Industry View: The Therapeutic Products Bill 2022

eHealthNews.nz: Sector

Tuesday, 7 March 2023

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VIEW - Ryl Jensen, chief executive, Digital Health Association (DHA)

Ryl Jensen The value of the digital health industry in New Zealand is significant and growing, as technology continues to transform healthcare delivery. The technology sector as a whole is touted to become the largest contributor to GDP by 2030.

Digital health has also been identified as one of six key priorities in Te Pae Tata – Interim Health Plan 2022, to help transform New Zealand’s health system as part of the recent health sector reforms.

The Therapeutic Products Bill
The Digital Health Association recently provided a submission on the Therapeutic Products Bill 2022.

The DHA and its members support the overall intent of the Bill – to ensure therapeutic product legislation is up to date, fit-for-purpose, and to provide a mechanism to keep New Zealanders safe from harm relating to therapeutic products.

However, we believe the problem the Government is trying to solve with the introduction of Software as a Medical Device (SaMD) in the Bill is unclear.

Defining SaMD
The Bill addresses regulation of several different types of therapeutic products, including medicines, natural health products, medical devices, and SaMD. As a result, the Bill, and its definitions of what constitutes a therapeutic purpose, are broad and all encompassing, including in the intended regulation of SaMD.

We support the regulation of software that we call ‘true SaMD’, which is used on patients for purposes such as diagnosing or treating medical conditions or sustaining life.

Health software is different in that it does not do things such as diagnose or treat medical conditions.

Many health software products do no more than facilitate patient-doctor communications and consultations and/or assist in practice management, and generally pose no more risk of harm to the patient than any other applications used to facilitate remote interactions or administrative functions at a medical practice.

A distinction between SaMD and Software in a Medical Device (SiMD) is recognised by a
number of key overseas jurisdictions, to account for the differences in relationship and function between health software and medical devices that rely on software to function.

Unintended consequences
The DHA is concerned that the current broad definition of SaMD will inadvertently capture health software that is low risk in nature and should not necessarily be subject to regulation.

This would decrease the productivity of the health software industry and negatively impact health services which rely on developments to health software.

By introducing significant compliance cost to health software companies, many could be forced out of business.

Additionally, this would affect how the health system operates and New Zealand’s economic growth, as well as have long lasting impacts on efficiency, R&D, innovation, and competition within the health software industry.

Keeping pace with digitalisation
The DHA believes that regulations should take into account the rapid rate of digitalisation and be able to keep up with this dynamic environment.

The government has a unique opportunity before the Bill comes into force to create modern regulations that are adaptable, flexible, agile, and forward-thinking, thus creating a global benchmark for exemplary regulation.

This must be led and supported by a capable Regulator with the capacity and expertise to regulate and make decisions on a wide range of therapeutic products. Given the current worldwide skills shortages and global economic and political uncertainty, the challenges posed in achieving this are significant.

We believe that significant consultation with the health software industry and changes to the Bill must happen in order to ensure that regulation does not stifle an extremely valuable and growing industry in Aotearoa New Zealand, or affect health services and patients in a negative way.

This View is an edited version of the Executive Summary of the DHA’s submission on the Therapeutic Products Bill 2022.

Picture: Ryl Jensen, chief executive, Digital Health Association