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Updated 16 November 2009

Generic meds: the facts

Find out why generic medicine is just as good for your health as original brand names, and considerably better for your wallet.

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“Louis Vuitton” and “Burberry” are for sale on every street market. Are they for real? Check the price: of course not.

With handbags and shoes you might not care whether you’ve got the real thing, as long as it looks good. But your health is a whole different story. Nobody wants to risk their health by taking cheap medicine.

But generic medicines are not fake medicines. Strict regulations ensure that generics are made according to the same “recipe” as the original, and they are generally sold for significantly less than the brand-name product.

In fact, the availability of generic medicines is one of the few truly good-news-stories in a world of constantly rising medical costs.

Are they really as good?
Maybe because they are cheaper, or because the brand-name (or innovator) drug has been on the market for longer, people often mistakenly doubt the quality of generic medicines. Furthermore, some brand-name manufacturers have actively questioned the quality of some of their generic competitors. In a number of cases, the Advertising Standards Authority of South Africa has ruled against advertisements by major pharmaceutical companies that misleadingly created doubt in the minds of consumers regarding the quality and efficacy of generic medicines.

And in a high-profile case from the US, researchers linked to the pharmaceutical company Novartis questioned the bioequivalence of a major generic competitor to one of Novartis's brand-name antipsychotic drugs, Clozaril. Eventually, the US Food and Drug Administration ruled that there was no evidence that the generic drug is any different to the brand-name drug.

Some docs concerned?
Still, some doctors and psychiatrists have expressed doubts over the quality and effectiveness of generic alternatives. We have, for example, learned that the South African Society of Psychiatrists (Sasop) a few years ago convened a task team to look at the use of generic medications in the treatment of psychiatric disorders.

A preliminary statement from Sasop says that a perception had arisen amongst treating psychiatrists that in some cases the generic products were not as efficacious and cost-effective as the innovator products. "This is due to observations of relapses or lack of response to treatment when some patients are ‘switched’ to generic medicines, or even when they are used as the first option in treatment.

“There also seem to be similar perceptions in the minds of the consumers (patients) who choose to use generic drugs as first line treatment, or switch to them at the insistence of their medical aids, or due to financial constraints, and experience them as being less effective or not effective at all," the statement said.

Apart from anecdotal evidence, Sasop has not yet offered any published research to back up their concerns. And it should be noted that Sasop and their activities are in part funded by the pharmaceutical industry.

Why generics are safe
The reality is that generic medicines are by law subject to the same strict regulations and approval processes as brand-name drugs and must meet the same standards of good manufacturing practice (GMP). The mere fact that the Medicines Control Council (MCC) has allowed the generic medication onto the market should offer you all the reassurance you need to know that you are not getting an inferior product.

It is, for example, worth pointing out that Aspen Pharmacare (South Africa's biggest producer of generic drugs) has manufacturing facilities accredited by the US Food and Drug Administration.

Tough criteria
"A drug is only registered in South Africa if it meets MCC criteria," says Professor Peter Eagles, chairman of the MCC. "Our aim is to ensure that each generic drug mirrors the patented drug."

According to Eagles, particular attention is paid to the bio-equivalency of drugs with a narrow therapeutic index, where small differences in the amount of active ingredient absorbed into the body can result in dramatic reactions to the drug.

"If a product isn’t absorbed in a completely predictable fashion, we’ll look at it very carefully," he says.

He adds that the public should be informed about the generic equivalent to patent drugs at their pharmacy and other dispensing points, and that the use of generics should be vigorously encouraged.

Why are generic medicines cheaper?
Generics become possible when patents expire. The research and development of a new drug may total billions, and they are patented to give their developing company a period of exclusivity in which to recoup some of those costs. Brand-name drugs are generally given patent protection for as long as 20 years from the date of submission of the patent. When that protection expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the MCC.

As soon as generics are introduced, the brand-name drug looses its monopoly and normal market forces tend to drive down prices significantly.

Less defensible (though a market reality), though, is the fact that brand-name drugs can sell for more due to brand loyalty and a distrust of generic alternatives.

How are generic medicines different?
In terms of the active ingredient, generic drugs are no different to brand-name drugs. Whether 7-chloro-1-methyl-5-phenyl-1, 3-dihydro-2H-1, 4-benzodiazepin-2-one is called Valium (the brand-name) or diazepam (the generic name), it is still 7-chloro-1-methyl-5-phenyl-1, 3-dihydro-2H-1, 4-benzodiazepin-2-one.

The MCC requires that a generic drug deliver the same amount of the same active ingredients into the bloodstream at the same rate – and they’re very strict about this requirement.

The only differences between a brand-name and a generic drug are the inactive ingredients (preservatives, colourants and compounds to hold the medicine together), which is why the colour and flavour of generic drugs and their brand-name counterparts may differ.

- (Marcus Low, Health24, updated January 2013)

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