Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2003 (NO. 1) 2003 NO. 111

STATUTORY RULES 2003 No. 111

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

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2003 (No. 1)

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.

Section 63 of the Act provides that the Governor-General may make regulations, not inconsistent with the Act, prescribing matters required or permitted to be prescribed by the Act, or necessary or convenient to be prescribed for carrying out or giving effect to the Act. Paragraph 63(2)(a) of the Act provides that the Regulations can make provisions in relation to the establishment of committees to advise the Minister for Health and Ageing (the Minister) or the Secretary of the Department of Health and Ageing (the Secretary) on matters relating to therapeutic goods and the functions and powers of those committees.

The purpose of the Regulations is to:

•       provide for the manner in which the Secretary may put in place arrangements for the disposal of any unused therapeutic goods when the exemption under subsection 18A(1) of the Act ceases to have effect and these goods have not been used;

•       increase the membership of the Therapeutic Goods Advertising Code Council (TGACC) and to require that the chairperson of that Council be a member nominated by the TGA; and

•       clarify the circumstances wherein a member of the Complaints Resolution Panel (CRP) would not be allowed to participate in the deliberation of complaints in relation to advertisements.

Subsection 18A(1) of the Act enables the Minister to exempt therapeutic goods from the usual registration or listing requirements needed for the supply of goods in Australia, where it is considered to be in the national interest to stockpile those goods in preparation for a potential threat to public health (paragraph 18A(2)(a)); or make available urgently goods that are required in response to an actual threat to public health caused by an emergency (paragraph 18A(2)(b)). Section 18A does not apply to medical devices. Generally, unless therapeutic goods are registered or listed in the Australian Register of Therapeutic Goods (the Register) or are exempted from the requirement to be included in the Register, the importation, manufacture or supply of such goods by their sponsors would be unlawful. It is important to emphasise that this exemption only allows the therapeutic goods concerned to be supplied without being registered or listed on the Register. The goods are not exempt from standards of Good Manufacturing Practice (GMP).

The exemption under subsection 18A(1) ceases to have effect at the end of the period specified by the Minister in the exemption as the period for which the exemption is to have effect, or when the exemption is revoked (subsection 18A(4)). In relation to "particular goods" specified in the instrument of exemption under subsection 18A(1), the exemption will cease to have effect when those goods become registered or listed goods or when the Minister varies the exemption by removing those goods from the exemption (subsection 18A(5)).

Subsection 30G(2) of the Act allows for the Secretary to arrange for the disposal of any unused goods exempted under subsection 18A(1) of the Act, in accordance with the Therapeutic Goods Regulations 1990 (the Principal Regulations), once the exemption ceases to have effect. While the goods remain "exempt goods" under the Act, the Minister is able to maintain control over these goods, through her power to impose conditions over the use, supply, storage and disposal of the exempt goods. However, once these goods cease to be "exempt", there is no power for the Minister to ensure that such goods are properly handled and disposed of. It is essential to ensure that any risks associated with the supply or use of these unevaluated goods will be minimised for the protection of the public and the environment.

The effect of the Regulations would be to allow the Secretary to closely monitor, deal with and dispose of the goods. The Regulations, in particular, prescribe the requirements and arrangements for the disposal of unused emergency goods. The disposal requirements and arrangements relate to: the giving of notice and records in relation to goods held; storage and disposal of goods; directions from the Secretary in relation to the disposal of unused emergency goods; the relocation of the unused emergency goods if they pose a risk to the public and the environment; destruction of the goods; export of the goods; supply of goods to authorised persons; compensation to the owner of the goods; record keeping requirements; and sanctions for non-compliance.

The Regulations also increase the number of members of the TGACC from 12 to 13 to allow the TGA to nominate an additional non-government member. The regulations would also provide that the chairperson of the Council would be nominated by the TGA. The reason for these changes relates to the recent establishment of the Interim Advertising Council (IAC) to assist in the development of a joint advertising scheme between Australia and New Zealand. An additional non-government member is necessary to facilitate the chairing of the TGACC by the same chair for the IAC, who is independent of both the industry associations and the TGA. This measure is consistent with the recently announced initiative by the Government for the formation of a Joint Trans-Tasman Agency to regulate therapeutic goods in both Australia and New Zealand. Given that the key role of the IAC is to progress the development of a Joint Trans-Tasman advertising scheme, it will be important that the IAC is able to closely observe the operations of the current Australian arrangements and the decisions and deliberations of the TGACC as part of it's consideration of the issues regarding a Joint Trans-Tasman advertising scheme.

The amendments to the Principal Regulations made on December 2002 relating to the consideration of complaints by the CRP resulted in unintended consequences in that when member organisations of a body represented in the CRP lodge a complaint relating to advertisements, the industry, consumer or professional representative to the CRP cannot take part in the deliberation of complaints. This is particularly a problem for bodies with a large membership. The amendments are intended to rectify this problem by only excluding a member of the CRP from the consideration of complaints relating to advertisements if that member or the body represented by that member in the CRP makes the complaint.

Details of the Regulations are set out in the Attachment.

The Regulations commence on gazettal.

ATTACHMENT

Details of the Therapeutic Goods Amendment Regulations 2003 (No. 1)

Regulation 1 states that the title of the Regulations will be the Therapeutic Goods Amendment Regulations 2003 (No. 1).

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

Regulation 3 provides that Schedule 1 amends the Therapeutic Goods Regulations 1990 (the Principal Regulations).

SCHEDULE 1 - AMENDMENTS

Item 1

Item 1 inserts a definition of "unused emergency goods" to mean therapeutic goods to which section 30G of the Act apply. Section 30G deals with the disposal of unused goods previously exempt under section 18A(1) of the Act. New regulations 12AAA, 12AAB and Schedule 5B have been made for the purposes of section 30G.

Item 2

Item 2 inserts new regulations 12AAA and 12AAB.

Regulation 12AAA applies when the exemption of specified therapeutic goods or therapeutic goods in a specified class declared by the Minister for Health and Ageing under section 18A(1) ceases to have effect before the end of the period specified in the instrument of exemption. The early cessation of the exemption could be due to the revocation of the exemption or when the Minister varies the exemption by removing particular therapeutic goods from the exemption. The Secretary of the Department of Health and Ageing is required to give notice of the cessation of exemption to all persons, who under the exemption, have been importing, manufacturing, supplying or exporting the goods, by writing to the person known to the Secretary or by widely publicising it in the Gazette. The notice will identify the goods covered by the early cessation of exemption and the date the exemption ceases to have effect. No notice will given where the exemption ceases at the end of the period specified by the Minister in the section 18A(1) instrument.

New subregulation 12AAB provides that new Schedule 5B to the Principal Regulations sets out the requirements of and arrangements for the disposal of unused therapeutic goods which were previously exempt under section 18A(1). However, regulation 12AAB and Schedule 5B will not prevent disposal, for example, through the supply of those goods to specified persons, in the following circumstances:

(a)       the goods have become registered or listed in the Register; the goods become exempt goods under section 18 of the Act; the goods become goods that are the subject of an approval or authority under section 19; or the goods are the subject of an approval under section 19A of the Act; and

(b)       the disposal is in accordance with other provisions of the Act and the Principal Regulations relevant to the particular goods.

Item 3

Item 3 increases the number of members of the Therapeutic Goods Advertising Code Council (TGACC) from 12 to 13.

Item 4

Item 4 substitutes new paragraph 42C(1)(e) which allows the TGA to nominate 2 members to the TGACC, consisting of one government member and one other member.

Item 5

Item 5 amends subregulation 42E(2) to the effect that the chairperson of the TGACC must be a member nominated by the TGA.

Item 6

Item 6 substitutes paragraph 42K(e) to the effect that a quorum must include a member nominated by the TGA. It is noted that as a result of Item 5, both members nominated by the TGA are included in the quorum.

Item 7

Item 7 substitutes a new subregulation 42Y(2) which restricts the circumstances wherein a member of the Complaints Resolution Panel (the Panel) would be excluded from a quorum for a meeting of the Panel. That member will not be included in the quorum if the complaint originated from that member or the body which nominated that member. However, if a complaint is made by an organisation which is a member of the body represented in the Panel, then the member nominated by that body would not be excluded from the quorum. Under the existing provision of subregulation 42Y(2) that member would be excluded from the quorum.

Item 8

Item 8 substitutes a new subregulation 42ZCAD(3) which restricts the circumstances wherein a member of the Panel would be excluded from participating in the deliberation of a complaint on advertisements relating to therapeutic goods if the complaint was made by that member or the body that nominated that member. If a member organisation of a body such as the Complementary Healthcare Council, for example, makes a complaint, the member of the Panel nominated by Complementary Healthcare Council can still participate in the deliberation of the complaint. Under the existing provision of subregulation 42ZCAD(3) that member would be excluded from participating in the deliberation of a complaint on advertisements.

Item 9

Item 9 inserts new item 9 in Schedule 5A of the Principal Regulations. The effect of this provision is to make unused emergency goods, directed by the Secretary to be exported under clause 7 of Schedule 5B, exempt goods under section 18 of the Act. However, the export of these goods is subject to the condition that the provisions of Schedule 5B continue to apply to these goods. For example, conditions specified under subclause 7(2) of Schedule 5B would apply such that a person who has control over these goods must still ensure that the goods are only accessible for the purposes relating to the export of the goods, the security of the good is appropriate to the level of risk that the goods could pose to the public and the environment and the integrity of the condition of the goods is maintained. Item 9 could allow in some instances the return of the unused emergency therapeutic goods to its overseas manufacturer or source.

Item 10

Item 10 inserts new Schedule 5B to the Principal Regulations. The scope of new Schedule 5B is not limited to persons specifically mentioned in the instrument of exemption under section 18A(1) of the Act. It also applies to person who has direct or indirect control over the unused emergency goods, unless otherwise stated in the specific provisions. New Schedule 5B sets out the requirements for, and arrangements for disposal of unused emergency goods. They provide for the following: the giving of notice and records in relation to goods held; storage and disposal of goods; directions from the Secretary in relation to the disposal, relocation, destruction, export and supply of goods; the owner's compensation rights as a result of the export or supply of goods to authorised persons; the keeping of records containing specified information about the goods and the right of the Secretary to order the destruction of the goods for failure to comply with the requirements under Schedule 5B. Disposal of the goods includes the destruction, exportation or supply of the goods.

SCHEDULE 5B

Clause 1. Clause 1 provides that a person who has been given a notice under subregulation 12AAA(2) of the early cessation of the section 18A(1) exemption in relation to specified goods is required to give written notice to the Secretary the quantities and location of any unused emergency goods over which the person has control. That person is also required to provide a copy of any records that the person is required to keep as a condition of the exemption for the particular therapeutic goods under section 18A(1). If the notice is given before the exemption ceases to have effect, the person is required to reply within 7 days after the exemption ceases. Otherwise, the person is required to reply within 7 days after the notice is given.

Clause 2. Clause 2 applies to persons who are importing, manufacturing, supplying or exporting goods permitted under an instrument of exemption made under section 18A(1) of the Act. This clause applies when the exemption under section 18A(1) ceases at the end of the period specified in the instrument and therefore no specific notice would have been given to those specified persons. These persons are required to give written notice to the Secretary within 7 days after the exemption under section 18A(1) ceases to have effect in relation to those goods, of the quantity and the location of goods under their control. Similarly they are also required to provide a copy of any records specified in the instrument of exemption for those goods.

Clause 3. Clause 3 provides the storage requirements that a person who has control over unused emergency goods must adhere to. The storage arrangements must ensure: that the goods are only accessible for supply, export, use or disposal in accordance with legislative requirements; appropriate security measures are accorded to the goods to avoid possible risks to the public and the environment; and the integrity of the condition of the goods is maintained. Clause 3 also requires that the disposal of unused emergency goods must be in accordance with the direction given by the Secretary under subclause 4(1).

Clause 4. Clause 4 allows the Secretary to give written direction to any person who has control over unused emergency goods to dispose of the goods as directed. A direction is not limited to persons specified in the section 18A instrument of exemption but must be given in accordance with clauses 5,6,7 and 8. Compliance with a direction given by the Secretary is mandatory.

Clause 5. Clause 5 allows the Secretary to direct that the goods at a particular location be relocated to another specified location if the existing storage conditions pose or would pose a risk to the public or the environment.

Clause 6. Clause 6 provides the circumstances wherein the Secretary could direct that unused emergency goods be destroyed within specified time limits. Clause 6 also includes a situation wherein a person who has control over the goods requests that the goods be destroyed. The person who is directed to destroy the goods needs to ensure that the method of destruction is approved by the Secretary and avoids or minimises harm to the public and the environment. It would be considered non-compliance with the Secretary's direction under this clause if the goods are not destroyed within the specified time limits.

Clause 7. Clause 7 allows for the exportation of goods to which any of paragraphs 6(1)(a) to (e) applies. The Secretary can direct that the goods be exported to a particular country instead of being destroyed, if the relevant authority of a country agrees to accept these goods. A person directed to export these goods must ensure that during the process of exportation the goods can only be accessed for purposes relating to the export, the goods are appropriately secured and the integrity of the condition of the goods is maintained.

Clause 8. Clause 8 allows the supply of unused emergency goods to specified persons defined in subclause 8(3) if the goods have become registered or listed goods, the subject of an approval or authority under section 19 of the Act allowing for the use in the treatment or for use solely for experimental purposes in humans, or become the subject of an approval under section 19A of the Act. In some circumstances the exempt goods may be available for legal supply in Australia, in relation to a different indication to that specified in the instrument of exemption under section 18A(1).

Clause 9. Clause 9 makes it clear that when a direction is given by the Secretary in relation to the export of unused emergency goods or allow for the goods to be supplied to specified persons under clause 8, it does not affect a person's liability to pay the owner of the goods for the export or supply of the goods to the person.

Clause 10. Clause 10 provides that a person who has or had control over unused emergency goods is required to keep certain records. These records relate to the quantities of the goods, storage conditions prior to disposal, actions taken to dispose of the goods in response to a direction from the Secretary, and details of persons to whom the goods were exported or supplied and in what quantity. These records are required to be retained for 7 years. Should the Secretary requests for a record in writing, that person must respond within 14 days or within 24 hours or a shorter period specified by the Secretary if the information is required to establish whether the goods pose imminent risk to the public or the environment.

Clause 11. Clause 11 provides that if the person who has control over any unused emergency goods has not complied with any of the provisions in Schedule 5B, the Secretary has discretion to destroy the goods. For example, if a direction is given by the Secretary to dispose of goods in the manner directed and the person who holds the goods refuse to comply with that direction, the Secretary can order the destruction of those goods.