New regulatory framework for the supply of medicines and poisons in New South Wales
We identify the key changes to the supply of medicines and poisons in NSW with the introduction of the Medicines, Poisons and Therapeutic Goods Act 2022.
The Poisons and Therapeutic Goods Act 1966 (NSW) (Current Act) is the primary source of regulation for the supply of medicines, poisons and therapeutic goods in NSW. However, it is on track to be replaced by a new piece of legislation: the Medicines, Poisons and Therapeutic Goods Act 2022 (NSW) which was assented to on 28 November 2022 (New Act).
The New Act adopts a more modern legislative drafting approach, including in relation to language and structure. This will be a welcome change for those seeking to navigate the often confusing and fragmented Current Act which is ‘…over 55 years old, is no longer fit for purpose and has not kept pace with contemporary healthcare and business frameworks’.
The commencement of the New Act is subject to the finalisation of the accompanying regulations which will first need to be subject to stakeholder consultation. It is unclear what priority will be given to this project by the newly elected Minns Government. The current regulations are a significant part of the regulatory regime and deal with substantive matters. While the New Act incorporates some issues currently provided for in the current regulations, it still defers some key issues to the regulations, with the potential for new offences and authorisations being provided for in the regulations. As a result, the full picture of the future regulation of medicines and poisons in NSW remains to be seen.
The current legislative framework has been amended a number of times over its long history. This has resulted in legislation that is fragmented and difficult to navigate. A key aim of the New Act is to modernise the regulatory framework regarding the supply of medicines and poisons, which means that much of the content has not been substantively changed, but has been restructured and rewritten to follow modern approaches to legislative drafting.
However, some substantive changes have also been made to reflect modern approaches in healthcare practice. The key changes in the New Act are summarised below:
- (Supply to authorised staff) The definitions of ‘supply’ and ‘supply by wholesale’ have been updated to recognise that authorised individuals and entities who obtain a stock of medicine are able to provide these to their authorised staff for on-supply, administration or use without this being considered supply or wholesale supply. This reflects modern (and safe) healthcare practices.
- (Wholesale supply to certain facilities) The New Act also facilitates private health facilities, managed correctional centres, residential care facilities, public hospitals, the NSW Vaccine Centre or a person with a licence to obtain wholesale stocks for use by authorised staff. Currently, only individuals who are authorised to supply medicines are able to receive a wholesale stock of medicine; the practical workaround generally being that one registered practitioner would obtain stock to be used by the whole organisation or the organisation would obtain a wholesale licence. Again, this reflects modern models of health care by allowing certain organisations to obtain a wholesale supply for use by authorised staff.
- (Limited regulation of administration) The New Act provides that ‘supply’ does not include administration and generally does not regulate the administration of medication but focuses instead on controlling supply. This recognises that there are a variety of people who will need to administer medicines (including carers and first aid officers, as well as medical practitioners) in a variety of circumstances and a policy decision has been made that it is not useful to regulate this activity provided there are strong controls on supply. The New Act does, however, leave the door open for the regulations to restrict administration in specific circumstances. The NSW Health discussion paper on the consultation draft of the New Act indicated that regulations may be made if there are high-risk settings where additional controls regarding administration are required.
- (Permitted wholesaling without a licence) The New Act permits certain wholesaling without a licence where safe and appropriate, including wholesaling between public health entities. The second reading speech indicated that the Ministry of Health will consult further with key stakeholders in relation to other wholesaling circumstances that are considered appropriate to take place without a licence with a view to providing for these in the regulations.
- (Increased and modernised penalties) Penalties, enforcement and compliance provisions have been made more robust in the New Act, with penalties generally having been increased. The New Act allows for the issuing of penalty notices. There is a compliance notice regime that provides for the issuing of compliance notices to require a person to remedy a particular contravention of the Act.
- (Emergency powers) The New Act takes into account learnings from the COVID-19 pandemic by including a power of the Health Secretary to make a ‘health risk authorisation order’. This power will be able to be used when there is a risk to the health or safety of humans or animals. The order will permit the Health Secretary to make an order authorising something that would otherwise be prohibited under the New Act. This power is intended to facilitate a flexible and transparent response to deal with urgent needs.
The introduction of the New Act is a good prompt for healthcare organisations to evaluate their processes and procedures regarding medicines and poisons to ensure they are compliant with the Current Act and will comply with the New Act.
While there is no indication of
when a consultation draft of the regulations to be made under the New Act will
be available, healthcare providers may also wish to consider if there are
circumstances not currently provided for in the New Act that would facilitate
the safe and efficient operation of their business with regard to medicines and
poisons in preparation for the opportunity to respond to the consultation draft
of the regulations.
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