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Climate Change
1. Draft "Regulations Governing the Collection of Carbon Fees", "Regulations for Administration of Voluntary Reduction Plans" and "Designated Greenhouse Gas Reduction Goal for Entities Subject to Carbon Fees"
On 29 April 2024, the Ministry of Environment announced the draft "Regulations Governing the Collection of Carbon Fees", "Regulations for Administration of Voluntary Reduction Plans" and "Designated Greenhouse Gas Reduction Goal for Entities Subject to Carbon Fees" for public consultation. The consultation period is 60 days. We summarize below:
(1) Regulations Governing the Collection of Carbon Fees
(a) The carbon fees apply to the electricity enterprises and manufacturing industries complying with "Emission Sources Where Enterprises Shall Review, Register and Inspect Greenhouse Gas Emissions " requirements and whose combined annual greenhouse gas emissions from direct emissions and indirect emissions from electricity usage at the entire facility meet or exceed 25,000 metric tons of carbon dioxide equivalent;
(b) Taking into account fair competition within the same industry, when calculating emissions to be charged, entities can in principle deduct the threshold of 25,000 metric tons of carbon dioxide equivalent;
(c) Starting from the following year of the year where the carbon fee shall be collected, entities subject to carbon fees shall calculate the greenhouse gas emissions and fee amount of the previous years before the end of May and report to the platform of competent authority; and
(d) The formula to calculate carbon fees is the charged emissions multiplied by the charging rate.
(2) Regulations for Administration of Voluntary Reduction Plans and Designated Greenhouse Gas Reduction Goal for Entities Subject to Carbon Fees
(a) Two types of voluntary reduction plans are established to encourage enterprises to reduce greenhouse gas emissions;
(b) Enterprises achieving the plan can apply for applicable preferential rates; and
(c) The central competent authority will annually audit the progress of the reduction plans, and enterprises shall submit progress reports by the end of April each year. Those who fail to comply with the plan will be required to pay the difference between the regular and preferential rates.
Reported by: Stacy Lo/ Eden Hsieh
Food and Drug Administration
2. Draft Act on Regenerative Medicine Treatments and Draft Act on Regenerative Medicinal Products
On 25 April 2024, the Executive Yuan passed the draft Act on Regenerative Medicine Treatments and the draft Act on Regenerative Medicinal Products. We summarize below:
(1) Draft Act on Regenerative Medicine Treatments
(a) To ensure safe and effective treatment for patients: Medical institutions shall conduct and complete human trials before performing regenerative medicine treatments, except under certain stipulated circumstances (Articles 7 and 8).
(b) To encourage the research and development of regenerative medicine: Central competent authorities can provide rewards or subsidies to promote the clinical applications of regenerative medicine (Article 10).
(c) To clearly stipulate the scope of regenerative medicine treatments performed by medical institutions and the qualifications of practicing physicians: (a) regenerative medicine treatments can only be performed in medical institutions; (b) a medical institution must obtain an approval from the central competent authority before performingregenerative medical techniques or using regenerative medicinal products; (c) the physician who performs regenerative medicine treatments must be a physician specialized in a field related to the disease and have relevant knowledge of regenerative medicine (Articles 11-13).
(d) To provides the standards that the institutions and personnels who perform cell manipulations must comply with: (a) a medical institutions can perform cell manipulations on its own or entrust a regenerative medicine / biotechnology company or another medical institution to perform cell manipulations; the aforementioned institution or entity that performs cell manipulation is exempted from obtaining a pharmaceutical manufacturing license under the Pharmaceutical Affairs Act; (b) some sets of regulations will be enacted for the methods, facilities, equipment, control measures, distribution of the cell manipulations, the qualifications, required trainings, inspections, license application conditions of operating personnel, and other matters (Article 14).
(e) To stipulate the obligations in performing regenerative medicine treatments: (a) before a medical institution performs a regenerative medicine treatment, it must fully explain to the patient the regenerative medicine treatment to be performed, its risks, effects, and related rights and obligations involved; regenerative medicine treatments can only be performed with consent; (b) for regenerative medical techniques performed or regenerative medicinal products used by a medical institutions, the records must be made and kept for at least 15 years (Articles 15 and 16).
(f) To manage and control the tissue and cell sources: an institution or entity that performs cell manipulations and a cell storage bank must determine the suitability of tissue and cell providers; some sets of regulations will be enacted for matters such as the establishment, quality management, and storage fee collection of cell storage banks (Articles 17-20).
(g) Supervision and relief: To ensure the safety and quality of regenerative medicine treatments and safeguard the rights and interests of the public and patients, entities allowed to do recruitment advertisements for tissues or cells providers of regenerative medicinal products, advertisements for regenerative medicine treatments and advertising management regulations are stipulated; regulations regarding reports on results of performing regenerative medicine treatments, proactive notifications mechanisms, relief measures and other matters are stipulated; clearly stipulate under what conditions a medical institution will be suspended or terminated against performing regenerative medicine treatments (Articles 21-27).
(2) Draft Act on Regenerative Medicinal Products
(a) Legislative purpose, competent authority, definition of regenerative medicinal products and their manufacturers and sellers, and classification of regenerative medicinal products are provided(Articles 1-5).
(b) An application for registration must be filed with and a license must be obtained from the central competent authority before manufacturing or importing regenerative medicinal products; the license is valid for five years, an application for extension may be filed before expiration, and each extension shall not exceed five years. (Articles 6-8).
(c) Considering the public’s rights and interests of early use of regenerative medicinal products, the central competent authority may, under certain circumstances, grant a business a license with additional conditions, which is valid for no more than five years and shall not be extended upon expiration; requirements on the additional conditions and the legal effects when the additional conditions are satisfied or not are stipulated (Articles 9 and 10).
(d) It is stipulated that businesses that manufacture or import regenerative medicinal products must determine the suitability of human tissue and cell providers, and must obtain written consents from the providers; the required information should be contained in the written consent; the regulations regarding the advertisements for recruitment of such providers and regarding the manufacture, transportation and marketing of regenerative medicinal products by pharmaceutical businesses are provided (Articles 11-16).
(e) To enhance the quality and safety of post-market regenerative medicinal products, it is stipulated that businesses must perform safety surveillance and keep data on supply sources and supply chain flows (Articles 17 and 18).
(f) Reliefs applicable to drug injury from regenerative medicinal products are provided (Article 19).
(g) Administrative penalties for violation of the Act are provided (Articles 20 and 21).
Reported by: Jolene Wang / Crick Liang
Labor
3. Amendment to " Enforcement Rules of Employment Service Law"
On 17 April 2024, the Ministry of Labor (MOL) announced the amendment to the draft "Enforcement Rules of Employment Service Law" (Rules) for public consultation. We summarize below:
(1) To delete the term of "disability identification" because of the replacement of the disability identification by the disability certification;
(2) To align with the amendment to Paragraph 1, Article 23 of the Immigration Act, it is newly stipulated that the alien may apply with the National Immigration Agency for the residence, if: (1) his/her spouse with the nationality died; or (2) he/she was a spouse of the nationality with the household registration, and factually nurses, exercises rights and bears obligations against, or meets and communicates with minor children; and
(3) To add the enactment date of the revised Rules on 1 January 2024.
Reported by : David Tsai/ Julia Kuo
4. Draft Amendments to Enforcement Rules of the Labor Insurance Act
On 17 April 2024, the MOL announced the draft amendments to "Enforcement Rules of the Labor Insurance Act". We summarize below:
(1) To add the provision that an insurer may entrust a medical service institution or a professional institution or group to assist in reviewing insurance payment based on business requirements;
(2) To add the provision that when the insured units are terminated due to division or transfer, the unpaid insurance premiums or late fees shall be assumed by the remaining, newly established or succeeding insured units;
(3) To add the provision that during the period of temporary suspension of duties of the accused party for sexual harassment due to the employer's investigation, the insured unit shall not adjust the insurance salary;
(4) To add the provision that the labor union adopting a mechanism for collecting insurance premiums in advance shall not continue to collect insurance premiums, provided that the accumulated months of unpaid insurance premiums are more than two months; and
(5) To amend the provision on applying for the insurance payments pursuant to Article 62 of the Labor Insurance Act.
Reported by: David Tsai / Sean Tsai
Tax
5. Regulation on the Determination and Report of the Number of Houses Used for Residential Purposes Provided by Article 5 and Item 9, Paragraph 1, Article 15 of the House Tax Act
On 22 April 2024, the Ministry of Finance (MOF) announced the Regulation on the Determination and Report of the Number of Houses Used for Residential Purposes Provided by Article 5 and Item 9, Paragraph 1, Article 15 of the House Tax Act. We summarize below:
(1) The total number of houses used for residential purposes held in the whole country shall be decided in accordance with the title deed of individual house; for those without first registration, the number shall be decided in accordance with the house number; for those without house number, the number shall be decided based on the independency of use;
(2) It provides the criteria to decide the owner of the house, including the title owner, the person who has the right to use the house with superficies, Dien holder, administrator, etc;
(3) It provides the types of houses which are not counted in the number of taxable houses, including the public house for residential use, qualified social housing and rental housing, workers dormitory, etc; and.
(4) When a person owns more than 3 houses used for residential purposes in the whole country, he/she shall report to the tax authority to decide the houses which shall be exempted from house tax by 40 days before the collection of house tax for each period.
Reported by: Paul Hsu
6. Amendment to the Standards for the Recognition of Owner-Occupied Houses and of the Status of an Individual to Rent Premises for Public-Welfare Purposes
On 25 April 2024, the MOF announced the amendment to the Standards for the Recognition of Owner-Occupied Houses and of the Status of an Individual to Rent Premises for Public-Welfare Purposes, which provides that the "person who has the right to use the house with superficies" may apply for the tax rate for houses used for residential purpose by the owner, provided that the house shall not be used for business purpose, and such person, his/her spouse or direct descendant shall complete the household registration.
Reported by: Paul Hsu
Securities
7. Commissioning the Taipei Exchange and Taiwan Stock Exchange Corporation to handle declarations and public disclosures in accordance with "Regulations Governing the Declaration of Acquisition of Shares in Accordance with Article 43-1, Paragraph 1 of the Securities and Exchange Act"
On 10 April 2024, the Financial Supervisory Commission (FSC) announced commissioning the Taipei Exchange to handle declarations and public disclosures made by acquirers acquiring over-the-counter or emerging stock market shares, and the Taiwan Stock Exchange Corporation to handle declarations and public disclosures made by acquirers acquiring stock exchange market or unlisted shares in accordance with "Regulations Governing the Declaration of Acquisition of Shares in Accordance with Article 43-1, Paragraph 1 of the Securities and Exchange Act", which shall take effect on 10 May 2024.
Reported by: Stacy Lo/ Zoe Chen
8. "Taiwan Stock Exchange Corporation Procedures for Handling Declarations and Public Disclosures in Accordance with Article 43-1, Paragraph 1 of the Securities and Exchange Act" and "Taipei Exchange Procedures for Handling Declarations and Public Disclosures in Accordance with Article 43-1, Paragraph 1 of the Securities and Exchange Act"
According to the commission of the FSC, on 15 April 2024, the Taiwan Stock Exchange Corporation announced the "Taiwan Stock Exchange Corporation Procedures for Handling Declarations and Public Disclosures in Accordance with Article 43-1, Paragraph 1 of the Securities and Exchange Act" and related registration form. The Taipei Exchange also announced the "Taipei Exchange Procedures for Handling Cases of Declarations and Public Disclosures in Accordance with Article 43-1, Paragraph 1 of the Securities and Exchange Act" on 17 April 2024. The acquirers shall file a declaration, submit registration forms, and upload to Market Observation Post System, and declare to the Taiwan Stock Exchange Corporation or the Taipei Exchange accordingly. The regulations shall take effect on 10 May 2024.
Reported by: Stacy Lo/ Zoe Chen
SITE/SICE
9. Announcement of "Template of Trust Deed of Securities Investment Trust Funds"
On 16 April 2024, the Securities Investment Trust and Consulting Association (SITCA) issued a ruling to announce the "Template of Trust Deed of Securities Investment Trust Funds of Exchange-Traded Funds (ETFs) (including equity, leveraged/inverse, and bond ETF templates)" for the industry's reference. The SITCA also reminded that if securities investment trust enterprises revise the prospectus for the section of "the base units for subscriptions and redemptions of the fund", it needs to report the relevant documents to the SITCA rather than the FSC.
Reported by: Jeffrey Liu / Winnie Su
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2024-05-07
