Verrall AyeshaThird ReadingHon Dr AYESHA VERRALL (Minister of Health): I present a legislative statement on the Therapeutic Products Bill.SPEAKER: That legislative statement is published under the authority of the House and can be found on the Parliament website.Hon Dr AYESHA VERRALL: I move That the Therapeutic Products Bill be now read a third time.This is a very important day for the future of the New Zealand health system. The Therapeutic Products Bill will introduce a new comprehensive regime to regulate therapeutic products in New Zealand. As well as replacing and modernising the existing regulatory arrangements for medicines it provides a fit for purpose regulation of medical devices—innovative products such as cell gene and tissue therapies that are currently not fully regulated. The bill also covers natural health products and these products will have their own regulations under the bill. It is very important to me having gone through the COVID pandemic to ensure that the regulation is flexible enough to support innovation while ensuring that effective control over quickly evolving health technologies is in place. The bill also aligns with international standards to uphold the standard quality of regulation currently carried out by Manatū Hauora. The bill will ensure the safe use of products used in healthcare delivery and support both imports and exports from New Zealand. This bill has been a long time in the making. I'm advised that work on this bill started in 2003. It is intended to replace the Medicines Act 1981 and the Dietary Supplements Regulations 1985. The Medicines Act currently provides insufficient coverage for many products used in modern healthcare delivery and dietary supplement regulations are not fit for purpose are inflexible and are out of date. So the bill is truly a once-in-a-generation change for our health system.I want to acknowledge some of the people who have been important to getting the bill across the line. It has been a significant undertaking. I want to acknowledge the input of all members of this House the many members of the public who submitted and all who have expressed their view both for and against since the bill has been introduced. In particular I want to acknowledge the former Minister of Health the Hon Andrew Little who introduced the bill to the House in November last year and also the Health Committee who recently reported back on the bill. I'd like to thank committee members for their hard work and over the last six months reviewing submissions and the many sensible changes that were made. In particular I want to acknowledge the chair Tracey McLellan and the deputy chair Neru Leavasa. Thank you both for your work. The committee did an excellent job reviewing more than 16500 submissions and hearing more than 300 submissions from organisations and officials. They worked tirelessly and produced an excellent bill when they reported back. I also want to acknowledge officials from the Ministry of Health who gave their support for navigating this bill especially Tim Vines Steve Waldegrave John McGrath Jane Hubbard and John Whaanga. Thank you all for your work and your support. I also want to acknowledge that it has taken almost two decades to get this bill in place and some of the officials working on the bill have been working on it for 15 years. I also want to give thanks to my colleague Peeni Henare for his contributions to the bill including in the areas of regulation of rongoā.You'll be aware of the changes to the bill since the second reading including the changes to make sure small-scale natural health products have the ability to be exempted from some of the provisions in the bill. There have also been sensible and proportionate changes in the areas of advertising. I acknowledge that there is concern about the harms caused by direct-to-consumer advertising. Currently in New Zealand medicines can be advertised direct to consumers under some controls. Officials have looked at the evidence around direct-to-consumer advertising of prescription medicine and they did not find sufficient evidence to justify a ban. However changes made to the bill strengthen the controls that can be placed on advertising and include the opportunity for prohibition should sufficient work be done to justify that in light of some of the New Zealand Bill of Rights Act concerns and that we work through the potential for unintended consequences there. As a doctor I am extremely attentive to the views of medical practitioners and advocates who have been in touch to ask for direct-to-consumer advertising to be banned. We do all want the very best for our patients and the public but as a legislator I take my role extremely seriously and want to ensure that we do not make legislation about such important matters in haste. I want to be careful that there are no unintended consequences for making decisions without due consideration. Some small-scale natural health product manufacturers raised concerns that the regulatory regime for natural health products is not risk-proportionate and that the costs involved may drive them out of business. A large number of these producers operate out of their homes and manufacture only a small quantity of goods sold locally—for example at farmers markets. While natural health products are not risk-free I'm comfortable that the evidence available suggests that these products do not pose a significant public health risk. After all the scale of that risk is influenced by the scale of distribution of the product. Under changes to the bill regulations can be made to small-scale natural health product manufacturers that will not need to obtain a product authorisation or manufacturing licence from the new regulator where their products are made and supplied to in-person customers in New Zealand. This is a sensible approach. Product authorisation will still be required for imported natural health products. There is still a need though to regulate natural health products. This is significant and the bill will bring New Zealand into line with international counterparts. It is vital that people have the information they need to make informed decisions about natural health products. The regulations will help ensure that products contain safe ingredients that there is assurance around the manufacturing process that health claims are based on evidence and products made in New Zealand and exported overseas meet international standards. The bill is designed to ensure a clear distinction between natural health products medicines food and cosmetics. It's also important to address some of the early misinformation that was reported about the bill and its potential impacts. Contrary to some reports on social media and feedback from some submitters you will still be able to buy natural health products. You will not need a prescription. Practitioners will still be able to deliver care to their clients. There is no list of prohibited ingredients in the bill. There is no proposal to ban common herbs and spices used in cooking. They are not covered by the bill. The impact of the bill on any particular natural health product or ingredient will be determined by secondary legislation following consultation with stakeholders and the public. We've already canvassed in the committee stage some of the changes around rongoā. Some people have asked why the Crown felt it had a right to bring rongoā into any system of law or regulation. The answer comes in two parts. Rongoā was already involved because many of the natural ingredients it uses such as mānuka or kawakawa fall into the category of a natural health product. Secondly the Crown has an obligation under Te Tiriti to actively protect rongoā and engage Māori on how rongoā could be protected under the law. That's why the ministry undertook a rongoā work stream last year to explore the relationship between the Therapeutic Products Bill and rongoā and how the legislation could protect it.There is no available evidence that the practice and regulation of rongoā to date has created significant risks to people's health. That is the view of Māori and the evidence supports that. Our decisions reflect what Māori have said so whānau will continue to use and manage rongoā as they have for generations.I'm also confident that the bill will be implemented in a way that supports and enables innovation. For New Zealand researchers innovators and businesses it's important to compete on the global stage and we need a regulatory regime that enables that innovation supports exporters and promotes trust and confidence in the products made here in Aotearoa. The bill does exactly that. It supports new technologies to come to market and accelerates their entry when necessary such as in a health emergency. It supports innovation more widely such as creating pathways that are easily navigated and aligned with international standards. It will make the job easier for importers local manufacturers suppliers and exporters. I'm very proud to see this bill go through after so many years. I've often reflected during the pandemic on the fact that had we gone into the pandemic with a modern regulatory regime for medicines we would have had a smoother path to approval of the COVID vaccine and the regulations of medical devices that—Nicola Grigg: Would you have got rapid antigen tests in any faster?Hon Dr AYESHA VERRALL: —for example diagnostic tests. Those are precisely arguments for this bill. I'm pleased that this Government has been able to see through this piece of regulation that has been 20 years of work across parties on both sides of the House. Alongside our record funding of Pharmac and our removal of the co-pays on medicines it shows the commitment of this Government to access to medicines for New Zealanders.