TGA Business Services improvements

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


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


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


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


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


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


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


Health & Medicine

TGA Business Services improvements