Pharmacy Control Act 2001 (Tas)

Pharmacy Control Act 2001 An Act to provide for the regulation of pharmacy business ownership, the registration of pharmacy business premises, to repeal the Pharmacy Act 1908 and for related purposes [Royal Assent 17 December 2001] Be it enacted by His Excellency the Governor of Tasmania, by and with the advice and consent of the Legislative Council and House of Assembly, in Parliament assembled, as follows: PART 1 - Preliminary 1. Short title This Act may be cited as the Pharmacy Control Act 2001 . 2. Commencement This Act commences on a day to be proclaimed. 3. Interpretation In this Act, unless the contrary intention appears – applicant means a person who submits an application to the Authority; approved means approved by the Authority; Authority means the Tasmanian Pharmacy Authority established under section 6 ; certificate of registration means a certificate given by the Authority under section 71F ; chairperson means chairperson of the Authority; committee means a committee established by the Authority under section 13 ; eligible person means a person who holds an eligibility certificate; eligibility certificate means a certificate issued by the Authority under section 61B ; exempt person means a person who is exempt, under section 61D , from the requirement to apply for an eligibility certificate; financial year means the 12 month period ending on 30 June in any year; Friendly Society means a body that was registered under the Friendly Societies (Tasmania) Code as a society immediately before the repeal of the Friendly Societies (Tasmania) Act 1997 ; functions includes duties; guidelines means guidelines issued by the Authority; Health Complaints Commissioner means the person appointed as Health Complaints Commissioner under the Health Complaints Act 1995 ; inspection means an inspection under section 59 ; interest in a pharmacy business – see section 3B ; lapsing date, for a provision of this Act, means – (a) 30 June or, if another date is prescribed for the provision, that other date; or (b) if the Authority determines in respect of a particular person, pharmacy business or pharmacy business premises that a date other than the date specified or prescribed under paragraph (a) of this definition should be the lapsing date for the provision, the other date so determined by the Authority for that person or business or those premises; member means member of the Authority and includes the chairperson; notice means notice in writing; owner, of a pharmacy business, means the person or persons for the time being holding an eligibility certificate and named in the certificate of registration for the relevant pharmacy business premises; pharmacist means a person who holds general registration under the Health Practitioner Regulation National Law (Tasmania) in the pharmacy profession; pharmacy business – see section 3A ; pharmacy business premises means a shop or other premises where a pharmacy business is carried on; register means the Pharmacy Business Premises Register kept under section 71L ; registered means registered under this Act; registration board means a board established under section 31 of the Health Practitioner Regulation National Law (Tasmania); relevant pharmacy business, in relation to any pharmacy business premises, means the pharmacy business carried on in or from those premises; relevant pharmacy business premises in relation to a pharmacy business, means the premises in or from which the business is carried on; report includes publish; responsible tribunal means the Tasmanian Civil and Administrative Tribunal; Secretary means Secretary of the Department; specified means specified in writing by the Authority. 3A. Meaning of "pharmacy business" (1) In this section – dispensing, of narcotic substances or restricted substances, means preparing the narcotic substances or restricted substances for sale or supply to members of the public; preparing includes packaging, labelling and recording. (2) In this section, the following expressions have the same meaning as they have in the Poisons Act 1971 – (a) medicinal poison; (b) narcotic substance; (c) potent substance; (d) restricted substance. (3) For the purposes of this Act, a business is a pharmacy business if it involves any or any combination of the following activities: (a) the compounding or dispensing, by a pharmacist, of narcotic substances and restricted substances on the prescription or lawful request of a medical practitioner or other health professional; (b) the sale or supply, by a pharmacist, of potent substances; (c) the sale or supply, by a pharmacist or by an employee of that pharmacist under his or her supervision, of medicinal poisons that are in the possession, custody or control of that or another pharmacist. (4) To avoid doubt, a business that is carried on by a person to whom section 27 of the Poisons Act 1971 applies is not a pharmacy business for this Act. 3B. Meaning of "interest in a pharmacy business" (1) For the purposes of this Act, the expression interest in a pharmacy business means any legal or beneficial interest in the business, including an interest as – (a) a sole proprietor; or (b) a partner; or (c) a director, member or shareholder of a company as defined in the Corporations Act; or (d) a trustee or beneficiary of, or unit holder in, a trust. (2) Without limiting the generality of subsection (1) , a person will be taken to have an interest in a pharmacy business for the purposes of this Act if the person is party to an arrangement of a kind prescribed by the regulations. 4. Act binds Crown This Act, other than Parts 4 , 5A and 6A , binds the Crown in right of Tasmania and, so far as the legislative power of Parliament permits, in all its other capacities. 5. Application of Act Nothing in this Act extends to or affects – (a) the business of a licensed manufacturing chemist or licensed wholesale chemist, within the meaning of the Poisons Act 1971 ; or (b) a person who is authorised under the Poisons Act 1971 to sell or supply a scheduled substance, within the meaning of that Act, other than a pharmacist. 5A. Inconsistency between Act and Health Practitioner Regulation National Law (Tasmania) In the event of an inconsistency between a provision of this Act and the Health Practitioner Regulation National Law (Tasmania), the provisions of the Health Practitioner Regulation National Law (Tasmania) prevail. PART 2 - Tasmanian Pharmacy Authority Division 1 - The Authority 6. Establishment of Authority (1) The Tasmanian Pharmacy Authority is established. (2) The Authority – (a) is a body corporate with perpetual succession; and (b) may acquire, hold, dispose of and otherwise deal with property; and (c) may sue and be sued in its corporate name. 7. Membership of Authority (1) The Authority consists of – (a) two pharmacists nominated by the Secretary; and (b) one person, who is not a pharmacist, nominated by the Secretary to represent the interests of consumers. (2) The members are appointed by the Minister. (3) The Secretary, on the recommendation of the members, must appoint a member as chairperson. (4) For the purpose of making nominations under subsection (1)(a) , the Secretary may – (a) request any body that purports to represent the professional interests of pharmacists to provide the Secretary within 28 days of the date of the request with a list of names; and (b) accept a recommendation from any body that purports to represent the professional interests of pharmacists or from any pharmacist; and (c) accept an expression of interest from any pharmacist. (5) Schedule 1 has effect with respect to membership of the Authority. (6) Schedule 2 has effect with respect to meetings of the Authority. Division 2 - Functions, powers and objectives 8. Functions of Authority The Authority has the following functions: (a) to administer a scheme of registration of pharmacy business premises; (b) to approve the ownership of and interests in pharmacy businesses; (c) to ensure that the services that pharmacy businesses provide from pharmacy business premises to the public are of the highest possible standard; (d) to prosecute offences against this Act; (e) to advise the Minister on matters relating to this Act; (f) such other functions as are imposed on the Authority by this or any other Act or as may be prescribed. 9. Powers of Authority The Authority has power to do all things necessary or convenient to be done in connection with the performance of its functions and, in particular, has power to – (a) share information with pharmacists registration authorities and other relevant bodies; and (b) publish and distribute information about this Act to pharmacists and other interested persons; and (c) do anything incidental to any of its powers. 10. Delegation The Authority may delegate any of its functions or powers, other than this power of delegation, to a member of the Authority, the Registrar or a committee. 11. Guidelines (1) The Authority may issue guidelines from time to time to provide practical guidance and direction to persons on the registration and renewal of registration of pharmacy business premises and other matters under this Act. (2) The guidelines – (a) are to be written in plain language, follow a consistent style and format, and be as brief as possible consistent with their intended application; and (b) may be made so as to apply differently according to such matters, limitations or restrictions, whether as to time, location, circumstance or otherwise, as are specified in them; and (c) may confer responsibilities and discretionary responsibilities on the Authority; and (d) may not purport to impose sanctions for any failure to comply with them; and (e) may not contain provisions that are repugnant to the provisions of this or any other Act. (3) In the event that the provisions of any guideline are inconsistent with the provisions of any Act, the provisions of the Act always prevail. (4) The Authority may publish guidelines as it thinks fit having regard to their intended application. (5) No fee is chargeable or payable for issuing, supplying, obtaining or accessing a copy of any guidelines. (6) Guidelines are not – (a) statutory rules for the purposes of the Rules Publication Act 1953 ; or (b) instruments of a legislative character for the purposes of the Subordinate Legislation Act 1992 . (7) Guidelines are taken to be instruments to which section 22 of the Acts Interpretation Act 1931 applies. 12. Compliance with Treasurer's Instructions Treasurer's Instructions issued under the Financial Management Act 2016 in relation to procurement and disposal apply to the Authority as if the Authority were an Agency within the meaning of that Act. Division 3 - Miscellaneous 13. Committees (1) The Authority may establish such committees as it considers necessary for the purpose of assisting it in the performance of any of its functions or the exercise of any of its powers or advising it on any matter relating to this Act. (2) Except as otherwise provided in this Act – (a) a committee comprises such persons as the Authority appoints; and (b) a member of the Authority may be a member of a committee. (3) A member of a committee is entitled to be paid such remuneration, including travelling and subsistence allowances, as the Authority may from time to time determine and any such remuneration is to be paid by the Authority. (4) The Authority may give written directions to a committee and the committee must comply with any such directions. (5) A committee must keep accurate minutes of its proceedings. (6) Except as otherwise provided in this Act, a committee may regulate its own proceedings. 14. Registrar (1) The Authority must appoint a Registrar. (2) The Registrar may be – (a) an independent contractor to the Authority; or (b) a person whose services are made available to the Authority pursuant to an arrangement under section 15 . (3) The Registrar is to act as secretary to the Authority. 14A. . . . . . . . . 15. Use by Authority of services of persons (1) The Authority may arrange with the Head of an Agency, within the meaning of the State Service Act 2000 , for the services of persons employed in that Agency to be made available to the Authority. (2) The Authority may arrange with any other person for the services of persons employed by that person to be made available to the Authority. (3) The cost of making a person's services available to the Authority in accordance with this section is to be met by the Authority. 16. Protection from liability (1) A person engaged in the administration of this Act does not incur any personal liability for an act done or purported or omitted to be done by the person in good faith for that purpose. (2) A person who makes a complaint in good faith does not incur any personal liability in respect of any loss, damage or injury suffered by another person as a result of the making of the complaint. Division 4 - Finance and reports 17. Funds of Authority (1) The Authority is to keep such authorised deposit-taking institution accounts as it considers necessary. (2) The funds of the Authority are to be paid to the credit of such of the accounts referred to in subsection (1) as the Authority determines and are to consist of – (a) money received by way of fees, fines, penalties and charges paid to or recovered by the Authority; and (b) any money borrowed by the Authority; and (c) any money received by the Authority from other sources. (3) The funds of the Authority are to be applied – (a) in payment or discharge of the expenses, charges and obligations incurred or undertaken by the Authority in the performance of its functions and the exercise of its powers; and (b) in the payment of any remuneration payable by the Authority. (4) The Authority may invest any money that it is holding in any manner in which a trustee is authorised by law to invest trust funds. 18. Audit (1) The accounts and records of the Authority are subject to the Audit Act 2008 . (2) The Authority must pay into the Public Account such amounts as the Treasurer may require towards the reasonable costs and expenses of audits conducted pursuant to this section. 19. Accounts The Authority must keep proper accounts and records of its financial affairs and, not later than 15 August after the end of each financial year, prepare a statement of accounts in a form approved by the Auditor-General exhibiting a true and correct view of the financial position and transactions of the Authority for that financial year. 20. Annual report (1) The Authority must, not later than 31 August after the end of each financial year, give the Minister a report on its operations for that financial year. (2) The report is to incorporate the audited statement of accounts prepared for the relevant financial year under section 19 . (3) The Minister may, in writing, direct the Authority to prepare the report in a particular way or to include particular information in the report. (4) The report may be appended to an annual report of the Department. (5) Subsection (4) has effect notwithstanding section 36(3) of the State Service Act 2000 . (6) If the Authority's report is not appended to an annual report of the Department, the Minister must cause the Authority's report to be laid before each House of Parliament by not later than 31 October after the end of the financial year to which it relates. PART 3 - . . . . . . . . 21. . . . . . . . . 22. . . . . . . . . 23. . . . . . . . . 24. . . . . . . . . 25. . . . . . . . . 26. . . . . . . . . 27. . . . . . . . . 28. . . . . . . . . 29. . . . . . . . . 30. . . . . . . . . 31. . . . . . . . . 32. . . . . . . . . 33. . . . . . . . . 34. . . . . . . . . 35. . . . . . . . . 36. . . . . . . . . 37. . . . . . . . . 38. . . . . . . . . 39. . . . . . . . . 40. . . . . . . . . 41. . . . . . . . . PART 4 - Inspections Division 1 - . . . . . . . . 42. . . . . . . . . 43. . . . . . . . . 44. . . . . . . . . Division 2 - . . . . . . . . Subdivision 1 - . . . . . . . . 45. . . . . . . . . Subdivision 2 - . . . . . . . . 46. . . . . . . . . 47. . . . . . . . . 48. . . . . . . . . Subdivision 3 - . . . . . . . . 49. . . . . . . . . 50. . . . . . . . . Subdivision 4 - . . . . . . . . 51. . . . . . . . . 52. . . . . . . . . 53. . . . . . . . . 54. . . . . . . . . 55. . . . . . . . . Division 3 - . . . . . . . . 56. . . . . . . . . 57. . . . . . . . . 58. Interpretation In this Division – relevant party means – (a) in the case of registered pharmacy business premises, the owner of the relevant pharmacy business; and (b) in the case of premises sought to be registered as pharmacy business premises, the applicant for registration; and (c) in the case of all other premises, the person apparently in charge of those premises. 59. Authorisation and powers of inspectors (1) If – (a) the Authority reasonably suspects that a person may be operating a pharmacy business in breach of this Act; or (b) the Authority reasonably suspects that a person may be operating a pharmacy business from premises that may not be suitable for registration having regard to the matters set out in section 71E ; or (c) the Authority receives a referral of a complaint from the Health Complaints Commissioner; or (d) the Authority receives a request from a registration Board to inspect any premises; or (e) premises sought to be registered are being made ready to be used or have been made ready to use for the purposes of a pharmacy business; or (f) premises registered as pharmacy business premises have been, or are being, renovated or altered; or (g) the Authority wishes to carry out a random inspection on registered pharmacy business premises for the purposes of auditing those premises against the matters set out in section 71E – the Authority may, in writing, authorise a person to act as an inspector. (2) On production of the authorisation, the inspector may at any reasonable time enter the relevant premises and do all or any of the following: (a) inspect the premises generally; (b) require the person apparently in charge of the premises to produce for inspection any document held at the premises; (c) inspect and take notes of or extracts from any such document; (d) make a copy of any such document; (e) ask questions of and require answers from persons on the premises; (f) take photographs; (g) open and inspect containers or packages that the inspector reasonably suspects are used for the purpose of, or in connection with, the practice of pharmacy; (h) examine or test any equipment held on the premises; (i) require a person claiming to be a pharmacist to produce evidence of his or her registration as a pharmacist; (j) if the inspector reasonably suspects that an offence has been committed against this Act, seize and, on furnishing a receipt, remove anything that in the reasonable opinion of the inspector is evidence of the offence or contravention; (k) remove, on furnishing a receipt, any document found on the premises to the custody and control of the Authority for as long as the Authority considers necessary or expedient. (3) If the Authority is satisfied that for legitimate reasons a person needs access to a document that has been removed from the person's pharmacy business premises to the custody and control of the Authority under subsection (2)(k) , the Authority in its discretion may – (a) grant the person reasonable access to the document or to a copy of the document; or (b) provide the person with a copy or certified copy of the document; or (c) retain a copy of the document and return the original to the person. (4) A person must not give, agree to give or offer to an inspector a gift, reward or other inducement to do or abstain from doing anything in relation to an inspection. Penalty: Fine not exceeding 25 penalty units. (5) Following an inspection, an inspector is to furnish the Authority with a report – (a) detailing the nature of the inspection; and (b) containing copies of any photographs or documents and particulars of any test, examination or items seized during the course of the inspection; and (c) advising any recommendations of the inspector. 59A. Powers of Authority following inspection (1) Following receipt of a report from an inspector under section 59 , the Authority may make a decision – (a) that no further action be taken; or (b) that action is required by the relevant party to ensure that the premises are suitable for use as pharmacy business premises; or (c) that the premises are being unlawfully used as pharmacy business premises. (2) If the Authority determines that action is required by the relevant party pursuant to subsection (1)(b) , the Authority may direct the relevant party to carry out specified works or actions in relation to the pharmacy business premises and, if it considers it appropriate to do so in the circumstances, further direct the relevant party to close, and not trade from, the pharmacy business premises until those works or actions have been carried out. (3) If the Authority determines that the premises are being unlawfully used as pharmacy business premises pursuant to subsection (1)(c) , the Authority may take appropriate action in accordance with this Act to prevent the further unlawful use of the premises as pharmacy business premises. (4) The Authority is to serve a notice of its decision made under subsection (1) on the relevant party. (5) The written decision of the Authority is to contain the following information: (a) the reason for the decision; (b) in the case of a decision referred to in subsection (1)(b) – (i) a general description of the work to be carried out at the premises; and (ii) whether the decision includes a direction under subsection (2)(b) that the pharmacy business premises be closed until the work or actions have been carried out; and (iii) the day on which the decision is to take effect; and (iv) the relevant party's right to appeal against the decision to the responsible tribunal under section 60 ; (c) in the case of a decision referred to in subsection (1)(c) – (i) a statement to the effect that the premises are being unlawfully used as pharmacy business premises; and (ii) a statement to the effect that the premises must not continue to be used as pharmacy business premises; and (iii) the date upon which the notice was served; and (iv) the relevant party's right to appeal against the decision to the responsible tribunal under section 60 . (6) A decision of the Authority referred to in subsection (1)(b) or (c) takes effect notwithstanding the relevant party's right of appeal. (7) Nothing in subsection (6) is intended to restrict – (a) a relevant party's right to appeal the decision of the Authority; or (b) the responsible tribunal's power to order a stay of the decision; or (c) the Authority's power to prosecute for an offence committed under this Act. (8) If the Authority's decision under subsection (1)(b) or (c) takes effect, the Authority may do any or all of the following: (a) give notice of its decision to a registration board and such other bodies as it considers appropriate; (b) give notice of its decision to the Secretary; (c) cause notice of its decision to be published in the Gazette, in any newspaper or in any professional publication related to the practice of pharmacy; (d) cause notice of its decision to be published in any other way it considers appropriate. (9) The Authority may not do any of the things specified in subsection (8) until – (a) the expiration of the period within which the relevant party may lodge an appeal against the decision; or (b) if the relevant party lodges an appeal against the decision, the decision is affirmed or varied by the responsible tribunal or the appeal is withdrawn. (10) The Authority, as an alternative to taking action under subsection (2)(a) or (b) , may accept an undertaking from the relevant party to take or refrain from taking specified action either generally or within a specified period of time. (11) If the Authority has appointed an inspector following the referral of a complaint from the Health Complaints Commissioner, the Authority must, within a reasonable period, notify the Health Complaints Commissioner of the outcome of the inspection, including details of any notice served under subsection (4) . (12) If the Authority has appointed an inspector following a request from a registration board, the Authority must, within a reasonable period, notify the relevant registration board of the outcome of the inspection, including details of any notice served under subsection (4) . 59B. Failure to comply with Authority's direction (1) If the Authority – (a) takes action under section 59A(2)(a) or (b) ; or (b) accepts an undertaking under section 59A(10) – and the relevant party fails to comply with the direction or undertaking, the Authority may take action under section 71H . (2) The Authority may not take action under section 71H until – (a) the expiration of the period within which the relevant party may lodge an appeal against the decision; or (b) if the relevant party lodges an appeal against the decision, the decision is affirmed or varied by the responsible tribunal or the appeal is withdrawn. PART 5 - Appeals 60. Right of appeal (1) A person may appeal to the responsible tribunal if the person is aggrieved by a decision of the Authority that is made for the purposes of this Act. (a) . . . . . . . . (b) . . . . . . . . (c) . . . . . . . . (d) . . . . . . . . (e) . . . . . . . . (f) . . . . . . . . (g) . . . . . . . . (h) . . . . . . . . (i) . . . . . . . . (j) . . . . . . . . (k) . . . . . . . . (2) The appeal is to be instituted within 28 days after notice of the Authority's decision is given to the person. 61. . . . . . . . . PART 5A - Interests in Pharmacy Businesses 61A. Application of Part (1) This Part does not bind the Crown. (2) This Part does not apply to a pharmacy business located wholly within a hospital operated by an agency or instrumentality of the Crown in right of Tasmania or the Commonwealth. (3) In this Part – close relative, of a pharmacist, means – (a) the spouse of the pharmacist; or (b) the son, daughter, grandson or granddaughter of the pharmacist; or (c) any child of the spouse of the pharmacist, of whom the pharmacist is not the natural parent; or (d) the father, stepfather, mother or stepmother of the pharmacist; or (e) the brother, step-brother, sister or step-sister of the pharmacist; spouse, in relation to a pharmacist, includes a person who is in a significant relationship with the pharmacist within the meaning of the Relationships Act 2003 . 61B. Applying to hold an interest in pharmacy business (1) A person, including a body corporate, that intends to hold an interest in a pharmacy business must apply to the Authority for a certificate deeming the person to be eligible to hold an interest in a pharmacy business (an eligibility certificate), unless the person is an exempt person. (2) An application is to be – (a) in an approved form; and (b) lodged with the Authority; and (c) accompanied by the prescribed application fee, if any; and (d) accompanied by such information or evidence as the Authority requires. (3) The Authority may require the applicant to provide such further information or evidence as it considers necessary in order to consider the application. (4) The Authority may waive all or part of the application fee. (5) The Authority, after considering an application for an eligibility certificate may – (a) issue an eligibility certificate; or (b) refuse to issue an eligibility certificate. (6) The Authority must issue an eligibility certificate to an applicant if – (a) the applicant is an eligible person within the meaning of section 61C ; and (b) the applicant is a fit and proper person, and in the case of a body corporate each of its members is a fit and proper person, to hold an interest in a pharmacy business; and (c) the applicant complies with subsections (2) and (3) . (7) An eligibility certificate remains in force until the earlier of the following: (a) the lapsing date following its date of issue; (b) the end of the period of 14 days commencing on the day a change occurs in the matters relied upon in support of the application for the certificate. (8) If the Authority refuses to issue an eligibility certificate, the Authority is to give the applicant notice of – (a) the refusal; and (b) the reasons for the refusal; and (c) the right to appeal the refusal. 61C. Eligibility (1) A person is eligible to hold an interest in a pharmacy business if, and only if – (a) in the case of a natural person, he or she is a pharmacist, whether or not that pharmacist has had his or her registration suspended within the meaning of the Health Practitioner Regulation National Law (Tasmania); or (b) in the case of a partnership, each member of the partnership is a pharmacist whether or not one or more of those pharmacists have had their registrations suspended within the meaning of the National Practitioner Regulation National Law (Tasmania); or (c) in the case of a body corporate, each director of the body corporate is a pharmacist and each other member of the body corporate is a pharmacist or a close relative of a pharmacist and – (i) the controlling interest in the body corporate is held by a pharmacist or by persons who are pharmacists; and