Inclusion in the TPP May Come at a Cost for Canada


Contributors: Ed Farrell, Jerry Chapin

As President Obama signed Trade Promotion Authority into law he removed a major stumbling block to completion of the Trans-Pacific Partnership (TPP) trade negotiation when chief negotiators, and then Ministers, meet in Maui July 24-31.  However, a sticking point for many of the countries in the negotiation may be Canada’s reluctance to nix their protectionist supply management system for dairy and poultry.

With respect to dairy, the system dates back seventy years to when Canada faced significant surpluses following World War II, as the strong profits realized by Canadian dairy farmers from their trade with the U.K during the war evaporated with the normalization of trade within Europe after the war. In an attempt to align production with demand, Canada adopted a system that established floor prices for certain dairy products, which in turn supported on-farm milk prices. In further pursuit of price stabilization, the government established a supply control system that targeted specific dairy products.  These policies eventually gave way to Canada’s current supply management system.  While this system has propped up Canada’s milk producers, it could now exclude Canada from the largest trade deal since NAFTA.

The Canadian system is best understood as comprised of three parts: Price setting, control of supply, and protection from foreign competition. Prices are set by the Canadian Dairy Commission and ultimately result in significant income for dairy farmers. To avoid overproduction, farmers are allotted a production quota, which is a transferable asset currently valued at about $28,000.00 per dairy cow. Thus, an average Canadian dairy farm of around 70 cows has about $2,000,000 worth of quota. The final component to Canada’s supply management system is protection from foreign competition, which brings us to the TPP.

Canada’s ability to regulate their market is dependent on keeping competitively priced imports out, and to this end Canada has very restrictive tariff rate quotas on dairy products, with over quota tariffs ranging from 246% for cheese to 300% for butter. The result of these supply management policies is that Canadians are currently paying just over C$7.87 for a gallon of milk, or nearly twice as much as the average U.S. consumer.

There is no question that as negotiators meet in Maui, all eyes will be on Canada, which is under pressure to open their dairy market to imports from TPP countries such as Japan, Australia and New Zealand, as well as the U.S. Some believe this pressure will be enough to bring the nation out of its protectionist mind set. However, Canada has long stood behind their supply management program and is not showing much indication that they plan on bending to foreign pressure, regardless of whether the pressure is coming from powerhouse neighbors such as the U.S. or allies half way around the world. As recently as last month, a spokesman for Canadian Trade Minister Ed Fast said Canada would defend dairy supply management in its negotiations.

Faced with elections in October, will the Harper administration de-regulate the dairy and poultry industry as they did their wheat industry in 2011, or will they hold firm in support of their unique and dated regulatory system? And if they hold firm on dairy and poultry, will the US and others take a hard line and exclude Canada altogether? Or will some middle ground be found? Whether preserving Canada’s regulatory system for dairy and poultry is worth losing inclusion in the TPP — a deal that will ultimately benefit Canada in a wide range of sectors — may ultimately be a decision the Harper administration has to make.

John Block: “COOL” Isn’t Cool

By John R. Block

As a farmer, we understand that if you have something that doesn’t work, you fix it. It will just cost you money if you ignore the problem. Somehow, the federal government doesn’t seem to understand that common sense fact.

The Country of Origin Labeling (COOL) law was first passed in 2002. Canada and Mexico have been challenging the law now for 13 years. The World Trade Organization (WTO) just this week ruled it to be a violation of U.S. international trade obligations. We are a member of the WTO and therefore should live within the rules. That is our obligation, and we expect other countries to do the same.

This week, for the third time, the WTO ruled against us. That ruling gives Canada and Mexico the legal right to retaliate. Canada already has a list of proposed restrictions, which will result in a dramatic cut in our exports to Canada and Mexico. That is serious. Canada and Mexico are our number 1 and 2 export markets. Besides, they are our closest neighbors.

Senator Pat Roberts (KS) had this to say: “If Congress doesn’t act swiftly, retaliation will wreak havoc on the U.S. economy.” I think we should be aware that if we don’t fix this law, it will cost us millions of dollars in ag exports as well as other exports.

The law today requires that meat from a calf born in Canada and shipped to the U.S. bare a label that reads “Born in Canada, raised and slaughtered in U.S.”  Just imagine the cost and confusion that can cause.  What about the Montana farmer who imports Canadian calves and mixes his own U.S. calves with the Canadian calves?  By law, he would have to keep track of them and market them separately. The U.S. processing plant would then have to process them separately. That would be the only way to ensure the Canadian label was on the Canadian steak.

Consumers say they have the right to know where that animal has been. Why? It isn’t worth the hassle. USDA just released new study results that point out the COOL labeling policy costs consumers nearly 8 billion dollars over 10 years.

We don’t need to try and change COOL. We’ve tried that before. COOL isn’t cool. Just get rid of it.

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

Medical Devices, Pharmaceuticals and Food Products as Consumer Products – Additional U.S. and Canadian Regulatory Considerations

A Webinar Presented by OFW Law and Davis, LLP

November 12, 2014, 1:00 p.m. EST

During this webinar, attendees will learn about additional regulatory requirements placed on medical devices, pharmaceuticals, and food products as consumer products in the U.S. and Canada. Topics will include, among others:

  • A general understanding of the interplay of obligations at the Federal and state/province levels in the U.S. and Canada
  • Additional labeling and advertisement requirements as consumer products
  • Additional reporting requirements in the U.S. and post-market recordkeeping requirements in Canada
  • Certification requirements under the U.S. Consumer Product Safety Improvement Act
  • The management of crises relating to medical devices, drugs and food products as consumer products in the U.S. and Canada and knowing when, how and why to recall products

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please go to http://www.cvent.com/d/14qf66.

About the presenters:

Elliot Belilos is of counsel to OFW Law and has more than eighteen years of regulatory and litigation experience representing corporations and associations in consumer product-related matters. Elliot counsels companies on product liability and regulatory compliance issues under the Consumer Product Safety Improvement Act, the Consumer Product Safety Act, the Federal Hazardous Substances Act, the Flammable Fabrics Act, the Poison Prevention Packaging Act, the Federal Food, Drug, and Cosmetic Act, and the Federal Insecticide, Fungicide and Rodenticde Act.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences, Food and Beverage and Intellectual Property Groups. Sara works with clients to get products from idea to market, providing strategic advice on approval and marketing strategies and intellectual property issues. She also works with clients on matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls.

How to Legally Import and Market Foods and Beverages in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 29, 2014, 1:00 p.m. EST

During this webinar, attendees will learn about the regulatory requirements necessary to successfully and legally import and market foods and beverages in the U.S. and Canada. Topics for each country will include, among others:

  • A general understanding of the regulatory framework for foods and beverages, including the distinction between foods and natural health products in Canada
  • Agencies responsible for regulating foods and beverages
  • Requirements for food and beverage imports
  • A general introduction to labeling and promotional requirements and restrictions
  • Enforcement and food safety compliance including an overview of the status of the U.S. Food Safety and Modernization Act and the Safe Food for Canadians Act, and managing a food recall.

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please go to http://www.cvent.com/d/14qf66.

About the presenters:

Bob Hahn is a principal at Olsson Frank Weeda Terman Matz PC in Washington, DC. He advises companies and trade associations on compliance with the Federal Food, Drug, and Cosmetic Act and Food and Drug Administration (FDA) regulatory requirements for foods and beverages, including product formulation, food safety, food defense, food labeling and advertising, import/export of food, and handling of inspections, recalls, and enforcement actions. Bob’s clients include all levels of the food production and distribution chain, including manufacturers, processors, packers, distributors, and retailers, as well as industry trade associations. He regularly speaks and writes on FDA food regulatory matters.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is head of the firm’s Food and Beverage Group. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of, among others, the food and beverage industry. Sara works with clients to get products from idea to market, providing strategic advice on approval and marketing strategies. She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls. Sara is a regular contributor to a number of food and beverage industry publications and conferences and is an active blogger on food safety and other regulatory matters (www.thefoodlawyer.ca).

How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 15, 2014, 1:00 p.m. EST

During this webinar, the second of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among others:

  • Requirements for drug importation into the U.S. and Canada
  • Pharmaceutical market approval pathways in both countries
  • Pharmaceutical manufacturing controls in both countries
  • Pricing of brand and generic pharmaceuticals in Canada
  • Labeling and promotional requirements and restrictions for drugs in the U.S. and Canada
  • Post-market requirements in both countries including recordkeeping and adverse event reporting in the U.S.
  • Inspections and enforcement

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Tish Pahl is a principal at the Washington, D.C.-based firm OFW Law where she has been practicing as a member of the firm’s Pharmaceutical Practice Group for nearly 20 years. In this capacity, she has counseled clients on the lawful marketing of their drugs, cosmetics, and dietary supplements under the Federal Food, Drug, and Cosmetic Act.  She has particular expertise in health care communications, advertising, labeling, and commercial distribution of products regulated by the U.S. Food and Drug Administration (FDA).  Tish frequently provides strategic advice to healthcare entrepreneurs and inventors on pathways into the U.S. market.  She has been a frequent speaker on numerous topics, including drug regulation, advertising and labeling compliance.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of the pharmaceutical and biotech industries. Sara works with clients to get products from idea to market, providing advice on approval and marketing strategies and intellectual property issues. Sara has particular experience navigating Canada’s Patented Medicines (Notice of Compliance) Regulations (the equivalent of Hatch-Waxman litigation in the U.S.) and with the Federal Court review of regulatory decisions.  She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls.

How to Legally Import and Market Foods and Beverages in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 29, 2014, 1:00 p.m. EST

During this webinar, attendees will learn about the regulatory requirements necessary to successfully and legally import and market foods and beverages in the U.S. and Canada. Topics for each country will include, among others:

  • A general understanding of the regulatory framework for foods and beverages, including the distinction between foods and natural health products in Canada
  • Agencies responsible for regulating foods and beverages
  • Requirements for food and beverage imports
  • A general introduction to labeling and promotional requirements and restrictions
  • Enforcement and food safety compliance including an overview of the status of the U.S. Food Safety and Modernization Act and the Safe Food for Canadians Act, and managing a food recall.

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please go to http://www.cvent.com/d/14qf66.

About the presenters:

Bob Hahn is a principal at Olsson Frank Weeda Terman Matz PC in Washington, DC. He advises companies and trade associations on compliance with the Federal Food, Drug, and Cosmetic Act and Food and Drug Administration (FDA) regulatory requirements for foods and beverages, including product formulation, food safety, food defense, food labeling and advertising, import/export of food, and handling of inspections, recalls, and enforcement actions. Bob’s clients include all levels of the food production and distribution chain, including manufacturers, processors, packers, distributors, and retailers, as well as industry trade associations. He regularly speaks and writes on FDA food regulatory matters.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is head of the firm’s Food and Beverage Group. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of, among others, the food and beverage industry. Sara works with clients to get products from idea to market, providing strategic advice on approval and marketing strategies. She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls. Sara is a regular contributor to a number of food and beverage industry publications and conferences and is an active blogger on food safety and other regulatory matters (www.thefoodlawyer.ca).

How to Legally Import and Market Medical Devices in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 1, 2014, 1:00 p.m. EST

During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market a medical device in the U.S. and Canada. Topics will include, among others:

  • Device classification schemes in the U.S. and Canada
  • Marketing authorization mechanisms in Canada and the U.S.
  • Manufacturing controls in both countries
  • Canadian and U.S. labeling and promotional requirements and restrictions
  • Reporting of adverse events in both countries
  • Recordkeeping and reporting requirements imposed by both countries

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Neil O’Flaherty is a principal at OFW Law, a Washington, D.C.-based law firm, where he has been practicing as a member of the firm’s Medical Device Practice Group for more than 23 years. Neil advises clients from around the world on a wide range of matters relating to the U.S. Food and Drug Administration’s (FDA) regulation of medical devices. Of particular relevance, Neil assists clients with labeling and promotional issues, the development of strategies to bring medical devices to market, pre-submission advocacy, adverse event reporting compliance and other postmarket requirements, and preparation of necessary regulatory filings.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by Canada’s Food and Drugs Act, its related regulations, and their intersection with intellectual property issues. She advocates before all branches of Health Canada on behalf of the medical device, pharmaceutical, biotech, food and beverage, natural health product, and cosmetic industries. Sara works with clients to get products from idea to market while providing advice on approval and marketing strategies.

Webinar Series: Regulatory Requirements for the Import of Medical Products and Foods Into the U.S. and Canada

Announcing OFW Law and Davis LLP’s New Four-Part Webinar Series:

REGULATORY REQUIREMENTS FOR THE IMPORT OF MEDICAL PRODUCTS AND FOODS INTO THE U.S. AND CANADA

OFW Law and Davis LLP have joined together to present a new webinar series to provide attendees with an overview of laws with which a firm must comply when importing medical products and foods into the U.S and Canada.  The webinars will include the following topics:

  1. How to Legally Import and Market Medical Devices in the U.S. and Canada

October 1, 2013, 1:00 p.m. EST

  1. How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

October 15, 2014, 1:00 p.m. EST

  1. How to Legally Import and Market Foods and Beverages in the U.S. and Canada

October 29, 2014, 1:00 p.m. EST

  1. Medical Devices, Pharmaceuticals and Food Products as Consumer Products — Additional U.S. and Canadian Regulatory Considerations

November 12, 2014, 1:00 p.m. EST

Each webinar will be approximately 40 minutes long with a Q and A session at the end.  There is no cost to attend the webinars, but space is limited.

To register for one or more of the webinars, please visit http://www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here

Webinar presenters are attorneys of OFW Law and Davis, LLP.

ofw logoWith over 400 years of combined legal experience and more than 30 attorneys and Senior Policy Advisors, OFW Law uses its background in government, medicine, and industry to create innovative solutions for clients in the food, pharmaceutical, medical device, and agricultural industries. OFW Law represents clients from around the world in FDA, USDA, and health care matters before federal agencies, courts, and the U.S. Congress.

Davis LLP logoDavis, LLP is a full service law firm that provides advice and efficient service in over 50 practice areas, including Life Sciences, Food & Beverage, Regulatory & Administrative Law, and Health Law.  Davis LLP works with clients to get products from idea to market, providing strategic advice on approval and marketing, and managing global product portfolios.

How to Legally Import and Market Pharmaceuticals in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 15, 2014, 1:00 p.m. EST

During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market pharmaceuticals in the U.S. and Canada. Topics will include, among others:

  • Requirements for drug importation into the U.S. and Canada
  • Pharmaceutical market approval pathways in both countries
  • Pharmaceutical manufacturing controls in both countries
  • Pricing of brand and generic pharmaceuticals in Canada
  • Labeling and promotional requirements and restrictions for drugs in the U.S. and Canada
  • Post-market requirements in both countries including recordkeeping and adverse event reporting in the U.S.
  • Inspections and enforcement

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Tish Pahl is a principal at the Washington, D.C.-based firm OFW Law where she has been practicing as a member of the firm’s Pharmaceutical Practice Group for nearly 20 years. In this capacity, she has counseled clients on the lawful marketing of their drugs, cosmetics, and dietary supplements under the Federal Food, Drug, and Cosmetic Act.  She has particular expertise in health care communications, advertising, labeling, and commercial distribution of products regulated by the U.S. Food and Drug Administration (FDA).  Tish frequently provides strategic advice to healthcare entrepreneurs and inventors on pathways into the U.S. market.  She has been a frequent speaker on numerous topics, including drug regulation, advertising and labeling compliance.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations. She advocates before all branches of Health Canada on behalf of the pharmaceutical and biotech industries. Sara works with clients to get products from idea to market, providing advice on approval and marketing strategies and intellectual property issues. Sara has particular experience navigating Canada’s Patented Medicines (Notice of Compliance) Regulations (the equivalent of Hatch-Waxman litigation in the U.S.) and with the Federal Court review of regulatory decisions.  She also works with clients in matters relating to product safety, including Health Canada inspections and enforcement, crisis management and product recalls.

How to Legally Import and Market Medical Devices in the U.S. and Canada

A Webinar Presented by OFW Law and Davis, LLP

October 1, 2014, 1:00 p.m. EST

During this webinar, the first of four which OFW Law and Davis LLP are teaming up to present, attendees will learn about the regulatory requirements necessary to successfully and legally import and market a medical device in the U.S. and Canada. Topics will include, among others:

  • Device classification schemes in the U.S. and Canada
  • Marketing authorization mechanisms in Canada and the U.S.
  • Manufacturing controls in both countries
  • Canadian and U.S. labeling and promotional requirements and restrictions
  • Reporting of adverse events in both countries
  • Recordkeeping and reporting requirements imposed by both countries

The webinar will be approximately 40 minutes long with a Q and A session at the end. There is no cost to attend this webinar, but space is limited.

To register for the webinar, please visit www.cvent.com/d/14qf66.

To view or share this information as a PDF, please click here.

About the presenters:

Neil O’Flaherty is a principal at OFW Law, a Washington, D.C.-based law firm, where he has been practicing as a member of the firm’s Medical Device Practice Group for more than 23 years. Neil advises clients from around the world on a wide range of matters relating to the U.S. Food and Drug Administration’s (FDA) regulation of medical devices. Of particular relevance, Neil assists clients with labeling and promotional issues, the development of strategies to bring medical devices to market, pre-submission advocacy, adverse event reporting compliance and other postmarket requirements, and preparation of necessary regulatory filings.

Sara Zborovski is a partner in Davis LLP’s Toronto office and is a member of firm’s Life Sciences and Intellectual Property Groups. Sara assists companies in navigating the regulatory landscape imposed by Canada’s Food and Drugs Act, its related regulations, and their intersection with intellectual property issues. She advocates before all branches of Health Canada on behalf of the medical device, pharmaceutical, biotech, food and beverage, natural health product, and cosmetic industries. Sara works with clients to get products from idea to market while providing advice on approval and marketing strategies.