In the wake of section 150 proceedings, the Pharmacy Council of NSW (the Council) appears to have a proclivity for imposing conditions requiring pharmacists to provide written evidence of their consent to an order being made under clause 175 of the Poisons and Therapeutic Goods Regulation 2008 (the Regulation).
Such an order empowers the Pharmaceutical Services Unit (the PSU), formally known as the PRU, to prohibit or restrict a pharmacist from (amongst other things) “possessing, supplying, manufacturing or dispensing any” Schedule 8 drugs (the Order). The PSU can make this Order by consent, or otherwise in circumstances where a practitioner has committed an offence, failed to comply with a previous order or for the safety and well-being of the public.[1]
Once consented to, the Order takes effect on the date specified[2] and remains in force until (1) a written application for revocation is made to the PSU and (2) the PSU issues written notification confirming revocation of the Order. A pharmacist who contravenes an active Order could face a monetary fine of up to $2,200 or imprisonment for up to six months, or a combination of both penalties.[3]
By making pharmacists consent to this Order as a registration condition, the Council has, in our view, forced pharmacists to provide consent to be placed under the control of the PSU, eliminated the need for the PSU to establish an alternative ground(s) and saved the PSU running the risk that such an Order might be the subject of a court challenge.
Why should a pharmacist consider challenging such a condition?
There is no automatic revocation of the Order just because the Council has removed the initiating condition. This means, even after being put to the cost of defending section 150 proceedings, complying with registration conditions and successfully applying to the Council to remove conditions, the pharmacist must then make a separate application to the PSU to revoke the Order, which could be rejected as the PSU is not bound by the Council’s decision.
The Council has no power to revoke the Order. That is solely vested with the PSU. The Council cannot force the PSU to do this.
Some of our clients, in making a revocation application, have been required to obtain letters of support from the Council. Obviously, this can delay the application process, with the Council generally having to (1) decide whether to provide support or ‘not object’ to the revocation application and (2) actually provide the letter. The PSU has then invited the pharmacist to attend a meeting with PSU officers, who will assess the pharmacist’s knowledge of Schedule 8 drugs and make a report of the meeting, which will be considered by the PSU in determining whether to approve the application. Despite these efforts, the PSU may still decide to uphold the Order, on the basis that the pharmacist does not meet relevant standards to have their authority reinstated or for other reasons.
During this whole process the pharmacist must continue to comply with the Order or risk penalties (outlined above).
On what grounds could you challenge the condition?
There are two obvious concerns arising from such conditions, being:
- whether a pharmacist’s consent to an Order is valid considering the serious penalties for non-compliance with registration conditions and if so, does the consent continue after the registration condition has been removed?
- whether the Council has power, under section 150 of National Law, to impose registration conditions which require a pharmacist to consent to be subject to another agency’s control which extends past the initiating condition?
Validity of consent
The NSW Civil and Administrative Tribunal (NCAT) is yet to consider if a pharmacist has exercised true consent, to be bound by an Order under clause 175 of the Regulation, in circumstances where the Council has made it a registration condition to submit to the PSU.
As you may be aware, conditions resulting from section 150 hearings take effect almost immediately and breaches are treated with utmost seriousness, carrying substantial consequences for a pharmacist, such as unsatisfactory professional conduct or professional misconduct proceedings before the Professional Standards Committee (PSC) or NCAT, which could result in disciplinary orders (amongst others) such as:
- a monetary fine up to $27,500;
- suspension or cancellation of registration;
- prohibition on providing health services for a period of time or permanently; and/or
- conditions placed on the pharmacist’s registration for a period of time or permanently.[4]
These are not insignificant penalties and as such, they can be a leading factor (if not the sole reason) for a pharmacist to consent to an Order. In such circumstances, it may not be a true exercise of ‘free and voluntary’ consent.
Following on from this, as the Order continues even if the condition is withdrawn, does the pharmacist’s consent, if only given because of the looming penalties for non-compliance with a registration condition, also continue and remain valid?
As far as we are aware, these questions are yet to make it before NCAT for determination and it would be very interesting to see what position NCAT would take.
Requisite power of Council
As you may already be aware, regulatory bodies require a clean and traceable delegation of power to authorise them to do certain things. For example, the power for the Council to impose conditions on a pharmacist’s registration is found in section 150(1)(b) of the Health Practitioner Regulation National Law (NSW) (National Law). While this power appears to be somewhat broad, does it really extend so far as to allow the Council to force a pharmacist to consent to an Order which is made and regulated by a separate regulatory body, operates entirely independently from the initiating condition and which the Council has no control over?
As discussed above, the power to make, revoke and punish non-compliance with an Order under clause 175 of the Regulation lies solely with the PSU. If the PSU was satisfied that an Order was necessary to protect the ‘safety and well-being of the public’ it could make the Order without consent.[5] Thus, it does not appear necessary for the Council to force consent by way of a registration condition.
Further, in looking at the ‘interim’ and ‘immediate’ nature of section 150 proceedings, the courts have made it clear they are designed to protect and not punish. It is possible that the Council, by imposing this type of condition, has failed to give proper consideration to the effect that such a condition (and the subsequent Order) would have on a pharmacist. Especially, given that (1) the Order stays in operation in the absence of the original complaint and condition, and (2) the financial impact it has on a pharmacist.
Conclusion
While the above challenges are yet to be tried before NCAT, it is important for pharmacists to be aware that:
- there is no obligation for the PSU to revoke an Order made by consent under clause 175 of the Regulation simply because the Council has removed the initiating condition; and
- you can challenge the Council’s decision to impose such a condition.
We are pleased to share that our office has been successful in an application to revoke an Order made under clause 175 of the Regulation, resulting in the pharmacist’s schedule 8 authority being reinstated.
Also, in recent appeals to NCAT we have run, the Council has agreed to remove this condition rather than have theses jurisdiction issues set out above decided by NCAT. This does mean than this issue remains unresolved at present by NCAT or any court.
If you are subject to section 150 proceedings, want to apply for revocation of an Order made under clause 175 of the Regulation or want more information, please contact Andrew Lambros or Maurice Hannan of Bennett & Philp Lawyers for advice.
This publication covers legal and technical issues in a general way. It is not designed to express opinions on specific circumstances. It is intended for information purposes only and should not be regarded as legal advice. Further professional advice should be obtained before taking action on any issue dealt with in this publication.
[1] Clause 175(2) of the Poisons and Therapeutic Goods Regulation 2008 (the Regulation).
[2] Clause 175(5)(b) of the Regulation.
[3] Clause 175(8) of the Regulation – 20 penalty units. As of January 2024, 1 penalty unit is equivalent to $110 (Revenue Ruling TAA 001).
[4] See sections 149A(1), 149B(1) and 149C(1), (4) and (5) of the Health Practitioner Regulation National Law (NSW) (the National Law). Under 149B(1) of the National Law, the maximum fine that the Tribunal may impose is 250 penalty units. As of January 2024, 1 penalty unit is equivalent to $110 (Revenue Ruling TAA 001).
[5] Clause 175(2)(d) of the Regulation.