Regulatory changes impacting the cosmetic injectables industry

This week in Health Law Insights, we look at two recent developments in December 2024 which have the potential to significantly impact the cosmetic injectables industry.

1. AHPRA announces new endorsement to allow RN’s to prescribe Schedule 2, 3, 4 and 8 medicines in a prescribing-in-partnership model

On 11 December 2024 AHPRA announced that Health Ministers had approved a new?Registration standard: Endorsement for scheduled medicines – designated registered nurse prescriber?(the standard), which will enable RNs who meet the training and clinical experience requirements to prescribe?Schedule 2, 3, 4 and 8 medicines?in partnership with an authorised health practitioner?under a prescribing agreement, in accordance with relevant state and territory legislation.

Each Australian State and Territory has its own legislation regulating the administration, obtaining, possession, prescription, supply and/or use of Schedule 2, 3, 4 and 8 medicines. In certain jurisdictions, such as Victoria, NSW and SA, obtaining the endorsement will authorise RN’s to undertake all of these actions. In other States, such as Qld, WA and Tas, regulations will need to be issued to add RN’s endorsed under the standard.

At this stage we haven’t seen a copy of the registration standard, however a draft circulated by the Nursing and Midwifery Board for consultation contained the following key points which could give an indication of what to expect:

How can I qualify for endorsement?

You can qualify for endorsement through one of the following pathways:

Successful completion of:

·?????? NMBA-approved units of study leading to endorsement as a registered nurse prescribing in partnership, or

·?????? units of study that are equivalent to the NMBA-approved units of study leading to endorsement as a registered nurse prescribing in partnership.

What are the supervised practice requirements for the endorsement?

You also need to complete a period of supervised practice in accordance with the requirements set out in the NMBA Guidelines for registered nurses applying for or with the endorsement for scheduled medicines - prescribing in partnership.

What are the other requirements for the endorsement?

1.???? Current general registration as a registered nurse in Australia with no conditions or undertakings relating to unsatisfactory professional performance or unprofessional conduct.

2.???? The equivalent of two years’ full-time post initial registration clinical experience (3,800 hours), immediately prior to the date when the complete application seeking endorsement as a registered nurse prescribing in partnership is received by the NMBA.

An advance copy of the standard will be published on the NMBA website in March 2025, with the endorsement, registration standard and guidelines scheduled to take effect mid-2025.

2. Medicines in beauty treatment/cosmetic businesses – Queensland Health

Perhaps not coincidentally, also in December 2024, Queensland Health issued a factsheet providing guidance on the buying, storage and use of these Schedule 4 cosmetic injectables as regulated by the Medicines and Poisons Act 2019 (Qld) and the Medicines and Poisons (Medicines) Regulation 2021 (Qld).

Although each Australian State and Territory has its own legislation regulating the buying, possessing, prescription, administration etc of Schedule 4 medications, Queensland's guidance is remarkable for the fact that it specifically addresses the application of the legislation to beauty treatment/cosmetic businesses in unambiguous terms.

Most noteworthy, the Queensland guidance expressly states that RN's without an endorsement working in Queensland can't:

·?????? prescribe or buy S4 medications even on behalf of or with the approval of a doctor or nurse practitioner,

·?????? place a purchase order with a medicine wholesaler or pharmacist for the supply of the S4 medicines, including sending an electronic order under the medical practitioner or nurse practitioner’s name or account; or

·?????? utilise standing orders to administer cosmetic injectables.

Furthermore, doctors and nurse practitioners that don't work for the beauty treatment/cosmetic business can't purchase medicines on behalf of that business. This must be done by a medical practitioner or nurse practitioner working for the business.? To remove any doubt about how telehealth prescription services fit in with this, the guidance expressly states that "Doctors and nurse practitioners cannot buy stock for a place that they do not practice from, which includes locations for which telehealth is provided."?

Licensed wholesalers or pharmacists need to have a reasonable belief that the buyer of any S4 medication is authorised under the legislation to give a purchase order.

Contact us

At Health Law Partners, we’re available to assist Queensland businesses who think they may be impacted by the information contained in the Queensland Health guidance and want to know what their options are. For a confidential discussion, feel free to contact us: [email protected]

Practices in other States and Territories are also welcome to contact us, should they want to assess compliance issues based on the laws applicable to their State or Territory.