Mr. Speaker, I want to congratulate the member for Windsor West for bringing the issue forward and colleagues who have spoken in the House who are very concerned about the balance that we are trying to create in Canada.
This is a unique balance in public interest. When we look at the implications of intellectual property in the pharmaceutical industry, the government must maintain a delicate balance between two important and competing policy objectives. On the one hand, we must encourage advancements in medicine by providing effective patent protection for new drugs on all fronts, and on the other hand, we must ensure that versions of drugs are able to move forward.
Bill C-274, introduced by the member for Windsor West, seeks to disrupt this balance by repealing the patented medicines notice of compliance regulations. The regulations together with the early working exemption under the Patent Act are two pillars of the government's balanced drug patent policy. The early working exception allows generic companies to use a patent drug for the purpose of seeking approval to market a generic version of a brand name drug.
Normally, the conduct of this would constitute patent infringement, but the early working exception allows a generic drug company to compete with Canada's health regulatory and approval process while the equivalent brand name drug is still under patent.
It is then possible for a brand name drug company to be in a position to enter the market as soon as possible after patent expiry. The generic pharmaceutical industry estimates that early working can accelerate the market entry of its products in Canada by three to five years.
While early working is intended to promote the timely market entry of generic drugs, the regulations are necessary to ensure that this exception to the patent infringement is not abused by generic companies who are seeking early product approval.
Patent protection is an important incentive in encouraging investment and promoting research and development of new and better medical therapies. The regulations provide incentives by ensuring that brand name drugs enjoy secure, stable, uninterrupted periods of market exclusivity prior to the eventual and irreversible arrival of generic competition.
If passed, the bill would seriously undermine Canada's balanced drug patent policy by effectively stripping brand name drug companies of the most effective patent enforcement mechanism that presently exists at their disposal.
Repealing the regulations would prompt the brand name pharmaceutical industry to withdraw its considerable R and D investments from Canada with a corresponding loss in research-intensive employment here. It would also compromise Canada's access to the latest medical therapies as brand name drug companies would no longer have any incentive to seek the Canadian market promptly.
Industry Canada and Health Canada are aware of the concerns of the member for Windsor West regarding the regulations and his reasons for advancing Bill C-274. In recent years representatives of the generic pharmaceutical industry have been increasingly vocal in allegations that brand name companies are abusing the regulations to unfairly delay generic competition, a practice they refer to as evergreening.
The government remains convinced however, that regulations are a vital part of this industry and Canada's balanced drug patent policy is important. Generic drug companies continue to challenge brand name patents early and often. And so, without the protection of regulations, infringing generic drugs could enter the market soon after the innovator and well before the expiry of the original product's patent.
That said, the government recognizes that there have been instances of behaviour compliance by the generic pharmaceutical industry. We have therefore developed a package of regulatory amendments intended to restore the original balanced policy intent behind the regulations.
The amendments, which were pre-published in the Canada Gazette Part I, on December 12, 2004 will facilitate the market entry of generic versions of brand name drugs immediately following expiry of relevant patents as the bill originally intended, while at the same time allowing brand name companies to duly promote improvements to the original form of the drug that are genuinely accepted.
If passed, this package of amendments would approve Canada's competitiveness as an investment location and would establish more predictable and stable rules relating to the intellectual property of pharmaceuticals. It is my hope that the member for Windsor West will support these amendments and, in so doing, support Canada's efforts to ensure that we continue to have a balanced drug patent policy regime that will continue to be the leading choice of investment for our pharmaceutical industry.