The Consumers’ Foundation acknowledges the MOHW’s parallel review system for new drugs, which will accelerate new drug listing and therefore benefit patients. However, the Foundation also expresses concern about the possible crowding-out effect, as the new expanded review agency will likely be funded by the NHI as a result of the reform. The Foundation urges the government to fund the review agency from the government’s general budget.
In a forum organized by the Consumers’ Foundation, Wu Jung-Ta, the President of the Foundation, told the press that the NHIA started implementing the parallel review system for new drugs this year, and has established a dedicated review agency. “If all review-related expenses are funded by the NHI budget, it may affect healthcare quality," said Wu, "as the NHI budget is already very tight.”
According to Wu, the new drug review process used to take 3 to 4 years, from the drug company’s submission, opinion collection, TFDA's review, to the final review by the NHI Drug Dispensing Items and Fee Schedule Joint Establishment Meeting.
During this lengthy process, over 1 year is contributed to the two reviews conducted by the TFDA and the NHI Joint Meeting. The two reviews have different objectives. The TFDA evaluates drug safety and efficacy, while the NHIA assesses the financial impact. Therefore, the parallel review system is implemented to streamline the process. This will reduce the total review time by 7 months.
To facilitate this new system, the NHIA set up a dedicated agency of 100 staff, with plans to expand to 300 in the future. The Consumers’ Foundation worries that this newly established large review agency will consume too much of the NHI budget and, hence, lower the NHI point-value.
Wu expressed that an NHIA staff member had informed him that although the review agency is currently funded by the general budget, after expansion, it may have to be funded by the NHI budget. He, therefore, urged the MOHW to promise to continue funding the review agency with the general budget to avoid impacting the quality of NHI healthcare.
【2024-03-19 / Central New Agency】
