Thank you, Mr. Chairman, committee members, for having me here today.
My name is Jim Keon and I'm the President of the Canadian Generic Pharmaceutical Association, the representative body for generic pharmaceutical companies in Canada.
With me is Jack Kay, the President of Apotex, the largest generic pharmaceutical company in Canada.
On January 24, 2007, CGPA provided its written submission to the government as part of the review of the Canadian access-to-medicines regime, and we've provided copies to the committee. If you have questions to ask in greater detail about the failures and challenges of the regime, I will be happy to answer those, and I hope that we have an opportunity to do so.
I want to clear up one misconception that may have emerged since the adoption of this legislation two years ago. We have seen and heard many times that not a single pill has been shipped under this legislation. While the statement is sadly true, it hides the fact of the real story about the donations of medicines made each and every year by Canada's generic drug makers.
Last year alone, Canadian generic pharmaceutical manufacturers donated nearly 100 million doses of medicines, with an approximate value of $20 million. These have been donated to Afghanistan, to South Asia in the aftermath of the tsunami, and elsewhere in Africa. Our companies have been there to donate first-line treatments for all of those medicines.
In fact, the Canadian generic pharmaceutical manufacturers were pleased to join Prime Minister Harper on February 16, in Mississauga, to highlight their substantial donations of medicines to Afghanistan.
But those are medicines that generic companies are currently manufacturing. Under the Canadian access-to-medicines regime, the products are under patent protection and are therefore by definition not being produced by generic companies.
I recall the initial optimism that greeted the announcement, back in 2003, that Canada would be the first country to implement the landmark decision of the WTO on the implementation of the Doha declaration on the agreement of trade-related aspects of intellectual property. But from that point on, the process and the outcome have become a disappointment.
More than two years ago, I appeared before this committee and stated that Canada's draft legislation to allow generic pharmaceutical companies to export patented medicines to developing countries was unlikely to meet the goal of getting affordable medicines to people who desperately need them. It became clear early in the process that the government intended to make too many concessions to brand-name drug-makers and that it would be virtually impossible for generic pharmaceutical manufacturers to use this scheme.
We stated at the time that the overall approach to the legislation should be a straightforward and faithful implementation of the WTO decision. It is clear now that even that might not be enough, as no eligible importing countries have applied to access medicines under the decision, despite the implementation legislation in five countries.
Therefore, we're calling on the Government of Canada to not only address the fundamental flaws in its own legislation but to also go to the WTO and use its experience in trying to implement the decision as the basis to call on countries to remedy the constraints of the WTO rules.
Without further ado, I'd like to turn the mike over to Jack Kay, who will tell you first-hand about the experience of Apotex in trying to work with this legislation.