Decision to list medical devices supplied by Obex Medical Limited

Hospital devices Decision

We are pleased to announce the approval of a listing agreement for the supply of medical devices to DHBs.

What we’re doing

We are pleased to announce the approval of a listing agreement with Obex Medical Limited (“Obex”) for the supply of:

In summary this will result in:

  • Obex’s medical devices, in the categories above, being listed in Part III of Section H of the Pharmaceutical Schedule from 1 November 2021 under a national agreement that all DHBs may purchase under (“Agreement”); and
  • DHBs being able to continue to purchase other suppliers’ brands of surgical drapes, gowns and procedure packs, and cardiac heart valves and accessories as the Agreement is not for sole supply.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 20 September 2021.

No changes were made to the original proposal as a result of consultation feedback.

Who we think will be most interested

  • Suppliers and wholesalers
  • DHB clinical staff in a range of clinical settings including:
    • Cardiac Service Managers
    • Cardiac Surgeons
    • Cardiologists
    • central sterile services personnel
    • general wards
    • infection control
    • perioperative
  • DHB procurement and supply chain personnel

Details about this decision

The decision results from two parallel processes. One for surgical drapes, gowns and procedure packs, and the other for cardiac heart valves.

Surgical drapes, gowns, and procedure packs

In 2018 PHARMAC issued a Request for Proposal (“RFPs”) for the supply of single-use sterile surgical drapes, gowns and procedure packs.

The RFP was for non-exclusive national agreements for listing in the Pharmaceutical Schedule.

After completing the RFP evaluation process, and consulting on the provisional Agreement reached with Obex, Pharmac has decided to list Obex’s surgical drapes, gowns and procedure packs in Part III of Section H of the Pharmaceutical Schedule from 1 November 2021.

Heart valves

In parallel, and in coordination with Pharmac, NZ Health Partnerships (“NZHP”) has previously released Requests for Proposals (“RFPs”) for ranges of medical devices which Pharmac may list on the Pharmaceutical Schedule. NZHP released an RFP for cardiac heart valves in December 2018 and Obex entered an agreement with NZHP via this process.

In February 2021 Pharmac issued a Registration of Interest (“ROI”) for cardiac heart valves and accessories to transfer responsibility for management of the medical devices from NZHP to Pharmac.

The Agreement between Pharmac and Obex for cardiac heart valves and accessories was based on the agreement between NZHP and Obex. As there were no material changes made to the terms and conditions that are currently in place Pharmac decided that consultation on the provisional Agreement was not required, and has decided to list cardiac heart valves and accessories in Part III of Section H of the Pharmaceutical Schedule from 1 November 2021.

The list of products will be available on PHARMAC's website from 1 November 2021, in both PDF and Excel formats.

DHBs can continue to choose which surgical drapes, gowns and procedure packs, and cardiac heart valves and accessories they purchase, including those from other suppliers. DHBs that purchase these medical devices from Obex, must do so under the terms and conditions, including pricing, in the Agreement, from 1 November 2021.

The Agreement includes terms and conditions for training and education to be provided by Obex on the appropriate use of its 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 are set out below:

Theme

Comment

No technical or resource impacts anticipated as a result of the proposal.

Noted.

Supports the proposal and endorses that the agreement is not for sole supply. Noted their expectation that training would be provided for any new product that may be introduced.

Noted

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.