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Embracing the benefits of generics

30 September 2010 Fedhealth
Dr Natie Finkelstein, Chairman of Fedhealth's Managed Healthcare Committee

Dr Natie Finkelstein, Chairman of Fedhealth's Managed Healthcare Committee

Generic medicines have been around for many years, and yet there still seems to be a general lack of understanding of, or confidence placed in generics.

In the minds of the lay public, a generic medicine or 'imitator' product, is often deemed to be inferior because it is cheaper than the branded or 'innovator' product. There may even be concerns in terms of its effectiveness - is it as safe or as strong as the originator ('innovator') medicine?

This needn't be the case however, believes Dr Natie Finkelstein, Chairman of Fedhealth's Managed Healthcare Committee. "Nowadays generics are bioequivalent to the original branded products and are a far more affordable medicinal option for many South Africans. They should be considered and recommended, where appropriate," he says.

However, in order for the public to start requesting generics, it first needs to be understood what generics are. Finkelstein explains that when a pharmaceutical or medicinal agent (drug) is discovered and manufactured, the manufacturer enjoys patent protection for a 15 year period. In this period, the manufacturer will generally recover the costs incurred during the drug's research and development phase. This drug in its pharmaceutical dosage form is known as the 'innovator' medicine (medicinal product). After 15 years, the patent expires and any generic manufacturer can produce a generic equivalent product and sell it at a lower cost and under a different trade name.

"However, it needs to be made clear that a generic medicine is also legally known as an interchangeable, multi-source medicine which means that it has to contain the same active substances which are identical in strength or concentration, dosage form (tablet, injection, suppository etc) and route of administration (i.e. oral, intravenous etc) as the innovator medicine.

All generic medicines are subject to bioavailability testing to ensure that they are bioequivalent to the innovator product. This means that the drug must be absorbed into the systemic circulation as quickly and in the same amount as the innovator. It should therefore have the identical therapeutic effect as the innovator."

Finkelstein points out that generics are generally charged at 40% or less than the cost of the innovator. "There is fierce competition in the generics market which is advantageous for South Africans, particularly in tough economic times. The stronger the competition, the more competitive prices become. Yet, South Africa is still ranked low in terms of generic usage when compared to Western countries worldwide. In the United States, for example, there is close to 70% generic usage. From 1999 to 2008, the USA saved $734 billion due to generic usage.

Moving forward, and in an effort to provide affordable healthcare for all South Africans, Finkelstein believes that generics will start to be recognised as sound alternatives to innovator products and medical professionals will prescribe them with more confidence. "The Medicines and Related Substances Act 1965, allows pharmacists to inform the public of the benefits of generics. Doctors too will start prescribing generics more readily in the future. Where there are requests from patients for cheaper generic alternatives, medical professionals will have to accede to such requests."

In terms of medical schemes, generics mean members get far more mileage out of their day-to-day benefits, especially those on chronic medication. "While there may not be generics available for all medications prescribed, there are many on the market. Members should consider generics, as these will assist in stretching their benefits, rather than them running out of benefits early in the year," says Finkelstein.

All allopathic medicines, including generics, are registered by the Medicines Control Council. They are evaluated against three criteria in order to be registered, viz. quality, safety and therapeutic efficacy. The active substances in a generic needs to be identical to the innovator and the generic is required to be of comparable quality and safety as well as be therapeutically effective to treat the symptoms it was designed to treat.

"The public should not be anxious about using generics, but appreciate the benefits they offer. It is highly recommended that should there be any concerns about changing from an innovator product to a generic equivalent product, the patient should be clinically monitored by the treating medical practitioner/specialist. The pros and cons of using a generic should be assessed and an informed decision made. While doctors and pharmacists have an obligation to educate their patients on generics, some responsibility also falls on the patient to pro-actively enquire and make educated decisions on their medicinal options," he concludes.

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