Reported by Chen Jing-Jer from Taipei
The number of reports of drug shortage has increased from 12 cases in 2011 to 128 cases in 2015. It is reckoned that the low drug price policy in Taiwan and international competition are the main reasons behind the drug shortage. This problem is found not only in Taiwan, but also in the US and Europe. The TFDA recently held an international conference on drug shortage with an attempt to resolve this pressing issue.
According to Pan Xiang-Ing, a Section Chief of the TFDA, the compliance with the PIC/S GMP becomes compulsory this year. As of January, 48 drug companies were yet to pass the PIC/S GMP assessment. 24 of them gave up; and 24 of them are still in the process of reassessment. As a result, the supply of 3000 drug products has been affected. Some drug manufacturers stopped the production of drugs whose prices are too low to cover the cost or to generate a reasonable profit.
The analysis of the shortage reports reveals that the majority of drugs in shortage were antibiotics, drugs for external use and anti-cancer drugs. Ms. Pang explained that the technical requirement is higher for antibiotic injections; therefore, if the payment price is too low, drug companies may decide to stop the production. Taking penicillin for example, there is only one manufacturer left in Taiwan. Any lapses in production will have a profound impact on the supply. Mr. Wang Shun-Mu, President of the TGPA, expressed that the NHIA has formulated a mechanism for re-negotiating prices.
Most anti-cancer drugs are new drugs which cannot be manufactured in Taiwan. The decision on drug procurement cannot be made simply based on prices. Global supply situation should also be taken into account. Ms. Pan said that drug shortage is an international problem, affecting every country. For example, in 2012, the US government passed a law to request drug companies to notify the authority of the risk of drug shortage at least 6 months in advance.
【2015-05-07 / Taiwan Hsin-Sheng Daily News】