EXPLANATORY STATEMENT
Therapeutic Goods Act 1989
Therapeutic Goods Information (Outcomes of Compliance Reviews of Listed Complementary Medicines) Specification 2012
The Therapeutic Goods Act 1989 (the Act) provides for the establishment and maintenance of a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.
Section 61 of the Act lists a number of persons or organisations, such as the World Health Organisation and relevant State or Territory authorities, to which the Secretary of the Department of Health and Ageing may release specified kinds of therapeutic goods information. Section 61 also provides that the Secretary may release certain kinds of such information to the public, including information specified by the Minister for the purposes of such release by the Secretary.
Therapeutic goods information in this context is defined in subsection 61(1) of the Act as, relevantly, information in relation to therapeutic goods that is held by the Department (of which the TGA is a part) and which relates to the performance of the Department’s functions.
The Therapeutic Goods Information (Outcomes of Compliance Reviews of Listed Complementary Medicines) Specification 2012 (the Specification) is made by the Minister under subsection 61(5D) of the Act, and specifies kinds of therapeutic goods information that the Secretary may release to the public under subsection 61(5C) of the Act, about listed complementary medicines that the TGA has reviewed for compliance with regulatory requirements, and the outcomes of those reviews.
The Specification has the effect of permitting the Secretary to release therapeutic goods information of a kind mentioned in the Specification to the public.
The Specification commenced on the day after it was registered on the Federal Register of Legislative Instruments.
BACKGROUND
Subsection 61(5D) of the Act empowers the Minister to, by legislative instrument, specify kinds of therapeutic goods information for the purposes of subsection 61(5C) of the Act. Under subsection 61(5C) of the Act, the Secretary may release to the public therapeutic goods information of a kind specified by the Minister under subsection 61(5D) of the Act.
The purpose of the Specification is to support the release to the public of information relating to the compliance reviews by the TGA of listed complementary medicines by identifying, under subsection 61(5D) of the Act, the kinds of information that the Secretary may publish under subsection 61(5C) of the Act.
On 8 December 2011, the Parliamentary Secretary for Health and Ageing, the Hon Catherine King MP, announced a number of initiatives for reforming the TGA. The proposals, outlined in the TGA document ‘TGA reforms: a blueprint for TGA's future’ (the Blueprint) are intended to improve the Australian community's understanding of the TGA's regulatory processes and decisions, and to enhance public trust in the safety and quality of therapeutic goods.
A copy of the Blueprint is available from the TGA’s website (www.tga.gov.au).
The Blueprint was released in response to several major reviews of therapeutic goods regulation that were undertaken in 2010 and 2011, including a review aimed at identifying options to improve the overall transparency of the TGA, a report by the Auditor-General on the regulation of listed complementary medicines, and a review of aspects of complementary medicines regulation by an informal working group (the Complementary Medicines Working Group).
Recommendation 3 of the Auditor General’s report[1] was that the TGA make information available to the Australian public about listed complementary medicines that have been subjected to post-market review by the TGA, when the medicine was reviewed and the outcome of that review.
As a result, the TGA has committed to publishing the outcomes of its compliance reviews of listed complementary medicines in a timely manner.
‘Listed complementary medicines’ are those that are included on the Australian Register of Therapeutic Goods (the Register) under section 26A of the Act other than sunscreens. In Australia, medicinal products containing herbs, vitamins, minerals, and nutritional supplements, homoeopathic medicines and certain aromatherapy products are referred to as 'complementary medicines'. Complementary medicines comprise traditional medicines, including traditional Chinese medicines, Ayurvedic medicines and Australian indigenous medicines.
Listed medicines may only contain ingredients that have been evaluated by the TGA to be low risk, must be manufactured in accordance with the principles of good manufacturing practice (GMP) and may carry indications only for health maintenance and health enhancement or certain indications for non-serious, self-limiting conditions. Most, but not all, complementary medicines included on the Register are listed medicines.
Listed complementary medicines are included on the Register under section 26A of the Act via the operation of the TGA’s computer program the Electronic Listing Facility (ELF). This process does not involve any pre-market regulatory oversight by the TGA.
Applicants for listing are required, however, to certify as to the matters listed in subsection 26A(2) of the Act in relation to their medicines as part of the listing process. This ensures market access for these low-risk products as soon as possible.
The matters listed in subsection 26A(2) include that the medicine is eligible for listing (i.e. contains only low risk ingredients that have been approved by the TGA for inclusion in listed medicines and carries only acceptable kinds of indications), that it conforms to any applicable standards (including in relation to its manufacture), that the presentation of the medicine is not unacceptable and that the medicine is safe for the purposes for which it is to be used.
As the Act does not require pre-market assessment of listed complementary medicines, the TGA aims to assure, to the extent possible, the safety and compliance of listed complementary medicines through a program of random and targeted compliance reviews of a proportion of those included in the Register under section 26A. These compliance reviews are intended to identify instances of non-compliance with important regulatory requirements.
A compliance review of a listed complementary medicine involves assessing information about the listed complementary medicine against relevant legislative requirements, including, for example the certifications made by the sponsor in relation to the medicine at the time of listing. A compliance review may focus on one or several aspects of the medicine.
Based on experience and the potential risk that non-compliance with particular regulatory requirements can represent to the public, the TGA may give greater attention to the following three areas when assessing listed complementary medicines as part of a compliance review:
- the evidence that a sponsor holds to support a listed medicine’s indications and other claims;
- the presentation of the medicine; and
- the advertising for the medicine.
If non-compliance with regulatory requirements is identified in relation to a listed complementary medicine during a compliance review, appropriate actions may be taken under the relevant provisions of the Act, including the issuing of a proposal to cancel the medicine from the Register under section 30(3) of the Act.
Under section 30 of the Act the Secretary has power to cancel a listed complementary medicine from the Register on a variety of grounds, including that the certifications given by the medicine’s sponsor at the time the medicine was listed were incorrect. If under that section of the Act the Secretary is required to give the sponsor notice of an intention to cancel a listing, then the cancellation cannot occur unless and until the Secretary has taken into account any submissions made by the sponsor about the proposal to cancel.
The Secretary may also cancel the listing at the request of the sponsor.
It should also be noted that a listed complementary medicine may be subject to a number of compliance reviews while it remains on the Register.
The information detailed by the Minister in the Specification that may be released by the Secretary in relation to a listed complementary medicine that has been the subject of a compliance review includes:
- the listing number of the medicine in the Register;
- the name of the medicine;
- the sponsor of the medicine (i.e. the person in relation to whom the medicine is listed);
- the date the compliance review was completed; and
- whether, at the conclusion of the compliance review, the medicine has remained on the Register or was cancelled from the Register by the Secretary.
The Specification also permits the Secretary to release the following kinds of information about listed complementary medicines that have been cancelled by the Secretary following a compliance review:
- the listing number of the medicine in the Register;
- the name of the medicine;
- the sponsor of the medicine;
- the date on which the medicine’s cancellation from the Register took effect; and
- the provision in the Act on the basis of which the medicine was cancelled and, except in the case of a medicine cancelled at the request of the medicine’s sponsor, the reasons for the cancellation.
The kinds of therapeutic goods information that the Secretary can decide to release is set out at Schedule 1 to the Specification.
CONSULTATION
A number of key stakeholders were informed of, and consulted on, the release to the public of the kinds of therapeutic goods information relating to compliance reviews of listed complementary medicines set out in the Specification.
These stakeholders included bodies that represent specific industries relating to listed complementary medicines, including the Australian Self-Medication Industry Incorporated and the Complementary Healthcare Council of Australia and relevant consumer bodies the Australian Consumers Association (Choice) and the Consumers’ Health Forum of Australia.
Stakeholder comments received in response were considered and, where appropriate, were reflected in the approach taken by the TGA in relation to the release of compliance review information.
The Specification is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
In relation to compatibility with human rights, it is considered that the Specification is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a Statement of Compatibility setting that out in further detail is attached.
ATTACHMENTS
1. Statement of compatibility for a legislative instrument that does not raise any human rights issues (The Therapeutic Goods Information (Outcomes of Compliance Review of Listed Complementary Medicines) Specification 2012).
[1] ANAO, The Auditor-General Audit Report No.3 2011-12 Performance Audit, Therapeutic Goods Regulation: Complementary Medicines, 30 August 2011, available at http://www.anao.gov.au/Publications/Audit-Reports/2011-12/Therapeutic-Goods-Regulation-Complementary-Medicines.