AN ACT TO PROVIDE ELIGIBLE PATIENTS THE RIGHT TO TRY INDIVIDUALIZED INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS, AND DEVICES TO TREAT LIFE-THREATENING OR SEVERELY DEBILITATING ILLNESSES. SL 2024-36. Enacted July 8, 2024. Section 1 is effective October 1, 2024. The remainder is effective July 8, 2024.
Bill Summaries: H98 RIGHT TO TRY INDIVIDUALIZED TREATMENTS. (NEW)
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Bill H 98 (2023-2024)Summary date: Jul 9 2024 - View SummaryCourts/Judiciary, Civil, Civil Law, Education, Elementary and Secondary Education, Higher Education, Government, State Agencies, Community Colleges System Office, UNC System, Department of Health and Human Services, State Government, State Personnel, Local Government, Health and Human Services, Health, Public Health
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Bill H 98 (2023-2024)Summary date: Jun 12 2024 - View Summary
Senate committee substitute to the 3rd edition replaces the previous edition in its entirety with the following. Adds new Part 3, Individualized Treatments, to Article 23A of GS Chapter 90, providing as follows.
Allows a manufacturer operating within an eligible facility and in accordance with federal laws to make available to an eligible patient, and an eligible patient may request, the manufacturer's individualized investigational drug, biological product, or device. Specifies that this does not require the manufacturer to make the item available. Allows such a manufacturer to provide the individualized investigational drug, biological product, or device to an eligible patient for free or may require the patient to pay the costs of, or the costs associated with, the manufacture of the individualized investigational drug, biological product, or device.
Defines an eligible patient as an individual who meets all of the following: (1) has a life-threatening or severely debilitating illness, attested to by a treating physician; (2) has, in consultation with a treating physician, considered all other treatment options currently approved by the US Food and Drug Administration; (3) has received a recommendation from the treating physician for use of an individualized investigational drug, biological product, or device for treatment of the life-threatening or severely debilitating illness; (4) has given informed consent in writing (as defined) to use of the individualized investigational drug, biological product, or device for treatment of the life-threatening or severely debilitating illness or, if the individual is a minor or is otherwise incapable of providing informed consent, the parent or legal guardian has given informed consent in writing to use of the individualized investigational drug, biological product, or device; and (5) has documentation from the treating physician that the individual meets all of the criteria for this definition. Defines an eligible facility as any institution operating under Federalwide Assurance for the Protection of Human Subjects in accordance with 45 C.F.R. § 46 and 42 U.S.C. § 289(a). Defines individualized investigational drug, biological product, or device as a drug, biological product, or device that is unique and produced exclusively for use for an individual patient, based on their own genetic profile, including individualized gene therapy antisense oligonucleotides and individualized neoantigen vaccines.
Provides that if a patient dies during treatment with the investigational drug, biological product, or device, their heirs are not liable for any outstanding debt related to the treatment.
Prohibits taking disciplinary action against a licensed health care provider, or action against their Medicare certification, based solely on their recommendation to an eligible patient regarding access to or treatment with the individualized item.
Prohibits State officials, employees, or agents from blocking or attempting to block an eligible patient's access to an individualized investigational drug, biological product, or device. Also prohibits bringing a private right of action against a manufacturer, or against any other person or entity involved in the patient’s care for any harm resulting from use of the individualized investigational drug, biological product, or device as long as the manufacturer or other person or entity has made a good-faith effort to comply with the provisions of this Part and has exercised reasonable care in actions undertaken pursuant to this Part.
Specifies that the Part does not affect a health benefit plan's obligation to provide coverage for an insured's participation in a clinical trial.
Effective October 1, 2024.
Makes conforming changes to the act's titles.
Courts/Judiciary, Civil, Civil Law, Education, Elementary and Secondary Education, Higher Education, Government, State Agencies, Community Colleges System Office, UNC System, Department of Health and Human Services, State Government, State Personnel, Local Government, Health and Human Services, Health, Public Health
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Bill H 98 (2023-2024)Summary date: Mar 29 2023 - View Summary
House committee substitute to the 2nd edition makes the following changes. Amends new GS 130A-158.3 (prohibiting COVID-19 vaccination requirements and setting forth certain exemptions) to clarify that neither a State nor local public health official may require proof of COVID-19 vaccination unless certain exemptions apply. (Previously, act just referred to a public health official.) Amends the effective date so that new GS 143-162.6 applies to employment actions taken on or after January 1, 2024.
Courts/Judiciary, Civil, Civil Law, Education, Elementary and Secondary Education, Higher Education, Government, State Agencies, Community Colleges System Office, UNC System, Department of Health and Human Services, State Government, State Personnel, Local Government, Health and Human Services, Health, Public Health
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Bill H 98 (2023-2024)Summary date: Mar 21 2023 - View Summary
House committee substitute to the 1st edition makes the following changes. Amends the act's long title.
Amends new (1) GS 143-162.6, which prohibits State and local governments from denying or refusing employment, or discharging from employment, any person for refusing to submit to a COVID-19 vaccine or series of vaccines, or provide proof of a COVID-19 vaccine; (2) GS 130A-158.3 (prohibiting State and local public health agencies and public health officials from requiring any person, including applicants for employment and employees, to submit to a COVID-19 vaccine or series of vaccines, or to provide proof of vaccination against COVID-19; (3) GS 153A-461 (prohibiting counties from requiring any person to submit to a COVID-19 vaccine or series of vaccines, or to provide proof of vaccination against COVID-19); and (4) GS 160A-499.6 (prohibiting cities from requiring any person to submit to a COVID-19 vaccine or series of vaccines, or to provide proof of vaccination against COVID-19) by adding the following exemption. Adds exemptions for: (1) any employee, vendor, volunteer, trainee, or student that is required by a facility certified by the Centers for Medicare and Medicaid Services to show proof of a COVID-19 vaccination, or to submit to a COVID-19 vaccination or COVID-19 series of vaccinations; (2) an employee employed by any entity that receives federal funding if complying with the statute would result in the loss of that funding; or (3) an employee employed by the Department of Health and Human Services in the Division of State Operated Healthcare Facilities if the Department requires the COVID-19 vaccination or series of vaccinations for that employee. Makes clarifying and conforming changes including changing the statutes' captions.
Deletes proposed new GS 115C-377.1 that prohibits governing bodies of public school units from (1) adopting policies regarding the use of face coverings and (2) quarantining healthy students. Deletes the conforming changes to GS 115C-12, GS 115C-47, GS 115C-218.75, GS 115C-238.66, and GS 116-239.8 that barred specified types of schools from implementing any health requirement prohibited by new GS 115C-377.1.
Amends GS 130A-152, which establishes immunization requirements for children in the state, by prohibiting the Commission for Public Health and public schools, community colleges and UNC constituent institutions (was, public colleges and universities) from requiring a student to submit to a COVID-19 vaccine or series of vaccines, or to provide proof of vaccination against COVID-19. Makes conforming changes. Adds an exception for when vaccination or proof of vaccination is required for participation in a program of study, or fulfilling educational requirements for a program, that requires working, volunteering, or training in a facility certified by the Centers for Medicare and Medicaid Services.
Changes the act's effective date from when it become law to January 1, 2024.
Courts/Judiciary, Civil, Civil Law, Education, Elementary and Secondary Education, Higher Education, Government, State Agencies, Community Colleges System Office, UNC System, Department of Health and Human Services, State Government, State Personnel, Local Government, Health and Human Services, Health, Public Health
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Bill H 98 (2023-2024)Summary date: Feb 13 2023 - View Summary
Section 1
Enacts GS 143-162.6 prohibiting State and local governments from denying or refusing employment, or discharging from employment, any person for refusing to submit to a COVID-19 vaccine or series of vaccines, or provide proof of a COVID-19 vaccine. Specifies that the statute does not prevent discharge for cause. Additionally prohibits State and local governments from acts of discrimination or retaliation against an employee who in good faith takes actions in reporting violations of the statute.
Section 2
Enacts GS 115C-377.1 to prohibit governing bodies of public school units from (1) adopting policies regarding the use of face coverings and (2) quarantining healthy students. Effective on the date the act becomes law, allows a student or parent to bring a civil action against a governing body for violating the statute and requires awarding reasonable attorneys' fees and court costs for prevailing claims.
Enacts new subsections to GS 115C-12, GS 115C-47, GS 115C-218.75, GS 115C-238.66, and GS 116-239.8 to bar the State Board of Education, local boards of education, charter school and regional school boards of directors, and chancellors of lab schools from implementing any health requirement prohibited by new GS 115C-377.1.
Applies beginning with the 2023-23 school year unless otherwise specified.
Section 3
Amends GS 130A-152, which establishes immunization requirements for children in the state, to enact a new subsection prohibiting the Commission for Public Health, and public schools, colleges and universities, from requiring a student to submit to a COVID-19 vaccine or series of vaccines, or to provide proof of vaccination against COVID-19. Makes conforming changes.
Enacts GS 130A-158.3 prohibiting State and local public health agencies and public health officials from requiring any person, including applicants for employment and employees, to submit to a COVID-19 vaccine or series of vaccines, or to provide proof of vaccination against COVID-19. Includes the Secretary of the Department of Health and Human Services and the State Health Director and the head of any State or local public health agency and their designees in the definition of State or local public health official. Includes other defined terms.
Section 4
Enacts GS 153A-461 relating to counties, and GS 160A-499.6 relating to cities, prohibiting counties and cities from requiring any person, including applicants for employment and employees, to submit to a COVID-19 vaccine or series of vaccines, or to provide proof of vaccination against COVID-19. Includes defined terms.
Courts/Judiciary, Civil, Civil Law, Education, Elementary and Secondary Education, Higher Education, Government, State Agencies, Community Colleges System Office, UNC System, Department of Health and Human Services, State Government, State Personnel, Local Government, Health and Human Services, Health, Public Health