Canada Considering External Agency For Drug Regulation

18 September 1997

Setting up a new, quasi-independent agency to regulate the approval ofnew prescription medicines and medical devices is being considered by Health Canada. Those proposing the concept say an external agency - to replace the function of the Health Protection Branch - would be a more efficient way to ensure that the people of Canada can get access to new drugs as fast as in other countries while not compromising safety.

However, those against this idea claim that a "special operating agency" was likely to give its approval too quickly, and this could result in health risks for those taking the medications. They also note that while such an agency might have to report to the Minister of Health or his deputy, it would still not be accountable.

Still At Preliminary Stage Health Minister Allan Rock has said that an internal review of the drug regulation system is underway, but is still at a preliminary stage, and stressed that before any responsibility was moved away from the Ministry, outside experts would be consulted. And assistant Deputy Minister for the Health Protection Branch Joe Losos, reported in The Ottawa Citizen, made it clear that no changes would be made until it was quite clear that these would result in an improved regulatory system, with accountability.

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