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Compassionate Use

Canada to review access to unauthorised drugs

In response to pressure from drug manufacturers, patients and medical practitioners, Health Canada has begun reviewing its programme that allows patients with serious or life-threatening conditions access to drugs and medical devices that have not yet been authorised for sale in the country1,2. Among other things, stakeholders are calling for more access than is currently allowed under the Special Access Programme, which is aimed at ensuring that these patients have timely access to a drug or a medical device in cases where conventional therapies have failed, are unavailable or are unsuitable.

The three-phase review involves evaluating how the programme is functioning within the existing framework developed in 1996, studying the ethical mandate of the SAP and preparing a guidance document to...

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