugs with no new therapeutic benefits were marketed.
According to our estimates, this has contributed to a 50% increase in the cost of drugs.
Mr. Speaker, I sense your impatience. There is no medicine for that. The only cure is for me to sit down and give the floor to someone else.