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Review of Canadian Access to Medicines Regime
Presentation by CGPA President Jim Keon to the House of Commons Standing Committee on Industry, Science and Technology

Thank you, Chair, and to all Committee Members for inviting me to be here today.

I am Jim Keon, President of the Canadian Generic Pharmaceutical Association, the national organization representing Canada’s generic pharmaceutical industry.

With me today is Jack Kay, President and COO of Apotex, Canada’s largest generic pharmaceutical manufacturer.

On January 24, 2007, CGPA provided its written submission to the federal government as part of the review of CAMR, and I have provided copies. If you wish to ask questions in greater detail about the failures of the regime and how it might be improved, these are addressed specifically in our written submission, and I am pleased to answer those questions today.

From the outset, I wish to clear up some misconceptions that have emerged since CAMR came into force nearly two years ago.

We have seen and heard many times that “not a single pill” has been shipped under this legislation. While that statement is sadly true, it sometimes hides 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 one hundred million doses of medicines at an approximate value of twenty million dollars.

Whether dealing with the ongoing turmoil in Afghanistan, the aftermath of the South Asian Tsunami, or human suffering in Africa, Canada’s generic pharmaceutical industry has been there, donating the first-line treatments such as antibiotics, analgesics, and diabetic treatments that are most urgently needed immediately on the ground in developing countries and during times of crisis.

In fact, 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 CAMR, the products are under patent protection and, therefore by definition, are not being produced by generic drug companies.

Back in 2003, I recall the initial optimism that greeted the announcement that Canada would be the first country to implement the landmark Decision of the World Trade Organization (WTO) of August 30, 2003 on Implementation of the Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health.

But from that point on, the process and outcome have become a bitter disappointment.

More than two years ago I appeared before this committee and stated that Canada’s draft legislation to allow generic pharmaceutical manufacturers 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 include too many concessions to brand-name drug makers and that it would be virtually impossible for Canadian generic pharmaceutical manufactures to use the scheme.

We stated at that 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.

The government of Canada therefore must not only address the fundamental flaws in CAMR, but “must use its experience trying to implement the Decision as the basis to act at the WTO in order to remedy the constraints of the WTO rules governing the delivery of generic medicines to those in need.”

I will now ask Mr. Kay to provide a first-hand account of Apotex’s experience in trying to produce pharmaceutical products under Canada’s Access to Medicines Regime (“CAMR”).

HAUT

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	Review of Canadian Access to Medicines Regime
	Review of Canadian Access to Medicines Regime