Experts call for additions to strengthen act amending drug legislation

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.

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.

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 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 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.”

Just Posted

Red Deer man says more cardiac care needed here

Ryan Gillies spent several extra days in hospital waiting to get a stent in Edmonton

Red Deer gets ready for CFR 45

A $20 to $25-million annual injection to the local economy

Former Red Deer teacher going to trial on child porn charges

Charges were laid in January 2017 after a woman came forward

Red Deer agency reports more than 1,000 lives saved with naloxone

Turning Point distributes 5,855 naloxone kits

WATCH: Ponoka residents enjoy first skate on ice path

A community initiative helped create a skate path for families in Ponoka.

Giddy up: Red Deer to host Canadian Finals Rodeo in 2018

The CFR is expected to bring $20-30 million annually to Red Deer and region

Got milk? Highway reopened near Millet

A southbound truck hauling milk and cartons collided with a bridge

Stettler’s newest residents overcame fear, bloodshed to come here

Daniel Kwizera, Diane Mukasine and kids now permanent residents

Giddy up: Red Deer to host Canadian Finals Rodeo in 2018

The CFR is expected to bring $20-30 million annually to Red Deer and region

Ice dancers Virtue and Moir to carry flag at Pyeongchang Olympics

Not since Kurt Browning at the 1994 Lillehammer Games has a figure… Continue reading

Beer Canada calls on feds to axe increasing beer tax as consumption trends down

OTTAWA — A trade association for Canada’s beer industry wants the federal… Continue reading

Central Albertans recall Hawaii’s false missile alert

Former Red Deer councillor Paul Harris was hanging out at the Ka’anapali… Continue reading

Most Read


Five-day delivery plus unlimited digital access for $185 for 260 issues (must live in delivery area to qualify) Unlimited Digital Access 99 cents for the first four weeks and then only $15 per month Five-day delivery plus unlimited digital access for $15 a month