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
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