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A generic medicine is an alternative brand of a medicine that has been on the market for many years. For a generic medicine to be approved for sale, it must contain the same active ingredient; in the same dose and strength; have the same onset of action; stay in the body for the same amount of time; and work in the same way as its brand name equivalent.
The government, through the Therapeutic Goods Administration (TGA), applies the same strict regulatory criteria to the generic medicine as are applied to the originator brand, ensuring its safety, efficacy and quality is to high standards. Generic medicines are therefore considered to be interchangeable with the brand equivalent without compromising patient care.
All ingredients – active or inactive – in any medicine, be it expensive brand or generic, must be evaluated for quality, safety and efficacy, and approved for sale by the TGA before introduction into the market, and regularly thereafter.
All ingredients in a medicine are listed at the end of the Consumer Medicine Information (CMI) document that is available for every medicine.
All medicine manufacturers must comply with the globally recognised standards of Good Manufacturing Practices (GMP) for their medicines to be sold on the Australian market. The TGA won't permit medicines made in substandard facilities, and conducts both routine and unannounced inspections to ensure standards are met.
Sometimes trademark laws do not allow the generic medicine to look or taste exactly like the originator brand, so there is a difference in colour, shape, size or flavour. Excipients that make the generic medicine look or taste different to the originator are still carefully chosen so that they do not affect the way the active ingredient works. Sometimes the newer version of a medicine is less likely to contain some of the older excipients, which, although technically inactive, may be known to cause sensitivity problems for some patients.
Irrespective of any differences that may exist between excipients, the active ingredient must be the same.
Firstly because they may cost you less, which provides you better value for money. And secondly, they also provide value for money for our health system because of the way medicines are subsidised by the government.
When a medicine is discovered, the company that develops it may apply for a patent. The patent provides the company with a competition-free period of up to 25 years, to allow it to recover research and development costs and profit from the discovery. A generic medicine can enter the market when this patent has expired. Generic medicines are less expensive because the manufacturers don't have the initial investment costs of the developing company.
Further, when generic medicines enter the market, there is greater competition, which can bring prices down. The government also subsidises medicines through the Pharmaceutical Benefits Scheme (PBS). However, some brands charge a higher price than the government is willing to subsidise. The difference between the subsidised price and full price is passed on to the consumer by the manufacturer as a brand premium.
As of December 2007, brand premiums ranged from $0.06 to $79.48, the average being around $2 per medicine. If you consider a few dollars difference on several medicines over the course of a year, the savings can be quite substantial. In fact, Australians pay approximately $100 million per annum in brand premiums.
For example, if you are taking medicines for managing diabetes, blood pressure, cholesterol and reflux, you could be paying more than $200* per annum in premiums.
*Annualised additional cost of Brand Price Premiums, as at December 2007.
Many doctors are happy for you to choose which brand of your medicine you wish to take. If, for some reason, the doctor wants you to take a specific brand, they will make this known to the pharmacist by filling in a particular section of the prescription.
Alphapharm pioneered the availability of generic medicine to Australians and have been making medicines here since 1982. Along the way we have spent millions on R and D, and have become the largest Supplier of medicines to the government subsidized PBS.
Alphapharm medicines are made to the highest global quality standards and exported to more that 40 countries, including the Europe and the US. In fact, millions of Australians take an Alphapharm medicine every day.
So why wouldn't you choose Alphapharm - Australia's leader in generic medicines.
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