Note: Where available, the PDF/Word icon below is provided to view the complete and fully formatted document
Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013

Bill home page  


Download WordDownload Word


Download PDFDownload PDF

 

 

 

 

 

2013

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

HOUSE OF REPRESENTATIVES

 

 

 

 

 

 

 

 

 

 

 

THERAPEUTIC GOODS AMENDMENT (2013 MEASURES NO.1) BILL 2013

 

 

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

 

 

 

 

(Circulated by authority of the Minister for Health, the Hon Peter Dutton MP)





THERAPEUTIC GOODS AMENDMENT (2013 MEASURES NO.1) BILL 2013

 

OUTLINE

 

The Therapeutic Goods Amendment (2013 Measures No.1) Bill 2013 (the Bill) makes a number of amendments to the Therapeutic Goods Act 1989 (the Act).

 

These amendments will contribute to:

 

·                 reducing regulation, where appropriate - for example, amendments enabling the Minister to make a legislative instrument specifying products that would not be therapeutic goods for the purposes of the Act, and amendments to enable the Secretary to remove products from the Australian Register of Therapeutic Goods (the Register) which are not, or are no longer, therapeutic goods;

·                 providing greater clarity, certainty and consistency in relation to the operation of the Act - for example, amendments to clarify that references in the Act to applicable advertising requirements include applicable provisions of the Therapeutic Goods Advertising Code, and amendments to clarify the processes by which registered medicines are approved under section 25 of the Act and the source of the power for the Secretary to approve product information for such medicines (section 25AA of the Act);

·                 reducing potential health risks to the public - for example, amendments to support the current transition process for the reclassification of hip, knee and shoulder joint implants from Class IIb medical devices to Class III by allowing for an alternative number of days (to be prescribed) to the current 20 working days for the Secretary to decide whether to audit an application for the inclusion of certain kinds of medical devices (also to be prescribed) in the Australian Register of Therapeutic Goods (the Register) which will also reduce potential administrative and regulatory burden; and

·                 improving the transparency of the regulatory regime established by the Act - for example, amendments to require that where the Secretary must publish details of a regulatory decision (e.g. cancelling goods from the Register) and that decision is overturned by the Minister on review, the Secretary must publish the details of that overturning, either on the TGA’s website or in the Gazette .

 

Supporting the upclassification of implantable joint medical devices

On 1 July 2012, medical devices that are hip, knee and shoulder joint replacement implants were reclassified from Class IIb to the higher risk Class III classification, in order to ensure, in part, that such products are subjected to a degree of pre-market scrutiny appropriate to their risk.  This followed an Inquiry in November 2011 by the Senate Standing Committee on Community Affairs on Regulatory Standards for the Approval of Medical Devices.

 

A two-year transition process is now in place which gives sponsors of implants approved for marketing in Australia as at 1 July 2012 as Class IIb devices until 1 July 2014 to apply to have their products approved as Class III devices.  Provided a Class III application is made before 1 July 2014, those Class IIb devices will not be cancelled from the Register until the application has been determined.

 

Under section 41FH of the Act, when a person applies to include a kind of medical device in the Register the Secretary has a discretion as to whether to select the application for auditing, and has 20 working days to decide whether to audit an application and inform the applicant of the information required to undertake that audit.

 

The amendments will allow the Therapeutic Goods Administration (TGA) sufficient time to identify those of the large number of Class III applications likely to be made in the lead-up to the 1 July 2014 deadline that warrant auditing and to decide what information to seek from the applicant for the purposes of that audit by including a power to prescribe in regulations an alternative period to the current 20 working days. 

 

Goods taken to not be therapeutic goods

The definition of therapeutic goods in subsection 3(1) of the Act is very broad and principally includes goods “ that are represented in any way to be ... likely to be taken to be (i) for therapeutic use ”.  ‘Therapeutic use’ is defined in subsection 3(1) of the Act to include “ preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons ” and “ influencing, inhibiting or modifying a physiological process in persons ”.

 

This definition can extend to a wide range of products that may not have been intended to be regulated under the Act in relation to which health-related claims are increasingly being made.  These products include those in relation to which public health is not, or is unlikely to be, an issue, and where the appropriate regulatory focus may be more one of consumer protection - for example, ’power band’ bracelets, and mattresses which contain bacteria designed to reduce the effects of dust mites. 

 

Currently, however, while it is possible to exempt goods coming within the definition of ‘therapeutic goods’ from various discrete requirements under the Act (for example, the requirement to be included in the Register for them to be supplied in Australia), it is not possible to entirely exclude such products from the regulatory scheme for therapeutic goods. 

 

That scheme imposes substantial criminal and civil penalties for persons importing or manufacturing goods that come within the definition of ‘therapeutic goods’ if those goods are not included in the Register or are not otherwise exempt or approved.  Inclusion in the Register requires those intending to import or supply the goods to comply with various regulatory requirements including, at a minimum, that the goods comply with all relevant standards, are manufactured according to good manufacturing principles and are safe for the purposes of which they are intended to be used.  Application fees and annual charges are payable.

 

It is important therefore that there is as much clarity as possible about which goods are covered by the regulatory scheme, and for the Minister to consider whether particular goods which may come within the definition are appropriate for regulation under the Act.

 

To allow for greater clarity and certainty, Schedule 3 of the Bill amends the Act to allow the Minister to make a legislative instrument determining that goods are not therapeutic goods for the purposes of the Act either generally or when used, advertised, or presented for supply in a particular way.  Such a determination would be required to be tabled before Parliament and would be disallowable.

 

Before making such an instrument, the Minister would be required to take into account certain criteria, whether the use of the goods in question would be likely to cause a health risk, whether it is appropriate to apply the regulatory scheme for therapeutic goods to those goods and whether the kinds of risks to which the public might be exposed from the supply or use of the goods would be more appropriately or effectively dealt with under another regulatory scheme.

 

Removal of products from the Register that are not therapeutic goods

Schedule 3 also amends the Act to include a power for the Secretary to remove a product from the Register if the product does not in fact meet, or no longer meets, the definition of a therapeutic good in subsection 3(1) of the Act.

 

This will be important in particular for medicines listed in the Register under section 26A of the Act on the basis of certifications made by the applicant, where the electronic listing process does not involve pre-market scrutiny by the TGA so there is not an opportunity to screen an application to establish that the relevant goods come within the definition before they are included in the Register.  It will also allow the Secretary to remove a product that may have come within the definition when it was included but no longer does so, for instance where claims about its therapeutic use are no longer being made or they come within a determination made under the new section 7AA.

 

Product information amendments

There is currently a lack of clarity about the source of the Secretary’s power to approve product information (PI) for medicines accepted for registration.  The amendment in Schedule 5 of the Bill makes it clear that the Secretary may approve PI under subsection 25AA(1), and under new subsection 25AA(1A) is obliged to notify the sponsor of the medicine of the approved PI.

 

Other amendments

The Schedules make a number of other amendments to the Act, including:

 

·                 providing that the Secretary may suspend or cancel the registration or listing of therapeutic goods where the presentation of the goods is not acceptable or, in the case of listed goods, is unacceptable;

·                 providing that the Secretary may cancel the registration or listing of therapeutic goods where a sponsor does not respond to a request from the Secretary under section 31 of the Act to provide specified information or documents about those goods;

·                 giving the Secretary the option of publishing information about various regulatory decisions made under the Act (including suspension and cancellation of goods from the Register) on the Department’s website rather than in the Gazette ;

·                 modifying the definition of a kit in section 7B of the Act to encompass kits containing (among other things) only one registered or listed therapeutic good, or a biological combined with other items (provided they are for use as a unit); and

·                 introducing an offence and a civil penalty where a sponsor provides information that is false or misleading in a material particular in relation to a request under section 9D of the Act for a variation to an entry on the Register, and extending the existing offence and civil penalty for providing information that is false or misleading in a material particular in response to a request for information about a complementary medicine to such requests for information about registered therapeutic goods (including prescription and over-the-counter medicines) and therapeutic devices.

 

Financial Impact Statement

 

The amendments made by this Bill will have a nil financial impact on the Commonwealth, as the TGA, which administers the Act, operates on a cost recovery basis.

 



Statement of Compatibility with Human Rights for a Bill that raises human rights issues

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

THERAPEUTIC GOODS AMENDMENT (2013 MEASURES NO.1) BILL 2013

This Bill 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 .

Overview of the Bill

This Bill amends the Therapeutic Goods Act 1989 (the Act) in relation to a range of matters including :

·          providing the Minister with the power to make legislative instruments excluding identified goods, or excluding identified goods if the goods are used, advertised or presented for supply in a particular way, from the definition of ‘therapeutic goods’ ;

·          including an offence and a civil penalty provision for providing information that is false or misleading in a material particular in connection with a request to vary an existing entry in the Register for therapeutic goods or in response to requests for information about registered therapeutic goods such as prescription and over-the-counter medicines as well as therapeutic devices;

·          amendments to support the current upclassification process for certain hip, knee and shoulder joint implants from Class IIb medical devices to Class III;

·          providing that the Secretary may cancel the registration or listing of therapeutic goods where the presentation of the goods is not acceptable or, in the case of listed goods, is unacceptable;

·          providing that the Secretary may cancel the registration or listing of therapeutic goods where a sponsor does not respond to a request from the Secretary under section 31 of the Act to provide specified information or documents about those goods; and

·          clarifying the arrangements relating to the approval by the Secretary of product information (PI) for medicines accepted for registration in the Register .

 

Human rights implications

 

The Bill contains one measure that appears to engage article 14(2) of the International Covenant on Civil and Political Rights (the ICCPR).  This measure is the addition to the Act of an offence (at new subsection 9G(2)), which sets out that it is an offence of strict liability for a person to make a statement that is false or misleading in a material particular in or in connection with a request under section 9D of the Act for a variation to an existing entry in the Register for therapeutic goods, where use of the goods, if the goods were used, would be likely to result in harm or injury to any person.

 

The maximum penalty for this offence is 2,000 penalty units, with no imprisonment.

 

This offence forms part of a tiered approach to conduct relating to the provision of false or misleading information in relation to a request under section 9D of the Act.

 

Section 9D of the Act allows the Secretary to vary an entry for therapeutic goods on the Register in certain circumstances, including at the request by the person in relation to whom goods are on the Register.

 

Requests to vary an entry of goods on the Register can relate to a variety of matters, including quite serious safety issues, such as adding a warning or a precaution to the product information of a prescription medicine in connection with the use of the medicine.

 

Requests may also involve the provision of significant amounts of data, such as (in the case of prescription medicines) clinical, pre-clinical or bioequivalence data necessary for the Secretary to determine whether statutory requirements set out in the applicable subsections in section 9D (e.g. in subsection 9D(3) that the variation does not indicate a reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used) are satisfied such that the requested variation should be made to the entry.

 

This information will in most cases be known only to the sponsor - thus there is a particular level of dependence on the accuracy and comprehensiveness of the supporting information provided with a section 9D request, especially in relation to higher risk goods such as prescription medicines.

 

The provision of false or misleading information that was relied upon by the Secretary to reach a decision to vary an entry in the Register under the section could potentially have serious consequences for public health. 

 

Currently, while the Act contains offences and a civil penalty provision for providing information that is false or misleading in a material particular in relation to applications for marketing approval, it  does not contain any offence or civil penalty provisions relating to the provision of such information in connection with a request under section 9D.

 

It is also important to note that new subsection 9G(2) does not incorporate any imprisonment element and the maximum penalty is capped at 2,000 penalty units.  This maximum penalty level reflects the seriousness of the conduct addressed by the offence - i.e. this offence will only apply where (among other components) use of the goods to which the relevant section 9D request relates would be likely to result in harm or injury to a person.

 

The strict liability offence at new subsection 9G(2) forms part of the Act’s tiered approach to criminal offences, and replicates the same approach adopted throughout the Act for the provision of information that is false or misleading in a material particular, where that information is relied upon to inform a range of regulatory actions (see for instance, section 22A in relation to applications for the registration of medicines, section 32DO in relation to applications for inclusion of a biological in the Register, section 41EI in relation to an application for a conformity assessment certificate). 

 

Where non-compliance with the requirement to provide accurate information that is not false or misleading is likely to cause harm or injury (as per proposed subsection 9G(2)), it is considered that non-compliance should attract a criminal sanction regardless of any mental element.  By setting out a strong deterrence against providing false or misleading information, and by forming an important component of the suite of sanctions proposed for such conduct, it is expected that subsection 9G(2) will significantly enhance regulatory enforcement and help to protect the public from exposure to therapeutic goods that have been approved for continued supply on the basis of false or misleading information.

 

In so doing, it will serve an important role in deterring and addressing conduct that could potentially endanger public health.

 

Conclusion

The addition of the strict liability offence for making false or misleading statements in connection with a request under section 9D of the Act is considered (for the reasons outlined above) to be a reasonable, necessary and proportionate limitation in relation to the engagement of article 14(2) of the ICCPR.

 

The Hon Peter Dutton MP, the Minister for Health



THERAPEUTIC GOODS AMENDMENT (2013 MEASURES NO.1) BILL 2013

 

NOTES ON CLAUSES

 

Clause 1 - Short Title

This clause provides that the Bill, once enacted, may be cited as the Therapeutic Goods Amendment (2013 Measures No.1) Act 2013 .

 

Clause 2 - Commencement

This clause provides that the Bill will commence on the day it receives Royal Assent.

 

Clause 3 - Schedule(s)

This clause provides that each Act that is specified in a Schedule to this Bill is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Bill has effect according to its terms.

 

SCHEDULE 1 — Advertising etc.

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments to the Act to put beyond doubt that in those instances where regulatory action in relation to therapeutic goods is predicated on whether or not the goods comply with advertising requirements, those requirements include applicable provisions of the Therapeutic Goods Advertising Code (the Code).

 

Items 1 and 2

These items amend subsection 25(1) of the Act to clarify one of the factors the Secretary must take into account when evaluating an application to register therapeutic goods in the Register.  This relates to assessing the compliance of the goods with advertising requirements.

 

Paragraph 25(1)(f) of the Act requires the Secretary to consider whether such goods conform to an applicable standard, or to any requirements relating to advertising applicable under Part 5-1 of the Act or the regulations.

 

The purpose of the amendment is to clarify that a reference to advertising requirements includes a reference to the Code.

 

These changes do not introduce any new requirements, but make it clearer that the requirement to consider compliance with the Code is part of the process of evaluating applications to register medicines and therapeutic devices in the Register.

 

Items 3 and 4

Under section 26 of the Act the Secretary must list in the Register therapeutic goods to which the section applies unless satisfied that the goods do not meet various requirements including those relating to advertising applicable under Part 5-1 of the Act or under the regulations.

 

The purpose of the amendments in items 3 and 4 is to clarify that a reference to advertising requirements includes a reference to the Code.  These amendments do not introduce any new requirements for applicants, but rather have the effect of making it clear that applicable provisions of the Code must be complied with in relation to goods listed in the Register under section 26 as well as any other applicable advertising requirements set out in Part 5-1 of the Act or under the regulations.

 

Items 5 and 6

These items relate to therapeutic goods listed in the Register under s.26A of the Act, where one of the matters in relation to which the applicant must certify is that the medicine conforms to every requirement (if any) relating to advertising applicable under Part 5-1 of the Act or under the regulations.  Again, the amendments under both these items clarify that a reference to advertising requirements includes a reference to the Code.  This is provided for in new paragraph 26A(2)(da).

 

Items 7, 17 and 21

These items make similar changes in relation to the Code to those outlined above in relation to the cancellation without notice of registered or listed goods, biologicals and medical devices for non-compliance with advertising requirements.

 

Currently under paragraph 30(1A)(c) of the Act the Secretary may, by notice in writing, cancel the listing of medicines listed under section 26A (which includes complementary medicines) if there is a serious breach, involving the medicine, of applicable requirements relating to advertising under Part 5-1 of the Act or under the regulations, and where the Secretary is satisfied that:

 

·                 the breach is significant and

·                 that, as a result of the breach, the presentation of the medicine is misleading to a significant extent.

 

Item 7 amends paragraph 30(1A)(c) to make it clearer that the reference to a breach of advertising requirements in paragraph 30(1A)(c), as a ground for cancelling a section 26A listed medicine from the Register, includes a reference to a breach of any applicable provisions of the Code.

 

Item 17 makes an equivalent amendment to paragraph 32GA(1)(j) of the Act to include a reference to applicable provisions of the Code in relation to the Secretary’s power to cancel without notice biologicals from the Register for a breach of advertising requirements.

 

Item 21 makes an equivalent amendment to paragraph 41GL(h) of the Act to include a reference to applicable provisions of the Code in relation to the Secretary’s power to cancel without notice the inclusion of a kind of medical device from the Register for a breach of advertising requirements.

 

Item 8

Subsection 30(2) of the Act sets out the grounds for cancelling the registration or listing of therapeutic goods in the Register in relation to which the Secretary must give notice of an intention to do so and invite submissions from the sponsor.  One of these grounds is that the goods do not conform to a requirement relating to advertising applicable to the goods under Part 5-1 of the Act or under the regulations.

 

As item 6 has inserted new paragraph 26A(2)(da) to clarify that advertising requirements includes applicable provisions of the Code, this item makes a minor consequential amendment to paragraph 30(2)(ba) of the Act to include a reference to new paragraph 26A(2)(da), introduced to the Act by item 6.

 

Items 9 and 10

These items make equivalent amendments to those outlined above, in relation to the Secretary’s power to (with notice) cancel registered or listed goods from the Register for non-compliance with advertising requirements.

 

Currently, under paragraph 30(2)(e) of the Act, the Secretary may, with notice, cancel registered or listed goods from the Register if the goods do not comply with an applicable standard or an advertising requirement applicable to the goods under Part 5-1 of the Act or the regulations.

 

Taken together, items 9 and 10 move the reference to advertising requirements from paragraph 30(2)(e) to new paragraph 30(2)(ea), which then includes (consistent with the above changes) a specific reference to applicable provisions of the Code.

 

Item 11

This item introduces a minor amendment to subsection 31(1) of the Act to bring it in line with other provisions in the Act relating to the Secretary’s powers to obtain information about therapeutic goods that are the subject of an application to include them in the Register, or about goods that are, or that were at any time in the previous 5 years, included in the Register.  The Secretary’s information gathering powers in the Act applying to registered and listed goods are replicated for biologicals (section 32JA of the Act refers) and medical devices (section 41JA of the Act refers).

 

Subsection 31(1) of the Act permits the Secretary to require a range of persons to give information or documents about specified matters relating to registered therapeutic goods, or goods the subject of an application for registration on the Register.  These persons include persons in relation to whom therapeutic goods are, or were at any time in the previous 5 years, registered, and applicants seeking to register their goods in the Register.

 

In contrast to the situation with listed goods, biologicals and medical devices, subsection 31(1) of the Act does not currently provide for the Secretary to require information or documents from sponsors or former sponsors about the conformity of registered goods with applicable standards.  As failure to comply with applicable standards is a ground for cancellation for registered goods (paragraph 30(2)(e) of the Act refers), the Secretary may well need such information from the sponsor to facilitate consideration of whether the goods should remain in the Register.

 

Item 11 includes new paragraph 31(1)(gb) in the Act to enable the Secretary to require a sponsor to provide information about the conformity of registered goods to a standard applicable to the goods.

 

This brings the Secretary’s powers to require information or documents about compliance with applicable standards for registered goods in line with the Secretary’s powers to obtain the same information about listed goods under subsection 31(2) of the Act, and also with comparable provisions relating to other classes of therapeutic goods i.e. biologicals and medical devices.

 

Items 12, 13, 14, 19 and 22

These items make equivalent amendments to the above changes relating to advertising in relation to the Secretary’s powers to obtain information and documents about advertising compliance in relation to therapeutic goods.

 

Currently under paragraph 31(1)(h) of the Act, the Secretary may require information or documents from persons mentioned in item 11 about the conformity of registered, or registrable, goods to a requirement relating to advertising applicable under Part 5-1 of the Act or the regulations.

 

Item 12 substitutes this with a new paragraph 31(1)(h) to make it clear that the Secretary may require information or documents about compliance with applicable provisions of the Code when seeking information about compliance of the goods with advertising requirements.

 

Similarly, in describing the Secretary’s powers to obtain information about compliance with advertising requirements for listable or listed goods, items 13 and 14 replace the reference to a requirement relating to advertising applicable to the goods under Part 5-1 or under the regulations with a specific reference to an applicable provision of the Code and any other requirement relating to advertising applicable under Part 5-1 of the Act or under the regulations.

 

Item 19 makes an equivalent amendment to the information gathering powers of the Secretary in relation to biologicals under paragraph 32JA(1)(m) of the Act, to clarify that the Secretary’s power to require information or documents about the compliance of biologicals with applicable advertising requirements includes information about compliance with applicable provisions of the Code.

 

Similarly, item 22 makes an equivalent amendment to paragraph 41JA(1)(h) of the Act to clarify that the Secretary’s ability to require information or documents about the compliance of medical devices with advertising requirements includes the ability to obtain details about compliance with applicable provisions of the Code.

 

Items 15 and 20

When applicants apply to include biologicals or medical devices in the Register, they are required to certify, among other things, that their products comply with applicable advertising requirements.  These items make equivalent amendments to the above in relation to references to complying with advertising requirements by including a specific reference to compliance with applicable provisions of the Code.

 

To this end, item 15 introduces (for biologicals) a new paragraph 32DA(3)(d), which, consistent with the above changes, includes a specific reference to the Code, and item 20 makes an equivalent amendment to section 41FD of the Act in relation to kinds of medical devices, introducing a new paragraph 41JA(1)(h) which includes a specific reference to the Code.

 

Item 16

Currently under paragraph 32DE(1)(d) of the Act, one of the matters to which the Secretary must have regard when evaluating biologicals for inclusion in the Register is whether the biological complies with every requirement (if any) relating to advertising applicable under Part 5-1 of the Act or under the regulations.

 

Item 16 introduces a new paragraph 32DE(1)(d) which, consistent with the amendments in Schedule 2, includes a specific reference to compliance with applicable provisions of the Code.

 

Items 17 and 18

These items amend the Secretary’s power to cancel a biological from the Register, with notice, for non-compliance with advertising requirements.

 

Under paragraphs 32GA(1)(j) and 32GC(1)(g) of the Act, the Secretary may, in the circumstances described under those provisions, cancel a biological from the Register if it does not comply with an advertising requirement applicable under Part 5-1 of the Act or the regulations.

 

Consistent with the changes made to other provisions in this Schedule, items 17 and 18 replace these paragraphs with new paragraphs 32GA(1)(j) and 32GC(1)(g) which include a specific reference to compliance with applicable provisions of the Code.

 

Item 21

Subsections 41GL(1) and 41GN(1) of the Act list the circumstances in which the Secretary may cancel a kind of medical device from the Register.

 

Paragraph 41GL(1)(h) of the Act provides that a kind of medical device may be cancelled from the Register where there is a serious breach of requirements relating to advertising applicable under Part 5-1 of the Act or under the Regulations, which the Secretary is satisfied is significant and which the Secretary is satisfied has caused the presentation of the kind of device to become misleading.

 

Items 21 amends paragraph 41GL(h) to include a specific reference to the Code consistent with the above amendments.

 

Application

 

Item 23 - medicines etc.

This item describes how the changes made under the various items in this Schedule in relation to registered or listed therapeutic goods will operate in relation to such goods.

 

Sub-items (1) - (3) provide, respectively, that the amendments to sections 25, 26 and 26A of the Act made by items 1-6 apply in relation to applications for registration or listing made on or after the commencement of item 23.

 

Sub-item (4) provides that the amendments to subsection 30(1A) of the Act (relating to cancellations without notice of goods from the Register) made by item 7 apply in relation to cancellations made under subsection 30(1A) on or after the commencement of item 23, whether the breach to which the notice relates occurs before or after that commencement.

 

Sub-item (5) provides that the amendments to subsection 30(2) of the Act (cancellations of goods from the Register with notice) made by items 8-10 apply in relation to cancellations under subsection 30(2) of which a person is informed under subsection 30(3) of the Act on or after the commencement of item 23, whether the circumstances giving rise to the proposed cancellation occurred or occur before or after that commencement.

 

Sub-item (6) provides that the amendments to section 31 of the Act made by items 11-14 apply in relation to notices given by the Secretary under section 31 on or after the commencement of item 23.  This is the case whether (for a notice given to an applicant for registration or listing) the application is made before or after that commencement and whether (for a notice given to a person in relation to whom goods are, or were at any time in the previous 5 years, registered or listed) the goods were registered or listed before or after that commencement.

 

Item 24 - biologicals

This item sets out how the amendments made to various items in this Schedule that relate to biologicals will operate.

 

Sub-item (1) provides that the amendments to section 32DA of the Act made by item 15 apply in relation to applications for the inclusion of a biological in the Register made on or after the commencement of item 24.

 

Sub-item (2) provides that the amendments to section 32DE of the Act made by item 16 apply in relation to applications for the inclusion of a biological other than a Class 1 biological in the Register made on or after the commencement of item 24.

 

Sub-item (3) provides that the amendments to subsection 32GA(1) of the Act made by item 17 apply in relation to notices of cancellation given by the Secretary under subsection 32GA(1) on or after the commencement of item 24, whether the breach to which the notice relates occurs before or after that commencement.

 

Sub-item (4) provides that the amendments to subsection 32GC(1) of the Act made by item 18 apply in relation to cancellations under subsection 32GC(1) of which a person is informed under subsection 32GC(2) of the Act on or after the commencement of item 24, whether the reason for the proposed cancellation occurs before or after that commencement.

 

Sub-item (5) provides that the amendments to section 32JA of the Act made by item 19 apply in relation to notices given under section 32JA on or after the commencement of item 24.  This is the case whether (for a notice given to an applicant for the inclusion of a biological in the Register) the application is made before or after that commencement and whether (for a notice given to a sponsor of a biological that is or was at any time in the previous 5 years included in the Register) the biological was included in the Register before or after that commencement.

 

Item 25 - medical devices

This item sets out how the amendments to various items in this Schedule that relate to medical devices will operate.

 

Sub-item (1) provides that the amendments to section 41FD of the Act made by item 20 apply in relation to applications for the inclusion of a kind of medical device in the Register made on or after the commencement of item 25.

 

Sub-item (2) provides that the amendments to section 41GL of the Act made by item 21 apply in relation to notices of cancellation given under section 41GL on or after the commencement of item 25, whether the breach to which the notice relates occurs before or after that commencement.

 

Sub-item (3) provides that the amendments to subsection 41JA(1) of the Act made by item 22 apply in relation to notices given under subsection 41JA(1) on or after the commencement of item 25.  This is the case whether:

 

·                 for a notice given to an applicant for a conformity assessment certificate or the inclusion of a kind of device in the Register - the application is made before or after that commencement; or

·                 for a notice given to a holder of such a certificate (or a person who previously held such a certificate at any time in the previous 5 years) the certificate was issued before or after that commencement; or

·                 for a notice given to a person who is or was a sponsor of a kind of medical device included in the Register - the kind of device was included in the Register before or after that commencement.



SCHEDULE 2 — Obtaining information etc.

 

Therapeutic Goods Act 1989

 

This Schedule principally contains amendments to the offences and civil penalty provision at subsections 31(5A), (5B) and (6), and section 31AAA, of the Act which relate to the provision of information that is false or misleading in material particular in response to a request for information or documents under section 31 of the Act, to allow those provisions to apply in respect of anyone to whom the Secretary can issue a notice under section 31 (currently these only apply to sponsors of listed medicines).

 

Items 1, 11 and 13

Currently under subsection 30(1C) of the Act the Secretary may, by written notice, cancel the listing of a medicine listed in the Register under section 26A of the Act if:

 

(a)            the Secretary has given the person in relation to whom the medicine is listed a notice under section 31 of the Act requiring them to provide information or documents; and

(b)           the notice is given for the purposes of ascertaining whether the medicine should have been listed; and

(c)            the person fails to comply with the notice within 20 working days.

 

Item 1 amends paragraph 30(1C)(b) to remove the reference to the section 31 notice having been given for the purposes of ascertaining whether the medicine should have been listed, and to refer instead to that notice having been given in order to ascertain whether any of the certifications made by the person under subsections 26A(2) or (2A) of the Act are incorrect.

 

This amendment is not intended to amend the effect or scope of subsection 30(1C) but simply to provide a clearer description of the purpose for which the relevant section 31 notice must have been given for the subsection to apply. 

 

Items 11 and 13 make equivalent amendments to paragraphs 32GB(1)(b) and 41GM(1)(b) of the Act in relation to biologicals and medical devices, respectively.

 

Item 2

This item adds a reference to documents in the heading of section 31 of the Act to reflect the fact that the Secretary can request documents as well as information under that provision.

 

Items 3 - 7

Subsections 31(5A), (5B) and (6) of the Act contain a criminal offence for providing information that is false or misleading in a material particular, in response to a notice to provide information or documents under section 31, by a person in relation to whom a medicine is listed under section 26A of the Act.

 

No such offence is currently included for others to whom the Secretary can, under section 31 of the Act, require information or documents to be provided even though that information may well be relevant to the continued inclusion of the goods in the Register on the basis of quality or safety.  The same justification for making it an offence to provide false or misleading information in relation to an application for registration or listing (sections 22A and 21A of the Act refer) are applicable here i.e. the integrity of the regulatory regime depends on the Secretary being able to make decisions based on accurate information.

 

Persons to whom a section 31 notice may be given, but who are not currently covered by this offence, include applicants seeking to register their goods in the Register under section 25 of the Act, sponsors seeking to list their goods in the Register under section 26 of the Act and sponsors of goods already registered or listed in the Register, as well as persons in relation to whom goods were registered or listed at any time in the previous 5 years.

 

Item 3 therefore introduces new paragraphs 31(5A)(a) - (c) making it clear that the offence in section 31(5A) may apply to any person issued a notice under section 31 and who provide either information or documents.

 

Item 4 makes a minor consequential change to subparagraphs 31(5A)(d)(i) and (ii) of the Act to reflect the changes made by item 4 that the offence applies to all persons to whom a section 31 request for information or documents is given by the Secretary.

 

Items 5 and 6 implement equivalent amendments to subsection 31(5B) of the Act to reflect that the offence applies to any person issued with a notice under section 31.

 

Item 7 makes a consequential and equivalent amendment to subsection 31(6) of the Act to replace the reference to a person whose goods are listed under section 26A to any person in relation to whom a section 31 notice may be issued.

 

Item 8

This item makes a change to the heading of section 31AAA of the Act describing what the civil penalty provision is directed at, to reflect the changes set out in item 9 below.

 

Items 9 and 10

Section 31AAA of the Act sets out a civil penalty for the same conduct covered by current subsections 31(5A), (5B) and (6) of the Act that create a criminal offence.

 

As with the criminal offence, the civil penalty provision currently only extends to cover persons who provide false and misleading information in a material particular who are sponsors of goods listed in the Register under section 26A.

 

In order to bring section 31AAA into line with the changes made to subsections 31(5A), (5B) and (6) by items 4-8 so that any person who is issued with a section 31 notice may be affected by that civil penalty provision, item 9 replaces paragraphs 31AAA(a) and (b) with new paragraphs (a) and (b).  The effect is that any person issued a notice under section 31 and who, in response, supplies information that is, or documents that are, false or misleading in a material particular may contravene the civil penalty in section 31AAA.

 

Item 10 makes a minor change to paragraph 31AAA(c) to refer to documents as well as to information, to be consistent with section 31, which enables the Secretary to require both information or documents from a sponsor, applicant or previous sponsor.

 

Items 12 and 15

Under subsection 32JB(1) of the Act, a person commits an offence if the person is given a notice by the Secretary under section 32JA of the Act to provide information or documents about biologicals and the person fails to comply with the notice.  The maximum penalty for this offence is 500 units.

 

As currently drafted, the persons who may commit the offence in subsection 32JB(1) of the Act include persons who are applicants for the inclusion of a biological in the Register (paragraph 32JA(1)(a) refers).

 

Other persons who may commit the offence in subsection 32JB(1) are persons in relation to whom biologicals are included in the Register, and persons in relation to whom biologicals were included in the Register at any time in the previous 5 years.

 

It is not considered necessary, however, for this offence to apply to applicants for the inclusion of a biological in the Register.  This is because such persons would already have an incentive to respond to a section 31JA request for information or documents, in that not doing so may affect the Secretary’s ability to evaluate their application.  By not responding to the request, the applicant risks rejection of the application.

 

Moreover, as making an application to include biologicals (or medical devices) in the Register is only a requirement if a person chooses to supply the goods in Australia, it would be inappropriate to make it an offence not to provide additional information or documents.

 

Item 12 therefore amends subsection 32JB(1) of the Act, with the effect that the offence in subsection 32JB(1) would only apply, in appropriate circumstances, to persons in relation to whom biologicals are included in the Register, and persons in relation to whom biologicals were included in the Register at any time in the previous 5 years, and not to applicants for the inclusion of a biological in the Register.

 

Item 15 sets out an equivalent amendment in relation to medical devices, removing applicants for the inclusion of a kind of medical device in the Register from the scope of the offence in subsection 41JB(3) of the Act (this offence mirrors subsection 32JB(1)).

 

These amendments will bring these offences for biologicals and medical devices into line with the relevant offence in relation to registered or listed therapeutic goods, which already excludes applicants (subsection 31(4) of the Act refers).

 

Item 14

This item adds a reference in the heading of section 41JA of the Act to documents to reflect the fact that the Secretary can request documents as well as information under that provision.

 

Application

 

Item 16

This item sets out the application of various items in this Schedule.

 

Sub-item (1) provides that the amendments to sections 30, 31 and 31AAA made by items 1-10 apply in relation to notices of cancellation given under section 31 of the Act on or after the commencement of item 16, whether the medicine to which the notice relates is registered or listed before or after that commencement.

 

Sub-item (2) provides that the amendments to sections 32GB and 32JB of the Act made by items 11 and 12 apply in relation to notices for the provision of information or documents given under section 32JA of the Act on or after the commencement of item 16.  This is the case whether:

 

·          for a notice given to an applicant for the inclusion of a biological in the Register - the application is made before or after that commencement, and

·         for a notice given to a sponsor of a biological included in the Register - the biological was included before or after that commencement.

 

Sub-item (3) provides that the amendments to sections 41GM, 41JA and 41JB of the Act made by items 13-15 apply in relation to notices for the provision of information or documents given under section 41JA of the Act on or after the commencement of item 16.  This is the case whether:

 

·                 for a notice given to an applicant for a conformity assessment certificate or the inclusion of a kind of device in the Register - the application is made before or after that commencement; and

·                 for a notice given to a holder of such a certificate or a sponsor of a kind of medical device - the certificate was issued, or the kind of device included in the Register, before or after that commencement.



SCHEDULE 3 — Goods that are not therapeutic goods

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments to the Act to allow the Minister to exclude from the definition of ‘therapeutic goods’ in subsection 3(1) of the Act goods determined by the Minister in a legislative instrument not to be therapeutic goods, or not to be therapeutic goods when used, advertised or presented for supply in a specified way.  The Schedule also includes a power for the Secretary to remove products from the Register that are not therapeutic goods.

 

Items 1 and 2

‘Therapeutic goods’ are defined, broadly, in subsection 3(1) of the Act as goods that are represented in any way to be, or that are, whether because of the way in which they are presented or for any other reason, likely to be taken to be for therapeutic use.

 

‘Therapeutic use’ is defined in subsection 3(1), as use in or in connection with a number of matters, listed in paragraphs (a) - (f).  Paragraphs (a) and (b) of that term refer, respectively, to use in or in connection with:

 

(a)     preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; or

(b)     influencing, inhibiting or modifying a physiological process in persons .

 

Subsection 3(1) also sets out, however, that the definition of therapeutic goods does not include the goods listed in paragraphs (e) - (f) of the definition.

 

These include, for example, goods (other than goods declared to be therapeutic goods in an order under section 7 of the Act) for which there is a standard (within the meaning of subsection 4(1) of the Food Standards Australia New Zealand Act 1991 ) (paragraph (e) of the definition of ‘therapeutic goods’ refers) or which have a tradition of use as foods in Australia or New Zealand (paragraph (f) of the definition of ‘therapeutic goods’ refers).

 

Item 1 amends the definition of ‘therapeutic goods’ in subsection 3(1) of the Act to include two additional excluding paragraphs, (g) and (h).

 

New paragraph (g) excludes from the meaning of ‘therapeutic goods’ goods that are covered by a determination made by the Minister under new subsection 7AA(1).  New paragraph (h) excludes from the meaning of ‘therapeutic goods’ goods that are covered by a determination made by the Minister under new subsection 7AA(2) - if the goods are used, advertised or presented for supply in the manner specified in the determination.

 

These amendments have the effect that the goods described in those paragraphs - i.e. goods which the Minister specifies in a determination under new subsections 7AA(1) or (2) that is current - will be taken not to be within the meaning of the term ‘therapeutic goods’ for the purposes of the Act.

 

Item 2 introduces new section 7AA.  New subsection 7AA(1) provides that the Minister may, by legislative instrument, determine that specified goods (other than goods declared to be therapeutic goods under an order in force under section 7) are excluded goods for the purposes of the Act.

 

New subsection 7AA(2) provides that the Minister may, by legislative instrument, determine that specified goods (other than goods declared to be therapeutic goods under an order in force under section 7) are excluded goods when used, advertised or presented for supply in the manner specified in the determination.

 

The notes under each subsection make it clear that the Minister can determine that a specified class of goods can be determined under either subsection to be excluded goods for the purpose of paragraph (g) of the definition of ‘therapeutic goods’.

 

The effect of items 1 and 2, taken together, is to provide the Minister with the power to make a determination identifying products that will be taken to be excluded from the meaning of ‘therapeutic goods’ for the purposes of the Act, under new section 7AA, including where the goods in question may otherwise come within the ‘therapeutic goods’ definition.

 

Any determination made by the Minister must be tabled in Parliament, and will be a disallowable instrument.

 

Inclusion of goods in a subsection 7AA(1) determination would mean that, regardless of whether suppliers of the goods claimed that using the goods provided a therapeutic benefit or not, such items would be excluded from the definition of ‘therapeutic goods’ and thus would be outside the scope of the legislation.

 

New section 7AA would also enable the Minister to specify in a determination that a particular product is not a therapeutic good if used, advertised or presented for supply in a specified manner, including if the product is used, advertised or presented for supply in a way other than a particular way of using, advertising or presenting the product.

 

These measures address the significant concern that, due to its breadth, the definition of ‘therapeutic goods’ may potentially extend to a wide range of goods, including clothing, household items and other products, for which public health is not, or is unlikely to be, an issue, and where the focus may be more one of consumer protection.  The definition may also extend to products for which there may be sound and important public policy reasons for excluding from the scope of the regulatory scheme under the Act.

 

Health claims are increasingly being made about a wide range of products, suggesting that these products can influence a person’s well-being or state of mind.

 

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, where it was claimed that the use of the latter would boost a wearer’s balance, strength and flexibility.

 

Many of the therapeutic claims being made about a wide range of products may be more appropriately addressed through consumer protection laws than under the Act.

 

This new power will allow the Minister to respond flexibly, on a case by case basis, to ensure the Therapeutic Goods Administration is not involved in the regulation of products for which there is no public health focus or for which there may be sound public policy reasons for their not being regulated under the therapeutic goods legislation.

 

In relation to the circumstances in which the proposed new power might be used to exclude products for public policy reasons, it is intended this would only occur where there are very clear reasons for doing so, and where such a measure is necessary to give effect to Australian Government policy.

 

The Minister would be required to take certain matters into account before making a determination excluding goods from regulation under the Act:

 

·                 whether it is likely that the specified goods, if not regulated under this Act, might harm the health of members of the public;

·                 whether it is appropriate in all the circumstances to apply the national system of controls relating to the quality, safety, efficacy and performance of therapeutic goods established by the Act to regulate the specified goods; and

·                 whether the kinds of risks from the specified goods to which members of the public might be exposed could be more appropriately managed under another regulatory scheme.

It is important to note that the reference to “another regulatory scheme” in the third criteria above is not intended to be limited to comprehensive regulatory schemes such as that established under the Act for therapeutic goods, but rather to refer more broadly to the existence of rules or requirements, or where a rule-maker has the ability to control or direct behaviour, that would include the goods being considered for exclusion.

 

The Minister could also have regard to any other matter he or she considered relevant.

 

By reason of the operation of subsection 33(3) of the Acts Interpretation Act 1901 , the Minister could repeal, rescind, revoke, vary or revoke the instrument in like manner.  This means the Minister, in taking such action, would be required to take the matters set out in subsection 7AA(3) into account and any other matter that he or she considered relevant. 

 

It should also be noted that the Act sets out significant penalties for importing into, exporting from, or manufacturing in, Australia, goods that come within the definition of ’therapeutic goods’ if those goods are not included in the Register or are not otherwise exempt or approved (see for instance, sections 19B and 19D of the Act in relation to registered and listed goods, sections 32BA, 32BB, 32BC and 32BD in relation to biologicals and section 41MI in relation to medical devices). 

 

Inclusion in the Register involves complying with a number of regulatory requirements including all relevant standards, ensuring that the goods are manufactured according to good manufacturing principles and ensuring that the goods are safe for the purposes for which they are intended to be used.  Fees and annual charges are also payable.  The Act also imposes ongoing obligations on sponsors for so long as a product stays in the Register to ensure that the TGA can appropriately monitor safety and ensure post-market compliance with regulatory requirements.

 

The exclusion of products from the regulatory scheme will mean that those products will be able to be supplied without these penalties in the Act applying, and without sponsors needing to comply with these ongoing regulatory requirements.

 

It is also important for product suppliers as well as the public that there is as much clarity as possible about which goods are covered by the regulatory scheme.  The new power will give the Minister the ability to clarify that particular goods which come within the definition, or where there may be uncertainty about whether or not they come within the definition, are not to be regulated under the Act.

 

The new power will not be used to exclude goods from the regulatory scheme where, if the goods were not regulated under the Act, they could represent a risk to the health of members of the public.

 

Items 3 and 4

These items make amendments to subsection 8(1) of the Act consequential to the amendments made by items 1 and 2 above.

 

Subsection 8 of the Act allows the Secretary to, by written notice, require a person importing into, or supplying in, Australia, therapeutic goods or goods in relation to which the Secretary is considering making a declaration under section 7 of the Act, to provide information relating to the composition, indications, directions for use, labelling or advertising of the goods.

 

Item 3 makes a minor formatting change to paragraph 8(1)(b) to accommodate item 4.

 

Item 4 adds a new paragraph 8(1)(c) to the Act, the effect of which is to allow the Secretary to require importers and suppliers of goods in relation to which the Minister is considering making a determination under new section 7AA to provide information.  This will allow the Secretary to collect relevant information of the kind referred to above which can then be provided to the Minister for the purposes of making such a determination.

 

Item 5

This item adds new section 9F to the Act.

 

New section 9F says that if there is an entry on the Register and the Secretary is satisfied that the goods are not therapeutic goods, the Secretary may remove the entry of the goods from the Register.

 

This power of removal is to be distinguished from the Secretary’s existing powers under the Act to cancel therapeutic goods from the Register (including section 30 (in relation to registered and listed goods), sections 32GA, 32GB and 32GC (in relation to biological), and 41GK, 41GL, 41GM and 41GN (in relation to medical devices).

 

Section 9F provides a specific power for the Secretary to remove a product from the Register where either a product was not ‘therapeutic goods’ within the meaning of the definition of that term in subsection 3(1) of the Act at the time it was included in the Register (for instance, it was a food within paragraph (e) or (f) of that definition) or at any time after its inclusion a product no longer meets that definition (where, for instance, therapeutic claims are no longer made in relation to the goods, or a declaration is made under section 7AA in relation to the goods).

 

Under the risk-based regulation contained in the Act, some low-risk products are included in the Register without prior assessment by the TGA.  For instance, an applicant for the inclusion of a complementary medicine in the Register can list the goods by means of the Electronic Listing Facility (ELF) under section 26A of the Act based on a series of certifications made by the applicant about the goods.  Similarly, an applicant for the inclusion of a low-risk kind of medical device can include the goods on the Register using the Device Electronic Application Lodgement system (DEAL) under subsection 41FF(1) of the Act on the basis of certifications made by the applicant under section 41FD of the Act.

 

There is no opportunity for the TGA to come to a view about whether the product comes within the definition of ‘therapeutic goods’ before it is included in the Register.

 

There may also be situations in which a product may have been a ‘therapeutic good’ at the time of entry on the Register, but has subsequently changed such that it ceases to be covered by the definition.

 

The introduction of new section 9F is intended to address these situations so that only products that are in fact ‘therapeutic goods’ are, or continue to be, regulated under the regulatory scheme.  Subsection 9A(1) of the Act makes it clear that the Secretary’s responsibility in maintaining the Register is limited to ‘therapeutic goods’.

 

It is important to note that, under new subsection 9F(3), before removing a product from the Register the Secretary will be required to inform the person in relation to whom the product is entered on the Register, and invite them to make written submissions in relation to the proposed removal.  Under new subsection 9F(4), the Secretary would be required to consider any such submissions before exercising her powers of removal.  This will allow the sponsor to provide information or evidence that might demonstrate that the product is in fact therapeutic goods and thus should remain on the Register.  Any decision to remove products from the Register would not come into effect until at least 20 working days after notification of the decision was given to the person.

 

A notice of any removal that takes place must be published on the Department’s website or in the Gazette .  Any decision made by the Secretary to remove the product from the Register is also subject to internal review, with a further avenue of review to the Administrative Appeals Tribunal (the AAT) (see item 7 below).

 

New subsection 9F(5) provides that a notice of removal given to a person by the Secretary under new subsection 9F(2) is not a legislative instrument.  The inclusion of this subsection is intended to assist readers, as such notices would not appear to be legislative instruments within the meaning of section 5 of the Legislative Instruments Act 2003 .

 

Item 6

This item makes a minor amendment to section 56A of the Act consequential to the addition of new section 7AA.

 

Section 56A of the Act enables the Secretary to certify certain facts about matters set out under that provision, which will be taken as prima facie evidence of the matters specified in the certificate for the purposes of proceedings for an offence or a contravention of a civil penalty provision under the Act.

 

Item 6 introduces a new paragraph 56A(1)(ha) to the Act, with the effect that the Secretary will be able to certify, under that paragraph, that as at a certain time or during a certain period of time, there was no determination under section 7AA of the Act in place in relation to particular goods.  This will facilitate, for instance, evidence being provided to a court in relation to an issue about whether a product was or was not therapeutic goods at a particular time, that no determination was in place at that time that it was not therapeutic goods.

 

Item 7

Section 60 provides persons whose interests are affected by an ‘initial decision’ made by the Secretary under the Act with a right to seek a review of that decision by the Minister, and also provides a right of review of the Minister’s decision by the AAT.

 

This item makes a consequential amendment to section 60 of the Act in light of the addition of the new Secretarial power to remove goods from the Register that are not therapeutic goods under new section 9F to the Act, to provide for internal review rights where that power is exercised.

 

Item 7 amends subsection 60(1) of the Act to add decisions of the Secretary under new section 9F to remove products that the Secretary is satisfied are not therapeutic goods from the Register, as a decision that may be reviewed by the Minister (and subsequently, by the AAT).

 

Application

 

Item 8

This item sets out how new section 9F will operate.

 

Item 8 provides that new section 9F introduced by item 5 of this Schedule applies to goods entered on the Register before or after the commencement of item 8.  This means the Secretary can remove products that are not therapeutic goods that were on the Register before that section came into operation.



SCHEDULE 4 — Restricted representations and prohibited representations

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments to the Act to remove a small number of inconsistencies relating to advertising offences in Division 3A of Part 5-1 of the Act.

 

Item 1

Currently under paragraph 42DL(1)(a) of the Act, it is an offence for a person to publish or broadcast an advertisement about therapeutic goods that contains a prohibited representation (whether in express terms or by necessary implication) about the goods.

 

Paragraph 42DL(1)(a) of the Act does not reflect the fact that the Secretary can actually permit the use of a prohibited representation on the label of therapeutic goods, or in information included in the package in which therapeutic goods are contained, under subsection 42DK(2) of the Act.

 

This is to be contrasted with paragraph 42DL(1)(c) of the Act, which makes it clear that the offence set out in that provision for publishing or broadcasting an advertisement containing a restricted representation only applies where the use of the representation has not been approved under subsection 42DF(1), or permitted under subsection 42DK(1), of the Act.

 

Item 1 therefore amends paragraph 42DL(1)(a) with the effect that the offence in paragraph 42DL(1)(a) will only apply where the use of the prohibited representation has not been permitted under subsection 42DK(2) of the Act.

 

Item 2

This item makes a minor amendment to subsection 42DL(2) of the Act for the purpose of achieving consistency in relation to strict liability.

 

Subsection 42DL(2) of the Act sets out that for the purposes of an offence against subsection 42DL(1), strict liability applies to specified physical elements of a number of the offences listed at paragraphs 42DL(1)(a) - (h).

 

Item 2 amends subsection 42DL(2) to include a new paragraph 42DL(2)(aa), to note that strict liability also applies to the element of the offence, as amended under paragraph 42DL(1)(a), covering the use of a prohibited representation that has not been permitted under subsection 42DK(2) of the Act.

 

Item 3

Currently under paragraph 42DL(3)(a) of the Act, it is a defence to a prosecution under paragraphs 42DL(1)(a) or (f) of the Act in relation to an advertisement containing a prohibited representation or a statement referring to goods, substances or preparations included in Schedules 3, 4 or 8 of the Poisons Standard, if the advertisement in question has been made by, or on behalf of, the Commonwealth.

 

There is not an equivalent defence, however, to a prosecution under paragraph 42DL(1)(c) of the Act for publishing etc. an advertisement containing a restricted representation the use of which has not been permitted by the Secretary under subsection 42DK(1) of the Act.

 

This would appear to be inconsistent with the availability of this defence in relation to the use of a prohibited representation (paragraph 42DL(1)(a) of the Act refers).

 

Item 3 would amend paragraph 42DL(3)(a) of the Act to achieve consistency in the availability of the defence where the advertisement has been made by, or on behalf of, the Commonwealth.

 

Application

 

Item 4

This item sets out the application of the amendments made under this Schedule, and provides that the amendments to section 42DL of the Act made by items 1-3 apply in relation to advertisements published or broadcast on or after the commencement of this item.



SCHEDULE 5 — Evaluation and registration of therapeutic goods

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments the Act to clarify that after completing an evaluation of an application for registration in the Register, the Secretary must decide to either register or not register the goods in question, and to make it clearer what steps the Secretary must take following such a decision.  The Schedule contains amendments which make it clearer under which provision of the Act product information for medicines accepted for registration is approved.  The amendments do not change for applicants the way in which prescription and other registered medicines are approved, or product information for those medicines is approved.

 

Item 1

This item makes a minor consequential change to paragraph 19A(8)(b) of the Act, to reflect the changes to be introduced by item 4 below.

 

Item 2

This item makes a minor consequential change to subsection 24D(3) of the Act, to also reflect the changes to be introduced by item 4 below.

 

Item 3

This item amends the heading of section 25 of the Act to remove the reference to “and registration”, to reflect the changes to be introduced by items 4 and 5 below.

 

Item 4

Section 25 of the Act deals with the matters which the Secretary must consider when evaluating an application for registration in the Register, and the steps the Secretary must take after completing the evaluation process and after a decision has been made as to whether or not to register the goods the subject of an application for registration.

 

However, section 25 does not currently expressly set out that the Secretary must make a decision as to whether or not to register the goods.

 

This power has been understood as being implied within section 25, for example in subsections (3) and (4) of the Act, which set out the steps the Secretary must take in relation to notifying applicants of a decision to register or not register their goods.

 

Item 4 amends section 25 to  provide greater clarity about the fact that the Secretary must make a decision in relation to the registration of the goods after the evaluation has been completed.  Item 4 also complements the amendments set out in item 9, which provide greater clarity about the steps that are required to occur following a decision to register goods.

 

To that end, item 4 replaces subsections 25(3), (4) and (5) of the Act with a new subsection 25(3) which sets out that after completing an evaluation of goods under section 25, the Secretary must decide to either register the goods or not to register the goods.

 

Items 5 and 8

Subsection 25AA(1) currently provides that if the Secretary includes a medicine in the Register in relation to which product information is required to be approved, the product information that is approved under subsection 25AA(1) is the product information referred to in subparagraph 25(4)(d)(ia) of the Act.

 

Item 5 introduces a new subsection 25AA(1) to the Act, which reflects the removal of subsection 25(4) of the Act by item 4 and requires the Secretary to approve product information if the Secretary has decided under subsection 25(3) to register goods for which product information is required to accompany the application.

 

New subsection 25AA(1A) also requires that the Secretary must not approve product information under subsection 25AA(1) unless satisfied that the product information reflects the basis on which the Secretary decided under subsection 25(3) to register the goods.

 

This measure is intended to refer to the importance of the product information not being inconsistent or out of step with the basis on which the Secretary, after taking into account all of the information provided in and with the application for a medicine’s registration and after balancing the risks and benefits of the medicine, decided that it was suitable for registration.

 

This would principally involve ensuring that the information contained in product information - for example, the indications approved for the medicine, any contraindications, the medicine’s pharmacology and the details of precautions for use and possible adverse events relating to the medicine precisely align with the conclusions come to by the Secretary when coming to the view that the medicine should be registered.  This measure is not intended to change the nature or extent of information currently included in product information that is approved by the Secretary.   

 

Nor is the amendment intended to imply that product information is, or is intended to be, a comprehensive record of all the information that was before the Secretary when conducting the evaluation of the medicine, or a statement of the Secretary’s reasons for approving the medicine for registration.  Product information is more a summary of key subsets of the information considered by the Secretary in the evaluation and in coming to the decision to register, such as the medicine’s indications, its precautions for use etc - these subsets are set out in the form approved under section 7D of the Act for applicants to provide product information to the TGA.

 

The intention is to require that those key pieces of information about a medicine that make up the product information align with, and do not contradict, the registration decision or the considerations that led to the Secretary to approve the medicine for registration.

 

This measure principally reflects that the product information is an integral component of the decision to register the medicine, and the fact that the content of the product information essentially underpins that registration decision including in relation to the quality, safety and efficacy of the medicine.

 

The product information is reviewed by the Secretary while the application for registration for the medicine is being evaluated and may be the subject of discussions with the applicant at that time.  A decision to register a medicine would not be made unless the Secretary was satisfied that the content of the product information to be approved was accurate in properly reflecting the circumstances in which the medicine was considered suitable for registration.

 

Item 8 makes an equivalent amendment to the above to section 25AA in relation to variations of approved product information for medicines that are already included in the Register.

 

Subsection 25AA(4) allows the Secretary to vary approved product information for medicines that are already in the Register if either the Secretary varies the entry in the Register for the medicine under section 9D of the Act or there is a change (under section 28 of the Act) in the conditions to which the registration of the medicine is subject, and as a result the Secretary is satisfied that a variation to the product information is needed to reflect those changes.

 

Item 8 introduces a new subsection 25AA(4A) to the Act which would preclude the Secretary from varying approved product information under subsection 25AA(4) unless the product information, as varied, would reflect the basis on which the Secretary decided to vary the entry in the Register for the medicine under section 9D or under which the Secretary decided to change the medicine’s conditions under section 28.

 

In summary, both proposed subsection 25AA(1A) and 25AA(4A) are intended to capture current practice in the approval of product information by the Secretary under the Act.

 

Items 6 and 7

These items make minor, consequential amendments to each of paragraphs 25AA(2)(b), (3)(b), and (3)(c) to reflect the changes introduced by item 4.

 

Item 9

This item introduces new sections 25AB and 25AC to the Act.  They replace (with some minor changes) the requirements currently in subsection 25(4) which is being repealed by item 4.

 

New section 25AB sets out the steps that the Secretary must take to notify applicants for registration when an application has been successful, including notifying applicants in writing of the Secretary’s decision to register goods within 28 days of making the decision (new subsections 25AB(1) (for therapeutic devices) and (2) (for other therapeutic goods) refer).

 

New subsection 25AB(3) of the Act essentially replicates the functions currently contained in subsection 25(4) of the Act, but provides greater clarity about the processes leading to the actual registration of goods in the Register.

 

New subsection 25AB(3) requires that the Secretary’s notice given to an applicant of the decision to register goods must also (for relevant medicines) set out the product information approved under subsection 25AA(1) for the medicine, and advise the applicant that, notwithstanding the decision on registration, the goods will not be included in the Register unless and until the applicant gives the Secretary the certificate required under subsection 26B(1) of the Act, or a notice (using the approved form) that such a certificate is not required.

 

The effect of new subsection 25AB(3) is to make it clear that this step must be completed before a medicine that has been approved for registration can actually be included in the Register.

 

New paragraph 25AB(3)(b) (taken together with the changes in item 5), by conferring an express power on the Secretary to approve product information under subsection 25AA(1), clarifies that it is under subsection 25AA(1) that the product information which is evaluated as part of the registration evaluation process (paragraph 25(1)(da) of the Act refers) is approved.

 

New section 25AC sets out that if the Secretary decides, in relation to an application for registration, not to register the goods, she must - within 28 days - notify the applicant of the decision, and her reasons for it.

 

Item 10

This item makes a minor, consequential change to section 26BA of the Act to reflect the changes introduced by item 9.

 

Application

 

Item 11

This item sets out how the amendments under this Schedule will operate.

 

Sub-item (1) provides that the amendments to sections 19A, 24D and 25 of the Act made by items 1-4 apply in relation to evaluations for registration completed on or after the commencement of item 11.

 

Sub-item (2) provides that the amendments to section 25AA made by items 5-7 (but not by item 8) apply in relation to therapeutic goods the evaluation of which under section 25 of the Act is completed on or after the commencement of item 11.

 

Sub-item (3) provides that new subsection 25AA(4A), as inserted by item 8, applies in relation to variations to product information made on or after the commencement of item 11.

 

Sub-item (4) provides that sections 25AB and 25AC, as inserted by item 9, apply in relation to therapeutic goods the evaluation of which under section 25 of the Act is completed on or after the commencement of item 11.

 

In summary, in relation to an evaluation completed after the commencement of the amendments, any notification by the Secretary  of the outcome of an evaluation of an application for registration will be done in accordance with new sections 25AB and 25AC.

 

Item 12

Item 12 is a savings provision in relation to forms approved by the Secretary for the purposes of subparagraph 25(4)(d)(i) of the Act for notices that a certificate under subsection 26B(1) of the Act is not required for a medicine accepted for registration.  That subparagraph is to be repealed by item 4.

 

Item 12 will have the effect that a form approved for that purpose by the Secretary under subparagraph 25(4)(d)(i) of the Act immediately before the commencement of item 12 is taken, after that time, to have been approved for the purposes of new subparagraph 25AB(3)(c)(ii).

 



SCHEDULE 6 — Conditions

 

Therapeutic Goods Act 1989

This Schedule contains amendments to the Act to allow changes made by the Secretary to conditions of registration, listing or inclusion of therapeutic goods in the Register, and changes to conditions of manufacturing licences and conformity assessment certificates, to take effect earlier than is currently possible under the Act, in certain circumstances (including, principally, that the sponsor or certificate or licence holder agrees to the earlier commencement of the changes).

 

Items 1 and 2

Under subsection 28(3) of the Act, the Secretary may, by written notice, impose new conditions on the registration or listing of goods already included in the Register, and vary or remove conditions imposed under subsection 28(2B) of the Act.  Subsection 28(3A) of the Act sets out that the Secretary’s power under subsection 28(3) may be exercised by the Secretary of her own motion, or upon a request by the person in relation to whom goods are registered or listed.

 

Under subsection 28(4) of the Act, the imposition of a new condition, or the variation or removal of an existing 28(2B) condition, takes effect:

 

(a)      if the action is necessary to prevent imminent risk of death or serious illness or injury - on the day on which notice is given; or

(b)     in any other case, on a day specified in the notice, not being earlier than 28 days after notice is given.

 

The requirement noted in (b) above that new conditions, or the variation or removal of existing conditions, may not start earlier than 28 days after notice is given (except where there is an imminent risk of death etc.) precludes the Secretary at the moment from responding flexibly to requests by sponsors for such changes even where it is clear in the circumstances that an earlier commencement would be appropriate from a regulatory perspective and the sponsor agrees.

 

To address this issue, item 1 amends subsection 28(4) to allow the imposition of new conditions, and the variation of existing conditions - where these have been requested by the person in relation to whom the goods are registered or listed - to commence earlier than at least 28 days from the date of the notice, but only if the sponsor agrees to an earlier day in that regard.

 

The item also allows the removal of existing conditions of registration or listing (whether requested by the sponsor or at the Secretary’s own initiative) to commence earlier than at least 28 days from the date of the notice , but only if the sponsor agrees to an earlier day in that regard.

 

Allowing for the removal of a condition earlier than 28 days from the date of notice in both cases - i.e. where a person has requested it, and where the Secretary has removed a condition on her own initiative - reflects that, in either situation, there will be expected to be a benefit to the sponsor in terms of a reduction in their regulatory burden through the removal of the condition. 

 

In either circumstance, it is important to note that in the absence of an imminent risk of death, serious illness or serious injury, the change of condition will only take effect earlier than 28 days from the date of notice if the sponsor agrees to the earlier start date.

 

Item 2 adds a new subsection 28(4A) to clarify that the earlier day that can be agreed to by the sponsor for the commencement of a change to conditions of registration or listing cannot be earlier than the day the notice is given to the sponsor (i.e. cannot be retrospective).

 

Items 3 and 4

These items implement equivalent amendments to those set out in items 1 and 2, in relation to when changes to conditions imposed on the inclusion of a biological in the Register can commence to operate.

 

Items 5, 6 and 7

Subsection 40(2) of the Act allows the Secretary to impose new conditions on a manufacturing licence granted to a person under section 38 of the Act, or to vary or remove existing conditions. 

 

Subsection 40(3) provides that the imposition or variation of a licence condition will take effect:

 

(a)        if the action is necessary to prevent imminent risk of death or serious illness or injury - on the day on which notice is given; or

(b)        in any other case, on a day specified in the notice, not being earlier than 28 days after notice is given.

 

Although subsection 40(2) of the Act allows the Secretary to remove existing conditions of manufacturing licences (as well as varying such conditions and imposing new conditions), subsection 40(3) only refers to when the imposition or variation of such conditions takes effect.

 

Item 5 therefore adds a reference to “removal” to subsection 40(3) to ensure that a time of effect is specifically provided for in relation to each of the possible regulatory decisions.

 

In addition, item 6 replaces the current paragraph 40(3)(b) of the Act with a new paragraph (b) which allows a new condition or the variation or removal of an existing condition to take effect earlier than 28 days from the date of the notice, if the licence holder agrees.

 

This is designed to provide for greater flexibility in relation to the implementation of changes to conditions of manufacturing licences.

 

Item 7 adds a new subsection 40(3A) which would make it clear that the earlier day that can be agreed to by the licence holder for the commencement of a change to conditions of their licence cannot be earlier than the day the notice is given to the licence holder (i.e. cannot be retrospective).

 

Items 8, 9 and 10

Subsection 41EL(1) of the Act allows the Secretary to impose new conditions on a conformity assessment certificate after it has been issued to a manufacturer of medical devices, or vary or remove existing conditions, either on the Secretary’s own initiative or upon request by the manufacturer.

 

Such conditions may relate to the kinds of devices manufactured by the certificate holder, or to the manufacturer’s quality management system.

 

Subsection 41EL(2) provides that the imposition or variation of such a condition will take effect:

 

(a)      if the action is necessary to prevent imminent risk of death or serious illness or injury - on the day on which notice is given; or

(b)     in any other case, on a day specified in the notice, not being earlier than 28 days after notice is given.

 

Although subsection 41EL(1) of the Act allows the Secretary to remove existing conditions applying to a conformity assessment certificate (as well as varying such conditions and imposing new conditions) subsection 41EL(2) only refers to when the “imposition or variation of such a condition takes effect”.

 

Item 8 therefore adds a reference to “removal” to subsection 41EL(2) to ensure that a time of effect is specifically provided for in relation to each of the possible regulatory decisions.

 

Items 9 and 10 then implement equivalent amendments to subsection 41EL(2) of the Act to those set out in items 1 and 2 above.

 

Items 11, 12 and 13

Item 11 amends subsection 41FP(2) of the Act to address the same situation as outlined above in relation to items 5 and 8.

 

Subsection 41FP(1) of the Act allows the Secretary to impose new conditions on the inclusion of a kind of medical device in the Register, or to vary or remove existing conditions, either on the Secretary’s own initiative or upon the request of the person in relation to whom the kind of devices are included in the Register.

 

Subsection 41FP(2) sets out when the imposition or variation of such a condition will take effect, but does not mention when the removal of a condition under subsection 41FP(1) will commence.

 

Item 11 therefore adds a reference to ‘removal’ to subsection 41EL(2) to ensure that a time of effect is specifically provided for in relation to each of the possible regulatory decisions.

 

Items 12 and 13 then implement equivalent amendments to subsection 41FP(2) of the Act to those set out in items 1 and 2 above.

 

Application

 

Item 14

This item sets out the how the amendments made under this Schedule will operate.

 

Sub-item (1) provides that the amendments to subsection 28(4) of the Act made by items 1 and 2 apply in relation to notices given under subsection 28(3) of the Act (in relation to the imposition of new conditions of registration or listing, or the variation or removal of existing conditions) on or after the commencement of item 14.

 

Sub-item (2) provides that the amendments to section 32EE made by items 3 and 4 apply in relation to notices given under that section (in relation to the imposition of new conditions of inclusion of a biological in the Register, or the variation or removal of existing such conditions) on or after the commencement of item 14.

 

Sub-item (3) provides that the amendments to section 40 of the Act made by items 5-7 apply in relation to notices given under that section (in relation to the imposition of new conditions on a manufacturing licence, or the variation or removal of existing conditions) on or after the commencement of item 14.

 

Sub-item (4) provides that the amendments to section 41EL made by items 8-10 apply in relation to notices given under that section (in relation to the imposition of new conditions on a conformity assessment certificate, or the variation or removal of existing conditions) on or after the commencement of item 14.

 

Sub-item (5) provides that the amendments to section 41FP of the Act made by items 11-13 apply in relation to notices given under that section (in relation to the imposition of new conditions on the inclusion of kinds of medical devices in the Register, or the variation or removal of existing such conditions) on or after the commencement of item 14.



SCHEDULE 7 — Presentation

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments to the Act to include a new power for the Secretary to cancel the registration or listing of goods where it appears to the Secretary that the presentation of registered goods is not acceptable or the presentation of listed goods is unacceptable.

 

Item 1

Under subsection 30(2) of the Act, the Secretary may, in writing and subject to subsection 30(3) of the Act, cancel the registration or listing of therapeutic goods if one or more of the circumstances listed at paragraphs 30(2)(a) - (f) apply.

 

Subsection 30(2) of the Act does not, however, currently provide for the Secretary to cancel the registration or listing of therapeutic goods if the presentation of the goods is, in the case of listed therapeutic goods, unacceptable or, in the case of registered therapeutic goods, not acceptable. 

 

The ‘presentation’ of therapeutic goods means the way in which the goods are presented for supply and includes matters relating to the name, labelling and packaging and any advertising or other informational material associated with the goods.

 

The requirement for the presentation of goods to be either ‘acceptable’ (in the case of registered therapeutic goods) or ‘not unacceptable’ (in the case of listed therapeutic goods) is a criterion that must be met before therapeutic goods may be included in the Register (paragraphs 26(1)(e), 26A(2)(c) and 25(1)(e) of the Act refer).  The Act contains (subsection 3(5) of the Act refers) a description of the circumstances in which the presentation of therapeutic goods will be taken to be ‘unacceptable’. 

 

To ensure that there is a mechanism by which therapeutic goods continue to satisfy this criteria for so long as they remain entered on the Register, this item amends subsection 30(2) of the Act to include (at new paragraph 30(2)(aa)) a power for the Secretary to cancel the registration or listing of therapeutic goods if it appears to the Secretary that:

 

·                 the presentation of listed therapeutic goods is unacceptable ; or

·                 the presentation of registered therapeutic goods is not acceptable .

 

It is important to note the distinction between the presentation of listed goods being ‘unacceptable’ and the presentation of registered goods not being ‘acceptable’, in new paragraph 30(2)(aa).

 

In relation to the presentation of listed therapeutic goods being ‘unacceptable’, this is intended to refer to the meaning of ‘unacceptable presentation’ as described in subsection 3(5) of the Act.  This subsection describes the presentation of a good as unacceptable if it is capable of being misleading or confusing as to the goods’ content, proper use or identification and if - without limiting that description - any of the circumstances at paragraphs 3(5)(a)-(e) apply.  Those paragraphs list a series of circumstances e.g. if goods have the same name as another good with different or additional therapeutically active substances (paragraph 3(5)(b) of the Act refers) and includes circumstances that are prescribed (paragraph 3(5)(e) of the Act refers).  Regulation 3A of the Regulations covers additional circumstances in which the presentation of therapeutic goods will be taken to be ‘unacceptable’.

 

In relation to registered goods, whether the presentation of such goods is ‘not acceptable’ can encompass a range of factors that might go beyond the scope of the definition of ‘unacceptable presentation’ in subsection 3(5) of the Act.  For example, the presentation of registered goods may cover matters such as the consumer medicine information for the goods.

 

As both cases suggest, there can be significant safety concerns associated with the presentation of therapeutic goods not being acceptable, or being unacceptable, and it is important that the Act contain an appropriate cancellation power to reinforce the fact that this issue is a factor that is taken into account in determining whether therapeutic goods should be included, and once included, remain, in the Register.

 

As with the other Secretary’s cancellation powers under subsection 30(2) of the Act, the Secretary is required under subsection 30(3) to first issue an affected person notice of a proposal to cancel and give them a reasonable opportunity to make submissions in relation to the proposal.  If the person makes submissions, the Secretary must not make a decision on cancellation until those submissions have been taken into account.

 

As a result of including the presentation of the goods as a grounds for cancellation of listed or registered therapeutic goods from the Register, the Secretary has the option under section 29D of the Act of suspending the goods from the Register for a period of not more than 6 months.

 

Item 2

This item makes a consequential change to section 30EA of the Act, which deals with the powers of the Secretary to impose requirements on a range of persons in relation to registered or listed therapeutic goods (or goods that are exempt from, or are the subject of an approval or authority in relation to, the requirement to be registered or listed).

 

Under subsection 30EA(2) of the Act, the Secretary may, in writing, impose on a person requirements relating to therapeutic goods if any of the circumstances set out in column 2 of the table in subsection 30EA(1) apply in relation to a person mentioned in column 3 of that table.

 

Under item 5A of that table, the Secretary may impose requirements on a person in relation to whom therapeutic goods are registered or listed if such goods are supplied by the person and it appears to the Secretary “that the quality, safety or efficacy of the goods is unacceptable or that the presentation of the goods is unacceptable”.

 

In light of the changes made by item 1, the reference in this description needs to be updated to reflect the distinction between the presentation of listed goods being ‘unacceptable’, and the presentation of registered goods not being ‘acceptable’.

 

Item 2 therefore amends item 5A of the table at subsection 30EA(1) to refer to the presentation of listed goods being unacceptable or the presentation of registered goods not being acceptable, as circumstances triggering the Secretary’s powers to impose requirements under subsection 30EA(2).

 

The effect of this will be to make it clear that the Secretary’s powers to impose requirements under subsection 30EA(2) in relation to the presentation of goods apply in respect of both registered and listed therapeutic goods.

 

Item 3

Under paragraph 32GC(1)(a) of the Act, the Secretary may (subject to subsection 32GC(2) of the Act), cancel the inclusion of a biological from the Register if (among other things) the presentation of the biological is ‘unacceptable’.

 

However, this would not appear to be consistent with paragraph 32DE(1)(b) of the Act, which requires the Secretary to consider, when evaluating an application for the inclusion of a biological in the Register, if the presentation of the biological is ‘acceptable’.

 

To correct this inconsistency, and to more closely align the cancellation power with the basis on which biologicals are assessed for marketing approval in relation to presentation, item 3 replaces the reference to the presentation of a biological being ‘unacceptable’ in paragraph 32GC(1)(a) with a reference to that presentation being ‘not acceptable’.

 

Item 4

Subsection 32HA of the Act deals with the powers of the Secretary to impose requirements on a range of persons in relation to biologicals.

 

Under subsection 32HA(2) of the Act, the Secretary may, in writing, impose on a person requirements relating to biologicals if any of the circumstances set out in column 2 of the table in subsection 30EA(1) apply in relation to a person mentioned in column 3 of that table.

 

Under item 9 of that table, the Secretary may impose requirements on a person in relation to whom a biological is included in the Register if (among other things) it appears to the Secretary that the presentation of the biological is ‘unacceptable’.

 

Item 4 amends item 9 of the table at subsection 32HA(1) of the Act to replace the reference in item 9 to ‘unacceptable’ presentation with a reference to the presentation of a biological being ‘not acceptable’.

 

This will bring the Secretary’s recall powers on presentation into line with her cancellation powers in relation to presentation (as amended by item 3 above) and with the criteria against which biologicals are evaluated for marketing approval regarding presentation.

 

Application

 

Item 5

This item sets out that the amendments made by this Schedule apply in relation to therapeutic goods included in the Register before and after the commencement of this item.



SCHEDULE 8 — Consent to the import, supply or export of goods

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments to the Act to provide a right of merits review where, under subsection 15(1) of the Act, the Secretary imposes conditions on the granting of her consent to the importing into, supplying in or exporting from, Australia, of therapeutic goods (other than medical devices) that do not comply with an applicable standard.

 

Item 1

Sections 14 and 14A of the Act set out criminal offences, and a corresponding civil penalty provision, relating to the importing into, supplying in or exporting from, Australia, of therapeutic goods other than medical devices, that do not comply with a standard made under the Act that is applicable to the goods.

 

Under these offence and civil penalty provisions, the Secretary may consent to the importing into, supplying in or exporting from, Australia, of therapeutic goods that do not comply with an applicable standard, with the effect that if such a consent is in place the relevant offence or civil penalty will not apply.  Under subsection 15(1) of the Act, the Secretary may give her consent under sections 14 and 14A unconditionally, or subject to conditions.

 

However, while a decision of the Secretary to not consent to the importing into etc. of goods that do not comply with an applicable standard is subject to review by the Minister under section 60 of the Act (and AAT review), a decision of the Secretary to impose a condition on such consent is not currently subject to section 60 review.

 

This is to be contrasted with the situation in relation to decisions by the Secretary to impose conditions on her consent to the importing into, supplying in or exporting from, Australia of medical devices that do not comply with the essential principles, which are subject to review under section 60 (paragraph (k) of the definition of ‘initial decision’ in subsection 60(1) of the Act refers).

 

This item amends the rights of review under subsection 60(1) of the Act to include a reference to conditions imposed by the Secretary on any granting of consent under sections 14 or 14A of the Act to the importing into, supplying in or exporting from, Australia, of therapeutic goods that do not comply with an applicable standard.

 

The effect here will be to provide sponsors with a right of merits review in relation to the imposition of conditions on such consents, including a right to appeal to the AAT in relation to the Minister’s review decision.

 

Application

 

Item 2

This item sets out that the above amendment will apply in relation to conditions imposed on or after the commencement of item 2.



SCHEDULE 9 — Review of decisions

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments to the Act to make it clear that where the Minister revokes an initial decision of the Secretary, and makes a decision in substitution, the substituted decision is to be treated as a decision of the Secretary (except for the purposes of any review of the substituted decision).  The substituted decision has effect on and from the date determined by the Minister.

 

Item 1

Section 60 of the Act makes provision for review by the Minister of certain decisions of the Secretary under the Act (‘initial decisions’), e.g. decisions to cancel the registration or listing of goods from the Register.

 

Subsection 60(2) of the Act allows a ‘person whose interests are affected’ by an initial decision to request the Minister to review such a decision within 90 days (see amendments to this subsection being made by item 3 in Schedule 13 below).

 

As soon as is practicable after receiving such a request, the Minister must reconsider the initial decision and either confirm the initial decision, or revoke it and substitute her own decision (subsection 60(3) of the Act refers).

 

This item introduces new subsection 60(3C) to clarify that if the Minister revokes an initial decision and makes a decision in substitution, the substituted decision:

 

(a)        is taken to be a decision of the Secretary (except for the purposes of any review of the substituted decision); and

(b)        has effect, or is taken to have effect, on and from the date determined by the Minister.

 

This amendment will support new section 25AB and sections 25 and 25AA as amended by the items in Schedule 5 above.  In circumstances where the Minister overturns a decision of the Secretary (or her delegate) for instance, not to register a medicine in the Register, then because the Minister’s decision is taken to be that of the Secretary, the Secretary can then complete the process of registration (by completing relevant administrative requirements in relation to the medicine under section 25AB of the Act and approving product information for the medicine under section 25AA of the Act).

 

The reason that it is not taken to be a decision of the Secretary for the purposes of any review of the substituted decision is to ensure that any person affected by the decision can seek a review of the Minister’s decision by the AAT (subsection 60(8) of the Act refers).

 

Application

 

Item 2

This item sets out that the amendments to section 60 made by the above item apply in relation to decisions revoked by the Minister on or after the commencement of this item.



 

SCHEDULE 10 - Kits

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments to the Act to modify the definition of a ‘kit’ in section 7B of the Act, to encompass kits containing (among other things) only one registered or listed therapeutic good, or a biological, rather than the current requirement for a minimum of two separate therapeutic goods needing to be included.

 

Item 1

Section 7B of the Act sets out the requirements for a package and its contents to be taken to be ‘kit’ for the purposes of the Act and the regulations.  If they constitute a kit within the meaning of section 7B, the package and its contents can be listed under either section 26 or 26A of the Act.

 

Subsection 7B(1) of the Act currently provides that a package and therapeutic goods in the package together constitute a kit for the purposes of the Act if:

 

·                 the package and the therapeutic goods are for use as a unit;

·                 each item of the therapeutic goods in the package are either registered or listed or (in the case of a biological) included in the Register, or exempted from the requirement to be entered on the Register; and

·                 the package and therapeutic goods are not a composite pack or a system or procedure pack.

 

Under this definition, for a package and therapeutic goods to be a kit there must be more than one therapeutic good in the package.  However there may be circumstances where a package contains a number of items for use as a unit but only one of those is a therapeutic good.  As such it could not be listed as a ‘kit’.

 

This item introduces a new subsection 7B(1) to the Act, with the effect that a package and each of the therapeutic goods and non-therapeutic goods in the package together constitute a kit provided that:

 

·                 the package and each of the goods are for use as a unit;

·                 at least one of the goods in the package is therapeutic goods;

·                 each therapeutic good in the package is either registered, listed or included in the Register, or exempt from entry on the Register; and

·                 the package and goods are not a composite pack or a system or procedure pack.

 

This amendment will support greater flexibility in allowing kit sponsors to only have one therapeutic good in their kits in order to access the listing process and make it clear that kits may contain - in addition to therapeutic goods - products that are not therapeutic goods (e.g. a shower cap, or a cosmetic such as a moisturiser) provided they are for use as a unit.

 

Application

 

Item 2

This item sets out that the amendments to section 7B of the Act made by the item 1 apply in relation to applications for the listing of therapeutic goods made on or after the commencement of this item.



 

SCHEDULE 11 - False or misleading statements

 

Therapeutic Goods Act 1989

 

Item 1

 

This Schedule contains amendments to the Act to include a new criminal offence provision, and a corresponding civil penalty provision, relating to the making of a statement that is false or misleading in a material particular in, or in connection with, a request under section 9D of the Act for a variation to an entry for therapeutic goods in the Register.

 

Criminal offences for false statements in variation requests

Section 9D of the Act allows the Secretary to vary an entry of therapeutic goods on the Register in certain circumstances either on her own initiative, or upon a request by the person in relation to whom goods are on the Register.

 

Requests to vary an entry on the Register may relate to a variety of matters, including quite serious safety issues including adding warnings or precautions in connection with the use of particular therapeutic goods.  Variations can only be made in the circumstances set out in the relevant subsection, including for instance, that the Secretary is satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy/performance of the goods for the purposes for which they are to be used (subsections 9D(3), (3A) and (3D) of the Act refers).

 

Requests may also involve the provision of significant amounts of data, such as (in the case of prescription medicines) clinical, pre-clinical or bioequivalence data necessary for the Secretary to determine whether statutory requirements set out in the applicable subsections in section 9D are satisfied such that the requested variation should be made to the entry.

 

This information will be peculiarly within the knowledge of the sponsor.  Moreover, it is up to the sponsor to demonstrate that the basis on which a product was approved for marketing in Australia (via inclusion in the Register) - i.e. that its quality, safety and efficacy/performance was acceptable - remains, and that, as such, the product should continue to be on the Register notwithstanding the proposed change.

 

Thus there is a particular level of dependence on the accuracy and comprehensiveness of the supporting information provided with a section 9D request, especially in relation to higher risk goods such as prescription medicines.

 

The provision of false or misleading information that was material to a decision by the Secretary to vary an entry in the Register under the section could potentially have serious consequences for public health.  Currently, however, the Act does not contain any offence or civil penalty provisions relating to the provision of false or misleading information in connection with a request under section 9D.

 

The Act does, however, contain offences for the making of false or misleading statements in relation to applications for marketing approval of therapeutic goods (subsections 21A(1), (2), (3) and (4), and sections 22A, 32DO and 41FE refer).

 

To address this, item 1 introduces new section 9G to the Act in relation to making statements in connection with a request to vary information on the Register.  New section 9G replicates the three-tiered offences structure with an alternative civil penalty provision, contained under the Act for making a statement that is false or misleading in a material particular in other circumstances where the Secretary relies on information provided to make regulatory decisions (see for instance in subsections 21A(1), (2), (3) and (4) of the Act in relation to applications for listing in relation to which certifications are given under section 26A of the Act, and section 22A of the Act in relation to applications for registration under section 23 of the Act).

 

These offences would apply where false or misleading information has been given in that context and:

 

·                 either use of the relevant goods has resulted in, or will result in, harm or injury to any person, or use of the goods, if used, would result in harm or injury to any person - maximum penalty imprisonment for 5 years or 4,000 penalty units, or both (new subsection 9G(1)); or

·                 use of the goods, if used, would be likely to result in harm or injury to any person - maximum penalty 2,000 penalty units (this is an offence of strict liability) (new subsection 9G(2)); or

·                 where there are no aggravating elements of harm or injury - maximum penalty imprisonment for 12 months or 1,000 penalty units, or both (new subsection 9G(4)).

 

This tiered approach, with higher penalty levels applying where use of the goods has had, or will or would have, serious health consequences, is consistent with the existing tiered offences in the Act relating to the provision of false or misleading information in connection with an application for marketing approval (subsections 21A(1), (2), (3) and (4), and sections 22A, 32DO and 41FE of the Act refer).

 

The maximum penalty levels for the three tiers of the new offence at 9G are higher than the benchmarks set out in the Commonwealth document “ A Guide to Framing Commonwealth Offences, Civil Penalties and Enforcement Powers ” (‘the Guide to Framing Offices’).  However, these penalty levels are considered to be appropriate and necessary to reflect the seriousness of the conduct to which they relate and the potentially serious consequences for public health of such conduct.  The penalty levels are also consistent with the maximum penalties for the existing offences in the Act mentioned above relating to the provision of false or misleading information in connection with an application for marketing approval.

 

For example, the offence at new subsection 9G(1), for which a maximum penalty of 5 years imprisonment or 4,000 penalty units is specified, includes as a component of the offence, in addition to the making of a false or misleading statement in connection with a section 9D request, that the use of the goods to which the request relates has resulted in a person suffering harm or injury or will or would (if used) result in a person suffering harm or injury.

 

In addition, it is noted that the offence at new subsection 9G(2) is an offence of strict liability (new subsection 9G(3) refers), and carries a higher maximum penalty than suggested for strict liability offences in the Senate Standing Committee for the Scrutiny of Bills’ Sixth Report of 2002 “ Application of Absolute and Strict Liability Offences in Commonwealth Legislation ”.

 

In relation to the concerns noted in that report about strict liability offences, and the concerns set out in the Guide to Framing Offences for such offences, it is important to note that new subsection 9G(2) does not incorporate any imprisonment element and the maximum penalty is capped at 2,000 penalty units.  This maximum penalty level reflects the seriousness of the conduct addressed by the offence - this offence will only apply where (among other components) use of the goods to which the relevant section 9D request relates would be likely to result in harm or injury to a person.

 

Where non-compliance with the requirement to provide accurate information that is not false or misleading is likely to cause harm or injury (as per proposed subsection 9G(2)), it is considered that non-compliance should attract a criminal sanction regardless of any mental element.

 

By setting out a strong deterrence against providing information that is false or misleading in a material particular, and by forming an integral part of the suite of sanctions proposed for such conduct, it is expected that the strict liability offence in new subsection 9G(2) will significantly enhance regulatory enforcement and help to protect the public from exposure to therapeutic goods that have been approved for continued supply on the basis of false or misleading information.

 

As such, the strict liability offence at new subsection 9G(2), as with equivalent strict liability offences throughout the Act that form part of the Act’s tiered approach to criminal offences, serves an important role in deterring and addressing conduct that endangers public health.

 

New section 9H - Civil penalty for false statements in variation requests

Item 1 of this Schedule also introduces, in new section 9H, a corresponding civil penalty provision to the above new offences for the provision of making a statement that is false or misleading in a material particular in, or in connection with, a request under section 9D.

 

The maximum civil penalty level under new section 9H is 5,000 penalty units for an individual, and 50,000 penalty units for a body corporate.

 

This is consistent with the existing civil penalty provisions in the Act relating to the provision of false or misleading information in connection with an application for marketing approval (subsection 21B(1), and sections 22B, 32DP and 41FEA of the Act refer), and with other civil penalty provisions in the Act.

 

As with the offences in new section 9G, the maximum penalty levels for new section 9H reflect the importance of deterring conduct involving the making of false or misleading statements in requests to vary an entry in the Register.

 

If the Secretary were to approve a variation of an entry based on false or misleading information (for example, information suggesting that the effect of a variation of the product included in the Register will not result in any reduction in the quality, safety or efficacy of that product), that could have serious consequences for users of the product concerned.

 

Item 2

This item makes a consequential amendment to section 53A of the Act to include a reference to new subsections 9G(1) and 9G(4) in a new item in the table in section 53A.

 

The effect of this amendment will be that if a jury acquits a person of the more serious offence at subsection 9G(1) but is satisfied beyond reasonable doubt of facts that prove the person is guilty of the lesser offence at subsection 9G(4), the jury may convict the person of the offence at subsection 9G(4).

 

This amendment is consistent with the current position in relation to each of the maximum penalty offence provisions relating to the provision of false or misleading information in connection with an application for marketing approval (items 6, 10, 13G and 18 of the table in section 53A refer).

 

Application

 

Item 3

This item sets out that the amendments above to introduce new sections 9D and 9H to the Act apply in relation to requests under section 9D of the Act made on or after the commencement of this item.



 

SCHEDULE 12 - Notice of cancellation of registration or listing

 

Therapeutic Goods Act 1989

 

This Schedule amends subsection 30(5) of the Act to provide a minimum notice period of at least 20 working days before a cancellation of therapeutic goods from the Register in relation to which the Secretary is required to give notice, may take effect.

 

Item 1

Currently under subsection 30(5) of the Act, where the Secretary cancels the registration or listing of a therapeutic good from the Register, the goods cease to be listed:

 

(a)        if the cancellation has been done under subsection 30(1), (1A) or (1C) (each of which enable the Secretary to cancel without first giving notice of a proposal to cancel) - on the day on which the notice of cancellation is given to the sponsor of the goods; or

(b)        in any other case - on such later day as is specified in the notice.

 

This item includes a new paragraph 30(5)(b) to the Act to give sponsors of goods cancelled other than under subsections 30(1), (1A) or (1C) at least 20 working days from the date of the notice of cancellation before the cancellation of their goods will take effect.

 

The cancellations to which the new paragraph applies are those made by the Secretary under subsection 30(2) of the Act in relation to which the Secretary is required to give the sponsor notice of a proposal to cancel and the opportunity to make submissions in response (subsection 30(3) of the Act refers).  This does not include cancellations where it appears to the Secretary that failure to cancel would create an imminent risk of death, serious illness or serious injury (paragraph 30(1)(a) of the Act refers) or whether the cancellation is of a medicine listed under subsection 26A of the Act which was in fact ineligible for listing (subsection 30(1A) of the Act refers).

 

The effect of this measure is to provide such sponsors with a known period of time to make necessary arrangements for removing products from the marketplace following a cancellation of their goods from the Register.  This amendment will bring subsection 30(5) of the Act into line with the arrangements under the Act for the cancellation of medical devices (section 41GQ of the Act refers).

 

Application

 

Item 2

This item sets out that the amendment of subsection 30(5) of the Act made by item 1 above applies in relation to cancellations of which a person is informed under subsection 30(3) of the Act on or after the commencement of this item, whether the circumstances giving rise to the cancellation occurred before, or occur after, that commencement.



 

SCHEDULE 13 - Publication etc.

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments to the Act to require the Secretary to publish in the Gazette or on the Department’s website a notice setting out the particulars of the cancellation of any registered or listed therapeutic goods from the Register under section 30 of the Act.  The Schedule also amends section 60 of the Act to clarify when the 90 day period commences in which a request for merits review of an initial decision must be made by a person who is not a sponsor of a therapeutic good, and amends a number of provisions in the Act that require or authorise the Secretary to publish information in the Gazette , to allow the Secretary at her discretion to publish that information in the Gazette or on the Department’s website.

 

Item 1

This item makes a minor consequential change to subsection 9A(6) of the Act, to reflect that item 4 below amends (among other provisions) subsection 9A(5) of the Act to permit the Minister to publish notices under subsection 9A(5) either in the Gazette or on the Department’s website.

 

The notices referred to are notices in which the Minister, under subsection 9A(5) of the Act, requires that specified therapeutic goods be included in the part of the Register for listed goods.  Currently under subsection 9A(5) of the Act, the Minister must publish such notices in the Gazette .

 

Item 2

This item introduces a new section 30B to the Act, the effect of which is to require the Secretary to publish the particulars of any cancellation of registered or listed therapeutic goods by her under section 30 of the Act either in the Gazette or on the Department’s website.

 

This amendment will bring the Secretary’s obligations in relation to these cancellations into line with the Secretary’s obligations in relation to the cancellation of biologicals and medical devices.  The Act currently requires the Secretary to publish the details of any cancellation of biologicals and kinds of medical devices from the Register (sections 32GE and 41GP of the Act refer).

 

Item 3

Subsection 60(2) of the Act currently sets out that a person whose interests are affected by an initial decision may, by written notice, request the Minister to review that decision.  Paragraphs 60(2)(a) and (b) set out the time periods within which such a request must be made:

 

(a)        in the case of a decision particulars of which are required to be notified in the Gazette - within 90 days after those particulars are so notified; and

(b)        in any other case - within 90 days after the decision first comes to the person’s notice.

 

This item introduces a new subsection 60(2) to the Act to clarify when the period commences within which a person who may be able to seek a review by the Minister of an initial decision must do so:

 

(a)        if the Act requires the person to be given written notice of the decision or particulars of the decision - within 90 days after the notice is given to the person;

(b)        otherwise - within 90 days of the earlier of when the notice or particulars of the decision are published, or the decision first comes to the person’s attention.

 

This is designed to minimise the possibility of a person arguing many months after a regulatory decision has been made that their right to seek the Minister’s review of a decision remained open because the person had only just become aware of the initial decision.

 

The amendment is related to the amendments to the Act made by item 4 below which provide the Secretary with the option of publishing information on the Department’s website instead of in the Gazette , including in relation to the publication of particulars of a range of regulatory decisions.

 

The outcome is that u nder the revised subsection 60(2):

·          in the case of a person to whom an ‘initial decision’ within the meaning of subsection 60(1) of the Act (in relation to which a review by the Minister is conferred under the section) is notified by the Secretary, the person will have 90 days from notification to make request a reconsideration of the decision;

·          in the case of any other person whose interests are affected by the initial decision, the person will have 90 days from the earlier of publication of notice of the decision in the Gazette or on the Department’s website, or the decision first coming to the person’s notice.

 

There is a public interest in having certainty and finality about rights of review for those about whom regulatory decisions are made and third parties whose interests may be affected by such decisions.

 

Item 4

This item amends almost all provisions in the Act that currently require, or authorise, the Secretary to publish information or the particulars of regulatory decisions in the Gazette , to give the Secretary the option of publishing on the website of the Department of Health instead.  

 

The provisions in the Act that are not proposed to be amended are those which:

 

·                 require the Secretary to publish in the Gazette particulars of exemptions by the Minister of therapeutic goods from the requirement to entered on the Register so that the goods can be made available urgently in Australia to deal with an actual threat to public health caused by an emergency that has occurred, and revocations and variations of such exemptions (subsections 18A(10), 32CF(1) and 41GW(1) of the Act refer);

·                 require the Secretary to publish in the Gazette particulars of decisions by her to require a person to recover batches of therapeutic goods which have been exempted from registration or listing in the Register or, in the case of biologicals, from inclusion in the Register, in order either for the goods to be stockpiled to create a readiness for an emergency or for use to deal with an emergency that has occurred, because the goods in that batch do not conform to an applicable standard or are otherwise not fit for their intended purpose (subsections 30F(4) and 32CJ(4) of the Act refer); and

·                 permit the Secretary to make orders, published in the Gazette , determining that groups of certain kinds of therapeutic goods identified in the order are gazetted therapeutic goods groups (subsection 16(2) of the Act refers).

 

Providing the Secretary with the option of publishing information on the Department’s website rather than in the Gazette (noting that the TGA is a division of the Department and the TGA has a departmental website at www.tga.gov.au ) will be an easier, and more familiar, way of accessing this information for the public, health care professionals and industry than through the Gazette .

 

Examples of the kinds of information that will be able to be published on the Department’s website include details of the suspension and cancellation of the various kinds of therapeutic goods (i.e. registered and listed medicines and other therapeutic goods (new section 30B - item 2 above refers), biologicals (section 32GE of the Act refers) and medical devices (section 41GP of the Act refers), the revocation or suspension of manufacturing licences (subsection 41(6) of the Act refers), and details of requirements imposed by the Secretary on a person who has supplied therapeutic goods which the Secretary is satisfied have been (or could possibly have been) subjected to tampering (subsection 42V(4) of the Act refers).

 

No change is being made in relation to the publication of orders relating to ‘gazetted groups’ in subsections 16(2), (3) and (3A) of the Act which will continue to be published only in the Gazette .

 

Item 5

Item 5 amends the headings for a number of subsections of the Act amended by item 4 above, to remove the reference in those headings to the Gazette , in order to reflect that those provisions now provide for publication of relevant information either in the Gazette or on the Department’s website.

 

Application

 

Item 6

This item provides that the amendments made by this Schedule that relate to the publication of information on the Department’s website apply in relation to matters the subject of those provisions that occur on or after the commencement of this item.

 

Item 7

This item provides that the amendments to section 60 of the Act made by item 3 apply in relation to initial decisions (as defined in subsection 60(1) of the Act) made on or after the commencement of this item.



 

SCHEDULE 14 - Auditing applications

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments to the Act to, principally, allow for an alternative period of time (to be prescribed) to the current 20 working days for the Secretary to decide:

·          whether to audit certain kinds of applications (to be prescribed) for the inclusion of a kind of medical device in the Register, and

·          what other information to ask the applicant to provide that would be relevant to the audit. 

These changes will support the current transition (up-classification) process for hip, knee and shoulder joint implants from the Class IIb medical device classification to Class III.

 

Item 1

Under subsection 41FH(1) of the Act, the Secretary must select for auditing any application for the inclusion of a kind of medical device in the Register that is of a kind prescribed.  Under subsection 41FH(2) of the Act, the Secretary has a discretion to also select for auditing any other application for the inclusion of a kind of device in the Register.

 

If an application is selected for audit, then under subsection 41FH(2) of the Act the Secretary must, within 20 working days after the application is made, advise the applicant that their application will be audited and request them to provide any further information necessary for the auditing of the application.

 

There is a need to provide greater flexibility for certain kinds of applications than is possible under the current requirements.  The kinds of applications involved are those involving medical devices that are hip, knee or shoulder joint implantable medical devices.

 

On 1 July 2012 these kinds of medical devices were reclassified under the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations) from Class IIb medical devices to the higher risk classification of Class III, in order that such products would be subjected to an increased degree of pre-market scrutiny proportionate to their risk.

 

This followed an Inquiry in November 2011 by the Senate Standing Committee on Community Affairs on ‘Regulatory Standards for the Approval of Medical Devices’.  One of the recommendations of this Inquiry related to increasing the rigour of regulatory assessment of higher risk devices.

 

A two-year transition process was provided for in those regulations, with sponsors of such devices that were already included in the Register as at 1 July 2012 having until the end of that transition process - 30 June 2014 - to lodge an application to include those devices in the Register as Class III devices rather than Class IIb.

 

The amendment of subsection 41FH(2) to allow for the prescribing of alternative periods of time for prescribed kinds of applications is needed in relation to these products because, based on experience, a large number of Class III applications are expected in the lead-up to the 30 June 2014 deadline.

 

Allowing more time in this regard will help ensure the TGA is able to manage all such applications efficiently as part of the up-classification process, in a manner that does not divert resources unnecessarily from the consideration of other kinds of medical device applications.

 

Item 1 therefore replaces the current subsection 41FH(2) with new subsections 41FH(2) and (3) - the latter of which sets out that notice of the selection of an applicant’s application for auditing must be given to the applicant either within 20 working days from the date of the application or, if the regulations prescribe a longer period for that kind of application - within that longer period.

 

This would then allow the MD Regulations 2002 to be amended to prescribe an appropriate longer period than 20 working days - with the period to be identified following consultation with industry - for applications involving the hip, knee and shoulder joint medical devices covered by the transitional arrangements.

 

This amendment will not adversely affect sponsors of affected products because, provided they have submitted a Class III application to the TGA by 30 June 2014, their Class IIb entries will not be cancelled until their Class III applications have been determined.

 

The new subsection 41FH(2) also replaces the current requirement for the Secretary to ask an applicant to provide any further information necessary for the auditing of the application when informing them that their application has been selected for audit, with a requirement that the Secretary must require the applicant to provide information that the Secretary is satisfied is relevant to the audit.

 

This reflects that it may often be difficult to identify all the information that will be necessary to complete an audit when the only material available to the Secretary to assist in making that assessment is the application itself.

 

It may be, for example, that a need for additional information will be identified as a result of reviewing information subsequently provided by the applicant in response to the Secretary’s request.

 

The new requirement is therefore intended to provide greater flexibility in this regard, and to refer to information the Secretary is satisfied, at the time of giving the applicant the selection notice, is relevant to the audit of the application.

 

New subsection 41FH(4) highlights that the Secretary also has the power under section 41JA to seek information, at any time, about a range of matters from different kinds of persons including applicants for the inclusion of a kind of medical device in the Register and that the inclusion of the new subsection 41FH(2) with its reference to the Secretary requiring certain information to be provided, does not limit that power.

 

Item 2

Currently paragraph 41FK(a) of the Act provides that an application to include a kind of device in the Register which the Secretary has asked for more information about in order to complete an audit will lapse if the applicant fails to provide that information.

 

However, paragraph 41FK(a) does not state any period of time after which an application lapses under that provision if the applicant fails to provide the requested information.

 

Item 2 therefore introduces a new paragraph 41FK(a) to clarify this and to reflect the changes to section 41FH implemented by item 1.

 

Under the new paragraph 41FK(a), an application will lapse if the applicant fails to comply with a notice under section 41FH to provide further information, within 10 working days after the end of the day specified in the notice.  This is consistent with the period of time given to sponsors of kinds of medical devices to comply with a notice to provide information or documents to the Secretary under section 41JA of the Act before their devices may be cancelled under subsection 41GM(1) of the Act.

 

This will ensure that the applicant has an incentive to provide the information within the required time period.  It should be noted that the applicant has certified as part of the application process about a range of matters that are relevant to any decision to include the kind of device in the Register and that it holds or can access information to substantiate that the kind of device complies with the essential principles and that an appropriate conformity assessment procedure has been applied to the kind of device.

 

Application

 

Item 3

Item 3 sets out that the amendments to sections 41FH and 41FK of the Act made by items 1 and 2 apply in relation to applications for the inclusion of a kind of medical device in the Register made on or after the commencement of item 3.



SCHEDULE 15 - Failure to comply with requirements to provide information etc.

 

Therapeutic Goods Act 1989

 

This Schedule amends subsection 30(2) of the Act to allow the Secretary to cancel the registration or listing of a product where the sponsor of the goods has failed to respond to a notice to provide information or documents issued under section 31 of the Act within 14 days after the date specified in the notice for production of the material.  The Schedule also amends the Act to state that the offences in the Act relating to failing to comply with a notice issued by the Secretary to provide information or documents about biologicals or medical devices (sections 32JB and 41JB of the Act) will not apply if the person issued the notice had a reasonable excuse.

 

Item 1

Subsection 30(2) of the Act sets out a number of circumstances in which the Secretary may, subject to the requirements of subsection 30(3) of the Act, cancel the registration or listing of therapeutic goods.

 

Currently, however, the grounds of cancellation in subsection 30(2) do not include where a person in relation to whom therapeutic goods are registered or listed has been issued a notice to provide information to the Secretary under section 31 of the Act, but has not responded.

 

Subsection 30(1C) of the Act, however, does set out a power for the Secretary to cancel from the Register without notice a medicine listed under section 26A of the Act where the person in relation to whom the product is listed (the sponsor) has failed to comply with a section 31 notice within 20 working days (if that notice was issued to ascertain whether the certifications made in relation to the listing of the medicine under sections 26A(2) and (2A) were correct - item 1 of Schedule 2 refers).

 

There is currently an inconsistency in the legislation in that the Secretary does not have the power to cancel a product from the register if the sponsor fails to respond to a section 31 notice in relation to registered goods or goods listed under section 26 of the Act (the latter are mainly export only goods and therapeutic devices).

 

This item amends subsection 30(2) of the Act to address this inconsistency, with the effect that the Secretary’s power to cancel for a failure to respond to a section 31 request for information or documents will apply in respect of all registered or listed goods and not, as currently, only in relation to medicines listed under section 26A of the Act.  Such a power is vital to underpin the integrity of the regulatory regime - the section 31 request may relate to safety issues for a medicine currently in the Australian market about which it is vital that the Secretary is able to obtain information from the sponsor.

 

While it is an offence to fail to comply with such a notice (subsection 31(4) of the Act), the possibility of a product being cancelled from the Register (with the effect that, once cancelled, it would be unlawful to supply the product in Australia) will provide an additional commercial incentive for the sponsor to comply with the request in a timely way.

 

This power to cancel will apply if the person has not complied with the notice within 14 days after the end of the period of time specified in the section 31 notice (e.g. if the notice states that the person has 28 days to comply with the notice, the Secretary could only cancel the goods from the Register if no response was received at the end of 42 days).

 

As with the other cancellation powers of the Secretary under subsection 30(2) of the Act, the Secretary is required under subsection 30(3) to first issue an affected person notice of a proposal to cancel and give them a reasonable opportunity to make submissions in relation to the proposal.  If the person makes submissions, the Secretary must not make a decision on cancellation until those submissions have been taken into account.

 

As a result of including failure to respond to a request to provide information as a grounds for cancellation of listed or registered therapeutic goods from the Register, the Secretary has the option under section 29D of the Act of suspending the goods from the Register for a period of not more than 6 months.

 

Item 2

This item amends section 32JB of the Act to include (at new subsection 32JB(1A)) a defence of reasonable excuse to the offence set out in subsection 32JB(1) for failing to comply with a notice issued by the Secretary under section 32JA of the Act.

 

Section 32JA of the Act sets out that the Secretary may require a person in relation to whom a biological is or was, at any time within the previous 5 years, included in the Register, or an applicant for the inclusion of a biological in the Register, to give her information or documents relating to any of the matters listed in paragraphs 32JA(1)(a)-(p).

 

Subsection 32JB(1) of the Act sets out that a person commits an offence if they have been given a notice under section 32JA and have failed to comply with that notice (the maximum penalty is 500 penalty units).  New subsection 32JB(1A) provides that the offence at subsection 32JB(1) does not apply where the person who was issued the notice has a reasonable excuse.

 

Including a defence of reasonable excuse in relation to the offence at subsection 32JB(1) will bring this offence for biologicals into line with the equivalent offence in relation to registered or listed goods (subsection 31(4A) of the Act refers).

 

New subsection 32JB(1A) sets out that the defendant will bear an evidential burden in relation to making out the defence.

 

Not only is this consistent with the reasonable excuse defence at subsection 31(4A) of the Act for registered and listed goods, it is appropriate as it reflects the fact that it would be significantly more difficult and costly for the prosecution to in effect prove a negative - i.e. that there was no reasonable excuse for a defendant - as the matters that might comprise a reasonable excuse would in most cases be peculiarly within the knowledge of the defendant.

 

Item 3

This item makes an equivalent amendment to item 2 above to section 41JB of the Act, in relation to medical devices, to include a defence of reasonable excuse to the offence set out at subsection 41JB(3) of the Act for failing to comply with a notice to provide information or documents issued by the Secretary under 41JA of the Act.

 

Application

 

Item 4

Sub-item (1) provides that the amendments to section 30 of the Act made by item 1 apply in relation to notices given under section 31 of the Act on or after the commencement of this item, whether the goods in relation to which the notices the notice is given are registered or listed before or after that commencement.

 

Sub-item (2) provides that the amendments to section 32JB of the Act made by item 2 apply in relation to notices given by the Secretary under section 32JA of the Act on or after the commencement of this item.

 

Sub-item (3) provides that the amendments to section 41JB of the Act made by item 3 apply in relation to notices given by the Secretary under section 41JA of the Act on or after the commencement of this item.



 

SCHEDULE 16 - Other amendments

 

Therapeutic Goods Act 1989

 

This Schedule makes amendments to the Act to allow holders of manufacturing licences and conformity assessment certificates, and sponsors of kinds of medical devices, who asked the Secretary to cancel their devices, licences or certificates, to be able to request the Secretary to reverse that cancellation.  The Schedule also requires the Secretary to publish the details of the overturning of certain kinds of regulatory decisions.

 

Item 1-4

Under section 30A of the Act, if the Secretary has cancelled the registration or listing of goods at the request of the sponsor of the goods, that person can, within 90 days and payment of a prescribed fee, request the revocation of that cancellation.

 

If the cancellation is so revoked, the cancellation is taken never to have occurred.

 

Section 32GD of the Act sets out an equivalent mechanism in respect of biologicals.

 

The Act does not currently contain, however, equivalent provisions for sponsors of kinds of medical devices, or holders of manufacturing licences or conformity assessment certificates.

 

Item 1 therefore amends the Act to include a new section 41AAAA permitting holders of manufacturing licences who have requested the revocation of their licence to, within 90 days of that request and upon payment of the prescribed application fee (if any), ask the Secretary to withdraw the revocation.

 

New subsection 41AAAA(2) will make it clear that if a revocation is withdrawn the revocation will be taken to have never occurred.

 

Item 2 makes a minor formatting change to accommodate the amendment in item 3.

 

Item 3 then introduces a new subsection 41ES(2) to the Act to implement an equivalent amendment to item 1 above in respect of withdrawing the revocation of conformity assessment certificates.

 

Item 4 introduces a new section 41GLA to the Act to implement an equivalent amendment to item 1 above in respect of revoking the cancellation of a kind of medical device from the Register.

 

These amendments will provide greater flexibility for medical devices sponsors and holders of manufacturing licences and conformity assessment certificate who, for example, have mistakenly requested a cancellation in relation to the wrong products, or who have changed their minds about a cancellation.

 

A simple reversal of the initial cancellation within 90 days would replace the more protracted (and costly) processes of the sponsor or holder seeking an internal review of the cancellation decision or making a new application for marketing approval or for the granting of a new licence or certificate.

 

Item 5

A number of provisions in the Act under which regulatory decisions relating to the suspension or cancellation of goods from the Register or manufacturing licences or conformity assessment certificates are made require the Secretary to publish the particulars of those decisions in the Gazette .

 

The amendments in Schedule 13 will give the Secretary the option of publishing this information on the TGA’s website instead.

 

These decisions are initial decisions for the purposes of subsection 60(1) of the Act, and a person whose interests are affected by such a decision can, within certain time limits, ask the Minister to reconsider the decision.

 

However, the Act does not include any requirement for the Secretary to publish the particulars of the overturning of such a decision which may result in therapeutic goods remaining on the Register rather than being cancelled.

 

To address this situation, item 5 amends section 60 to require that, in relation to initial decisions of the Secretary:

 

·                 in relation to which the Secretary was required under the Act to publish particulars; and

·                 are overturned by the Minister under section 60,

the Secretary must publish the particulars of that overturning (either in the Gazette or on the TGA’s website).

 

This will also include a requirement to publish the particulars of any decision substituted by the Minister for an initial decision that the Minister or delegate has revoked.

 

Application

 

Item 6

 

Sub-item (1) sets out that new section 41AAAA, as inserted by item 1, applies in relation to revocations of manufacturing licences under section 41 of the Act occurring on or after the commencement of item 6.

 

Sub-item (2) sets out that the amendments to section 41ES by items 2 and 3 apply in relation to revocations of conformity assessment certificates under that section occurring on or after the commencement of item 6.

 

Sub-item (3) sets out that new section 41GLA, as inserted by item 4, applies in relation to cancellations of kinds of medical devices from the Register under section 41GL of the Act occurring on or after the commencement of item 6.

 

Sub-item (4) sets out that the amendment to section 60 of the Act by item 5 applies in relation to requests for reconsideration made on or after the commencement of item 6.