The regulation of certain medications and poisons in Queensland has, for more than 80 years, been managed under the Health Act 1937 (Qld) in combination with the Health (Drugs and Poisons) Regulation 1996 (Qld) and Health Regulation 1996 (Qld). Separately, licensing and approvals for pest management have been regulated by the Pest Management Act 2001 and its subordinate regulation.

The repeal of large tracts of the Health Act over time have contributed to an increasingly complex substance management scheme reliant upon subordinate regulation rather than an headline Act of Parliament.

The Medicines and Poisons Act brings a complete overhaul of the current regulatory framework into a single overarching substance management scheme, which will modernise and streamline regulation. We highlight key changes for regulated medicines, focussing on real-time prescription monitoring, streamlined authorisation processes and new offence provisions.

The new framework is expected to commence in the second half of 2020.

Objectives of the Medicines and Poisons Act

The existing framework is outdated, complex and difficult to understand. The Medicines and Poisons Act is expected to reduce barriers for industry and practice, to promote efficiency and reduce the costs of regulation with the overarching aim to help move Queensland towards an "outcomes-focused approach" to substance management. The scheme is focussed on the monitoring and compliance of trained professionals and industry, rather than the broader community. 

The key objectives of the Medicines and Poisons Act are to improve safe and effective management of certain substances (and protect public harm, for example, from dependence-forming medication), to ensure that competent people are approved to hold authorities and to build enhanced public confidence in the regulation and monitoring of medicines, poisons, and other regulated substances.

The scheme has been aligned with comparable national and interstate frameworks promoting certainty for manufacturers operating in multiple jurisdictions, as well as reducing confusion around application of the law.

Preparing for the new framework

Real-time prescription monitoring

The new framework will enhance public safety by providing instantaneous and accurate prescription data of 'monitored medications' by a real-time monitored medicines database, to be linked with the Commonwealth National Data Exchange.

The Medicines and Poisons Act does not define the 'monitored medicines' but we expect the regulations will capture pharmaceutical opioids, prescription-only medications and other dependence forming drugs such as sedatives, sleeping tablets and products that combine codeine with other medications.

The key obligations for practitioners under the real-time prescription monitoring scheme are as follows:

• prescribers and dispensers must first check the monitored medicines database when making a decision to prescribe, supply, dispense or give a treatment dose of a monitored medicine to a person and take account of their monitored medicine prescribing and supply history. The penalty for failing to check the database is 20 penalty units (or $2669): s41.
• prescribed information must be provided to the database by 'information providers'. That term, once prescribed by regulations, will likely include persons and entities authorised to prescribe and dispense monitored medicines. A failure to comply without reasonable excuse may result in a penalty up to 100 penalty units (or $13,345): s226. 

The real-time prescription monitoring will be an important support for clinical decision-making, reducing doctor shopping and minimising over-prescription of regulated monitored medicines.

Streamlined authorisation scheme

The regulated substance management scheme, including for monitored medicines, will operate as follows:

• a person or entity must be authorised to perform regulated activities with regulated substances (persons will be authorised if they are approved, acting under an emergency order, the holder of a substance authority, or another person acting under a substance authority): s30.
• a regulated substance is a medicine, poison, prohibited substance, fumigant or pesticide: s17.
• the regulated activities include dealing with a regulated substance and pest management activities: s20.

The scheme introduces several categories of 'substance authorities' including manufacturing, wholesale, retail and pest management 'licences', and prescribing and general 'approvals': s61.

The new regime allows for representative authorisations which will increase efficiency to allow, for example, manufacturers operating on multiple sites to be authorised under a singular licence on a fee per site basis. This is opposed to the current requirement for multiple licences. Holders of wholesale or manufacturing Commonwealth licences will not be required to obtain a Queensland licence.

Rather than obtaining individual licences, medicine wholesalers will also be able to access wholesale licences to enable their representatives to perform regulated activities with regulated substances under the authority of their employer's manufacturing or wholesaling licence. Interstate wholesalers of medicines and international wholesalers of poisons will also not require a wholesale licence, but will require an equivalent authority under their respective jurisdiction. This does not extend to storing of regulated substances in Queensland.

The streamlined authorisation processes are expected to increase flexibility in business and practice. Responsible entities will be required to ensure 'adherence to adequate governance measures, policies and procedures, and training to manage the public health and safety risk associated with the regulated substance'.

Substance management plans

The Medicines and Poisons Act 2019 requires each place, where dealings with regulated substances occurs, to have a 'substance management plan'. Dealings with regulated substances include manufacturing, buying, possessing or supplying a substance, and for medicines, administering, prescribing or making a standing order for the medicine.

Substance management plans will be required, for example, for manufacturers, wholesalers and entities such as schools, hospitals, prisons and community pharmacies.

There must be a responsible person at each regulated place, who is responsible for developing the plan and ensuring it is compliant with the Act and Regulations and available to all staff (s93). Based on the explanatory materials, a number of interconnected sites managed by the same entity might be permitted to adopt a uniform substance management plan for each site.

We understand that Departmental Standards are being drafted to assist regulated places manage the risks associated with dealing with regulated substances and to ensure consistency in approach and regulation, and in turn, to promote community safety. Once published, organisations should review existing policies to ensure compatibility and compliance. The penalty for noncompliance with the substance management plan provisions is 250 penalty units.

Offence provisions

The offence provisions are outlined in Chapter 2 of the Medicines and Poisons Act. These include existing offences, which have been reviewed, and where necessary updated to reflect modern drafting styles and community expectations as well as a number of new offences.

In relation to the administration and supply of medicines and particular substances. These include that a person must not, without reasonable excuse:

• administer a medicine to a person or animal, unless in the authorised way: s36
• supply for human use, administer to a human, or self-administer an animal medicine: s37
• prescribe or make a standing order for a medicine, unless in the authorised way: s37
• use a document the person has unlawfully prepared, or knows has been unlawfully prepared, for buying a diversion-risk medicine: s39
• a person must not dispose of waste from a schedule 8 medicine unless the person disposes of the waste by giving it to an appropriate person or disposes of it in the authorised way: s42

The penalties that apply to these offences range between 100 and 200 penalty units and are aligned with comparable legislation, including the Therapeutic Goods Act and the Agricultural and Veterinary Chemicals Code Act.

There are a number of exclusions to the offence provisions including for state officers, persons authorised under other laws, defined agents and carers and clinical trials. A worker may also be excluded if working for an entity and it can be proven that the entity did not provide the worker with suitable equipment, facilities, training or other resources that would have allowed the worker to comply with the provision.

It is expected that the new offence provisions will provide a simplified and consistent approach to regulation for the regulated substances captured by the Medicines and Poisons Act.

There are also some overarching offences such as for unauthorised manufacture, possession or supply of a regulated substance. These offences prevent unauthorised dealings with regulated substances and can result in significant penalty. A person who is alleged to have engaged in unauthorised manufacture, possession or supply of a regulated substance, may raise a defence of 'reasonable excuse'. Examples of reasonable excuses include a health practitioner taking possession of a regulated substance in a hospital while treating a patient, or where the person becomes responsible for the affairs of the holder of a substance authority who is critically ill, dies, is imprisoned or becomes bankrupt.

It is expected that the new offence provisions will provide a simplified and consistent approach to regulation for the regulated substances captured by the Medicines and Poisons Act.

Anticipated regulations

Regulations to prescribe the scheme details are expected to be formalised shortly, to include the Medicines and Poisons (Medicines) Regulation and the Medicines and Poisons (Pest Management, Poisons and Other Regulated Substances) Regulation. The Medicines and Poisons (Medicines) Regulation 2019 remains in draft, but currently contains a number of proposed changes to the existing regime including:

• an obligation to notify the police for lost or stolen medicines
• changes to the classification of certain medicines. 

The Medicines and Poisons Act 2019 received Royal Assent on 26 September 2019 and will take effect on a date to be fixed by proclamation.

We will provide a further update, highlighting the practical implications and tips for compliance with the new regulated substances regime, once the regulations are passed.

Queensland Health will continue to provide updates on its website