January 2024
Biotech and Pharmaceutical Law Team of Lee, Tsai & Partners[1]
In 2023, Taiwan witnessed significant transformations in the field of biomedicine. The imminent implementation of the “ Medical Accident Prevention and Dispute Resolution Act ” underscored Taiwan’s emphasis on healthcare quality and patient rights. In the meantime, the inclusion of “Next Generation Gene Sequencing Tests” in the National Health Insurance signaled the rapid development of personalized medicine. The establishment of the “New Cancer Drug Fund” and the implementation of “Parallel Review System” accelerated the pace of new drug development, market-entry, and integration into the health insurance system.
Lastly, the review of the “Regenerative Medicine Act” and the “Regenerative Medicine Product Regulations” reflected the attention and support for the prospects of regenerative medicine. These issues profoundly influenced the trajectory of Taiwan’s biopharmaceutical industry in 2023, highlighting the joint efforts of the government and the industry to promote innovation, safety, and accessibility. This overview will reflect on the developments of these critical issues in 2023 and anticipate the trends in the development of biomedicine and healthcare in 2024.
I. The “Medical Accident Prevention and Dispute Resolution Act” was implemented on January 1, 2024.
The “Medical Accident Prevention and Dispute Resolution Act” (hereinafter referred to as the “Act”) was implemented on January 1, 2024. The Act follows three major principles: “immediate care for medical accidents,” “precedence of mediation in medical disputes,” and “enhancement of quality for medical accident prevention.” It also establishes the “medical professional consultation” and “medical dispute analyses” system, with key points as follows:
1. Medical care institutions with one hundred beds or more should organize a “medical accident response group”. After a medical accident occurs, immediate assistance and care services should be provided, along with timely explanations, to ease the tension between medical practitioners and patients and prevent disputes from arising (Article 6 of the Act). Parties involved in medical accidents may also apply for “medical professional consultation” through foundations entrusted by the Ministry of Health and Welfare (Articles 4 and 9 of the Act).
2. Local health bureaus should establish a “medical dispute mediation committee.” Civil and criminal cases related to medical disputes should undergo mediation by this committee. The mediation period is limited to three months after convening the mediation meeting, with the possibility of extension for an additional three months if necessary (Articles 12, 14-16 of the Act). Additionally, the competent central authority shall by itself or commission government funded foundations to introduce a neutral third party providing “medical professional consultation” and “medical dispute analysis”. This aims to assist in narrowing the cognitive gap between the medical practitioners and patients during the dispute resolution process (Articles 4 and 9 of the Act).
3. Hospitals should establish an internal patient safety management system. In addition to strengthening the reporting of patient safety events by internal staff members, hospitals should analyze the fundamental causes of major medical accidents, propose improvement plans, and report to the competent authority (Articles 33 and 34 of the Act).
II. Inclusion of Next-Generation Gene Sequencing Tests in National Health Insurance Benefits
Through Next-Generation Gene Sequencing (referred to as “NGS”) tests, healthcare providers can more efficiently identify a patient’s cancer type and staging, enabling the timely adoption of precision treatment plans. In light of this, the National Health Insurance Administration (referred to as “NHIA”) is considering incorporating the relatively expensive NGS into the National Health Insurance (referred to as “NHI”) benefits to alleviate the financial burden on patients. The first phase is expected to cover 11 types of cancers, including lung, breast, and thyroid cancers. The actual number of applicable patients and costs will be determined after expert discussions[2].
III. Upcoming Launch of the New Cancer Drug Fund
The NHIA plans to establish a New Cancer Drug Fund, with the budget allocated from the NHI. It will provide temporary payments for drugs with clinical urgency that have not completed Phase III clinical trials. Additionally, it will support new drugs, special materials for new functional types, and newly added treatment items. The total budget for these two categories is NTD 6 billion, which is expected to be implemented in 2024 after approval[3]. The NHIA also stated that in the future, it will refer to the usage status of the NHI Fund in 2024 to strive for additional budget and plan to establish a New (Cancer) Drug Fund independent of the NHI Fund[4]
IV. Accelerating New Drug Approvals through Parallel Review System
The lengthy process from drug application for drug permit to inclusion in NHI benefits has been a persistent concern. The NHIA announced the implementation of a parallel review system for new drugs starting in January 2024 to expedite the process. This system allows companies to simultaneously apply for reimbursement recommendations from the NHIA while registering new drugs with the Food and Drug Administration. This initiative aims to shorten the overall time for new drugs to be included in NHI benefits, meeting the medication needs of the public[5].
In response to calls from patient groups for a more traceable and transparent NHI approval process, the NHIA anticipates promoting digital transformation in NHI in 2024. This will involve digitizing the management of drug reimbursement reviews, allowing companies to track the processes and timelines of their cases, thereby improving review efficiency and information transparency[6].
V. “Regenerative Medicine Act” and “Regenerative Medicine Product Regulations” Dual Legislation Review
On February 16, 2023, the Executive Yuan passed the draft of the “Regenerative Medicine Act” and “Regenerative Medicine Product Regulations” [7](collectively referred to as the “Regenerative Medicine Dual Legislation”) proposed by the Ministry of Health and Welfare, and submitted them to Legislative Yuan for legislative review.
The draft of the “Regenerative Medicine Act” regulates matters related to the scope of regenerative medicine performed in medical institutions, physician qualifications, tissue and cell source management, supervision and prevention, and cell provider recruitment advertising.
The draft of the “Regenerative Medicine Product Regulations” specifies regulations for the inspection and registration of regenerative medicine products, conditional permit, manufacturing and sales, post-market management, and strengthens the assessment of suitability for cell providers in regenerative medicine products, informed consent and recruitment advertising, patient rights to advanced treatment, and post-market flow management.
The Regenerative Medicine Dual Legislation were negotiated by political parties in April 2023 and was scheduled for the third reading in the Legislative Yuan on May 16. However, due to widespread questioning of the content of the draft and insufficient discussion, the Legislative Yuan ultimately did not pass the legislation. The draft has been suspended and has not yet been scheduled for the Legislative Yuan session until the end of 2023. Among them, the main controversial points of the draft “Regenerative Medicine Act” are as follows[8]:
1. Controversy over the use of “allogeneic cells” for treatment: Article 3 of the Executive Yuan version of the draft stipulates that “regenerative medicine” refers to “products or technology that use genes, cells and their derivatives to treat, repair or replace human cells, tissues and organs.” There seems to be a lack of clear definition regarding whether allogeneic cells fall within the scope of permissible regenerative medicine.
2. Provision regarding exemption from applying for a drug permit or obtaining a conditional permit for the treatment of life-threatening or seriously disabling diseases (Article 9 of the Executive Yuan version of the draft[9]). People are concerned that the standards above are too loose and may compromise the effective quality control and safety of regenerative medicine.
[1] The Biotech and Pharmaceutical Law Team consists of Taiwan-licensed attorneys, including Dr. Chung-Teh Lee, Teresa Huang, Oli Wong, Sally Yang, Hannah Kuo, Tina Lee, Albert Yen and Elesha Wang.
[2] United Daily News, “Next-Generation Gene Sequencing Tests Targets 11 Cancers; Clinical Trial Drugs Not Yet Covered by National Health Insurance,” November 17, 2023, https://udn.com/news/story/7266/7581558 (last visited December 25, 2023).
[3] Legislative Yuan, 1st Joint Meeting of The 10th Session, 8th Term of Joint Meeting of the Social Welfare and Environmental Hygiene Committee and Judicial and Legal Committee, Legislative Yuan Gazette Volume 112, No. 73, Committee Records, p. 319; NOW Health, “New Cancer Drug Fund Will Be Launched Next Year: Xue Ruiyuan – NHI Budget Allocated Approximately 60 Billion,” October 23, 2023, https://healthmedia.com.tw/main_detail.php?id=60501&OpBrowser=1 (last visited December 25, 2023); Ministry of Health and Welfare, “Continuously Improving the National Health Insurance Reimbursement Review Process, Expanding Care for Patients,” December 5, 2023, https://www.mohw.gov.tw/cp-6557-76843-1.html (last visited January 11, 2024).
[4] Ministry of Health and Welfare, “Continuously Improving the National Health Insurance Reimbursement Review Process, Expanding Care for Patients,” December 5, 2023, https://www.mohw.gov.tw/cp-6557-76843-1.html (last visited January 11, 2024).
[5] Ministry of Health and Welfare, “Health Policy and Medical Technology Assessment Center Launch Ceremony – A New Milestone in Taiwan’s Pharmaceutical Technology Assessment,” December 27, 2023, https://www.mohw.gov.tw/cp-16-77037-1.html (last visited January 11, 2024).
[6] Ministry of Health and Welfare, supra note 4.
[7] Ensuring the Quality of Regenerative Medicine and Safeguarding Patient Rights: The Executive Yuan approved the draft of the “Regenerative Medicine Act” and “Regenerative Medicine Product Regulations.” https://www.ey.gov.tw/Page/9277F759E41CCD91/2a6f10eb-21f3-422a-8871-8ee2d39e9757 (last visited December 20, 2023).
[8] Reference to Legislative Yuan Gazette Volume 112, Issue 48, Party Negotiation Records, pp. 289-305 (retaining the text of Articles 3 and 9 of the draft).
[9] Reference to Article 9 of the Executive Yuan version of the draft: “When medical institutions perform regenerative technology and fall under one of the following situations, they are exempt from the provisions of the Regenerative Medicine Product Regulations for applying for a drug permit or a conditional permit: 1. Treating diseases that are life-threatening or severely disabling, and there are no appropriate drugs or medical devices domestically. 2. Based on the results of human trials, confirming its safety and preliminary efficacy. 3. Providing cell therapy without genetic modification or transgenic human cells and their derivatives. The periods, conditions, and other matters related to human trials in the second paragraph and the items of cell therapy in the third paragraph shall be announced by the central competent authority.”
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