Pharmacy Regulation Bill 2010
Introduction Print
EXPLANATORY MEMORANDUM
561467
BILL LA INTRODUCTION 5/5/2010
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 1sets 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.
The Bill also makes a number of consequential amendments to the Health Professions Registration Act 2005 and other Acts.
Clause 2is 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 3provides a number of definitions.
The definitions of pharmacy, pharmacy business, pharmacy department and pharmacy depot are the same as the definitions in theHealth Professions Registration Act 2005.
Clause 4provides that the Act binds the Crown.
PART 2—OWNERSHIP AND OPERATION
Division 1—Requirements of ownership
Clause 5Subclause (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.
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 6makes 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 7requires 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 8empowers 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 9provides 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 10provides 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 11prevents the use of commercial arrangements from removing control of a pharmacy business from the licensee.
Division 2—Caps on growth of pharmacy ownership
Clause 12defines 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 13specifies 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 14provides 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 15makes 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 16makes 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 17makes 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 18provides 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 19provides that for the purpose of calculating the total number of pharmacy businesses owned by a company clause 15(b), 16 or17, the total number of pharmacy businesses must be rounded up to the whole next number.
Division 3—Requirements of establishment and operation
Clause 20provides 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 21makes 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. Apenalty of 240penalty units for a natural person and 1200penalty units for a body corporate applies.
Executors and administrators as described in clause 6 are excluded.
Clause 22provides for the establishment of a pharmacy department. Aperson 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. Thepremises of the pharmacy department must be registered bythe 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 23provides for the establishment of a pharmacy depot. Apharmacy 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.
Clause 24provides 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 25requires 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 26requires 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 10penalty units applies.
Clause 27requires 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. Apenalty of 10 penalty units applies.
Clause 28requires 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 29provides 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 30provides 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.
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 31provides 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 32provides 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. Theregistered 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 33sets 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 34provides 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. Apenalty of 60penalty units for a natural person and 300penalty units for a body corporate applies.
Subclause (2) provides a list of circumstances in which the prohibition on subclause (1) does not apply.
Clause 35provides 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 38to 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 36provides 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 37sets out who is eligible to apply for a licence to carry on a pharmacy business.
An applicant must satisfy the ownership requirements in clause5 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 38sets 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 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 39sets 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 40provides 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 28days 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 41provides 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 42provides 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 43provides 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 44provides 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 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 45sets 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 46sets 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.