UKTI Australia's take on opportunities in the Australian Healthcare industry for British companies, in collaboration with Commercial Eyes

1. 1

2. Australia – Healthcare Opportunities for British Business
• 9.30 am Thursday 18th October 2012
• Speakers:
– “Introduction to Australia & the Healthcare Market”
Joe Dodd, Manager Trade & Investment, UKTI Melbourne
– “The device market in Australia – some useful facts”
Mark Glover, Manager Commercial Optimisation, Commercial Eyes
– “How do I get my product registered?”
Jeanette Lodge, Project Manager Regulatory Affairs, Commercial Eyes
2

3. Australia – Healthcare Opportunities for British
Business
Joe Dodd
Manager, Trade & Investment, British Consulate-General Melbourne
3

4. Why Australia?
• You’ll feel at home immediately:
– Over 1,000 UK companies and more Brits than in any other country
– Very similar business, legal and regulatory culture
• Best performing OECD country economically, with good growth prospects
• Strong Australian dollar making UK goods and services more affordable
• Closely linked to fast growing Asia-Pacific nations
• Well funded, growing healthcare market
4

5. Australia – an economic snapshot
Australia UK
Population 22.5 million 62 million
Global GDP ranking 13th 7th
GDP growth est. 2012 3% 0.6%
GDP per capita ($US 2011) $40,800 $36,600
Ease of doing business (World Bank 2011) 15th 4th
Unemployment (Sept 2012) 5.1% 8%
Land mass – sq kms 7 692 000 000 295 000
5

6. UK/Australia trade links
• UK exports to Australia grew by
over 60% from 2007 - 2011 (to
more than £10 billion)
• UK’s overall exports contracted
first half of 2012, to Australia rose
• 7th biggest market for services
exports and 18th largest for goods
• UK is 2nd biggest foreign direct
investor in Australia
6

7. Australia – Country Background
States: 6 states (parliaments
are elected) and 2 territories
(Chief Ministers are appointed
by Federal Govt)
Cities: Sydney 4.5 million
Melbourne 4 million
Brisbane 2 million
Perth 1.6 million
Adelaide 1.2 million
7

8. Australian Healthcare Overview
• Australia has well developed and well funded system, total expenditure
around AU$100 billion per annum
• 15th largest healthcare market in the world with growing and ageing
population.
• Rated as best healthcare market to do business in Asia Pacific looking at
market size, opportunity & risk.
• Forecasted to grow at 3.5% for next 5 years.
8

9. Public System Overview
• Public System run by combination of
Commonwealth and State
governments.
• Commonwealth – policy, research,
information, major initiatives.
• States – delivery of public health
services
9

10. Hospital Distribution
Hospitals by Public Private
State
NSW 226 173
Victoria 150 161
Queensland 170 106
Western Australia 95 55
South Australia 80 56
Tasmania 24 8
ACT 3 12
Northern Territory 5 2
FreeDigitalPhotos.net
10

11. Funding System
• “Medicare” – major part of funding system
• Medicare Benefits Schedule provides fee for service to health
professionals at point of care.
• Public hospitals funded jointly by federal and state governments –
managed by state governments.
• Medicare levy 1% additional bill for individuals / families earning
over certain level if they don’t take out private health cover.
11

12. Private System
• Federal government pays 75% of Medicare benefit schedule fee to private
provider
• Private health insurance will cover additional 25%, plus other associated
costs such as accommodation.
• 1,275 total hospitals in Australia of which 547 are private.
• 45% of private hospitals run by not-for-profit groups including charities and
religious bodies.
• 55% for profit companies.
• Ramsay Healthcare – 65 hospitals, <7000 beds, 28% of private beds in
Australia. Also 33 facilities in UK
• Healthscope – 47 hospitals plus pathology services.
12

13. Aged Care
• Around 3 million people of retirement age and older
• $30 billion spend on aged care per year
• Caring for an ageing population is an ongoing issue
• Residential – mainly non-government providers but financed by
Commonwealth government with subsidies paid to providers.
• Residents may also pay care fees
• Home and Community – both public and non-government with programmes
of funding combining Commonwealth and State funds.
• 50% providers are non-profit charitable organisations.
13

14. How can UKTI Australia help British companies?
• Carry out in-depth research on the market to
your specifications
• Find local distributors for your products
• Arrange meetings with key potential clients
• Help you attend trade fairs and missions
• Product launches, industry seminars and PR
and marketing support Joe Dodd
• Whatever you need to succeed in the Tel: +61 3 9652 1605
Email: joe.dodd@fco.gov.uk
market!
14

15. 15
Opportunities for British Business
“The Device Market in Australia
Some useful facts”
Mark Glover
Commercial in confidence
Commercial Optimisation
18th October 2012

16. Commercial in confidence
16

17. Commercial in confidence
17

18. Commercial in confidence
18

19. 19
Health Expenditure
Commercial in confidence
Source: Australian Institute of Health and Welfare, Health expenditure Australia 2009-10 @ current prices
19

20. 20
Healthcare Funding in Australia -1
• Medicare
– Is funded from taxation and subsidises healthcare for all Australians
• Prescribed drugs, Rx from Doctors & Dentists, access to public
hospitals
• Pharmaceuticals
– Subsidised via the Pharmaceutical Benefit Scheme $9.6B (£6.1B)
– Patient contribution
• General $35.40; Concessional $5.80
• Private Health Insurance
– Patients choose Clinician and Hospital
Commercial in confidence
– Implantable Device reimbursement – Prostheses List
– Selected extras
• Optical, Dental, Well being
20

21. 21
Healthcare Funding in Australia - 2
• Consumable medical technology
– E.g. Rehabilitation Appliances, National Diabetes services, Continence
Aids
• Implantable Devices
– Public Hospitals provides implantable, provide surgery, both restricted by
Hospital / State budgets
– National Procedure Banding Schedule covers theatre fees and
consumables
– Prostheses List – private insurers are required by law to pay benefits for a
range of prostheses.
Commercial in confidence
– There are over 9,500 prostheses on the list in 3 categories
• Part A – Prostheses
• Part B – Human Tissue (includes products that are substantially derived
from human tissue)
• Part C – Non-implantable devices
21

22. 22
Pharmaceuticals
Process to gain PBS listing for registered products
Commercial in confidence
Source: Department of Health and Ageing, PBPA Policies, Procedures and Methods, 9th December 2011
22

23. 23
PBS Growth – 10 years
Commercial in confidence
Source: From Discovery to Off-Patent: The Changing World of Medicines and Implications for Policymakers 22 nd Mrch 2012

24. 24
What is a Medical Device
A “medical device” is any instrument, apparatus, implement,
appliance, implant, invitro reagent or calibrator, software,
material or other similar or related material.
a)Intended by the manufacturer to be used, alone or in combination, for human beings
for one or more of the specific purpose(s) of:
– Diagnosis, prevention, monitoring, treatment, or alleviation of disease
– Diagnosis, monitoring, treatment, alleviation or or compensation for an injury
– Investigation, replacement, modification, or support, of the anatomy or of a
physiological process
– Support or sustaining life
– Control of conception
– Disinfection of medical devices
Commercial in confidence
– Providing information for medical or diagnostic purposes by means of the in
vitro examination of specimens derived from the human body
And
b)Which does not achieve its primary intended action in or on the human body by
pharmaceutical, immunological or metabolic means, but which may be assisted in its
intended function by such means
24

25. 25
Device vs. Pharmaceutical
Commercial in confidence
Source: Medical Technology in Australia: Key Facts and Figures 2011

26. 26
Changing needs for medical technology with
Commercial in confidence Australia’s ageing population
Source: Medical Technology in Australia: Key Facts and Figures 2011
26

27. 27
Value of the medical technology
industry in Australia
• There is no official source of data
• Total revenue 2009-2010
• ~ $7.6B (£4.9B)
• ~ $8.4B (£5.4B) with in-vitro diagnostic (IVD)
• ~ $9.2B (£5.9B) with IVD & Dental
Commercial in confidence
• Expected CAGR 9% over the next 5 years
Source: Extrapolation of date from contracted provider. Medical Technology in Australia: Key Facts and Figures 2011
27

28. 28
Classification of medical technology
Commercial in confidence
companies in Australia
Source: Data from 240 companies in the MTAA database. Medical Technology in Australia: Key Facts and Figures 2011
28

29. 29
Categorisation of medical
Commercial in confidence technology items on the ARTG
Source:.Medical Technology in Australia: Key Facts and Figures 2011
29

30. 30
How do I get my product
registered?
Jeanette Lodge
Project Manager – Regulatory Affairs
Commercial in confidence
30

31. Agenda
• Regulatory framework
• Local sponsor responsibilities
• Summary of legislation & guidance
• Comparison EU v AUS
• What is the same?
• What is different?
• Some TGA specific requirements
• Cost and Timelines
• TGA Reforms
• Post-market requirements
• New Zealand

32. Regulatory Framework
• Therapeutic Goods Administration (TGA)
• Department of Health and Ageing
• Regulate medicines, biologicals and
medical devices
• ARTG
• Administers the TG Act 1989
• Devices loosely regulated 1991 >
• Act revised in 2002 (to 2007): risk
classification
• Global Harmonisation Task Force
(GHTF)
• Office of Devices Authorisation
• Ms Andrea Kunca
• Reforms ongoing (see later)
• Industry association - MTAA

33. Local Sponsor Responsibilities
• Located in Australia (legally
responsible)
• Procedures & agreement with
Manufacturer*
• Ensure manufacturer:
• complies with Essential Principles
(declaration)
• Applies an appropriate conformity assessment procedure
• Holds current conformity assessment evidence
• TGA eBS (e Business Services) account
• Regulatory Applications to TGA (see later)
• Pay fees and annual charges (see later)
• Post market requirements (see later)
* May also be the sponsor

34. Legislation &
Guidance
• The Therapeutic
Goods Act 1989
‘The Act’
• The Therapeutic Goods Regulations 1990
• The Therapeutic Goods (Medical Devices)
Regulations 2002 (the Regulations)
• Guideline: Australian Regulatory Guidelines for
Medical Devices (ARGMD)
• Additional guideline for boundary products
• Relevant state legislation and customs
requirements may also apply

35. Comparison: EU v AUS

36. What is the same?
• Basis in GHTF procedures and TGA framework
based on EU MDD/AIMDD
• TGA has signed MRA with EU and EFTA for
several industry sectors, including medical devices
• Definition of medical device (accessory also a
medical device in Australia)
• Device Classes (although classification may vary)
• Conformity Assessment Procedures are closely
aligned, except for CE Marking process
(MDD/AIMDD Annex II to VII = TGA Device Regs
2002 Schedule 3, Parts 1 to 6 – refer TGA table)

37. What is different?
EU Australia
EU MDD/AIMDD TG Act and Regulations
18 Classification Rules 5 Classification Rules
One Class III; Class I ‘Straight’ v ‘Special’ Class III (e.g. medicine,
with animal ingredient human, animal, microbial, recombinant)
Essential Requirements Essential Principles (e.g. device specific,
(e.g. software validation clinical requirements, English labelling/
more stringent) packaging/IFU, other)
CE Certification and CE Mark not required, EC Certificate
marking accepted under MRA for some devices
EU DoC TGA DoC

38. What is different?
EU Australia
Labelling to include authorised Must include local sponsor name and
representative or importer address as well as manufacturer
details details
Hip, Knee, Shoulder - Class III Transitioning from Class IIb to III
(current TGA reforms)
CNS contact – Class III Transient use - Class I to IIb; Short,
long-term, implantable - III
Definition of circulatory system Definition includes common iliac
does not include common iliac arteries, therefore some Class III in
arteries Aus not EU
Separate IVD Directive IVD are subset of medical devices
See also TGA website: ARGMD Section 8

39. TGA Specific
• TGA Applications:
• Lodge manufacturer’s evidence (and periodic updates)
• Submit product inclusion application (and any ‘substantial’ changes)
• Lower risk products: EC Certificate: Random application audit
• Higher risk products: mandatory application audit unless EU or
EFTA MRA certificate of conformity can be supplied
• Special products: TGA Conformity Assessment audit
• Design and type examination: not suitable manufacturers
evidence
• Grouping under Section 41BE
• Class III: UPI plus variants
• Formulated devices: ‘random’ audit always conducted
• Pay or delay!

40. Cost &
Timelines
Item Cost (AUD) Timeline
Manufacturer’s Evidence nil 1 to 4 weeks
TGA Conformity $870 plus $19,400 to 6 to 12 months +
assessment $51,200
Class I Inclusion nil Automatic
Class Im/s to AIMD $890 to $1,150 4 weeks to decision
Inclusion or audit request
Application audit nil, $3,360 or $6,170 30 or 60 days +
Substantial variations $390 plus $11,800 to Varies with change
$30,800
Annual charges $70 to $1,150 N/A

41. TGA Reforms
• Increased rigor with assessment of higher
risk devices
• Four proposed changes (Nov 2010
consultation):
• Joint reclassification – in progress
• Use of third party assessment bodies
• Transparency around grouping
• Publication of product details on TGA website

42. Post Market Requirements
• Manufacturer v Sponsor responsibilities
• May delegate activities by written
agreement, but responsibility lies with
manufacturer or sponsor
• Requirements include:
• Adverse event reporting (device monitoring &
vigilance), device tracking (maintain audit trail,
TGA sampling, inspection or ‘desk-top’ audit)
• Recall Procedures
• Application for low-volume turnover
(LVT)

43. New Zealand
• ANZTPA
• ‘Piggy-backs’ on TGA process
• Medsafe notification required within 30 days of
supply of new device
• Notification via WAND
• Web Assisted Notification of
Devices
• Can clone TGA eBS details
to WAND (although databases
no longer linked)
• Devices containing medicine component are
regulated as medicines

44. Commercial in confidence
Where we can help…….
44

45. 45
Commercial Eyes
"We take the complexities out of commercialisation
so that your products can achieve their full potential"
www.commercialeyes.com.au
Commercial in confidence
Jeanette Lodge: +61 3 9428 1899
jeanette.lodge@commercialeyes.com.au
Mark Glover: +61 422 009 582
mark.glover@commercialeyes.com.au

46. Questions, Comments or Follow up?
Joe Dodd
Tel: +61 3 9652 1605
Joe.dodd@fco.gov.uk
Jeanette Lodge
Tel: +61 3 9428 1899
jeanette.lodge@commercialeyes.com.au
Mark Glover:
Tel: +61 422 009 582
mark.glover@commercialeyes.com.au
46