Bills Digest No. 7  2000-01 Therapeutic Goods Amendment Bill (No 3) 2000


Numerical Index | Alphabetical Index

WARNING:
This Digest was prepared for debate. It reflects the legislation as introduced and does not canvass subsequent amendments. This Digest does not have any official legal status. Other sources should be consulted to determine the subsequent official status of the Bill.

CONTENTS

Passage History
Purpose
Background
Main Provisions
Concluding Comments
Endnotes
Contact Officer & Copyright Details

Passage History

Therapeutic Goods Amendment Bill (No 3) 2000

Date Introduced: 29 June 2000

House: Senate

Portfolio: Health and Aged Care

Commencement: On the 28th day after Royal Assent

Purpose

To amend the Therapeutic Goods Act 1989 to provide additional powers to the Secretary of the Department of Health and Aged Care to monitor the supply and use of unapproved therapeutic goods, chiefly through the imposition of conditions and the power to obtain information and documents.

Background

The Therapeutic Goods Act 1989 establishes a uniform national system of controls on the availability within Australia of therapeutic goods.(1) The basic scheme of the legislation is that, unless exempt or given a specific approval by the Secretary of the Department, therapeutic goods must be entered on the Australian Register of Therapeutic Goods (the Register) as either 'registered' goods or 'listed' goods(2) before they may be supplied in, or exported from Australia.(3)

Before therapeutic goods are entered on the Register and made available to the public they are evaluated having regard to:

  • their quality, safety and efficacy for the purposes for which they are to be used;
  • their conformity with the applicable Australian and international standards;
  • the manufacture and quality control procedures used; and
  • other matters such as presentation.(4)

However, not all therapeutic goods are assessed and entered on the Register. Some therapeutic goods are specified in the Therapeutic Goods Regulations to be exempt from the registration and listing process.(5) For example, drugs to treat a Category A patient (a patient who is seriously ill and likely to die within months) are exempt if the treating medical practitioner signs a statement and sends it to the Secretary.(6) This is because in a life-threatening situation it is often impractical to wait months or years until the drug can be evaluated and entered on the Register. In addition, under the Personal Import Scheme, individuals can legally import most therapeutic goods for personal use, subject to restrictions on the quantity that can be imported in any twelve-month period,(7) without the goods being entered on the Register.

In addition to drugs which are exempt by Regulations, drugs which have been given written approval by the Secretary do not have to go through the assessment process and be entered on the Register. Approval may be granted to import, export or supply a particular drug for use in the treatment of an individual (special treatment approval) or for use in experiments in humans (clinical trial approval).(8) Approval may also be granted where similar registered goods are in short supply or are unavailable (substitute product approval).(9)

Where a particular medical practitioner is likely to treat a significant number of patients with the same condition with the same drug, he or she may apply to the Secretary for approval to supply a specified drug or drugs to a specified class of patients (authorised prescriber authority).(10) This removes the need for the medical practitioner to obtain a separate approval for every patient.

The purpose of permitting some drugs that have not yet been approved for entry on the Register to be either exempt or approved is to give the Australian community access to new, potentially life-saving treatments, and to allow access to drugs for the purpose of conducting clinical trials. The Government claims that:

The resulting exemptions have been very successful in achieving greater patient access to new drugs. Notification of clinical trials to the Therapeutic Goods Administration under the [Clinical Trial Notification] scheme has resulted in a very marked increase in clinical trial activity in Australia. From less than 50 clinical trials conducted in 1990 there are now well over 400 new clinical trials notified to the [Therapeutic Goods Administration] each year.(11)

However, there has been some concern about the minimal level of Commonwealth involvement, and the extent to which reliance is placed on medical practitioners and institutions.(12) The amendments proposed by the Bill go some way towards addressing these concerns, giving the Commonwealth powers designed to achieve greater control over the use, handling and supply of unapproved therapeutic goods. These include:

  • power to require persons to provide information or documents about how approved or exempt therapeutic goods are used
  • power to impose conditions on the manner in which clinical trials are conducted, and
  • a requirement that authorised prescribers be vetted and approved by an ethics committee.

Main Provisions

All references to items are to items in Schedule 1 of the Bill.

Conditions of clinical trial approvals

Special treatment approvals, clinical trial approvals and substitute product approvals given by the Secretary are already subject to any conditions the Secretary stipulates in the notice of approval.(13) The Bill continues to permit the Secretary to impose conditions specifically on individual approvals.

Proposed subsection 19(1A) makes clinical trial approvals additionally subject to any conditions specified in the regulations. This gives the Secretary additional power to make all clinical trial approvals, or a particular class of clinical trial approvals, subject to generic conditions (such as requirements relating to the provision of information), without the need to individually specify these conditions in each clinical trial approval granted. This power to impose conditions by regulations does not apply to special treatment approvals or substitute product approvals.

Specific conditions may also be imposed by the regulations on the use by a person of particular therapeutic goods which have been given clinical trial approval (proposed subsection 19(4A)). These conditions may set out matters such as how the goods are to be used, monitoring of their use and the results of their use, and the circumstances in which their use must be stopped.

Any conditions imposed by the regulations on clinical trial approvals apply both to clinical trials currently approved as well as to approvals to be granted in the future (items 6 and 8).

It is currently an offence under the Act to breach a condition of an exemption or a condition of an approval given by the Secretary. Item 13 makes it also an offence to breach a condition imposed by regulations on a clinical trial approval. The maximum penalty remains a fine of 60 penalty units (currently $6,600).(14)

Conditions of authorised prescriber authorities

Currently, there is no power to impose conditions on an authorised prescriber authority. The Bill amends this, providing that a particular authorised prescriber authority can be made subject to conditions if the Secretary gives written notice of the conditions (proposed subsections 19(5A) and (5B)). The Secretary can impose conditions on an authorised prescriber authority granted either before or after the Bill commences (item 10).

Power to require information

Item 16 inserts proposed sections 31A to 31F into the Therapeutic Goods Act. Proposed sections 31A and 31B enable the Secretary to obtain detailed information and documents about:

  • the supply of unapproved therapeutic goods
  • the medical condition of a person to whom a medicine is supplied,
  • what monitoring is being undertaken of the supply of these therapeutic goods (for example, for potential adverse reactions or side effects), and
  • the result of the administration of the particular goods (in terms of their success, lack of efficacy, side effects or other adverse consequences).

Proposed section 31A gives the Secretary power to obtain specified information or documents relating to exempt therapeutic goods from the sponsor of exempt drugs used in human experimentation, or the medical practitioner prescribing exempt drugs to a Category A patient. Even goods which were exempt under the regulations before the Bill commenced will now be subject to the information disclosure requirements (item 4).

Proposed section 31B gives the Secretary power to require detailed information or documents relating to therapeutic goods to be given by the person who is granted a special treatment approval or a clinical trial approval. Although the Secretary may already obtain information at the approval application stage,(15) this information can be provided after the approval has been granted, thus enabling the Secretary to monitor the use and effects of the goods.

The Secretary may also require information or documents relating to the use of the goods to be provided by the person using them (proposed subsection 31B(2)). An authorised prescriber may be required to provide detailed information about the supply, handling, monitoring and effect of the therapeutic goods prescribed (proposed subsection 31B(3)). The Secretary can request information under proposed section 31B relating to any approval, whether obtained before or after the Bill commences (item 17).

The Secretary must give a written notice to the person from whom information or documents are required. He or she may specify the form in which the information or documents are to be provided, including specific software requirements or by a specified kind of electronic transmission (proposed subsection 31C(2)). The person who is required to provide the information or documents must be given at least 14 days to provide the information (proposed subsections 31A(3) and 31B(4)), and must provide it within that timeframe (proposed subsection 31C(1)).

The Secretary also has power to release any information or documents obtained to State or Territory medical or pharmacy registration boards, as well as to appropriate Commonwealth, State or Territory authorities whose functions relate to therapeutic goods (proposed subsection 61(3A)).

Offences

The Bill creates a number of offences designed to ensure that full and correct information is provided to the Secretary on request.

It is an offence not to provide information in the form required or within the specified time period. The maximum penalty is a fine of 60 penalty units (currently $6,600) (proposed section 31C).

It is an offence to provide false or misleading information in response to a request for information, or to omit certain information, without which the information provided is misleading (proposed section 31D). It is also an offence to produce a document knowing it is false or misleading (proposed section 31E). The maximum penalty for both offences is imprisonment for 12 months. It is a defence to prove that the information or document is not false or misleading in a material particular, but the onus is on the person charged with the offence to prove that it was not material. No offence will be committed if a person produces a false or misleading document, but also provides a signed statement setting out the particulars in which the document is false or misleading (proposed subsection 31E(3)).

The privilege against self-incrimination does not excuse a person from giving information or producing a document, but the information or document will not be able to be used as evidence in criminal proceedings against the person who produced it (proposed section 31F). The only exception is that the information or document may be used in criminal proceedings for the offences contained in proposed sections 31D or 31E, relating to provision of false or misleading information or documents.

Ethics committees

Currently, a medical practitioner can only become an authorised prescriber if he or she falls into a specific class of medical practitioners described in the regulations. Proposed paragraph 19(6)(a) requires a medical practitioner also to be approved by an ethics committee (except in exceptional circumstances) to supply the specific drug or class of drugs before he or she can be approved by the Secretary. Item 1 defines "ethics committee" to mean a committee which:

  • is constituted and operates in accordance with the National Health and Medical Research Council's (NH&MRC) guidelines,(16) and
  • has notified its existence to the Australian Health Ethics Committee (AHEC).(17)

As ethics committees have an important role in the approval of practitioners to supply unapproved products, it is desirable that they function in accordance with the NH&MRC's established guidelines and have access to documents and guidance of the AHEC.(18)

Concluding Comments

In regulating the availability of therapeutic goods, a delicate balance needs to be struck between the need to ensure drugs are safe and effective for human use, and the understandable desire of those suffering debilitating or life-threatening conditions to have access to new, even experimental, drugs. The Therapeutic Goods Act 1989 has sought to strike that balance by permitting exemptions from the lengthy evaluation and registration process in the case of clinical trials or serious individual circumstances. This Bill maintains those procedures, but inserts additional safeguards for the patients involved, in the form of power to impose conditions on approvals, as well as extensive powers to obtain information relating to the use of exempt or approved drugs.

There is no indication in the Explanatory Memorandum as to why conditions should be imposed on existing clinical trial approvals as well as prospective approvals. Presumably, if the conditions include the provision of information about the conduct of trials and the results of such trials, this information would be relevant in relation both to existing and prospective trials. However, neither the Explanatory Memorandum nor the second reading speech confirms that the power to impose conditions will be used in this manner.

The Bill does not specify any criteria which an ethics committee must have regard to in making a decision whether to approve a medical practitioner as eligible to become an authorised prescriber. Nor is there any mechanism established by which a medical practitioner aggrieved by a decision not to approve him or her as an authorised prescriber can seek to have the decision of ethics committee reviewed.(19) Given that an ethics committee's decision affects the individual rights of both the patients who are under the medical practitioner's care as well as the practitioner himself or herself, the lack of any guidance as to the exercise of the discretion is curious.

Apart from these matters, the steps taken to increase Commonwealth scrutiny of the supply and use of unapproved therapeutic goods are to be welcomed.

Endnotes

  1. Therapeutic goods are divided broadly into two classes - drugs and devices. Therapeutic products are defined broadly to include items such as prescription medicines and vaccines, non-prescription medicines including vitamins and sunscreens, and traditional or alternative medicines such as herbal products, aromatherapy and homeopathic products. Therapeutic devices include devices such as pacemakers, heart valves, bandages and contraceptives.
  2. Therapeutic goods are divided into goods which must be registered (those assessed as having a higher level of risk) and those which may be listed on the Register (those of lower risk). Both registered and listed goods are assessed by the TGA for quality and safety, although registered goods undergo a more rigorous and detailed level of assessment. Only registered goods are assessed to see if they are efficacious. Listed medicines only contain well known established ingredients, usually with a long history of use, such as vitamin and mineral products or sunscreens, not scheduled poisons. The majority of listed medicines are self-selected by consumers and used for self-treatment. For more information see the TGA's publication Medicines Regulation And The TGA (December 1999), available at: http://www.health.gov.au/tga/docs/pdf/medregs.pdf.
  3. Registration occurs under subsection 25(3) and listing under subsection 26(1) of the Therapeutic Goods Act 1989.
  4. Subsection 25(1) of the Therapeutic Goods Act 1989.
  5. Section 18 of the Therapeutic Goods Act 1989.
  6. Regulation 12A of the Therapeutic Goods Regulations 1990.
  7. With the exceptions of drugs prohibited by Customs legislation or injectable drugs that contain material of human or animal origin, unless an import permit has been obtained. See Therapeutic Goods Regulations 1990, Schedule 5.
  8. Subsection 19(1) of the Therapeutic Goods Act 1989.
  9. Section 19A of the Therapeutic Goods Act 1989.
  10. Subsection 19(5) of the Therapeutic Goods Act 1989.
  11. Senator Ian Campbell, Parliamentary Secretary to the Minister for Communications, Information Technology and the Arts, Second reading speech, Senate Hansard, p. 15955.
  12. Senator Ian Campbell, Parliamentary Secretary to the Minister for Communications, Information Technology and the Arts, Second reading speech, Senate Hansard, p. 15955.
  13. Subsections 19(1) and 19A(6) of the Therapeutic Goods Act 1989.
  14. The current value of a penalty unit is $110: subsection 4AA(1) of the Crimes Act 1914 (Cth).
  15. Subsection 19(2) of the Therapeutic Goods Act 1989.
  16. Currently, the NH&MRC's National Statement on Ethical Conduct in Research Involving Humans. The full text of the statement is available at http://www.health.gov.au/nhmrc/publicat/synopses/e40syn.htm (4/8/00).
  17. The Australian Health Ethics Committee is a subcommittee of the NH&MRC which advises the NH&MRC on ethical issues relating to health. It is responsible for developing guidelines for conduct of medical research involving humans.
  18. Senator Ian Campbell, Parliamentary Secretary to the Minister for Communications, Information Technology and the Arts, Second reading speech, Senate Hansard, p. 15955.
  19. Section 60 of the Therapeutic Goods Act 1989 provides for review, first by the responsible Minister and then by the Administrative Appeals Tribunal, of decisions of the Secretary or the Secretary's delegate. However, the Secretary only has power to delegate his or her powers or functions, section 57. The decision of an ethics committee to approve a medical practitioner to obtain an authorised prescriber approval is not a power or function of the Secretary, it is conferred directly on ethics committees.

Contact Officer and Copyright Details

Katrine Del Villar
8 August 2000
Bills Digest Service
Information and Research Services

This paper has been prepared for general distribution to Senators and Members of the Australian Parliament. While great care is taken to ensure that the paper is accurate and balanced, the paper is written using information publicly available at the time of production. The views expressed are those of the author and should not be attributed to the Information and Research Services (IRS). Advice on legislation or legal policy issues contained in this paper is provided for use in parliamentary debate and for related parliamentary purposes. This paper is not professional legal opinion. Readers are reminded that the paper is not an official parliamentary or Australian government document.

IRS staff are available to discuss the paper's contents with Senators and Members
and their staff but not with members of the public.

ISSN 1328-8091
© Commonwealth of Australia 2000

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Published by the Department of the Parliamentary Library, 2000.

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