TGA Business Services Improvements
Proposed changes to the low value turnover (LVT)
scheme
Ms Nicole McLay
Assistant Secretary, Regulatory Business Services Branch
Regulatory Support Division, TGA
ARCS Scientific Congress 2015
6 May 2015
Annual Charge Exemption Scheme Proposal
• Background
• Key features
• The new scheme
• Waivers
• New rates of annual charges
• Compliance program
• Sponsor actions
• Key dates
TGA Business Services improvements
Background
1990
2015
• Low value turnover exemption scheme introduced
1990
– No longer meets objectives
– Complex and burdened with red tape
– High number of complaints
– Inconsistent with government’s cost
recovery policy
– Unsustainable and inequitable
• Consultation paper released in 2014
• New scheme proposed
TGA Business Services improvements
Key features
• TGA proposes to offer an exemption scheme for annual charges
• Rates of annual charges would reduce for some product categories
– from 5% to 23%
• Self declaration
• Significant reduction in administration - $3m p.a. in savings to industry
• A new waiver option for annual charges
TGA Business Services improvements
New ACE Scheme - components
Annual Charge
Exemption (ACE)
Scheme
Proposed to start
1 July 2015
New entries from
1 July 2015 will
automatically
qualify
ACE applies
until
commencement
of turnover
No application
fee required
No TGA
delegate
decision
required
Annual self-
declaration
through client
portal or by mail
Existing entries at 1 July
2015 pre-qualify if LVT
exempt in last 2 years
on basis of $0 turnover
A significant administrative saving for both industry and the TGATGA Business Services improvements
Proposed changes from LVT to ACE• No application fee – additional saving of $2.4m p.a. to industry
• A high number of current exemptions continue (74%)
• No third party accountant certification
• Annual charge invoices only issued for non-exempt entries
• Annual charges would reduce for:
– non-biologic prescription medicines, and
– medical devices class IIa and above
• Waivers available on public health/financial viability grounds
TGA Business Services improvements
Waivers proposal for waiver option under ACE
Waiver criteria• public health risk if product
is removed from the ARTG
• no reasonable alternatives
available
• product becomes financially
unviable if annual charge
applies
Available for registered medicines,
biologicals, devices
class IIa or higher and
IVD class 2 or higher
Annual
application
Decision by a
TGA delegate
Decision
appealable
Waiver refused,
annual charge
payable
TGA Business Services improvements
Proposed compliance activities
• Audit and compliance assurance program
• Uses existing information collecting provisions in the legislation
• Failure to provide information in response could result in
suspension/cancellation of entry
• Providing incorrect declaration results in cancellation of the
exemption
• Criminal Code applies
• Exempt and waived entries published on the website
TGA Business Services improvements
Proposed sponsor actions
• Self-declaration of $0 turnover by 22 July each year
first declaration in July 2016
• Payment of annual charges by 15 September each
year
• Notify commencement of turnover at any time
TGA Business Services improvements
Plans for key dates
June 2015
Advice to sponsors on existing entries, other communications and website material
1 July 2015
ACE scheme commences
Between 1 July and 22 July (annually starting 2016)
Sponsor self-declares that entry had $0 turnover in the previous financial year
Sponsor may notify commencement of turnover at any time
July (annually)
Annual charge invoices issued for non-exempt entries
15 September (annually)
Due date for the payment of annual charges
TGA Business Services improvements