TPA repeal positive but will leave regulatory hole – industry

eHealthNews.nz: Sector

TPA repeal positive but will leave regulatory hole – industry

Tuesday, 20 February 2024

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NEWS - eHealthNews.nz editor Rebecca McBeth

The repeal of the Therapeutic Products Act is positive for digital health innovation, but leaves a regulatory hole and a clear roadmap for regulation is needed, industry experts say.

The Act, passed by the Labour government in 2023, introduced a new regulator and market authorisation regime for software as a medical device (SaMD), such as software that performs image processing to help detect breast cancer

This meant vendors would need authorisation before their product could be imported, supplied in, or exported from New Zealand, as well as a robust surveillance and response system for their products.

eHealthNews reported that digital health suppliers were concerned about the unintended consequences of the Act, which could stifle investment and innovation in the sector.

The new Government has indicated that it will be repealed, with “begin work to repeal the Therapeutics Products Act 2023” included at number 47 out of 49 points on the Government's plan for its first 100 days.

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Repealing the Act means therapeutic products will continue to be covered by the Medicines Act of 1981, with no regulation for many classes of healthcare products used for consumers in New Zealand.

Ryl Jensen, chief executive of the Digital Health Association (DHA), says the repeal is both a good and a bad thing for industry.

The DHA felt that the definition of SaMD in the Act is too broad and would have inadvertently caught up around 80 percent of their members. Also, the Act didn’t necessarily follow international best practice, especially in what constitutes a therapeutic purpose.

However, a repeal leaves regulatory gaps and burdens those who spent significant time on submissions, who now will have to go through a similar process again, she says.

In a briefing to incoming Ministers, the DHA said “secondary legislation was going to be developed and this was meant to provide a flexible way of dealing with any concerns around the definition and what would or would not constitute SaMD.

“The process will delay the enactment of the Act by a minimum of one year, probably longer, which leaves a regulatory hole around those devices that should be regulated as SaMD.

“Theoretically the Acts that are currently in play should be sufficient to safeguard consumers, but it would be better to have a robust Act in place and a robust regulation body to conduct the process,” the DHA said.

Josh Robb, co-founder of Tend, was concerned about the unintended consequences of regulatory treatment of SaMD and how that could impact primary and community care providers, who cannot afford an increase in technology costs.

“Regulating global pharma companies, medical device manufacturers, software related medical devices, software used in other clinical contexts, and rongoa and other natural therapies through a single act was always going to be challenging and make it very difficult to get the settings right,” he says.

“The importance of the regulator being able to keep up with this workload is critical and there are well documented pre-existing concerns with MedSafe's performance.”

Robb says there is an explosion of digital products and services with current regulation based primarily on the Privacy Act.

“What the sector needs is a clear roadmap for regulation of the various high risk unregulated categories/use cases,” he explains.

“This is so that providers and producers/manufacturers/developers can continue to work to deliver health care outcomes to New Zealanders without uncertainty about costs, regulatory impact and time to market.”