Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2000 (NO. 7) 2000 NO. 358

EXPLANATORY STATEMENT

STATUTORY RULES 2000 No. 358

Issued by authority of the Parliamentary Secretary to the Minister for Health and Aged Care

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2000 (No. 7)

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

The Governor-General may, under section 63 of the Act, make regulations for the purposes of the Act. In particular, the Governor-General may, under subsections 19(1A) and 19(4A), prescribe conditions under which approvals may be granted for the importation, exportation or supply of unapproved therapeutic goods used for experimental purposes in humans, as well as conditions for using such goods in the conduct of such experiments. Under paragraph 19(6)(a) and subsection 19(7) of the Act, the Governor-General may also prescribe the class of medical practitioners who may be authorised to supply unapproved therapeutic goods and the circumstances in which therapeutic goods may be supplied by medical practitioners who have been authorised to supply unapproved therapeutic goods.

The Therapeutic Goods Amendment Act (No. 3) 2000 amended the Therapeutic Goods Act 1989 (the Act) to strengthen the powers of the Secretary to require information from persons who are permitted under the Act to supply, or approve the supply, of therapeutic goods that have not been assessed and approved for general marketing pursuant to Part 3 of the Act. The amendments also strengthen some of the criteria allowing access by individuals to therapeutic goods that have not been approved for general supply. To ensure that access under the existing scheme to unapproved therapeutic goods occur within the permitted parameters, the amending Act permits conditions to be prescribed in connection with the grant of approvals to access unapproved goods, as well as for the use of such goods. Regulations may also be made to enable proper monitoring of the use of unapproved products, and prescribe conditions under which access to unapproved goods may occur without an approval.

The purpose of the Regulations is to enable the supply and use of unapproved therapeutic goods to be properly monitored to ensure that the supply and use of such goods accord with regulatory requirements. The amendments also make those who are permitted to supply or use such goods to be accountable for their actions

The amending regulations therefore:

(a) prescribe what information may be required to be lodged by an applicant seeking approval to supply unapproved therapeutic goods for experimental purposes, to enable the Therapeutic Goods Administration to properly monitor the lawful supply and use of such goods (Item 9 - new regulation 12AA);

(b) prescribe conditions for the grant of approvals for the supply of unapproved therapeutic goods for experimental purposes (Item 9 - new regulation 12AB);

(c) prescribe conditions for the use of unapproved therapeutic goods in clinical trials (Item 9 - new regulation 12AD);

(d) allow "authorised persons" to exercise powers under the Regulations, similar to those set out in section 48 of the Act, for the purposes of monitoring compliance with the requirements attaching to the supply and use of unapproved therapeutic goods (Item 9 - new regulation 12AC);

(e) prescribe the class of medical practitioners who may be authorised to supply unapproved therapeutic goods to prescribed classes of patients (Items 10 and 11); and

(f)       extend the existing reporting requirements for the supply of unapproved therapeutic goods to sponsors of such goods, as these sponsors may also be granted permission to supply unapproved goods in various circumstances (Item 13).

Details of the Regulations are set out in the Attachment.

The Regulations commenced on gazettal.

ATTACHMENT

Therapeutic Goods Amendment Regulations 2000 (No. 7)

Regulation 1 states that the title of these regulations will be the Therapeutic Goods Amendment Regulations 2000 (No. 7)

Regulation 2 provides that these regulations commence from the date of gazettal.

Regulation 3 provides that these regulations amend the Therapeutic Goods Regulations 1990 as provided in Schedule 1.

SCHEDULE 1 - AMENDMENTS

Item 1 inserts a new definition for "authorised person" under regulation 2 to refer to a person who has been authorised by new regulation 47AA to exercise powers under a provision of the Regulations, as an "authorised person". An "authorised person" has been conferred powers under new regulation 12AC to establish compliance with the requirements of the Regulations, and in particular those requirements relating to the supply of, and access to, unapproved therapeutic goods.

An "authorised person' is defined under paragraph (a) of the definition of "authorised person" in subsection 3(1) of the Act to mean, among other things, a person who has been authorised by the Secretary to exercise powers under those provisions of the Act which confer powers upon an "authorised person".

Item 2 removes the definition of "ethics committee" because there is now a definition for "ethics committee" in the Act.

Item 3 inserts two new definitions for "principal investigator" and "Practice Guidelines". A "principal investigator" means the person who is in charge of the conduct of a clinical trial of therapeutic goods. The meaning of "Practice Guidelines" is described in new paragraph 12AB(2)(a). The "Practice Guidelines" refer to the "Guidelines for Good Clinical Practice", as in force from time to time, published jointly by the International Conference on Harmonisation on Technical Requirements for Registration of Pharmaceuticals for Human Use, and the Committee for Medicinal Products.

Item 4 inserts a new definition for "specialist" which has the same meaning as in the Health Insurance Act 1973.

Items 5, 6 and 8 make consequential changes to reflect recent amendments to the Act which specifically provide that goods exempted from the operation of Part 3 of the Act (relating to the requirement for therapeutic goods to be included in the Australian Register of Therapeutic Goods before they may be lawfully marketed to the general public) are not exempt from the operation of sections 31C to 31F of Part 3 of the Act. Likewise, those sections (sections 31C to 31F of the Act) will also apply to unassessed therapeutic goods in relation to which special permission has been granted for their supply to individuals in certain circumstances. Sections 31C to 31F of Part 3 of the Act relate to the requirement to provide information or documents to the Secretary about the supply or use of, or access to, exempted or "unapproved" therapeutic goods, and the offences provisions that apply to the provision of false or misleading information or documents about such goods. The effect of the amendments effected by Items 6, 7 and 9 is to repeat the qualification that goods exempted from Part 3 of the Act are not exempt from the operation of sections 31C to 31F of that Part of the Act.

Item 7 makes consequential changes to reflect amendments made to the Act. The Act was amended to provide for two separate definitions for "exempt goods", and the effect of paragraph 12(2)(a) of the Regulations is to clarify that the reference to "exempt goods" in that provision is a reference to goods exempted from Part 3 of the Act, relating to requirements to include goods in the Register, and not Part 4 of the Act, relating to manufacturing requirements.

Item 9 inserts a new Regulation 12AA, 12AB, 12AC and 12AD.

New regulation 12AA: sets out the kind of information the Secretary may require to be lodged by an applicant seeking approval to conduct clinical trials of therapeutic goods. Information that may be required include:

-       the names of members of the ethics committee that gave its approval for the conduct of any trial and for which the committee has responsibility to monitor its conduct of the trial;

-       the name of the person who is in charge of each site at which the clinical trial is being conducted, unless that person is also the principal investigator; and

-       information about whether or not any conditions specified by the ethics committee has been met.

New regulation 12AB: sets out the conditions that attach to an approval granted under subsection 19(1) of the Act to allow a person to import, export or supply unapproved therapeutic goods used for experimental purposes in humans (generally, "unapproved therapeutic goods" are unregistered or unlisted goods that have not been evaluated or assessed to determine suitability for generally supply). These conditions are:

-       before any clinical trial may commence in relation to the goods for which an application has been made for the purposes of paragraph 19(1)(b) of the Act, the National Manager of the Therapeutic Goods Administration must have received, in relation to each approval granted pursuant to paragraph 19(1)(b) of the Act, the following written assurances and undertakings from both the person who has been granted an approval, as well as the principal investigator at each site of a clinical trial:

*       a written assurance that the trial will be conducted in accordance with the Practice Guidelines, as in force from time to time, and;

*       a written undertaking that each will comply with requests from an authorised person, whether made before or after the start of the trial, to give information about any aspect of the conduct of the trial, as well as allow an authorised person to do any of the things or all things mentioned in new regulation 12AC of the Regulations.

New regulation 12AC sets out the powers of a person who has been authorised to be an "authorised person" for the purposes of new R. 12AC of the Regulations. These powers are similar to the powers conferred upon an authorised person under section 48 of the Act for the general purpose of establishing whether the Act is being complied with. For the purposes of the Regulations, an "authorised person" is permitted to:

-       enter the site of a clinical trail;

-       search the site and any thing on the site;

-       inspect, examine, take measurements of and conduct tests on anything on the site that relates to the trial;

-       take photographs, make video recordings or make sketches of the site or any thing on the site;

-       inspect any books, records or documents on the site relating to the trial;

-       request the principal investigator to answer questions put by the authorise person and produce any book record or document requested by an authorised person.

An authorised person may search more than one area of a site at the same time.

New regulation 12AD sets out the conditions that may be prescribed, for the purposes of subsection 19(4A) of the Act, when therapeutic goods are approved for use for experimental purposes. These prescribed conditions are as follows:

-       any use of the goods in a clinical trial must be in accordance with the Practice Guidelines;

-       any use of the goods must also comply with a procedural protocol determined by the ethics committee that gave the approval for the trial of the goods and that has the function of monitoring the conduct of the trial at each site;

-       use of the goods must also be in accordance with the ethical standards set out in the national Statement on Ethical Conduct in Research Involving Humans, as in force from time to time, published by the National Health and Medical Research Council; and

-       use of the goods must cease if the ethics committee that granted the approval and has responsibility for monitoring the conduct of the trial informs the principal investigator that the use of the goods is inconsistent with either the procedural protocol determined by that committee or the use is inconsistent with any condition to which the approval for the use was given.

Item 10 amends subregulation 12B to qualify the classes of medical practitioners to whom authorisations may be granted for the supply of unapproved medicines to specified classes of recipients. The class of practitioners are medical practitioners engaged in a clinical practice outside a hospital and who has demonstrated that in relation to the proposed supply of an unapproved medicine the practitioner does not have access to an ethics committee that could approve the supply of that medicine, and who has instead obtained endorsement to supply that medicine from a specialist college having an established expertise relevant to the use of the medicine proposed to be supplied.

Item 11 amends paragraph 12B(4)(a) of the Regulations to qualify the circumstances in which unapproved therapeutic devices may be supplied by a medical practitioner for the purposes of subsection 19(5) of the Act to certain recipients. The circumstances are that the medical practitioner authorised to supply unapproved therapeutic devices must be a specialist engaged in clinical practice at a hospitals well as being endorsed by a relevant ethics committee of that hospital to supply that device.

Item 12 inserts new regulation 47AA to provide that an "authorised person", defined under paragraph 3(1)(a) of the Act, is a person who is authorised to exercise any powers given to such a person under a provision of the Regulations.

Item 13 amends regulation 47B to require a sponsor of therapeutic goods to provide a report to the Secretary every 6 months setting out the information required under subregulation 47B(3). This includes a list of each unapproved medicine and device supplied over the period covered by the report, and the number of medicines supplied during that period. Item 14 also amends subregulation 47B(1) to extend the period within which a medical practitioner or sponsor is required to lodge reports relating to the supply or 'approval' of unapproved therapeutic goods by that practitioner or by a sponsor for the purposes of paragraph 19(1)(a) and subsection 19(5) of the Act, from the current every 3 months to every 6 months.

Subregulation 47B(3) has been amended to specify what must be included in a report required to be lodged by a practitioner or sponsor who is permitted to supply unapproved therapeutic goods to individuals under paragraph 19(1)(a) or subsection 19(5) of the Act. The report must list each kind of therapeutic goods supplied by the person during the period covered by the report, and in the case of a sponsor, the report must also indicate the number of times therapeutic goods were supplied to medical practitioners, and the quantity supplied, in all circumstances where such goods were supplied without first being included in the Australian Register of Therapeutic Goods.

Items 14 and 15 amend the terms of the exemption applying to the supply of unapproved therapeutic, goods for the purposes of clinical trials. The amendment has the effect of including the same conditions, set out in new regulation 12AD, applying to the grant of an approval for the conduct of a clinical trial, to goods that may be supplied for clinical trial purposes without a person seeking approval to conduct the trial under subsection 19(1) of the Act. Supply of therapeutic goods in the second instance is subject to a number of conditions.


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