H 4262 — Gene Therapies

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27, 2025) - South Carolina Legislature Online South Carolina General Assembly126th Session, 2025-2026Bill 4262Indicates Matter StrickenIndicates New Matter(Text matches printed bills.

Document has been reformatted to meet World Wide Web specifications.)                 A bill   TO AMEND THE SOUTH CAROLINA CODE OF LAWS BY ADDING SECTION 44-1-175 SO AS TO PROHIBIT THE USE OF CERTAIN SYNTHETIC MRNA-BASED GENE THERAPIES BY HEALTHCARE PROFESSIONALS IN THE STATE OF SOUTH CAROLINA;

TO ESTABLISH PENALTIES FOR VIOLATIONS BY HEALTHCARE PROFESSIONALS;

TO REQUIRE PROFESSIONAL LICENSING BOARDS TO REPORT VIOLATIONS TO THE DEPARTMENT OF PUBLIC HEALTH;

AND FOR OTHER PURPOSES.

  Be it enacted by the General Assembly of the State of South Carolina:

  SECTION 1.  The General Assembly finds that:

      (1) synthetic messenger ribonucleic acid (mRNA)-based gene therapies, such as the COVID-19 vaccine, have caused substantial numbers of deaths, disabilities, and a wide range of serious adverse events;

    (2) synthetic mRNA-based gene therapies are known to be contaminated with DNA fragments, metallic particles, and other undisclosed and/or otherwise poorly characterized adulterants;

    (3) no long-term studies have been completed on synthetic mRNA-based gene therapies regarding shedding, fertility, teratogenicity, mutagenicity, or oncogenicity;

    (4) the risk of integration of synthetic mRNA-based gene therapies and/or associated DNA fragment adulterants into the human genome of either somatic or germ cells are uncharacterized, and any germ cell integration creates risk of random human genomic modifications being passed on to the next generation of Americans;

    (5) recipients of a synthetic mRNA-based gene therapy are not provided adequate information both as to the nature of the harm posed to them as well as of the current federal law barring them from compensation for recovery for injury, and therefore do not have the ability to give valid consent to have medical products employing this material or the delivery procedure administered;

    (6) evidence suggests that spike proteins in synthetic mRNA-based gene therapy medical products may be communicable to others (by a process known as "shedding") and may cause side effects or harm even in individuals who are not the intended recipient;

    (7) the safety of synthetic mRNA-based gene therapy on the unborn child has not been adequately studied and reports of severe fetal injury and death after administration during pregnancy have been documented;

and     (8) synthetic mRNA-based gene therapy drug products pose an inadequately characterized potential public health threat due to their unknown long-term safety profile, adulteration and potential for shedding.

  SECTION 2.  Chapter 1, Title 44 of the S.C.

Code is amended by adding:

      Section 44-1-175.  (A)(1) Except as provided in item (4), no healthcare professional practicing within the State shall administer a synthetic mRNA-based gene therapy product to any person within the State.

       (2) For the purposes of this section, "synthetic mRNA-based gene therapy" means a product that mediates its effects by administration of foreign genetic material with the intention of delivering such genetic material into the cells or tissues of a human so that the material exerts a medical effect via transcription and/or translation to produce a protein, by integrating into the host genome, or by causing genetic modification of the cells or tissues so treated.

       (3) This section expressly applies to medical products comprised of synthetic messenger ribonucleic acid (mRNA) technology, modified synthetic messenger ribonucleic acid technology employing pseudouridine or modified pseudouridine, self-amplifying synthetic messenger ribonucleic acid technology, or any related biologic thereof, that are intended to prevent or mitigate the transmission of a communicable disease.

       (4) This section does not apply to the use of:

           (a) mRNA-based gene therapy for the treatment of noninfectious diseases, such as rare genetic conditions or cancer;

           (b) traditional live attenuated vaccines;

           (c) FDA-authorized recombinant bacterial or viral vaccines;

or            (d) FDA-authorized genetic therapies that do not employ synthetic mRNA-based technology.

    (B) Intentional or wilful violation of this section shall result in a suspension of the healthcare professional's license by the applicable licensing board for no less than one year.

The applicable licensing board may apply additional penalties and fines at its discretion.

    (C) Each professional licensing board shall report any violation of this section to the Director of the Department of Public Health, who shall keep record of the violations for no less than seven years and shall inform the General Assembly of the number and nature of violations no less than annually.

  SECTION 3.  This act takes effect upon approval by the Governor.

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