Healthy Skepticism Library item: 977

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Publication type: news

Vasil A.
Smart Regs really dumb: "Efficiency" scheme on eco and health regs threaten our own protections
Toronto's 'NOW' Magazine 2005-2005 Apr-Apr 21-27

Full text:

You know those Canadian-style earthquakes you don’t realize are earthquakes until the 6 o’clock news tells you? Well, sorry, kids, but no alert was issued when the president of the Treasury Board of Canada assembled some of his closest industry buds for an intimate luncheon last month to announce serious seismic upheaval in Ottawa. Activists say this one was right off the Richter scale.

Though it’s being touted as a safe and sensible streamlining of Canada’s bureaucratic mess, a tidying of excess red tape, a growing mass of critics are saying the federal government’s new Smart Regulation initiative will, at its core, compromise protections on everything from the pills we pop to the lands we drill.

They contend that the massive effort, which sweeps across 15 departments, is fundamentally designed to grease international trade wheels by squashing Canuck standards and “harmonizing” them with those of the U.S. And to ease the corporate burden even more, companies that manufacture chemicals, prescription drugs, pesticides, biotechnology – hell, even offshore oil drillers – are promised speedier approvals under the new system. Officials insist it’s all in the name of greater safety, health and protection, but observers charge that the plan looks more like Canada’s version of No Lobbyist Left Behind.

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Whoever came up with the name is one clever cookie. Any intelligent person would want “smart” regulations, no? It makes sense to cut overlapping paperwork, clarify fuzzy rules, allow companies to fill out forms online, as the initiative proposes to do, and generally, as the feds like to say, bring government into the 21st century. And why shouldn’t we harmonize with our major trading partner, the U.S., when it comes to silly differences in standards? The feds point to discrepancies in how much real cheese has to be in cheddar-flavoured popcorn. Is any sensible Canadian snacker really going to say, “No, I don’t want my cheese puffs to have 4 per cent more real cheddar, like the Yanks’ do”?

But as Guy Caron of the Council of Canadians says, “They are leaving the more potent and dangerous examples out.” Under the test-once policy, for instance, if the U.S. or any other major trading partner approved a drug, then we’d fast-track it.

It’s an idea that Joel Lexchin, a health policy and management prof at York U, says is fraught with danger. “There are lots of examples of drugs that have been approved in the United States that we haven’t approved, and vice versa,” says Lexchin. An anaesthetic called Raplon was not approved for use in Canada because of severe lung spasms in many children, but the U.S. went ahead and okayed it – until five deaths led to a voluntary recall.

Then again, we approved Diane-35, an acne-fighting birth control pill linked to fatal blood clots, while the U.S. did not. Adds Lexchin, “Having one organization look at this thing doesn’t always produce the correct answer. There’s value in having multiple assessments.”

But what of Canada’s dusty backlog on drug evaluations? Isn’t it a good thing to get vital meds out to patients in a “timely manner,” as the feds and patient groups say Smart Regs will do? Explains Lexchin, “You’re dealing with a situation in which only 5 to 10 per cent of drugs that come on the market in any given year [offer] major benefits, and the rest are out there essentially to grab market share. We don’t need faster approval of these.”

Besides, adds the medical policy consultant, “some work that’s been done in the U.S. and the UK shows that faster access means safety problems down the line.” The study in question revealed that quicker market approvals of drugs led to more patients being exposed to unsafe drugs and more drug recalls.

The feds say they’re pumping extra cash into safety to offset that kind of thing, but Lexchin says it’s far from enough.

Naturally, Big Pharma isn’t worried. Drug companies were among the half-dozen industry groups that shot off celebratory press releases moments after the government made its Smart Reg announcement. Biotech reps, pesticide makers and CEO orgs, all of whom were promised speedier approvals and U.S.-harmonized regs, giggled about how wonderful and important the new initiative is in the context of global competitiveness.

And all this just one day after the three amigos, Paul Martin, George W. Bush and Mexican president Vicente Fox, pinky-swore that they’d work to cut back on testing requirements, harmonize standards and generally minimize barriers to increased corporate profits continent-wide under the new Security And Prosperity Partnership. With Smart Regs, good old Canada seems to be the first to step up and sacrifice its independent standards and rules for the sake of freer trade for all.

Beyond harmonization and rushed approvals, enviros like Mark Winfield of the Pembina Institute for Appropriate Development are worried the initiative will actually make it more difficult to enact regulations that strengthen enviro protection, like controls on greenhouse gases. “They’re proposing to put in place exactly the sorts of things the Conservatives did in Ontario under the Red Tape Commission, this process of putting more and more hurdles in the way of adopting regulation [that contributed to] the Walkerton disaster,” says Winfield.

The woman in charge of overseeing the implementation of Smart Regs, Julia Hill, says claims of hurdles to green protection just ain’t so. “Obviously, we haven’t been doing a very good job at communicating that.”

Hill also takes exception to the implication that Smart Regs will mean harmonizing with the States. “What we’re trying to do is find best practices around the world. Sometimes those are in Australia, sometimes in the European Union and sometimes in the U.S.” Adds Hill, “If harmonizing (with the States) meant decreasing standards, then it’s off the table.”

But the advisory committee that devised the Smart Regs initiative offers no firm guarantees that we’ll be harmonizing up. One of the core tenets behind the regs, according to the report, is simply that “the government should adopt international approaches wherever possible and limit specific Canadian regulatory requirements.” And it minces no words in telling us exactly where those “international approaches” reside. It calls for the development of an inventory of regulatory differences “in particular between Canada and the United States, and [alignment of] regulatory requirements in cases where differences are not warranted.” Full stop.

Of course, the politicians will continue to refer us to their own special dictionary. The one where “safety” means “speed,” “best practices” means “American practices” and “smart,” of course, always means just that.