Western Australian Medicines and Poisons Act 2014 Commenced

The Medicines and Poisons Act 2014 (No 13 of 2014) (WA) (the new Act) has been proclaimed to commence (excluding section 14(2)) on 30 January 2017 (see Gazette 13, 17 January 2017, p 404) and to compliment that commencement, a new set of principal regulations, the Medicines and Poisons Regulations 2016, has also been gazetted (see Gazette 14, 17 January 2017, p 443).

Progress to Enactment

The commencement of the legislation concludes a reform process which, according to the Minister in his second reading speech, commenced with approval  to begin the drafting of replacement legislation in 2009, was followed by extensive consultation of major stakeholders, the circulation of an exposure draft in September 2011, the introduction of the Bill in 2013, the Bill receiving assent in 2014, and three years latter in 2017 commencement of the legislation - in all an eight year process.

Objectives of the New Legislation

The objectives of the new Act can be broadly stated as being to regulate and control the manufacture and supply of medicines, poisons and therapeutic goods in Western Australia; to repeal the Poisons Act 1964 (WA) and the White Phosphorus Matches Prohibition Act 1912 (WA) and various regulations under the existing legislation; and to amend the Health Act 1911 (WA), the Misuse of Drugs Act 1981 (WA) and various other related laws.

Reasons for Reform

The repeal of the existing legislation (the Poisons Act 1964) was, according to the Minister, seen as necessary because the existing legislation was:

An example of the existing legislation's limits, given by the Minister, was the limited powers to authorise new groups of suitably qualified health professionals to handle medicines and improve consumer access to care in response to current health workforce issues. Another area of deficiency identified the inadequate regulatory support for new initiatives aimed at reducing diversion and misuse of drugs of addiction. The existing legislation did not allow for ready alignment of controls over poisons with nationally accepted best practice, resulting in added compliance costs to industry and a failure to support the timely prohibition of chemicals of unacceptably high risk to the public.

Structure and Operation

The structure and operation of the new Act, outlined by the Minister at Bill stage, is that Part 2 of the new Act sets out offences, while Parts 3, 4 and 5 provide a ". .  . high-level framework of controls" over medicines and poisons designed to protect public health and safety - high level, because  the finer detail of the controls of the manufacture, use, sale or supply of medicines and poisons is to be dealt with in the subsidiary legislation (as to which see Medicines and Poisons Regulations 2016 Part 2 - 4 in particular). 

The new Act retains the majority of the controls associated with the to be repealed existing legislation and substances controlled through the current poisons legislation are classified into a set of nine schedules.

Substances are included in a particular schedule based on their risk to human health and the requirement for expert oversight. The nine schedules are consistent with the national approach to regulating medicines and poisons under the Standard for the Uniform Scheduling of Medicines and Poisons (the SUSMP). Controls applied to a particular substance are related to the schedule that it resides in and controls vary commensurate with the risk posed by the substance. Some examples are: medicines available over the counter at pharmacies come under Schedules 2 "Pharmacy medicines" and 3 "Pharmacist only medicines", whilst other medicines must be prescribed under schedule 4 "Prescription only medicines, or Prescription Animal Remedy". The remaining Schedules deal with drugs requiring "caution", that are a "poison" or a "dangerous poison", that are "controlled drugs" or  "prohibitted substances".

With respect to the control of the handling medicines and poisons such is to continue as it does under the existing law with key reforms said by the Minister, to be that the new Act  will include:

• simplification of the procedures for licences and permits; 
• an ability to recognise new roles for a wider range of health professionals in handling medicines supporting a broader roll out of health programs, particularly in rural and remote areas; 
• improved control of drugs of addiction, with greater transparency and protections for those affected by drug   dependence;
• clarification of the rights of employers and employees who handle medicines and poisons, including protection for carers; and 
• a more modern approach to the use of automated medicine systems that will increase the accountability, safety and efficiency of medicine supply.

The new Act takes into account the part that technology now plays in the purchasing, recording, storing, monitoring and dispensing of medicines and poisons in industry and in the hospital system and accommodates and facilitates electronic transactions and automated dispensing systems in hospitals and other healthcare settings (see for example; Part 4 - "Prescriptions and prescribing", at  Division 3 - "Electronic prescribing systems" (regs 18 - 22) of the new Principal regulations).

To control the potential for the misuse of hard drugs, Part 7 of the new Act includes, according to the Minister in his second reading speech, an Australian first, by implementing a system to identify and regulate "doctor shopping", a system whereby persons present at a number of different medical practitioners seeking medication for their personal addiction or for resale to others. This is to be done by setting up a record of persons who are legitimately prescribed drugs of addiction (see Schedule 4 "reportable poisons" and Schedule 8 "poisons"). Registered health professional will then be able to check the record before prescribing to determine whether the patient has been recently prescribed the same or a similar substance.

Ahead

As already stated, the new Act and the new principal regulations are a major reform set to commence on 30 January 2017 and follow closely on the commencement of other major health law reforms in WA in the form of the Public Health Act 2016 (No 18), the bulk of which is to commence on 24 January 2017 (see Gazette 7, 10 January 2017, p 163). 

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Medicines and Poisons Act 2014 (No 13 of 2014) [the 2013 Bill] (WA), Medicines and Poisons Regulations 2016 [WA] and related speeches and explanatory material as reported in the TimeBase LawOne Service.