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Breaking News Thursday, April 17 9:38 AM | |||
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Legislation worthy of our support Andre Picard From Thursday's Globe and Mail Last week, the government of Stephen Harper tabled Bill C-51, the much-anticipated amendment to the Food and Drugs Act. Within minutes, critics - consumer advocates, industry, academics and journalists - pounced on the proposed legislation like a pack of wild dogs thrown a hunk of raw meat. The new law, we were told, would: Weaken the drug review process; Allow for the rubber stamping of new drugs and turn Canadians into a nation of unwitting guinea pigs; Throw the doors open to direct-to-consumer advertising, transforming us into drugged-out zombies clamouring for every pill touted on TV; Place an unfair burden on the poor, beleaguered pharmaceutical companies by making even more onerous demands of them; Limit consumer choice by over-regulating "alternative therapies" as a sop to Big Pharma. This type of criticism is legitimate, though many of these views are uttered by rote and don't represent the law fairly. More concerning is that the piecemeal attacks obscure the big picture. The stark reality is that the existing Food and Drugs Act is dated, toothless legislation that has not been meaningfully amended in half a century. The status quo is indefensible. Bill C-51 is not perfect, but the policy folks toiling in the backrooms of Health Canada have done a decent job of creating a 21st-century legislative framework for products that have a tremendous impact on our lives. Canadians, who consume $20-billion-a-year in drugs, will finally have decent consumer-protection legislation, and not a moment too soon. In the 1930s, when drug legislation was first introduced, the emphasis was on cracking down on those who watered down real remedies or fraudsters who sold snake oil and dangerous pseudo medication. In the 1960s, the beginning of the consumer era, there was a shift to pre-market review, to ensuring that drugs were actually tested before being sold to the public to avoid debacles such as thalidomide. The new legislation focuses on the safety of drugs throughout their life cycle, from the clinical trials that are designed to produce good results through to the risks (and benefits) that spring up in the real world. And let's not forget that where the safety of drugs really matters is in the real world, an area that is currently totally unregulated. It is impossible to draft drug legislation that will please everyone. Patients with specific conditions can never get drugs quickly enough. For-profit corporations will always complain about restrictions on their activities. Consumer activists will always be skeptical about the intentions of big business and government. Researchers will always be able to point to shortcomings and decry political motivations. Bill C-51 - all 62 pages of legal jargon - provides no shortage of material for nitpickers with an agenda. But, when all is said and done, it does a pretty good job of balancing competing demands and it should ultimately do a pretty good job of protecting consumers. The main critique of the proposed law, that drug approvals will be easier, appears to have no basis. Those sections of the act are not substantially changed. Drug approvals are and will continue to be a long, onerous process - and assessing the safety and quality of drugs should be. Submissions for approval of new drugs aren't delivered in envelopes, they are delivered on palettes in big trucks; they are up to 60,000 pages long and reviewing that much material can't be done quickly if it's going to be done well. What's markedly better about the new law is that it will allow regulators to be pro-active. They will get involved from the get-go, approving clinical trials for new drugs and doing post-marketing surveillance. Better still, the new law allows the Minister of Health to convene public hearings on new drugs, a welcome dose of transparency. There are also beefed-up inspection powers and fines for violations will jump to as high as $5-million. Currently, drugs are approved and they stay on the market unless something really horrible happens and, even then, Health Canada has no legislative power to act. The concerns expressed about Bill C-51 opening the door to direct-to-consumer advertising also seem misplaced. In fact, there is no prohibition on advertising prescription drugs in the existing Food and Drugs Act; the rules are in accompanying regulations. Now those rules will be moved into the body of the law, giving them permanence. There is much more that can be said on the subject, and much will be when Bill C-51 is reviewed in parliamentary hearings. But before politicians start attacking the law, they need to get their facts straight. They also need to put consumer safety above partisan politics. Bill C-51 is good public policy and long-overdue legislation. In this case, the government got it largely right. Let's not allow politics and fear-mongering to screw it up. apicard@globeandmail.com | |||
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