Trump said he doesn't see a recession after the bond market spooked investors and the Dow suffered its worst day of the year last week.Marketsread more
Ahead of the deadline, U.S. President Donald Trump told reporters that Huawei was a national security threat.Technologyread more
Baidu is gearing up to release its second-quarter earnings on Monday with the market expecting a sharp decline in profit.Technologyread more
Americans now say they approve of free trade by 64%-27%, a margin of better than two to one. That's up from 57%-37% early in Trump's presidency, and 51%-41% near the end of...Politicsread more
Stocks in Asia rose on Monday as U.S. Treasury yields bounced higher after plunging last week.Asia Marketsread more
The problem with tanking equities lies elsewhere, writes Michael Ivanovitch, because traders see no end to America's unfolding trade disputes with Europe and China.World Economyread more
Beijing wants to use reforms to support a slowing economy.China Marketsread more
Trump said Cook made a "good case" that it would be difficult for Apple to pay tariffs, when Samsung does not face the same hurdle because much of its manufacturing is in...Technologyread more
The yield on the benchmark 10-year Treasury note briefly fell below the 2-year rate on Wednesday, a phenomenon in the bond market known as yield curve inversion, which is...Marketsread more
Despite aggressive strides, Waymo needs one thing before their self-driving cars become a seriously useful transportation system: people. We talked to the ones closest to it.Technologyread more
The hearing will now begin next Monday to allow time for the completion of a previous trial that revolves around former 1MDB unit SRC International, a Kuala Lumpur High Court...Asia Newsread more
(Repeats for additional clients with no changes to text)
TORONTO, May 8 (Reuters) - A tiny, little-known government agency is ramping up regulation of Canada's pharmaceutical industry, seeking to rein in prices for patented drugs that are among the highest in the world, according to industry sources and a Reuters analysis of government data.
The federal Patented Medicine Prices Review Board (PMPRB) is targeting an increasing number of expensive drugs, including a rare-disease medication made by Horizon Pharma that can cost C$325,000 ($253,409) a year, documents reviewed by Reuters shows.
The agency can challenge the list price of any patented drug in Canada and order companies to repay some revenue. Data show the number of open PMPRB investigations into potentially overpriced drugs has more than doubled since 2013, reaching 122 as of March 2018.
(See graphic on escalating enforcement actions here https://tmsnrt.rs/2LuY5og)
New proposed regulations could enhance the PMPRB's powers and help set a broader agenda for taming prices in Canada.
This shift toward greater regulation - years in the making but not always so visible - could hurt pharmaceutical revenues in Canada and has alarmed drugmakers. But it could benefit private drug plans and provincial governments and help patients with out-of-pocket costs.
In addition, although Canada is a relatively small market for major drugmakers, lower prices in Canada could spread into the U.S. market, experts say. Washington is considering a proposal to base some drug prices on the cost of medicines in other developed nations.
Cross-border sales could also put pressure on U.S. prices for patented drugs, which lead the world and well exceed even Canada's. Some American patients already buy prescription drugs illicitly from Canada, and last year the U.S. Food and Drug Administration created a working group to study legalizing some wholesale imports.
The pharmaceutical industry's main lobby group in Canada, Innovative Medicines Canada, has argued that the changes, if approved by the cabinet of Prime Minister Justin Trudeau, could delay or limit Canadians' access to new patented medicines. Reuters reported in February that drug companies offered to give up C$8.6 billion($6.4 billion) in revenue over 10 years to head off the PMPRB reforms.
Last month, the U.S. Trade Representative said in a report that it was closely monitoring the reform effort, noting it "would significantly undermine the marketplace for innovative pharmaceutical products."
Drugmakers around the world are under pressure as governments and insurers grapple with skyrocketing drug prices, especially the United States.
Stephen Frank, president of the Canadian Life and Health Insurance Association, said changes at the PMPRB reflect a broader willingness to tackle drug prices.
"There's a momentum and an energy around becoming more engaged on pricing issues," he said. "There's many layers to this, that have sort of aligned to give them the space they need to try and be more active."
From its founding in 1987, the PMPRB was an unusual agency. With a budget of C$15.4 million and approved staff of 83, it is one of the smallest federal departments in Canada. By comparison, the National Film Board employs about 400.
Healthcare is generally a provincial responsibility in Canada, but the PMPRB draws its power from federal patent law. Instead of bargaining drug prices down, it can declare some to be an illegal abuse of patent rights. It caps prices paid by private as well as public plans. The agency's cases are most often settled out of court.
Its size belies its importance. Canada's universal healthcare system does not cover most patented - or generic - prescription drugs, which are paid for by more than 1,000 public and 100,000 private, employer-sponsored drug plans as well as patients themselves.
Executive Director Douglas Clark, who took over in 2013, said he believes the rise in investigations has been driven more by the escalating prices set by pharmaceutical companies than by his agency's toughened stance.
But the agency could soon gain more muscle. The reform proposal, shepherded by federal regulator Health Canada, would allow PMPRB to figure in the effectiveness of drugs and what Canadian governments can afford when determining whether costs are excessive.
Announced in 2017, the rules were scheduled to take effect in January but have been delayed as the government reviews feedback.
There is no guarantee the reforms will proceed, especially given the uncertainty of federal election results in the fall. But even if they are shelved, Clark said, his agency has some ability to change pricing guidelines on its own.
"We don't have the same maneuverability if we don't have regulatory change, but we'll make the best of what scope we have," he said.
PUNCHING ABOVE ITS WEIGHT?
The PMPRB is already taking on some of the drug industry's big players.
The agency recently targeted Horizon Pharma, for instance, deeming its drug Procysbi, tagged at C$325,000, excessively priced.
Health Canada approved the drug in 2017 to treat a genetic disorder known as cystinosis, which afflicts about 100 Canadians. Without treatment, the condition causes irreversible kidney damage.
The federal approval essentially elbowed out a far cheaper alternative drug, making it difficult for patients to get.
Horizon argued that its medication was superior, that the$180 million it spent on research and development justified the price and that patients unable to afford Procysbi were able to get it on discount or for free.
Sales in the United States and Canada were $154.9 million in 2018.
In January, PMPRB sought to force the company to reduce Procysbi's list price by at least 71 percent. The agency argued that the current price was so much higher than the similar alternative drug - listed at around C$25,000 - that PMPRB should set aside its usual guidelines, based largely on what is charged internationally.
Horizon is fighting back, saying in a recent statement that PMPRB wants the drug to sell at "a small fraction of the lowest price in the world." The matter is set for hearings and could be decided in federal court.
But in the end, said Joel Lexchin, a University of Toronto professor and pharmaceutical policy expert, the problem of escalating drug prices won't be settled by individual showdowns with drug makers over specific drugs. A broader approach - like the new proposed regulations - is needed, he said.
"We can't really keep going with these one-offs," he said. "We need a general policy."
($1 = 1.3437 Canadian dollars)
(Editing by Denny Thomas and Julie Marquis)