Australian Government
Department of Health
Immunise
Australia Program
Essential Vaccines
Procurement Strategy
Essential Vaccines Procurement Strategy
Online ISBN: 978-1-74241-972-5
Publications approval number: 10871
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2
Table of Contents
1 PURPOSE
5
2 POLICY CONTEXT
5
2.1 Immunise Australia Program
5
2.2 National Immunisation Program (NIP)
6
2.3 Transition to Commonwealth procurement
7
2.4 National Partnership Agreement for Essential Vaccines
(NPEV)
7
2.5 National Immunisation Strategy
8
3 PRINCIPLES OF QUALITY VACCINE PROCUREMENT
3.1 Commonwealth Procurement Rules
9
9
3.2 Principles in developing a procurement process
10
3.3 Governance and Advice
11
3.4 Maintaining security of supply and choice of vaccine
12
4 NEW ARRANGEMENTS
13
4.1 Aims and Objectives of the new arrangements
13
4.2 Anticipated improvements, efficiencies and benefits of
new arrangements
14
4.3 Roles and Responsibilities
4.3.1 Commonwealth
4.3.2 States/Territories
4.3.3 Industry
14
14
15
16
4.4 Consultation and Communication
4.4.1 Regularity
17
18
5 PROCUREMENT PROCESS
18
5.1 Proposed staging of vaccine procurements
18
5.2 Summary of process and timelines
19
5.3 RFT development
20
5.4 Tender evaluation process
20
5.5 Contractual arrangements/Head Agreement
21
6 IMPLEMENTATION OF NEW ARRANGEMENTS
6.1 Forecasting
22
22
3
6.2 Vaccine ordering, supply and delivery under Head
Agreements and Deeds
23
7 REVIEW/EVALUATION
24
APPENDICES
25
APPENDIX A - Procurement Schedule
26
APPENDIX B - National Health (Immunisation Program –
Designated Vaccines) Determination 2012 (No.1)
27
APPENDIX C - Pharmaceutical Benefits Advisory Committee
(PBAC) Process
28
APPENDIX D - National Immunisation Program (NIP)
Schedule
31
APPENDIX E - Performance Indicators for the NPEV
32
4
1 PURPOSE
This paper describes the reform to national purchasing arrangements for
essential vaccines funded under the National Immunisation Program (NIP).
The transition moves from an arrangement where the Commonwealth
supplied funds to the states and territories for purchase
of vaccines on the NIP under the previous Australian Immunisation
Agreements (AIAs) which expired on 30 June 2009, to the new
Commonwealth Own Purpose Expense (COPE) arrangements. Under these
new arrangements, the Commonwealth will undertake to procure vaccines at
the best value for money for the NIP.
A series of staggered tenders will be conducted between 2010 and 2015 to
procure high quality, safe and efficacious vaccines and to obtain the best
value for money for the Commonwealth. This rolling series of tenders will
allow the Commonwealth to manage the workload. It is expected that the
Commonwealth will conduct, on average, two tenders per financial year which
will minimise the burden on industry.
This paper provides a framework under which all procurement processes will
be conducted and a proposed schedule and timeline for undertaking each
vaccine tender (Appendix A). The timetable will need to be flexible to take into
account changing circumstances such as policy changes, new vaccines
assessed and new technologies given the timeframe for implementation. This
schedule will be updated regularly as tenders progress or circumstances
change.
This paper should be considered in the context of the National Partnership
Agreement on Essential Vaccines (NPEV) which is available on the Federal
Financial Relations website.
2 POLICY CONTEXT
2.1 Immunise Australia Program
The Immunise Australia Program (IAP) aims to increase national
immunisation rates by funding free vaccination programs under the NIP,
administering the Australian Childhood Immunisation Register (ACIR),
administering of the National Human Papillomavirus Vaccination Program
Register (HPV register) and communicating information about immunisation to
the general public and health professionals. Further information on the
Immunise Australia Program is available on the Immunise Australia Program
website.
The key aims of the IAP are to:
5
•
provide free vaccines to Australians in accordance with the NIP Schedule;
•
use delivery methods to maximise opportunities for immunisation of
eligible cohorts;
•
achieve the lowest possible incidence of vaccine preventable disease by
attaining and maintaining the highest possible levels of immunisation
coverage across eligible population cohorts; and
•
achieve improvement in effective immunisation coverage among those
groups at the highest risk of vaccine preventable disease.
2.2 National Immunisation Program (NIP)
The NIP is a critical public health program that provides population based
essential vaccines free to all eligible Australians.
The NIP operates under a partnership arrangement between the
Commonwealth and state and territory governments under the NPEV.
The NIP Schedule outlines the recommended vaccines by age group which
are funded under the IAP. The NIP Schedule is described in accordance with
the National Health (Immunisation Program – Designation Vaccines)
Determination 2012, (No.1), made pursuant to section 9B of the
National
Health Act 1953, (the Determination), (Appendix B, current at time
of publication). The target groups for vaccination supplied under the NIP
include the universal program for all infants, young children, adolescents and
older Australians, to the provision of vaccines for people who are at greater
risk of adverse consequences from acquiring the disease; for example,
Indigenous Australians or other people with co-morbidities in the case of
influenza.
For a vaccine to be deemed an ‘Essential
Vaccine’, the vaccine has to be
designated under the Determination by the Minister for Health (or delegate).
Prior to designation, the vaccine must be assessed for cost effectiveness and
recommended for designation by the Pharmaceutical Benefits Advisory
Committee (PBAC). Further information
on the PBAC process is provided at
Appendix C. The current NIP Schedule includes vaccines against sixteen
conditions/indications/diseases (Appendix D).
Previously under the AIAs, whichever combination of vaccines and suppliers
the states and territories wished to use from those listed on the Determination
as best suited the needs of their population was purchased by the jurisdiction
via its usual procurement process. Under the new arrangements the
Commonwealth will directly purchase the NIP vaccines and the states and
territories will continue to be responsible for the ordering and distribution of
vaccines.
6
2.3 Transition to Commonwealth procurement
In 2007-08 the Council of Australian Governments (COAG) agreed to a reform
agenda that
included a new intergovernmental agreement
on
Commonwealth-state and territory financial arrangements. The
Intergovernmental Agreement on Federal Financial Relations (IAFFR) was
established to improve the quality and effectiveness of government services
by reducing Commonwealth prescriptions on service delivery by the states
and territories, and providing the states and territories with increased flexibility
in the way they deliver services to the Australian people. This agreement was
accompanied by a major rationalization of the number of payments to the
states and territories as Specific Purpose Payments (SPPs).
More information on the IAFFR is available on the Council of Australian
Government website.
As part of this process COAG agreed that the funding for the NIP should
change from an SPP to a COPE with commencement in 2009-10. Under
a
COPE arrangement, the Commonwealth is responsible for procurement of
NIP vaccines. These new arrangements mean that the procurement
and the
payment for the supply of essential vaccines under the NIP will be managed
by
the Commonwealth while functions associated
with implementation of
the NIP will remain the responsibility of the states and territories.
As part of the rationalisation of SPPs to the states and territories, COAG
developed a new integrated approach to improving health outcomes for all
Australians and the sustainability of the Australian health system through the
National Healthcare Agreement (NHA) which replaces the previous Australian
Health Care Agreements. The NHA defined the objectives, outcomes and
high level performance measures, and clarified respective roles and
responsibilities to guide the Commonwealth
and the states and territories in
delivery of
services across the health sector (Appendix E).
The NHA was superseded on 25 July 2012 by the National Health Reform
Agreement (NHRA). The NHRA builds on and reaffirms the Medicare
principles and high level outputs in the National Healthcare Agreement.
2.4 National Partnership Agreement for Essential Vaccines (NPEV)
The NPEV sits under the IAFFR and NHRA and was developed between the
Commonwealth and the states and territories to ensure continuity of the
delivery of vaccines under the NIP following on from the previous AIAs. It
provides a framework to progress the national purchase of vaccines for the
NIP. The NPEV was agreed by First Ministers in August 2009.
The NPEV provides for:
• transitional arrangements for the continued Commonwealth funding of the
7
purchase by the states and territories of essential vaccines until the new
contracts are completed;
•
progressively moving to new arrangements whereby the Commonwealth
will directly purchase the essential vaccines for use by the states and
territories;
•
performance indicators to monitor and assess the achievement of
objectives and outcomes for immunisation under the NHA or NPEV;
•
incentive payments to promote effective service delivery by the states and
territories and facilitate the states and territories undertaking projects to
maintain and enhance the effectiveness of the NIP; and
•
transition to centralised vaccine procurement by the Commonwealth and
the states and territories.
State and territory reporting on performance indicators will be assessed by
COAG to determine the overall performance by states
and territories on the
delivery of immunisation programs under the NIP. The NPEV performance
indicators can be found at Appendix E.
The NPEV may need to be reviewed to reflect changes to program delivery
arising from the new procurement arrangements. As specified in the NPEV
this would occur no later than 2014.
The state and territory Immunisation Co-ordinators have provided, and will
continue to provide, advice during the transition process from the existing
arrangements. Regular meetings are held and will continue to be held both to
keep Jurisdictional Immunisation Co- ordinators informed and to obtain their
advice.
The new purchasing arrangements will be sufficiently flexible to allow the
states and territories to purchase additional supplies of vaccines under the
same procurement arrangements to fulfil any state or territory-based
vaccination scheme requirements.
The NPEV is available on the Federal Financial Relations website.
2.5 National Immunisation Strategy
A National Immunisation Strategy is being developed, in collaboration with
states and territories, to guide Australia’s approach to the prevention and
control of vaccine preventable diseases with the view to reduce the
occurrence of vaccine preventable diseases.
The National Immunisation Committee (NIC)
has overseen the development
of the National Immunisation Strategy. The NIC, a subcommittee of
Communicable Diseases Network Australia (CDNA), is chaired by the
8
Commonwealth and comprises all states and territories, consumer
representatives and expert advisors from a range of peak organisations
(including the Australian Medical Association, Australian Medicare Local
Alliance, Rural Doctors Association Australia and the National Aboriginal
Community Controlled Health Organisations).
The National Immunisation Strategy will provide a framework for future
immunisation policy
and be endorsed by the Australian Standing Council on
Health (formerly AHMC).
3 PRINCIPLES OF QUALITY VACCINE
PROCUREMENT
The principles of quality vaccine procurement have been developed with
consideration of the NPEV, IAFFR, Commonwealth Procurement Rules
(CPRs) and National Medicines Policy as informing the Procurement Strategy
to ensure:
•
timely access to vaccines that Australians need, at a cost the community
can afford;
•
that vaccines meet appropriate standards of quality, safety and efficacy;
•
quality use of vaccines; and
•
maintaining a responsible and viable medicines [vaccine] industry. All procurement processes will be undertaken
in accordance with best
practice guidelines
and in line with government policies and procedures to
ensure that fair, open, transparent and accountable processes are conducted
to achieve the best value for money for the Commonwealth and states and
territories.
3.1 Commonwealth Procurement Rules
Procurement processes will be conducted
in accordance with the
Commonwealth Procurement Rules (CPRs) which can be found on the
Department of Finance website.
The CPRs are the policy framework under which agencies undertake
procurement. The underlying key principles of the CPRs include:
•
achieving value for money;
•
encouraging competition;
•
efficient, effective and ethical use of resources; and
9
•
accountability and transparency.
Health will utilise internal expertise and where necessary engage specialist
legal, probity and financial advisers to ensure that all processes are
conducted to the highest possible standards of ethics and probity and the best
value for money outcomes are achieved.
The Commonwealth and the states and territories will be partners in
developing tender documentation and assessing the outcomes of
procurement processes.
3.2 Principles in developing a procurement process
The following principles have been adapted from the World Health
Organization - Immunization supply and procurement (available on the
WHO website) and have been used to design the procurement process for
vaccines on the NIP.
Products Meeting Required Standards
All vaccines should meet Australian regulatory requirements. Products are
required to be
registered for use in Australia by the Therapeutic Goods
Administration (TGA) and assessed by Pharmaceutical Benefits Advisory
Committee (PBAC) for cost effectiveness. This ensures that vaccines of the
desired standard of quality, safety and efficacy are procured for Australian
use. Products must also adhere to tender requirements as set out in the
statement of requirement documents.
•
Value for Money
Cost is not the only determining factor in assessing value for money.
Rather a whole-of-
life value for money assessment would include
consideration of factors such as: fitness for purpose; the performance
history of each prospective supplier as obtained from references; a risk
assessment of each proposal; minimising impact of changes to vaccines
used by states and territories; the flexibility to adapt to possible change
over the lifecycle of an agreement; financial considerations including all
relevant direct and indirect benefits and costs over the whole procurement
cycle; and the evaluation of contract options (for example, contract
extension options).
•
Reliable Suppliers
Reliability of suppliers will be considered in terms of quality, timeliness,
delivery, responsiveness to issues and compliance with contracts.
Engaging suppliers with demonstrated experience supplying large
volumes of vaccine to government funded programs is desirable (taking
into account state and territory health department experience). Reliability
will be monitored and measured through active management of contracts
to identify and mitigate any potential issues and to inform future
interactions with suppliers.
10
•
Security of Supplies
Where supplies meet the tender specifications, contracting with more than
one supplier, particularly where vaccines are interchangeable, will
maximise the security of supplies, to fulfil the requirement of each state
and territory’s NIP schedule and enable different population health needs
within different areas where these exist to be addressed as may be
required. Suppliers will also be required to hold a minimum supply of
vaccine as a buffer.
•
Delivery of Quality Vaccines on Time
Supplier capacity and capability to deliver required vaccine on time and in
accordance with vaccine management requirements is
a priority. Supply
and delivery arrangements which minimise the risk of any stock
disruptions is key; this requires accurate forecasting and good
communication within the supply chain to ensure that it remains
optimally filled.
•
Reliable Forecast of Demand
Reliable short and long term demand forecasting gives the flexibility to
Health to conduct the processes to best meet the needs of the NIP
demand. It also facilitates appropriate industry planning and budgeting to
meet needs and allows for greater flexibility to engage with suppliers with
a longer term view.
•
Flexibility and Responsiveness
Contractual arrangements in place need to
be sufficiently flexible to allow
for changing circumstances such as increasing orders and changes to
cohort size or introduction of new vaccine technologies, the addition or
removal of vaccine from NIP due to schedule changes and policy
decisions around changes to the NIP.
•
Good Coordination and Communication
Coordination and communication between
all stakeholders involved in
the procurement process is essential. Key stakeholders include: state and
territory health departments, the TGA, PBAC, the Australian Technical
Advisory Group on Immunisation (ATAGI), and industry through
Medicines Australia and directly with individual suppliers. Timely
communication with suppliers is considered mandatory.
•
Regular Performance Evaluation
Internal monitoring and periodic evaluations within clear guidelines and
performance indicators should be conducted to assess the performance
of the procurement process; identify areas for improvement and
implement any recommendations identified to improve processes and
outcomes.
3.3 Governance and Advice
The aim of the procurement framework is to secure the continual supply of
high quality, safe and efficacious vaccines at value for money for the NIP.
11
This will be achieved through continued joint Commonwealth/state and
territory collaboration on a planned procurement process.
Health will maintain a dedicated Immunisation Procurement Section that will
undertake the procurement processes and provide secretariat support to each
newly established tender evaluation committee. This section sits within the
Immunisation Branch and has links with policy and program aspects of the
NIP.
Consultation with the Communicable Disease Network Australia (CDNA) and
the Australian Health Protection Principal Committee (AHPPC) will be
undertaken in considering a procurement approach.
Health, while utilising internal expertise
in relation to legal advice, probity,
financial and procurement advice, will engage external experts to provide
independent advice to ensure that
each procurement process is conducted
to the highest standard and that processes are fair, open, transparent and
accountable. Health will utilise the expertise of its medical officers,
technical/regulatory advisors from the TGA, and ATAGI members and other
experts as required for assessment of tenders and input into tender
documentation and statements of requirements.
Through the Jurisdictional Immunisation Co-ordinators (JIC), Health is able to
access advice in relation to ‘on the ground’ use of vaccine and the
implementation of immunisation programs.
In relation to timing of tenders, Health will consult with Medicines Australia as
required to understand the potential burden on industry to meet tender
timeframes in relation to industry national and global manufacturing
commitments and schedules.
3.4 Maintaining security of supply and choice of vaccine
States and territories will be actively engaged and consulted throughout the
implementation of the new purchasing process. While states and territories
have indicated a preference for the maintenance, where possible, of a choice
of vaccine, this approach impacts on flexibility requirements for a demand
driven program. The breadth of choice will be linked to the outcome of the
procurement processes and alignment with tender negotiations. To support
this, and to ensure security of supply, contracting with more than one supplier
for each indication, particularly where vaccines are interchangeable, is
recommended where possible.
This preference, in part, is in recognition of the costs that could be incurred by
states and territories through changing a schedule to a vaccine that requires
different timing/doses of administration.
12
The requirements for security of vaccine supply need to be balanced with
ways to ensure vaccine pharmaceutical companies will provide adequate
supplies of high quality vaccines. It may not be economically viable for the
companies to supply vaccines unless they achieve reasonable economies of
scale in the contracted supply arrangements.
To maintain efficiencies, vaccine procurement deeds for supply are likely to
stipulate specific market shares. Determination of market share
will be based
on assessment of potential supply offers and the findings of the tender
evaluation committee in accordance with the tender evaluation plan and the
CPR’s including assessment of value for money. States and territories will be
consulted during the tender evaluation process on how such market shares
are to be determined. In the event that a contracted vaccine cannot be
provided, negotiation with alternate contracted suppliers may be required to
maintain continuity of supply.
4 NEW ARRANGEMENTS
4.1 Aims and Objectives of the new arrangements
The aims and objectives of the new arrangements are to:
•
secure the ongoing supply of quality, safe and efficacious vaccines to
the
Australian population;
•
ensure that vaccines purchased meet technical and programmatic
specifications and legislative requirements;
•
ensure that there is no disruption to the supply, coverage and uptake of
vaccines provided under the NIP;
•
ensure that there is more than one supplier, wherever possible, for the
supply of essential vaccines;
•
achieve administrative efficiencies in procurement and contract
management;
•
maintain sustainable competition for vaccines through competitive
procurement/tender processes;
•
ensure a commitment to regular monitoring and evaluation of the NIP;
•
maintain and enhance cooperation between the Commonwealth, the
states and territories and industry; and
•
achieve no visible change to everyday business for vaccine providers or
13
for the public.
4.2 Anticipated improvements, efficiencies and benefits of new
arrangements
The key benefits of the new arrangements are expected to be:
•
continued supply of approved high quality vaccines in a timely manner in
accordance with the eligible population cohorts listed in the NIP schedule;
•
increased capacity to ensure security of supply and ability to respond to
escalating vaccine prices through multi- year arrangements for supply;
•
increased capacity to reduce wastage and leakage through national
forecasting and co-ordination of purchasing;
•
enhancement of nationally based data collection in relation to purchasing
and usage data and improved program monitoring;
•
decreased administration costs relating to centralised procurement and
potential ‘Head’ contract management arrangements;
•
improved and standardised procurement documentation and processes;
•
efficiencies for industry by each pharmaceutical company only having
to
negotiate with the Commonwealth (rather than multiple states and
territories) around contractual arrangements; and
•
ability to better monitor individual vaccine costs via direct Commonwealth
payment to vaccine providers.
4.3 Roles and Responsibilities
The new arrangements will progressively replace the current state and
territory based purchasing arrangements, align with the NPEV and will be fully
implemented once all vaccines on the NIP are procured under new
multipartite contracts. Roles and responsibilities are consistent with the roles
and responsibilities agreed in the NPEV.
4.3.1
Commonwealth
Under the new arrangements the Commonwealth will be responsible for:
•
developing and providing national vaccine forecasting to vaccine
suppliers;
•
maintaining all aspects of contractual arrangements with vaccine
manufacturers, including performance management and risk monitoring;
•
purchasing the vaccines for delivery by the states and territories through
the NIP; and
14
•
analysing national data on vaccines. The Commonwealth, through the Immunisation Branch, Department of Health,
will:
•
develop, manage and evaluate project and tender documentation,
including the evaluation framework, and governance requirements;
•
manage the procurement/tender process;
•
obtain advice as required in order to support a professional and compliant
tender process;
•
develop and manage contract negotiations with industry after the tender
evaluation;
•
negotiate contractual agreements with industry;
•
enter into multipartite deeds for supply;
•
provide, as early as possible, requirement forecasting data to industry to
facilitate industry planning;
•
take into account advice from industry on the timing and schedule of
procurement/tenders to minimise the burden on industry during peak
manufacturing periods; and
•
manage all contractual agreements throughout their terms.
4.3.2
States/Territories
Under the new arrangement the states and territories will be responsible for:
•
assisting and advising the Commonwealth on the procurement process;
•
entering into multipartite deeds for supply;
•
participating in tender evaluations;
•
providing forecasts of essential vaccine requirements;
•
ordering essential vaccines under a Head Agreement or Deed;
•
placing orders with vaccine sponsors;
•
ownership of and responsibility for any such essential vaccines acquired;
•
verifying to the Commonwealth, within an agreed timeframe, that essential
vaccines have been delivered;
•
advising the Commonwealth of orders and invoices;
•
coordinating the delivery of NIP vaccines to immunisation providers;
15
•
managing the efficient and effective delivery of the NIP;
•
monitoring and minimising vaccine wastage and leakage upon arrival of
vaccines in state and territory warehouses;
•
managing all mutually agreed administrative matters relating to the
essential vaccine and its contracts under the NPEV and the multipartite
supply deeds; and
•
notifying the Commonwealth as soon as practicable in relation to:
»
the rejection of any essential vaccine under a contract or recall by the
supplier of any essential vaccine; and
»
any problems or issues concerning a relevant supplier as stipulated in
the NPEV Part 20.f.(ii).
4.3.3
Industry
Industry is responsible for:
•
ensuring that quality, safe and efficacious vaccine is provided in
compliance with TGA requirements and in accordance with any deed
entered into for vaccine supply;
•
maintaining the quality of vaccine up to the point of delivery into
designated state and territory distribution centres for example, maintaining
cold chain;
•
working in cooperation with the Commonwealth and the states and
territories to ensure NIP requirements are delivered;
•
advising the Commonwealth of supply issues;
•
advising the Commonwealth when the payment cap has been reached;
•
compliance with supply deeds; and
•
provision of intelligence on:
»
adverse events;
»
potential delays in delivery or shortages of vaccine; and
»
new technologies. Effective relationships between industry, the Commonwealth and the states
and territories are crucial to the success of this strategy and continuity in
supply of vaccine provided under the NIP.
16
4.4 Consultation and Communication
Stakeholders affected by the transition to centralised procurement
arrangements will be consulted during the planning, implementation and
evaluation of this Strategy. To ensure a broad understanding of sector issues and to identify areas for
consideration in the changed arrangements, bilateral consultations were
undertaken between the Commonwealth and each jurisdiction and various
pharmaceutical suppliers. In addition, the Department has met with the peak
industry representative body Medicines Australia. As the procurement process proceeds, consultations with states and
territories and industry will continue, enabling ongoing improvements to the
process. The preferred consultation mechanisms with the states and
territories and industry are via JIC and Medicines Australia respectively.
The JIC will be actively consulted throughout the procurement process about
the:
•
formation of any assessment panels that are required for the procurement
process, including the involvement of JIC representatives;
•
project timelines and the priorities for the central procurement of particular
vaccines;
•
development of tender documentation, including the statement of
requirement;
•
provision of technical advice as part of the tender evaluation and
negotiation phases;
•
deeds of agreement for each tenderer; and
•
management of any risks to achieving procurement outcomes. The JIC will receive regular updates through JIC meetings and timely advice
of pertinent matters which arise during each procurement process. External key stakeholders to be consulted include (but are not limited to):
•
National Immunisation Committee;
•
Australian Technical Advisory Group on Immunisation;
•
Medicines Australia;
•
Communicable Diseases Network Australia; and
•
Australian Health Protection Principal Committee.
17
4.4.1
Regularity
Key stakeholders will be regularly updated, by Health, at least quarterly, and
also informed when there is a change made to the schedule of
procurements/tenders. Stakeholders can seek information or make enquiries
by email via the Immunisation RFT inbox.
5 PROCUREMENT PROCESS
The proposed strategy is to roll out a competitive tendering process (where
possible) in accordance with CPRs, to secure the supply of all essential
vaccines for administration by the states and territories under the NIP.
As the states and territories have existing contracts for the supply of all
vaccines the possibility of the Commonwealth novating the existing contracts
was considered but not accepted because this would not secure competitive
pricing for the supply of vaccines. Additionally, it was considered potentially
problematic to have to renegotiate the terms and conditions of state and
territory agreements to meet the Commonwealth’s requirements.
The Requests for Tender (RFTs) may be either an open tender or prequalified tender. Limited tender sourcing may be used where there is only one
known supplier. Only companies that produce vaccines which are registered
for use in Australia and eligible to be designated vaccines on the NIP will be
eligible to tender.
Where possible, a six month lead in time for the commencement of each new
procurement following each tender process will be in place to allow for the
completion of any existing state and territory contracts and to allow for the
preparation of the new arrangements.
5.1 Proposed staging of vaccine procurements
It is proposed that tenders for the 16 NIP indications for vaccine preventable
diseases will be conducted between 2010 and 2015. A rolling schedule of
tenders over this period is considered to be the most sustainable method to
have arrangements in place for vaccine supply within this time frame.
While it is anticipated that each tender process will take up to nine months to
complete, up to twelve months has been allowed for most procurement
processes to allow more scope to manage any unforeseen delays. Following
the finalisation of contracts with successful suppliers there will ideally be a
minimum six months transition period to the new arrangements with specific
details to be negotiated. The Commonwealth will commence payment under
the NIP for the vaccines and the states and territories will cease procurement
and payment by the end of that six month period.
18
Staggered procurement will allow for a smooth transition when moving from
state and territory contracts to Commonwealth contracts. A staggered
approach should also enable the program to take account of peak industry
manufacturing periods. In addition, a staggered procurement would allow for
refinement of the procurement process with each subsequent tender.
The order and combination of vaccine tenders has been determined based on
relative priorities, the realistic achievable workload in Health,
the addition of
new vaccines on the NIP, and in consultation with the states and territories
and industry, noting NIP is subject to change, for example, through the
introduction of vaccine variants or replacement vaccines or a cohort change.
Priority will be given to procurement of new vaccines to the NIP where states
and territories are unable
to use existing contracts to secure supply.
As a result of the national procurement being undertaken by the
Commonwealth, a vaccine may be listed on the Determination, but where
there are a range of potential vaccines for a specific schedule point, there is
no guarantee that a listed vaccine will be successful in an RFT process.
5.2 Summary of process and timelines
The anticipated timing for the procurement of each vaccine or set of vaccines
will be communicated to stakeholders through regular updates and also
updated on Health’s Annual Procurement Plan that can be found on the
AusTender website.
Stakeholders can now search the AusTender
site by United Nations
Standard Products and Services Code (UNSPSC), Agency or Keyword and
then create a ‘watch list’. If there is any activity,
for example, if the tender or
timing is amended
or opens to the market on a ‘watched’ planned
procurement, the stakeholder will be notified.
A period of up to twelve months has been allocated for each tender process.
This includes the:
•
development of a procurement plan, engagement of state and territory
representatives and establishment of the Tender Evaluation Committee
(TEC);
•
development of the RFT documents, including the statement of
requirement and tender evaluation plan, consultation with states and
territories and approval by Health’s delegate;
•
application phase – companies should be given at least 25 business days
19
to respond;
•
tender evaluation; and
•
contract negotiation and signing of a final agreement
During the procurement process, if there is more
than one supplier of a
vaccine the tender evaluation committee may recommend to the delegate
entering into market share arrangements across all jurisdictions.
A schedule of indicative release dates for the proposed procurements is
provided at Appendix A. This schedule will need to be flexible to account for
changing priorities, fluctuations in industry production schedules and Health’s
workload. Although each vaccine will have individual statements of
requirement, grouping some vaccines together
under the one procurement
process will be more efficient. This staggered approach has been broadly
supported by the states and territories and industry.
5.3 RFT development
RFT documentation, including the procurement plan, RFT and statements of
requirements, will be developed in consultation and agreement with the states
and territories, and, where required, technical expertise sought from the TGA
and from the ATAGI.
Essential tender requirements will include, but are not limited to:
•
products must be registered for use in Australia on the Australian Register
of Therapeutic Goods;
•
products must have received a positive recommendation by PBAC for
inclusion on NIP prior to the tender closing date; and
•
products must be listed on the Determination for designated vaccines
prior to the deeds being executed.
5.4 Tender evaluation process
A TEC will be established for each tender process. The TEC will comprise
members with a range
of relevant skills and knowledge in public health
programs and vaccine preventable diseases. The Commonwealth will chair
each TEC and there will be at least two state and territory representatives on
each TEC to provide program implementation experience to the TEC. State
and territory representatives will be nominated by the JIC, and will depend on
a number of factors including, vaccine
to be tendered for, population and
diversity of the state and territory, and immunisation programs of the state and
territory. States and territories can choose to nominate alternate experts. The
TEC will consult with medical officers, technical/regulatory advisers from the
TGA, and ATAGI members and other experts as required in its assessment of
each tender.
20
There will be a Tender Evaluation Plan (TEP) for each process, developed
with the agreement
of the TEC and approved by the Health delegate before
the tender closing date. State
and territory representatives on the TEC will
be actively involved in the development of the TEP. This plan will clearly set
out how each tender will be assessed for its ability to meet the tender
statement of requirement and compliance with the proposed Deed/Head
Agreement (discussed in more detail below) or new schedule to the Head
Agreement.
Each tender will be assessed against the statement of requirement. The
statement of requirement will align with the recommendations of the PBAC,
where relevant, and any Government decision on funding. Evaluation criteria
will be defined for each tender process and will include consideration of:
safety, efficacy and quality of supplies, security of supply, timeliness for
provision and production capacity, compliance with the statement of
requirement, price and risk. All aspects of the evaluation of the tender will be
in accordance with CPRs. States and territories will have the opportunity to
provide input into tender specifications and criteria.
The approximate number of doses required nationally for a vaccine will be
outlined in the RFT. However, when applying for the tender, the potential
supplier will have no guarantee of volume or market share of vaccine/s and/or
doses they will be contracted to supply until the end of the tender selection
process and the finalisation of the Deed of Agreement.
A final evaluation report making recommendations in relation to a preferred
tenderer(s) will be provided to the Health delegate for approval.
Health and its legal advisers, in consultation with the states and territories, will
then conduct negotiations leading to the signing of a new Deed/Head
Agreement or schedule to an existing Head Agreement.
5.5 Contractual arrangements/Head Agreement
Following a procurement process the Commonwealth and states and
territories will establish a Head Agreement with the successful tenderer/s.
The Head Agreement will set out the terms and conditions of the
Commonwealth/state and territory acquisition arrangements with the supplier.
Thus, this arrangement will be a standing offer by the supplier for the term of
the Head Agreement.
Each vaccine for which the supplier successfully wins a tender will be listed
(along with its relevant specifications) in a schedule to the Head Agreement.
New schedules for vaccine products may be added throughout the term of the
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Head Agreement when an existing supplier is successful in a procurement
process, with each product having its own
effective date and term. This
approach provides certainty for the supplier and the Commonwealth
in that
once the terms and conditions of the
Head Agreement have been negotiated
the only significant amendments will be via the addition of schedules for the
supply of additional vaccines.
The initial term of the Head Agreement will be five years with the option to
renew the Agreement for two extensions of three years.
The Head Agreement will be between the Commonwealth, states and
territories and the supplier. Under this arrangement the Commonwealth is the
payment agent for the states and territories.
In addition to the purchase of essential vaccines under the NIP, each state
and territory will be able to place purchase orders under the Head Agreement
in its own right for state and territory funded vaccines. This arrangement is
similar to the current deeds for seasonal influenza vaccine supply. Where
states and territories agree the Commonwealth will sign the Head Agreements
with the suppliers on the state or territory’s behalf.
The Head Agreement will be flexible enough to take into account the
development of an improved vaccine or method of delivery or the addition of
new cohorts. It will include new technologies and variation and termination
clauses for the contract or schedule. Additional schedules will be added to the
Head Agreement with a Supplier as additional vaccines are procured with that
Supplier.
6 IMPLEMENTATION OF NEW ARRANGEMENTS
6.1 Forecasting
Strategic and operational forecasting will be used
to inform future vaccine
supply. Australian Bureau
of Statistics (ABS) population cohort data will
be
the main source of forecasting vaccine/dose volumes. This will be
supplemented by historical ABS population data. These two data sources will
be used to project the expected demand. To predict the operational forecast,
states and territories will provide data on actual uptake of vaccines and
estimate volumes, forecasting through quarterly and annual reports as per the
requirements of the NPEV.
There will be flexibility within the deeds to order additional supplies if required,
for example, if population growth within the Head Agreement term indicates
that additional supplies are warranted.
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6.2 Vaccine ordering, supply and delivery under Head Agreements and
Deeds
States and territories will provide the Commonwealth with annual vaccine
forecasts and expected delivery schedules on the numbers of each vaccine
they anticipate ordering. These forecasts are non- binding and can be varied,
based on changes in demand, by notifying the Commonwealth.
Based on these forecasts the Commonwealth will authorise the nominated
supplier to accept orders from the states and territories for vaccines up to the
agreed volume of vaccines. There
will be capacity to vary the volume
ordered if demand is higher than anticipated and this is substantiated by the
states and territories.
States and territories will be responsible for ordering vaccines for the NIP from
the supplier and will
need to ensure that ordering processes are in
line with
relevant state and territory government accountability provisions. Copies of all
orders to suppliers will be provided to the Commonwealth so that the
Commonwealth can ensure that it
has sufficient evidence and funding to pay
the supplier and to provide the opportunity to monitor orders against the nonbinding forecast.
The Commonwealth will not pay for orders in excess of agreed estimated
volumes (payment caps). The Commonwealth acknowledges that there
may
be fluctuations in the volume of supply required; therefore, any volumes
over and above the payment cap must be agreed prior to ordering vaccines.
The supplier will be responsible for the delivery of the vaccine to the specified
delivery site within each state and territory. Ownership of the vaccine will pass
to the states and territories upon receipt of
the vaccine. States and territories
will need to have appropriate insurance and systems in place to store and
distribute vaccine, following acceptance.
The states and territories will notify the Commonwealth of the quantity and
quality of goods received and verify that goods have been included on the
state and territory asset register. On this basis the Commonwealth will make
payments based on invoices issued by the vaccine supplier.
The states and territories will report any issues relating to vaccine supply
including quality, quantity and timeliness of supply to the Commonwealth,
which will be responsible for undertaking
any negotiations relating to
contractual non- compliance with the vaccine supplier.
States and territories can also purchase additional vaccines for their own
purposes under the
deeds. This will be through a separate ordering, billing
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and payment process direct with the states and territories. The
Commonwealth will not pay for State Scheme supplies.
Through the NPEV the Commonwealth and the states and territories are
committed to maintaining and, where possible, improving immunisation
coverage rates through immunisation initiatives to reduce the incidence of
vaccine preventable diseases in the Australian population. To achieve
this,
the Commonwealth and the states and
territories will collaborate to
guarantee the supply of essential vaccines as the new arrangements for the
procurement of vaccines are progressively introduced.
7 REVIEW/EVALUATION
A formal evaluation of the new arrangements and their impact on the
Commonwealth, states and territories and the suppliers will be undertaken
when all contracts have been transitioned to the new arrangements. This will
likely coincide with the review of the NPEV which is scheduled no later than
2014. The evaluation may consider, but will not be limited to:
•
the overall efficiencies gained for vaccine purchasing;
•
efficiencies in administrative arrangements;
•
ongoing service delivery and impact of the new arrangements on the NIP;
•
the procurement process and the identification of improvements for future
procurement; and
•
a comparison of the relationship between the states and territories and
the suppliers in the existing and new arrangements.
A framework for the evaluation criteria will be developed in consultation with
the JIC and industry.
While a formal evaluation process will occur, it is important that all
stakeholders are engaged in regular communication as these new
arrangements are established. The appropriate forums for such discussions
are the JIC, the NIC and meetings with Medicines Australia and its vaccine
industry group.
Regular monitoring will assess the success of this strategy against the
following measures:
•
security of supply of approved high quality vaccines for the Australian
public;
•
adequate national forecasting of vaccines commensurable with demand
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for vaccines;
•
effective cooperation between the Commonwealth and all jurisdictions;
•
industry engagement in the process;
•
development of an effective and efficient program of procurement as
evidenced by:
•
»
achievement of value for money;
»
completion of contract tender negotiations within the required
timeframe; and
»
seamless transition from state and territory to Commonwealth
procurement for suppliers and the public; and
completion of the NIP procurement process by 2015.
APPENDICES
Appendix A Appendix B Appendix C Appendix D Appendix E -
Procurement Schedule
National Health Determination 2012 (No. 1)
Pharmaceutical Benefits Advisory Committee process
Vaccines on the NIP (NIP Schedule)
Performance Indicators for the NPEV
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APPENDIX A Procurement Schedule
Expected release of tenders
It is proposed that the staggered approach to procurement/tender be
implemented as follows:
Vaccine
Expected Release of RFT
Influenza
Completed 2011
Human Papillomavirus
Completed 2013
Haemophilus influenzae type B /
meningococcal C for the
12 month old cohort
Completed 2013
Measles, mumps, rubella and
varicella
Completed 2013
Pneumococcal
In progress
Human Papillomavirus
3rd Quarter 2014-15
Hepatitis A
3rd Quarter 2014-15
Rotavirus
4th Quarter 2014-15
Influenza
2nd Quarter 2015-16
Diphtheria, tetanus and acellular
pertussis, Hepatitis A, Hepatitis B,
Polio and Haemophilus influenzae
type b
4th Quarter 2015-16
Correct as at July 2014
Prospective tenderers are encouraged to check the Department of Health’s
latest Annual Procurement Plan on the AusTender website for any updates to
the proposed procurement schedule since the time of publication.
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APPENDIX B National Health (Immunisation Program – Designated Vaccines)
Determination 2012 (No.1)
National Health (Immunisation Program – Designated Vaccines)
Determination 2012 (No. 1)
27
APPENDIX C Pharmaceutical Benefits Advisory Committee (PBAC) Process
Overview of process for the listing of a vaccine on the NIP
There is a legislative requirement for all vaccines provided under the NIP or
the Pharmaceutical Benefits Scheme (PBS) to undergo a thorough and
objective assessment process. The initial step is the requirement under the
Therapeutic Goods Act 1989 that medical products to be imported into or
supplied in Australia be included in the Australian Register of Therapeutic
Goods (ARTG).
In order for a product to be included in the ARTG, a sponsoring company is
required to make an application accompanied by data to support the quality,
safety and efficacy of the product for its intended use.
Australia has a number of agreements with
other countries relating to mutual
recognition
of therapeutic agents including the recognition
of Good
Manufacturing Practice compliance. If vaccines have already received
approval from the European Medicines Agency and the U.S. Food and Drug
Administration the TGA requirements for the approval process in Australia are
shortened.
Once a vaccine is registered by the TGA, the vaccine sponsor can make an
application to the PBAC to list the vaccine on either the PBS and/ or the NIP
schedule. The vaccine sponsor can seek pre-submission technical advice
from the ATAGI on matters relating to the strength of evidence of safety and
effectiveness of vaccines and use in Australian populations, taking into
account the epidemiology of the disease. A flow diagram of this process is
outlined below.
The PBAC’s Economic Sub-Committee reviews and interprets economic
analyses, advises the PBAC
on these analyses and on the technical
aspects
of requiring and using economic evaluations.
The PBAC considers the clinical and economic data in the application to
determine whether the use of the vaccine will provide value for taxpayers’
money.
Once a vaccine has been recommended by PBAC, a number of processes
need to be completed before the medicine can be listed on the NIP. These
include:
•
consideration by the Pharmaceutical Benefits Pricing Authority (PBPA);
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•
pricing negotiations between the manufacturer and the Department of
Health;
•
finalisation of the details for listing the vaccine on the NIP;
•
quality and availability checks; and
•
consideration by Government for funding.
The role for the PBPA in vaccine assessment is
to ensure there is a reliable
supply of vaccine at
the most reasonable cost to Australian taxpayers and
consumers. The PBPA recommends prices
for new items which then
becomes the Nationally Negotiated Price (NNP) of the vaccine. Companies
can also apply to the PBPA for a review of the NNP.
All PBAC recommendations are considered by Government.
Following agreement to funding by Government, the Department of Health
progresses implementation of the new vaccine on the NIP. Activities may
include:
•
addition of vaccine to the Australian Childhood Immunisation Register
(ACIR);
•
implementation planning with states and territories;
•
procurement of vaccine;
•
communication activities; and
•
legislative changes to the National Health (Immunisation Program –
Designated Vaccines) Determination 2012 (No.1) made pursuant to
section 9B of the National Health Act 1953 (the Determination)
The timeframe for implementing a vaccine on the NIP following Government
allocation of funding will depend on progressing all these activities. Health will
meet with industry to discuss supply and potential timeframes soon after a
Government decision is announced.
As a result of the national procurement being undertaken by the
Commonwealth, a vaccine may be listed on the Determination, but where
there are a range of potential vaccines for a specific schedule point, there is
no guarantee that a listed vaccine will be successful in an RFT process.
A vaccine safety plan will be developed for each new vaccine added to the
NIP. Technical input and advice will be sought from the Advisory Committee
on the Safety of Vaccines (ACSOV).
29
It is anticipated that, during the life of the procurement strategy new vaccines
may be added to the NIP and others possibly removed.
30
APPENDIX D National Immunisation Program (NIP) Schedule
The current National Immunisation Program (NIP) Schedule from 1 July 2013,
outlines the recommended vaccines by age group, which is funded by the
Immunise Australia Program. States and territories may choose whatever
combination of vaccines from those listed on the Determination as best suits
the needs of geographic and demographic conditions.
More information can be found at the Immunise Australia Program website.
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APPENDIX E Performance Indicators for the NPEV
The reward payment will be paid if a State has met two of the following
performance benchmarks:
Performance Benchmark
Measurement and Reporting
1. Maintaining or increasing
vaccination coverage for
Indigenous Australians;
The proportion of Indigenous
Australian children reported as fully
immunised
as defined in the
Australian Childhood Immunisation
Register (ACIR) at 12 ≤ 15 months,
24 ≤ 27 months and 60 ≤ 63 months
of age.
2. Maintaining or increasing
coverage in agreed areas of low
vaccination coverage;
Immunisation coverage rates in
agreed areas where there is more
than 5 % below national annual
average for 12 ≤ 15 months and 60 ≤
63 months of age.
3. Maintaining or decreasing
wastage and leakage; and
Number of National Immunisation
Program (NIP) vaccines lost to
wastage and leakage divided by the
total number of NIP vaccines
distributed.
4. Maintaining or increasing
Proportion of Australian children
vaccination coverage for four year reported as fully immunised as
olds.
defined in the ACIR at 60 ≤ 63
months of age.
Immunise Australia Program Website
All information in this publication is correct as at July 2014.
10871 July 2014
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