Grundene til uenigheden var, at nogle af medlemsstaterne havde gjort indsigelser i forbindelse med folkesundheden, fordi der var påvist bioækvivalens i fastende tilstand, men at dette ikke var tilfældet under ikke- fastende tilstande.
The reasons for disagreement were, that some Member States have raised public health objections on the grounds that while bioequivalence was proven in the fasting state, the same was not the case under fed conditions.