Drug law too lax, says lawmaker

As Taiwan prepares to enter the WTO, stricter regulations on imported medications are needed to prevent disqualified pharmaceutical manufacturers from selling drugs even after their operations overseas are closed down, a DPP lawmaker said yesterday.

Due to a lack of clear regulations regarding the extension of drug certificates, drugs with false certificates can often be found in the market. This situation will deteriorate when Taiwan is admitted to the WTO and more drugs come onto the market, according to DPP Legislator Chang Ching-fang (張清芳).

By law, certificates are required for any drugs that are imported into Taiwan, Chang said, and to protect consumers, tight regulations are applied on issuing certificates for new medicines. But in contrast, he said, extensions for expiring certificates are not scrutinized closely enough.

The lack of an effective evaluation process has cast doubt on at least 60 drug certificates among more than 10,000 on the market, and it is also common knowledge that one certificate is often used for many different kinds of medicine. In addition, certificates and drugs are sometimes found to be mismatched, the lawmaker said.

While Chang commended the Department of Health for enforcing stricter controls on issuing certificates for new medicine, the lawmaker lashed out at the bureau's assessment procedures regarding the extension of old ones.

Under current practice, foreign pharmaceutical producers intending to renew their existing certificates need only present approval from two places -- one from the health department of the country of the manufacturer, the other from that country's Taiwanese embassy or representative office.

Certificates will be renewed as long as the written documents are submitted, and investigations are not carried out to verify the credibility of these papers, or the quality of these manufacturers' goods.

The lawmaker gave one example to reveal the severity of the issue. He said that Ford Laboratory, a pharmaceutical factory located in New Jersey, no longer exists, but is still selling drugs in Taiwan with valid certificates.

According to information provided by the Board of Foreign Trade's office, stationed in the US, Ford Laboratory was forced to shut down in 1995 due to tax evasion. But according to records of the Department of Health, the manufacturer still has 10 valid certificates in Taiwan, and eight of them were approved for extension between 1998 and 1999, Chang said.

Chien-min (健銘) Pharmaceutical Company, an agent for drug importation, is still selling drugs produced by Ford Laboratory.

Responding to the lawmaker's censure, Hu Yoa-pu (胡幼圃), director of the Bureau of Pharmaceutical Affairs, said that he had been informed of the abuse of drug certificates in February and the bureau had requested the responsible company to offer an explanation within a month.

"If [the agent] fails to provide a reasonable account within a month, we will order the questionable products be taken off the shelf," the official said. "But it is still within the one-month grace period, therefore the selling of Ford Laboratory products is still legal."