Speech to Medicines New Zealand annual dinner

It’s a pleasure to join you for the Medicines New Zealand Annual Dinner 2022.

Thank you for the valuable role you play in being part of and advocating for medical innovation in Aotearoa New Zealand.

The search for new treatments and cures is as unrelenting as the demand from patients and health professionals to have them.

The technology of medicines is developing to such a high degree of sophistication that it is increasingly a challenge for health systems to keep up. But more on that later.

What COVID has taught us

The past two-and-a-half years have shown why we urgently need a flexible health system that can provide appropriate and timely care.

Our health system has performed admirably throughout the pandemic – let’s not forget that it has saved thousands of lives - and the people working in it are world-class.

But it is also true that ours is a system under pressure. Under-investment in the workforce and health infrastructure has led to a system that struggles in the face of the unforeseen – and, to be fair, sometimes the foreseen.

That is why this Government has substantially increased funding for the sector, including in workforce development and hospital infrastructure, and reformed the structure of the system to achieve better coordination across the country.

But we need to create a sustainable, future-proof system that works for all New Zealanders, no matter who they are or where they live.

The reforms that came into effect on July 1 - along with the record investment we’re making in health - show our commitment to do that.

It will not be an overnight fix. We’re trying to rebuild after years of underinvestment, and there’s a lot to do. But the momentum is there.

New Zealanders want to, and should be able to, access health information, support, and services close to home, and even in their own homes.

COVID-19 was a catalyst for a significant shift in the way we support the health of New Zealanders.

Our health sector needed to respond to new ways of doing things, and, critically in my view, be able to deliver many of those things in a different way.

The systems of “virtual” care we saw developing during the COVID pandemic show some of the ways people can have access to safe, quality, and convenient services.

It has raised peoples’ expectations about what can be done.

In the end, it is about health services focussing not only on a person’s need for health treatment, but on broader wellbeing issues as well; the stuff that affects quality of life.

The rapid development of effective and safe vaccines during the pandemic represents an unprecedented collaboration between researchers, industry, clinicians and Government.

As a result of the pandemic technologies like mRNA vaccines came into their own, giving us new gene-based tools to fight not only COVID-19, but future pandemics and seasonal illnesses like influenza.

Reforms

As I said, the changes that came into effect last month are critical. Our health system had become complex and fragmented. Twenty different district health boards meant the sort of healthcare you got depended on where you lived.

The changes we made are about the health system being fairer and shifting towards keeping as many people as possible well so that they don’t need to go to hospital.

The Pae Ora (Healthy Futures) Act created two new entities. Te Whatu Ora – Health New Zealand, is responsible for the planning, commissioning and delivery of services. Te Whatu Ora will work closely with Te Aka Whai Ora – the Māori Health Authority which has a broad range of policy, strategy, commissioning and co-commissioning functions to influence and drive the health system and improve Māori health.

Te Tiriti principles, Maori leadership and decision-making in genetic technologies and medicines

Genetic information, whether about an individual or population group, has significant implications beyond its clinical usefulness.

In Aotearoa New Zealand, the collection, storage and use of genetic data to support research and development, must be undertaken in a manner that upholds the principles of Te Tiriti.

The future health system, including Crown and non-government organisations alike, must not repeat past mistakes, such as where genetic information and data have been collected, without full and informed consent, or presented in ways that stigmatised communities and populations.

The establishment of Te Aka Whai Ora – the Māori Health Authority and the ongoing policy leadership of the Ministry of Health will ensure the Crown’s adoption of future health technologies – including those which rely on genetic information – is done in a way that respects the whakapapa of Māori data and builds on existing models of Māori ‘data sovereignty’.

Therapeutic Products Bill

The Therapeutic Products Bill is an integral part of the health and disability reforms.

The Medicines Act 1981 has not kept pace with changes in policy, clinical practice, or technological advances.

As a result, there are longstanding gaps in the regulation of some therapeutic products.

The response to COVID-19 has highlighted the lack of regulation of medical devices in particular, and gaps in the regulation of advanced cell and gene therapies.

The Bill will address these challenges and regulatory gaps in order to enable timely development and adoption of emerging health technologies, such as genetic technologies and medicines.

What we have learnt from COVID-19 is that an enabling regulatory environment is not achieved through the absence of regulation but can be achieved with regulation that is flexible and risk-proportionate.

Obviously, patient and consumer safety remain paramount. But this need not be a barrier to encouraging innovation and development of therapeutic treatments.

The Therapeutic Products Bill, which covers medicines, medical devices, biologics, cell and tissue therapies, and natural health products, is a key Government priority. Now, to be clear, it started life under the last Labour Government and languished under National. I have made it my personal mission to see it through and the Bill is expected to be introduced to Parliament in late 2022.

The Bill will help deliver better health for people and ensure greater safety.  It will provide New Zealanders with the assurances they would expect about the quality, safety and efficacy of therapeutic products and devices, and the quality and safety of natural health products.

The new regulatory regime will complement the transformed health and disability system. It will enable service innovation, particularly in primary care and community settings.

Examples of where the Bill will enable greater innovation in service delivery include:

• pharmacy services
• rules around prescribing authorities
• standing orders to authorise other professionals engaged in the delivery of health services, to supply and administer medicines.

Te Tiriti and equity

The Bill will embed the principles of Te Tiriti which will mean that we never lose sight of the need to deliver and provide for equitable health outcomes.  

The new regulator will need to build productive Māori-Crown relationships and ensure the development and administration of the wider therapeutic products regulatory regime has an appropriate equity lens.

Genomic medicine

Turning now to genomic technology – which is rapidly expanding in testing, sequencing and genetic modification techniques (such as CRISPR[1]), and may give rise to new treatments and interventions.

Products involved in genomic medicine intended for a therapeutic purpose will be regulated under the Bill through their appropriate product categories. For example, gene therapies and advanced cell-based therapies (such as CAR T-cell[2] personalised cancer treatments) are defined as ‘biologics’ (i.e., the class of therapeutic products that are or contain human cells or tissues) and will be regulated as medicines. Genetic testing kits used at home or in a clinical setting will likely be regulated as medical devices. 

Under the Bill, these products will be assessed by the regulator in a risk-proportionate manner to ensure safety, quality and efficacy for genomic medicines for market authorisation.

New and bespoke pathways will be designed for novel genomic medicines and their clinical trials will be regulated as a controlled activity requiring a licence or permit.

The therapeutic product regime for biologics will run in parallel with other regulatory approval processes, including approval through the Environmental Protection Authority for all genetically modified organisms under the Hazardous Substances and New Organisms Act, and existing ethics approval processes.

Where appropriate, the product will be aligned with other regimes involving human cells and tissues and genetic information, including the Human Tissue Act and the Human Assisted Reproductive Technology Act.

Pharmac

New Zealand has one of the best medicine-funding systems in the world, but for years it was starved of money, including a three-year budget freeze by the previous government.

We’ve increased Pharmac’s budget to a record $1.2 billion next year – 43 per cent higher than it was when we came in in 2017.

In Budget 2022, we allocated an extra $71 million this year and $120 million next year for Pharmac to fund medicines on its options for investment list. Decisions on just which medicines will be funded rest with Pharmac, but much of it is going towards cancer treatments.

 You’ll be aware that the Pharmac Review was released earlier in June. The review looked into how Pharmac makes its contribution to improving health outcomes for all New Zealanders, particularly Māori and Pacific peoples.

The focus was on the transparency of Pharmac’s decision-making and its engagement with stakeholders, including other parts of government.

It found that overall Pharmac is doing a good job for New Zealanders, but there are areas which can be improved.

Among the recommendations from that review that are now being put into practice are greater transparency, greater engagement with consumers and greater collaboration with other parts of government.

Closing

I’ve talked a lot about what we’re doing, what’s possible and how we’ve increased funding to make much of it happen.

But the reality is we – like every health system – have not got limitless resources.

Governments operate under constraints. Allocations of funding for health will always be limited in some way and will not meet every demand there is.

That means we have to allocate our resource in line with priorities, and make sure we get the most we can for every cent we spend.

Healthcare is a fifth of the Government’s entire budget, and with a growing and ageing population to look after, we have to be smart with our spending.

It’s not a zero-sum game, however. There are things we can do in other parts of the health system to ease the pressure on the medicines budget.

For example, better public health approaches could reduce the incidence of diabetes, and therefore the need for diabetes medicines.  Access to screening and early support for people with pre-diabetes will prevent disease progression.

The reforms will take time to bed in, but I’m encouraged by progress to date. The building blocks are in place, the commitment is there, and the momentum is there.

The contribution of the pharmaceutical industry to our health system is a vital one. The relationships your industry have with our regulator, Medsafe, and our procurement agency, Pharmac, are also important even if sometimes they give rise to healthy tensions.

In the end, I think we all agree that your investors and armies of brilliant clinical researchers, and our clinical administration professionals want the same thing – modern, effective, safe treatments that extend and improve quality of life.

When we each keep our focus on that objective, the natural points of tension are easier to manage.

Enjoy your night tonight.

Nō reira, tēnā koutou, tēnā koutou, tēnā tātou katoa.