- ADIA Dental Regulation Update: Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013

On 20 March 2013 the Australian Government presented to the Senate the Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013, which amends the Therapeutic Goods Act (Cth) 1989. The Australian Dental Industry Association (ADIA), the peak representative body for suppliers of quality dental product, is currently reviewing this legislation.

The purpose of this bill is to make a number of minor but important changes that the Australian Government claims will streamline and improve the operation by the Therapeutic Goods Administration (TGA) of the regulatory scheme for therapeutic goods under the act. Most of the amendments are of a minor, technical nature, designed to ensure, where appropriate, consistent regulatory treatment of the different types of therapeutic goods including prescription, over-the-counter and complementary medicines, therapeutic devices, biologicals and medical devices. Many of the changes, including a new offence, standardise or replicate existing regulatory requirements so that common regulatory rules and processes apply to all classes of therapeutic goods under the act.

There are two new measures included in the bill and they are intended to reinforce the objects of the act concerning the quality, safety, efficacy and timely availability of goods intended to have a therapeutic use.

Exclusion of therapeutic goods

The first is to include a power for the Minister for Health to make a legislative instrument, the effect of which will be to exclude products from the definition of 'therapeutic goods' and thus remove them from regulation under the act. The definition of 'therapeutic goods' in the act is very broad and can capture products wherever claims are made suggesting that they can modify any physiological process in persons. Increasingly, health and wellbeing claims are being made in relation to products for which public health is not, or is not likely to be, an issue. Some recent examples of goods for which therapeutic use claims have been made include mattresses which contain bacteria spores designed to reduce the effects of dust mites and 'power band' bracelets, which were claimed would boost a wearer's balance, strength and flexibility. Consumer protection may in fact be a more appropriate regulatory focus for these products than the more prescriptive therapeutic goods framework contained in the act.

This new power will allow the minister to respond flexibly, on a case-by-case basis, to ensure that products that are not suitable for regulation under the act can readily be removed. The new power cannot be used to expand the range of goods coming within the definition of 'therapeutic goods'.

Removal of therapeutic goods from the register

The second new measure is to provide specific power for the secretary of the department of health to remove goods that are not in fact 'therapeutic goods' from the Australian Register of Therapeutic Goods (ARTG) . Circumstances can arise where products are on the register although they were never - or were, but are no longer - therapeutic goods. This can come about, for instance, because sponsors of complementary medicines and low-risk medical devices can list their goods in the register without pre-screening or assessment by the TGA using an electronic listing facility by certifying as to a range of matters about the goods. As a consequence there can be instances where products are on the register that are actually foods or that otherwise do not come within the definition of 'therapeutic goods'. It is also possible that goods that were therapeutic goods when they were included in the register no longer come within the definition when claims of therapeutic use are no longer made. Any decision by the secretary to remove goods from the register could only be made after the sponsor of the goods has been given the opportunity to make submissions. The decision will also be subject to both internal review and review by the Administrative Appeals Tribunal.

A new power will be provided for the secretary to cancel the registration or listing of therapeutic goods from the register where a sponsor does not respond within the required period to a request from the secretary to provide specified information or documents about those goods. Such a power is already available to the secretary in relation to biologicals and medical devices on the register and provides an important incentive where the secretary is seeking information from the sponsor when considering whether to suspend or cancel goods from the register because their quality, safety or presentation may be unacceptable.

The secretary will also have the power in certain circumstances - for instance, where therapeutic goods have been cancelled from the register or in relation to which the secretary has come to the view that its safety, quality, efficacy, performance or presentation is unacceptable - to require a sponsor or supplier of the goods to provide information about the goods to the public or a class of persons, such as healthcare professionals or patients. Sponsors will also be required to provide the secretary with information about persons to whom the goods have been supplied. This will assist in the timely dissemination of information relevant to the safety or continued use of the goods.

Penalties for misleading amendments to the register

A new offence will be included for providing to the secretary false or misleading information in a material particular in connection with a request by the sponsor of therapeutic goods to vary its entry on the register. Such information can relate to whether the proposed variation will either have the effect of reducing the patient population for which the goods were originally approved - for instance, by removing an indication for a medicine - or to demonstrate that the proposed change will not result in any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used. It is critical that when making a decision to approve such a request the secretary has available accurate information about the goods and the effect of the proposed variation. The proposed offence and alternative civil penalty provisions mirror the sanctions that are already in place in the act for providing false or misleading information in connection with an application for inclusion of therapeutic goods in the register.

Suspension or cancellation of medicines from the register

A new ground for the secretary to suspend or cancel medicines from the register will be added to the act where its presentation no longer reaches an acceptable standard. It is currently a requirement under the act that the presentation of medicines - which includes the name, labelling, packaging of the goods and any advertising or other informational material associated with the goods - must be 'acceptable', in the case of registered medicines, or 'not unacceptable', in relation to listed medicines, for them to be included in the register. This ensures that those using the medicine are not misled about its use or characteristics and do not confuse it with other medicines. The secretary will be able to suspend or cancel the goods from the register if the presentation of the goods ceases to meet this criterion but only after giving the sponsor the opportunity to make submissions. Such a decision will be subject to internal review and review by the Administrative Appeals Tribunal.

Streamlining regulatory processes

The amendments will also streamline some of the processes and regulatory requirements applying to the regulation of different categories of therapeutic goods. For example, the secretary has under the act various information-gathering powers to ensure that information and data is available to support the making of regulatory decisions. For instance, the secretary can suspend or cancel low-risk therapeutic goods from the register, such as complementary medicines, if the secretary is of the view that certifications given by the sponsor at the time of the inclusion of the goods in the register were incorrect.

These lower-risk goods are included in the register if the sponsor certifies that their goods meet a number of specified requirements including, for example, that they conform to applicable standards, do not have an unacceptable presentation and comply with applicable advertising requirements. Because these lower-risk products are included in the register and are therefore available for supply in Australia without pre-evaluation by the TGA, it is important that the secretary can be satisfied about the correctness or otherwise of these certifications. Amendments in the bill will ensure that the secretary can request sponsors of all classes of lower-risk therapeutic goods - medicines, biologicals and medical devices - to provide information and documents relating to any of those certifications. It is a ground of suspension and cancellation of the product if the sponsor does not provide the material requested.

Standardisation and clarification of regulatory requirements

The bill also contains a number of other measures to standardise or clarify the operation of a number of regulatory requirements that support the objectives of the act of securing the safety, efficacy, quality and timely availability of therapeutic goods.

For example, it is a requirement for inclusion of therapeutic goods in the register, a matter in relation to which the secretary can seek information from a sponsor and a ground for suspension or cancellation of goods from the register, that the goods comply with relevant advertising requirements.

The amendments will make it clear that these advertising requirements include not only relevant advertising provisions in the act itself but also those contained in the therapeutic goods advertising code, which is made by the minister under the act.

Publication of regulatory decisions on the website

Currently the secretary is required to publish particulars about various regulatory decisions made under the act, including suspension and cancellation of goods from the register, in the Commonwealth Gazette. In order to ensure that this information is more readily accessible to the public, consumers, healthcare professionals, patients and industry, the amendments will give the secretary the option of publishing that information on the TGA's website rather than in the Commonwealth Gazette.

The measures contained in this bill will increase the efficiency of the therapeutic goods regulatory scheme, and make more clear and transparent a number of regulatory processes and requirements applying to the regulation of all classes of therapeutic goods, which the Australian Government claims will benefit the public, industry and other stakeholders alike.

The proposed legislation is currently being reviewed by the ADIA-DRC Dental Regulation Committee and a response will be tendered to the Senate Community Affairs References Committee.  ADIA's policy objective is to achieve an outcome that supprts the growth of member businesses, both small and large.  If you would like further information, please feel free to contact ADIA Chief Executive Officer, Troy Williams, via email at troy.williams@adia.org.au or by telephone on 1300 943 094.

Members wishing to learn more about full suite of TGA reforms should attend the Breakfast Briefing - TGA Boss Talks Openly About Reforms scheduled for Melbourne (24 May 2013) and Sydney (19 April 2013).

Member Engagement

The Australian Dental Industry Association (ADIA) is the Australian Government’s key reference point when negotiating changes to the regulatory standards for dental product. ADIA members convene under the umbrella of the ADIA-DRC Dental Regulation Committee as a means of keeping member businesses up to date with and influencing the commercial, technical and regulatory environment. If you would like to participate in the work of ADIA-DRC, please send an email to dental.regulation@adia.org.au or telephone 1300 943 094.




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