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Therapeutic Goods Amendment (2013 Measures No. 1) Bill 2013

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2010 - 2011 - 2012 - 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 Hon Catherine King MP, Parliamentary Secretary for Health and Ageing)





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 include:

 

·                 amendments to the definition of ‘therapeutic goods’ in subsection 3(1) of the Act to enable the Minister, by legislative instrument, to specify products that are taken not to be therapeutic goods for the purposes of the Act;

·                 a new provision enabling the Secretary to remove products from the Australian Register of Therapeutic Goods (the Register) which are not, or are no longer, therapeutic goods within the definition in the Act;

·                 clarify the source of the power for the Secretary to approve product information under section 25AA of the Act; and

·                 a number of other minor amendments designed to ensure consistency in the way the different classes of therapeutic goods are treated under the Act.

 

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 ”.

 

The definition of ‘therapeutic goods’ in subsection 3(1) has the potential, depending on how it is interpreted, to extend to a wide range of goods that may not have been intended to be regulated under the Act, including clothing and household items.  This is particularly likely to be the case as health-related claims are increasingly being made about a range of products.

 

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), 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 supplying 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 (sections 19B and 19D of the Act refer).  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.

 

Increasingly, health and wellbeing claims are being made in relation to a wide range of 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 - for example, ’power band’ bracelets, and mattresses which contain bacteria designed to reduce the effects of dust mites.  The definition may also cover products for which there may be sound and important public policy reasons for excluding from the scope of the regulatory scheme 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 to be 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.

 

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 Therapeutic Goods Administration (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.

 

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 ;

·                 giving the Secretary the power to require in particular circumstances (for instance where therapeutic goods have been suspended or cancelled from the Register, or where the Secretary has come to the view that the safety, quality, efficacy/performance, or presentation of therapeutic goods, is unacceptable), the sponsor of those therapeutic goods to provide information about the goods to the public or to a class of persons such as health care professionals or patients, and to give to the Secretary information about persons to whom the goods have been supplied;

·                 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 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.

 

Financial Impact Statement

 

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



STATEMENT OF COMPATIBILITY 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 false or misleading information in connection with a request to vary an existing entry in the Register for a therapeutic good;

·          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 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(1) of the International Covenant on Civil and Political Rights (the ICCR).  This measure (item 10 of Schedule 5 of the Bill refers), removes the right to merits review by the Minister and, subsequently, by the Administrative Appeals Tribunal (the AAT), in relation to a decision of the Secretary to approve or vary PI for a medicine (subsections 25AA(1) and (4) of the Act refer).  However, judicial review remains available in relation to these decisions.

 

The removal of merits review rights in these instances is considered to be necessary because a decision to approve, or to approve a variation to, PI is an integral part of the decision by the Secretary to register the medicine to which the PI relates or to approve a variation to that medicine’s entry in the Register.

 

The Bill clarifies that the approval by the Secretary of PI for a medicine is a separate decision to the Secretary’s decision approving its registration (in the case of an application for registration under section 23 of the Act) or varying the medicine’s entry in the Register (in the case of a request under section 9D of the Act by the sponsor of a register medicine to vary the medicine’s entry in the Register).  However, in practice the PI is always reviewed at the same time as the application for registration is evaluated or the request for a variation is being considered (see for instance, paragraph 25(1)(da) of the Act).

 

The Secretary would not be expected to accept a medicine for registration (or make a variation to a registered medicine’s entry) unless satisfied that the content of the PI was correct and properly reflective of the circumstances in which the medicine was considered suitable for registration (or continued registration) on the basis of its quality, safety and efficacy for the purposes for which it is to be used (paragraphs 25(1)(d) and 9D(3)(c) of the Act refer).

 

A person whose interests are affected by a decision under the new subsection 25(3) (see item 4 in Schedule 5 below) to register a medicine in relation to which PI must be provided or by a decision by the Secretary under subsection 9D(1), (2) or (3) to vary the entry in the Register of such a medicine, has a right to seek internal review of that decision.  As the PI approved by the Secretary will reflect the decision of the registration or variation decision of the Secretary (which is amenable to review) any concerns with the PI can effectively be addressed through a review of the registration or variation decision.

 

The Bill also contains one measure that appears to engage article 14(2) of the ICCR.  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.

 

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.

 

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 - 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 false or misleading information, where that information is relied upon to inform a range of regulatory actions.  In so doing, it will serve an important role in deterring and addressing conduct that could potentially endanger public health.

 

Conclusion

As applicants and sponsors would retain a right to merits review in the circumstances outlined above in relation to an application for registration or a request to vary an existing entry in the Register, and as the option of judicial review remains, to the extent that the Bill may limit article 14(1) of the ICCR, this limitation is reasonable, necessary and proportionate.  In relation to the addition of the strict liability offence for making false or misleading statements in connection with a request under section 9D of the Act, this is also considered (for the reasons outlined above) to be a reasonable, necessary and proportionate limitation.

 

The Hon Catherine King MP, Parliamentary Secretary for Health and Ageing



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 sections 1-3, and Schedules 1-15, of the Bill will commence on the day the Bill receives Royal Assent, and that Schedule 16 of the Bill will commence on a single day to be fixed by Proclamation.  However, if the commencement of Schedule 16 is not proclaimed within the period of 6 months from the date of Royal Assent, that Schedule will commence the day after the end of that 6 month period.

 

The amendments made by Schedule 16 will commence on a date to be fixed by Proclamation in order to allow the appropriate forms to be approved by the Secretary prior to that commencement.

 

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

 

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, made by the Minister under section 42BAA of the Act (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 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 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 23

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 23 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.

 

Items 21 and 22

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.

 

These circumstances do not currently include a reference to non-compliance with advertising requirements notwithstanding that applicants seeking to include their medical devices in the Register must certify compliance with advertising requirements (paragraph 41FD(h) of the Act refers), and the Secretary has the power to obtain information concerning compliance with this requirement (paragraph 41JA(1)(h) of the Act refers).

 

Items 21 and 22 respectively amend paragraph 41GL(h) and add a new paragraph 41GN(1)(g) to the Act, to provide that the Secretary can cancel a kind of medical device from the Register where it does not comply with an applicable provision of the Code, or any other advertising requirement applicable to it under Part 5-1 of the Act or under the regulations.

 

This amendment will mean that the Secretary will be able to issue a notice to cancel or a proposal to cancel a kind of device from the Register in the event of a breach of advertising requirements, including a breach of an applicable provision of the Code.

 

Application

 

Item 24 - medicines and therapeutic devices

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 24.

 

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 24, 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 item 8 apply in relation to a proposal to cancel of which a person is informed under subsection 30(3) of the Act on or after the commencement of item 24, 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 24.  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 25 - 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 25.

 

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 25.

 

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 25, 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 proposed cancellations of which a person is informed under subsection 32GC(2) of the Act on or after the commencement of item 25, 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 25.  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 26 - 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 26.

 

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 26, whether the breach to which the notice relates occurs before or after that commencement.

 

Sub-item (3) provides that the amendments to subsection 41GN(1) of the Act made by item 22 apply in relation to proposed cancellations of which a person is informed under subsection 41GN(2) of the Act on or after the commencement of item 26, whether circumstances giving rise to the proposed cancellation occurred or occur before or after that commencement.

 

Sub-item (4) provides that the amendments to subsection 41JA(1) of the Act made by item 23 apply in relation to notices given under subsection 41JA(1) on or after the commencement of item 26.  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 contains amendments to the Act to remove inconsistencies between the matters in relation to which an applicant must certify when including certain kinds of therapeutic goods in the Register, and the Secretary’s ability to require information and documents from sponsors about the correctness of those certifications.  The Schedule also amends the offence and civil penalty provision at subsections 31(5A), (5B) and (6), and section 31AAA, of the Act, relating to the provision of false and misleading information 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.

 

Items 1, 12 and 15

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)(2)(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 subsections 26A(2) or (2A) of the Act are incorrect.

 

This amendment has the effect of aligning the revised description of the Secretary’s power to obtain information from sponsors about whether or not certifications they made when applying to include their goods in the Register are correct (see items 3, 13 and 17 below), with the ground for cancelling the goods from the Register if the sponsors fail to provide the requested information.

 

Items 12 and 15 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. 

 

Item 3, 13 and 17

Paragraph 31(2)(fa) of the Act currently provides that the Secretary may require a person seeking to list their goods in the Register, or a person in relation to whom therapeutic goods are, or have been at any time in previous 5 years, listed in the Register, to provide information or documents relating to a number of the matters in relation to which that person certified at the time they included their goods in the Register, being matters relating to criteria their goods must meet before being included in the Register.

 

The effect of the amendment set out in item 3 is to expressly provide that the information or documents the Secretary can seek can relate to any of the matters in relation to which the sponsor is required to certify under section 26A of the Act before entering their goods in the Register.  This will have the effect of ensuring that the Secretary can ask a sponsor of a listed medicine for information or documents relating to any of the matters certified to by that person when listing their medicines in the Register.

 

The Secretary can cancel the goods from the Register if any of these certifications is incorrect (paragraph 30(2)(ba) of the Act refers).  The amendment in item 3 will thus allow the Secretary to seek information or documents from the sponsor of a medicine listed under section 26A relevant to this ground of cancellation.

 

Item 13 makes an equivalent amendment to subsection 32JA(1) of the Act in relation to Class 1 biologicals, and item 17 makes an equivalent amendment to subsection 41JA(1) of the Act in relation to medical devices.

 

Items 4 - 8

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 4 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 5 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 6 and 7 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 8 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 9

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 10 below.

 

Items 10 and 11

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 10 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 or documents that is false or misleading in a material particular may contravene the civil penalty in section 31AAA.

 

Item 11 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 14 and 18

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 14 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 18 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 16

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 19

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 1-11 apply in relation to notices of cancellation given under section 31 of the Act on or after the commencement of item 19, 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, 32JA and 32JB of the Act made by items 12-14 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 19.  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 15-18 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 19.  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 goods 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 in relation to which the Minister has made a determination under new subsection 7AA(1).  New paragraph (h) excludes from the meaning of ‘therapeutic goods’ goods in relation to which the Minister has made a determination under 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) - 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 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.

 

Section 7 of the Act currently provides that where the Secretary is satisfied that particular goods are or are not therapeutic goods, or are or are not therapeutic goods when used, advertised or presented for supply in a particular way, she may, by order published in the Gazette , declare the goods to be therapeutic goods or not.  However, the Secretary may only exercise these powers to declare a product not to be a therapeutic good if satisfied that the product is not, in fact, a therapeutic good.  As such, section 7 would not provide a basis for excluding from the regulatory scheme in the Act products which come within the scope of the definition of ‘therapeutic goods’ in subsection 3(1) of the Act or where there may be uncertainty as to their characterisation.

 

The power for the Minister under new section 7AA of the Act will not require the Minister to come to a view that a product is not in fact therapeutic goods for it to be included in a determination.

 

It should also be noted that the Act sets out significant penalties for importing into, exporting from, or supplying 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 (sections 19B and 19D of the Act refer).  Moreover, inclusion in the Register involves complying with a number of regulatory requirements, such as complying with 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.  Application fees and annual charges are also payable.

 

It is important therefore 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.

 

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 sections 30, 32GA, 32GB, 32GC, 41GK, 41GL, 41GM and 41GN of the Act).

 

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.

 

A notice of any removal that takes place must be published on the Department’s website.  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).

 

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 a 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, and to clarify that when, at her own initiative, the Secretary permits the use of a restricted or prohibited representation in an advertisement for therapeutic goods, the Secretary may impose conditions on that permission.

 

Item 1

Under subsection 42DK(1) of the Act, the Secretary may, on her own initiative, permit the use of a restricted representation in relation to therapeutic goods, including the use of such a representation on the label or packaging of the goods.

 

Under subsection 42DK(2) of the Act, the Secretary may, on her own initiative, permit the inclusion of a prohibited representation on the label of therapeutic goods, or in information in the package in which therapeutic goods are contained, if the representation is necessary for the appropriate use of the goods.

 

The Act does not, however, provide for the Secretary to impose conditions when deciding to permit the use of a restricted or prohibited representation under sections 42DK(1) or (2).

 

This contrasts with the Secretary’s ability to impose conditions when she grants an approval to use a restricted representation in response to an application for such an approval under section 42DF of the Act.

 

To remove this inconsistency, and to enable the Secretary to put in place appropriate safeguards on the use of restricted or prohibited representations permitted under section 42DK, item 1 adds new subsection 42DK(3) to the Act to make it clear that the Secretary may permit the use of restricted or prohibited representations subject to any conditions specified by her under that new provision.

 

Item 2

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 2 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 3

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 3 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 4

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 4 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 5

This item sets out the application of the amendments made under this Schedule.

 

Sub-item (1) provides that the amendments to section 42DK of the Act made by item 1 apply in relation to permissions given under section 42DK on or after the commencement of sub-item (1).

 

Sub-item (2) provides that the amendments to section 42DL of the Act made by items 2-4 apply in relation to advertisements published or broadcast on or after the commencement of sub-item (2).



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.

 

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 (taken together with item 5) provide greater clarity about the operation of this provision.

 

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.

 

Item 5

This item introduces new sections 25AAA and 25AAB to the Act.

 

New section 25AAA 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 25AAA(1) (for therapeutic devices) and (2) (for other therapeutic goods) refer).

 

New subsection 25AAA(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 25AAA(3) requires that the Secretary’s notice given to an applicant of the decision to register goods must also advise the applicant that, notwithstanding the decision on registration, the goods will not be included in the Register unless and until:

 

(a)        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; and

(b)        for restricted medicines and any other medicine in relation to which the Secretary has indicated that the applicant must provide product information as part of their application - the Secretary has approved product information in relation to the medicine under subsection 25AA(1) of the Act.

 

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

 

New paragraph 25AAA(3)(b) (taken together with the changes in item 6), 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 25AAB 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.  This mirrors the existing requirements in subsection 25(4) for such circumstances.

 

Item 6

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)(ai) of the Act.

 

Item 6 amends subsection 25AA(1) of the Act to clarify that the Secretary must approve product information in relation to therapeutic goods if the Secretary:

 

·                 has decided under subsection 25(3) to register goods for which product information is required to accompany the application; and

·                 is satisfied that the product information in question is appropriate in the circumstances.

 

Items 7, 8 and 9

These items make minor, consequential amendments to each of paragraphs 25AA(2)(b) and (3)(b), 25AA(3)(c) and subsection 26BA of the Act to reflect the changes introduced by item 5.

 

Item 10

This item amends subsection 60(1) to make clear that decisions of the Secretary under section 25AA of the Act are not ‘initial decisions’ for the purposes of section 60.

 

The main effect of this change is that a decision by the Secretary to approve product information under new subsection 25AA(1) for a medicine which the Secretary has decided to register under new subsection 25(3), will not be subject to a separate right to internal review or subsequent merits review by the AAT under section 60 of the Act.  However, the decision remains amenable to judicial review.

 

A decision by the Secretary to vary approved product information under subsection 25AA(4) of the Act for a medicine that is already registered in the Register in relation to which a variation in the Register entry has been approved, will also not be subject to a separate right to internal or AAT review.

 

These amendments principally reflect that a decision to approve product information for a medicine is an integral part of the decision to actually register the medicine, and that the content of the product information essentially underpins the registration decision and the basis on which the Secretary has decided, after evaluating a medicine, that it is suitable for registration.

 

The Bill clarifies that the approval by the Secretary of product information for a medicine is a separate decision to the Secretary’s decision approving its registration (in the case of an application for registration under section 23 of the Act) or varying the entry of the medicine in the Register (in the case of a request under section 9D of the Act by the sponsor of a registered medicine to vary the entry of the medicine in the Register).  However, in practice the product information is always reviewed at the same time as the application for registration is evaluated or the request for a variation is being considered (see for instance, paragraph 25(1)(da) of the Act).

 

The Secretary would not be expected to accept a medicine for registration (or make a variation to the Register entry of a registered medicine) unless satisfied that the content of the product information was correct and properly reflective of the circumstances in which the medicine was considered suitable for registration (or continued registration) on the basis of its quality, safety and efficacy for the purposes for which it is to be used (paragraphs 25(1)(d) and 9D(3)(c) of the Act refer).

 

A person whose interests are affected by a decision under the new subsection 25(3) (see item 4 in Schedule 5 below) to register a medicine in relation to which PI must be provided, or by a decision by the Secretary under subsection 9D(1), (2) or (3) to vary the entry in the Register of such a medicine, has a right to seek internal review of that decision.  As the product information approved by the Secretary will reflect the decision of the registration or variation decision of the Secretary (which is amenable to review) issues with the PI can effectively be addressed through a review of the registration or variation decision.

 

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 sub-item (1).

 

Sub-item (2) provides that new sections 25AAA and 25AAB apply in relation to therapeutic goods the evaluation of which under section 25 of the Act is completed on or after the commencement of sub-item (2).

 

Sub-item (3) provides that the amendments to sections 25AA of the Act made by items 6-8 apply in relation to therapeutic goods the evaluation of which under section 25 of the Act is completed on or after the commencement of sub-item 3.

 

The effect of these application provisions is that, in relation to an evaluation completed after commencement of the amendments, any notification by the Secretary under section 25 of the outcome will be done in accordance with section 25 as so amended and the new sections 25AAA and 25AAB.

 

Sub-item (4) provides that the amendments to section 60 of the Act made by item 10 apply in relation to product information approved on or after the commencement of sub-item (4).



SCHEDULE 6 — Conditions of registration or listing

 

Therapeutic Goods Act 1989

This Schedule contains amendments to the Act to allow new conditions of registration or listing, or the variation of an existing condition of registration or listing, to commence earlier than the current 28 days after the date notice of the new or varied condition is given to the sponsor, where the sponsor has requested the new or varied condition.  The Schedule also allows a removal of a condition, whether upon request by the sponsor or on the Secretary’s own initiative, to commence earlier than the current 28 day period.

 

Item 1

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 from responding flexibly to requests by sponsors for such measures.

 

Such requests may seek a change in conditions to allow particular batches of goods to be supplied without breaching an existing condition (e.g. to allow a slightly different shelf-life to apply for a particular batch), or a new condition to address concerns the regulator might have about some batches of goods.

 

In such circumstances, the changes may need to be imposed earlier than 28 days after the notice in order to achieve a quicker result (and, by corollary, may not need to be in place for long).

 

To address this issue, this item 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 on a day specified in the notice (not being earlier than the actual day notice is given), rather than only after 28 days from the date of notice.

 

The item also allows the removal of existing conditions to commence on the day specified in the notice, rather than after 28 days, regardless of whether the change was requested by the sponsor.

 

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.

 

Item 2

Currently under paragraph 28(5)(e) of the Act, registered or listed goods are subject to a condition that the person in relation to whom the goods are registered or listed will comply with any reporting requirements prescribed for the purposes of that paragraph.  ‘Reporting requirements’ here refers to requirements relating to pharmacovigilance reporting - i.e. the reporting of adverse reactions to therapeutic goods.

 

Regulation 15A of the Therapeutic Goods Regulations 1990 currently prescribes reporting requirements for the purposes of paragraph 28(5)(e) of the Act for sponsors of registered and listed medicines.  It sets out that such sponsors must comply with the reporting requirements set out in the TGA document ‘ Australian Requirements and Recommendations for Pharmacovigilance Responsibilities of Sponsors ’, as in force from time to time.

 

In addition to reporting requirements, however, the maintaining of accurate and up to date records relating to adverse reactions is also important, particularly for ensuring that sponsors are able to meet their reporting requirements in relation to adverse reactions, and generally in terms of supporting effective safety monitoring.

 

As such, it is envisaged that, in the future, the TGA document referred to in regulation 15A may (following appropriate consultation, and the completion of best practice regulation requirements) be amended to include record-keeping requirements.

 

Item 2 therefore amends paragraph 28(5)(e) of the Act to include a reference to record-keeping requirements, to facilitate that outcome.

 

Item 3

This item implements equivalent amendments to those set out in item 1, in relation to when conditions imposed on the inclusion of a biological in the Register can commence to operate.

 

Items 4 and 5

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 4 therefore adds a reference to “removal” to subsection 41EL(2) to ensure that all the regulatory possibilities are covered.

 

Item 5 then implements equivalent amendments to subsection 41EL(2) of the Act to those set out in items 1 and 3 above.

 

Items 6 and 7

Item 6 amends subsection 41FP(2) of the Act to address the same situation as outlined above in relation to item 4.

 

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 6 therefore adds a reference to ‘removal’ to subsection 41EL(2) to ensure that all regulatory possibilities are covered.

 

Item 7 then implements equivalent amendments to subsection 41FP(2) of the Act to those set out in items 1, 3 and 5 above.

 

Application

 

Item 8

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 item 1 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 sub-item (1).

 

Sub-item (2) provides that the amendments to subsection 28(5) of the Act made by item 2 apply in relation to therapeutic goods registered or listed as at, and on or after, the commencement of sub-item (2).

 

Sub-item (3) provides that the amendments to section 32EE made by item 3 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 sub-item (3).

 

Sub-item (4) provides that the amendments to section 41EL made by items 4 and 5 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 sub-item (4).

 

Sub-item (5) provides that the amendments to section 41FP of the Act made by items 6 and 7 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 sub-item (5).



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 the items 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 25AAA and sections 25 and 25AA as amended by the items in Schedule 6 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 25AAA 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 (i.e. is a therapeutic good);

·                 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.

 

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.

 

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 amendments to subsection 30(5) of the Act made by item 1 above apply in relation to proposed 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 proposed cancellation occurred before, or occur after, that commencement.



 

SCHEDULE 13 - Publication

 

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, which has the effect of setting out that a person whose interests are affected by an initial decision may request the Minister to reconsider that decision:

 

(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 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.

 

New subsection 60(2) also has the effect of indicating that, in the case of a decision in relation to which the Secretary is required to give notice in writing to a person, the 90 days for the person to ask the Minister to undertake a review commences from when notice is given to the person.  This replaces the current provision for that period to commence from when the decision first comes to the person’s notice.

 

This change is designed to avoid situations whereby a person might argue years 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 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 Department’s website 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 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 - Public notification and recovery

 

Therapeutic Goods Act 1989

 

This Schedule contains amendments to provisions in the Act relating to the public notification and/or recovery of registered or listed therapeutic goods, biologicals and medical devices (sections 30EA, 32HA and 41KA of the Act, respectively) to broaden the dissemination of information requirements the Secretary may impose on a sponsor or supplier under those provisions.  The Schedule also amends the Act to allow the Secretary to require persons to whom those provisions apply to give her information about persons to whom their goods were supplied.

 

Items 1 and 2

Under section 30EA of the Act, the Secretary can impose requirements on specified persons in relation to the public notification and/or recovery (i.e. recall) of 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) where certain specified circumstances exist in relation to those goods.  In particular, the Secretary can under subsection 30EA(2) impose on a person mentioned in column 3 of the table in subsection 30EA(1) requirements relating to therapeutic goods if any of the circumstances set out in column 2 of the table apply.

 

The specified circumstances set out in column 2 of the table in subsection 30EA(1) include the following:

 

·          the goods are in the Register, but are supplied when they do not conform to an applicable standard or the manufacturing principles have not been observed in relation to their manufacture;

·          the goods are exempt from the requirement to be in the Register or are the subject of an approval or an authority with the effect that they are approved for supply while not being in the Register, but they have been supplied while not conforming to an applicable standard or the manufacturing principles have not been observed in relation to their manufacture;

·          the goods are supplied in breach of the offence provisions in section 19B (e.g. being not exempt, they are imported or supplied while not in the Register or otherwise approved from supply) or are counterfeit;

·          the goods are in the Register but it appears to the Secretary that their safety, quality or efficacy, or presentation, is unacceptable;

·          one of more steps in the manufacture of the goods has been carried out by an unlicensed manufacturer; and

·          the goods are supplied while their registration or listing is suspended or has been cancelled.

 

The requirements are set out in subsection 30EA(2) of the Act.

 

Items 1 and 2 amend subsection 30EA(2) to include powers for the Secretary to require persons mentioned in the table in subsection 30EA(1) in relation to each of the circumstances referred to above (usually the sponsor of the relevant goods) to:

 

·       inform the public, or specified persons, about specified information regarding therapeutic goods and the circumstances set out in the table, e.g. about the circumstances in which the goods were cancelled or information about the basis on which the Secretary has come to a view that the safety of the goods is unacceptable (item 1 refers); and

·       give the Secretary specified information about the persons to whom the therapeutic goods in question have been supplied (item 2 refers).

 

This will clarify the powers the Secretary currently has under that subsection and ensure that relevant information can be provided directly by the sponsor to health care professionals, patients and consumers about the goods.  The Secretary does have the power under paragraph 30EA(2)(b) of the Act to inform the public of the fact that circumstances mentioned in the table under subsection 30EA(1) have occurred.  However, the information that may be needed to be communicated in order to fully inform the public or specified persons (e.g. patients using a particular medicine) about a problem may go beyond the scope of just advising that the specified circumstances (such as the fact that the product has been cancelled from the Register) has occurred.

 

It should be noted that the Secretary also has a range of powers under section 61 of the Act to release information to the public about decisions made about therapeutic goods and the safe use of therapeutic goods.

 

It is also important that the Secretary have the ability to require the sponsor or supplier (e.g. where the goods are counterfeit) of goods to provide her with information about who relevant goods have been supplied to, so that patients who may be at risk can be quickly identified and contacted.

 

Items 3 and 4

Items 3 and 4 makes equivalent amendments to items 1 and 2 above to subsection 32HA(2) of the Act in relation to the Secretary’s power to impose requirements on specified persons in relation to the public notification and recovery of biologicals.

 

Item 5

Item 5 makes a minor consequential amendment to subsection 41KA(2) of the Act to accommodate the changes set out in item 6 below.

 

Item 6

Item 6 adds to new subparagraphs (c) - (d) to subsection 41KA(2) of the Act in order principally to make equivalent amendments to items 1 and 2, and items 3 and 4 above, to subsection 41KA(2) of the Act, regarding the Secretary’s power to impose requirements on specified persons in relation to the public notification and recovery of kinds of medical devices.

 

The effect of these amendments to section 41KA is that the Secretary will be able to ensure that relevant information is provided by a sponsor to the public, relevant health care professionals and patients where for instance, an implantable medical device is cancelled from the Register after reports of safety concerns.  The requirement to provide information to the Secretary about persons to whom the device has been supplied will assist the TGA to facilitate the appropriate dissemination of material about the device.

 

Item 6 also includes the power for the Secretary to require persons specified in the table under subsection 41KA(1) of the Act to publish specified information relating to the manufacture or distribution of medical devices in relation to which the person is either the sponsor or supplier.  This brings the Secretary’s powers in relation to medical devices into line with those currently available to her under subsection 30EA(2) of the Act in relation to registered and listed goods and under subsection 32HA(2) of the Act in relation to biologicals.

 

Application

 

Item 6

Sub-item (1) provides that the amendments to section 30EA of the Act made by items 1 and 2 apply in relation to requirements imposed by the Secretary under subsection 30EA(2) of the Act on or after the commencement of this item, whether the goods to which the requirement relates are registered or listed before or after that commencement.

 

Sub-item (2) provides that the amendments to section 32HA of the Act made by items 3 and 4 apply in relation to requirements imposed by the Secretary under subsection 32HA(2) of the Act on or after the commencement of this item, whether the biological to which the requirement relates is included in the Register before or after that commencement.

 

Sub-item (3) provides that the amendments to section 41KA of the Act made by items 5 and 6 apply in relation to requirements imposed by the Secretary under subsection 41KA(2) of the Act on or after the commencement of this item, whether the kind of medical device to which the requirement relates is included in the Register before or after that commencement.



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 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.  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, or

·                 for a sponsor or previous sponsor - whether their goods were included in the Register 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 - Information

 

Therapeutic Goods Act 1989

 

This Schedule amends sections 9D (requests by sponsors to vary existing entries in the Register for therapeutic goods) and 23 of the Act (applications for the registration or listing of goods in the Register) to enable the Secretary to, by legislative instrument, specify kinds of information that must accompany section 23 applications and certain section 9D requests.

 

Items 1 and 2

Section 23 of the Act sets out the procedures and requirements relating to applying for the registration or listing of therapeutic goods in the Register.

 

Subsection 23(2) of the Act currently provides that an application will not be effective unless a number of steps have been complied with including, at paragraph 23(2)(b), if the applicant has delivered to the relevant office:

 

such information, in a form approved, in writing, by the Secretary, as will allow the determination of the matter .

 

Applications under section 23 of the Act cover a range of different kinds of goods, for example, prescription medicines, over-the-counter medicines, ‘complementary medicines’ and medicines for which listing under section 26 of the Act is sought including ‘export only’ medicines.

 

Depending on the goods involved, different kinds and amounts of information may be needed to enable the Secretary to assess such applications for registration or listing.  As such, it is important that the Secretary is able to specify the kinds of information that must accompany section 23 applications for the various types of therapeutic goods.

 

Item 2 sets out amendments that achieve that effect, by requiring in a new paragraph 23(2)(b) that an application must be accompanied by such information as will allow the determination of an application, and which is information of the kind specified in a legislative instrument made for the purposes of new paragraph 23(2)(b)

 

Item 1 makes the same kind of amendments to item 2 above to section 9D of the Act, in relation to the Secretary’s ability to require that different kinds of information (again, with a power for the Secretary to make a legislative instrument specifying relevant kinds of information) must accompany requests under that section from persons in relation to whom goods are included in the Register to vary the entry of those goods in the Register, depending on the nature of the goods and the kind request.

 

Application

 

Item 3

Sub-item (1) provides that the amendments to section 9D of the Act made by item 1 apply in relation to requests made under that section made on or after commencement of this item.

 

Sub-item (2) provides that the amendments to section 23 of the Act made by item 2 apply in relation to applications for the registration or listing of therapeutic goods made on or after the commencement of this item.