Mr. Speaker, I am pleased to engage in debate on this private member's initiative. We always congratulate each other for our private members' initiatives and I applaud the member on this one. In the end, I find that I am not able to support it and I will try to explain why in the few minutes that are available to me.
As has been stated a number of times, Canada's drug patent policy seeks to benefit effective patent enforcement for new and innovative drugs on the one hand, with the timely market entry of their lower priced generic alternatives on the other.
The current manner in which that balance was realized was established in 1993 with the enactment of Bill C-91. That bill introduced into the Patent Act what is commonly called the early working exception as well as the enabling authority for the NOC regulations, which sounds a little technical but that is what they are called, and which Bill C-274, which we are looking at here today, proposes to repeal.
I should confirm as well for the record that I conspicuously voted against Bill C-91 when it was proposed at the time. Since then there has been a massage of the provisions in the regulations and the balance, which I referred to earlier, has been created, although in my view that balance is still not effective. However to remove the whole regulations without putting something else back into place would not achieve the public interest purposes that I seek.
In the pharmaceutical industry the early working exception does allow generic companies to work or develop a patented product while in the process of applying for Health Canada approval to sell that product on the market. Generic drug companies are therefore able to complete the regulatory approval process during the lifetime of the patent and be in a position to enter the market as soon as the patent expires.
The NOC regulations were conceived in order to prevent generic copies of patented drugs from going to market in breach of the patent. They do so by linking Health Canada's ability to approve generic drugs to the patent status of the brand name drug that the generic is seeking to copy. If passed, as I said, Bill C-274 would undermine our attempt to provide balance and would strip the patent holder from what they argue is the most effective means of protecting their patent.
There has been a significant debate over the last while in intellectual property circles about how we regulate pharmaceuticals in this way. Rising concern has been expressed about the balance between fostering innovation and the availability of generic drugs. Many countries have made adjustments to their laws in order to optimize that balance between innovation and access to affordable medicines. For instance, in 2003 the United States introduced reforms to its so-called Hatch-Waxman rules which are similar in many respects to the NOC regulations we maintain here.
Here in Canada, recent court decisions have enabled patent holder drug companies to list new patents on Health Canada's patent register on the basis of just inconsequential changes to the original drug product. The listing of these additional patents, which in the industry is sometimes called evergreening, has resulted in repeat litigation between innovative and generic companies and, in some instances, the unwarranted delay of generic market entry, and I regret that evergreening.
The process appears costly and not in the public interest. Some observers have suggested that we put in place a once only procedure whereby the patent holder could not evergreen after an NOC application began. There would only be one 24 month stay triggered by the generic company's NOC application.
To address these problems, the government recently proposed some regulatory amendments designed to readjust that balance between the enforcement of the intellectual property rights of the patent holder and encouraging the generic entry. The amendments are directed to both the NOC regulations and other intellectual property instruments, including what is called data protection under the food and drug regulations.
These amendments were pre-published in part I of the Canada Gazette on December 11 last and pre-publication was followed by a 75 day consultation period, during which the pharmaceutical industry and other interested parties could submit their comments. The government is currently reviewing those comments.
In my view, the government should include in the new regulation package, however it wishes to put it in, the new “once only” 24 month stay so generic companies will know where they stand and they will not have to face this repeated evergreening, this artificial device now apparently relied on by the patent holding companies.
By restoring the balance to the NOC regulations and shoring up the data provisions in the food and drug regulations, the government's proposed regulatory amendments, and the one I have just proposed here and which other members may propose, would provide greater overall stability and predictability to our intellectual property environment for pharmaceuticals.
These new changes would attract new medical therapies to Canada, encourage real improvements to existing drugs and ensure more timely competition in the marketplace.
While I salute the hon. member's interest in this issue, I am confident that the amendments that have been described in my remarks will better address the concerns that motivated the tabling of the bill in the first place and avoid the wild west scenario that might evolve in the event there were a complete revocation of these regulations as the bill proposes.