Therapeutic Products Bill

Members, we come now to Part 10. This is the debate on clauses 363 to 382, “Administrative matters”. The question is—

💬 Camilla Belich: Point of order. I seek leave for all provisions to be taken as one question.

CHAIRPERSON (Greg O’Connor): Leave is sought. Is there any objection? There is objection. The question is that Part 10 stand part. I call the Hon Gerry Brownlee.

💬 Hon Gerry Brownlee: I am leaving.

CHAIRPERSON (Greg O’Connor): It was an impressive entry.

💬 Chris Penk: Point of order. Just to point out, I think that’s what you call an involuntary withdrawal and apology.

CHAIRPERSON (Greg O’Connor): We’ll bank it.

Thank you, Mr Chair. I wish to speak to a Supplementary Order Paper in my name, number 381. I think it’s really important that we don’t try and recreate the wheel. You know, there’s a lot of information that’s held by international regulators, very well respected international regulators that have already done essentially what New Zealand is aiming to do. We have very safe products found throughout the world in jurisdictions quite similar to ours that already have regulators. I think it’s important that we have the ability for our regulator to use information that other regulators hold, and to be able to adopt that, rather than having to go through the process of using new information in New Zealand that will end up getting you to the exact same place.

So my amendment is about inserting a clause, after clause 379, saying that “An exemption may be granted in reliance, in whole or in part, on the report, assessments, or decision made by, or information received from, an entity designated under section 346." A lot of information is stored internationally about medicines and devices and products that are already highly regulated throughout the world. Why do we need to impose more cost, more time, more resource on getting to the exact same point? Wouldn’t it be easier if we could make sure that we can be guaranteed that information that’s trusted internationally can be considered by this regulator to grant an exemption? That means we have less delay for new technology. We have less uncertainty about whether or not a product would get an exemption under this regulator and law, and make it easier for people to have access to products that benefit their health. Thank you, Mr Chair.

Thank you, Mr Chair. Of course it is already the case that New Zealand’s medicine regulator Medsafe relies on the decisions of overseas regulators in about 50 percent of the approvals that it makes. It’s certainly not the case that everything begins afresh when medicine that’s well established and authorised by trusted regulators seeks authorisation in New Zealand. In fact, that approach is already taken in this bill: clause 346 provides the regulator with a general ability to rely on the decisions of designated entities in evaluating a therapeutic product or making a decision under this bill, and that is why the Government does not support Supplementary Order Paper 381.

Dr Shane Reti’s amendments to clauses 363 and 364 of Supplementary Order Paper 368 set out on Supplementary Order Paper 384 are out of order as being inconsistent with a previous decision of the committee.

The question is that the Minister’s amendments to Part 10 set out on Supplementary Order Paper 368 be agreed to.

The question is that Brooke van Velden’s amendment set out on Supplementary Order Paper 381 be agreed to.