Generic & Biosimilar Medicines Southern Africa
Your Questions Answered
WHAT IS A GENERIC MEDICINE?
A generic medicine is identified either by its own brand name or by its internationally approved scientific name.
WHY GENERIC MEDICINES?
Generic medicines provide a major benefit to you as they ensure that you and your family have access to quality, safe and effective medicines while reducing your medicine costs and if you are a medical aid member ultimately increase your medicine benefits further. Generic medicines account for a major percentage of all prescriptions dispensed in Britain, according to their Department of Health, likewise in the USA. In South Africa generic medicine use is between 50% and 60% of dispensed medicines.
ARE GENERIC MEDICINES APPROVED BY THE MEDICINES CONTROL COUNCIL?
In South Africa, all medicines including generics must be approved by the Medicines Control Council, an independent and impartial statutory council that exercises its powers in terms of the Medicines and Related Substances Control Act (101 of 1965).
WHY ARE GENERIC MEDICINES LESS EXPENSIVE?
HOW ARE GENERICS DEVELOPED?
A company that first develops a new medicine is applies for a legal patent, typically for 20 years. This allows the innovator a period of exclusive supply, enabling it to recover its research and development costs.
Once the patent expires, generic companies can then copy, register and manufacture the medicine.
ARE GENERIC MEDICINES AS EFFECTIVE AS BRANDED MEDICINES?
Generic medicines are subject to the same stringent controls as branded products. In fact branded and generic medicines are sometimes made by the same company.
Generic medicines contain the same active ingredients, are of the same dosage form and are identical in strength to the original medicine. They work in the same way in the body and are associated with the same benefits of the original medicine.
The Medicines Control Council employs a team of doctors, scientists and pharmacists who investigate the product to ensure its safety, quality and efficacy.
While the generic has the same key clinical characteristics as the branded product, it can be of a different shape or colour, or may be packaged differently.
DO I NEED TO KNOW ABOUT GENERIC SUBSTITUTION?
The Medicines Control Amendment Act which came into force on May 2, 2003, places a legal obligation on person dispensing the medicine, either the pharmacist or the doctor, to inform patients of generic medicine options is one exists.
ARE THERE HAZARDS TO GENERIC SUBSTITUTION?
Strict control of safety, quality and efficacy of medicines in South Africa means that generic substitution makes good sense. Many doctors already prescribe generically where they feel that the use of a generic rather than a branded medicine would be of equal benefit to their patients.
Both originator and generic medicine companies are obliged to have a tracking system, which is called pharmaco-vigilance. Through this system any problems with medicines can be reported by healthcare professionals or even patients. Should there be any problems the MCC would order the recall of a medicine.
WHO IS GENERIC AND BIOSIMILAR MEDICINES OF SOUTHERN AFRICA (GBM)?
This body is an association of generic medicine manufacturers who make and /or supply generic medicines. The Membership comprises both local and international pharmaceutical companies.
This Not for Profit Company is an extension of the National Association of Pharmaceutical Manufacturers (NAPM) which was founded in 1977 to promote the use of generic medicines.
The reason for the name change in 2017 was to incorporate the utilization of biosimilar medicines, a close copy of biotechnology medicines, which patents have expired. The aim is to create greater access for patients to these highly targeted and effective medicines through a reduction in price.