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because once provisionally applied it will be too difficult to deal with these issues,'" said Jason Langrish, executive director of the Canada Europe Roundtable for Business, who's been championing the deal for years. "There needs to be a resolution to that difference of opinion." Asked why implementation was taking so long, Trudeau told reporters at an event Toronto Wednesday he understands that some people are getting impatient. "We are right now moving forward in the last steps for implementation. I'm very much looking forward to crossing the finish line on this one," he said. CBC News reported earlier this month that some Europeans don't like how Canada plans to allocate its cheese import quotas. But now CBC News has learned that the European pharmaceutical industry doesn't want the EU to set a date to start implementing the deal until Canada publishes and consults on some regulatory changes promised to generic drug manufacturers, and some member states are expressing these concerns to the European Commission. Persistent legal confusion in Europe over whether the intellectual property measures affecting pharmaceutical patents can be applied without individual member countries' ratification may also be prompting some to want to hit pause. At the time an agreement in principle was reached on CETA in 2013, the Canadian Generic Pharmaceutical Association said it had received "written assurances" from the Canadian government that it would end dual-track litigation, a practice in which brand-name pharmaceutical companies can sue generics multiple times on the same patents, adding to the cost and risk of bringing drug alternatives to market. The generic industry said the move would reduce the burden on the courts, end patent disputes faster and make investments in the generic drug industry more attractive. But the CETA text itself doesn't make this change. It was a separate pledge to placate the generic drug industry because other parts of the deal may benefit brand-name pharmaceuticals. When Stephen Harper's government reached an agreement in principle with the European Union in 2013, written assurances were provided to Canada's generic drug industry that it would get regulatory concessions outside of the deal. (Paul Chiasson/Canadian Press) During the negotiations, Canada agreed to extend the terms of pharmaceutical patents for up to two years, bringing Canada closer in line with the EU, which extends patents for up to five years. Canada was the only G7 country that didn't provide extensions to offset delays from clinical trials and bureaucratic reviews. The Europeans also sought and received a new right of appeal in Canada's patent review process. Roughly one-quarter of Canada's bill to implement CETA, C-30, dealt with changes to intellectual property rules for pharmaceuticals. But the end of dual-track litigation had been expected separately, in the form of new regulations published in the Canada Gazette. Similar to European fears in the cheese import dispute, a perceived lack of transparency on Canada's part seems to be fuelling concerns. Confidential industry consultations were held by Innovation, Science and Economic Development Canada, the federal department responsible for patent laws. "Tied as they are to CETA implementation, the regulatory changes to end dual-track litigation will come into force when the agreement is provisionally applied," the department said in a statement emailed to CBC News Thursday. "Over the last 2.5 years, consultations have been held with industry stakeholders and legal experts, including on the regulations, with input fully considered." But the government hasn't revealed what the new regulations to end dual-track litigation look like, and this is making European brand-name drug manufacturers nervous. Innovative Medicines Canada, which represents Canada's brand-name pharmaceutical companies, told CBC News in an email that it has "has significant concerns regarding the changes and their implementation, "most of which are not required under CETA," but it cannot discuss them because it is "bound by government non-disclosure agreements." The changes "may have the effect of complicating and destabilizing pharmaceutical patent litigation in Canada once implemented," the statement says.
For the original version including any supplementary images or video, visit http://www.cbc.ca/news/politics/ceta-provisional-application-pharmaceutical-litigation-1.4179676
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