CONTROLLED SUBSTANCES (THERAPEUTIC GOODS AND OTHER MATTERS) AMENDMENT BILL

Second Reading

Second reading.

The Hon. P. HOLLOWAY (Minister for Mineral Resources Development, Minister for Urban Development and Planning, Minister for Industrial Relations, Minister Assisting the Premier in Public Sector Management) (1:00): I move:

That this bill be now read a second time.

I seek leave to have the second reading explanation inserted in Hansard without my reading it.

Leave granted.

This Bill amends the Controlled Substances Act 1984 (the Controlled Substances Act) to:

take account of national registration of health practitioners and enable registered health practitioners to practise to the full scope of their competence

authorise eligible midwives and nurse practitioners to prescribe Schedule 4 and Schedule 8 prescription drugs and thereby access prescribing arrangements under the Pharmaceutical Benefits Scheme (PBS) under collaborative arrangements with medical practitioners

apply the Commonwealth Therapeutic Goods Act 1989 (the Therapeutic Goods Act) as a law of South Australia to help ensure that there are no gaps in the regulation of medicines and medical devices in South Australia

ensure that there are adequate controls over the sale of those poisons, medicines and medical devices that would be permitted to be sold via automatic vending machines.

The Bill also includes some miscellaneous amendments, which primarily enhance administration of the Act and take account of current drafting style and terminology.

National registration of health practitioners

Background

National registration of health practitioners came into operation in South Australia on 1 July 2010. The Health Practitioner Regulation National Law Act 2009 (Qld) (HPRNL Act) is adopted in South Australia by the Health Practitioner Regulation National Law (South Australia) Act 2010. Section 94 of the HPRNL Act enables a national health practitioner registration board, in accordance with a Ministerial Council approval, to endorse the registration of a health practitioner who holds an approved qualification and who complies with any approved registration standard relevant to the endorsement, as qualified to administer, obtain, possess, prescribe, sell, supply or use scheduled medicines (a scheduled medicines endorsement). The national boards may issue supporting guidelines for these scheduled medicines endorsements.

The controls over who is authorised to prescribe, sell, administer and supply scheduled medicines remain under the State and Territory drug and poisons legislation - the Controlled Substances Act in South Australia.

The Controlled Substances Act consists of an authorisation regime, which pre-dates the introduction of national registration. It effectively presents a barrier in that, even if endorsed by a national board, the Controlled Substances Act currently does not provide the necessary flexibility for the endorsed health practitioner to be able seamlessly to prescribe, supply, sell or administer the scheduled medicines covered by the endorsement.

Under the Controlled Substances Act scheduled medicines are Schedule 2, 3, 4 and 8 poisons. Schedule 4 and Schedule 8 poisons are prescription drugs. Examples of Schedule 4 prescription drugs include antibiotics, antihypertensive drugs and oral contraceptives. Examples of Schedule 8 prescription drugs include strong analgesics, such as morphine and fentanyl.

The Controlled Substances Act needs to be amended to provide the authorisation for a registered health practitioner whose registration is endorsed by a national board with a scheduled medicines endorsement to prescribe, sell, supply or administer Schedule 4 and Schedule 8 prescription drugs. The registered health practitioner could only prescribe the prescription drugs or classes of prescription drugs specified in the endorsement. This would allow a registered health practitioner whose registration is endorsed with a scheduled medicines endorsement to practise within the full scope of the endorsement and provide consistency if they move from one jurisdiction to another. Patients of registered health practitioners who are practising within the parameters of the scheduled medicines endorsement would not need to consult a medical practitioner to obtain a prescription.

Proposed amendments

Amendments to sections 18 and 18A of the Controlled Substances Act are proposed to specify the persons who can prescribe Schedule 4 and Schedule 8 prescription drugs.

In the case of Schedule 4 and Schedule 8 prescription drugs this would be a registered health practitioner who is acting in the ordinary course of their profession and is:

(a) a dentist, medical practitioner or nurse practitioner; or

(b) a practitioner whose registration is endorsed under section 94 of the HPRNL Act as being qualified to prescribe a scheduled medicine or class of scheduled medicines and the drug is a scheduled medicine or of a class of scheduled medicines specified in the endorsement; or

(c) a practitioner who is authorised to prescribe the drug by the Regulations.

A person licensed to do so by the Minister would be authorised to prescribe a Schedule 4 prescription drug.

A veterinary surgeon acting in the ordinary course of their profession would be permitted to prescribe a Schedule 4 or Schedule 8 prescription drug for an animal.

There would no longer be reference to a member of a prescribed profession acting in the ordinary course of their profession. The registered health practitioners who are currently members of a prescribed profession that is authorised to prescribe prescription drugs, for example optometrists and podiatric surgeons, would have their registration endorsed with a scheduled medicines endorsement. These practitioners would be authorised to prescribe the prescription drugs specified in the scheduled medicines endorsement.

Regulations under the Controlled Substances Act would enable limits to be placed on the range of drugs that a registered health practitioner or veterinary surgeon, acting in the ordinary course of their profession, can prescribe, manufacture, pack, sell, supply, administer or possess.

If the scheduled medicines that the registered health practitioners are qualified to prescribe, sell, supply or administer are specified in the national board's registration standard or guidelines for the scheduled medicines endorsement, it is intended that a health practitioner whose registration is endorsed would be authorised to prescribe, sell, supply or administer this range of drugs. This approach would promote national consistency and help ensure that registered health practitioners can practise to the full extent that they are qualified.

A pharmacist would be able to sell or supply a prescription drug when dispensing a prescription written by a person who is authorised to prescribe the drug. This would take account of the range of persons who are authorised to prescribe prescription drugs.

The Bill includes a new offence of prescribing a Schedule 8 prescription drug without authority. The maximum penalty for this offence is imprisonment for 2 years or $10 000. This is consistent with the penalty for the existing offence of prescribing a Schedule 4 prescription drug without authority.

All registered health practitioners would be subject to the same exemptions and controls when they manufacture, prescribe, supply or administer poisons. Amendments to sections 13 and 15 of the Controlled Substances Act will help achieve this outcome.

Prescribing by midwives and nurse practitioners

Under a Commonwealth Budget measure, eligible midwives and nurse practitioners are able to access prescribing arrangements under the Pharmaceutical Benefits Scheme (PBS) from 1 November 2010. Midwives and nurse practitioners who prescribe medicines under the PBS need to be in a collaborative arrangement with a medical practitioner. Patients of these eligible midwives and nurse practitioners will be able to obtain subsidised medicines. This is part of the National Improving Maternity Services Budget Package. It will give women more choice in maternity care.

The Controlled Substances Act as it currently stands presents a barrier to prescribing of Schedule 8 prescription drugs by nurse practitioners and Schedule 4 and Schedule 8 prescription drugs by midwives.

Currently, nurses acting in the ordinary course of their profession are permitted to prescribe Schedule 4, but not Schedule 8 prescription drugs. It is considered to be in the ordinary course for a nurse who is a nurse practitioner to prescribe Schedule 4 prescription drugs. Midwives cannot prescribe either Schedule 4 or Schedule 8 prescription drugs.

A nurse whose registration is endorsed as a nurse practitioner must have experience in advanced nursing practice and complete a master's degree approved by the Nursing and Midwifery Board of Australia. The amendments to sections 18 and 18A of the Act would authorise a nurse whose registration is endorsed as a nurse practitioner to prescribe Schedule 4 and Schedule 8 prescription drugs.

The Nursing and Midwifery Board of Australia has published a registration standard for a scheduled medicines endorsement for midwives. The amendments to sections 18 and 18A of the Controlled Substances Act that take account of national registration would authorise a midwife whose registration is endorsed with a scheduled medicines endorsement to prescribe Schedule 4 and Schedule 8 prescription drugs.

The Nursing and Midwifery Board of Australia has not as yet, published a list of scheduled medicines applicable to the registration standard for endorsement for scheduled medicines for midwives. A midwife whose registration is endorsed with a scheduled medicines endorsement would be restricted to prescribing a limited list of Schedule 4 and Schedule 8 prescription drugs, which would be specified in the Regulations under the Controlled Substances Act. These are the drugs that the Pharmaceutical Benefits Advisory Committee has determined are appropriate for an eligible midwife to prescribe, for example antibiotics and analgesics. Most other jurisdictions are taking a similar approach in limiting the range of drugs that midwives would be authorised to prescribe.

Applying the Commonwealth Therapeutic Goods Act as a law of South Australia

Background

The objective of the Therapeutic Goods Act is to provide a national framework for the regulation of therapeutic goods in Australia to:

ensure the quality, safety and efficacy of medicines

ensure the quality, safety and performance of medical devices.

Therapeutic goods must be entered on the Australian Register of Therapeutic Goods before they can be supplied in Australia, unless exempt. The Therapeutic Goods Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods. Australian manufacturers of medicines must be licensed under Part 3-3 of the Therapeutic Goods Act, unless exempt and their manufacturing processes must comply with the principles of Good Manufacturing Practice.

The Commonwealth Therapeutic Goods Administration is responsible for administering the legislation, and also carries out a range of assessment and monitoring activities to ensure the therapeutic goods available in Australia are of an acceptable standard.

The Therapeutic Goods Act applies to foreign and trading corporations and persons who are engaged in interstate or overseas trade. It does not apply to an individual or an unincorporated body that trades only within South Australia. Applying the Therapeutic Goods Act as a law of South Australia would cover this gap in regulation.

Adoption of legislation complementary to the Therapeutic Goods Act by all States and Territories would enable a more unified system of controls to ensure medicines and medical devices that have the potential to affect public health are of appropriate quality, safety and efficacy. In June 2005, the Council of Australian Governments endorsed the Australian Health Ministers Advisory Council (AHMAC) Working Party response to the Review of Drugs, Poisons and Controlled Substances Legislation (the Galbally Review). The AHMAC Working Party accepted recommendation 23 of the Galbally Review. The recommendation was 'that all Commonwealth, State and Territory jurisdictions agree that all States and Territories adopt the Therapeutic Goods Act by reference into the relevant legislation'.

New South Wales, Tasmania and the Australian Capital Territory have adopted the Therapeutic Goods Act by an 'application of laws' approach. Other States and Territories are in the process of making the appropriate amendments to their drug and poisons legislation. Victoria attempted a corresponding law approach to applying the Therapeutic Goods Act. However, it was impractical to keep the Victorian Act consistent with the Commonwealth Act. This caused difficulties for the Commonwealth in enforcement. The Therapeutic Goods (Victoria) Act 2010, which adopts the Commonwealth Act by an 'application of laws' approach will come into operation on 1 February 2011. The States and Territories that have completed the appropriate amendments have copied the provisions under Part 4A of the New South Wales Poisons and Therapeutic Goods Act 1966 into the relevant drug and poisons legislation, in the case of the Australian Capital Territory, or into a separate Act in the case of Tasmania and Victoria.

Proposed amendments

A new Part 2A, based on the provisions under Part 4A of the New South Wales Poisons and Therapeutic Goods Act 1966, is proposed to be included in the Controlled Substances Act to apply the Therapeutic Goods Act as a law of South Australia.

The effect of the new provisions are that:

The Commonwealth therapeutic goods laws, as in force for the time being, apply as a law of South Australia, subject to any modification by the South Australian Regulations.

The South Australian Act is to be interpreted in accordance with the Commonwealth Acts Interpretation Act 1901 to the exclusion of the South Australian Acts Interpretation Act 1915.

The Commonwealth Minister, the head of the Commonwealth Department and authorised persons, authorised officers or official analysts appointed under the Commonwealth Act have the same powers and functions under the South Australian Act as they have under the Commonwealth therapeutic goods laws.

Delegations by the Commonwealth Minister or the head of the Commonwealth Department (the Commonwealth Secretary) extend to the South Australian Act.

An appointment under the Commonwealth therapeutic goods laws is taken to extend to the South Australian law.

An offence against the South Australian Act is to be treated as if it were an offence against the Commonwealth laws.

Administrative appeal rights have been conferred upon the District Court of South Australia rather than the Commonwealth Administrative Appeals Tribunal.

A person who is guilty of an offence against both the Commonwealth therapeutic goods laws and the South Australian law cannot be punished twice for the same conduct.

If any specific State issues arise in relation to applying the Commonwealth therapeutic goods legislation, as a law of South Australia, there is provision for the South Australian law to be modified by the Regulation.

Applying the Commonwealth Therapeutic Goods Act as a law of South Australia would address the current gap in regulation of therapeutic goods. This would help ensure that the therapeutic goods available to South Australians are safe, effective and of appropriate quality.

Controls over the sale or supply of the poisons, medicines and medical devices that would be permitted to be sold via automatic vending machine

Background

Currently, section 26A of the Drugs Act 1908 is relied on to prohibit the sale or supply of drugs and medicines via automatic vending machine. The definition of a drug in the Drugs Act 1908 is out-of-date and includes items such as soap, deodorants and cosmetics.

The Galbally Review recommended that:

there should be a prohibition on the sale of scheduled medicines from vending machines

there should be provisions that permit the supply of packs containing no more than two adult doses of unscheduled medicines from vending machines provided the machines are presented and located in a way that makes unsupervised access by children unlikely.

Section 20 of the Controlled Substances Act prohibits the sale or supply of poisons, therapeutic substances and therapeutic devices via an automatic vending machine. There is provision for some poisons, therapeutic substances and therapeutic devices, to be permitted to be sold via automatic vending machine if specified in the Regulations. Section 20 has not been brought into operation as there is no power to put conditions on the installation and operation of vending machines. Accordingly, the Controlled Substances Act needs to be amended to provide the power to put conditions on the operation and installation of automatic vending machines.

The terms 'therapeutic substances' and 'therapeutic devices' are currently used in the Controlled Substances Act. These terms and their definitions do not reflect the contemporary definitions and terminology. The terms 'medicines' and 'medical devices' are used in the Therapeutic Goods Act and so it is proposed to adopt these terms and repeal references to 'therapeutic substances' and 'therapeutic devices'.

Proposed amendments

Section 20(2) of the Controlled Substances Act would be amended to include the power to specify in the Regulations the circumstances in which the sale or supply of poisons, medicines and medical devices via automatic vending machine would be permitted. Section 63 of the Controlled Substances Act would be amended to provide the power to regulate the installation or operation of an automatic vending machine and the sale or supply of the poisons, medicines and medical devices which would be permitted to be sold via automatic vending machine to protect public health or safety.

Section 20 of the Controlled Substances Act would be brought into operation and the Drugs Act 1908 would be repealed. The poisons, medicines and medical devices that would be permitted to be sold via automatic vending machine and the conditions applying to such sale would be specified in the Regulations. The products that are currently sold via automatic vending machine would still be able to be sold. Some additional products, including soaps and cosmetics, would be permitted to be sold via automatic vending machine.

The poisons, medicines and medical devices that would be permitted to be sold via automatic vending machine are:

(a) Condoms with or without spermicide or viricide

(b) Lubricant with or without spermicide or viricide

(c) Injecting equipment with the condition that the site and location of the vending machine must be approved by the Minister

(d) Unscheduled medicines with the conditions that they are:

supplied in the original unopened pack as supplied by the manufacturer

in packs that contain not more than two adult doses of the medicine

the vending machine must be presented and located in a way that makes unsupervised access by children unlikely.

(e) Car wash operators would be permitted to sell Schedule 5 poisons with the condition that appropriate first aid instructions, safety directions and warning statements are displayed at the car wash facility.

Tampons and sanitary pads do not meet the definition of a medical device. These items could be sold via automatic vending machines.

Unscheduled medicines are medicines which can be sold by general retail outlets, for example, paracetamol tablets. The sale of packs of paracetamol tablets via automatic vending machine would be limited to packs of 4 tablets (two adult doses). The medicines would be required to be appropriately packaged and labelled.

Sale of condoms and lubricant via automatic vending machine enables access to these items when other retail outlets are not open or easily accessible. This has benefits in reducing unwanted pregnancies and the spread of sexually transmitted infections.

Pharmacists, medical practitioners or persons acting in the course of a declared health risk minimisation program are permitted to sell needles and syringes to injecting drugs users. A trial of sale of injecting equipment from an automatic vending machine at four Clean Needle Program sites has shown promising results. Supply via automatic vending machine would help address significant gaps in current Clean Needle Program service delivery; to increase access to sterile injecting equipment across the State (particularly after-hours and on weekends); and to augment existing staffed Clean Needle Program sites. The site and location of the automatic vending machine would have to be approved by the Minister. This would ensure that the machines are appropriately sited, for example, within an existing Clean Needle Program. Locating a vending machine at such a site would enable injecting drugs users who were previously unwilling to engage with a Clean Needle Program to access injecting equipment. Making access to needles and syringes easier for injecting drug users has public health benefits in helping reduce the spread of blood borne diseases.

Some car wash facilities currently sell alkaline cleaning solutions which are Schedule 5 poisons via vending machine. Schedule 5 poisons are also available for sale in a wide range of retail outlets. The car wash facilities would be required to display the first aid information, safety directions and warning statements that are on the packs of these products when they are sold at retail outlets. This would reduce the risk associated with supply of the solutions at these facilities.

Other Miscellaneous Proposed Amendments

The Bill includes some miscellaneous amendments to the Controlled Substances Act. These amendments generally enhance administration of the Controlled Substances Act and take account of current terminology and drafting style.

References to therapeutic substances and therapeutic devices

There are references throughout the Controlled Substances Act to 'therapeutic substances' and 'therapeutic devices'. This is not the current terminology and is not consistent with the Therapeutic Goods Act and would be amended to use the words 'medicines' and 'medical devices' for consistency.

Manufacture and packing of Schedule 4 prescription drugs (section 13)

The offence in relation to manufacture and packing of Schedule 4 prescription drugs would be under section 18. The penalty for the offence would be consistent with that applying to the other offences in relation to Schedule 4 prescription drugs.

Sale by wholesale of Schedule 4 prescription drugs (section 14)

The offence in relation to sale by wholesale of Schedule 4 prescription drugs would be under section 18. The penalty for the offence would be consistent with that applying to the other offences in relation to Schedule 4 prescription drugs.

Sale of certain precursors (section 17B, section 17C)

Sections 17B and 17C would be amended to take account of the range of registered health practitioners who are authorised to sell, supply and administer poisons for therapeutic use. There would be reference to sale to a registered health practitioner or veterinary surgeon acting in the ordinary course of their profession.

Additional requirements for supply or administration of prescribed prescription drugs (section 18(2))

Section 18(2) specifies that a member of a profession must not supply or administer a prescribed prescription drug unless they hold prescribed qualifications. Regulation 29 of the Controlled Substances (Poisons) Regulations 1996 details the additional requirements for the prescribed prescription drugs listed in Schedule K of the Regulations. Section 18(2) would be amended to better reflect Regulation 29. There would be reference to prescribing, as well as supply or administration, and to meeting the qualifications or requirements specified in the Regulations.

Issuing a temporary authority for supply of a drug of dependence (section 18A)

In the case of an emergency, the Minister may issue a temporary authority to a person to prescribe or supply a drug of dependence (Schedule 8 prescription drug) for a person. It would be clarified that a temporary authority can only be issued to a registered health practitioner who is authorised under the Controlled Substances Act to prescribe a drug of dependence.

Prohibiting the advertising of controlled drugs (s28)

Section 28 provides the ability to prohibit the advertising of those poisons, therapeutic devices and therapeutic substances specified in the Regulations.

The National Standard for the Uniform Scheduling of Medicines and Poisons recommends that the States and Territories prohibit the advertising of Schedule 9 poisons. Schedule 9 poisons include heroin, ecstasy and cannabis.

Schedule 9 poisons are not declared as poisons under the Controlled Substances legislation. Schedule 9 poisons are listed in Part 1 of Schedule 1 of the Controlled Substances (General) Regulations 2000 as controlled drugs other than drugs of dependence.

Section 28 would be amended to provide the ability to prohibit the advertising of controlled drugs.

Exception from the Part 5 offences relating to controlled drugs, precursors and plants (section 31)

Part 5 of the Controlled Substances Act includes the serious drug offences provisions relating to controlled drugs, plants and precursors. Section 31 provides an exception from these Part 5 offences for specified health professionals or veterinary surgeons who sell, manufacture, supply, administer or possess any substance when acting in the ordinary course of their profession. This would include substances that are not poisons, for example heroin or ecstasy. The exception should only apply to the substances and activities that registered health practitioners or veterinary surgeons are authorised to undertake under the Controlled Substances Act. Section 31 would be amended to clarify that the scope of the exception for a registered health practitioner or veterinary surgeon is limited to the sale, manufacture, supply, administration or possession of a poison.

Authorised officers (section 50)

The Minister may appoint authorised officers for the purposes of the Controlled Substances Act. The Minister must provide an authorised officer who is not a police officer, a certificate of identification in the prescribed form. The form of the certificate of identification is a matter for the Minister. Section 50 would be amended to remove the reference to 'in the prescribed form'.

Entry under warrant (section 52)

Section 52 would be amended to refer to a warrant issued by a senior police officer, magistrate or a justice. This is more specific and takes account of current terminology. The exception where a warrant is not required would be broadened to cover entry to premises that are used by a registered health practitioner or veterinary surgeon in the course of their profession. This would take account of the range of registered health practitioners who might be authorised to prescribe, supply, possess or administer poisons.

Ministerial power to issue warnings (section 57A)

Section 57A would be amended to refer to the Minister only being able to take action in relation to a device, if the device is a medical device or is a device that the Minister is satisfied is or may be used, or designed to be used, as a medical device. This would reflect the current terminology and definition of a medical device.

Ministerial power to publish information (section 58)

Section 58 would be amended to permit the Minister to publish information to registered health practitioners. This would take account of the range of registered health practitioners who might be authorised to prescribe, supply or administer poisons.

Ministerial power to certain information to be given (section 60)

Section 60 would be amended to refer to the Minister requiring information from a registered health practitioner. This would take account of the range of health practitioners who might be authorised to prescribe, supply or administer prescription drugs.

I commend the Bill to members.

Explanation of Clauses

Part 1—Preliminary

1—Short title

2—Commencement

3—Amendment provisions

These clauses are formal.

Part 2—Amendment of Controlled Substances Act 1984

4—Amendment of long title

The long title is adjusted to refer to the application of the Commonwealth therapeutic goods laws as a law of South Australia and to new terminology to reflect those applied provisions.

5—Amendment of section 4—Interpretation

New definitions are added to support the applied provisions and other amendments relating to the Health Practitioner Regulation National Law. Therapeutic substances is replaced with medicines and therapeutic devices with medical devices, in line with the Commonwealth therapeutic goods laws. New definitions of midwife, nurse practitioner and registered health practitioner are added.

6—Insertion of Part 2A

New Part 2A applies the Commonwealth therapeutic goods laws as a law of South Australia. It is based on similar provisions in New South Wales, Victoria and Tasmania. However, in South Australia, a reference to the Administrative Appeals Tribunal is converted to a reference to the Administrative and Disciplinary Division of the District Court and a reference to the Federal Court is converted to a reference to the District Court. New section 11L provides that the District Court may sit with assessors. New section 11A(4) provides that to the extent of any inconsistency between the applied provisions and the Act, the applied provisions prevail.

7—Amendment of section 12—Declaration of poisons, prescription drugs, drugs of dependence, controlled drugs etc

These amendments are consequential on relying on the meaning of medicine and medical device in the applied provisions rather than on a declaration by the Governor of therapeutic substances and devices. The amendments to the following provisions of the Act are consequential on this approach: sections 13(1) and (2), 14(1) and (2), 15(1) and (3), 20, 23, 24, 26, 27, 28, 29, 52(4), 53(2), 56, 57A, 58(1) and 63.

8—Amendment of section 13—Manufacture and packing

Prescription drugs are now to be dealt with exhaustively in section 18 and so the application of sections 13, 14 and 15 to prescription drugs is excluded. This approach will apply the same more significant penalty to all actions involving prescription drugs.

The reference to medical practitioner, pharmacist or dentist is replaced with a reference to a registered health practitioner to recognise that if a practitioner manufactures or packs a poison etc. in the ordinary course of his or her profession the practitioner will not be committing an offence.

9—Amendment of section 14—Sale by wholesale

See clause 7.

10—Amendment of section 15—Sale or supply to end user

The reference to medical practitioner, pharmacist or dentist is replaced with a reference to a registered health practitioner to recognise that if a practitioner sells by retail or supplies to a person a poison etc. in the ordinary course of his or her profession the practitioner will not be committing an offence.

11—Amendment of section 17B—Storage and sale of certain precursors

The reference to medical practitioner, pharmacist, dentist or nurse is replaced with a reference to a registered health practitioner to recognise that if a practitioner sells or is sold a prepackaged section 17B precursor in the ordinary course of his or her profession the practitioner will not be committing an offence.

12—Amendment of section 17C—Regulation of sale of certain precursors

The reference to medical practitioner, pharmacist, dentist or nurse is replaced with a reference to a registered health practitioner to recognise that if a practitioner sells or is sold a prepackaged section 17C precursor in the ordinary course of his or her profession the practitioner will not be committing an offence.

13—Amendment of section 18—Regulation of prescription drugs

This section is reworked to cover all aspects of dealing with prescription drugs in the one provision and to spell out more precisely what each category of professional may do in relation to prescription drugs. It reflects the new endorsement scheme for health practitioner registration in the Health Practitioner Regulation National Law. It enables the regulations to manage how certain categories of health practitioners deal with prescription drugs as is contemplated at the national level. The authorisations for veterinary surgeons and pharmacists are continued. The Minister continues to be able to authorise activities through licences.

The definition of manufacture for the purposes of section 13 is applied for the purposes of section 18.

14—Amendment of section 18A—Restriction of prescription or supply of drug of dependence in certain circumstances

The section is modified to include an express prohibition on prescribing drugs of dependence except as set out in the provision by registered health practitioners and veterinary surgeons. Registered health practitioners may only prescribe if they are dentists, medical practitioners or nurse practitioners, hold a relevant national law endorsement or are authorised to do so by the regulations.

The amendment to subsection (6) clarifies that temporary authorities will only be given to registered health practitioners otherwise able to prescribe drugs of dependence.

15—Amendment of section 20—Prohibition of automatic vending machines

The amendment to section 20(2) provides a greater level of flexibility in framing the regulations.

16—Amendment of section 23—Quality

17—Amendment of section 24—Packaging and labelling

18—Amendment of section 25—Storage

19—Amendment of section 26—Transport

20—Amendment of section 27—Use

See clause 7.

21—Amendment of section 28—Prohibition of advertisement

This amendment enables the prohibition of advertisements to be extended to controlled drugs.

22—Amendment of section 29—Regulation of advertisement

See clause 7.

23—Amendment of section 31—Application of Part

The exemptions to the Part for registered health practitioners, veterinary surgeons and persons granted a licence or permit are reworked to reflect the new approach in section 18. National scheme endorsements of registered health practitioners are recognised.

24—Amendment of section 50—Authorised officers

This amendment removes the requirement for the regulations to set out the form of a certificate of identification for an authorised officer. This is a matter left to the Minister in a modern drafting approach.

25—Amendment of section 52—Power to search, seize, etc

The references to officers of police and special magistrates are updated to senior police officer and magistrate. The reference to medical practitioner, pharmacist and dentist is broadened to cover all registered health practitioners as a consequence of other amendments.

26—Amendment of section 53—Analysis

27—Amendment of section 56—Permits for research etc

28—Amendment of section 57A—Warnings

See clause 7.

29—Amendment of section 58—Publication of information

The reference to medical practitioner, pharmacist and dentist is broadened to cover all registered health practitioners to reflect the other amendments.

30—Amendment of section 60—Minister may require certain information to be given

The reference to medical practitioner, pharmacist, dentist and nurse is broadened to cover all registered health practitioners to reflect the other amendments.

31—Amendment of section 63—Regulations

The regulation making power is modified to make it clear that the regulations can deal with questions of the classes and term of licences and permits, provide exemptions that relate to the applied provisions and leave matters to the discretion of the Minister. A special regulation making power is included to make sure that where automatic vending machines for poisons, medicines or medical devices are allowed, the regulations can deal with questions of installation, sale, supply and operation of the machines.

Schedule 1—Statute law revision amendments of Controlled Substances Act 1984

The Schedule contains amendments of a statute law revision nature.

Debate adjourned on motion of the Hon. T.J. Stephens.