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Thursday, 12 December 2013
Page: 2585


Mr DUTTON (DicksonMinister for Health and Minister for Sport) (12:38): I move:

That this bill be now read a second time.

I am pleased to introduce the Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, which amends the Therapeutic Goods Act 1989.

The purpose of this bill is to make a number of changes that will contribute to a reduction in regulation or in potential health risks to the public, improving the transparency of the regulatory scheme or providing greater clarity and certainty about the operation of the act.

An important measure included in the bill, which is the power of the minister to remove products from the operation of the Therapeutic Goods Act in appropriate circumstances, will provide a basis to address the growing trend of therapeutic claims being made for all manner of products to appeal to health conscious consumers. Jewellery, bedding and even clothing may be marketed for their claimed health or wellbeing benefits, and because of such claims, may draw those products within the regulatory scheme for therapeutic goods, a scheme which is primarily directed at the regulation of goods designed specifically to, amongst other things, ameliorate, prevent, treat or influence ailments, diseases or injuries.

This has come about because the definition of 'therapeutic goods' in the act is very wide, and may capture goods in respect of which any claim is made that it could, for example, influence or modify a physiological process in persons. Claims made that a good will influence a person's wellbeing, physical attributes or mood could well bring those products within the description of 'therapeutic goods' and attract regulation under the act.

New section 7AA will allow the minister to remove such products from the regulatory scheme for therapeutic goods, and reduce unnecessary or inappropriate regulation of goods that are caught by the act only because of claims made about them, particularly where any concerns about the nature and extent of those claims may be more appropriately dealt with under other existing regulatory schemes, such as the consumer protection laws.

In making decisions to remove products from the operation of the act, the minister must consider a number of factors, including whether it is likely that the goods in question—if not regulated under the act—might harm the health of members of the public, whether it is appropriate in all the circumstances for the goods to be regulated under the act, and whether the goods could be more appropriately dealt with under another regulatory scheme. The new section will provide the first opportunity for particular goods to be removed from the regulatory constraints of the act where those goods, for instance, do not represent a health risk, or where there may be other sound reasons for not regulating the products under therapeutic goods legislation. The Australian public should be assured that there is no intention to use this power to remove from the regulatory oversight of the TGA medicines and medical devices in relation to which standards, level of assessment for marketing approval and post market monitoring and compliance under the act is appropriate.

Any decision to exclude particular goods from the operation of the act will be by way of a legislative instrument, and will be subject to parliamentary scrutiny and where appropriate will involve industry and public consultation.

Consistent with this approach of ensuring that the focus of regulation under the act remains directed at products that have a genuine public health focus, the bill also includes a power for the secretary to remove goods from the Australian Register of Therapeutic Goods where they are not, in fact, therapeutic goods.

Such goods can find their way into the register where sponsors of low-risk products, such as complementary medicines, include goods that may be, for instance foods, into the register by means of electronic listing without pre scrutiny by the TGA.

A new power will allow the secretary to remove those products from the register but only after the sponsor has been afforded an opportunity to make submissions and any decision is subject to internal and, indeed, external review by the Administrative Appeals Tribunal.

Another measure that will have the effect of reducing regulation is the removal of the offence provisions directed at applicants seeking marketing approval for their therapeutic goods who fail to provide information required by the TGA about their goods. The application of these offence provisions to such applicants is unnecessary because if an applicant fails to respond to a requirement to provide information this could lead to a refusal to grant marketing approval for the applicant's goods, and this will mean that the goods may not be lawfully manufactured or supplied.

Other measures that reduce regulation include expanding the scope of the definition of a 'kit' which will allow a greater range of products to be subject to a simpler regulatory approval process, and amendments to allow the reversal of cancellation decisions done at the request of sponsors and holders of licences thus avoiding review procedures or the need to seek new marketing approval or licences.

To assist industry with complying with current regulatory requirements, a number of changes have been made to clarify the operation of existing provisions in the act.

One of those is the reference to the obligation to comply with requirements relating to advertising applicable under the act and regulations. An amendment has been included to clarify that these advertising requirements include complying with applicable provisions of the Therapeutic Goods Advertising Code, a document that sets out rules for the advertising of therapeutic goods. Among other things, this requirement to comply with 'advertising requirement' forms one of the criteria for determining whether goods should be included in the register and whether goods should be removed from the register because of non-compliance with this requirement. Information about compliance with advertising requirements may also be required from sponsors of therapeutic goods applying to include their goods in the register or who have goods already included in the register.

The process by which higher risk medicines are registered in the register has been made clearer, with changes to the act that clarify under which provisions of the act decisions to approve product information, and decisions to approve an application to register medicines, are made. Both decisions are interrelated, and the amendments clarify that, where a decision to approve an application and a decision on product information have both been made, additional administrative steps that are already required under the act must be followed before the medicine may actually be included in the register, from which time the sponsor of that medicine may then lawfully market it.

To assist with clarity and provide greater consistency, amendments have been included to address a legal anomaly to ensure that the offence for publishing or broadcasting an advertisement about therapeutic goods to the public containing a prohibited representation for a low-risk medicine (for example, a reference to the treatment of cancer) does not apply where the sponsor of the goods has been given the TGA's permission under the act to use the representation in particular circumstances. This will ensure that a sponsor with such permission will be able to use the representation in accordance with the permission without fear of committing an offence.

To reduce potential health risks to the public, two new grounds for cancelling goods from the register have been included in the bill. One of these grounds enables the TGA to cancel products from the register where the presentation of therapeutic goods is no longer acceptable. Presentation includes how the goods are named, how they are labelled and packaged, and any advertising or other informational material associated with the goods. Presentation is one of the matters that is relevant to a decision whether to include medicines and biologicals in the register. The effect of the new ground of cancellation is to ensure that this important pre-condition to the inclusion of goods in the register continues to apply while they remain in the register but will not increase the regulatory burden on compliant sponsors and is aimed solely at safeguarding public health. It should be noted in this context that the TGA already has the power under the act to cancel medicines from the register that do not comply with applicable standards such as the standard on medicine labelling and packaging.

The second ground of cancellation of goods from the register relates to a failure by a sponsor to comply with a request to provide information about its medicines after the medicine has been included in the register. This information may be required to inform the TGA about whether the medicine in question should remain in the register, or whether regulatory action should be taken in relation to that medicine because of any concerns about its safety, efficacy or quality. Again, this measure would not increase regulatory burden for compliant sponsors who respond to requests for information about their products within the required time.

Sponsors have a right to both internal and external review about decisions the TGA makes to cancel products from the register.

Currently, it is an offence or a breach of a civil penalty provision for a sponsor of complementary medicines to give false or misleading information in response to a request by the secretary for information about their goods. An amendment has been included in the bill to extend this offence to also cover all sponsors of registered goods and other persons such as applicants for registration or listing to whom such requests for information can be made.

The bill also introduces offences and a civil penalty provision where sponsors of therapeutic goods give information that is false or misleading in a material particular in a request for approval of changes to their goods. The kinds of information that may accompany such requests can include complex and extensive scientific data about the goods, for example clinical trial results or the incidence of adverse reactions to prescription medicines. This information will often only be known to the sponsor, and can be critical to determining the quality, safety or efficacy of the goods. It is therefore important that the act contains an effective deterrence against providing false or misleading information to the TGA about goods that are being used by the Australian public.

These measures will not increase the regulatory burden on compliant sponsors but are, rather, aimed solely at safeguarding public health.

An amendment has become necessary to support the current transition arrangement for the reclassification of hip, knee and shoulder joint implants from class IIb medical devices to class III. These products were reclassified following the November 2011 inquiry by the Senate Standing Committee on Community Affairs on regulatory standards for the approval of medical devices. The proposed amendment will allow for an alternative number of days (to be prescribed in the regulations) to the current 20 working days for the secretary to decide whether to audit an application for marketing approval for a class IIb device seeking up-classification to class III and what information is required from the applicant for the purposes of undertaking that audit.

A large number of these transitional applications are expected in the lead-up to the end of the transition period on 30 June 2014. Allowing more time to determine whether an application should be audited will help ensure that the TGA can manage all the applications efficiently but will not adversely affect sponsors because their class IIb devices will remain on the register, allowing these to continue to be marketed, until their application for up-classification has been processed, providing their application is lodged before 30 June 2014. It will also help ensure that resources are not diverted from consideration of applications for other kinds of medical devices during that period.

Finally, measures that will require the TGA to publish details of cancellations of medicines on the TGA's website or in the gazette, and measures to allow the publication of decisions currently required to be published in the gazette to be published on the TGA's website, plus a new requirement for TGA to publish the outcomes of any internal review decision where the effect is to overturn a decision to suspend or cancel a product from the register, will improve transparency of the regulatory scheme established under the act.

In conclusion, the measures contained in this bill will make improvements to the regulatory scheme by making a contribution to reduction in regulation where appropriate and in potential health risks to the public, create greater transparency about decisions made under the act and assist industry by providing greater clarity, certainty and consistency in relation to the operation of the act.

Debate adjourned.