A Canadian judge has ruled that Health Canada must provide a University of Maryland researcher with clinical trial data for various medicines, a move that may increase efforts to independently verify studies used to win regulatory approval for prescription drugs.
In a 43-page ruling last week, the judge decided that Health Canada failed to follow a federal law that is designed to provide clinical trial transparency, and also adopted a “rigid policy” of releasing data only if the researcher agreed to strict confidentiality, which denied freedom of expression.
“Health Canada’s decision was unreasonable,” wrote Federal Court Justice Sebastien Grammond.
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