Reported by Lai Yu-Jen from Taipei
From next year, all drugs manufactured or sold in Taiwan have to be produced by manufacturers in compliance with the PIC/S GMP. Those who do not have a valid PIC/S GMP certificate will not be allowed to manufacture drugs or apply for NHI reimbursement. Legislator Lin Shu-Feng (DPP) and the NHI Supervision Alliance held a press conference on the 18th and pointed out that 59 manufactures had not yet obtained the PIC/S GMP certificate, affecting 7215 drugs. Legislator Lin suspected that the MOHW intends to go easy on those products and might allow drug companies to continue supply products manufactured this year.
According to the DOH’s announcement issued on July 30, 2009, from January 1, 2015, all manufacturers must be PIC/S GMP certified so that they can carry on manufacturing and selling pharmaceutical products in Taiwan; otherwise, the NHIA can refuse to reimburse drug fees. Teng Xi-Hua, the spokesperson of the NHI Supervision Alliance, pointed out that there are still 59 manufactures not yet being PIC/S GMP certified. 7215 drug licenses are involved. Among them, 36 manufacturers are in need of improvement and 23 haven’t filed the application at all. In reply to the question, the TFDA expressed that the law only requires those drug companies without the PIC/S GMP certificate to stop manufacturing; however, it does not mean that they should stop trading. This interpretation will encourage those drug manufacturers to stock up old drugs, said Teng.
Teng Xi-Hua said that those 7215 drug licenses are common medications for problems of digestive system, dermatology, tumour, respiration system, cardiovascular system, etc. Patients will have difficulties to access those drugs if they are not reimbursed by the NHI. Those drug manufacturers are using consumers’ agonies as leverage, said Teng.
Legislator Lin Shu-Feng blamed the MOHW for playing a passive role in pushing the implementation of the PIC/S GMP. Lin pointed out that drug companies’ hoard of old drugs will pose health risk to the public. The government should request those manufacturers to obtain the PIC/S GMP certificate as soon as possible without any compromise. She suggested that the TFDA should immediately inform all hospitals of drugs in question and should request the NHIA to stop reimbursing those drugs until the manufacturers obtain the PIC/S GMP certificate. In the meantime, the authority should have a contingency plan for drug shortage.
Chen Chan-Bin, a researcher of the NHIA, replied that the NHIA has the obligation to reimburse hospitals for the use of any drugs approved by the regulatory authority. Unless the regulatory authority abolishes the old CGMP certificate, the NHIA cannot reject reimbursement. Huang Cin-Liang of the TFDA expressed that the latest data shows that another 90 manufacturers have obtained the PIC/S GMP certificate, 30 are making improvement to meet the standards, and as for the rest, many of them would not apply for the PIC/S GMP because the sites and equipment are just too old. Those manufacturers plan to contract out the manufacturing process to qualified manufacturers.
Lien Hung-Rong of the TFDA expressed that the future of about 5000 drugs is pending, awaiting the outcome of their manufacturers’ application of the PIC/S GMP certificate. Hospitals will be able to inquire the TFDA about which drugs are banned from manufacturing. A platform is already in place for coordinating the supply of drugs and for receiving hospitals’ reports in case of shortage.