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THERAPEUTIC GOODS REGULATIONS (AMENDMENT) 1991 NO. 485
EXPLANATORY STATEMENTSTATUTORY RULES 1991 No. 485
Issued by authority of the Minister for Aged, Family and Health Services
Therapeutic Goods Act 1989
Therapeutic Goods Regulations (Amendment)
The Therapeutic Goods Act 1989 provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia.
Sections 17, 18, 19, 57 and 63 of the Therapeutic Goods Act 1989 relevantly provide in part as follows:
(a) Section 17 - the Secretary is to maintain a register, to be known as the Australian Register of Therapeutic Goods ("the ARTG"), which is to contain 2 parts, one relating to goods to be known as registered goods and the other relating to goods to be known as listed goods. Regulations may prescribe the therapeutic goods, or the classes of therapeutic goods, that are required to be included in each part of the Register;
(b) Subsection 18(1) - the regulations may, subject to any conditions, exempt all therapeutic goods, except those included in a class of goods prescribed for the purposes of paragraph 18(1)(a), specified therapeutic goods or a specified class of therapeutic goods, from the requirement to be included in the ARTG;
(c) Subsection 19(5) - the Secretary may, in writing, authorise a specified medical practitioner to supply specified therapeutic goods, or a specified class of such goods, to the class or classes of recipients specified in the authority. The regulations may prescribe the circumstances in which therapeutic goods may be supplied under an authority issued pursuant to subsection (5);
(d) Subsection 57(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; and
(e) Subsection 63(1) - the Governor-General may make regulations, not inconsistent with this Act, prescribing matters which include:
- the establishment of committees to advise the Minister or the Secretary on matters relating to therapeutic goods, and the functions and powers of those committees;
- providing for penalties not exceeding $1000 for offences against the regulations;
- setting different fees under this Act in relation to different classes of goods; and
- providing for the refund, reduction or waiving of fees or charges in cases identified in the regulations.
The amending regulations amend the Therapeutic Goods Regulations to:
(a) introduce the "Special Access Scheme" under which certain categories of persons, as identified in proposed new subregulations 12A and 12B, will be able to gain access, in the circumstances set out in those new regulations, to drugs that have not been approved for general marketing in Australia. These new provisions give effect to some of the recommendations contained in Professor Peter Baume's publication "A Question of Balance - Report on the Future of Drug Evaluation in Australia", commissioned for the minister for Aged, Family and Health Services. The Report contains recommendations designed to improve the Australian drug evaluation process and to bring it in line with other comparable developed countries. Professor Baume's recommendations contained in the Report were adopted as a package by the Government in July 1991;
(b) enable the Secretary to delegate his power to grant approvals for other persons to supply unapproved therapeutic goods to individuals. This function may now be delegated by the Secretary to certain medical practitioners employed in institutions that have an ethics committee;
(c) provide that breast implants will be required to be registered in the ARTG to ensure adequate evaluation of such products before they are marketed for supply to the general public;
(d) in line with recommendations contained in the Baume Report, make changes to the membership of, and tenure of office in, the Australian Drug Evaluation Committee, and to the membership and functions of the Therapeutic Device Evaluation Committee established under the Regulations; and
(e) provide for a reduction of evaluation fees for processing minor evaluations of data relating to therapeutic goods. Evaluation fees may also be reduced or waived in relation to applications to register therapeutic goods, or to vary information relating to registered drugs, if the Secretary has information relating to those goods or drugs that allows the evaluation of the applications to be abridged.
Details of the Regulations are set out in the Attachment.
ATTACHMENT
DETAILS OF THE THERAPEUTIC GOODS REGULATIONS (AMENDMENT)
Regulation 1 provides that the Therapeutic Goods Regulations are amended as set out in the proposed regulations;
Regulation 2 defines "Ethics Committee" for the purposes of new regulation 12B and new regulation 47A, inserted by proposed regulations 3 and 10 of these amending Regulations. An "ethics committee" means a committee that is constituted, and operates, as an ethics committee in accordance with guidelines, issued by the National Health and Medical Research Council, that are in force from time to time.
Regulation 3 inserts new regulations 12A and 12B. New regulation 12A describes the circumstances in which a wide range of therapeutic goods would be exempted from the operation of Part 3 of the Therapeutic Goods Act 1989, and therefore the requirement to be evaluated for safety, quality and efficacy before being supplied to a certain category of persons. New regulation 12B empowers the Secretary to grant an authority to specified medical practitioners, as set out in new subregulations 12B(1) and (3), for those practitioners to supply unapproved therapeutic goods, specified by the Secretary in the instrument of authorisation, to persons who suffer from a life-threatening, or otherwise serious, illness or condition.
New subregulation 12A(1) provides that, in the circumstances provided in this new regulation, all drugs, except those of a class or kind listed in the 9th Schedule to the Poisons Standard as in force from time to time, are exempted from the operation of Part 3 of the Therapeutic Goods Act 1989.
New subregulation 12A(2) provides that the exemption referred to in subregulation (1) applies only in relation to drugs that are set apart for supply to persons:
- who are 'Category A patients' as defined in new subregulation 12A(4); and
- who have given their informed consent, or whose guardians have given informed consent, to the drug being given to them; and
- whose treating physicians, at whose direction, or by whom, the drug is to be given, has signed a statement in relation to the use of that drug by those persons in a form approved by the Secretary.
In addition, the drug must be supplied on the prescription of a medical practitioner who has prescribed the.drug in accordance with good medical practice.
New subregulation 12A(3) provides that a medical practitioner who signs a statement in relation to a person supplied an unapproved drug, in the form referred to in new paragraph 12A(3)(b), must send a copy of the statement to the Secretary within 4 weeks of signing that form. The maximum penalty for a failure to comply with this requirement is $1,000.
New subregulation 12A(4) clarifies that the exemption contained in new regulation 12A does not affect the operation of any of the exemptions effected by Regulation 12.
New subregulation 12A(5) defines "category A patient" and "informed consent" for the purposes of new regulation 12A. "Category A patient" is defined as a person who is seriously ill, with a condition which is reasonably likely to result in death within a matter of months, or with a condition in respect of which premature death is likely if the condition is not treated early. "Informed consent", in relation to a treatment or proposed treatment, is defined as consent freely given after the person who has to give "informed consent" has been provided with sufficient information concerning the potential risks and benefits of the treatment to enable that person to make an informed decision whether to consent to the treatment.
New subregulation 12B(1) provides that, for the purposes of paragraph 19(6)(a) of the Therapeutic Goods Act 1989, the medical practitioners whom the Secretary is empowered to grant an authority to administer drugs identified in the Secretary's instrument of authorisation are the classes of medical practitioners listed in this new subsection.
New subregulation 12B(2) identifies the class of prescribed persons to whom medical practitioners, pursuant to an instrument of authorisation issued by the Secretary under subsection 19(5) of the Act, may supply unapproved drugs specified in the authorisation. These are persons who suffer from a life-threatening, or otherwise serious, illness or condition.
New subregulation 12B(3) provides that the person supplying drugs pursuant to an authority issued by the Secretary for the purposes of subsection 19(5) of the Act must comply with the treatment directions, if any, mentioned in the authority for that drug or class of drugs.
New subregulation 12B(4) sets out the prescribed class of medical practitioners to whom the Secretary may grant an authorisation to supply unapproved therapeutic devices, identified in the instrument of authorisation, and the condition which is to apply to the grant of that authorisation.
New paragraph 12B(4)(a) provides that the medical practitioners the Secretary may authorise for the purposes of supplying unapproved therapeutic devices must be a specialist in clinical practice at a hospital who is endorsed by the relevant ethics committee of that hospital, or by a relevant specialist medical college or specialist medical society, as a practitioner to whom an authorisation may be given by the Secretary.
New paragraph 12B(4)(b) provides that the instrument of authorisation is to state the particular intervention, or class of therapeutic intervention, for which the authorised practitioner may supply the therapeutic device or class of devices.
Regulation 4 introduces changes to the functions and membership of the Therapeutic Device Evaluation Committee (TDEC) by replacing subregulations 35(2) and (3) with new subregulations (2) and (3), and inserting new subregulation (3A).
New subregulation 35(2) provides that TDEC's functions are to give advice to the Minister or the Secretary in respect of the following matters:
- the safety, quality, efficacy, maunfacture, use and availability of therapeutic devices that are, or may be, imported into, exported from or supplied within, Australia;
- the priorities, policies and procedures that should be applied to the way the Act and the Regulations should be administered in relation to therapeutic devices;
- matters raised by sponsors or other persons about decisions or actions in relation to:
• the supply, use or modification of therapeutic devices;
• information provided on therapeutic devices; and
- drugs to the extent that the matters involved relate to the other functions of the Committee referred in this new subregulation.
New paragraph 35(2)(b) provides that where the Minister directs TDEC to do so in writing, TDEC is to give advice to other persons or bodies, in accordance with such a direction, in respect of matters about which TDEC has given advice under new paragraph 35(2)(a).
New subregulation 35(3) provides that TDEC is to comprise of at least 6, and not more than 9, persons appointed by the Minister, being persons who are eminent in their profession and who have qualifications and expertise in one or more fields relevant to the functions of the Committee.
New subregulation 35(3A) provides that in making appointments to TDEC, the Minister is to ensure that at least 4 members are medical practitioners, and that no more than 2 members be appointed who have expertise in the same field.
Regulation 5 substitutes subregulations 36(3) and (4) of the Regulations with new subregulations (3) and (4) to effect changes to the membership of and tenure of office in the Australian Drug Evaluation Committee (ADEC).
New subregulation 36(3) provides that ADEC is to consist of core and associate members, with 6 or 7 core members and between 10 to 20 associate members.
New subregulation 36(4) provides that of the members:
- appointed as core members by the Minister,
• at least 3 must be persons who are medical practitioners eminent in the medical profession, 2 of whom at least must be specialists in clinical medicine, and
• at least 1 person who is either a pharmacologist, or who holds a university degree in science or a branch of science and furthermore has specialised in pharmaceutical science;
- appointed as associate members,
• at least 1 must be a pharmaceutical chemist with recent experience in the manufacturing of therapeutic goods; and
• at least 1 person who is a toxicologist; and
• the remainder of associate members must either be a person fitting the description of any one of the persons described above in new paragraph 36(4)(b) or who is a medical practitioner with specialist qualifications and experience in a field of medicine that complements the expertise of core members with medical qualifications.
Regulation 6 substitutes subregulations 38(1) and (2) with new subregulations 38(1) and (2) to establish the length of time core members and associate members of ADEC may serve on that Committee.
New subregulation 38(1) provides that, except in relation to ADEC, and subject to subregulation 38(3), a member of a Committee established under Part 6 of the Regulations holds office for a term not exceeding 3 years.
New subregulation 38(1A) provides that, subject to subregulation 38(3), a member of ADEC may serve as a core member for a term not exceeding 3 years, and as an associate member for a term not exceeding 5 years.
New subregulation 38(2) provides that subject to the constraints affecting ADEC members set out in new subregulation (2A), a member of a Committee established under Part 6 of the Regulations is eligible for reappointment.
New subregulation 38(2A) provides that a person is not permitted to serve as a core member of ADEC for more than 3 consecutive terms, or for more than 5 terms in total.
Regulation 7 makes changes to the conduct of meetings by ADEC and TDEC.
Subregulation 7.1 substitutes paragraph 41(2)(b) to provide that 6 members, at least 3 of whom are core members, constitute a quorum at a meeting of ADEC.
Subregulation 7.2 inserts new subregulations 41(2A), (2B) and (2C).
New subregulation 41(2A) provides that associate members of ADEC eligible to attend a particular ADEC meeting are those invited to do so by the chairperson of the Committee.
New subregulation 41(2B) provides that ADEC is empowered to delegate to the chairperson of the Committee any function of the Committee.
New subregulation 41(2C) provides that TDEC may delegate to the chairperson of the Committee any function of the Committee.
Regulation 8 inserts new subregulation 45(4) to provide a further circumstance in which the Secretary may waive or reduce evaluation fees, set out in Schedule 9, payable by applicants applying to register therapeutic goods in the Australian Register of Therapeutic Goods or applying to vary written information relating to drugs registered in the Register.
New subregulation 45(4) permits the Secretary to waive or reduce the evaluation fees set out in Schedule 9 payable by an applicant seeking either to register therapeutic goods, or seeking to modify, or to vary written information relating to a registered drug, where the Secretary has information relating to the goods referred to in the application that allows the evaluation to be abridged.
Regulation 9 effects a technical change to regulation 47, and inserts new regulations 47A and 47B.
New subregulation 47A(1) provides that, for the purposes of this new regulation, 'delegation' means a delegation made, pursuant to subsection 57(3) of the Act, of the Secretary's power set out in paragraph 19(1)(a) of the Act to approve the supply by another person of unapproved therapeutic goods for the treatment of another person.
New subregulation 47A(2) provides that a delegation under this regulation may only be made to a person who is:
- a medical practitioner registered in a State or Territory who is employed by an institution that has an ethics committee, and
- subject to new regulation 47A(3), is proposed by the medical superintendent or, where there is none, a person occupying a position comparable to that of medical superintendent, of the employing institution, as a person the Secretary may appoint as a delegate under subsection 57(3) of the Act.
New subregulation 47(3) provides that where a person proposes, under new paragraph 47A(2)(b), a medical practitioner to be a delegate of the Secretary for the purposes of paragraph 19(1)(a) of the Act, and the Secretary decides to delegate that power to that practitioner as proposed, the person must then supervise any approval that the Secretary's delegate grants under the delegation.
New subregulation 47A(4) provides that a delegation must describe the person or class of persons to whom the relevant therapeutic goods may be supplied.
New subregulation 47A(5) provides that a delegation may be made to permit a practitioner to grant an approval for the supply of either a particular item of therapeutic goods, or a class of therapeutic goods, for treating a specific illness or condition.
New subregulation 47A(6) provides that a delegate may grant an approval for a person to supply therapeutic goods where the following circumstances have been met:
- the person granted approval to supply the therapeutic goods, who must be someone other than the delegate, has stated in writing that the person to be treated with the therapeutic goods referred to in the instrument of delegation has an illness or condition that requires treatment with the therapeutic goods; and
- an ethics committee has agreed to the granting of an approval by the delegate for the supply of the particular therapeutic goods, identified in the instrument of delegation, in the circumstances in which the delegate proposes to grant his or her approval.
New subregulation 47B(1) provides that a person who has been appointed as a delegate under subsection 57(3) of the Act, or a person who has been authorised by the Secretary to supply specified unapproved therapeutic goods under subsection 19(5) of the Act, must provide a report in accordance with this new regulation every 3 months to the Secretary.
New subregulation 47B(2) provides that a report must:
- be made in accordance with a form approved by the Secretary; and
- list each drug and therapeutic device approved for administration or supply by that person during the period covered by the report; and
- state the number of new approvals, and the number of repeat approvals, of drugs and therapeutic devices that the person gave during that period.
Revelation 10 amends Item 3 of Schedule 3 by inserting "implantable breast prosthesis" as a therapeutic device required to be registered in the ARTG.
Regulation 11 amends paragraph (b) of Item 5 of Schedule 5 of the Regulations to qualify the present condition that all injectables not included in the ARTG require an approval under section 19 of the Act before they may lawfully (providing all other conditions in Item 1 of Schedule 5 have been met) be imported for the use of the importer or the importer's immediate family. The amendment restricts the requirement for a section 19 approval, insofar as injections are concerned, to injections containing material of human or animal origin.
Regulation 12 amends the schedule of fees contained in Schedule 9 of the Regulations.
Subrecrulation 12.1 amends Item 4 to provide that the fee for an evaluation of information covered by Item 4 that involves an evaluation of not more than 10 pages of data is to be $350.
Subregulation 12.2 amends Item 5 of Schedule 9 to provide a fee of $350 to effect a modification or variation of information relating to a drug included in the Register that was registered following processing by the Compliance Branch of the Therapeutic Goods Administration.
Subregulation 12.3 inserts new Item 15 to provide a fee of $350 for the evaluation of small quantities of data about a therapeutic device that takes half a day or less to process.