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PHARMACY REGULATION BILL 2010

           Pharmacy Regulation Bill 2010

                         Introduction Print

              EXPLANATORY MEMORANDUM


                                  General
The Pharmacy Regulation Bill 2010 provides for the regulation of pharmacy
businesses, pharmacy departments and pharmacy depots and establishes the
Victorian Pharmacy Authority.

                               Clause Notes

                      PART 1--PRELIMINARY
Clause 1     sets out the main purposes of the Act.
             As of 1 July 2010 a national scheme will operate in relation to
             10 health professions for the registration, accreditation and
             complaints functions currently performed in accordance with
             the Health Professions Registration Act 2005.
             One of those professions is pharmacy. As a result, the
             Pharmacy Board of Victoria (the Pharmacy Board) will no
             longer perform the registration, accreditation and complaints
             functions in relation to registered pharmacists after 1 July 2010.
             The Pharmacy Board currently performs a second role under the
             Health Professions Registration Act 2005 as the regulator of
             the operation of pharmacy businesses, pharmacy departments
             and pharmacy depots.
             This role will need to be performed by a new entity after the
             Pharmacy Board ceases to exist, which will occur on 1 July
             2010, or on a later date when this Bill comes into effect.
             This Bill establishes a new entity, the Victorian Pharmacy
             Authority, to take over the role of regulating pharmacies
             previously performed by the Pharmacy Board under the Health
             Professions Registration Act 2005. The Bill will provide for
             the future regulation of the operation of pharmacy businesses,
             pharmacy departments and pharmacy depots by the new entity.


561467                                1       BILL LA INTRODUCTION 5/5/2010

 


 

The Bill also makes a number of consequential amendments to the Health Professions Registration Act 2005 and other Acts. Clause 2 is a commencement provision. The provisions will come into effect on a day or days to be proclaimed, or on 1 July 2011 if not proclaimed before that date. Clause 3 provides a number of definitions. The definitions of pharmacy, pharmacy business, pharmacy department and pharmacy depot are the same as the definitions in the Health Professions Registration Act 2005. Clause 4 provides that the Act binds the Crown. PART 2--OWNERSHIP AND OPERATION Division 1--Requirements of ownership Clause 5 Subclause (1) specifies who may own or have a proprietary interest in a pharmacy business, including a registered pharmacist, a company owned and controlled by registered pharmacists and other companies who have the structure of a friendly society or mutual company. The clause sets out the types of companies that may own or have a proprietary interest in a pharmacy business. Subclause (2) provides that a registered pharmacist or a company owned and controlled by registered pharmacists must not own more that 5 separate pharmacy businesses. Subclause (3) and (4) make provision for the limitations on the ownership of pharmacy businesses by friendly society type companies. The clause clarifies that friendly society type companies are not for profit and any income or property that is derived from the corporation is returned to the benefit of its shareholders. The clause continues the existing requirements in the Health Professions Registration Act 2005. Those who do not fall within the categories specified in this clause will not be eligible to apply for a licence to operate a pharmacy business or pharmacy department. Subclause (5) provides that this includes registered pharmacists who hold provisional registration, which applies to newly qualified pharmacists in their first year of practice. 2

 


 

The clause makes it an offence for a person who does not fall within one of the categories specified in the section to own or have a proprietary interest in a pharmacy business. A penalty of 240 penalty units applies to a natural person and 1200 penalty units for a body corporate. Clause 6 makes an exception to the restrictions on ownership for executors and administrators to allow them to carry on a pharmacy business for a period of 6 months (or for any further period approved by the Authority) when a registered pharmacist dies or is bankrupt. Clause 7 requires friendly society type companies to inform the Authority within 30 days of specified changes to the company or to a company of which it is a wholly owned subsidiary. Clause 8 empowers the Authority to require a person who falls within the ownership categories specified in clause 5(1) to provide the Authority with any information and documents regarding the ownership of, or holding of a proprietary interest in, a pharmacy business. The required information and documents will enable the Authority to enforce the restrictions on pharmacy ownership specified in clause 5(1). While the clause requires a person to give information or documents to the Authority a protection against self- incrimination is provided in clause 78 in relation to a natural person. Clause 9 provides that it is an offence for a person to fail to inform the Authority as required by clause 7 or to provide the Authority with information or documents required by the Authority under clause 8. A protection against self-incrimination is provided in clause 78 in relation to natural persons. Clause 10 provides that each pharmacy business carried on at separate premises is to be treated as a separate pharmacy business for the purposes of this Bill. The premises of each separate pharmacy business will need to be registered, and an eligible person must be licensed to operate the pharmacy business at that premises. This means a chain of pharmacy businesses operating under the same name is not one business, but many separate pharmacy businesses, for the purposes of the Bill. Clause 11 prevents the use of commercial arrangements from removing control of a pharmacy business from the licensee. 3

 


 

Division 2--Caps on growth of pharmacy ownership Clause 12 defines own to include having a proprietary interest in a pharmacy business for the purposes of the operation of the cap on growth of ownership of pharmacy businesses. Clause 13 specifies the businesses to which the cap on growth of ownership in this Division applies. These are businesses carried on at premises approved or taken to be approved by the Pharmacy Board of Victoria under previous legislation and premises registered or taken to be registered by the Authority under this Bill. Clause 14 provides for the cap on pharmacy ownership for friendly society type companies. It provides that the companies referred to in clause 5(1)(c), (d) and (e) must not acquire ownership of any pharmacy business. A penalty of 1200 penalty units applies. Clause 15 makes provisions to preserve the status quo for companies that are currently limited to ownership of six pharmacy businesses, and for amalgamations of any friendly society type companies that occurred on or after 17 November 2008. The clause makes no change to the arrangements already in place under the Heath Professions Registration Act 2005. Clause 16 makes provisions to preserve the status quo for amalgamations of any friendly society type companies that occurred on or after 16 November 2004 and before 17 November 2008. The clause makes no change to the arrangements already in place under the Heath Professions Registration Act 2005. Clause 17 makes provision to preserve the status quo for amalgamations of companies referred to in clause 5(1)(e) that occurred on or after 17 November 2008. The clause makes no change to the arrangements already in place under the Heath Professions Registration Act 2005. Clause 18 provides that the number of pharmacy businesses owned by a company referred to in clause 5(1)(c) includes any pharmacy businesses owned by a wholly owned subsidiary of that company if the subsidiary was acquired or incorporated on or after 16 November 2004. Clause 19 provides that for the purpose of calculating the total number of pharmacy businesses owned by a company clause 15(b), 16 or 17, the total number of pharmacy businesses must be rounded up to the whole next number. 4

 


 

Division 3--Requirements of establishment and operation Clause 20 provides that a person who intends to establish or carry on a pharmacy business must notify the Victorian Pharmacy Authority as soon as is practicable. Clause 21 makes it an offence for a person to establish or carry on a pharmacy business unless the person is eligible to do so under the requirements in clause 5, and if the Authority has registered the premises at which the person will conduct the pharmacy business, and if the person has been granted a licence to carry on the pharmacy business at those premises. A penalty of 240 penalty units for a natural person and 1200 penalty units for a body corporate applies. Executors and administrators as described in clause 6 are excluded. Clause 22 provides for the establishment of a pharmacy department. A person cannot establish a pharmacy department unless the person is a registered funded agency (this includes public hospitals), registered community health centre, privately operated or private hospital within the meaning of the Health Services Act 1988 acting in accordance with that Act. The premises of the pharmacy department must be registered by the Victorian Pharmacy Authority, and the Victorian Pharmacy Authority must have granted a licence to the person to carry on the pharmacy department at the registered premises. It is an offence to contravene these requirements. A penalty of 240 penalty units for a natural person and 1200 penalty units for a body corporate applies. Clause 23 provides for the establishment of a pharmacy depot. A pharmacy depot is defined in clause 3 as premises where written prescriptions for the supply, compounding or dispensing of medicines may be left for a pharmacist, or where medicines supplied, compounded or dispensed by a registered pharmacist may be left for collection by or on behalf of the person to whom they are addressed. It is an offence for a person to establish a pharmacy depot if a person is not a licensee under this Bill and if the Authority has not registered the premises of the pharmacy depot. A penalty of 60 penalty units applies. 5

 


 

Clause 24 provides that a licensee must not authorise, cause or permit anyone to carry on a business or activity at the registered premises of the licensee unless it is permitted by the licence or approved by the Victorian Pharmacy Authority. A penalty of 60 penalty units applies. Clause 25 requires the licensee of a pharmacy business to notify the Victorian Pharmacy Authority as soon as is practicable and at least 14 days before the licensee ceases to carry on the pharmacy business. A penalty of 10 penalty units applies. Clause 26 requires the licensee carrying on a pharmacy department to notify the Victorian Pharmacy Authority within at least 14 days before the pharmacy department closes. A penalty of 10 penalty units applies. Clause 27 requires a licensee that is a company to notify the Victorian Pharmacy Authority within 14 days of changes to the shareholding, directorships of office bearers of the licensee. A penalty of 10 penalty units applies. Clause 28 requires a registered pharmacist to notify the Victorian Pharmacy Authority of the address of a pharmacy or pharmacy department within 14 days of the pharmacist commencing to supply, compound or dispense medicines from that premises, unless the registered pharmacist and the Victorian Pharmacy Authority have agreed on another arrangement. Clause 29 provides that a registered pharmacist may only supply, compound or dispense medicines from the premises of a registered pharmacy business or pharmacy department or in other circumstances approved by the Victorian Pharmacy Authority. Subclause (2) provides that a registered pharmacist providing pharmacy services from a registered pharmacy business or pharmacy department must not allow any person to supply, compound or dispense medicines except under the supervision of the registered pharmacist. Clause 30 provides that a pharmacy or pharmacy department must be personally supervised by a registered pharmacist at all times it is open for business. Subclause (2) makes it an offence for certain persons to knowingly allow a pharmacy service to be provided at a pharmacy or pharmacy department unsupervised by a registered pharmacist. 6

 


 

Subclause (3) defines personally supervised by a registered pharmacist to mean personally supervised by a registered pharmacist who is present at the pharmacy or pharmacy department. Clause 31 provides that the registered pharmacist regularly and usually in charge of a pharmacy and the person licensed to carry on the pharmacy business must not allow another person to have access to the pharmacy when it is not open for business unless a registered pharmacist is present. A penalty of 60 penalty units applies. Subclause (2) provides that the registered pharmacist regularly and usually in charge of a pharmacy department and the person licensed to carry on the pharmacy department must not allow another person to have access to the pharmacy department when it is not open for business unless a registered pharmacist is present. A penalty of 60 penalty units applies. Clause 32 provides that a registered pharmacist must take reasonable steps to ensure that the dispensing of medication in accordance with a prescription or order is consistent with the safety of the person named in the prescription or order. The registered pharmacists must also keep a record of every prescription supplied, compounded or dispensed in accordance with subclause (3). Subclause (3) sets out the information that must be contained within the prescription. Subclause (4) sets out the requirements for keeping a record of the prescription. Clause 33 sets out matters concerning security which the operator of a pharmacy depot must adhere to. In particular, the operator must keep secure medicines left for collection at the depot as well as prescription and client records. Division 4--Use of title offences Clause 34 provides that a person must not intentionally or recklessly use the title "pharmacy", "pharmacy practice" or "pharmacy business" except in relation to a pharmacy or pharmacy business licensed to operate under clause 38. A penalty of 60 penalty units for a natural person and 300 penalty units for a body corporate applies. Subclause (2) provides a list of circumstances in which the prohibition on subclause (1) does not apply. 7

 


 

Clause 35 provides that despite the protection of title provisions in the Health Practitioner Regulation National Law it is not an offence for a person to use the name or title "pharmacist" or to use a name or title, in respect of a pharmacy business, where a person is licensed under clause 38 to carry on a pharmacy business, if the pharmacy services are provided by or under the supervision of a registered pharmacist. Subclause (2) provides that a registered pharmacist who carries on a pharmacy business but does not personally provide pharmacy services from the pharmacy is not to be treated for the purpose of the Health Practitioner Regulation National Law as practising as a pharmacist in respect of that pharmacy business. This clause allows for the name of a pharmacist to be used in a banner title for a number of pharmacies without an offence being committed. PART 3--LICENSING AND REGISTRATION Division 1--Licensing Clause 36 provides that an eligible person may apply to the Victorian Pharmacy Authority for a licence to carry on a pharmacy business or pharmacy department. Subclause (2) sets out the requirements for a licence application. A fee fixed by the Victorian Pharmacy Authority is payable. Subclause (3) sets out that a fee may apply on a pro rata basis. Clause 37 sets out who is eligible to apply for a licence to carry on a pharmacy business. An applicant must satisfy the ownership requirements in clause 5 and must be in compliance with the cap on ownership contained in Division 2 of Part 2. Subclause (2) sets out who is eligible to apply for a licence to carry on a pharmacy department. These are a registered funded agency (which includes public hospitals), a registered community health centre or a private or privately-operated hospital within the meaning of the Health Services Act 1988, acting in accordance with that Act. Clause 38 sets out when the Victorian Pharmacy Authority may grant a licence. The Authority must be satisfied that the applicant is eligible to be granted a licence, and that the facilities, equipment, security, management and operation of the 8

 


 

pharmacy business or pharmacy department meet the requirements set out in the clause and the Schedule to the Bill. Subclause (2) sets out further matters to which the Victorian Pharmacy Authority may have regard when considering whether to grant a licence. Subclause (3) provides that the Victorian Pharmacy Authority must consult with the Secretary to the Department of Health before granting a licence to a registered funded agency to carry on a pharmacy department. Clause 39 sets out the grounds on which the Victorian Pharmacy Authority may refuse a licence. These grounds include that the applicant has previously failed to carry out a pharmacy business or pharmacy department in accordance with the Bill or with the conditions of another licence or registration granted by the Authority. Clause 40 provides that the Victorian Pharmacy Authority may grant a licence subject to any conditions it considers appropriate, and may place conditions on a licence at the time of application, during the period of the licence, or at renewal of the licence. The clause provides that notice must be given to the licensee 28 days before imposing a condition without consent during the licence period. Conditions to which a licence is subject must be set out on the licence. Clause 41 provides that the Victorian Pharmacy Authority must give written notice of its decision on an application for a licence, and if the decision is to refuse the application, must also set out the reasons for the decision. Clause 42 provides that a licence ends on 30 June next after the date on which it is granted. It is intended that a licence will be renewable annually. Clause 43 provides that an application to renew a licence must be made before 1 July each year and will be subject to a fee fixed by the Victorian Pharmacy Authority. The clause sets out the requirements for a renewal application. Division 2--Registration of premises Clause 44 provides that a person who is eligible to be granted a licence under Division 1 to carry on a pharmacy business or pharmacy department may apply to the Victorian Pharmacy Authority to register the premises for the pharmacy business or pharmacy department. The application for registration of premises may be 9

 


 

made at the same time as application for a licence to carry on a pharmacy business or pharmacy department at the premises. Subclause (2) sets out the requirements for a registration application. A fee fixed by the Victorian Pharmacy Authority is payable. Clause 45 sets out the matters of which the Victorian Pharmacy Authority must be satisfied to register the premises. These include that the applicant is eligible for a licence to carry on a pharmacy business or pharmacy department and that the premises are suitable for the provision of pharmacy services and meet the requirements that relate to premises set out in the Schedule. Subclause (2) provides that the Victorian Pharmacy Authority must consult with the Secretary to the Department of Health before registering part of the premises of a registered funded agency as a pharmacy department. Clause 46 sets out the grounds on which the Victorian Pharmacy Authority may refuse an application for registration. These are similar to the grounds for refusing a licence. Subclause (2) provides that without limiting the matters to be considered as set out in clause 45, the Victorian Pharmacy Authority may refuse to register premises if the premises are freely accessible to persons from other premises where a business or a charity other than providing pharmacy services is carried out. Subclause (3) provides that the Victorian Pharmacy Authority must not refuse an application for registration on the ground that the Authority disapproves of the geographical location of the premises. Clause 47 provides that a person who is licensed to carry on a pharmacy business or pharmacy department may apply to the Victorian Pharmacy Authority to register a pharmacy depot. Subclause (2) sets out the requirements for a registration application. A fee fixed by the Victorian Pharmacy Authority is payable. Clause 48 sets out the matters of which the Victorian Pharmacy Authority must be satisfied to register a pharmacy depot. These include that the applicant is a licensee and the person who will operate the depot is over 18 years of age. 10

 


 

Clause 49 provides that the Victorian Pharmacy Authority may register the premises of a pharmacy business, pharmacy department or pharmacy depot subject to any conditions it considers appropriate, and may place conditions on the registration at the time of application, during the period of registration, or at renewal of the registration. The clause provides that notice must be given to the registration holder 28 days before imposing a condition without consent during the period of registration. Conditions to which the registration is subject must be set out on the registration. Clause 50 provides that the Victorian Pharmacy Authority must give written notice of its decision on an application for registration, and if the decision is to refuse the application, must also set out the reasons for the decision. Clause 51 provides that a registration ends on 30 June next after the date on which it is granted. It is intended that registration will be renewable annually. Clause 52 provides that an application to renew registration of a pharmacy business, pharmacy department or pharmacy depot must be made before 1 July each year and will be subject to a fee fixed by the Victorian Pharmacy Authority. The clause sets out the requirements for a renewal application. Division 3--Investigations Clause 53 provides that a person may notify the Victorian Pharmacy Authority about any matter relating to a licensee if the notifying person believes it indicates that the licensee's ability to carry on a pharmacy business may be affected, among other things, because of a physical or mental health issue of the licensee. The notifying person may also believe that the licensee has contravened an Authority standard or this Bill, or that the licence was or may have been improperly obtained or that other circumstances set out in subclause (1) exist. Subclause (2) provides that a person may notify the Victorian Pharmacy Authority about any matter relating to the holder of a registration if the notifying person believes that it indicates that the registered premises do meet the statutory requirements, or that the holder may have contravened a condition of a licence or registration, or that the registration was or may have been improperly obtained. 11

 


 

Clause 54 provides that the Victorian Pharmacy Authority may investigate a matter relating to a licence or registration without notification if there is evidence of any of the matters set out in clause 53. Division 4--Revocation of a licence or registration Clause 55 sets out the grounds on which a licence may be revoked. These include grounds such as that the licensee is no longer eligible or has been convicted of an offence against the Bill or the regulations, and grounds such as that the premises of the pharmacy business are no longer suitable or are unhygienic, or there has been a failure of good pharmaceutical practice at the premises that presents a risk to public health or safety. Clause 56 sets out the grounds for revocation of registration. These are largely the same as those for revocation of a licence. Clause 57 provides that the Victorian Pharmacy Authority may convene a panel to hear a matter that has been the subject of an investigation under Division 3 of Part 3. Subclause (2) provides that a panel may be made up of 3 members of the Authority or two members of the Authority and one person with suitable expertise co-opted onto the panel for the purposes of the hearing. In either case, two members of the panel must be registered pharmacists. Subclause (3) provides for the allowances to which a person co-opted on to a panel is entitled. Clause 58 sets out the procedure for a panel hearing. Clause 59 provides that a panel may decide that a condition be placed on a licence or registration, or that a licence or registration continue or be revoked. The panel may also decide to caution or reprimand a licensee or registration holder. Clause 60 provides that if the Victorian Pharmacy Authority decides to revoke a licence or registration without referring the matter to a panel, the Authority must give written notice to the licensee or holder of the registration. Subclause (2) sets out the requirements for the notice to be given, which must be at least 28 days before the revocation of the licence or registration. Subclause (3) sets out the matters to be taken into consideration by the Victorian Pharmacy Authority in determining whether to give such notice. 12

 


 

Subclause (4) provides that the Victorian Pharmacy Authority may revoke a licence or registration immediately without giving notice if it believes it is necessary to do so to reduce or prevent a serious risk to public health and safety. Clause 61 provides that the Victorian Pharmacy Authority may also caution or reprimand a licensee or the holder of a registration if it considers it appropriate to do so. Division 5--VCAT review Clause 62 provides that a person affected by a decision of the Victorian Pharmacy Authority to impose conditions on a licence or registration, to refuse to grant a licence or registration, or to revoke a licence or registration may apply to the Victorian Civil and Administrative Tribunal for review of the decision. Subclause (2) provides that the application to VCAT must be made within 28 days after the date on which the person concerned received notice of the decision and the reasons for it. Subclause (3) provides that the Victorian Pharmacy Authority must publish a notice of the finding or determination of a review by VCAT on the Authority's Internet site. Subclause (4) provides that the Victorian Pharmacy Authority must notify any person notified of the original decision of the Authority of the decision on review. Division 6--Public register Clause 63 provides that the Victorian Pharmacy Authority must keep a public register of all licensees and all registered premises of pharmacy businesses, pharmacy departments and pharmacy depots and sets out the particulars that must be included on the register. The Authority may publish the register on the Authority's Internet site. The Authority may also publish on the Internet site a separate list of persons who have had a licence or registration revoked. PART 4--ENFORCEMENT Clause 64 provides that the Victorian Pharmacy Authority may authorise the registrar or other employee of the Authority to take proceedings under the Bill. Subclause (2) provides that any proceeding instituted in the name of the Victorian Pharmacy Authority must be taken to 13

 


 

have been instituted by the Authority in the absence of evidence to the contrary. Clause 65 provides that the Victorian Pharmacy Authority may authorise the registrar or other employee of the Authority, or a person engaged to provide services to the Authority, to carry out functions and exercise powers under Part 4 This will enable the Authority to use the services of an investigator or other qualified person such as a forensic accountant, to conduct an investigation in appropriate cases. Subclause (2) provides that only the registrar or other employee of the Victorian Pharmacy Authority may exercise the special powers of entry exercised under section 68. Clause 66 provides that the Victorian Pharmacy Authority must issue an identity card to each person authorised by it under section 66. Subsection (2) provides that an authorised person must produce his or her identity card for inspection before exercising a power under Part 4 (other than a requirement made by post) and at any time during the exercise of a power under Part 4 if asked to do so. Clause 67 provides that the Victorian Pharmacy Authority may require a registered pharmacist or a licensee to submit for examination at its offices any documents kept by the pharmacist or licensee in connection with the carrying on of the pharmacy business. Clause 68 sets out special powers of entry that may be exercised by the registrar or other employee of the Victorian Pharmacy Authority in order to ascertain whether the Bill and regulations are being complied with. An authorised person may only enter the premises of a pharmacy business, pharmacy department or pharmacy depot when the business, department or depot is open for business or providing pharmacy services. The authorised person may enter into the premises of a pharmacy business, pharmacy department or pharmacy depot or other place where medicines are being supplied, compounded or dispensed and may examine any room or part of the premises for the purpose of inspecting stocks of medicines and other goods, equipment, prescriptions or documents, and may make copies or extracts of the documents. 14

 


 

The clause provides that a person must not refuse or fail to admit an authorised person requesting to enter the premises under this section, or cause or permit such a refusal or failure to admit. Clause 69 provides that a copy of or extract from a document certified as correct by an authorised person is taken to be a true and correct copy or extract for the purposes of any hearing or review of a decision under this Bill. Clause 70 provides that a person appointed by the Victorian Pharmacy Authority to do so may apply to a magistrate for the issue of a search warrant in relation to particular premises if the person believes on reasonable grounds that there is or has been a contravention of the Bill or regulations on the premises, or that entry is necessary for the purpose of investigating a matter in a notification made under the Bill which if substantiated may provide grounds for the revocation of a licence or registration. Subclause (2) provides that if the magistrate is satisfied there are reasonable grounds the magistrate may issue a search warrant authorising the specified authorised person to-- · enter the premises or part of the premises named in the warrant; and · search for and seize a thing named or described in the warrant; and · bring the thing before the Magistrates' Court. Subclause (3) provides that the search warrant must be issued in accordance with the Magistrates' Court Act 1989. Subclause (4) sets out additional requirements for the search warrant. Subclause (5) provides that for the requirements to be observed with respect to search warrants mentioned in the Magistrates' Court Act 1989 apply to warrants issued under this section. Clause 71 requires a person before entering under a search warrant to announce that she or he is authorised to enter by the warrant. Announcement is not necessary if the person believes on reasonable grounds that immediate entry is required to ensure the safety of any person or the effective execution of the warrant. 15

 


 

Clause 72 requires that if an occupier or other person who apparently represents the occupier is present at the time of the execution of a search warrant the person executing the search warrant must produce their identity card and give the person a copy of the warrant. Clause 73 provides that if a document or other thing is seized under this Part, a copy of the document or other thing seized must be given to an occupier or other person from whom it was seized who requests a copy as soon as practicable after the seizure. If a copy is not provided a receipt must be provided. Clause 74 provides that if an authorised person retains possession of a document taken or seized from a person, the authorised person must give the person a certified copy of the document within 21 days of the seizure. Subsection (2) provides that a copy certified as correct under subsection (1) shall be received in all courts and tribunals to be evidence of equal validity to the original. Clause 75 provides that if an authorised person seizes a document or other thing under this Part he or she must take reasonable steps to return the document or other thing to the person from whom it was seized if the reason for the seizure no longer exists. Subclause (2) provides that if a document or other thing seized has not been returned within 3 months the authorised person must take reasonable steps to return it unless it is required for proceedings which have been commenced but not completed or unless the Magistrates' Court makes an order extending the period during which it may be retained. Clause 76 provides for application to the Magistrates' Court for extension by a maximum of 3 months at a time of the period for which an authorised officer may retain a seized document or other thing. The total period of retention must not exceed 12 months. Subclause (2) sets out the circumstances in which the Magistrates' Court may grant an extension. Subclause (3) provides that the owner of the seized document or other thing must be given at least 7 days' notice of the hearing of an application under this clause. Clause 77 makes it an offence for a person to refuse or fail to comply with a requirement of the Authority or an authorised person under Part 4 without a reasonable excuse. 16

 


 

Clause 78 provides that a person may refuse or fail to give information or do any other thing that the person is required to do by or under this Bill if the giving of the information or the doing of the thing would tend to incriminate the person. Subsection (2) provides that despite subsection (1) a person must not refuse or fail to produce a document that the person is required to produce by or under this Bill if the production of the document would tend to incriminate the person. Subsection (3) provides that if the person claims, before producing the document, it would tend to incriminate them, then it is not admissible in evidence against the person in criminal proceedings. Clause 79 makes it an offence for a person to provide false or misleading information to an authorised officer or to produce a document that the person knows is false or misleading in a material particular. A penalty of 60 penalty units applies. Clause 80 makes it an offence to hinder or obstruct an authorised person exercising a power under this Bill. A penalty of 60 penalty units applies. PART 5--VICTORIAN PHARMACY AUTHORITY Division 1--Establishment Clause 81 establishes the Victorian Pharmacy Authority as a body corporate with perpetual succession and outlines other features of the entity. Division 2--General powers and functions Clause 82 outlines the functions of the Victorian Pharmacy Authority including the functions of licensing persons to carry on a pharmacy business or pharmacy department and registering the premises of a pharmacy business, pharmacy department or pharmacy depot. A further function is the issuing of an Authority standard in relation to the operation of pharmacies, pharmacy businesses, pharmacy departments and pharmacy depots. Clause 83 provides that the Victorian Pharmacy Authority has all the powers necessary to enable it to perform its functions. 17

 


 

Clause 84 requires that in carrying out its functions and exercising its powers the Victorian Pharmacy Authority must consult with the Minister and have regard to the Minister's advice. Clause 85 sets out the objectives to which the Victorian Pharmacy Authority must have regard in carrying out its functions and exercising its powers. Clause 86 provides that the Victorian Pharmacy Authority may issue standards in relation to the operation of pharmacies, pharmacy businesses, pharmacy departments and pharmacy depots and sets out requirements relating to the standards including requirements for consultation and publication. Division 3--Membership and procedure Clause 87 provides that the Victorian Pharmacy Authority consists of members appointed by the Governor in Council on the nomination of the Minister. Subclause (2) provides that 3 members must be registered pharmacists, one must be an Australian lawyer and one must be a person who is not a registered pharmacist. Clause 88 provides that a member of the Victorian Pharmacy Authority holds office for the period not exceeding 3 years that is specified in the instrument of appointment. Subsection (2) provides that a member is eligible for reappointment. Subsection (3) provides that the Public Administration Act 2004 (other than Part 3) applies to a member in respect of the office of member. Subsection (4) provides that despite anything to the contrary in subsection (1) and anything to the contrary in the member's instrument of appointment a member may, with the consent of the Minister, hold office for a period not exceeding 3 months at the end of his or her term of appointment to enable the vacancy in the member's office to be filled. Clause 89 provides that a member of the Victorian Pharmacy Authority ceases to be a member if he or she is absent, without leave from the Authority, from 3 consecutive meetings of which the member had reasonable notice. Subclause (2) provides that a member may resign in writing, signed by the member and delivered to the Minister. 18

 


 

Subclause (3) provides that the Governor in Council may at any time remove a member of the Victorian Pharmacy Authority from office. Subclause (4) provides that if a member dies, resigns or is removed from office; the Minister may fill the vacancy with a suitably qualified person. Subclause (5) provides that a member holds office for the rest of the term of the appointment of the member whose place he or she fills. Clause 90 provides that the Governor in Council may on the recommendation of the Minister, appoint a member of the Victorian Pharmacy Authority as Chairperson and another member as Deputy Chairperson. Subclause (2) provides that the Minister may only recommend a member who is a registered pharmacist to be Chairperson or Deputy Chairperson, unless the Minister considers that it is necessary to do otherwise. Subclause (3) provides that the Chairperson and Deputy Chairperson each hold office for the term specified in his or her instrument of appointment and are eligible for reappointment. Subclause (4) provides that the Chairperson and Deputy Chairperson may resign the office by writing signed by the person and delivered to the Minister. Subclause (5) provides that the Governor in Council may at any time remove the Chairperson or Deputy Chairperson from office. Subclause (6) provides that the Chairperson and Deputy Chairperson cease to hold that office on ceasing to be a member of the Victorian Pharmacy Authority. Clause 91 provides that if a member of the Victorian Pharmacy Authority is unable to perform the duties or functions of the office, the Minister may appoint a suitably qualified person to act as that member during the period of the member's inability. Subclause (2), (3) and (4) provide that the terms and conditions for an acting member are the same as those for the member for whom he or she is acting and that while the appointment of an acting member remains in force the acting member has and may exercise all the powers and perform all the duties and functions of the member. Further, the Minister may at any time terminate the appointment of an acting member. 19

 


 

Clause 92 provides that a member or acting member of the Victorian Pharmacy Authority (other then a member who is a member of the public service within the meaning of the Public Administration Act 2004) is entitled to receive the fees fixed from time to time by the Governor in Council for that member. Subclause (2) provides that each member or acting member is entitled to receive the allowances that are fixed from time to time by the Governor in Council. Clause 93 sets out the procedures of the Authority and provides that the Chairperson, or in his or her absence, the Deputy Chairperson, must preside at a meeting of the Authority at which he or she is present. Subclause (2) provides that if neither the Chairperson nor Deputy Chairperson are present at a meeting the members present may elect a member to preside at the meeting. Subclause (3) provides that the person presiding at a meeting has a deliberative vote and a second or casting vote. Subclause (4) provides that a majority of the members of the Victorian Pharmacy Authority currently holding office constitutes a quorum. Subclause (5) provides that subject to this Bill the Authority may regulate its own proceedings. Clause 94 provides that an act or decision of the Victorian Pharmacy Authority is not invalid only because of a vacancy in membership, or of a defect or irregularity in the appointment of any of its members or, in the case of an acting member, because the occasion for that member so acting had not arisen or had ceased. Clause 95 sets out the procedure for resolutions without meetings. Clause 96 provides that if not less than a majority of the members for the time being holding office so agree, a meeting of the Victorian Pharmacy Authority may be held by means of a method or methods of communication approved by the Chairperson for the purposes of that meeting. An example of such a means would be a teleconference. Subclause (2) provides that for the purposes of this Part, a member of the Victorian Pharmacy Authority who participates in such a meeting is present at the meeting even if he or she is not physically present at the same place as another member participating in the meeting. 20

 


 

Subclause (3) provides that this section applies to a meeting or part of a meeting but does not apply to a meeting conducted for the purposes of Division 3 or 4 of Part 3, which relate to investigations and to the revocation of a licence or a registration. Clause 97 provides that a member of the Authority or a member of a panel co-opted by the Authority under section 57 is not personally liable for anything done or omitted to be done in good faith while exercising the powers or discharging the duties under Part 3 of this Bill. Any liability resulting from an act or omission that would otherwise attach to the member of the Authority or a co-opted member of a panel attaches to the Victorian Pharmacy Authority. Clause 98 empowers the Victorian Pharmacy Authority to delegate in writing to a member of the Authority, the registrar or other employee or to a person engaged by the Authority to provide services to the Authority any of its functions and powers under this Bill other than the power to refuse or to revoke a licence or a registration, a power under Part 4 dealing with enforcement of the Bill, or the power of delegation. Division 4--Staff Clause 99 provides that the Victorian Pharmacy Authority may employ a registrar and any other persons that are necessary for the purposes of administering this Bill. Division 5--Committees Clause 100 provides that the Victorian Pharmacy Authority may establish a committee for the purposes of providing advice to the Authority on any matter elating to the licensing of persons to carry on a pharmacy business or pharmacy department, the registration of pharmacy premises or the operation of pharmacy businesses, pharmacy departments or pharmacy depots. Subclause (2) provides that the Authority may determine the matters to be considered by a committee. Clause 101 provides that the members of a committee are to be appointed by the Victorian Pharmacy Authority and that at least one member of a committee is to be a member of the Authority and each member of the committee is to have expertise in the matters to be considered by the committee. 21

 


 

Division 6--Authority funds, assets and fees Clause 102 provides that the Victorian Pharmacy Authority must establish and keep a fund to be called the Victorian Pharmacy Authority Fund. Subclause (2) provides that all fees and penalties paid or recovered by the Authority under this Bill must be paid into the Fund. Subclause (3) provides that any other money received by the Authority including income from investments must be paid into the Fund. Subclause (4) lists what must be paid out of the Fund. Subclause (5) provides that the Victorian Pharmacy Authority must pay out of the Fund each financial year an amount determined by the Authority to meet the expenses of VCAT in performing functions under this Bill during the year. Subclause (6) provides that the amount in any financial year must not be less that the amount (if any) specified in relation to that year by the Attorney-General by written notice given to the Authority. Clause 103 provides that the Victorian Pharmacy Authority may invest money it does not immediately require in any manner allowed under the Trustee Act 1958 or in any other manner approved by the Minister. Clause 104 sets out the requirements for the setting of the fees that the Victorian Pharmacy Authority is empowered to fix under this Bill. Clause 105 provides for the repayment by the Authority of advances from the Public Account for the operation of the Authority. PART 6--GENERAL Clause 106 provides that the Victorian Pharmacy Authority must collect and keep information that it receives in carrying out its functions under this Bill. Subclause (2) provides that the Authority must provide to the Minister any information that is reasonably required by the Minister relating to the licensing of persons to carry on a pharmacy business or pharmacy department or the registration of the premises of pharmacy businesses, pharmacy departments and pharmacy depots. 22

 


 

Clause 107 provides that the Victorian Pharmacy Authority may disclose the information relating to registered pharmacists, applicants for a licence or registration, licensees and registration holders that it collects under this Bill to the Pharmacy Board of Australia or a State committee of that Board, or a person or body established in another State that has functions and powers that correspond to those of the Authority. The Authority may also disclose information to the Secretary in relation to the administration of the Drugs, Poisons and Controlled Substances Act 1981. Subclause (2) sets out the purposes for which the information may be disclosed. Clause 108 provides a regulation-making power. PART 7--TRANSITIONAL PROVISIONS Clause 109 contains definitions for the purposes of the transitional provisions. The old Board that will be replaced by the Victorian Pharmacy Authority is the Pharmacy Board of Victoria continued under the Health Professions Registration Act 2005. Clause 110 provides that nothing in this Part limits the operation of the Interpretation of Legislation Act 1984. Clause 111 provides that on the commencement of Part 3 the Pharmacy Board of Victoria is abolished and its members go out of office and the Victorian Pharmacy Authority becomes the successor in law to the Pharmacy Board of Victoria. Clause 112 makes provision for the transfer of the pharmacy-related assets and liabilities of the Pharmacy Board of Victoria to be assets and liabilities of the Victorian Pharmacy Authority. Clause 113 makes provision for the pharmacy-related records of the Pharmacy Board of Victoria to be records of the Victorian Pharmacy Authority. Clause 114 provides that applications for approvals made before the commencement of Part 3 but not yet determined when it commences will be taken to be applications made under this Bill. Clause 115 provides that persons approved to carry on a pharmacy business or pharmacy department at the time of commencement of Part 3 will be taken to be licensed under this Bill until 30 September 2010 at which time the licence may be renewed. 23

 


 

Subclause (2) provides that if a person was approved under Part 6 of the Health Professions Registration Act 2005 on or after 31 March 2010 they are taken to be licensed under this Bill until 30 June 2011, at which time the licence may be renewed. Clause 116 provides that premises approved at the time of commencement of Part 3 will be taken to be registered under this Bill until 30 September 2010 at which time the registration may be renewed. Subclause (2) provides that if premises were approved under Part 6 of the Health Professions Registration Act 2005 on or after 31 March 2010 they are taken to be registered under this Bill until 30 June 2011, at which time the registration may be renewed. Clause 117 makes provision for the completion by the Victorian Pharmacy Authority of the annual report of the Pharmacy Board of Victoria, if the Pharmacy Board of Victoria has not completed the report by the commencement of Part 3. Clause 118 empowers the Governor in Council to make regulations containing provisions of a transitional nature arising as a result of the enactment of this Bill. The clause includes a retrospective regulation making power for a limited period to ensure that transitional issues that arise after commencement of Part 3 can be dealt with appropriately. This clause will be repealed on 1 July 2012. PART 8--REPEALS AND CONSEQUENTIAL AMENDMENTS Division 1--Amendments to the Drugs, Poisons and Controlled Substances Act 1981 Clause 119 makes amendments to the Drugs Poisons and Controlled Substances Act 1981 so that references to Part 6 of the Health Professions Registration Act 2005 are replaced with references to Part 3 of the Pharmacy Regulation Act 2010. Clause 120 makes amendments to the Drugs Poisons and Controlled Substances Act 1981 so that references to Part 6 of the Health Professions Registration Act 2005 are replaced with references to Part 3 of the Pharmacy Regulation Act 2010. Subclause (2) amends references contained within the Drugs Poisons and Controlled Substances Act 1981 to reflect the licensing system established under this Bill. 24

 


 

Division 2--Amendments to the Education and Training Reform Act 2006 Clause 121 amends definitions in the Education and Training Reform Act 2006 to reflect the definitions contained within the Health Practitioner Regulation National Law. Division 3--Amendments to the Health Professions Registration Act 2005 Clause 122 repeals the definitions of pharmacy, pharmacy business, pharmacy department, pharmacy depot, pharmacy services and unprofessional conduct as contained in section 3(1) of the Health Professions Registration Act 2005. Subclause (2) repeals section 3(4) of the Health Professions Registration Act 2005. Clause 123 repeals Part 6 of the Health Professions Registration Act 2005 which is repealed by the Bill. Clause 124 repeals section 186 of the Health Professions Registration Act 2005 to be inserted by the Statute Law Amendment (National Health Practitioner Regulation) Act 2010 in relation to the Pharmacy Board of Victoria. Clause 125 repeals Schedule 3 to the Health Professions Registration Act 2005. This Schedule is re-enacted in the Schedule to the Bill Division 4--Amendments to the Mental Health Act 1986 Clause 126 makes amendments to the Mental Health Act 1986 to substitute "Medical Practitioners Board of Victoria" with "Medical Board of Australia". Division 5--Amendments to the Severe Substance Dependence Treatment Act 2010 Clause 127 makes amendments to the Severe Substance Dependence Treatment Act 2010. Clause 128 makes amendments to section 38(3) and (8) of the Severe Substance Dependence Treatment Act 2010 by omitting the term "registered". 25

 


 

Division 6--Amendments to the Statute Law Amendment (National Health Practitioner Regulations) Act 2010 Clause 129 provides for sections 22 and 23 of the Statute Law Amendment (National Health Practitioner Regulations) Act 2010 to be repealed. If the Bill commences on 1 July 2010 these provisions will not be required. Clause 130 repeals proposed section 186, in section 29 of the Statute Law Amendment (National Health Practitioner Regulations) Act 2010. If the Bill commences on 1 July 2010 this provision will not be required. Division 7--Amendments to the Victorian Civil and Administrative Tribunal Act 1998 Clause 131 amends Schedule 1 of the Victorian Civil and Administrative Tribunal Act 1998 to insert Part 15AC--Pharmacy Regulation Act 2010 to provide for the constitution of the Tribunal for hearings under the Bill. Division 8--Repeal of amending Part Clause 132 provides that Part 8 of the Bill will be repealed on 1 July 2012. The repeal of this Part will not affect the continuing operation of the amendments made by it. (See section 15(1) of the Interpretation of Legislation Act 1984). SCHEDULE The Schedule sets out the matters that are required for applications under Division 1 and 2 of Part 3 of the Bill. These matters include certain requirements for the lay-out, maintenance, security and access to a pharmacy. It further provides that a registered pharmacist must be appointed to act as the pharmacist who is regularly and usually in charge of the premises. Further, certain arrangements must be in place to ensure that medicines are dispensed appropriately and that records of prescriptions are kept in the required manner. 26

 


 

 


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