Two pieces of draft legislation on regenerative medicine — the regenerative medicine bill and the regenerative medicine products bill — that are to be considered in a line-by-line review in the legislature adopt a dual-track approach to the provision of regenerative medicine services.
Worryingly, articles 9 and 11 of the draft regenerative medicine bill would allow internal use of genetically modified drug products in cases of non-life-threatening emergencies as long as they have been tested for “preliminary efficacy.” They would not have to have been tested or registered with the Food and Drug Administration as long as they were not produced in unlicensed factories.
The bill’s explanatory text does say that it would be limited to “customized products with specific applications produced on a small scale” and would not be allowed for commercial use, but the spirit of those caveats is not evident in the bill.
Regenerative medicine uses cells as its basic building block, but there are common examples of the risks of putting new cells into the body. Transplanted organs risk being rejected by a host and anti-rejection drugs are required. Even blood transfusions must be done with consideration for blood types.
Genetically modified cells introduce another element of uncertainty and risk, and extra care must be taken with patient selection and drug safety.
However, the usage scope in the second item in Article 9, Clause 1 of the draft regenerative medicine bill is not limited to compassionate use or life-threatening cases. It includes routine treatments, essentially making it an alternative track for marketing such products.
The proposal would be a blank check for testing standards, including human trials, and cell production standards. There is no way to know whether future sublaws would be lenient or strict.
Legislation like this does not exist overseas. Vaccines produced under emergency use authorization during the COVID-19 pandemic or right-to-try laws in the US allow people to access drugs that have not passed third-phase clinical trials, but these situations were because of a public health crisis and life-threatening emergencies.
The lenient draft legislation for routine regenerative medicine treatments is unprecedented.
Moreover, causal relationships between emerging drugs and harmful effects are so difficult to prove that it would be virtually impossible for people to receive compensation.
Article 27 of the regenerative medicine bill, which covers medical disputes, has been left blank.
The provisions of the Drug Injury Relief Act (藥害救濟法) are not applicable to such disputes, as the draft does not deal with pharmaceuticals. Disputes would instead be resolved through liability insurance, so the Medical Accident Prevention and Dispute Settlement Act (醫療事故預防及爭議處理法) — which was passed last year and does not take effect until next year — would also not likely apply.
Neither does the draft give any clues as to what criteria would be for insurance claims, which are under the purview of the Financial Supervisory Commission.
Regenerative medicine is a ground-breaking innovation and might require regulation through special, innovative methods, but the bills have far too many clauses with blank authorizations. Until sublaws are proposed, the public will have no way to judge the risks.
Regenerative medicine can be dual-tracked, but patient safety standards cannot. The legislature should be responsible for the authorization standards of routine medical treatment to ensure medical safety.
Chen Chih-hsiung is dean and professor of the National Yang MIng Chiao Tung University School of Law.
Translated by Paul Cooper
US President Donald Trump and Chinese President Xi Jinping (習近平) were born under the sign of Gemini. Geminis are known for their intelligence, creativity, adaptability and flexibility. It is unlikely, then, that the trade conflict between the US and China would escalate into a catastrophic collision. It is more probable that both sides would seek a way to de-escalate, paving the way for a Trump-Xi summit that allows the global economy some breathing room. Practically speaking, China and the US have vulnerabilities, and a prolonged trade war would be damaging for both. In the US, the electoral system means that public opinion
They did it again. For the whole world to see: an image of a Taiwan flag crushed by an industrial press, and the horrifying warning that “it’s closer than you think.” All with the seal of authenticity that only a reputable international media outlet can give. The Economist turned what looks like a pastiche of a poster for a grim horror movie into a truth everyone can digest, accept, and use to support exactly the opinion China wants you to have: It is over and done, Taiwan is doomed. Four years after inaccurately naming Taiwan the most dangerous place on
In their recent op-ed “Trump Should Rein In Taiwan” in Foreign Policy magazine, Christopher Chivvis and Stephen Wertheim argued that the US should pressure President William Lai (賴清德) to “tone it down” to de-escalate tensions in the Taiwan Strait — as if Taiwan’s words are more of a threat to peace than Beijing’s actions. It is an old argument dressed up in new concern: that Washington must rein in Taipei to avoid war. However, this narrative gets it backward. Taiwan is not the problem; China is. Calls for a so-called “grand bargain” with Beijing — where the US pressures Taiwan into concessions
Wherever one looks, the United States is ceding ground to China. From foreign aid to foreign trade, and from reorganizations to organizational guidance, the Trump administration has embarked on a stunning effort to hobble itself in grappling with what his own secretary of state calls “the most potent and dangerous near-peer adversary this nation has ever confronted.” The problems start at the Department of State. Secretary of State Marco Rubio has asserted that “it’s not normal for the world to simply have a unipolar power” and that the world has returned to multipolarity, with “multi-great powers in different parts of the
RSS