HLS 25RS-336 ORIGINAL 2025 Regular Session HOUSE BILL NO. 377 BY REPRESENTATIVE OWEN Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana. HEALTH SERVICES: Authorizes an individual to refuse certain medical treatments 1 AN ACT 2To enact Subpart D of Part II of Chapter 5-D of Title 40 of the Louisiana Revised Statutes 3 of 1950, to be comprised of R.S. 40:1162.1 through 1162.3, relative to the use of 4 drugs with emergency use authorization; to provide for definitions; to provide for 5 notice from a healthcare provider to an individual about a drug's emergency use 6 authorization status; to establish methods for an individual to refuse to receive a drug 7 authorized for emergency use; to provide for documenting an individual's decision 8 to refuse a drug; to provide for penalties; and to provide for related matters. 9Be it enacted by the Legislature of Louisiana: 10 Section 1. Subpart D of Part II of Chapter 5-D of Title 40 of the Louisiana Revised 11Statutes of 1950, comprised of R.S. 40:1162.1 through 1162.3, is hereby enacted to read as 12follows: 13SUBPART D. RIGHT TO REFUSE EMERGENCY USE AUTHORI ZATION DRUGS, 14 DEVICES, TESTS, AND PROCEDURES 15 §1162.1. Title; purpose 16 A. This Subpart shall be known and may be cited as the "Right to Refuse 17 Emergency Use Authorization Drugs Act". 18 B. The purpose of this Subpart is to ensure that individuals are fully 19 informed of their right to refuse a medical device, test, pharmaceutical, drug, 20 vaccine, or biological product that is authorized by the United States Food and Drug Page 1 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 25RS-336 ORIGINAL HB NO. 377 1 Administration through the Emergency Use Authorization process and to provide 2 procedures for obtaining informed consent before any medical device, test, 3 pharmaceutical, drug, vaccine, or biological product with an emergency use 4 authorization is administered. 5 §1162.2. Definitions 6 As used in this Subpart, the following terms mean: 7 (1) "Covered drug or vaccine" means any medical device, test, 8 pharmaceutical, drug, or biological product that has received only Emergency Use 9 Authorization from the United States Food and Drug Administration. 10 (2) "Healthcare provider" means any healthcare professional, clinic, hospital, 11 or entity administering a covered drug or vaccine. 12 (3) "Informed consent" means the process by which an individual, after 13 receiving full and accurate information about the risk, benefits, and alternatives to 14 a covered drug or vaccine, voluntarily agrees to its administration. 15 §1162.3. Notice before use of a covered drug; acknowledgment; right to refuse 16 A.(1) A healthcare provider shall give written and verbal notice to an 17 individual receiving a covered drug or vaccine of his right to refuse the treatment. 18 The notice shall include all of the following: 19 (a) A statement that the covered drug or vaccine is authorized for treatment 20 under a Emergency Use Authorization and has not undergone the full United States 21 Food and Drug Administration approval process. 22 (b) A statement that the individual may refuse the covered drug or vaccine 23 without facing any discrimination, retaliation, or loss of service. 24 (c) A statement of the known risks, benefits, and alternatives to the covered 25 drug or vaccine including nonintervention and other treatments. 26 (d) A summary of any known risks of refusing the covered drug or vaccine. 27 (2) The healthcare provider shall offer the individual a verbal explanation of 28 the key points outlined in Paragraph (1) of this Subsection and answer any questions 29 posed by the individual. Page 2 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 25RS-336 ORIGINAL HB NO. 377 1 (3) The healthcare provider shall obtain the signature or electronic 2 authentication of the individual as an acknowledgment that the individual has 3 received the notice required by Paragraph (1) of this Subsection. This 4 acknowledgment does not constitute consent to a treatment. 5 B. No healthcare provider shall coerce, threaten, or pressure an individual 6 into accepting a covered drug or vaccine. If an individual refuses a covered drug or 7 vaccine, no negative consequences shall befall him including but not limited to 8 denial of treatment, loss of employment, or denial of benefits or services. 9 C. A healthcare provider shall document an individual's decision to refuse 10 a covered drug or vaccine in the individual's medical record along with the date and 11 the specific covered drug or vaccine the individual declined. The individual and 12 provider shall acknowledge the refusal by signature or electronic authentication. 13 D. Any healthcare provider that fails to comply with the requirements of this 14 Section may be subject to disciplinary action including revocation or suspension of 15 licensure, fines, or other penalties as determined by the healthcare provider's 16 licensing authority. Individuals who believe that the requirements of this Section 17 have been violated may file a complaint with the appropriate professional board or 18 state or federal agency for investigation. DIGEST The digest printed below was prepared by House Legislative Services. It constitutes no part of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)] HB 377 Original 2025 Regular Session Owen Abstract: Provides that an individual has the authority to refuse a drug or other pharmaceutical if the product has only received Emergency Authorization from the United States Food and Drug Administration (FDA). Present law states that an individual may refuse a drug or medical treatment, and a healthcare professional or healthcare institution is required to obtain informed consent prior to providing a medical treatment or drug except in emergency circumstances. Proposed law defines "informed consent", "healthcare provider", and "covered drug or vaccine". Proposed law retains present law and adds that a healthcare provider is required to provide written and verbal notice to a patient informing him that he may refuse a covered drug or Page 3 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 25RS-336 ORIGINAL HB NO. 377 vaccine when the drug or other product is approved only by an FDA Emergency Use Authorization. Proposed law provides that a healthcare provider is required to explain the emergency use authorization status of a covered drug or vaccine, the known risks and benefits of the covered drug or vaccine, and that the patient may refuse a covered drug or vaccine. Proposed law requires a healthcare provider to obtain a signature of electronic verification from a patient as an acknowledgment that the patient received the notice required by proposed law. Proposed law states that a healthcare provider who fails to provide notice to and record acknowledgment from a patient may be subject to a disciplinary action from the healthcare provider's licensing body or other appropriate state or federal agency. (Adds R.S. 40:1162.1-1162.3) Page 4 of 4 CODING: Words in struck through type are deletions from existing law; words underscored are additions.