RFP - Supply of orthopaedic implants and associated products - Deadline extended to 24 June 2016

Hospital devices

RFP Closed

PHARMAC invites proposals for the supply of orthopaedic implants and associated products to DHB hospitals in New Zealand.

Answers to questions will be provided through the Government Electronic Tenders Service (GETS). PHARMAC will also post any addenda through GETS. We encourage interested suppliers to register with GETS and subscribe to this RFP to be kept up to date.

This request for proposals (RFP) letter incorporates the following schedules:

RFP - Supply of orthopaedic implants and associated products [PDF, 170 KB]

All proposals must be submitted to PHARMAC via the Government Electronic Tenders Service (GETS) (www.gets.govt.nz(external link)) no later than 5.00 p.m. on 24 June 2016.

If you have any questions about this RFP, please post these on GETS or alternatively contact Maree Hodgson (Device Category Manager) by email maree.hodgson@pharmac.govt.nz at PHARMAC.

Schedule 1: Medical Devices, background to RFP and types of proposals sought

  1. Medical Devices

    PHARMAC is interested in considering any proposal from suppliers of orthopaedic implants and associated products used in the repair or replacement of bones that have been damaged through injury or disease.
  2. Background to RFP

    The background to this RFP is as follows:

1. PHARMAC’s involvement with orthopaedic implants

As a result of initial consultations and sector discussions, and taking into account the 2013 status of national contracts in orthopaedic implants under Health Benefits Limited, PHARMAC focused initial work in orthopaedic implants in the trauma, spine and craniomaxillofacial (CMF) sub-specialties to expand the suite of national contracts in those areas. There were also recently negotiated contracts in place for hip and knee implants with two rights of renewal through to April 2017 that offered savings to DHBs.
As PHARMAC has progressed work with the trauma, spine and CMF sub-categories several issues have become clear:

  • there is a degree of overlap of both products and suppliers in many of the orthopaedic implant sub-category areas;
  • CMF implant procedures are primarily undertaken by maxillofacial and plastic surgeons and although they are used in bone replacement/augmentation and generally have the same supplier network, these also require clinical input from areas other than orthopaedic specialists;
  • multiple agency involvement within the various sub-categories has led to a degree of sector confusion;
  • usage data is reported inconsistently;
  • scope of the orthopaedic implant category needs to consider the inclusion of associated instruments and consumables essential for the use of the implants; and
  • with current hip and knee contracts due to expire in April 2017 and many other areas without contracts it is timely to look at the entire category.

2. Reasons for running the RFP

PHARMAC has been asked to take a greater role in medical devices. Orthopaedic implants make up a large proportion of the medical device market and the need for intervention with orthopaedic implants, with our ageing population and other health and activity factors, is growing.

In order to resolve some of the issues outlined in 2 (a) above, PHARMAC proposes to enter into national contracts for all orthopaedic implants currently used in New Zealand. This should provide clarity for suppliers, health professionals and other stakeholders involved with the supply, distribution and purchase of orthopaedic implants as well as simplify the contractual arrangements for all parties.

As a result of this RFP process, we expect to enter into national contracts for all orthopaedic implants and associated products by the end of April 2017. This timeframe should allow sufficient time for the expiry of any non-PHARMAC contracts (eg hip and knee implants) and allow smooth transition to any new national contracts with PHARMAC.

3. Impact of RFP on current national contracts

As part of its work, to date, PHARMAC has entered into one agreement relating to spine, trauma and CMF products with Stryker. Current listing arrangements with PHARMAC for orthopaedic implants or associated products would not be affected by this RFP unless superseded by a further arrangement with the supplier in question. This RFP does not offer any exclusivity for the supply of orthopaedic implants or associated products in DHB hospitals.

Suppliers who currently have their orthopaedic implants listed in Part III of Section H of the Pharmaceutical Schedule may choose to submit additional proposals via the RFP to amend their current agreement, to extend their product ranges or submit an entirely new proposal for consideration.

3. Expected outcome of the RFP

4. Types of proposals sought

Schedule 2: RFP process

PHARMAC expects to follow the process set out below in the sequence indicated.

1. Submission

  1. You may submit more than one proposal. Each proposal will be considered as a separate proposal.
  2. All proposals must be submitted to PHARMAC via GETS no later than 5pm (New Zealand time) on 24 June 2016. Late proposals will only be considered at PHARMAC’s discretion, taking into account the need for fairness to other suppliers and integrity of the RFP process.
  3. You cannot withdraw your proposal, once submitted, while the RFP process is continuing.
  4. If you have any enquiries about this RFP you should submit them on GETS or alternatively contact Maree Hodgson (maree.hodgson@pharmac.govt.nz).

2. Evaluation

3. PHARMAC may request further information

4. Negotiation

  1. PHARMAC may negotiate with the suppliers of one or more preferred proposals, in the latter case whether or not the acceptance of either supplier’s proposal would exclude acceptance of the other proposal.
  2. Negotiations will proceed on the basis that PHARMAC’s standard terms and conditions for supply of medical devices, which are available from GETS, will apply.
  3. Given that PHARMAC expects your proposal to be the best you can offer, PHARMAC does not intend to initiate negotiation with you on price. However, PHARMAC does not exclude the possibility that the final price agreed will be different from the price put forward in your proposal, as a result of the impact that other negotiated terms may have on price.
  4. PHARMAC may negotiate and enter into a provisional agreement with a preferred supplier(s) on whatever special terms, in addition to PHARMAC’s standard terms and conditions, PHARMAC considers appropriate.
  5. If PHARMAC and the supplier(s) are unable to reach a provisional agreement within what PHARMAC considers being a reasonable time, PHARMAC may terminate those negotiations and negotiate with a different supplier(s).

5. Consultation and approval

6. Miscellaneous

7. Anticipated timetable

Following receipt of proposals, PHARMAC anticipates:

  1. the Evaluation Committee evaluating proposals from13 June – July 2016;
  2. negotiating with submitter(s) of one or more preferred proposals in August – September 2016;
  3. consulting on provisional agreement(s) from October 2016;
  4. PHARMAC’s Board, or the Board’s delegate, considering provisional agreements for approval in or after November 2016; and
  5. orthopaedic implants and associated products being listed as agreements are approved, and that all agreements would be finalised for 1 April 2017 listing,

provided that the above timeframes are only approximate and may be extended, without notice being required from PHARMAC, if any stages of the RFP process take longer than anticipated.

8. Governing Law

This RFP is governed by New Zealand law, and the New Zealand courts have exclusive jurisdiction in all matters relating to this RFP.

Schedule 3: Information to be included in your proposal

Requirement

Evidence requirement is met

Response

All products must be WAND registered

WAND registration number must be provided as per the format in Attachment 1.

Mandatory

International compliance

Evidence of international compliance certificates must be provided.

Mandatory

DHB current usage data

Provide usage and current pricing information by DHB for the period

1 April 2015 – 31 March 2016 for all line items submitted.

Mandatory

Current contract status

Provide information on active DHB hospital contracts with expiry date.

Mandatory

Impact analysis of your proposal

Provide financial impact analysis of your proposal for DHBs based on current usage patterns.

Mandatory where DHBs are currently using your products

Supply chain arrangements you would have in place to support NZ market requirements

Information relating to continuity of supply of products in New Zealand. This should include information on:

  • distribution arrangements and stockholding in New Zealand;
  • minimum order size;
  • delivery frequency and lead times for:
    • a stable demand situation;
    • in the event of supply disruptions; and
    • when there is an unexpected surge in demand for your product.

Please include any specific measures you will take to secure stock for New Zealand from international production.

Mandatory

Consignment stock arrangements you would have in place to support NZ market requirements

  1. Describe your current consignment stock management system including but not limited to;
    • risk and liability arrangements;
    • responsibility for stock management; and
    • auditing arrangements.
  2. Provide information relating to current arrangements with DHBs in regard to consignment products and associated instruments, and cost of consignment held at each DHB, as per schedule 4, table 1 if you are currently providing this service.
    OR where not currently providing this service
    Provide information relating to your ability to support consignment products and associated instruments if a DHB hospital required that service.

Mandatory

Change management process

Detailed plan to support DHBs during any product swap out. Provide details of the process you would follow to support a DHB if they were interested in changing to your product range, including but not limited to:

  • establishing requirements;
  • timelines for change;
  • forecasting to meet increased demands; and
  • training & education provided.

Mandatory

Gs1 status

Provide GTIN codes for items.

Desirable

UNSPSC

Provide UNSPSC codes for items.

Desirable

Does the manufacturer operate a waste reduction policy? Is there a recycling process for their products in New Zealand?

Please give details.

Desirable

NB Mandatory response requirements: Where provision of a response to a requirement is indicated as mandatory in the above table a response to that requirement must be submitted, otherwise the proposal will not be able to be considered.

Schedule 4: Proposal form

An electronic version of this form is available on PHARMAC’s website at www.pharmac.govt.nz and on GETS (www.gets.govt.nz(external link)). You should expand the boxes as necessary.

[Supplier to insert date]

Director of Operations
PHARMAC
C/- Maree Hodgson
Device Category Manager

By electronic transfer using GETS (www.gets.govt.nz)

Dear Sir/Madam

Proposal for the supply of orthopaedic implants and associated products

In response to your request for proposals (RFP) dated 29 April 2016 we put forward the following proposal in respect of orthopaedic implants and associated products.

You must also include information as outlined in Schedule 3 and Attachment 1 (Excel document) as part of your proposal.

Set out below is further information in support of our proposal.

(a) Our contact details:

Full legal trading name in NZ

 

Key Contact person

 

Address

 

Phone

 

Facsimile

 

Email address

 

(b) Key features of our proposal and associated services available:

(c) Information relating to pricing ($NZ, GST exclusive), including any related conditions or proposed terms affecting cost for DHBs (e.g. reference price protection, risk sharing mechanisms, etc.):

(d) Evidence of market approval and any other required consents:

WAND registration details supplied against line items in Attachment 1

[yes/no]

TGA/FDA/CE details supplied against line items in Attachment 1

[yes/no]

(e) Information about our ability to ensure the continuity of supply of the medical devices:

(f) Information about our previous supply performance and relevant expertise including our overseas market (nb: site references show which products are supplied to these sites, and referees are available to contact):

(g) Proposals/suggestions (e.g. pricing, risk sharing arrangements, etc) regarding the medical device not expressly identified in this RFP that we would like PHARMAC to consider as part of our proposal: 

(h) Reasons why PHARMAC should accept our proposal:

(i) Additional information that PHARMAC should consider when evaluating our proposal:

(j) Consignment stock information for current service provision, if applicable:

Table 1

DHB DHB hospital/locations where stock is held Description of each consignment set held Number of each set held Current value of each set held New value of each set held based on proposal Annual spend on replenishment of each consignment set per DHB 1 April 2015 – 31 March 2016 Storage provisions provided with sets (trolleys, shelving etc) Weight of individual trays in Kilograms (Kg) Stocktake process and timings (staff involved) Requirements review process and staff positions involved – DHB signing authority Date requirements were last reviewed

[DHB name in full]