Questions and Answers
What are generic medicines?
Generic medicines are medicines that contain the same pharmaceutical material (active agent), with the same dosage and pharmaceutical form, administered via the same route and with the same therapeutic indication as the reference medicine in the country, presenting the same safety as well, therefore being interchangeable with the latter. Interchangeability, i.e., safe substitution of the reference medicine by the generic version, is assured by bioequivalence tests that are presented to the National Sanitary Surveillance Agency of the Health Ministry. This interchangeability can only be done by the pharmacist responsible for the pharmacy or drugstore, and must be registered on the medical prescription.
What are similar medicines?
Similar medicines contain the same pharmaceutical material, concentration, pharmaceutical form, administration route, dosage, therapeutic indication and quality as the reference medicines, but are not interchangeable with these. They are identified by a brand name and are also not interchangeable with generics and vice versa.
What are reference medicines?
These are usually innovative medicines whose efficiency, safety and quality were scientifically proven at the time of registration with the Health Ministry, through ANVISA. They are medicines that have generally been on the market for a very long time and have a well-known commercial trademark.
How can the existing medicines in the Brazilian market be identified as generics or branded medicines?
The difference is on the packaging. Only generic medicines have the phrase “generic medicine – law no. 9,787 of 1999” on their packaging, just under the name of the active agent. In addition to this, generics are identified by a big blue letter “G” printed over a yellow border, located on the lower part of the product packaging. This is what was established by RDC resolution no. 333, of November 19, 2003.
What is a pharmaceutical equivalence test?
This is the test done on the generic medicine, which should contain the same active agent, in the same quantity and with the same characteristics as the reference medicine. This pharmaceutical equivalence is required by Brazilian legislation and the tests are done "in vitro" (they do not involve human beings), in quality control laboratories qualified by the National Sanitary Surveillance Agency.
What is bioavailability?
Bioavailability is related to the quantity and speed of absorption of the medicine’s active agent into the blood stream. When two medicines present the same bioavailability in the organism, their clinical efficiency is considered comparable.
What is a bioequivalence test?
The bioequivalence test consists of a demonstration that the generic medicine and its respective reference medicine (for which clinical research was conducted to prove its efficiency and safety before the registration) present the same bioavailability in the organism. The bioequivalence test assures that the generic medicine is therapeutically equivalent to the reference medicine, i.e., that it presents the same clinical efficiency and the same safety as the corresponding reference medicine.
What is an active agent?
This is the substance within the medicine’s formula that is responsible for its therapeutic effect, i.e., its action in the organism. Also called pharmaceutical material.
Why are generic medicines cheaper than reference medicines?
Because the manufacturers of generic medicines do not need to make investments in research for their development, since the formulations have already been defined for the reference medicines. Another reason why generics have lower prices is related to marketing. Generics manufacturers do not need to advertise, because there is no brand to be publicized.
Which are the actions developed for creating generic medicines?
The central point in these actions is seen among the guidelines of the national medicines policy that was approved in October, 1998 (GM ordinance no. 3,916/98), the instrument that has come to direct all the actions of the Health Ministry, in the field of medicines for the public sector. Thus, on February 10, 1999, through law no. 9,787, the legal basis was established for generic medicines and for powers bestowed for ANVISA (National Sanitary Surveillance Agency) for the regulation of registration conditions and quality control. Before that, there were no generic medicines in the country: only branded and similar medicines, which utilized the name generic.
What are the advantages of generic medicines?
- To offer the population medicines with better quality, safety and efficiency that have been proven through tests to present pharmaceutical equivalence and bioequivalence;
- To make lower-priced medicines available, since generic manufacturers do not need to invest in advertising, nor in research to develop them;
- To reduce the prices of reference medicines, through the entry of competing medicines (generics);
- To contribute towards increased access to medicines;
- To strengthen national companies;
- To change the behavior of health professionals (prescribers and dispensers);
- To provide technological development for the industry and consequently for the country.
How can the quality of generic medicines be guaranteed?
Generics have the same quality as the reference medicines, since pharmaceutical equivalence and bioequivalence tests are done prior to the granting of registration by ANVISA. These tests are performed in laboratories at institutions such as USP – Universidade de São Paulo (University of São Paulo), Unicamp – Universidade Estadual de Campinas (State University of Campinas), UFC – Universidade Federal do Ceará (Federal University of Ceará), Santa Casa do Rio de Janeiro and others. Additional information can be obtained in the sections on “Bioequivalence Centers” and “Laboratories and Qualified Centers – Pharmaceutical Equivalence”. The entity responsible for the quality guaranteeing of the medicine is the manufacturer. It is ANVISA’s duty to monitor the quality assured by the manufacturer and the bioequivalence conditions, through systematic sanitary inspections.
What is the difference between the packaging for generic medicine and the packaging for other medicines?
Reference medicines and similar medicines are commercialized with a brand name. The generics are commercialized with the name of the active agent and they have a yellow border with a prominent letter “G” printed on the package, with the wording: “Generic Medicine – law no. 9,787, of 1999”, in conformity with RDC resolution 333 of November 19, 2003.
What factors have stimulated the growth in the world market for generic medicines?
- The expectation that 35 billion dollars in medicine patents will expire over the next few years;
- The growth in health costs;
- The aging of the population with the increase in chronic diseases, which causes high public expenditure on the health sector;
- The dissemination of new and more expensive medical technologies; and
- The decrease in mortality and the increase in prospects of life for the population.