Kenya: Generics Not Only Cheap but Safe, Effective

Barely months after the uproar caused by a Kenyan insurance company's directive that doctors only prescribe generic medicines, the generic-versus-branded drugs debate has once again been resurrected by events thousands of miles away.

PATENT PROTECTION

A few days ago, the CEO of American biotechnology firm Gilead Sciences, Inc. was hauled before the United States Congress over the exorbitant price of one of its flagship drugs, Truvada. A critical antiretroviral used mainly to prevent HIV infection for high-risk populations, such as call girls, Truvada was recently introduced in Kenya for use in the pre-exposure prophylaxis (PrEP) programme.

A monthly dose of Truvada costs $2,000 (Sh200,000) in the US but less than $10 (Sh1,000) in Australia and many other countries. Under pressure from firebrand freshman Congresswoman Alexandria Ocasio-Cortez, Mr Daniel O'Day proffered an explanation.

Apparently, Truvada enjoys patent protection in the US but not in other countries. It is, therefore, marketed as a branded medicine in the US and a as a generic drug elsewhere.

A branded drug is one developed by a pharmaceutical company through a research and development process. Because companies invest heavily in a new drug, they are given the sole right to manufacture and distribute it for a period of time. During that time, the company has a patent on the drug to enable it to recoup the development costs.

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Generic drugs are 'copies' of the branded ones. They are produced when the patent of a brand medication expires or a government gives explicit permission for its production in the public interest.

A generic version of a drug is similar in dosage, safety, strength, performance, route of administration, quality, stability and effectiveness as the brand-name version. It contains the same active ingredient(s), works in the same way and provides the same clinical benefit.

STRINGENT STANDARDS

Importantly, generics should not be mistaken for counterfeits, which are illegally manufactured copies that may or may not contain the same active ingredient(s) as branded drugs. Besides, they must also meet stringent quality and safety standards like the brand-name version of the drug.

As with Truvada, generic drugs are often substantially cheaper than their branded versions. Many people, therefore, become concerned and think their quality and effectiveness is compromised to make them less expensive.

But generics are only cheaper because the manufacturers did not incur research and development expenses. Also, multiple generic companies are often approved to market a single generic product, which creates competition and, typically, results in lower prices.

Generics are emerging as the future of the pharmaceutical industry even in the developed world. Besides increasing access to life-saving medications, their safety and efficacy has been proven to be at par with brands.

Continuous vigilance is, however, required to prevent infiltration of counterfeits into the generic drugs market, which would decrease public confidence in the safe and affordable generic medicines.

Dr Kivuva, a pharmacist in Mombasa, is a postgraduate student at the University of Nairobi. [email protected]

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