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NEWS: Canada-EU CETA would drive up pharmaceutical costs

STRASBOURG, 9:20 am (3:20 am ET) – The Globe and Mail reports this morning that, “Canada has fallen behind many other leading advanced countries in patent protection, impairing the country’s investment climate, concludes the report by the Canadian Intellectual Property Council, an arm of the Canadian Chamber of Commerce composed of drug makers, consumer product companies, technology companies and lawyers. The report, being released Wednesday, urges Ottawa to give patented drug makers up to five years of ‘restored’ patent life to offset regulatory delays, exclusive use of drug trial data for an extra two years plus new legal tools to fight patent challenges launched by generic manufacturers.”

“The prospect of a free-trade deal between Canada and the European Union is likely to put added pressure on Canada to improve its intellectual property protections. European negotiators are seeking near-identical patent changes.”

The article highlights, “Any move to strengthen patent protection would be extremely contentious because it would mean higher prices for many new drugs, raising costs for consumers, insurers and provincial health plans. And Canada’s generic drug industry, along with several provincial governments would likely fight them vigorously. The Canadian Generic Pharmaceutical Association (CGPA) warned that the patent changes sought by the industry could cost Canadians up to $3-billion a year in higher drug costs.”

“Current Canadian law provides 20 years of patent protection, in line with other developed countries. But the actual length of market exclusivity is typically much shorter – seven to nine years in Canada – because of extensive research and regulatory hurdles, as well as legal challenges. Both Europe and the United States provide up to five years of what’s called ‘patent term restoration’. That gives drug makers an extended monopoly on new treatments before cheaper generic equivalents can be sold.”

As previously noted in a campaign blog, on October 25, 2010, the National Post reported that, “Canada’s pharmaceutical industry and the European Union have been quietly lobbying for changes that could give brand-name drugs several years more patent protection here — and potentially add hundreds of millions of dollars to Canadian medication costs annually. The EU has reportedly proposed the measures be included in a landmark free-trade agreement now being negotiated between the jurisdictions, with the fifth round starting last week in Ottawa. The changes would delay the entry of cheaper, generic copies of medication onto the market…”

“One change (to the current 20-year patent on newly invented medicinal molecules) would extend the patent period to compensate for delays in the approval process for a new drug. Another would lengthen the so-called data-protection period by about two years, delaying generic copying of certain drugs without active patents. The issue being pursued most vociferously by the industry, though, relates to a process under which brand companies can challenge a generic firm as it applies to copy a drug still under patent. The brand gets an automatic stay of up to two years on the generic version entering the market while a court rules on the issue. But if the brand company loses, it cannot appeal the decision, unlike the generic competitor. The brand-name industry is pushing for that right of appeal. Brand-name companies and some provinces say the measures are needed to restore fairness to the complex patent system, and generate more drug research in Canada. The generic industry, however, is voicing outrage at the proposals, insisting they will do nothing positive for Canada. ‘This would be a nasty piece of policy if it went through,’ said Jim Keon, head of the Canadian Generic Pharmaceutical Association.”

“At least three provinces have written letters in support of the (brand-name) industry stance, including Alberta, where a senior aide in the premier’s office used to work for a major pharmaceutical company. …Quebec and New Brunswick also sent letters of support to Tony Clement, the federal Industry Minister.”

“While many Canadians are barely aware of the trade talks, Peter Van Loan, the International Trade Minister, has predicted that the eventual deal would bring billions of dollars in benefits to Canada’s economy. He refused in an emailed statement to comment on the drug-patent issue, saying he does not want to negotiate in the media, but noted that the government ‘is committed to opening markets for Canadian workers and businesses.’”

Today’s Globe and Mail article is at http://www.theglobeandmail.com/report-on-business/canada-needs-tougher-drug-patent-protection-report/article1874987/. The National Post article from last October is at http://www.nationalpost.com/news/Trade+deal+would+include+increased+protection+brand+name+drugs/3719673/story.html#ixzz13N8hML00.