Drug Information Q&A Q40. What is a "generic drug"?
Answer
A generic drug is a drug manufactured and marketed by another pharmaceutical company after the reexamination of an original drug has been completed and the patent for that product has expired. Generic drugs are drugs that have been approved as containing the same active ingredients, in the same quantities, and with the same efficacy and effectiveness as the brand name drug. Generic drugs are also called generic drugs.
Explanation
Generic drugs are manufactured and marketed without spending tens of billions of yen on research and development, as is the case with brand-name drugs, and are therefore priced at a lower level. The price is about 30 to 60% of the price of brand-name drugs.
Since 1961, Japan's medical insurance system has achieved the world's longest average life expectancy and a high level of insured medical care by establishing a system that allows people to receive necessary medical services with a certain level of co-payment. However, medical costs are expected to continue to rise in the future due to advances in medical technology and the aging of the population. In order to maintain universal health insurance, it has become important to ensure necessary medical care and to improve efficiency where possible. By promoting the use of generic drugs, it is possible to reduce the burden of drug costs without compromising the quality of medical care, while at the same time making more effective use of limited financial resources for medical care by encouraging the development of more innovative new drugs by giving them a higher rating under medical insurance. In April 2013, the Ministry of Health, Labour and Welfare (MHLW) formulated the "Roadmap for Further Promotion of Generic Drug Use," which includes the following items: "stable supply," "ensuring reliability of quality," "information provision measures," and "environmental improvement for promotion of generic drug use. The government is working with prefectural governments, pharmaceutical companies, and insurers to promote the use of generic drugs, with the goal of achieving a volume share of 60% or more by the end of March 2008. In our immediate surroundings, the prescription line has been changed to allow patients to switch to generic drugs unless otherwise instructed by their physicians. Patients themselves can also consult with their doctors and pharmacists about changing to generic drugs.
Chart/Column
40｜Generic drugs and original drugs (new drugs)
When both the reexamination period and the patent term for a new drug expire, it becomes possible for other pharmaceutical companies to manufacture and sell drugs with the same active ingredients as the new drug as "generic drugs. In order to manufacture and sell a generic drug, it is necessary to obtain a manufacturing and marketing approval from the Ministry of Health, Labour and Welfare. At this time, scientific evidence that the product is equivalent in quality and bioequivalence to the original drug is required.
Source: Adapted from JPMA Guide (2012-2013).
Recommended Contents
-
Let's have fun learning about basic knowledge of drugs and how to use them correctly with Capsule-kun!
-
Information for patients and their families on health conditions and provision of medical care.
-
As people get older, the number of medicines they take increases, causing side effects and making it difficult for them to take their medicines properly.
