Proposal to list medical devices supplied by Ivoclar Vivadent Limited

Hospital devices Consultation Closes 07 Feb

Pharmac is seeking feedback on a proposal to list a range of medical devices in Part III of Section H of the Pharmaceutical Schedule.

What we’re proposing

Pharmac is seeking feedback on a proposal to list medical devices supplied by Ivoclar Vivadent Limited (“Ivoclar Vivadent”) in Part III of Section H of the Pharmaceutical Schedule from 1 March 2023.

We propose to list medical devices supplied in the following categories:

Consultation closes at 4pm Tuesday 7 February 2023 and feedback can be emailed to adyam.markos@pharmac.govt.nz.

What would the effect be?

From 1 March 2023 the above medical devices would be listed under proposed national agreements for all Te Whatu Ora Hospitals to purchase under, subject to consultation and approval by Pharmac’s Board or delegate (“Agreements”).

The Agreements would not be for sole supply and Te Whatu Ora Hospitals can continue to purchase other suppliers’ brands of dental and oral health products and sterilisation and decontamination equipment and associated consumables.

The Agreements would supersede any existing Te Whatu Ora agreements with Ivoclar Vivadent, for products included in the Agreements. Any products listed in the Agreements and purchased by a Te Whatu Ora would be in accordance with the terms and conditions, including price, stated in the Agreements effective from the date of listing in the Pharmaceutical Schedule.

As part of the Agreements Ivoclar Vivadent would provide appropriate training and education services that would be tailored to the individual needs of Te Whatu Ora Hospitals, in formats and at times as required by Te Whatu Ora Hospitals.

Pricing for the medical devices in the Agreements, subject to any prior termination, would not be increased without prior consultation and approval by Pharmac.

Who we think will be interested

Dental and oral health

  • Te Whatu Ora staff including but not limited to:
    • Dental Hubs
    • Mobile Schools
    • Clinicians
    • Community Dental Clinics
    • Orthodontists
  • Suppliers and wholesalers

Sterilisation and decontamination equipment and associated consumables (SDEAC)

  • Te Whatu Ora Staff including but not limited to:
    • Sterile services department
    • Infection control department
    • Occupational health and safety department
    • Procurement and supply chain department
    • Facilities and support services department
    • Biomedical engineers (potentially involved in the validation process / outsourced)
    • Dental units
    • Theatre staff
    • General ward staff
  • Professional bodies’
    • NZNO
    • Sterile Services Association NZ
  • Equipment validation service providers
  • Suppliers and wholesalers

About the medical devices

Dental and oral health

The dental and oral health category includes medical devices used in dental settings in Te Whatu Ora hospitals for the management of dental and oral health.

Sterilisation and decontamination equipment and associated consumables (SDEAC)

The SDEAC are utilised by Te Whatu Ora Hospitals and other healthcare services, where devices need to be reprocessed for re-circulation, decontamination, or sterilisation.

Why we’re proposing this

In September 2019 Pharmac issued a Request for Proposals (“RFP”) for the supply of dental and oral health products.

In August 2021 Pharmac issued a Request for Proposals (“RFP”) for the supply of sterilisation and decontamination equipment and associated consumables.

The RFPs were for non-exclusive national agreements for listing on the Pharmaceutical Schedule.

Pharmac has been working with suppliers who responded to the RFPs, and proposals were progressed to contract negotiations, to seek provisional agreements.

This proposal is the latest to arise from these processes and we expect to consult on further provisional agreements with the suppliers of dental and oral health products and sterilisation and decontamination equipment and associated consumables throughout 2023.

Details about our proposal

Pharmac has entered into a provisional agreement with Ivoclar Vivadent for the supply of dental and oral health products and SDEAC.

The proposal would result in listing 3746 medical devices in the Pharmaceutical Schedule covering the following product ranges:

Category

Line items

Brands

Dental and oral health products

3736

Accudent, Adhese Universal, Amalcap, Equipment Consumable, Astropol, Bluephase, Ivoclar, Cention, Cervitec, Detax, DryShield, Bimssteinpulver, Poliresin, IPS Empress Direct, Fusion, ExciTE F, Freeprint, Composi-Tight, PerForm, FitStrip, A+Wedge, BlueView, ReelMatrix, WedgeWands, Slick Bands, Garrison, FenderWedge, SoftWedge, Heliomolar, Helioseal, IPS e.max CAD

SDEAC

10

W&H and Data Logic

Further information, including pricing and contractual details, has been provided to Te Whatu Ora Procurement personnel. Clinicians interested in further detail on what this change means for their Te Whatu Ora Hospital should engage with their Procurement teams.

To provide feedback

Send us an email: adyam.markos@pharmac.govt.nz by 4pm 7 February 2023.

All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on this proposal.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.