Guideline No. 02 - Disease State
Definition of “Disease” as per the Medicines Act 1981
In addition to the TAPS guideline on "Therapeutic Claim/Purpose" it is important to cover the issue of "disease" as defined in the Medicines Act. A "disease" or "medical disorder" is defined under section 2 "Interpretation" of the Medicines Act. These two guidelines are interrelated and it is useful to read the two prior to any advertising of a product without Ministerial Consent for a therapeutic claim as a medicine.
The definition is as follows:-
"Disease includes any injury , ailment, deformity, disorder, or adverse condition, whether of body or mind"
Like the definition for "therapeutic purpose" under section 2 of the Medicines Act this is comprehensive and embraces essentially any "abnormal functioning" or "abnormal physiological function" or any disorder of both the body and the mind. Both physical and mental disorders are therefore covered as well as any situation where there is infection of bacterial, viral, parasitical or protozoan type.
It covers even the simple things like "sore throats" and more generalised non-specific conditions like "pain".
It is therefore important in advertising products in the health/therapeutic area that the following are considered.
The product has Ministerial consent to make a claim for a "therapeutic purpose" following evaluation by Medsafe. The fees will vary from about $8000-$15000 depending on the complexity of the compound. The time involved is also difficult to estimate in view of the dossier required by Medsafe. This is best discussed directly with Medsafe. (c.f. Medsafe website www.medsafe.govt.nz under the heading Regulatory New Zealand Regulatory Guidelines for Medicines NZRGM Volume 1.) A company can then make a claim for a registered therapeutic purpose following Ministerial consent. This option may not be possible for smaller companies re the expense and time in compiling a regulatory dossier.
Not all products require Ministerial consent to market;
Products do not contain a substance listed in the Medicines Schedules; and
Make only "health type claims" i.e. claims in support of the normal physiological or bodily function rather than for prevention, relief, alleviation, treatment or cure of a "disease" or "medical disorder" as outlined above;
do not require Ministerial consent to market and are permitted to advertise.
While this rule clearly limits the scope of claims that can be made for a product, the law has been drafted to permit consumers access to the product while preventing manufacturers from marketing products with misleading claims and claims that do not have the adequate burden of scientific support/evidence.
In order not to breach the Medicines Act it will be necessary to confine "health claims" to the help and support of the normal physiological function that might also be responsible for combating a disease, injury, ailment or adverse state.
Note that nearly 60 specified "disease states" or "medical conditions" are outlined in the First Schedule Parts 1 & 2 of the Medicines Act. Unless Ministerial Consent has been granted then any claim in advertisements made to "prevent, alleviate, or cure any disease, or prevent, reduce, or terminate any physiological condition specified (in the First Schedule) would be a breach of section 58 of the Medicines Act. It is important to note that in Part 2 both the "common cold" and "influenza" are specifically mentioned. Essentially these are all the common disease states or medical conditions.
Care is therefore needed in claims relating to the above.
Making a Therapeutic claim
It should be noted that the appropriate gold standard required for applications to market a product making therapeutic claims such as preventing or treating a disease or medical condition is double blind randomised controlled trials in human subjects with the relevant disease state.
"In vitro" or "laboratory tests" and "trials in animals" are not sufficient to establish a claim for a "therapeutic purpose". Evidence derived from this type of approach is subject to many confounding factors and these are unreliable models of the human physiological response to a substance. At best "in vitro" or animal models can only generate a hypothesis that the product may have some effect in humans. Adequately conducted clinical trials in appropriate patient numbers are required to confirm or test the hypothesis.
