Pharmacy Law

Applications for approvals of pharmacies under the Pharmaceutical Benefits Scheme (“PBS”) are assessed by the Australian Community Pharmacy Association (“ACPA”), which makes a recommendation to the Secretary of the Department of Health with respect to such approval. 

The ACPA’s decision is made pursuant to the National Health (Australian Community Pharmacy Authority Rules) Determination 2011 (“Determination”), which is a legislative instrument in force pursuant to the National Health Act 1955 (Cth).  The criteria by which the ACPA assesses an application will depend on the categories of applications set out in the Determination.

An adverse decision by the ACPA is a reviewable decision and may be referred to the Administrative Appeals Tribunal (“AAT”) for review on a de novo basis.

A recommendation by the ACPA will subsequently need to be considered and adopted by the Secretary of the Department of Health.

Parties affected by the decision of the ACPA may apply to the AAT to be joined to the proceedings.  In these circumstances, the ACPA allows the affected party to contradict the application and generally limits its participation to assisting the AAT and the other parties as to questions of law and procedure.

Rowe Bristol Lawyers is experienced in advising clients with respect to pharmacy approvals and objections under the PBS, including:

  • advising clients as to the requirements of the Determination from time to time;
  • considering and advising clients as to objections to adverse decisions by the ACPA;
  • considering and advising clients as to whether the client has standing to join the AAT proceedings as an affected party with respect to a third party application; and
  • advising and representing an affected party who has joined AAT proceedings with respect to acting as a contradictor in such proceedings.

If you require legal advice in relation to pharmacy approvals and objections under the PBS, please do not hesitate to contact us to arrange a meeting so that we may consider your specific circumstances.

The above information is provided as general information only and should not be relied upon as legal advice.  The accuracy of this information may have changed from the date when it was published.