Whangārei cancer clinic stalls awaiting Medsafe approval

But strict regulations on new medicines and therapeutic devices mean the Nosoviches do not have approval to use OncoRob beyond clinical trials.

Medicines normally require a series of clinical trials involving up to hundreds of patients, including testing the new treatment against the standard treatment or a placebo.

Medsafe told the Nosoviches to follow this process but they said it was not appropriate for a novel medical device like OncoRob.

Sophie Nosovich claimed their study showing efficacy in terminally ill cancer patients was a more powerful result than any randomised clinical trials.

Medical devices do not need pre-market assessment and approval.

Novother Cancer Research’s Sophie Nosovich (from left) and Dr Armand Nosovich hope to offer a world-leading new cancer treatment from their Whangārei facility. Photo / Denise Piper

But Armand Nosovich claimed they required a manufacturing certificate which could cost up to $200,000 a year, putting it out of reach for the small facility.

Discussions with Medsafe have stopped over fears they could expose Armand Nosovich’s trade secrets – which he felt was the only way to protect his three decades of research.

“No one in the world has anything close to this. I would like to keep this intellectual property – it’s my own invention.”

Medsafe said it cannot determine the regulatory pathway without detailed information about the product.

When Medsafe asked for more information about OncoRob’s mode of action, the Nosoviches asked the regulator to sign a confidentiality agreement, but this was declined.

Neighbours of Novother Cancer Research were sent this flyer, encouraging them to support its cancer clinic. Photo / Denise Piper

They were advised information provided to Medsafe would be available to others through the Official Information Act, putting the trade secrets at risk, Sophie Nosovich said.

Novother Cancer Research was effectively in limbo, she said.

“It’s very slow progressing but in the meantime people are dying [of cancer] and don’t have this option.”

Armand Nosovich said he was able to show the benefits of OncoRob firsthand, having used it to treat his prostate cancer, diagnosed in 2017.

The Nosoviches have also started a charitable trust called Bio-Robots Against Cancer, which would help fund treatment for patients who couldn’t afford it.

Dr Armand Nosovich (right), supported by his wife, oncology nurse Sophie Nosovich, says OncoRob effectively treated his prostate cancer. Photo / Denise Piper

Medsafe awaiting information, regulator says

Medsafe said it had sufficient flexibility to regulate novel therapeutic treatments under the Medicines Act 1981, whether they were medicines or medical devices.

For any novel therapeutic product, it was important regulatory decisions were based on robust scientific and clinical evidence, group manager Chris James said.

“The fact that a product is innovative or New Zealand-developed does not alter the need for appropriate evidence to support its safety, quality, performance and/or efficacy and any therapeutic claims made for its use.”

Medsafe was awaiting information about OncoRob so it could to assess its safety, quality and performance, James said.

Medsafe group manager Chris James says the regulator is awaiting more information so it can assess OncoRob’s safety and quality. Photo / NZME

“Dr Nosovich has been in contact with Medsafe a number of times over the status of his product under the Medicines Act.

“Medsafe requires full information about the specific product to be able to advise on the regulatory requirements in New Zealand. Medsafe awaits that information.”

James said Medsafe routinely engaged with sponsors, researchers, developers and manufacturers seeking to understand the regulatory requirements.

The regulator gave advice based on the product’s expected mode of action and characteristics, he said.

Denise Piper is a news reporter for the Northern Advocate, focusing on health and business. She has more than 20 years in journalism and is passionate about covering stories that make a difference.