Mr. Speaker, I am pleased to take part in this debate on Bill C-274. I would like to congratulate the member for Windsor West who, in putting forward the bill, seeks to exclude certain medicines from the scope of the regulation-making power set out in subsection 55.2(4) of the Patent Act and to repeal the patent medicines notice of compliance regulations.
Members on both sides have spoken with great eloquence and a huge amount of insight into the manner in which the whole pharmaceutical industry operates. Many people have criticized the regulations because they are special rules that only exist in the pharmaceutical industry.
I would put forward the opinion that when one considers the amount of risk associated with pharmaceutical research and development, and society's vital need for the best available medicines at a reasonable price there is a compelling rationale to have special rules in place with respect to this industry.
In no other industry are the stakes as high. The quality of life of people not only in this country but throughout the world is dependent on investment in this particular site. This can only be achieved by an architecture of legal and enforceable rules that would ensure a certain degree of predictability in this particular industry. This is precisely why these regulations are in place. They provide an enforcement mechanism that is time limited, effective, and tailored to the particular features of the industry.
It has been pointed out very eloquently and in a very informed manner that there are problems and shortcomings with respect to the present regulations. However, they are predictable and they are what we have in place at this time. Under these regulations, patent disputes are addressed concurrently with the health and safety review process, and the majority of cases are resolved within a reasonable timeframe.
The enforcement mechanism of the 24 month stay is clear, predictable, and minimizes market disruption. It gives patentees the certainty that the generic competitor will not be able to market its product until infringement issues have been addressed.
The stay also serves as a convenient clock for judges to render a timely decision. The process under the regulations is less expensive and faster than traditional patent infringement litigation, which I am sure my learned colleague would agree is extremely expensive.
Repealing these regulations could be expected to have a number of detrimental consequences. It would necessitate much more costly and protracted patent enforcement litigation. It would also seriously undermine the ability of these companies to compete with their counterparts in other jurisdictions for research and development capital.
While there have been problems with excessive litigation between innovative and generic companies on certain drugs protected by multiple patents, I do not believe the bill provides an appropriately measured solution.
Industry Canada, with the assistance of Health Canada, has completed an exhaustive review of patent listing behaviour and litigation outcomes, and concluded that while the fundamentals of the regime are sound, a number of recent court decisions have enabled more aggressive patent enforcement practices on the part of generic drug companies.
The amendments in the regulations will reaffirm the strict rules for listing patents on Health Canada's patent register and will clarify when generic companies must address listed patents. This will ease Health Canada's administrative burden, cut down on litigation, and accelerate the market entry of generic versions of patented innovative drugs. As a whole, these amendments will bring greater stability and predictability to the intellectual property environment for pharmaceuticals by introducing firmer lower and upper boundaries to the market exclusivity of innovative drugs.
In contrast, the radical measures that have been proposed in this bill would forsake any semblance of balance, undermine R and D investment, and lead to instability and unpredictability in the marketplace. As I said, while the hon. member for Windsor West may have the best and most well intentioned desire in tabling the bill, its objectives will be counterproductive and would be better served by the government's current regulatory initiative.