Therapeutic Products Bill — First Reading

THERAPEUTIC PRODUCTS BILL

First Reading

Hon ANDREW LITTLE (Minister of Health): I present a legislative statement on the Therapeutic Products Bill.

ASSISTANT SPEAKER (Hon Jacqui Dean): That legislative statement is published under the authority of the House and can be found on the Parliament website.

Hon ANDREW LITTLE: I move, That the Therapeutic Products Bill be now read a first time. I nominate the Health Committee to consider the bill.

Today is a somewhat historic step forward towards a more modern, comprehensive, and risk-proportionate regulatory regime for therapeutic products in Aotearoa New Zealand. Bluntly, this bill is overdue. It's been more than 40 years since the introduction of the Medicines Act 1981, which this bill will replace. The Medicines Act does not cover all of the products used in modern healthcare delivery, and it simply hasn't kept pace with technological change.

Natural health products, which will be now covered by this bill, contribute $2.3 billion to our GDP. Goods exports are worth $642 million per annum, but the development of a natural health products industry and its potential to create jobs has been stymied by piecemeal regulatory responsibilities spread across multiple Government entities. The regulatory regime for natural health products has been hard-coded into antique legislation—specifically, the Dietary Supplements Regulations from 1985, which is mandated, mysteriously, by the Food Act of 2014.

I haven't been in this House for very long, which is why I'm very pleased to have the opportunity, hopefully, to continue, but when I was first elected in 2011, the very first piece of legislation that I dealt with before a select committee was the Natural Health Products Bill. That bill never passed, and the issues that it sought to address have now no legislation or proposed legislation to cover them. The Therapeutic Products Bill, which we're considering today, has been literally decades in the making, and, finally now we have an opportunity to move forward, notwithstanding the work of Todd Muller and his sunscreen products legislation that were put in place temporarily to cover this. The work of Todd Muller will now be covered by this bill.

Following the passing of the Pae Ora (Healthy Futures) Act, the Therapeutic Products Bill is one of the two foundational modernisations we must make to the law governing our public health system if we are to achieve healthy futures for all New Zealanders. The other is the mental health Act, and that work is well under way right now.

The Therapeutic Products Bill will provide for the timely, comprehensive, risk-proportionate regulation of medicines, medical devices, active pharmaceutical ingredients, and natural health products, and it will also include cell, gene, and tissue therapies. The bill will regulate how products are manufactured, tested, imported, promoted, supplied, and exported. The new system will align with international best practice and will be futureproofed with flexibility to ensure effective control over new technologies.

Government intervention in and regulation of this sector is fundamental because of the potential for serious harm from the use and misuse of therapeutic products. Given the bill's significant impact on our future health and disability system, it's crucial that we get it right. After more than a decade of debate, I believe we have a strong bill for the Health Committee to now have a look at.

I'm conscious also that the bill draws lessons from our COVID experience. A key lesson was that we needed to make safe and effective therapeutic products available quickly during emergencies like that. It's my view that deficiencies in the current Medicines Act contributed to the rise of disinformation about the safe COVID-19 vaccine at the very time we needed our law to perform at its best. Conspiracy theories around how the vaccine was approved had their genesis in the present prescript requirements around emergency approval. In reality, that was the only mechanism for making an advance purchase order; indeed, it was the only mainstream mechanism, but it was never approval to administer the vaccine in New Zealand.

This bill will finally provide a modern, comprehensive, and flexible regulatory regime for natural health products. This is a significant part of the bill and it will bring New Zealand in line with our international counterparts in export markets. Natural health products are categorised as therapeutic products because they are intended to have a therapeutic purpose. However, they will be regulated as a separate category to medicines and medical devices. The bill is designed to ensure there's a clear distinction between natural health products, medicines, foods, and cosmetics. The regulations applying to natural health products will reflect that they are generally lower-risk than medicines and medical devices.

I want to talk a little bit about rongoā and Te Tiriti. Rongoā are spiritual practices and taonga. Rongoā is not medicine by the Western definition. The kawa and tikanga on the safe preparation, practice, and application of rongoā is diverse across iwi and hapū. I've seen commentary that rongoā is not presently regulated under the current law, but that's incorrect. Goods supplied with therapeutic claims are already captured under many parts of regulation. What has been missing has been appropriate and respectful protection of rongoā.

Te Tiriti o Waitangi principles are woven throughout this bill, reflecting how this is a fundamental component of it. However, rongoā is not mentioned or referred to in the bill. It's important that our overall regulatory settings support the traditional practice of rongoā while balancing this objective against the need to provide assurances for patient safety and export market access for rongoā practitioners. The Associate Minister of Health Peeni Henare and I have commissioned a stream of work to consider how these objectives might be achieved. This work will be led by Te Aka Whai Ora and Manatū Hauora—the Ministry of Health—and guided by rongoā practitioners and Māori. I acknowledge Te Kāhui Rongoā, who have met with us and will be engaged in that work.

Turning to one of the bill's key aspects, there is a requirement that therapeutic products receive a market authorisation before they can be lawfully imported into and exported from or supplied in New Zealand. Market authorisation for medicines and medical devices will be granted following an evaluation by the regulator of a product's safety, quality, and efficacy or performance. Natural health products will need to demonstrate that they are safe, that they are made to appropriate quality standards, and that health benefit claims are substantiated by either scientific or traditional evidence.

The bill empowers secondary legislation for risk-proportionate approval pathways and determination of product standards. Reflecting their generally lower risk, natural health products will be able to apply for market authorisation through a self-assessment and declaration pathway. Some provisions in the bill will allow for the importation and supply of products without a market authorisation under tight controls.

The bill provides for regulation of controlled activities, including manufacturing, wholesale and non-wholesale supply, exporting, and conducting a clinical trial with medicines and medical devices. The bill authorises a number of practitioners to undertake controlled activities with therapeutic products. For example, health practitioners will be able to prescribe and dispense prescription medicines, and pharmacists will be able to compound medicines for customers. Likewise, natural health practitioners will be able to manufacture natural health products for their clients as part of a consultation. Other individuals seeking to undertake a controlled activity with a therapeutic product will need to apply to the regulator for a licence or a permit. The bill provides for a broad regulation-making power to allow other classes of individuals to engage in controlled activities—for example, surgeons to retrieve a whole organ for immediate transplantation. This provides flexibility to allow the regulatory regime to develop and evolve.

While Medsafe has operated as an effective regulator, providing trusted and quality advice, including during the COVID-19 pandemic, the Medicines Act does not provide it with the modern regulatory tools needed to ensure timely and safe access to therapeutic products. The bill will establish a new therapeutic product regulator and give it the tools it needs to implement and oversee an effective, trusted regulatory regime. This will be a significant undertaking and will form a key part of our future health and disability system.

The new regulator will be a branded business within the Ministry of Health, with an independent statutory officer appointed to head the unit. Although it will exercise functions independently, the regulator will not work in isolation. It will be an integral part of our wider health and disability system and will contribute to achieving a vision of pae ora—healthy futures—for all New Zealanders.

I want to acknowledge two matters where I expect submissions and where I will be looking forward to the considered recommendations from the Health Committee. These are direct consumer advertising of prescription medicines and pharmacy ownership. I just point out that the bill does not change current policy settings on either of those issues, but I'm keen to see what submitters say, because I know that these are somewhat controversial areas in some quarters. But I record for the record that I am open to change on both those matters.

This is a historic and comprehensive bill. It is complex and technical. Along with our recent structural reforms in health, the Therapeutic Products Bill will contribute to pae ora, or healthy futures, for Kiwis. I commend the bill to the House.

ASSISTANT SPEAKER (Hon Jacqui Dean): Members, the House stands adjourned until 2 p.m. this afternoon.

Debate interrupted.

The House adjourned at 1.01 p.m. (Wednesday)