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Experts call for changes to act amending drug bill

TORONTO - Several experts say the federal government's attempt to strengthen the powers of the Food and Drug Act haven't gone far enough.

They applaud some of the provisions in Bill C-17, but say additional powers are needed to protect the public.

They make their argument in a commentary published in this week's issue of the Canadian Medical Association Journal.

The act, which was introduced in Parliament in early December, gives the federal health minister long-overdue powers to order the recall of a drug for safety reasons.

Currently Health Canada must negotiate recalls with drug manufacturers, which can result in a drug remaining on the market after it has been deemed to be dangerous.

The researchers worry that the proposed amendments say recalls can be unilaterally ordered when evidence shows a drug is unsafe; they say the minister should be able to act when he or she has reasonable grounds to believe the drug could cause harm.

They also suggest the legislation should exempt the health minister from liability on drug suspensions and recalls, saying that without it the threat of being sued would be a strong disincentive to use the recall power.

The lead author of the commentary was Matthew Herder, who teaches health law in Dalhousie University's faculty of medicine.

He and his co-authors argue that the act should address the need for greater transparency in the data drug companies derive from the clinical trials they conduct in the process of bringing drugs to market.

The U.S. and Europe require that clinical trials are registered — a move Canada has not followed to date. Health Canada maintains a database of clinical trials, but stipulates it is not a registry and doesn't contain comprehensive information about all clinical trials. The authors suggest the data from these trials should be available for scrutiny by independent researchers.

They also call for more transparency on the part of Health Canada, saying the regulator should make public the rationale for its decisions — and, in fact, should make all its decisions public. Currently Health Canada does not disclose when it has turned down a drug application, though its European counterpart, the European Medicines Agency, does release negative opinions.

As the legislation currently stands — or is interpreted — too much information that the public needs is withheld on the grounds it is proprietary or is a trade secret, the commentary notes.

"These assertions overstate what the law actually requires and prevent important information about safety and effectiveness from being released," the authors write.

"Bill C-17 should explicitly state that the results of clinical trials, including de-identified patient level data, post-marketing studies and adverse drug reactions reported by drug manufacturers and health-care institutions are not proprietary and therefore should be publicly disclosed."

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