The Minister of Health wants to replace Medsafe with a single regulator for medicines, medical devices and natural remedies. We need to balance regulation with concerns about the consequences of unregulated markets
Opinion: The debate over how to regulate natural health products has been going on for more than a decade. The option currently being discussed is to extend Medsafe’s role to policing therapeutic claims for these remedies. Health Minister Andrew Little said he preferred a single body to regulate pharmaceuticals, natural remedies, as well as other products such as sunscreens.
Is it a good thing that a single body regulates all products that claim therapeutic benefits? Expanding Medsafe this way may work, with a name change (Therasafe!), but it also raises concerns, including the adequacy of any assessments and the implications for natural health product manufacturers.
Medsafe’s role is to regulate therapeutic products and oversee pharmacovigilance (monitoring drug safety) activities. Much of its work involves regulating pharmaceuticals. Clinical trial data is essential to determine whether these products are approved for use in New Zealand.
Clinical trials of pharmaceuticals are hopefully very rigorous. They are also very expensive. Clinical trials provide information about the benefits of pharmaceuticals. The first clinical trial that reached the standard we expect today, which is the randomized controlled trial (RCT), took place in 1946 to evaluate the effectiveness of streptomycin for the treatment of pulmonary tuberculosis.
Although RCTs were subsequently undertaken, the thalidomide tragedy gave a real impetus to their use. In many countries, thalidomide was marketed as a sedative. But thousands of babies have been born with serious birth defects after the drug was used to treat their mothers for morning sickness. This has led to a call for stricter evaluation of the safety of pharmaceuticals (not just their effectiveness).
Pharmaceuticals, even the best ones, can have a narrow toxicity-to-treatment ratio, so it’s important to get this assessment right. However, if RCTs were applied to natural remedies before they could be marketed, the industry would be wiped out overnight. And there is no intention to do so, because the safety concerns for natural products – although there are – are far less than for pharmaceuticals.
Instead, for natural remedies, another standard of evaluation would be required. The suggestion at present is that it is not a question of whether they should be put on the market, but of what type of claims can be made about the therapeutic benefits of the products.
Should Medsafe then regulate both pharmaceuticals and natural remedies? I would say there are some dangers in taking this approach. With Medsafe’s current committee setup, there could be confusion for committee members about what they were evaluating and to what standard.
There are currently three committees under the Medsafe umbrella: a Drug Classification Committee that makes recommendations on whether drugs should be prescription drugs, restricted-use drugs, or pharmacy-only drugs; a drug evaluation advisory committee that advises on the risk-benefit profile of drugs; and an Adverse Drug Reaction Committee that advises on the safety of approved drugs.
If Medsafe is to oversee the regulation of natural remedies, it would be essential that new Natural Products Committees be created. These committees would need separate staff who would use criteria appropriate to the evaluation of natural remedies and not simply mimic what existing Medsafe committees do.
Also, it is likely that there will be a flux on the impacts of further regulation of natural products over time. If there were to be something like a Natural Remedies Adverse Reaction Committee, it would put additional strain on our already overburdened and frankly inadequate pharmacovigilance system.
The central pharmacovigilance agency is the Adverse Effects Monitoring Center (CARM). With such low numbers, we are not well served in terms of pharmacovigilance. There are not the necessary staff to proactively search for possible adverse reactions in the community. Instead, Carm relies heavily on receiving reports of adverse reactions, particularly from medical professionals, as the agency does not have high visibility and few people outside of professionals. of health, are aware of its existence.
International research tells us that under-reporting of adverse drug reactions can be as high as 94%. So, are we now making room for Carm, or someone else, to oversee natural products?
Another concern is that if we model the regulation of natural remedies on the regulation of pharmaceuticals, where might it stop? Are we going to start seeing a situation where natural remedies cannot be brought to market, even without making therapeutic claims, because they must meet pharmaceutical safety assessment standards?
In such a situation, consumers would lose choice in how they want to go about managing their health. However, this concern has to be weighed against producers of natural therapeutic products who make unsubstantiated claims that may cause people to waste their money. We must balance any apprehension about the slippery slope of regulation with concerns about the consequences of unregulated markets.