Association concerned with ‘generic’ drug quality

“About 85 percent of respondents in our survey believe that generic drugs’ curative ability and long-term stability is lower than for ‘innovative drugs’ already available on the market,” said Yeh Jin-ying, assistant professor at Taipei Medical University.

The term “innovative drugs” refers to drugs developed by research-based pharmaceutical companies, as opposed to “generic drugs” which are produced by companies once the drug’s original copyright has expired.

The survey, which was conducted on physicians from 20 different medical associations, also shows that once a generic drug is substituted for an innovative one, 70 percent of the respondents felt they had experienced an improvement in medical treatment.

“To the respondents, quality and curative effects are more important than the drug’s price or the hospital’s financial situation,” said Yeh.

According to the IRPMA, the research and development costs associated with the introduction of new drugs on the market are evaluated at hundred of millions of dollars, given that four phases of testing are imposed by medical authorities. Yet the 15-year period in which a company’s copyright is protected is extremely short.

On the other hand, generic drugs do not have the burden of clinical studies, which therefore makes their price much cheaper.

Now, because of the high costs of medicine in the current health system, the IRPMA said it understands that the Bureau of National Health Insurance promotes the use of generic drugs. However, it also stressed that authorities should pay more attention to the quality of generic drugs and ask for clinical studies before allowing them on the market.

Accordingly, IRPMA made various suggestions in order to test the quality of generic drugs, such as implementing random tests to trace the origins of the medicine’s components.

For reference, generic drugs are usually made by local companies that have succeeded in manufacturing a medicine, for which its original copyright has expired.

However, yesterday’s conference was not endorsed by the Taiwan Pharmaceutical Industry Association (TPIA), which issued a statement decrying IRPMA’s arguments.

For instance, TPIA said 70 percent of the medicine covered by the Bureau of Health insurance is generic, while the quality of these generic drugs’ contents is supervised by the government.

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