September 6, 2018

The Honourable Chrystia Freeland
Minister of Foreign Affairs
125 Sussex Drive
Ottawa, Ontario K1A 0G2

Dear Minister Freeland,

I am writing to request your confirmation that Canada will continue to treat pharmaceutical intellectual property as a redline and hold firm against the extensive pharmaceutical intellectual property demands of the United States in the NAFTA negotiations.

While public attention has been focused on biologic data protection, the CGPA is concerned that there are many aspects of the US-Mexico proposal on pharmaceutical intellectual property that are incongruent with Canadian law and would lead to much longer monopoly periods for brand- name drug companies.

If Canada were to adopt the proposals, every single Canadian would be negatively impacted by the billions of dollars in additional drug costs created through delayed access to generic and biosimilar medicines. Businesses that sponsor employee drug benefit programs, provincial and federal drug plans, and Canadians who pay for drugs out of pocket and those who make co- payments for the medicines would all be forced to shoulder the burden of the high cost of delayed competition from generic and biosimilar medicines.

There are also industrial implications that negatively impact Canadians. As you may be aware most of the pharmaceutical manufacturing capacity in Canada is operated by the generic pharmaceutical industry. The industry employs more than 10,000 Canadians in highly skilled jobs and exports to more than 115 countries. Delayed access to Canadian markets would mean that generic drug companies would be unable to effectively compete for new R&D and production mandates. Those mandates – and the jobs that come with them – would go elsewhere.

Canada is already recognized as a high barrier market globally by generic and biosimilar medicines companies, with increasing regulatory costs, unique Canadian-specific regulatory requirements, complex intellectual property rules, risk exposure on launch, and low prices for second entry products. Companies are already removing products from the Canadian market due to these unsustainable conditions, and further disruptions in the domestic supply of medicines is anticipated. If Canada were to further increase intellectual property protections as a result of NAFTA, generic and biosimilar medicines companies would be less likely to make investments in litigation. If generic and biosimilar medicines companies do not litigate and instead wait for the expiration of the many strategically timed patents originator companies obtain for their products before filing submissions for regulatory approval, cost-saving competition could be delayed by decades or more. The cost of becoming an unattractive market for product launches would be astronomical.

I urge you to stand firm and not trade away timely access to generic and biosimilar medicines in NAFTA. This would be harmful to Canadians, harmful to our industry and provide an enormous gift to the brand-name pharmaceutical industry – an industry that already enjoys some of the highest prices in the world for their products and some of the world’s most favourable IP laws, while making virtually no investments in Canada.

Any concessions on pharmaceutical IP that go beyond Canadian law are clearly not in the public interest, and would be harmful to middle class Canadians.

Thank-you for reviewing these concerns. I would welcome the opportunity to discuss with you in greater detail the importance of support for the generic and biosimilar medicines industries, Canadian businesses, provincial and federal drug plans, and all Canadians.

Sincerely,

Jim Keon
President

Cc:

The Honourable Navdeep Bains, Minister of Science, Innovation and Economic Development
The Honourable Ginette Petitpas Taylor, Minister of Health Provincial Premiers
Provincial Ministers of Health
Provincial Ministers of Economic Development and Trade
Steve Verheul, Canadian Chief Negotiator, NAFTA