In applying these increases, the following rounding policy has been applied:

*                for fee items that are less than $10,000 - to the nearest $5; and

*                for fee items that are greater than or equal to $10,000 - to the nearest $100.

 

The Regulation also adds a new application fee and a new evaluation fee for generic prescription medicines in certain circumstances.  Where there is a generic version of an 'innovator' prescription medicine in the Register and the innovator medicine receives approval for an additional indication, the sponsor of the generic medicine can apply for a corresponding extension to the indications for that medicine.  Where the indication is the same as that already evaluated for the innovator, there is less work required of the TGA, because bioequivalence and clinical data is not required to support the application.  This data will have been previously evaluated in relation to the innovator medicine and, subject to section 25A of the Act (if applicable), may be relied upon for the evaluation of the additional indication for the generic medicine. 

 

However, the present fees for this work do not reflect this fact.  Accordingly, the Regulation introduces a new application fee and a new evaluation fee which are considerably lower than the current applicable fees, to apply in these circumstances.  These new fees will only apply where clinical and/or bioequivalence data are not required to support the application for the extension of the generic medicine's indications.

 

The Regulation also makes a minor amendment (not related to fees) to the TG Regulations to recognise the Medicines, Poisons and Therapeutic Goods Act 2012 and the Medicines, Poisons and Therapeutic Goods Regulations of the Northern Territory (NT) as a "corresponding State law" for the purposes of the TG Act.  This enables the NT to confer, subject to the Constitution, functions and powers upon Commonwealth officers as part of its implementation of its own therapeutic goods laws.

 

Details of the Regulation are set out in the Attachment.

 

The TG Act does not specify conditions that would need to be met before the power to make the Regulation may be exercised.

 

The Regulation is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Regulation commences on 1 July 2015.

 

Consultation

 

Consultation on proposals to increase TGA fees and charges was undertaken at bilateral meetings with industry peak bodies in early March 2015. Some attendees raised concerns about the TGA's capacity to absorb cost increases with a lower-than-CPI increase - overall, however, the lower increase was welcomed, and there was acceptance of the proposal to reduce fees for relevant generic medicines. Following bilaterals, the TGA wrote to industry bodies with the final proposed rate of 2.12 per cent.

 

 

 

Authority: Subsection 63(1) of the Therapeutic Goods Act 1989

ATTACHMENT

 

Details of the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2015

 

Section 1 - Name of regulation

This section provides for the Regulation to be referred to as the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2015.

 

Section 2 - Commencement

This section provides for the Regulation to commence on 1 July 2015.

 

Section 3 - Authority

This section provides that the Regulation is made under the Therapeutic Goods Act 1989 (the TG Act).

 

Section 4 - Schedule

Each instrument that is specified in a schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

Schedule 1 - Amendments

 

Therapeutic Goods (Medical Devices) Regulations 2002

 

Item 1 - Amendments of listed provisions

 

Item 1 sets out a table of amendments to provisions of the Therapeutic Goods (Medical Devices) Regulations 2002 (the MD Regulations).

 

The effect of these amendments is to increase the fee for an abridged conformity assessment in paragraph 9.4(2)(b) of the MD Regulations, and the fees for all relevant items in Schedule 5 to the MD Regulations, by 2.12 per cent, subject to the TGA's rounding policy. 

 

Therapeutic Goods Regulations 1990

 

Item 2 - Amendments to recognise Northern Territory therapeutic goods laws as corresponding laws

 

Item 2 adds the Medicines, Poisons and Therapeutic Goods Act 2012 (NT) and the Medicines, Poisons and Therapeutic Goods Regulations (NT) to the list of laws prescribed as

corresponding State laws under subregulation 3(3).

 

As with a number of other jurisdictions, the Northern Territory's laws in relation to therapeutic goods apply the TG Act in that Territory as if it were a law of the Northern Territory.  Where a State's or a Territory's therapeutic goods law is recognised as a corresponding State law for the purposes of the TG Act, this enables the State or Territory to confer, subject to the Constitution, functions or powers on Commonwealth officers as part of the State or Territory's implementation of its own therapeutic goods laws.

 

 

Items 3 to 5 - Amendments to add new fee items to Part 2 of Schedule 9

Items 3 and 5 have the effect of introducing two new fees to Part 2 of Schedule 9 to the TG Regulations - being, an application fee and an evaluation fee relating to extensions of indications for generic forms of prescription medicines - that will apply in certain circumstances. 

 

Those circumstances are where the requested extension mirrors one that has already been approved by the TGA for the corresponding "innovator" medicine (in terms of containing the same active ingredient or active ingredients, the same dosage form and the same strength), and where the TGA does not need to evaluate clinical, pre-clinical or bioequivalence data to evaluate the application.  Regulation 16G of the TG Regulations applies to such applications which means a decision on the application must be notified within 45 working days unless an objection is raised concerning the application.

 

To this end, item 3 adds a new application fee that will apply in the above circumstances, in the amount of $1,035.  This fee will be payable for an application to which the new evaluation fee applies (item 5 refers).  The new application fee represents a significant reduction when compared with the currently applicable fee of $26,300.

 

Item 5 adds a new evaluation fee that will apply in the above circumstances, in the amount of $4,120.  The new evaluation fee represents a significant reduction when compared with the currently applicable fee of $105,300.  Both of the reduced fees better reflect the work required for the TGA to assess such applications.

 

Item 4 makes a minor, technical amendment to ensure that the existing full evaluation fee usually payable, listed at paragraph (b) of the table at Item 4, does not apply to the generic in the above circumstances.

 

Item 6 - Amendments of listed provisions

Item 6 sets out a table of amendments to provisions of the TG Regulations.

 

The effect of these amendments is, principally, to increase various fees specified in subregulations 45(4A), 45(9) and 45(11) of the TG Regulations, and in Part 2 of Schedule 9 and Part 2 of Schedule 9A to the TG Regulations, by 2.12 per cent for the financial year 2015-16, subject to the TGA's rounding policy.

 

Statement of Compatibility with Human Rights

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

 

Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2015

 

This legislative instrument 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 Legislative Instrument

The Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulation 2015 (the Amendment Regulation) is made under subsection 63(1) of the Therapeutic Goods Act 1989 (the Act). 

The Amendment Regulation amends the Therapeutic Goods Regulations 1990 to, principally, increase fees relating to the regulation of therapeutic goods and manufacturing licences by 2.12 per cent, subject to the TGA's rounding policy. This figure principally reflects the TGA's budget outlook for 2015-16. The increase in fees applies, for example, to application fees for the registration, listing or inclusion of most therapeutic goods (including medicines, therapeutic devices, biologicals and medical devices) in the Australian Register of Therapeutic Goods, application fees for manufacturing licences, evaluation fees, clinical trial notification fees, application fees for export certificates and inspection fees relating to manufacturing premises.

The Amendment Regulation also introduces new, significantly reduced, application and evaluation fees for sponsors of generic prescription medicines seeking to extend the indications for their products to match the indications of the corresponding innovator medicine, where clinical or bioequivalence data is not needed to assess the generic application.  The Amendment Regulation also recognises the therapeutic goods legislation of the Northern Territory (NT), to enable the NT to confer functions and powers on Commonwealth officers, so that such officers can assist the NT in implementing its own therapeutic goods regulatory scheme.

 

Human rights implications

As the Amendment Regulation does not introduce any changes to the Principal Regulations other than to implement the changes mentioned above, it does not engage any of the applicable rights or freedoms.

 

Conclusion

This legislative instrument is compatible with human rights as it does not raise any human rights issues.

 

 

Fiona Nash, Assistant Minister for Health