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LATEST LEGAL NEWS
The Ministry of Health and Welfare announced draft acts for regenerative medicine, aiming to strike a balance between patient safety and bio-industry development
　　With the pandemic highlighting biotech's strategic importance, the authority is trying to draw up new laws to guide the development of bio-industry, especially regenerative medicine. The Ministry of Health and Welfare announced three draft acts for regenerative medicine on January 13, 2022, namely “Regenerative Medicine Development Act” (再生醫療發展法), “Regenerative Medicine Therapy Act” (再生醫療施行管理條例) and “Regenerative Medicine Product Act” (再生醫療製劑管理條例) to provide a more comprehensive legal environment for the use of regenerative medicine and development of the industry. These drafts are now under the Executive Yuan’s review, and are expected to be submitted to the Legislative Your of deliberation in 2023 as described by officials.
　　However, according to recent news, “Regenerative Medicine Development Act”have been merged into the other two draft acts, but no further details were given out about the changes. For comprehensive understanding, we still have introduced the background and content of three draft acts below.
Background of draft acts for regenerative medicine
　　Currently, regenerative medicinal products are regulated by the “Pharmaceutical Affairs Act” (藥事法) as medicaments. Hence, under current regulation regime, regenerative medicinal products need to complete comprehensive clinical trials to be issued a “drug permit license”. However, since medicinal products mostly are intended to treat rare diseases, it would be very difficult to collect enough data to completing clinical trials.
　　Besides the “Pharmaceutical Affairs Act”, the “Regulations Governing the Application or Use of Specific Medical Techniques or Examinations, or Medical Devices” (特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法) which are formulated in accordance with the “Medical Care Act”（醫療法）allow patients to receive certain types of cell therapies, mainly autologous cell therapies. This limited scope and high cost of cell therapies, which would cost 1.8 million NTD averagely for entire treatment, restrain population from accessing cell therapies.
Content of draft acts for regenerative medicine
　　The three drafts are designed to ease aforementioned challenges. The draft “Regenerative Medicine Development Act”, it mainly focused on the policy principles and capacity building of regenerative medicine regime. This draft would require government to set up advisory committee for providing professional advice on regenerative medicine, and to foster the development of the industry by adopting policies, making laws, and offer financial support or tax benefits to the industry. Besides, the draft also require government taking steps to ensure the fair use of regenerative medicine, to help nurture talent for the industry, and to make sure the ethicality of regenerative medicine research by issuing ethical guidelines. Lastly, it require government to entrust other agencies (or establish one) to handle specific cell processing, solicitation, and promotion.
　　The draft “Regenerative Medicine Product Act” is designed to expedite the process of issuing drug permit licenses to regenerative medicinal products while the quality and safety are still ensured. To achieve these goals, the draft requires government to establish specific requirement for the production, processing, and the sale of regenerative medicinal products for those completed comprehensive clinical trials, and to give “conditional approval licenses” for those medicinal products that had achieved certain requirements but only completed phase II clinical trial. It also ask government to establish requirement for post-market surveillance and other measures like drug injury relief.
　　On the other hand, the draft “Regenerative Medicine Therapy Act” puts it’s focus on the use of regenerative therapies. To accomplish its goal, the draft set up requirements for medical professionals that performing regenerative medicine, standardizing regenerative medicine implementation reports and reporting mechanisms, and clearly define the procedures for or terminating the implementation of regenerative medicine.
Prospective about the drafts form industry
　　From the industries’ prospective, the draft acts are viewed as the way to encourage the development of regenerative medicine and popularize the use of regenerative medicine. They expected once these drafts finished legislation procedures more patients would get benefit from regenerative therapy at relatively lower cost, and regenerative medicine industry would get growth momentum.
[1] Pharmaceutical Affairs Act, available at https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=L0030001 (last visited December 20 2022).
[2] Act for the Development of Biotech and Pharmaceutical Industry, available at https://law.moj.gov.tw/ENG/LawClass/LawAll.aspx?pcode=J0040046 (last visited December 20 2022).
[4] 吳碧娥，〈再生醫療三法變兩法，隱藏什麼玄機？生醫業受惠三利多？〉，經濟日報，2022/10/15， https://money.udn.com/money/story/5612/6689270 ，（最後瀏覽日︰2022/12/20）。
[5] 蘇嘉瑞，〈再生醫療三法及生技醫藥條例的制度實益與產業影響〉，KPMG，2022， https://home.kpmg/tw/zh/home/insights/2022/02/2022-kpmg-insight/act-for-the-development-of-biotech-and-new-pharmaceuticals-industry-and-its-influence.html ，（最後瀏覽日︰2022/12/20）。
[6] 衛生福利部，〈1110113預告制定「再生醫療製劑管理條例」(草案) 〉，衛生福利部食品藥物管理署，2022/01/13， https://www.fda.gov.tw/TC/siteContent.aspx?sid=11996 ，（最後瀏覽日︰2022/12/29）。
 
NCC halts proposing controversial digital act due to lacking of consensus
　　Due to the development of the Internet, the problems of fraud and disinformation are more and more serious. National Communications Commission (NCC) pronounced the proposal of "Digital Intermediary Service Act"( hereinafter referred as to “proposal”) on June 29, 2022. The goal of the proposal is to promote the transparency of large online platforms, to require the platform to take the responsibility of "gatekeeper," to supervise online content and speech, and to establish a safe and reliable network environment.
　　The proposal mentions that the digital intermediary services generally refer to communication intermediary services provided by transmitting audio, video, text, data or other information in digital formats through wired, wireless, satellite or other electronic transmission facilities. Digital intermediary service providers are divided into mere conduit, caching and hosting services based on service styles and scales.
　　The hosting service providing information storage service covers forum, applications, and social media services, such as Dcard, Bahamut, LINE, YouTube, Facebook, and so on. Under the proposal the regulated intermediary service providers must abide by eight basic obligations, including information disclosure, designation of an agent, announcement of service terms, transparency report, data retrieval, information restriction order, and urgent information restriction order to promote a well-functioning environment.
　　Finally, after holding three public hearings, NCC commissioners reached a consensus and decided to draw the proposal back to the internal working group to revisit later. The controversies of the proposal concerned by the industries and scholars are as including:
　　1. Unclear legal norms: according to Article 18 of the proposal, if there is a violation of regulations based on investigations, the competent authority may apply to the court for an "information restriction order" to require the intermediary service provider to take countermeasures against the illegal content. However, the scope of illegal content isn’t defined in proposal.
　　2. Breach to freedom of speech: according to Article 18 of the proposal, before the court makes an information restriction order, the competent authority is entitled to require the intermediary service provider to warn against the disinformation up to 30 days. However, the warning could bring negative effect to public speech.
　　3. Insufficient trial capacity of the court: according to Article 20 of the proposal, if there is an urgent necessity and suspicious of being illegal, the competent authority may apply to the court for an "urgent information restriction order." The court must make a decision within 48 hours, which is a burden to the court.
　　4. Difficult management for intermediary service providers: according to Article 2 of the proposal, intermediary service providers should self-regulate online content by taking legal and necessary investigations, detections, and identifications; otherwise it could be fined up to 10 million NTD based on Article 46. Severe penalty will hinder the development of innovative.
[1] 國家通訊傳播委員會，數位中介服務法草案專區， https://www.ncc.gov.tw/chinese/news.aspx?site_content_sn=5542 （最後瀏覽日︰2022/12/15）。
[2] 〈數位中介服務法喊卡 退回NCC工作小組〉，工商時報，2022/9/8， https://ctee.com.tw/news/tech/712690.html （最後瀏覽日︰2022/12/15）。
 
Academia Sinica Revealed its Strategic Recommendations for Science and Technology Actions towards Net Zero Emission in Taiwan
　　Academia Sinica (中央研究院) revealed the Strategic Recommendations for Science and Technology Actions Towards Net Zero Emission in Taiwan (臺灣淨零科技研發政策建議書, hereinafter the Recommendationson) November 30, 2022. Since Academia Sinica established the “Consulting Committee for Policy Recommendations on Decarbonizing Energy Sources Leading to Sustainability (永續轉型減碳路徑政策建議諮詢平台)” in 2020, it has conducted workshops with academic and industrial experts and representatives from relevant sectors to discuss decarbonization challenges and possible solutions in Taiwan, and formulated policy recommendations. Focused on promoting new technologies and incorporating social, economic, and governance measures, the Recommendations intend to drive energy and industrial transition through technology implementation and cultivate adaptability of the society to achieve Net Zero by 2050.
　　Attaining to Net Zero by 2050 requires new and still developing technologies with social and economic measures in both demand and supply sides of energy markets. The issues discussed in the Recommendations include different renewable energy options, carbon reduction options, and future groundbreaking technologies. Moreover, social and economic changes are also necessary for developing and implementing the Net Zero target, involving policy incentives, economic tools, social communication, legislation, and governance strategies.
　　As the Recommendations mentioned, currently in Taiwan there are more than 90% of greenhouse gas emissions coming from the power sector, which contains 48% emissions from electricity production. Accordingly, apart from efforts to reduce demand, enhance energy efficiency and diversify supply, the top priority should be decarbonizing electricity generation and developing zero-carbon electricity technology.
　　Analyzed with technical advantages, existing limitations and future challenges from an objective perspective, the technology options and related measures in the Recommendations for decarbonizing electricity generation and developing zero-carbon electricity technology have been categorized into four priority stages:
　　(1) Critically Urgent
　　First of all, some high-risk but high-efficient technologies which are yet to be matured and generally deployed, such as Pyrolysis-based Hydrogen, Geothermal Energy, Marine Energy, High-Efficiency Solar Energy, and Biomass Carbon Sinks, should be developed immediately to accelerate progress to Net Zero target.
　　(2) Scale Up Development
　　Secondly, there are some technologies which are current under preliminary phase of development, such as Wind Power, Emerging Biofuels, Power Systems Support (Smart Grids, Energy Storage), and Social, Economic, and Governance Measures , and require further advancement efforts.
　　(3) Continued Development
　　Thirdly, some technologies which have been developed for years, such as Traditional Biofuels, Hydroelectric Energy, Carbon Capture Utilization and Storage (CCUS), Natural Carbon Sinks (Agriculture), are on the right track and should be developed continuously.
　　(4) Emerging
　　Finally, some of the technologies which are still in the initial phases, and worth anticipating in the future, including Future Nuclear Technology, and Emerging CCUS, should be closely followed for its future development.
　　While focus on these technology developments, future efforts should also center on collaboration between different sectors to facilitate technology implementation, strengthen social communication and enforce governance measures.
[1] Strategic Recommendations for Science and Technology Actions Towards Net Zero Emission in Taiwan, Academia Sinica, available at: https://www.sinica.edu.tw/downloadFile_m.php?_downloadName=advice_17.pdf&file=00039i.pdf (last visited Dec. 21, 2022).
[2] Academia Sinica Announces its Strategic Recommendations for Science and Technology Actions towards Net Zero Emission in Taiwan, Academia Sinica, available at: https://www.sinica.edu.tw/ch/news/7403 (last visited Dec. 21, 2022).