A therapeutic substance is something that has a therapeutic effect on the body. This means that it has a healing or remedying effect. It does not mean that it is a drug.

A drug is a type or class of substance that has been defined as such by a statutory body. Thus, the word ‘drug’ is a defined term; it has no bearing on the therapeutic value of a material. In order for a substance to be defined as a drug it usually has to meet certain criteria. We are referring, of course, to drugs usually used in the field of medicine. There are many valuable therapeutic materials which are not classified as drugs. In fact, at one time, substances such as insulin, penicillin and acetyl salicylic acid (now aspirin) were not drugs. What, then, is the purpose of a drug, and why are some therapeutic preparations classed as drugs and others not? The answer to these questions involves two factors. One is advertising; the other is government subsidy.

Whilst there are other reasons for therapeutic substances being registered as ‘drugs’ by the appropriate governmental authorities, the main ones concern the two conditions above, which, in turn, concern money. In order to explain what is meant by this it will be necessary to generalize, otherwise we will become involved in a lengthy discussion involving the laws relating to the sale of foods and drugs.

Registration of drugs

Under the appropriate laws of most countries the advertising of therapeutic properties of any substances which are not registered as drugs is prohibited. Thus, in effect, it is illegal to claim that ‘an apple a day keeps the doctor away’ because this is making a therapeutic claim for apples, which are not classified as a drug. If apples were to be put through the trial procedures and production requirements which would satisfy the drug licensing authorities, then it would become legal to make the claim as written. Obviously, this is a far-fetched example, but it is quite pertinent. This is the advertising factor. Basically, it means that unless a product is registered as a drug it cannot be advertised for its beneficial properties and thus its commercial potential is considerably hampered.

On the aspect of subsidy, drugs are eligible for inclusion on prescription lists. This means that they can be prescribed by practicing physicians and the cost of them will be subsidized

ó the government. Not all countries have this system of prescription drug subsidy, but where it is available only registered drugs are usually allowed to be treated this way. Therefore, we can have the situation of a valuable therapeutic substance that doctors cannot prescribe because it is not a classified ‘drug’. The doctor can, of course, recommend a patient to use this particular substance, but the patient must pay for it himself. If this is the case, why not have all therapeutic substances registered as drugs? The answer involves an explanation of the requirements for drug registration.

These requirements are such that valuable therapeutic materials do not qualify for drug registry because of some particular feature. This does not mean that they are not effective or safe. It might simply be that the material is of natural origin and that its absolute composition cannot be defined. Alternatively, the active part of the material may not have been identified or isolated and thus the criteria required in drug registry are not satisfied.

*31/48/5*