The Act defines a “pharmacy business” by reference to the activities it involves, namely any or any combination of: the compounding or dispensing by a pharmacist of narcotic substances and restricted substances on prescription or lawful request; the sale or supply by a pharmacist of potent substances; or the sale or supply by a pharmacist or an employee under the pharmacist’s supervision of medicinal poisons in the possession, custody or control of that or another pharmacist (s 3A(3)). A business carried on by a person to whom section 27 of the Poisons Act 1971 applies is not a pharmacy business (s 3A(4)). The expression “interest in a pharmacy business” is defined broadly to include any legal or beneficial interest, including as a sole proprietor, a partner, a director, member or shareholder of a company, or a trustee or beneficiary of or unit holder in a trust (s 3B(1)). A person may also be taken to have an interest if party to a prescribed arrangement (s 3B(2)). The central gatekeeping mechanism is the “eligibility certificate”, issued by the Authority under section 61B. A person who intends to hold an interest in a pharmacy business must apply for an eligibility certificate unless exempt (s 61B(1)). The Authority must issue an eligibility certificate if the applicant is an “eligible person” (as defined in s 61C), is a fit and proper person (and each member of a body corporate is fit and proper), and complies with application requirements (s 61B(6)). Eligibility under section 61C is restricted: a natural person must be a pharmacist; a partnership must consist only of pharmacists; a body corporate must have each director a pharmacist and each other member a pharmacist or a close relative of a pharmacist, with controlling interest held by pharmacists, all shares held by pharmacists or close relatives, and control and supervision of pharmacy services vested in a pharmacist. A Friendly Society that held an interest before the Pharmacists Registration Amendment Act 2010 is also eligible (s 61C(1)(d)). The concept of “close relative” includes spouse, son, daughter, grandchild, stepchild, parent, stepparent, sibling and stepsibling (s 61A(3)). “Exempt person” includes a member of a body corporate that holds an eligibility certificate, a beneficiary or unit holder under a trust whose trustee holds a certificate, and certain executors, administrators, liquidators and mortgagees who assume an interest (s 61D). The Act also establishes the Pharmacy Business Premises Register and requires the Authority to keep it (s 71L). Registration is for a maximum of 12 months and is renewable (s 71G). The lapsing date is 30 June or another date determined by the Authority (definition in s 3). A “supermarket” is defined for the purpose of the prohibition on pharmacy business premises being located within, entered from, or used to enter a supermarket (s 71E(2)(c), (4)).

The Act primarily affects pharmacists, bodies corporate that own or intend to own pharmacy businesses, partnerships of pharmacists, Friendly Societies, and any person who holds or seeks to hold an interest in a pharmacy business in Tasmania. It also affects owners of pharmacy businesses (defined as the person or persons holding an eligibility certificate and named in the certificate of registration - s 3). The Act applies to applicants for registration of pharmacy business premises (s 71D), applicants for eligibility certificates (s 61B), and persons who are exempt from those requirements (s 61D). The Crown in right of Tasmania and, so far as legislative power permits, in all other capacities is bound by the Act except Parts 4, 5A and 6A (s 4). Those Parts (inspections, interests, registration) do not bind the Crown (ss 61A(1), 71B(1)). Hospital pharmacy businesses operated by an agency or instrumentality of the Crown are excluded from Parts 5A and 6A (ss 61A(2), 71B(2)(a)). The Act does not extend to the business of a licensed manufacturing chemist or licensed wholesale chemist within the meaning of the Poisons Act 1971, or to a person authorised under that Act to sell scheduled substances other than a pharmacist (s 5). Prescribed premises, persons or pharmacy practices may also be exempted by regulation (s 71B(2)(b)). The Tasmanian Pharmacy Authority itself is established as a body corporate (s 6) and is the key regulator. Inspectors appointed by the Authority (s 59) may enter premises. The Health Complaints Commissioner may refer complaints to the Authority (s 59(1)(c)). Registration boards under the Health Practitioner Regulation National Law (Tasmania) may request inspections (s 59(1)(d)). The responsible tribunal (the Tasmanian Civil and Administrative Tribunal) hears appeals from decisions of the Authority (s 60). The Secretary of the Department of Health and Human Services has a role in nominating members of the Authority (s 7(1)) and in making rulings on whether premises are a supermarket (s 71E(5)). The Act also imposes obligations on owners of pharmacy businesses, whether individuals or bodies corporate, and on persons concerned in the management of bodies corporate (s 79 provides that if a body corporate commits an offence, each person concerned in its management is taken to have also committed the offence unless the person proves lack of knowledge or consent).

A person who intends to hold an interest in a pharmacy business must apply for an eligibility certificate unless exempt (s 61B(1)). The application must be in approved form, lodged with the Authority, and accompanied by the prescribed fee and required information (s 61B(2)). The holder of an eligibility certificate must apply for its annual renewal on or before the lapsing date (s 61E(1)). The owner of a pharmacy business must ensure that the pharmacy business premises are registered (s 71C) and must apply for annual renewal of that registration (s 71K). Registration must not be used if the premises are located wholly or partly in a supermarket, or are capable of being entered from or used to gain entry to a supermarket (s 71E(2)(c)). The owner must not cause or allow an alteration to the premises that is likely to affect dispensing, storage, access, security or professional activities unless the alteration has been approved by the Authority (s 71KB). The owner must notify the Authority within 7 days of a disruptive event (fire, flood, extended utility interruption) that prevents the business for more than 3 days (s 71KF). The owner must also notify the Authority within 14 days of certain major events: abandonment, winding up, change in interests in the premises, major changes to leasehold arrangements, or prescribed events (s 71KG). Any person holding an eligibility certificate must, within 14 days of becoming aware of a relevant event (suspension or cancellation of pharmacist registration, being charged with an imprisonable offence, conviction, cancellation of authority to handle scheduled medicines, or change of trustees, beneficiaries or unit holders of a trust holding an interest) give the Authority written notice (s 70A). The holder of an eligibility certificate who knows or ought to know that facts relied upon have changed must apply for a new certificate within 14 days (s 62(2)). A person must not hold an interest in more than 4 pharmacy businesses at any one time (s 65(1)). A person must not use the word “pharmacy” to describe a business or premises unless the premises are registered (s 66). A person aggrieved by a decision of the Authority may appeal to the Tasmanian Civil and Administrative Tribunal within 28 days after notice of the decision (s 60). The Authority must give notice of its decisions, including reasons and the right to appeal (ss 59A(5), 61B(8), 61E(7), 71F(3), 71H(3), 71K(9), 71KE). A relevant party may be heard before suspension of registration, but the Authority is not required to afford that opportunity (s 71H(6)). The Authority may accept an undertaking from a relevant party as an alternative to directing works or closure (s 59A(10)). The Authority may grant exemptions from registration for premises on its own initiative, at the request of the Director of Public Health, or on application by a pharmacist (s 71J). Exemptions may be conditional and may be revoked (s 71J).

The Act creates a range of offences with penalties expressed in penalty units. The penalty unit value is set under other Tasmanian legislation. The most significant penalty is for holding an interest in a pharmacy business without an eligibility certificate or exempt status: a fine not exceeding 200 penalty units and, in the case of a continuing offence, a further fine not exceeding 20 penalty units for each day the offence continues (s 62(1)). The same penalty applies for failing to apply for a new eligibility certificate within 14 days of a change in facts (s 62(2)). Exceeding the 4-pharmacy limit attracts a fine not exceeding 100 penalty units and a daily penalty of 10 penalty units (s 65(1)). Using unregistered premises for a pharmacy business carries a fine not exceeding 100 penalty units and a daily penalty of 10 penalty units (s 71C). Making a false or misleading statement in connection with an application or an inspection is an offence with a fine not exceeding 100 penalty units (s 68(1)). Obstructing, hindering, threatening or intimidating a person in the exercise of a power or duty under the Act attracts a fine not exceeding 100 penalty units (s 69). Failing without reasonable excuse to attend an inspection, produce a document, or answer a question carries a fine not exceeding 50 penalty units and a daily penalty of 5 penalty units (s 70(1)). Giving an inspector a gift, reward or other inducement is an offence with a fine not exceeding 25 penalty units (s 59(4)). Failure to notify the Authority of a relevant event within 14 days attracts a fine not exceeding 100 penalty units and a daily penalty of 10 penalty units (s 70A(2)). Directing, inducing, assisting or allowing a person to engage in conduct that constitutes or is reasonably likely to constitute a breach of the Act carries a fine not exceeding 100 penalty units (s 70B(2)). Failure to comply with a direction of the Authority or an order concerning confidentiality of meetings carries a fine not exceeding 100 penalty units (s 71). Contravening a condition of an exemption for premises attracts a fine not exceeding 25 penalty units (s 71J(7)). Making an alteration to premises without approval carries a fine not exceeding 20 penalty units (s 71KB). Failing to notify of a disruptive event or a major change carries a fine not exceeding 2 penalty units (ss 71KF(2), 71KG(2)). Proceedings for an offence may be commenced within 24 months after the date of the alleged offence (s 67). The Authority may prosecute offences (s 8(d)). Fines and fees are paid to the Authority (s 77). If a body corporate commits an offence, each person concerned in its management is taken to have also committed the offence unless they prove lack of knowledge or consent (s 79). The Authority may also enforce compliance through non-penalty mechanisms: it may direct a relevant party to carry out specified works or actions and may direct the closure of premises until those works are carried out (s 59A(2)). Failure to comply with such a direction or an undertaking may lead the Authority to cancel or suspend registration of the premises (s 59B, s 71H). The Authority may also cancel registration if premises are no longer suitable, or have temporarily or permanently ceased to be used for pharmacy purposes (s 71H). The Authority may publicise its decisions in the Gazette, newspapers or professional publications after appeal rights have expired (s 59A(8), (9)).

Section 5A provides that in the event of inconsistency between a provision of this Act and the Health Practitioner Regulation National Law (Tasmania), the provisions of that National Law prevail. This is significant because the National Law governs the registration of pharmacists, while the Pharmacy Control Act governs pharmacy businesses and premises. The Act defines “pharmacist” by reference to the National Law: a person who holds general registration under that Law in the pharmacy profession (s 3). The Poisons Act 1971 is also closely linked. The definition of “pharmacy business” in section 3A incorporates terms from the Poisons Act (medicinal poison, narcotic substance, potent substance, restricted substance) and gives them the same meaning (s 3A(2)). A business carried on by a person to whom section 27 of the Poisons Act applies is excluded from being a pharmacy business (s 3A(4)). The Act does not extend to the business of a licensed manufacturing chemist or licensed wholesale chemist within the meaning of the Poisons Act, nor to a person authorised under that Act to sell scheduled substances other than a pharmacist (s 5). The Act interacts with the Health Complaints Act 1995: the Health Complaints Commissioner may refer complaints to the Authority, and the Authority must notify the Commissioner of the outcome of any resulting inspection (s 59A(11)). The Authority may also share information with the Commissioner (s 73A(2)). The Act interfaces with the Financial Management Act 2016: the Authority must comply with Treasurer’s Instructions on procurement and disposal as if it were an Agency (s 12). The Audit Act 2008 applies to the Authority’s accounts and records (s 18). The State Service Act 2000 permits arrangements for employees to be made available to the Authority (s 15). The Relationships Act 2003 definition of “significant relationship” is used for “spouse” (s 61A(3)). The Act references the Corporations Act for the definition of “company” and related terms in the context of “interest in a pharmacy business” (s 3B(1)(c)). The Therapeutic Goods Act 1989 (Commonwealth) is referenced in the definition of “scheduled medicine” in section 70A(1) through the SUSMP. The Rules Publication Act 1953 and the Subordinate Legislation Act 1992 are mentioned to clarify that guidelines issued by the Authority are not statutory rules or legislative instruments (s 11(6)). The Acts Interpretation Act 1931 section 22 applies to guidelines (s 11(7)). The Act binds the Crown (except Parts 4, 5A, 6A) (s 4). The Act also contains consequential amendments to other Tasmanian Acts listed in Schedule 6, including the Poisons Act 1971 and the Pharmacists Registration Act 2001 (now repealed or superseded by the National Law). The responsible tribunal is the Tasmanian Civil and Administrative Tribunal (s 3, as amended by No.18 of 2021).

The Act as presented in the source includes accumulated amendments. Key amending Acts include: No.42 of 2003 (amended s 20 schedule); No.72 of 2004 (amended s 62, s 65); No.62 of 2005 (amended numerous sections, inserted Part 6A registration scheme, amended s 3, s 4, s 8, s 9, s 10, s 28, s 30, s 32, s 37, s 38, s 43, s 53, s 56, s 59, s 60, s 62, s 65, s 67, s 80, and Sch 6); No.2 of 2007 (amended s 3, s 38, s 73); No.66 of 2007 (amended Sch 3, later repealed); No.2 of 2008 (amended s 14, s 16, repealed s 14A); No.50 of 2008 (amended s 18, s 19, s 20); No.80 of 2009 (amended Sch 1); No.3 of 2010 (inserted s 5A, applied 1 Jul 2010); No.47 of 2010 (major overhaul: substituted Part 2, repealed Part 3 and many sections, inserted Part 5A (interests in pharmacy businesses), inserted Part 6A Divisions 4 and 5 (register), added new offences, amended practically every remaining section); No.33 of 2011 (amended definition of “registration board” in s 3); No.22 of 2016 (significant amendments: inserted s 3A, s 3B, amended definitions, substituted s 11, amended s 61C, inserted s 61F, amended s 62, s 65, s 70A, s 71E, s 71H, s 71I, s 71K, inserted Divisions 3, 4, 5 of Part 6A (alterations, notices, register), amended s 73, s 74, and others); No.13 of 2019 (amended s 61C, s 80); No.15 of 2019 (amended s 80); No.4 of 2017 (amended s 12, s 18, s 20); No.18 of 2021 (amended s 3 (responsible tribunal), repealed s 61, amended s 60). The Act originally commenced on a day to be proclaimed (s 2). The repeals of earlier pharmacy legislation (Pharmacy Act 1908) and the inclusion of consequential amendments in Schedule 6 show the Act’s role in consolidating Tasmanian pharmacy regulation.

The Act does not refer to any specific cases or litigation. No cases are named in the text of the Act provided. The Act establishes a right of appeal to the Tasmanian Civil and Administrative Tribunal (formerly the Health Practitioners Tribunal, then the Magistrates Court, now TASCAT) for any person aggrieved by a decision of the Authority made for the purposes of the Act (s 60). The appeal must be instituted within 28 days after notice of the decision. The Authority’s decisions under sections 59A(1)(b) and (c) take effect despite the right of appeal, but the responsible tribunal may order a stay (s 59A(6), (7)). Matters that have come before the tribunal or courts under this Act are not recorded in the legislation itself. The Act contains standard evidentiary presumptions (s 76) and provisions on service of documents (s 74) that would be relevant in any proceedings. The provision that a person may be required to answer questions or produce documents despite self-incrimination, but that such answers or documents are not admissible in other proceedings except for offences under section 68 or appeals under Part 5 (s 70(2), (3)), is a notable feature that has likely been considered in enforcement contexts. The offence provision concerning bodies corporate (s 79) creates personal liability for persons concerned in management unless they prove lack of knowledge or consent, which shifts the evidentiary burden. The 24-month limitation period for commencing prosecutions (s 67) is extended beyond the usual summary period. Practitioners should consult the database of decisions of the Tasmanian Civil and Administrative Tribunal and Tasmanian courts for any reported cases interpreting the Act.

Several provisions contain traps for the unwary. The eligibility certificate under section 61B expires on the earlier of the lapsing date (30 June or another date) and the end of 14 days after a change occurs in the matters relied upon in support of the application (s 61B(7)). This 14-day grace period is short. A person who knows or ought to know that facts have changed and does not apply for a new certificate within 14 days commits an offence (s 62(2)). This means that even minor changes in the ownership structure of a body corporate could invalidate a certificate if not promptly reported. The 4-pharmacy limit in section 65 applies broadly: a person must not hold an interest in more than 4 pharmacy businesses at any one time, “either alone or in partnership with another person or as a member of a body corporate or as a trustee, beneficiary or unit holder of a trust”. This aggregates interests across all capacities. The definition of “pharmacy business” for the purpose of this limit means a business carried on from the one premises, and “premises” does not include individual premises that are exempted for a period not exceeding 3 months (s 65(2)). This exemption from the cap is only temporary. The supermarket restriction in section 71E(2)(c) is detailed. Premises must not be located wholly or partly within a supermarket, must not be capable of being entered from within a supermarket, and must not be capable of being used to gain entry to a supermarket. A supermarket is defined broadly as any large enclosed shop that primarily sells fresh and processed foods on a self-serve basis, even if customer advice or service is available and other goods are also sold. A department store is not a supermarket even if it has a restaurant or sells specialty foods (s 71E(4)). The definition of “alteration” in section 71KA is broad and includes any alteration likely to affect dispensing, storage, access, security or professional activities, whether permanent or temporary. Prior approval from the Authority is required for such alterations (s 71KB). The obligation to notify the Authority of a disruptive event arises if the event prevents business for an extended period (more than 3 days) and notice must be given within 7 days (s 71KF). The penalty for failing to notify is only 2 penalty units, but the underlying offence of using unregistered or unsuitable premises may be more serious. The joint and several liability provisions (ss 71KB(2), 71KF(3), 71KG(3), 73(4)) mean that each joint owner is liable for the entire obligation, but if one owner complies, the others are discharged. Officers of bodies corporate face personal liability under section 79 unless they prove lack of knowledge or consent - this is a reverse onus. The Authority may accept an undertaking instead of directing works or closure (s 59A(10)), but failure to comply with an undertaking can lead to cancellation or suspension of registration (s 59B). The Authority may give a relevant party an opportunity to be heard before suspending registration but is not required to do so (s 71H(6)). The Protection from liability provision (s 16) protects a person engaged in the administration of the Act from personal liability for acts done in good faith, and also protects a person who makes a complaint in good faith from liability for loss, damage or injury suffered as a result of the making of the complaint. The definition of “relevant party” for inspections includes the owner of the relevant pharmacy business, the applicant for registration, or the person apparently in charge of premises (s 58). This means that an employee or manager could be the relevant party for an inspection if they are the person apparently in charge. The Act does not provide for a cooling-off period for relinquishment of registration, and no refund of fees is payable (s 71I(3)). Finally, guidelines issued by the Authority may not contain provisions repugnant to the Act, and the Act always prevails over guidelines (s 11(2)(e), (3)). Guidelines are not statutory rules and do not have legislative character, but they are taken to be instruments to which section 22 of the Acts Interpretation Act 1931 applies, meaning they may be subject to tabling and disallowance.

A person wishing to own or operate a pharmacy business in Tasmania should follow a structured compliance path. First, determine whether the business involves any of the activities listed in section 3A(3) (compounding or dispensing narcotic or restricted substances, sale of potent substances, sale of medicinal poisons). If so, the business is a pharmacy business subject to the Act. The person must apply to the Tasmanian Pharmacy Authority for an eligibility certificate under section 61B unless they are an exempt person (e.g., a member of a body corporate that already holds a certificate, or a beneficiary under a trust whose trustee holds a certificate). The application must be in the approved form, lodged with the Authority, and accompanied by the prescribed fee and supporting information. The Authority must be satisfied that the applicant meets the eligibility criteria in section 61C (generally, that natural persons are pharmacists, partners are pharmacists, body corporate directors and members are pharmacists or close relatives, with control and supervision vested in a pharmacist). Once the eligibility certificate is obtained, the applicant must apply for registration of the pharmacy business premises under section 71D. The premises must not be located within, entered from, or used to gain entry to a supermarket (s 71E(2)(c)). The premises must be suitable in terms of presentation, physical condition, security, professional requirements, public access, and compliance with legislative requirements (s 71E(3)). The application must be in approved form, with fee and supporting evidence. The Authority will register the premises and issue a certificate of registration (s 71F). Registration is valid until the lapsing date (usually 30 June) but not exceeding 12 months (s 71G). Before the lapsing date each year, the owner must apply for renewal of both the eligibility certificate (s 61E) and the registration (s 71K). Late applications may be accepted up to 30 days after the lapsing date with a late fee, but if more than 30 days late, the Authority may refuse to renew (ss 61E(6)(d), 71K(8)(d)). Throughout the year, the owner must comply with ongoing obligations: hold the eligibility certificate and not allow it to lapse (s 62); not exceed 4 pharmacy businesses (s 65); not alter premises without prior approval (s 71KB); notify the Authority within 7 days of a disruptive event (fire, flood, extended utility outage) (s 71KF); notify the Authority within 14 days of major changes (abandonment, winding up, change of interests, major lease changes, or prescribed events) (s 71KG); notify the Authority within 14 days of a relevant event (cancellation or suspension of pharmacist registration, being charged with a serious offence, conviction, cancellation of scheduled medicine authority, or change of trustees/beneficiaries/unit holders) (s 70A). If the facts relied upon in the eligibility certificate change, a new certificate must be applied for within 14 days (s 62(2)). The owner must also respond to any request for information from the Authority under section 73 within a reasonable period (not less than 21 days). The owner must permit inspections by authorised inspectors and must not obstruct, hinder, threaten or intimidate inspectors (s 69). Answers given under compulsion during an inspection may be used in proceedings for an offence under section 68 or in appeal proceedings, but not generally in other proceedings if the person objected on self-incrimination grounds (s 70(2),(3)). If the Authority directs works or closure after an inspection, the owner must comply within the time specified, or risk cancellation or suspension of registration (s 59B, s 71H). If the owner disagrees with a decision of the Authority, they may appeal to the Tasmanian Civil and Administrative Tribunal within 28 days (s 60). It is advisable to keep accurate records of ownership structures, trust deeds, partnership deeds, and lease terms, as the Authority can require production of these documents (s 73). The owner should also ensure that the business does not use the word “pharmacy” unless the premises are registered (s 66). Any person concerned in the management of a body corporate that owns a pharmacy business should be aware of their personal liability under section 79.