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Industry committee  Thank you. For a generic drug, the research would be to develop your own formulation for the drug. You would either develop or import, define chemicals, develop the formulation. You then do your clinical trials to determine that the product has the same medicinal effect as the brand name company.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  A generic drug by definition is an equivalent product to a brand name product. Our value is in bringing the cost down and increasing the headroom for expenditures to go elsewhere in the health system.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  As I said, our volumes have been increasing. We have had significant growth in Canada for the last number of years. So I think in part the fact that governments are willing to put our products on their formularies faster than in the past, they recognize the value better.... So in return for some improvement in their listing process and the process for reimbursing generic drugs in Ontario and Quebec, we were able to negotiate those prices.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  We have forced our way into a few meetings this week, yes.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  Thank you. As I said earlier with regard to the changes that are now published in the Canada Gazette--and the comments have to be in by Monday--there was no consultation. We were completely surprised. I have some difficulty in understanding the rationale. Pharmaceuticals have extra patent protection that doesn't exist for any other type of patent.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  I think I mentioned briefly in my comments that prices of generics now in both Quebec and Ontario are capped at 50% of the equivalent brand, which is already subject to the Patented Medicine Prices Review Board. So those prices have come down over 25%, and if an up-to-date study were done, Canadian generic prices would now be very competitive.

May 8th, 2008Committee meeting

Jim Keon

May 8th, 2008Committee meeting

Jim Keon

Industry committee  Yes, thank you. The data that we present in our brief come from the government agency, the Patented Medicine Prices Review Board. Those are not our data; they're data that it reports every year. I think we had provided to the clerk this morning a chart that basically shows that subsequent to Bill C-22 and Bill C-91, going back 20 years and then 15 years, the commitment of 10% in R and D--the research companies' commitment--has fallen below that for several years now.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  Yes. It's almost double.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  We were given no notice. And from talking to the provinces, I believe they were given no notice either.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  I would just repeat that the product Lipitor is the largest-selling product in the history of pharmaceuticals. Canada-wide sales are $1.1 billion. In British Columbia, sales would be over $100 million. Delaying a generic for a year or two years adds an extra $50 million a year, if we assume the price would be roughly half the current price.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  Thank you. Yes, I mentioned briefly in my comments that we were very disappointed in the changes. You're right, in 2006 the government had taken steps to seal off evergreening, to make it much more difficult to add on patents. And then after the government did that, the Supreme Court validated that and said yes, that was the law.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  I have a couple of comments on the regulatory situation on patents in Canada. In October 2006 regulatory changes were made to the patented medicine notice of compliance regulations to stop the practice of evergreening of drug patents by brand name companies. We applauded the government for those changes.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  Thank you, Mr. Chair. On behalf of the Canadian Generic Pharmaceutical Association and our member companies, I thank you for inviting us to appear during your study of Canadian science and technology. The CGPA is the national association representing the generic drug industry in Canada.

May 8th, 2008Committee meeting

Jim Keon

Industry committee  I was just going to say, in line with what Mr. McTeague said, again, the brand-name companies own these medicines, they have the patents, now they can go to any country they want and offer the product at any price. Why did the developing countries want the system under the WTO? Why do they support the Canadian legislation?

April 23rd, 2007Committee meeting

Jim Keon