South African HCPs told to ‘get their facts straight’ on generics

Generics/General | Posted 08/11/2013 post-comment0 Post your comment

The South African National Association of Pharmaceutical Manufacturers (NAPM) urged healthcare professionals (HCPs) to ‘get their facts straight’ with respect to generics at a special workshop held at the Johannesburg Country Club on 17 October 2013.

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The workshop, titled ‘Generics, Get the Facts Straight’, discussed the manner in which generics are developed and registered in South Africa. In order to address the concern that some HCPs have over the fact that generics are not tested in humans, Professor Jacques Snyman, former head of the Department of Clinical Pharmacology at the Steve Biko School of Medicine, described how bioequivalence studies are carried out. He referred to trials which showed overall differences between standards in brand-name medicines and generic drug equivalents to be in the region of 3.5%. He also indicated that when most originator companies made improved versions of older drugs, they did not repeat the clinical trials but used bioequivalence to show non-inferiority.

Other topics addressed at the workshop were the ethics of prescribing medicine and the way formularies were developed for the physical and economic welfare of patients. It was pointed out that patients had a right to be informed and communication was one of the ethical duties of a healthcare professional, and that other considerations, such as affordability, were secondary to the patients’ interest.

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Source: NAPM

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