Decision to list medical devices

Hospital devices

Decision

We are pleased to announce the approval of listing agreements for medical devices with Gallay Medical & Scientific NZ Pty Limited, Intermed Medical Limited, Jackson Allison Medical & Surgical Limited and Universal Specialities Limited.

What we are doing

We are pleased to announce the approval of listing agreements for medical devices with the following suppliers:

Supplier

Category of medical device

Gallay Medical & Scientific NZ Pty Limited (“Gallay”)

  • Patient warming and cooling

Intermed Medical Limited (“Intermed”)

  • Non-invasive ventilation
  • Patient warming and cooling
  • Surgical suction, chest and wound drainage

Jackson Allison Medical & Surgical Limited (“Jackson Allison”)

  • Non-invasive ventilation
  • Patient warming and cooling
  • Surgical suction, chest and wound drainage

Universal Specialities Limited (“USL”)

  • Patient warming and cooling
  • Respiratory equipment and consumables (“respiratory care products”)
  • Surgical suction, chest and wound drainage

In summary this will result in:

  • Medical devices, from the suppliers and in the categories listed above, being listed on the Pharmaceutical Schedule from 1 May 2019 under individual national agreements that all DHBs may purchase under (“Agreements”).
  • DHBs continuing to be able to purchase other suppliers’ brands of medical devices in non-invasive ventilation, patient warming and cooling, respiratory equipment and consumables (“respiratory care products”) and surgical suction, chest and wound drainage products categories.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 11 March 2019.

During consultation:

  • it was identified that product warranty details had been omitted from the agreement with Intermed;
  • it was identified that the agreement with Jackson Allison included product codes that were included in multiple categories and one patient warming product is no longer available; and
  • USL requested an amendment to its pricing model.  
All three agreements were amended to reflect these changes.

Who we think will be most interested

  • Suppliers and Wholesalers
  • DHB Staff:
    • Anaesthetists and Anaesthetic Technicians
    • Clinical engineers
    • Clinical staff involved with airway management and emergency respiratory resuscitation
    • ICU clinicians
    • Perioperative staff
    • Procurement and supply chain personnel
    • Pulmonary function specialists
    • Pulmonary rehabilitation specialists
    • Respiratory clinicians
    • Respiratory therapists
    • Sleep therapy clinicians
    • Surgical and general ward staff
  • Patients with chronic obstructive pulmonary disease, sleep apnoea or degenerative disorders requiring ongoing ventilation

Detail about this decision

In 2017 and 2018 PHARMAC issued Requests for Proposals (“RFPs") for:

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

After completing the RFP evaluation processes and consulting on the provisional Agreements reached with Gallay, Intermed, Jackson Allison and USL PHARMAC has decided to list the medical devices in Part III of Section H of the Pharmaceutical Schedule from 1 May 2019.

The list of products will be available on PHARMAC's website from 1 April 2019, in both a PDF document and an Excel spreadsheet.

DHBs that purchase medical devices in these categories from the suppliers listed above must do so under the terms and conditions, and at the prices included in the Agreements, from 1 May 2019. DHBs can continue to choose which non-invasive ventilation, patient warming and cooling products, respiratory care products and surgical suction products they purchase.

The Agreements include terms and conditions for training and education to be provided by the suppliers on the appropriate use and maintenance of their products, which is to be provided at times as agreed with individual DHBs.

Our response to what you told us

We appreciate the time people took to respond to this consultation.

A summary of the main themes raised in feedback and our responses to the feedback received are set out below:

Theme

PHARMAC comment

No technical or resource impacts anticipated for Ministry of Health.

Noted.

Request for update on the progress of contract negotiation for a supplier whose proposal was successful to progress to contract negotiation.

Clarification that these suppliers are in addition to suppliers that have already been notified.

PHARMAC is in negotiation with a number of suppliers for the categories included in the consultation and is expecting to consult on further provisional agreements in the coming months. These suppliers are in addition to suppliers that have previously been notified.

Information included in the consultation is insufficient to provide feedback on the adequacy of the products. It was unclear whether multiple suppliers will be involved or whether this is a sole supply arrangement as it is important that a full range of products is available.

The proposal is not for sole supply and PHARMAC is in negotiation with a number of suppliers in each category. PHARMAC is aware of the need to ensure that a range of products are available for clinicians to select from. 

 

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.