The bill underwent its second reading last Thursday (June 29), with MPs claiming the new rules could become a “red tape nightmare”.
The closely watched Therapeutic Products Bill – first introduced last November – underwent its second reading in the parliament after the Ministry of Health (MOH) introduced changes to the bill on June 13.
Several members of the parliament were against the Bill. For example, Dr Shane Reti, MP from the opposition party, the National Party, took issue with the market authorisation process, explaining that this could adversely affect both small and medium-sized manufacturers.
The process is applicable to all therapeutic products, including natural health products, before they could be sold in the market.
A Supplementary Order Paper (SOP), however, would be introduced to amend the bill, so that small-scale natural health products would be exempted, said health minister Dr Ayesha Verrall.
To which, Dr. Reti pointed out that product authorisation could drive medium-size manufacturers out of business as well.
Citing the example of a manufacturer based in Whangārei, he claimed that the firm would have to close its seven franchises if market authorisation was required for all their products.
“I met with some of with some of the medium-sized natural health product companies. There is one in Whangārei that is a manufacturer and has seven franchises, and they tell me they will have to close all franchises if they have to through a manufacturing approval process and a market authorisation approval process for all of their products.
“So while some still somewhat unknown work has been done around small manufacturers, the medium-sized manufacturers will still have a significant consequence,” said Dr Reti.
He was also displeased with how information around the Bill, such as the introduction of SOP – was not fully available to the Select Committee which was made up of MPs from different political parties.
His said that his party, the National Party, would therefore oppose the bill.
In contrast, MPs from the Labour party were in favour of the bill.
MP Dan Rosewarne, for example, said that the government had taken “a common sense” approach to the bill and has struck “the right balance”.
“The bill is intended to support product safety. We took a common-sense approach, and I think we've struck the right balance with this regulation being proportionate to the risk. So we've taken a common-sense approach to this bill, and it's striking the right balance, and, as a result, I commend it to the House.”
Costs and delays
The Natural Health Products New Zealand (NHPNZ), which represents around 80 per cent of the natural health products sector, also believes that demanding individual product authorisation would create delays and costs for the industry.
“A new regulator tasked with individually assessing 20,000 different natural health products through a bureaucratic authorisation and assessment scheme is a red tape nightmare that will create untenable delays and costs for industry,” said Samantha Gray, NHPNZ’s government affairs director in a statement released on June 30.
Instead of product authorisation, Gray said that a notification system would be preferred, since it was regarded as the international best practice.
The stakes were high, Gray said, adding that the industry’s concerns have not been “taken seriously”.
“The sector contributes around $2.3 billion to the New Zealand economy annually, and our lack of appropriate regulation is costing around NZ $500 million per year in lost exports. If the Bill is not amended adequately, or if the regulatory reform process is further delayed and restarted yet again, we will see a significant loss of existing manufacturing capability and capacity and jobs.
“Consultation from the Government has been poor, and we do not believe our concerns have been taken seriously. The Bill needs to be amended urgently or it risks causing significant economic harm to our industry, in turn costing jobs and exports for New Zealand at a time when we need it most,” she said.
Far too many questions than answers?
MPs from the other opposition parties were also concerned with the capability of the regulatory body that would be formed to oversee the market authorisation process.
“We're going to be creating regulatory reform secondary legislation, and we need regulators to be able to assist with our medicines and natural health products. Now, what red tape and what cost is that going to put on these companies that create and bring in these products, and where are these regulators coming from?
“We already have a staffing problem. Again, are they going to be qualified? Are they actually going to understand what they are going to be regulating? Now, this is why I said this lovely bill has still got far too many questions than answers,” Toni Severin, MP from the ACT Party said.
Nicola Grigg, MP of the National Party, was also sceptical of the capacity that the new regulator would have to oversee market authorisation.
“We don't believe that the proposed regulator is either going to have the time, resource, or indeed the inclination to make sure timely factory approval or market authorisation is given, particularly to the cottage industries that have emerged, especially in and around the natural health products area.”