Reported by Deng Quei-Fen and Lee Shu-Jen from Taipei
The MOHW announced on Monday (the 3rd) that six cell therapies will become accessible in Taiwan from the 4th of September. Patients who would like to receive cell therapies will no longer need to wait for the opportunity to take part in clinical trials or travel abroad for expensive treatments. According to the MOHW, those cell therapies are not restricted to cancer patients. They are also available to non-cancer patients, such as patients with severe burns. The MOHW estimates that tens of thousands of patients will benefit from this new policy.
Teng Xi-Hua, the spokesperson of the NHI Supervision Alliance, urged the MOHW to properly regulate the fee charges because stem-cell therapies, gene therapies, immunotherapies, etc. are expensive and of high risk. Teng suggested that the government should set the ceiling prices and a uniform fee schedule. Chi Chun-Lin, the President of the Taiwan Cancer Immune Cell Association, hoped that hospitals would publish their fee charges so as to keep patients informed.
Chen Shih-Chung, Minister of the MOHW, expressed that the MOHW’s decision of giving the green light to six cell therapies is based on their safety assessment. Shi Chung-Liang of the MOHW also stated that the six cell therapies soon to be available in Taiwan are all autologous cell therapies which are relatively safe and effective. According to the MOHW’s announcement, these six autologous cell therapies are available to late stage cancer patients, as well as patients who have failed to respond to stages 1-3 cancer treatments.
To support the new policy, the MOHW has drafted the Regulations Governing Regenerative Medicinal Products. The draft includes regulations on donor’s eligibility, the issuance of conditional temporary licenses, post-marketing surveillance mechanism, etc. These regulations are to ensure the quality, safety and efficacy of regenerative medicinal products, to protect patient’s rights and to support the development of regenerative medicinal products.
Shih Chung-Liang pointed out that almost every major medical center in Taiwan already has the experience of clinical trials of cell therapies. Hospitals are ready to provide those cell therapies after receiving the TFDA’s approval on their documents and lab facilities.
Chi Chun-Lin urged patients not to consider cell therapies the only option and not to make decisions too hastily.
In responding to the high costs of cell therapies, Shih Chung-Liang stated that the fee charges have to be pre-approved by the central and local governments. The government will make every effort to protect patient’s rights and to ensure that the charges are lower than those in other countries. Chen Shih-Chung encourages hospitals to provide cell therapy treatments under the policy of “no results, no fees”, like the drug companies guarantee on immunotherapy products.
【2018-09-04/ United Daily News】
