Verrall AyeshaWEDNESDAY 28 JUNE 2023(continued on 29 June 2023)THERAPEUTIC PRODUCTS BILLSecond ReadingHon Dr AYESHA VERRALL (Minister of Health): I present a legislative statement on the Therapeutic Products Bill.ASSISTANT SPEAKER (Hon Poto Williams): 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 second time.The Therapeutic Products Bill intends to replace the current Medicines Act 1981 and the Dietary Supplements Regulations 1985 made under the Food Act 2014 to provide for comprehensive and risk-proportionate regulation of therapeutic products. I will focus my remarks today on some of the changes made at select committee but I think before that I will reiterate briefly the absolute importance of these reforms to our medicines regulation.We need modern medicines regulation that will allow for 21st century treatments that are used in New Zealand today but are poorly served by our current legislation. We need legislation that is flexible for public health emergencies like the pandemic we have just experienced. We need legislation to regulate the use of medical devices that are currently inadequately regulated and the example of the harm caused by surgical mesh is one area where these changes are needed. Another important imperative is to make sure we have flexible regulation to allow for innovative health products to be tested and used in New Zealand.But to focus on the work that that has been proceeded more recently the bill was introduced on 30 November last year and referred to the Health Committee in December. The committee recently reported back on the bill and I'd like to take this opportunity to thank committee members for their work over the last six months. I'd also like to thank everyone who made a submission particularly those who shared their personal experiences. More than 16500 submissions were received and this shows how important these issues are to New Zealanders. Oral hearings were held in late March and 210 organisations and 127 individual submitters were heard.I recognise that many people who submitted on the bill were opposed to it or had concerns about how it would affect them their whānau or their businesses. Over 9000 submissions focused on the inclusion of natural health products (NHPs) and called for their exclusion from the bill or that they be regulated in a risk-proportionate way. I also acknowledge that more than 700 submitters expressed concerns about the bill's potential effect on rongoā Māori.When the Health Committee reported back to the House recently the Government announced that small-scale NHP manufacturers would be excluded from the legislation as well as rongoā. The Government intends to introduce a Supplementary Order Paper (SOP) to amend the bill during the committee of the whole House debate. A number of NHP producers operate out of their homes and produce only a small quantity of goods. These are often sold locally—for example at farmers markets. I'm comfortable that the evidence available suggests these products don't pose a significant risk to public health so the SOP will introduce changes so that small-scale natural health products will be able to be exempted from a product authorisation or manufacturing licence from the new regulator where their products are made and supplied in person to customers in New Zealand.There is still a need to regulate natural health products as they are not risk-free. It's also important people have the information they need to make informed decisions about these products. Regulations can help ensure that products contain safe ingredients with information that is clear on the use and recommended dose that quality manufacturing processes are in place to provide assurance that products are not contaminated that health claims are substantiated and that products made in New Zealand and exported overseas meet international standards.Natural health products are categorised as a therapeutic product if they are intended to have a therapeutic purpose. They will however be regulated as a separate category to medicines and medical devices and reflect that they are generally lower-risk.Contrary to reports on social media and feedback from submitters on the bill you will still be able to buy natural health products and you will not need a prescription. Practitioners of natural medicine will still be able to deliver care to their clients. There is also no list of prohibited ingredients in the bill and no proposal to ban common herbs and spices used in cooking. If we did my mother would never forgive me! The impact of the bill on any particular natural health product or ingredient will be determined by a secondary legislation following consultation with stakeholders and the public.Turning now to rongoā under the SOP Māori will retain determination about what rongoā means to them and who is a rongoā practitioner. It's important for the Crown to ensure mātauranga rongoā can access the export market if they choose and protect rongoā from those who might abuse it. The Government will establish an advisory committee of rongoā experts and Māori leaders to implement the new provision of the bill.The committee recommended a number of amendments to the bill that the Government will support. Many submitters expressed concerns about the provisions of the importation of prescription medicines. People were concerned they would not be able to import life-saving medicines that are not available in New Zealand or not affordable. The Government is seeking in this bill to protect people from counterfeit or contaminated products. The committee has proposed amendments that achieve this sensible balance. People will be able to order and import prescription medicines for their own use provided they have a prescription from a New Zealand health practitioner. To address concerns about cost health practitioners will be explicitly able to consider affordability when prescribing an unauthorised medicine. I know this has been a major issue for a number of people and I welcome the proposed changes. The committee has also proposed amendments to the advertising provisions in the bill. While it agreed with the need to regulate advertising of therapeutic products especially products that have not been authorised for use in New Zealand sensible amendments will clarify that patient fundraising advocacy and media activities are not intended to be prevented. Other amendments proposed by the committee will ensure advertising over social media platforms and the internet is appropriately regulated. I also want to provide reassurance that Government has never had any intention to restrict Givealittle pages around unfunded drugs. In addition new defences have been added to the misrepresentation offence and the offence of unlawful advertising to protect research and media activities advocacy and satire. Supporting and enabling innovation is also very important to me. We need a regulatory regime that enables innovation supports exporters and promotes trust and confidence in products made here in Aotearoa. This bill does exactly that. It supports new technologies coming to market expediting when necessary such as in a health emergency. It supports innovation more widely creating pathways that are easily navigated and aligned with international standards. The amendments proposed by the Health Committee will ensure that a regime can respond to advances in health technologies such as software as a medical device or cell or gene therapies. We have listened to New Zealand exporters and I'm confident the bill will be implemented in a way that supports those businesses. The bill enables a risk-proportionate approval pathways for export-only products and it's my expectation that the new regulator will engage constructively with exporters. In summary the bill provides a risk-proportionate approach to regulation. Pre-market controls will provide assurances that products are made to the proper standards while in-market and post-market controls will enable a timely response if safety issues arise. While the Medicines Act has served us well by and large it has not kept pace with international developments and there are gaps in the regulations of some therapeutic products such as medical devices and advanced cell and tissue therapies. Consumer safety is our top priority in this bill. The bill will provide New Zealanders with the assurances they would expect about the safety and quality of therapeutic products. In a time of significant change in the health sector the bill will also provide flexibility for businesses like pharmacies and for the health workforce. The new regulator will cover a much broader scope of therapeutic products and activities. The new regime will become fully operational by 2026 following the development of secondary legislation and further consultation on that. This is a historic and comprehensive bill. I would like to acknowledge my colleague Andrew Little who as previous health Minister did the work to introduce this bill. The bill will provide reassurance to consumers about safety and will help deliver the Government's vision of pae ora health futures for all New Zealanders. It is a fundamental and significant part of our new health system. I commend this bill to the House. ASSISTANT SPEAKER (Hon Poto Williams): The question is that the motion be agreed to.