Generic Drugs
 

1. What are generic drugs?
A generic drug is one which contains the same active substance in the same dose and pharmaceutical form, and is administered in the same way and with the same therapeutic dosage as the reference drug in Brazil. A generic can also be taken with the same degree of safety as the reference drug in this country and can be totally interchangeable with the latter. The Ministry of Health, through ANVISA, tests for bioequivalence between the generic version and its reference drug when the product is submitted by the manufacturers for quality testing.

2. What are "similar" drugs?
Similar drugs are those that contain the same active agent, the same concentration and pharmaceutical form, and are administered in the same way and with the same dosage and have the same therapeutic result as the reference (or branded drug), but which do not have the same bioequivalence as the proven reference drugs.

3. What are "reference" drugs?
These are usually innovatory drugs whose effectiveness, safety and quality have been proven scientifically at the time of their registration with the Ministry of Health, through ANVISA. They are drugs that generally have been a long time on the market and which carry a well known brand name.

4. How to identify the three types of drugs in the Brazilian market: generic, similar and branded?
The difference can be told from the pack in which the product is presented. Only generic drugs display on the outside of the box or package immediately under the name of the active substance which they contain the phrase "Generic Drug - Law 9.787/99." Furthermore, generic drugs will begin to be identified with a large letter "G" in blue, printed over a yellow emblem, located in the lower part of the packages which carry the products. This is all set forth in Resolution RDC 47, of March, 28 2001.

5. Does the generic drug have the same effect as the branded drug?
Yes. Generic drugs have the same therapeutic effect as the branded or reference drugs. The generic drug is the only that can be interchanged with the reference drug, since it has been submitted to bioequivalence testing.

6. Who carries out the tests that make it possible for a product to be registered as a generic?
The pharmaceutical equivalence and bioequivalence tests are carried out in centers that have been properly licensed by ANVISA. Click here to obtain additional information.

7. What is the pharmaceutical equivalence test?
According to Brazilian law, the generic drug should be pharmaceutically equivalent to its respective reference drug( ie it must contain the same active substance, in the same dosage and pharmaceutical form). The pharmaceutical equivalence tests carried out "in vitro" (no human beings involved), by quality control laboratories licensed by ANVISA.

8. What is the bioavailability test?
Bioavailability is related to the quantity absorbed and the speed of the absorption process of the liberated active substance in the pharmaceutical form administered. When two drugs present the same bioavailability in the organism, its clinical effectiveness is considered to be comparable.

9. What is the bioequivalence test?
The bioequivalence test consists of demonstrating that the generic drug and its respective reference drug (that for which clinical research was carried out to prove its effectiveness and safety before being registered) present the same bioavailability in the organism. Bioequivalence, in the great majority of cases, ensures that the generic drug is the therapeutic equivalent of the reference drug (ie: that which has the same clinical effectiveness and the safety level as the reference drug).

10. What is the active substance?
This is the substance in the formula of the drug responsible for its therapeutic effect. It is also known as the "pharmaco".

11. What should doctors do when prescribing the drug?
Prescription of generic drugs is obligatory only in the public health service (SUS). In other cases, it is up to the health professional concerned to use his judgement as to whether to prescribe the generic drug or one carrying the branded name.

12. Can the doctor refuse to change the branded drug for a generic?
The health professional can restrict substitution of the reference drug for the generic (interchageability). However, this particular instruction must be clearly and legibly written in his own handwriting.

13. If the generic drug is not available at the drugstore , how should the customer proceed?
The customer must ask the pharmacist for guidance on substitution of the drug, in accordance with the prescription, or seek another establishment which can supply the generic drug prescribed by the doctor.

14. What is the advantage of buying the generic drug?
Good quality of the generic drug, as confirmed by ANVISA, and on account of its lower cost as compared to the reference drug.

15. Why does buying the drug for its active ingredient lower its price?
The manufacturers of generic drugs do not need to invest in research to develop the drug, because the formulas are already defined for the reference drugs and serve as parameters for the production of the generics. A further reason to be taken into account concerns marketing. The manufacturers of generic drugs have no need to advertise the product, since the generic drug carries no brand name.

16. Is a prescription needed to buy a generic drug?
Yes. Any drug, except ones that can be sold freely, whether a branded, similar or generic drug, must be sold under medical prescription. Self-medication is a dangerous practice.

17. Are generic drugs available in other parts of the world? Have they been successful?
The United States and many European countries have had such policies for over 20 years. The world market for generic drugs is growing by about 11% a year. In the United States, prescriptions of generic drugs account for around 42% of all prescriptions. The United States, Japan and Germany account for approximately 60% of the world generics market and its growth is inevitable. Drugs sold under the name of the active substance are so successful that in the US market the average cost to the user represents a saving of 30% over that of branded drugs.

18. Do the foreign drugs companies in Brazil manufacture more similar than generic drugs? What about Brazilian manufacturers?
The foreign drugs companies operating in Brazil manufacture more reference or branded drugs because they carry out research in large high technology facilities in their country of origin and make huge investments in working capital in this research. Nevertheless, these international companies do produce "similars" and are capable of can manufacturing generic drugs. Brazilian companies in fact have a larger output of similar drugs. At present, generic drugs are being manufactured by Brazilian companies.