Consultation questions and responses

How are contracted and uncontracted items on the devices list different?

• We are adding hospital medical devices to the Hospital Medical Devices List (on the Pharmaceutical Schedule) and will continue to negotiate contracts as we go. 
• Health New Zealand hospitals’ preference will be to purchase products with contracted terms for pricing and supply chain security so having a contract in place would be more advantageous to suppliers.
• Non-contracted items will be listed without a price.
• You can view our website to see which categories have been contracted and which categories are yet to contracted. 

What it means to be on the Health System Catalogue (HSC) versus the Pharmac list 

• The HSC is a standardised information set that records all items a supplier markets in New Zealand, and the Pharmaceutical Schedule describes what products are funded and used by public hospitals. Pharmac makes use of the HSC and encourages suppliers to participate in this work. 
• The HSC will make providing information to Pharmac easier, as we use it as a reference point for product level information. 
• For example, those suppliers that had information in the HSC prior to the consultation only needed to provide us the product codes, GTINs and level of sales for this consultation, and we could source all other product information from the HSC. We expect to make use of the HSC more and more as a reference source for product details, allowing more efficient exchange of information with suppliers. 

How will data be connected between Pharmac and Health NZ

(such as Financial, Procurement, and Information Management (FPIM), HSC)

• The Pharmac list reflects what will be available for Health NZ to purchase. We share our listing information regularly with Health NZ, and it is integrated into Health NZ’s finance system to support purchasing activity.

What are Global Trade Item Numbers (GTINs)

• GTINs are globally unique identifiers used to identify products, including medical devices, in a standardised way. They are part of the GS1 system of standards, which is widely used in healthcare to improve supply chain efficiency, traceability, and patient safety. GTINs are a key requirement for:
• • Product identification in the health and disability system
  • Listing on the Pharmaceutical Schedule (as managed by Pharmac)
  • Compliance with Health NZ’s supply chain standards.
• Pharmac can, for now, list items on the Pharmaceutical Schedule without GTINs as there are still some items that don’t easily fit with the data standards (e.g. custom products).
• Our preference is that all items that can have GTINs should have them, and over 70% of items on the Schedule currently have GTINs.
• You can find more information or start the registration process at GS1 New Zealand’s website(external link) or follow up with Health NZ. 

Do all sizes of a range need to included even if they haven’t got sales

• This consultation focused on what has been in use by hospitals during the last two years. 
• Pharmac’s contract process would consider the broader context of your portfolio (i.e. range extensions and other additional items can be considered for listing as part of contracting with us). 
• Suppliers who already have relevant medical device agreements with Pharmac can apply to have their range extensions listed through their Pharmac contract manager at any time. We would want to understand the benefits the wider range could provide and the commercial implications.  

What are the medical devices in scope for Pharmac

• We use the term ‘medical devices’ to cover a range of things that are used by public hospitals or provided by a hospital service for people to use at home.
• Medical devices are products, equipment and consumables that are used to diagnose, monitor, treat, modify, prevent or support a health need.
• This includes things like clinical diagnostic instruments, implants (such as pacemakers), hospital beds, software, robotic surgery machines, surgical products and more. Items such as bandages, continence support products and rehabilitation equipment are also included. 

How the list will be maintained

• The list of hospital medical devices within the Pharmaceutical Schedule is updated monthly. This work includes updates and changes to product details, listing additional devices and removing items no longer in use.
• Around 60,000 changes to the list were made in the last 12 months (this does not include the non-contracted listings), and there are established processes for managing changes relating to contracted products.
• We are building on the above, with the addition of the non-contracted items. Further processes are being developed and we are planning to consult more on this in the coming months. 

How will a ‘closed list’ environment work?

(including the importance for transparent assessment processes for adding/removing listed devices which gives appropriate clinical input)

• Once the comprehensive list is live on 1 July 2025 we will continue to progress the medical device programme and work towards a future where there is a single national list from which public hospitals will select their medical devices. 
• This single national list will clearly set out what is available for use in public hospitals, ensuring consistent access, reduce duplication, and promoting equity.
• We have sometimes referred to this as a 'closed list' to describe moving the list to a more controlled environment for the devices used by Health NZ. This list will be regularly monitored and reviewed to ensure it meets the needs of patients, consumers and the sector, while also supporting cost management. 
• This national list will always be dynamic and updated to reflect changes in medical technology and evolving public needs.
• We will need to implement new procedures for receiving and assessing requests for new medical device technology, obtaining expert advice, and managing applications, exceptions, and the ongoing monitoring of purchasing activities.
• Importantly, we will not move to this ‘closed list’ environment until the above policies and processes have been established. This developmental work will happen in close collaboration with all key stakeholders, with clear milestones and timelines in place to ensure all operational and regulatory requirements are met.

Suppliers awaiting responses to previous Pharmac RFP processes 

• We expect to continue to engage with suppliers where we know there are gaps.

Concern about the health and safety of the use of some devices

• Medsafe is the medicines and medical device regulator. Any questions or concerns relating to the safety of a device should be raised with Medsafe.
• Medical devices need to be WAND notified to be able to sell into NZ. NZ representation requirements will be dependent on the type of tech and their associated support requirements.
• We are aware that Health NZ have their own internal processes for reporting safety issues or concerns.

How were the relevant key agencies and users included in the consultation

• We undertook a broad range of communications. This included sending information to key contacts within Health NZ and Ministry of Health, emailing our list of professional healthcare and consumer advocacy groups. Hosting a webinar and emailing suppliers, and updates into Device Advice, our bi-monthly online newsletter.
• We encouraged people we shared the consultation with to share it any other stakeholders that may be interested that we may have missed.

We also received and responded to all the questions that were specific to individual supplier products, or questions related to a parallel contracting process we were undertaking with suppliers. We believe we have now answered all queries, however if you have not yet had a response, please email devices@pharmac.govt.nz.