This Supplementary Order Paper amends the Therapeutic Products Bill to extend the maximum periods for which temporary authorisations for medical devices and temporary licences to undertake activities with medical devices remain valid.

The purpose of these changes is to extend the period of time that the new Therapeutic Products Regulator will have to process and make decisions on applications for medical devices that are currently in the market. The time frames that are currently in the Bill significantly underestimate how long this is likely to take a brand new Regulator navigating a brand new and extensive piece of legislation. For example, the Bill currently contemplates the Regulator being able to assess and make decisions about all in vitro diagnostic medical devices that are—

• currently supplied to consumers (for example, pregnancy tests retailed in pharmacies and supermarkets):

• currently used in laboratories (for example, the equipment, reagents, and consumables used to screen for cancer, test for HIV, and identify blood types)—

within six months of the Bill coming into force. This time frame is patently unachievable and will need to be extended.

While the Bill allows regulations to be passed to extend the transitional time frames, in order to achieve an “orderly transition” from the Medicines Act 1981 to the Bill, those time frames should be extended in the primary legislation, and not be left to secondary legislation. Waiting to be see if regulations are passed will result in significant uncertainty for medical device businesses, retailers, laboratories, healthcare providers, and practitioners. This uncertainty may lead to disruptions to the supply of medical devices (including some, such as pregnancy tests, that New Zealanders tend to regard as basic consumer goods), and threaten patient access and care. This threat may be significant—especially where there are disruptions to the supply of medical devices that are—

• designed to save or sustain lives or diagnose life-threatening conditions); and

• have no substitutes.

There was serious disruption to the EU medical device market when new medical device regulation was introduced in 2021. Although the new EU regulations were much narrower in scope than those proposed in the Bill and were being implemented by an established, experienced regulator, the changes had a significant and negative effect on the market, resulting in suppliers withdrawing devices. There were concerns that up to 75% of medical devices in some countries covered or affected by the new regulations were at risk of becoming unavailable. New Zealand should learn from examples like this and ensure that the transition from the Medicines Act to the Therapeutic Products Bill is as orderly, certain, and predictable as possible. Such a transition requires the new Regulator to have reasonable time frames in which to assess product currently in the market and for industry to have confidence that those time frames are achievable.