Attention News/Heath Editors:

Patient coalition welcomes drug safety measures; progressive, flexible approach benefits patients

TORONTO, April 8 /CNW/ - New legislation will enable Health Canada to implement more effective ongoing safety monitoring of drugs without unnecessarily restricting patient access, said the Best Medicines Coalition, an organization representing patients across Canada.

Amendments to the Food and Drug Act tabled in the House of Commons today modernize the current system while harmonizing with established practices internationally, allowing strengthening of measures to monitor drug safety issues throughout the product lifecycle and harmonization internationally. This includes from when applications for approval are first filed, as is the case with the current regulatory regime, through the period when drugs are available on the market and the years following. The legislation includes measures to ensure compliance, including some mandatory reporting of adverse events, and enforcement of regulations.

“For patients with serious illnesses, an inflexible ‘one-size-fits-all’ approach to drug licensing as we have had in the past simply does not work,” said Louise Binder, Chair of the Best Medicines Coalition. “Weighing risks and benefits of any drug is complicated and demands a subtle and sophisticated regulatory regime, so a progressive approach with staged licensing makes sense. Safety assessments must take into account the needs of patients with life-threatening illnesses who may need access to new therapies.”

“Some safety issues may not emerge until well after a drug reaches the market, and this intelligence must be captured and incorporated into patient care. Canada has an abysmal record in terms of the reporting and tracking of adverse events for marketed drugs which are now in use, and we are optimistic that this new framework will allow reporting rates to be improved,” Binder added.

The Best Medicines Coalition has been closely involved in the consultative process leading up to the tabling of this legislation. Moving forward, the Best Medicines Coalition will be seeking opportunities to work collaboratively with Health Canada to ensure that patient interests are protected as regulations are developed and through implementation phases. Specifically, wording addressing personal information and Ministerial powers are of concern and warrant careful consideration.

Formed in 2002, the BMC is a national alliance of patient-driven organizations and individuals, representing those living with or affected by chronic disease or illness, who are concerned about drug review reform, treatment access, patient safety and general health policy development.