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Canada–EU trade agreement expected to increase drug costs

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Representatives of the brand-name The additional two years of patent anada has agreed in principle pharmaceutical manufacturers welcome protection will apply only to drugs to a new trade agreement with the agreement, saying the increased approved after the deal is passed, InterEurope that grants two more patent protection compensates for a national Trade Minister Ed Fast wrote years of patent protection to the manulengthy regulatory and government in a letter to Keon. facturers of brand-name pharmaceutiapproval process and creates a “more The trade deal does include some cals, a provision that even the federal level playing field” in intellectual provisions that will help generic drug government acknowledges will likely property protection. But drive drug costs up. Russell Williams, president Prime Minister Stephen of RX&D, the association Harper signed the agreement in that represents brand-name principle in Brussels, Belgium, drug makers, insists it is on Oct. 18, despite the fact that impossible to know for sure neither partner has released a if the changes will mean final text to its Parliament or consumers paying more made the precise wording pubmoney — either in taxes or lic. The federal government out-of-pocket — for drugs. claims the deal could increase “Intellectual property does trade between the two partners not drive cost,” Williams by 20%, adding $12 billion a writes in an email. “Europe, year to the Canadian economy for example, benefits from and 80 000 jobs by providing better intellectual property Canadian businesses with preferential access to the European The trade agreement will effectively extend patents for brand- protection than Canada, but Union’s 500 million consumers. name pharmaceuticals to 22 years from the current 20, limiting has implemented other effective methods to control innoThe federal government is the market for cheaper generic drugs. vative and generic medicine considering a compensation costs, which are also available to our manufacturers, including an exception program for the provinces and territogovernments.” allowing them to continue to produce ries to cover any additional costs of The changes proposed as part of the and market drugs they are exporting to stocking their provincial formularies as trade agreement will be implemented countries with shorter patent proteca result of the changes, which will over as many as 10 years, “on medition periods. In addition, the federal effectively extend patent protections to cines that don’t even exist today,” he government has promised to simplify 22 years from the current 20, limiting writes. “We will continue to work with the patent litigation process, which the market for cheaper generic drugs. governments and private drug plans to Keon believes will reduce costs for the The resulting cost to provinces, territoensure that Canadians have access to generic industry. ries, employers and consumers could the next generation of new medicines in “We’re hoping that if the system is rise by $1.5 billion to $3.5 billion per a sustainable way.” actually simplified, some of the litigayear, according to various estimates. The agreement will stimulate addition costs can go into product developAlthough the additional patent protional investment and more clinical trials ment and that might actually help our tection falls short of the five years the in Canada, Williams writes. industry,” he says. European Union was originally demand“More clinical trials in Canada mean Overall, the trade deal’s intellectual ing, it will still increase health care costs more chances for patients to benefit property provisions required Canada to for those without drug plans, says Jim from potentially life-saving or lifemake changes while the European Keon, president of the Canadian Generic changing medicines.” Union does not have to change anyPharmaceutical Association. Before the agreement takes effect, thing about its patent protection regime. “With the two-year extension, the all 28 EU nations as well as all the “In pharmaceuticals, this was a net loss introduction of new generic medicines provinces and territories must approve for Canada,” says Keon. “I think what will be delayed into Canada by an extra it. The process could take up to two the government is saying is that it two years,” says Keon. “Rather than years. — Laura Eggertson, CMAJ needed to do that in order to get the buying a product for 25 cents, you are Europeans to agree to other provisions going to have to continue to buy a of the deal.” product for a dollar.” CMAJ 2013. DOI:10.1503/cmaj.109-4637

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CMAJ, November 19, 2013, 185(17)

© 2013 Canadian Medical Association or its licensors

Canada-EU trade agreement expected to increase drug costs.

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