Opinion: Debate about how to regulate natural health products has been going on for more than a decade. The option now being mooted is to expand Medsafe’s role to police therapeutic claims for these remedies. Minister of Health Andrew Little has stated it’s his preference to have one body regulating pharmaceuticals, natural remedies, as well as other products such as sunscreens.

Is it a good thing to have one body regulate all products that claim therapeutic benefit? Expanding Medsafe in this way may work, with a name change (Therasafe!), but it does also raise concerns, particularly about the appropriateness of any assessment and the consequences for manufacturers of natural health products.

New-look regulator will demand ‘robust’ evidence for natural remedies’ claims

Medsafe’s role is to regulate therapeutic products and to oversee pharmacovigilance (drug safety monitoring) activities. A large part of its work involves regulating pharmaceuticals. Clinical trial data is central to its determinations of whether these products are permitted for use in New Zealand.

Clinical trials of pharmaceuticals are, hopefully, very rigorous. They are also very costly. Clinical trials provide information on the benefit of pharmaceuticals. The first clinical trial that reached the standard we expect today, which is the randomised controlled trial (RCT), occurred in 1946 to assess the efficacy of streptomycin for the treatment of pulmonary tuberculosis.

Although RCTs were undertaken following this, the Thalidomide tragedy provided a real impetus for their use. In many countries, Thalidomide was marketed as a sedative. But thousands of babies were born with serious birth defects after the drug was used to treat their mothers for morning sickness. This led to a call for more stringent assessment of the safety of pharmaceuticals (not just their efficacy).

Pharmaceuticals, even the best ones, can have a narrow toxicity-to-therapy ratio, so it is important to get this assessment right. However, if RCTs were applied to natural remedies before they could go on the market, the industry would be wiped out overnight. And there is no intention to do this, as safety concerns for natural products—although there are some—are far less than for pharmaceuticals.

Instead, for natural remedies, some other standard of assessment would be required. The suggestion at the moment is that this is not to determine whether they should go on the market, but determine what kind of claims can be made about the products’ therapeutic benefits.

Should Medsafe then regulate both pharmaceuticals and natural remedies? I would suggest there are some dangers in taking this approach. With the current configuration of committees Medsafe has, there could be confusion for committee members about what they were assessing and to what standard.

There are currently three committees under the Medsafe umbrella: a Medicines Classification Committee that makes recommendations on whether medications should be prescription medicines, restricted medicines or pharmacy-only medicines; a Medicines Assessment Advisory Committee that advises on the risk-benefit profile of medicines; and a Medicines Adverse Reactions Committee that advises on the safety of approved medicines.

If Medsafe is to oversee the regulation of natural remedies, it would be essential that new natural products committees be established. These committees would need to have separate personnel who would use criteria appropriate to the assessment of natural remedies and not simply emulate what the existing Medsafe committees do.

In addition, there are likely to be flow on impacts of further regulation of natural products over time. If there is to be something like a Natural Remedies Adverse Reactions Committee then this would put further pressure on our already overstretched and frankly inadequate pharmacovigilance system.

The central agency in pharmacovigilance is the Centre for Adverse Reactions Monitoring (Carm). With staffing levels so low, we are not well-served in pharmacovigilance. There are not the staff to proactively seek out possible adverse reactions in the community. Instead, Carm is heavily reliant on receiving reports of adverse reactions, particularly through health professionals, as the agency does not have a high profile, and few people, outside of medical professionals, know of its existence.

Overseas research tells us that underreporting of adverse reactions to medications may be as high as 94 percent. So, do we now make room for Carm, or someone else, to monitor natural products?

A further concern is that if we model regulation of natural remedies on the regulation of pharmaceuticals, where might this end? Will we start to see a situation where natural remedies cannot go onto the market, even without making therapeutic claims, because they need to reach the safety assessment standards of pharmaceuticals?

In such a situation, we would have consumers losing choice about how they want to go about managing their health. However, this concern needs to be balanced against producers of natural therapeutic products making unsubstantiated claims that may lure people into wasting their money. We need to balance any apprehension about the slippery slope of regulation with concerns about the consequences of unregulated markets.

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