The Parliamentary Budget Officer released a report last week providing its estimate on the economic impact of the Canada – EU Trade Agreement. While the Liberal government made CETA its top trade priority when it came into office (and the Conservatives claimed that the deal would add $12 billion to the Canadian economy), the PBO report concludes that the economic benefits will be modest at best.
The report devotes a full chapter to CETA’s intellectual property provisions, particularly the patent related rules that will have a direct impact on the pharmaceutical industry. CETA establishes patent restoration and patent appeal rules that will extend the term of patent protection for pharmaceutical products, thereby increasing consumer prices and royalty outflows. With a regulatory framework designed to address pricing in place, the report focuses on increased royalty outflows with extended protection.
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In the early 1990s, Eli Lilly applied for patent protection in Canada for two chemical compounds, olanzapine and atomoxetine. The company had already obtained patents over the compounds, but asserted that it had evidence to support new uses for the compounds that merited further protection. The Canadian patent office granted the patents based on the content in the applications, but they remained subject to challenge.
Both patents ultimately were challenged on the grounds that there was insufficient evidence at the time of the applications to support the company’s claims. The Federal Court of Canada agreed, invalidating both patents. Eli Lilly proceeded to appeal the decision to the Federal Court of Appeal and later to the Supreme Court of Canada. The company lost the appeals, as the courts upheld the decision to invalidate the patents.
Under most circumstances, that would conclude the legal story as several Canadian courts reviewed Eli Lilly’s patent applications and ruled that they failed to meet the standards for patentability. Yet in June 2013, the company served notice that it planned to use the ISDS provisions in the North American Free Trade Agreement to claim that in light of the decisions, Canada was not compliant with its patent law obligations under the treaty. As compensation, Eli Lilly sought at least $500 million in damages.
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The costs associated with the increased patent protections for pharmaceutical drugs in the trade agreement between Canada and the European Union has long been one of the most controversial elements of the deal. At least one study has pegged the cost to provincial health care at more than a billion dollars. In response to those concerns, the Conservative government promised to compensate the provinces for the increased costs. Earlier this year, when officials from Health Canada appeared before a House of Commons committee, they acknowledged that it is hard to estimate the actual cost but that they knew that the agreement would increase the costs of drugs in Canada.
Last week, Steve Verheul, the lead Canadian CETA negotiator, appeared before another House of Commons committee and was asked if the department has done any analysis on the financial impact of the extended patent protection. Remarkably, Verheul said that it has not, arguing that it is difficult to come up with a projection. In fact, when pressed on the issue, Verheul speculated that perhaps costs would not increase since Canadians already pays higher prices for pharmaceutical drugs than consumers in European countries such as the UK, France or Germany.
These comments from Canada’s lead CETA negotiations are simply bewildering.
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Donald Trump’s surprise U.S. presidential election victory promises to result in an overhaul of U.S. trade policy, including the immediate end of support for the Trans Pacific Partnership, the controversial trade pact involving 12 Pacific countries including Canada, the U.S., and Japan. While President Barack Obama held out hope that the TPP could be salvaged during the “lame duck session” of Congress that occurs immediately after the election, his administration was quickly forced to concede that the deal has become politically toxic and stands no chance of passage. Since U.S. ratification is required for it to take effect, it’s effectively dead.
My Globe and Mail column notes that the Canadian government’s view of the TPP was always difficult to discern. It was negotiated by the previous Conservative government, but Prime Minister Justin Trudeau and International Trade Minister Chrystia Freeland have been non-committal, focusing instead on TPP public consultations that are still scheduled to run until early 2017.
Their ambivalence was not a function of trade skepticism – the Liberals emerged as enthusiastic backers of the trade deal between Canada and the European Union – but rather stems from the recognition that Canadian interests in the TPP were largely defensive in nature. With agreements already in place with many TPP countries, the agreement offered at best limited benefits for Canada’s economy.
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The Canadian government moved quickly from signing the trade agreement between Canada and the European Union on Sunday to tabling Bill C-30, the CETA implementing legislation, on Monday. While most of the attention has focused on the political issues surrounding CETA in Europe and the potential gains for Canadian exporters due to tariff reductions, the implementing bill provides a reminder that there are significant costs associated with CETA that have generated far less discussion. In fact, the majority of the 140-page bill features changes to Canada’s intellectual property rules, requiring changes that largely serve European interests.
Mandated reforms to patent protections (in the form of term restoration provisions) and the expansion of protections for dozens of European geographical indications was always part of the price to be paid for CETA. There were concerns expressed throughout the negotiations on both issues. Geographic indications rules grant protections to foods widely produced around the world and establish new marketing and naming restrictions on Canadian food producers. Meanwhile, the patent term restoration provisions are likely to increase health care costs in Canada by delaying the availability of generic pharmaceuticals due to the extension in the term of protection for patented pharmaceuticals.
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