Community Services and Health Legislation Amendment Act 1991

No. 84 of 1991

TABLE OF PROVISIONS

PART 1—PRELIMINARY

Community Services and Health Legislation Amendment Act 1991

No. 84 of 1991

An Act to amend various Acts relating to matters dealt with by the Department of Community Services and Health, and for related purposes

[Assented to 26 June 1991]

The Parliament of Australia enacts:

PART 1—PRELIMINARY

Short title

1. This, Act may be cited as the Community Services and Health Legislation Amendment Act 1991.

Commencement

2. (1) Subject to this section, this Act commences on the day on which it receives the Royal Assent.

(2) Section 14 commences at the same time as the commencement of section 7 of the Nursing Homes and Hostels Legislation Amendment Act 1986.

Principal Act

3. In this Part, “Principal Act” means the Health Insurance Act 19731.

Interpretation

4. Section 3 of the Principal Act is amended:

(i) a treating practitioner; or

service rendered by or on behalf of a medical practitioner.”;

(e) by inserting in subsection (1) the following definition:

“ ‘clinically relevant service’ means a service rendered by a medical or dental practitioner or an optometrist that is generally accepted in the medical, dental or optometrical profession (as the case may be) as being necessary for the appropriate treatment of the patient to whom it is rendered;”.

5. After section 19da of the Principal Act the following section is inserted:

Offence where approval of premises as accredited pathology laboratory has been revoked

“19db. Where:

the proprietor or proprietors must cause to be taken such steps as are reasonable in all the circumstances to ensure that, before a pathology service is rendered in the laboratory:

are informed that a Medicare benefit would not be payable in respect of the pathology service if it were rendered in the laboratory.

Penalty: $100.”.

Accredited pathology laboratories

6. Section 23dn of the Principal Act is amended by inserting after subsection (7) the following subsection:

“(7a) Where the Minister revokes the approval of premises as an accredited pathology laboratory otherwise than at the request of the proprietor of the premises, the Minister must:

(i) in the Gazette; or

(b) cause a copy of the notice to be laid before each House of the

Parliament within 15 sitting days of that House after the notice has been given by the Minister.”.

Principal Act

7. In this Part, “Principal Act” means the National Health Act 19532.

Approval of nursing home

8. Section 40aa of the Principal Act is amended by omitting “and” from the end of paragraph (6) (ce).

Statements may be published about satisfaction of standards for nursing home care

9. Section 45da of the Principal Act is amended:

“to:

(a)     an approved nursing home; or

(b) by inserting after paragraph (2) (a) the following paragraph:

(c)     by omitting paragraphs (2) (c) to (h) (inclusive);

10. After section 45da of the Principal Act the following sections are inserted:

General information about approved nursing homes may be made available to the public

“45db. (1) The Secretary may make available to the public, in any way that the Secretary thinks fit, any or all of the relevant information in relation to:

(a)     an approved nursing home; or

(b)    premises that were an approved nursing home at any time

during the period of 5 years before the information is made available to the public.

“(2) The following is relevant information for the purposes of subsection (1):

(a)     the name and address of the nursing home;

(d)    services provided in the nursing home;

(e)     fees imposed, and charges made, in the nursing home;

(g)    the name of the proprietor of the nursing home;

(h) the number of vacancies (if any) in the nursing home;

“(3) The information made available must not be such as to enable the identification of an individual patient of a nursing home.

Information about Ministerial action and other information about approved nursing homes may be made available to the public

“45dc. (1) The Secretary may make available to the public, in any way that the Secretary thinks fit, any or all of the relevant information in relation to:

(a)     an approved nursing home; or

“(2) The following is relevant information for the purposes of subsection (1):

(c)    such other information (if any) as is specified in the regulations.

“(3) A reference in paragraph (2) (a) to action taken by the Minister under a particular provision includes a reference to:

“(4) A reference in paragraph (2) (b) to action the Minister intends to take under a particular provision includes a reference to action that the Minister intends to take under section 105aab in relation to a decision of the Minister made under the provision concerned.

“(5) The information made available must not be such as to enable the identification of an individual patient of a nursing home.

“(6) Before making the information available, the Secretary must allow the proprietor of the nursing home not less than 30 days to consider the information and to make submissions to the Secretary about the information.

“(7) If it appears to the Secretary in the light of any submission made by the proprietor that the information should be altered, the Secretary is to alter the information accordingly before it is made available.

“(8) Subsections (6) and (7) do not apply if the Secretary considers that there is an urgent need to make the information available in order to protect the welfare or interests of persons who are, or may become, patients of the nursing home.”.

11. After section 45e of the Principal Act the following section is inserted:

Declaration of non-compliance with conditions

“45ea. (1) If one or more conditions applicable to an approved nursing home have not been complied with, the Minister may, by written notice served on the proprietor, declare that the home does not satisfy those conditions.

“(2) Where a declaration is in force under subsection (1), the Minister may, by written notice served on the proprietor of the nursing home, determine that, while the declaration remains in force, Commonwealth benefit is not payable to the proprietor of the nursing home in respect of a patient admitted to the nursing home after the making of the determination.

“(3) While a determination under subsection (2) is in force:

“(4) On the revocation of a declaration under subsection (1), any determination under subsection (2) ceases to have effect.

“(5) This section does not imply that the Minister may not, in circumstances where the Minister is satisfied of the matter referred to in subsection (1) (whether or not the Minister has taken any action under this section), suspend or revoke the approval of the nursing home concerned as an approved nursing home under section 44 if he or she considers that to be a more appropriate course of action.

“(6) Section 45E does not limit this section.”.

Applications for review by Tribunal of certain decisions under Part V

12. Section 105aab of the Principal Act is amended:

(a)     by inserting in subsection (1) “or section 45ea” after “45a”;

(b)    by inserting after subsection (1) the following subsection:

“(1a) This section applies in relation to a decision of the Secretary under section 45db or 45dc as if:

Statements to accompany notification of decisions

13. Section 105ac of the Principal Act is amended:

Certain instruments subject to disallowance

14. Section 139b of the Principal Act is amended by inserting before paragraph (1) (b) the following paragraph:

PART 4—AMENDMENT OF THE NURSING HOMES AND HOSTELS LEGISLATION AMENDMENT ACT 1986

Principal Act

15. In this Part, “Principal Act” means the Nursing Homes and Hostels Legislation Amendment Act 19863.

Repeal of section 22

16. Section 22 of the Principal Act is repealed.

PART 5—AMENDMENT OF THE THERAPEUTIC GOODS ACT 1989

Principal Act

17. In this Part, “Principal Act” means the Therapeutic Goods Act 19894.

Interpretation

18. Section 3 of the Principal Act is amended by inserting in subsection (1) the following definitions:

“ ‘data processing device’ means any article or material (for example, a disc) from which information is capable of being reproduced with or without the aid of any other article or device;

‘gazetted therapeutic devices group’ has the meaning given by subsection 16 (3);

‘gazetted therapeutic goods group’ has the meaning given by subsection 16 (2);

‘grouped therapeutic goods’ means therapeutic goods included in:

(a)     a gazetted therapeutic goods group; or

(b)     a gazetted therapeutic devices group;”.

Power to obtain information with respect to therapeutic goods

19. Section 8 of the Principal Act is amended:

(a)     by omitting from subsection (1) “in writing” (second occurring);

(b)    by inserting after subsection (1) the following subsection:

“(1a) A notice under subsection (1) may require the information to be given:

(a)     in writing; or

(b)     in accordance with specified software requirements:

(i) on a specified kind of data processing device; or

Therapeutic goods, gazetted therapeutic goods groups and gazetted therapeutic devices groups

20. Section 16 of the Principal Act is amended:

(d)    by adding at the end the following subsection:

“(4) An order under subsection (2) or (3) may make provision for or in relation to a matter by applying, adopting or incorporating, with or without modification, a document as in force from time to time, if the document is:

(b)     available for sale to the public; and

Australian Register of Therapeutic Goods

21. Section 17 of the Principal Act is amended by adding at the end of subsection (4) the following word and paragraph:

Applications generally

22. Section 23 of the Principal Act is amended:

(c)     by omitting paragraphs (c) and (d);

(d)    by adding at the end the following subsections:

“(2) An application is not effective unless:

(a) if:

(i) the goods are not grouped therapeutic goods; or

the prescribed application fee has been paid; and

“(3) An approval of a form may require or permit an application or information to be given in accordance with specified software requirements:

(a)     on a specified kind of data processing device; or

(b)     by way of a specified kind of electronic transmission.”.

Applications for registration

23. Section 24 of the Principal Act is amended:

(a)    by inserting in subsection (1) “by the applicant” after “payable”;

“(2) An application for registration of therapeutic goods lapses if any part of the evaluation fee payable in respect of those goods remains unpaid at the end of the period of 2 months after the day on which the amount became due and payable.”.

24. After section 24 of the Principal Act the following sections are inserted:

When evaluation fee due for payment

“24a. Subject to section 24b, an evaluation fee under section 24 payable by an applicant is due and payable on the day on which the applicant is notified of the amount of the evaluation fee.

Payment of evaluation fee by instalments

“24b. (1) The regulations may provide for the payment of an evaluation fee under section 24 to be made by such instalments and at such times as are ascertained in accordance with the regulations, and the evaluation fee is due and payable accordingly.

“(2) Regulations made for the purposes of subsection (1) may provide that a person is not allowed to pay an evaluation fee under section 24

by instalments if any part of an instalment of that or any other evaluation fee payable by the person was unpaid immediately after the time when it became due for payment.

“(3) Subsection (2) does not limit the generality of subsection (1).

Recovery of evaluation fee

“24c. An evaluation fee under section 24 may be recovered by the Commonwealth as a debt due to the Commonwealth.”.

Evaluation of therapeutic goods

25. Section 25 of the Principal Act is amended by omitting paragraph (1) (b) and substituting the following paragraph:

(i) is due and payable by the person; and

(ii) remains unpaid; and”.

26. Section 27 of the Principal Act is repealed and the following section is substituted:

Registration or listing number

“27. (1) Where the Secretary includes therapeutic goods (other than grouped therapeutic goods) in the Register, the Secretary is to assign a unique registration or listing number to the goods.

“(2) Where the Secretary includes grouped therapeutic goods in the Register, the Secretary is to assign a single, unique registration or listing number to the grouped therapeutic goods.”.

Conditions on registration or listing

27. Section 28 of the Principal Act is amended:

(a) by inserting after subsection (3) the following subsection:

“(3a) The Secretary’s power under subsection (3) may be exercised at the request of the person concerned or of the Secretary’s own motion.”;

(b) by adding at the end the following subsection:

“(6) The regulations may make provision in relation to the charging of fees in respect of requests under subsection (3a).”.

Secretary may require information

28. Section 31 of the Principal Act is amended by adding at the end the following subsection:

“(3) An approval of a form may require or permit information to be given in accordance with specified software requirements:

(a) on a specified kind of data processing device; or

(b) by way of a specified kind of electronic transmission.”.

Inspection and variation of entries in Register

29. Section 32 of the Principal Act is amended by inserting after subsection (2) the following subsection:

“(2a) If a person makes such a request, then, instead of providing a copy of an entry to the person, the Secretary may, if the request is for the provision of the copy in an electronic form, provide the information contained in the entry:

(a)     on a data processing device; or

(b)     by way of electronic transmission.”.

Time for payment of charges

30. Section 44 of the Principal Act is amended:

(b)    by inserting after subsection (1) the following subsection:

“(1a) An annual registration charge or annual listing charge for a financial year that relates to grouped therapeutic goods becomes payable by a person on the day specified in relation to those grouped therapeutic goods in a written notice given by the Secretary to the person.”.

Delegation

31. Section 57 of the Principal Act is amended:

(b)    by adding at the end the following subsections:

“(3) Subject to the regulations, the Secretary may, in such circumstances as are prescribed, by signed instrument, delegate all or any of his or her powers under paragraph 19 (1) (a) to a person who is registered, in a State or internal Territory, as a medical or dental practitioner.

“(4) A delegate under subsection (3) is, in the exercise of a delegated power, subject to the directions of the Secretary or of an officer of the Department authorised, in writing, by the Secretary.

“(5) Without limiting the generality of matters that may be dealt with by regulations made for the purposes of subsection (3), the regulations may make provision in relation to the following:

(a) the persons who may be delegates;

Release of information

32. Section 61 of the Principal Act is amended by inserting after subsection (8) the following subsections:

“(8a) The regulations may make provision in relation to the charging of fees in respect of applications for information under subsection (6), including requiring deposits on account of such fees.

“(8b) Without limiting the generality of regulations that may be made for the purposes of subsection (8a), those regulations:

(i) searching for or retrieving information;

“(8c) If, in accordance with regulations made for the purposes of subsection (8a), a person is liable to pay a fee in respect of an application for information, the Secretary must notify the person, in writing, accordingly, and must give to the person, together with that notification, a statement setting out the basis on which the amount of that fee is calculated.”.

Application of amendments—registration or listing applications

33. The amendments made by sections 22, 23, 24 and 25 apply to applications made on or after the date of the commencement of this section.

Application of amendments—time for payment of charges

34. The amendments made by section 30 apply as follows:

Transitional—grouped therapeutic goods

35. (1) In this section:

“amended Act” means the Principal Act as amended by this Act;

“deemed single therapeutic goods” means therapeutic goods which, under section 16 of the Principal Act, are treated as single therapeutic goods for the purposes of Part 3 of the Principal Act.

(2)     For the purposes of the amended Act, an order under subsection 16 (2) of the Principal Act determining that a group of goods is to be treated as single therapeutic goods has effect as if it were an order under subsection 16 (2) of the amended Act determining that the group is a gazetted therapeutic goods group.

(3)     For the purposes of the amended Act, an order under subsection 16 (3) of the Principal Act determining that a group of goods is to be treated as single therapeutic goods has effect as if it were an order under subsection 16 (3) of the amended Act determining that the group is a gazetted therapeutic devices group.

(4)     For the purposes of the amended Act, a notice under section 19 or 31 of the Principal Act relating to deemed single therapeutic goods has effect as if it were a notice relating to the corresponding grouped therapeutic goods.

(5)     For the purposes of the amended Act, an application for registration or listing of deemed single therapeutic goods under section 23 of the Principal Act has effect as if it were an application for registration or listing, as the case may be, of the corresponding grouped therapeutic goods.

(6)     If a registration or listing (in this subsection called the “original registration or listing”) of deemed single therapeutic goods is in force immediately before the commencement of this subsection, the amended Act has effect, after the commencement of this subsection, as if a registration or listing, as the case may be, of each of the corresponding grouped therapeutic goods had commenced at the original registration or listing.

(7)     For the purposes of the amended Act, an assignment of a registration or listing number to therapeutic goods other than deemed single therapeutic goods under section 27 of the Principal Act has effect as if it had been made under subsection 27 (1) of the amended Act.

(8)     For the purposes of the amended Act, an assignment of a registration or listing number to deemed single therapeutic goods under section 27 of the Principal Act has effect as if it had been an assignment

to the corresponding grouped therapeutic goods under subsection 27 (2) of the amended Act.

(9) For the purposes of the application of Part 5 of the Principal Act to charges:

(b)     in respect of registrations or listings:

(i) in force at a particular time before that date; and

(ii) that commenced before that date;

if therapeutic goods were treated, at that time, as single therapeutic goods for the purposes of Part 3 of the Principal Act, then those goods are taken to have been treated as single therapeutic goods.

Transitional—prescribed application fees and approved forms— section 23 of the Principal Act

36. (1) In this section:

“amended Act” means the Principal Act as amended by this Act.

(2)     For the purposes of the amended Act, an application fee prescribed for the purposes of a provision of section 23 of the Principal Act has effect as if it had been prescribed for the purposes of the corresponding provision of section 23 of the amended Act.

(3)     For the purposes of the amended Act, a form approved for the purposes of a provision of section 23 of the Principal Act has effect as if it had been approved for the purposes of the corresponding provision of section 23 of the amended Act.

NOTES

NOTES—continued

118, 131 and 132, 1987; Nos. 79, 87, 99 and 155, 1988; No. 95, 1989; Nos. 3, 84, 106 and 141, 1990; and Nos. 6, 68, 70 and 73, 1991.

3.      No. 115, 1986.

4.      No. 21, 1990, as amended. For previous amendments, see No. 141, 1990.