Reti ShaneDr SHANE RETI (National): Thank you Madam Chair. We want to address the issue of natural health products (NHPs) again through Part 4 starting with clause 122 as we continue to be of the view that natural health products are over-regulated and are an overreach in this bill. Despite the post - select committee Supplementary Order Paper (SOP) 368 we continue to believe that this bill is an overreach for the natural health products market. Supplementary Order Paper 376 that we're proposing amends the Therapeutic Products Bill and we do it in quite an elegant way. What we say is that OK continue with the market authorisation process—that's fine. Do whatever you're doing there even though we've got concerns that there are thousands of natural health products that are going to require authorisation. Even removing the small manufacturers we don't believe that there's going to be enough administration or if it will it'll be exceedingly cumbersome to actually regulate those. Go through that process but here's the operative clause we're wanting to insert: Clause 123(2) For the purpose of subsection (1) the Regulator must accept the applicant's declaration referred to in section 124 as sufficient evidence of the matters declared unless there is evidence to the contrary." Now under the bill natural health products require market authorisation—certainly our moderate and medium sized manufacturers. Information and statements around the self-identifying method of market authorisation would seem to be unclear and sometimes contradictory. There are concerns as I've mentioned with the capacity of the regulator to moderate a large number of NHP authorisations. This SOP effectively develops functional notification instead of legislative authorisation by maintaining the market authorisation framework for NHPs but it has the authorised criteria the sponsor criteria and the applicant's declaration all accepted by default. In this respect the legislation would function more like the near-unanimous cross-party support for a previous natural health and supplementary products bill. It's an elegant way to achieve what we're wanting to achieve—to move towards market notification of natural health products rather than cumbersome bureaucratic market authorisation—and the way we do that is we say "OK go through the market authorisation process but again the operative clause is here: "the Regulator must accept the applicant's declaration referred to in section 124 as sufficient evidence of the matters declared unless there is evidence to the contrary." So it is a market notification process by default. It sits within the market authorisation framework that this bill is proposing. Certainly our discussions with the industry were that this would make a significant difference. They have the grave concerns for their industry that they have had right from the beginning. That hasn't been substantively allayed. There has been some shift around small manufacturers—and that was appreciated by a number actually—but there are still many who will be caught up in this legislation who remain of the view that it is an overreach. We are offering here a midway point that utilises the framework that the Government is proposing albeit we still have concerns about the bureaucracy around market authorisation. But if that is where the Government is committed to going then accept that documentation by default unless as we say there is evidence to the contrary. That would reasonably achieve what the industry is looking for which is a more "market notification by default" sort of process rather than a cumbersome bureaucratic and expensive market authorisation process. So we've put this forward as a middle ground that utilises existing frameworks which we have concerns about—but if the Government is committed to going down that path there it is—but provide an option and an ability to achieve what industry is looking for in changing the focus with just a few words: "sufficient evidence of the matters declared" "must accept the applicant's declaration". That's the word—"must" accept the applicant's declaration—and we think that that will make a difference. Industry think that that will make a difference and we'd ask the Minister and her team to reconsider this please."