When a medication is first filed, a patent is often placed on the formula. The brand name medication can then be sold without any competition. After a certain period of time, usually 20 years, the patent expires. At this point, generic versions of the same medication can be made and sold. It usually takes two to three years and about a million dollars to develop a generic copy.
All medications are made up of active and inactive ingredients. The active ingredient is the actual medicine that makes you feel better. Inactive ingredients, or fillers, give the medication shape and colour.
Active ingredients in both brand and generic medications must meet strict requirements set by Health Canada. Generic makers must prove that active ingredients are comparable to those in the brand medication. Ingredients must:
To prove that a generic medication is safe and effective, makers can test in one of two ways. The first involves repeating all tests originally done by the brand maker on the generic medication. Clinical trials, animal and human studies may all be involved.
The second option compares generic to brand medication using a series of bioequivalence tests. If two medications affect the same part of the body in the same way, they are bioequivalent.
Most generic makers prefer the second method. The first choice of repeating all of the clinical trial testing is just that – a repeat. The brand product has already been proved safe and effective by the original studies and research. It is more efficient to show the generic medication safe by comparing it directly to the brand.
Each batch of medication is also tested during and after production to make sure it is safe and effective.
The main difference between a generic and a brand medication is the price. Generic medications are usually less expensive than brand versions. More than 40 per cent of all prescriptions in Canada are filled using generics. However, of the $17.8 billion spent on prescription medications in 2006, generics only accounted for 18 per cent.
Brand and generic versions may also differ in appearance. Some look completely different. Others only vary the markings on the tablet or capsule.
As more people in our society reach middle age, more stress is placed on our health care system. The system must survive for years to come if future generations are to use it. To address this concern, provincial and some private drug plans have adopted ‘generics first’ policies. When possible, generics are used instead of the more costly brand name versions. Hospitals are already using many generic products.
Talk with your doctor or pharmacist about whether generics can be used to fill your prescriptions. If a generic is available for a particular medication, the pharmacist often automatically uses it to fill the prescription. This may be true even if your doctor wrote the brand name on the prescription. Unless the doctor notes a particular manufacturer of the medication, or that no substitutions can be made, a generic version may be used.
If you would prefer to use the brand name product, just ask the pharmacy to do so before the prescription is filled.
Some medications, such as clozapine, cannot be substituted. Each clozapine maker uses a different system to monitor side effects. Switching from one brand to another is only allowed if the doctor completes certain paperwork.
Some medications are only available as brand because the 20 year patent has not run out yet. For instance, Viagra™ (used for difficulties with penile erections), Lipitor™ (used to lower cholesterol), and Avelox™ (an antibiotic), are still under patent.
On the other hand, some medications are only available as generics. In this case, the medications have been around for so long that the brand makers have stopped making them. This is true of amoxicillin (an antibiotic), hydrochlorothiazide (a diuretic or ‘water-pill’), and prednisone (a corticosteroid).
Knowing the facts can help in making the decision between generic or brand name medication. Keep in mind that generic medications in Canada are strictly regulated. These measures exist to make sure medications are safe and effective. As generics usually cost less, they can help reduce health care expenses. While they usually resemble brand name versions, sometimes the two can look quite different.
Generic medications may be best if price or coverage by an insurance plan is an issue. However, some of us tolerate certain makes of medications better than others. Colours, fillers and preservatives used by different manufacturers can all affect the way you respond. If you are sensitive to these things, you may prefer not to switch. Being aware of how your body responds is important.
Ultimately, you are the person who will use the medication. You need to be comfortable with your choice. Don’t hesitate to ask questions! Be sure that your pharmacist and doctor answer fully so that you are able to make an informed decision.