Boehringer Ingelheim Pty Limited v Department of Health and Ageing [2005] FCA 284

Boehringer Ingelheim Pty Limited v Department of Health and Ageing [2005] FCA 284

A serious question exists as to whether the applicants were denied procedural fairness due to not being given an opportunity to comment on expert advice relied upon in the decision to amend the Product Information; the balance of convenience favours granting interlocutory relief, as substantial business harm would occur if the decision takes effect before the final hearing.

Jurisdiction
Australia
Judgment Date
10 March 2005
Procedural Posture
Application for Judicial Review / Interlocutory (application for Stay/suspension)
Outcome
Interlocutory relief granted; operation of decisions stayed pending judgment or further order.
Legal Topics
['procedural Fairness' 'judicial Review' 'therapeutic Goods Act' 'interlocutory Relief']
['administrative Law' 'health Law' 'pharmaceuticals'] ['procedural Fairness' 'judicial Review' 'therapeutic Goods Act' 'interlocutory Relief']

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Procedural Posture

Application for Judicial Review / Interlocutory (application for Stay/suspension)

Legal Issues

  1. 1 ['Whether the respondents breached procedural fairness (natural justice) in making decisions to amend the Product Information for meloxicam (Mobic, Movalis)' 'Whether interlocutory relief should be granted to stay the operation of the decision under section 28 Therapeutic Goods Act 1989 pending final hearing']

Ratio Decidendi

A serious question exists as to whether the applicants were denied procedural fairness due to not being given an opportunity to comment on expert advice relied upon in the decision to amend the Product Information; the balance of convenience favours granting interlocutory relief, as substantial business harm would occur if the decision takes effect before the final hearing.

Court Disposition

Interlocutory relief granted; operation of decisions stayed pending judgment or further order.

Orders

  • ['Leave granted to file affidavit of Paul Gregory Duchen sworn 8 March 2005.' 'Certain exhibits treated as confidential and not to be disclosed without leave of Court and notice.' "The operation of two decisions imposing conditions under s 28 Therapeutic Goods Act 1989 to amend Product Information for meloxicam...