Reported by Chiang Hui-Chun from Taipei
From January, all drug substances must be GMP-certificated in Taiwan. This new requirement has aroused concerns over drug shortage. The NHIA expressed that the authority is ready to request importers to make emergency purchases from the international market in case there is a drug shortage. The NHIA will provide unlimited budget to guarantee patients sufficient drug supply for at least a year.
Lee Cheng-Hua, the Deputy Minister of the NHIA, expressed that, pursuant to Article 41 of the NHI Act, essential drugs and drugs for rare diseases are exempt from drug price adjustment. Furthermore, they are subject to a maximum price increase of 30% if deemed necessary. Though there is a drug shortage reporting system in place, the NHIA encourages medical centers to report, of their own accord, on any drug shortage incidences so as to help the authority to monitor the situation.
The NHIA is studying how to use the international rescue mechanism as a contingency measure for drug shortage which might be triggered by the implementation of the GMP for drug substances. If there is a drug shortage, the NHIA will request importers to source drug products from the international market. The NHIA promised to set an unlimited budget enough to guarantee patients sufficient drug supply for at least a year. The NHIA has also requested large local manufacturers to prepare to expand production scale upon request.
Chi Row-Fong from the TFDA expressed that doctors and hospitals can report to the TFDA on drug shortage incidences at any time. The TFDA will take actions to protect patients’ medication rights by either specifying suitable substitutes or requesting manufacturers to increase production scale. Based on previous data, injections, oral medicines and eye medicines were the top three categories on the drug shortage list.
Teng Xi-Hua, the spokesperson of the NHI Supervision Alliance, criticized that this policy was announced in 2008, giving manufacturers sufficient time to make necessary adaptations. Their lack of preparation only shows that manufacturers are not serious about the policy. The government is meant to improve drug quality; however, they adopt a policy to keep cutting drug prices. This low price policy not only fails to keep original manufacturers in Taiwan, but also fails to assure the quality of generic drugs.
【2015-12-27/ United Daily News】