Aiming at the revision of the Regenerative Medicine Act, several non-governmental organizations and Times Power Legislator Chen Jiaohua (3rd from left) held a press conference today (2nd) to call on the government to "rein in the brink."

From left to right are Wu Rongda, chairman of the Consumer Culture and Education Foundation of the Republic of China, Kang Zhaozhou and Chen Jiaohua, directors of the Taiwan Pharmaceutical Regulations Association, Liu Shuqiong, chairman of the Taiwan Medical Reform Foundation, Wu Quanfeng, an associate researcher at the Institute of Law of the Academia Sinica, and Taiwanese recipients Teng Xihua, executive director of the Test Person Protection Association, and Wu Honglai, chairman of the Taiwan Patient Alliance.

(Provided by Legislator Chen Jiaohua Congress Office)

[Reporter Yang Chengyu/Taipei Report] The "Regenerative Medicine Law" and the "Regenerative Medicine Preparations Bill" are currently being negotiated in the Legislative Yuan. Some civil society groups and experts held a press conference yesterday to strongly question whether the restrictions on the implementation of regenerative technologies by medical institutions are too loose.

Wu Quanfeng, an associate researcher at the Institute of Law of the Academia Sinica, questioned whether general cosmetic medical treatment would also be in line with the draft of the Executive Yuan?

Kang Chiu-chou, chairman of the Taiwan Association of Pharmaceutical Regulations, questioned that if there is no rigorous scientific verification and review, regenerative medical technology and cell therapy products "may be no different from secret or folk remedies."

According to Article 9 of the original draft proposed by the Executive Yuan, medical institutions implementing regenerative technology, in any of the following circumstances, are exempted from the "Regulations on Regenerative Medicine Preparations" to apply for a drug license or license with additional fees.

1. The treatment of life-threatening or serious disability diseases, and there is no appropriate medicine or medical equipment in the country.

2. The safety and preliminary curative effect are confirmed by the results of human experiment.

3. The provision of cell therapy that does not contain genetically modified or transformed human cells and their derivatives.

A number of non-governmental organizations appealed yesterday that the treatment should be limited to life-threatening or severely incapacitated diseases, and there is no appropriate medicine in the country.

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Liu Shuqiong, chairman of the Taiwan Medical Reform Foundation, said that the second point allows medical institutions to implement allogeneic cell therapy technology with only preliminary human trials and curative effects under the "urgent needs of non-treatment of special patients".

The third point is that as long as domestic and foreign research literature is put forward as the empirical basis, it can be implemented on patients.

These two models may not meet the needs of treating special patients, and there is no urgent treatment, but the unknown blank authorization terms are equivalent to opening the door to convenience.

Wu Quanfeng pointed out that with regard to Article 9, most scholars do not object to the first point, and the original "mercy therapy" is also regulated in this way.

What everyone questioned is that the risk of regenerative medicine is relatively high, so why should it be used on patients who are not urgent?

Wu Quanfeng said that patients may spend a lot of money to get treatments with high risks and unclear curative effects.

If you are worried that the first point cannot be applied to rare diseases, then they should be included explicitly instead of opening such a big hole.

Otherwise, does general aesthetic medicine also comply with relevant regulations?

This problem is relatively large.

Kang Zhaozhou said that the draft regenerative medicine law emphasizes the need to ensure quality, safety and effectiveness, and to ensure the medical rights of patients.

However, many experts and scholars raised doubts.

Without scientific review in line with international norms, how can we ensure that products are in line with international regulations?

How can it be recognized by the international medical market?

Kang Zhaozhou also said that without rigorous scientific verification and review, regenerative medical technology and cell therapy products are "no different from secret or folk remedies."

Liu Shuqiong also mentioned that since 2013, Japan has successively enacted several regenerative medicine laws, and many phenomena have occurred since their implementation.

Citing the research results released by Kyoto University in February this year, she pointed out that there are five major problems, including loose clinical trial regulations and unscrupulous review, resulting in the prevalence of treatment, but the decrease in cell therapy research; about a quarter of the scientific basis attached to the application for treatment There are doubts; the doctor's profession is not closely related to the disease it is applying for; some official review committees themselves are providers of the technology, and there are conflicts of interest; more than half of regenerative medicine involves advertising violations.

Liu warns that unbalanced legislation will hinder a normal and healthy industrial environment.

Wu Honglai, chairman of the Taiwan Patient Alliance, is worried that patients who try regenerative medicine are usually tempted by "long-term illnesses that have not healed", but patients do not have the ability to distinguish the scientific basis of the therapy.

If the law opens a side door, will it form a loophole and induce the public to make irrational choices? This is also a problem that many patients worry about.

Teng Xihua, executive director of the Taiwan Association for the Protection of Subjects, also questioned that if health food endangers human safety, in addition to fines, there may even be criminal penalties.

In contrast, regenerative medical treatments cost millions, but the draft only has a fine.

Times Power Legislator Chen Jiaohua said that "regenerative medical technology" is mainly customized, and there is no standardization or standardization, but the draft does not expressly regulate whether the source of cells is autologous, allogeneic or heterogeneous.

The cells currently used under the "Special Measures" are autologous cells, and must comply with the "Somatic Cell Therapy Human Trial Application and Operation Specification" announced by the Ministry of Health in 2003. Should be strictly controlled.