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GENERIC DRUGS
The decision to use generic medications has ultimately to be made in consultation with one's doctor, specialist or Pharmacist. Since they have the intimate knowledge of the patient's medical history, they would be in the best position to offer appropriate advice.
"In the long run, any medicine that is affordable to most patients is critical in ensuring that patients can adhere to their therapy, especially for chronic ailments such as hypertension, diabetes, arthritis, heart disease or hyperlipidemia. It is of no use to use a branded drug for a short period, and then stopping because of patient drop-out due to costs constraints. It is better to ensure that patients can afford whichever drug that is prescribed. Hence there is a great role to play for good quality generic drugs to ensure greater universal compliance with treatment.
"Generic drugs are important because they help to reduce the cost of prescription medications in any country. It is important for South Africans to be aware of the options when it comes to their medicines. Generic drugs do offer patients an accessible and affordable option. They play an essential role in maintaining public health.
Consumers have the right to know and make an informed decision based on the correct information which is readily available from your family doctor and/or pharmacists
• You can trust generic medicines
• Generics are approved by the Medicines Control Council
• Generics and branded medicines are equally effective and safe
• Generics cost less
SEP database - www.doh.gov.za
FAQ'S
WHAT ARE GENERIC MEDICINES?
A generic medicine contains the same active ingredients, has the same dosage strength, is safe, is equally effective and is therefore interchangeable with an original brand name product.
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 ultimately stretching your Medical Aid medicine benefits further.
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?
Generic companies spend less money on advertising, promoting and marketing their medicines, their development costs are also less and they employ highly efficient economies of scale in their manufacturing plant.
HOW ARE GENERICS DEVELOPED?
A company that first develops a new medicine is allowed to patent it, typically for up to 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 manufacture this product.
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 who check the product to ensure it is 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 is 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.
ARE THERE HAZARDS TO GENERIC SUBSTITUTION?
Strict control of safety, quality and efficacy of medicines in South Africa means that generic substitution make 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.
WHAT IS THE DIFFERENCE BETWEEN INNOVATOR DRUGS AND GENERIC DRUGS?
An innovator drug is the first drug of its kind to be discovered, developed and subsequently marketed by a pharmaceutical company. When a new, effective and safe drug is discovered, it is common for the pharmaceutical company that discovered the new drug to apply for patent protection.
A patent protects the company by not allowing other drug companies to manufacture or market the patented drug until after the patent expires. During the patent period, the drug is supplied exclusively by the innovator company and sold under the company's trademarked name. All new drugs have patent protection for a period of
at least 20 years.
After the patent expires, generic versions of the drug can be developed and marketed. Generic drugs manufacturers may market them under their own brands or under the drug's chemical name, also known as the international non- proprietary name (INN).
QUALITY OF GENERIC DRUGS
Before a generic drug can be marketed, it must be registered with the drug regulatory agencies (the Medicines Control Council - MCC in South Africa) in order to ensure that the generic drug meets the same quality, safety, dosage and performance standards as the innovator drug. In addition, pharmaceutical manufacturers are required to comply with the Good Manufacturing Practices as laid out by the MCC.
A significant number of consumers, including some healthcare providers, still hold the perception that generic medicines are not similar in efficacy and quality to innovator drugs. This is totally inaccurate. In fact, it is common for a local pharmaceutical manufacturer to produce both innovator drugs (under license from multinational drug companies) and generic drugs within the same facility. Many of these misconceptions are due to lack of awareness and understanding of generic drugs.
EFFICACY OF GENERIC DRUGS
Although the appearance of a generic drug may be different in shape, colour and size, it must, nevertheless, contain the same active ingredient as an innovator drug.
In addition, generic drug manufacturers conduct clinical efficacy trials such as bio-equivalence studies to establish efficacy. A bio-equivalence clinical efficacy trial study involves comparing a generic versus innovator drug in the same dosage under the same conditions on human subjects. This clinical efficacy trial is conducted on human test subjects to prove that the generic and innovator drug work and act in the same way on all test patients.
In short, the bioequivalence must show that the efficacy of the generic drug is exactly the same as the innovator counterpart. When the generic and innovator drugs are interchanged or substituted, no significant difference in safety and efficacy should be observed.
IF GENERIC DRUGS ARE AS GOOD AS INNOVATOR DRUGS, WHY DO THEY COST LESS?
The cost of a drug can be divided simply but broadly into two components - new drug discovery cost and manufacturing cost. The main cost of an innovator drug company goes into the discovery of the drug, the ensuing clinical trials to determine the safety and efficacy of that newly discovered drug and aggressive marketing campaigns.
Generic drug companies focus principally on the manufacturing process which includes formulation development, bio-equivalence (BE) clinical efficacy studies, stability studies, quality control and assurance, and therefore the "discovery" cost component does not feature in the cost equation. This is ultimately reflected in the competitive pricing of generic drugs, a benefit that is passed on to consumers.
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