2024-08-30
On June 4th, the Legislative Yuan passed the Regenerative Medicine Treatments Act and the Regenerative Medicinal Products Act, two controversial pieces of legislation that had been stuck in limbo for nearly a decade. The signing of these acts into law will offer new protection for patients' rights and give the development of Taiwan's biomedical industry a shot in the arm.
Jarret Su (蘇嘉瑞), senior lawyer at the KPMG Law Firm, explains that these acts lay the ground rules for regenerative therapies. Intricacies such as the scope of coverage and the standards of cell therapy products are now less opaque. Medical facilities and biomedical companies have a clear path forward, and competent authorities have a basis for regulation.
What is regenerative therapy? In simple terms, it is a branch of medical science that utilizes the regenerative properties of cells to repair damaged tissues and organs.
For example, certain immune cells may be extracted from a cancer patient's body to be cultivated and multiplied so that they can be made into a cell therapy product, which can then be introduced back into the patient's body to combat the cancer. Under the new law, all cancer patients may opt to receive regenerative therapy that has been approved by the Ministry of Health and Welfare (MOHW)—unlike before, when such options were only made available to terminally ill patients or patients for whom all other forms of treatments had failed.
The two acts also clearly state that only medical facilities may provide regenerative therapies, and all cell therapy products used in regenerative treatments must be GMP-certified, the same as any other drug. This will prevent unethical practices in the market.
Over the past decade, cancer patients have been targeted by unscrupulous operators who sold them untested treatments for hundreds of thousands or even millions of Taiwan dollars. Other treatment providers touted unproven therapies that were purported to reverse aging or cure sleeping disorders. None of these products were properly tested or approved by the relevant authorities.
The new Regenerative Medicine Treatments Act bans these practices. Providing unauthorized treatments or advertising regenerative therapies without getting approval from relevant agencies can incur a fine of up to NT$20 million.
| Changes | Details |
|---|---|
| 1. Source of Law | The Regenerative Medicine Treatments Act and Regenerative Medicinal Products Act replace the “Regulations of Special Medical Techniques”. |
| 2. Medical Practices | Can only be practiced by medical facilities. No restrictions on type or stage of cancer, but procedure must be approved by the MOHW and registered with local competent authorities. |
| 3. Drug Production | Regenerative medicinal products are classified as drugs. The manufacturing or import of drugs must be registered with and checked by the MOHW. A drug permit license will be issued to products that pass the approval process. |
| 4. Compassionate Use | The MOHW has established a "regenerative therapy review committee". Patients with urgent medical needs may be issued a permit by the committee which authorizes them to use unlicensed regenerative medicinal products. The MOHW can approve the use of regenerative therapies without human trials or immediately after the completion of human trials. |
| 5. False Advertising | Advertisements for recruitment agencies, cell providers, and regenerative therapy providers must be registered with the MOHW. The effects of treatments may not be falsely advertised. Failure to comply may result in fines. |
| 6. Relief Measures | Medical facilities must prepare relief measures for adverse effects resulting from treatments, such as purchasing liability insurance. |
Deng-Chyang Wu (吳登強), CEO of the Regenerative Medicine and Cell Therapy Research Center at Kaohsiung Medical University, points out that in the past, the biomedical industry was afraid of major investments going up in smoke because there were no clear guidelines on how to apply for government approval. Now, abiding by the rules will reward operators with legal licenses to sell their drugs to those in need.
Once cell therapy products can be produced at scale, regenerative medicine will no longer be criticized as treatments that are "only for the affluent". Legislator Shiou-Fang Huang (黃秀芳), who was in charge of reviewing the two acts, opines that once the rules are in place, regenerative therapy will have the chance to become ubiquitous, which will further lower the cost of treatment.
According to an industry survey published by Precedence Research, the global regenerative treatment market is expanding rapidly. The market was valued at US$24.2 billion in 2022; it is expected to grow to US$174.7 billion in 2032, with a CAGR of around 22.8%. "Regenerative medicine is about to enter a new era in Taiwan," says Wu.
With all these benefits, why has it taken eight years for these important pieces of legislation to finally pass?
Huang explains that a previous version of the bill had a controversial line that read, "treatments that offer preliminary curative results may be exempt from human trials." Over a hundred medical experts petitioned to remove this, because overly lax regulations may infringe on patients' rights. Negotiations fell through and the bill failed to pass.
This time around, the MOHW took all opinions into consideration and amended the controversial points. "It was a rare instance of bipartisan consensus," says Huang. The committee was able to present the bills without further negotiations, and so the Legislative Yuan passed them into law.
Although Taiwanese law is a decade behind that of Japan in this regard, Wu feels that Taiwan is on a level playing field with the rest of the world. The truth of the matter is, countries across the globe are still studying regenerative therapies and their effects. To use cancer treatments as an example, most current applications are oftentimes more supportive than directly curative.
Wu compares it to a hare-and-turtle race. "We are progressing slowly and carefully. People need to believe in the quality of the treatments if you wish to win in the long term."
Huang stresses that the new laws require the MOHW to form a "regenerative therapy review committee" that regulates regenerative therapy testing and trials more strictly than even Japan.
It must be noted that regenerative treatments are expensive. To use autologous cell therapy for treating cancer as an example, the price tag can run up to millions of Taiwan dollars. To date, there is no concrete scientific evidence to prove the effectiveness of these treatments.
This May, the MOHW published for the first time the median survival time of cancer patients who received autologous cell therapy. It appeared to be longer than patients who did not receive such treatment. However, Chia-Ning Shen (沈家寧), a Research Fellow at the Genomics Research Center of Academia Sinica who frequently participates in international conferences on gene therapy and regenerative medicine, warns that, "This is not enough data to determine whether the therapies are effective or not."
One of the problems is because the sample size was too small: only 197 people. The second problem is the lack of a consistent basis of comparison. Differences in age, methods of treatment, and patient care after treatment can all influence the figures.
So, what is the best way to interpret this data? "The most we can say is that patients will now have one more option," says Shen. Currently, regenerative therapies are mostly used in a supporting role, as it cannot replace conventional treatment.
Because the effects of the treatments are not yet proven, the MOHW will continue to reward and subsidize research in regenerative medicine. It will also regularly disclose the actual results of regenerative therapies.
Although more research will be necessary, Shen is of the opinion that this is belated good news from the standpoint of industry advancement. He says that effective cell therapy must be used in tandem with gene modification. "In fact, Taiwan's cell therapy technology is still at a relatively early stage."
With the passing of the Regenerative Medicine Treatments Act and the Regenerative Medicinal Products Act, will Taiwan's regenerative medicine industry experience a boom? Only time will tell.
Source： CommonWealth Magazine web only 2024-06-06
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