The South Carolina Medical Informed Consent ACT S.54 has moved out of Senate Committee and onto the full Senate

Here is a summary of the amendments

A significant number of posts on this substack have been devoted to a discussion of South Carolina’s Title 44- Health, its defects as law, its defects with implemention, and the bureaucracy that implements it. The road has been long and we have just started the journey to reform.

This is a summary of the amendments passed by committee, along with a few remarks.

(Author’s note: Unfortunately, substack has limited format options, including poor support for text underlining and no support for color coding. The formatting of South Carolina’s bills does not transfer well to substack. I have to do a lot of hand editing and some formatting has to be dropped. In this case, to understand what was added or removed by the amendments, I have removed most of the strikeouts/deletions of text that were in the original bill. That is so the new strikeouts are clear. Most everything should be understandable as to whether it was added or deleted by the amendments. You can refer to the original document for the exact text. )

The amendments as blocks with comments as regular text:

Amend the bill, as and if amended, SECTION 2, by striking Section 16-17-780(A)(3) and inserting:

(3) "Vaccine" means a suspension of attenuated or killed microorganisms, or of antigenic proteins derived from them, that is administered for prevention or amelioration of infectious disease; and which has obtained Emergency Use Authorization, or which has been approved by the U.S. Food and Drug Administration and has been licensed for use.

This says to me a “vaccine” does not have to have been approved or tested at any level of the federal government.

(4) "Novel vaccine" means a vaccine which has obtained Emergency Use Authorization by the U.S. Food and Drug Administration (FDA), or which has otherwise not been approved by the FDA, or which has been approved by the FDA and marketed to the public for less than ten years. The term "novel vaccine" does not include vaccines for which the contents have only been modified by antigenic subtype to address the most prevalent strain of virus including, but not limited to, the yearly influenza vaccine.

A novel vaccine does have to be approved to some degree by the Federal government. It has to be “on the market,” presumable in South Carolina, though this is not specified, for less than 10 years. And the vaccine is not in the “novel” classification if it is antigenic but modified from a previous “version” to address a prevalent (new? Hmmm, but not novel?) strain of a virus. Presumably this is the same virus species for which the original vaccine was developed. And I assume this is to get around any requirement for safety and efficacy testing as well as updating and accurately reporting changes in the informed consent process.

Amend the bill further, SECTION 2, by striking Section 16-17-780(B) and inserting:

(B) It is unlawful for any person, partnership, for-profit or nonprofit corporation, limited liability corporation, institution of higher learning, or the State and its political subdivisions and their agents that employ one or more employees to mandate employees, contractors, students, patrons, customers, clients, or guests to receive a novel vaccine, indemnified product, or gene therapy described in this section as a precondition for employment, entry into buildings and grounds, attendance, participation, or purchase or receipt of any products and services offered.

It is not unlawful to mandate for those corporations and others in the list to mandate “vaccines” as a precondition for the listed situations. But fortunately, it is unlawful to mandate an indemnified product or gene therapy.

Amend the bill further, SECTION 3, by striking Section 41-1-55(A)(6) and inserting:

(6) "Vaccine" means a suspension of attenuated or killed microorganisms, or of antigenic proteins derived from them, that is administered for prevention or amelioration of infectious disease; and which has obtained Emergency Use Authorization, or which has been approved by the U.S. Food and Drug Administration, and has been licensed for use.

(7) "Novel vaccine" means a vaccine which has obtained Emergency Use Authorization by the U.S. Food and Drug Administration (FDA), or which has otherwise not been approved by the FDA, or which has been approved by the FDA and marketed to the public for less than ten years. The term "novel vaccine" does not include vaccines for which the contents have only been modified by antigenic subtype to address the most prevalent strain of virus including, but not limited to, the yearly influenza vaccine.

Repeating the definitions used earlier.

Amend the bill further, SECTION 3, by striking Section 41-1-55(B) and inserting:

(B) Employers are prohibited from taking any adverse pre-employment or employment action including, but not limited to, discrimination, termination, suspension, involuntary reassignment, unpaid leave, demotion, harassment, coercion, or retaliation against an individual who declines to receive a novel vaccine, indemnified product, or gene therapy as defined in this section.

It is not unlawful to mandate for those corporations and others in the list to mandate “vaccines” as a precondition for employment and the other situations listed. But fortunately, it is unlawful to mandate an indemnified product or gene therapy.

Amend the bill further, SECTION 4, by striking Section 40-43-86(E)(1)(f)(6) and inserting:

(f)(6) number of refills authorized. No prescription marked "PRN" or any other nonspecified number of refills may be refilled more than two years beyond the date it was originally written. Nothing in this subsection abridges the right of a pharmacist to refuse to fill or refill a prescription; and

Amend the bill further, SECTION 4, by deleting Section 40-43-86(E)(2) from the bill.

(2) A pharmacist may refuse to fill or refill a prescription when:

(a) a contradiction is detected in the patient's records;

(b) patterns of narcotic abuse are observed in the patient's records;

(c) the order is not complete or unclear;

(d) the pharmacist objects to filling the prescription for religious, moral, or ethical reasons pursuant to the Medical Ethics and Diversity Act, Title 44, Chapter 139. Nothing in this subsection allows pharmacists to deny "right to try" prescriptions as defined in Section 44-137-10; or

(e) the prescription is for off-label use of the prescribed drug, during a state of emergency declared by the governor, and the patient is unable to pay for the prescription or a pharmacy is under-reimbursed or not reimbursed by the insurance carrier. For purposes of this subitem, "off-label use" means the practice of prescribing a prescription drug for a different purpose than the federal Food and Drug Administration's approved purpose.

Amend the bill further, by adding appropriately numbered SECTIONS to read:

(Author note: There appears to be a typo for the HH “addition” below. It is not marked in the text with the appropriate style indicating this is a true additional element. Reading the original text for this section, it seems it must be an addition, so I have formatted it to be an addition.)

SECTION X. Section 40-43-86 of the S.C. Code is amended by adding:

(HH) (A) If a pharmacist refuses to fill a prescription for a patient, the pharmacy shall make a reasonable effort to contact the prescribing practitioner to inform them of the refusal and the reason for such action.

(B) The requirement shall not apply in cases where:

(1) The prescription is not being filled due to early refill limitations, quantity restrictions, or other dispensing guidelines, and the pharmacist has communicated this to the patient.

(2) The pharmacist assists the patient in locating an alternative pharmacy that can dispense the prescribed medication and provides reasonable guidance on transfer options.

(C) Nothing in this section shall be construed to require a pharmacist to dispense a prescription in violation of state or federal law, professional judgment, or ethical obligations.

SECTION X. Section 40-43-170 of the S.C. Code is amended by adding:

(C) A pharmacist may not deny a prescription for the off-label use of any drug approved by the Food and Drug Administration prescribed to treat an infectious disease or life threatening illness during a public health emergency or the declaration of a state of emergency by the Governor

Let’s see. In the deleted section the pharmacist can refuse a prescription under various conditions. Under the new section, there don’t appear to be stipulated conditions regarding refusal. The pharmacist can just refuse to fill the prescription. However, the pharmacist must contact the the prescriber and provide a reason. Except, there are conditions where contacting the prescriber isn’t necessary. I don’t see any issues with this.

I think 40-43-170 (C) says something about the pharmacist not denying a drug for off- label use, but the wording is weird. The conditions when this can occur seem to be:

1. Must be FDA approved, and

2. Must be prescribed to treat an infectious disease or life threatening illness, and

3. Must be prescribed during a public health emergency or whatever a “declaration of a state of emergency by the Governor” is.

I interpret this to mean: The stipulation of FDA approved doesn’t mean that it has to be an “on label” prescription; the approval doesn’t have to be for the disease or life threatening illness covered by #3. Off-label prescriptions can be denied if conditions in #3 are not met.

It seem to me that, with proper informed consent, off-label use should be permitted and the pharmacist can talk to the prescriber about the off-label use, but that it is ultimately up to the patient and the prescriber to determine whether or not the prescription should be filled. That is what informed consent is about.

Amend the bill further, SECTION 6, by striking Section 44-4-130(H) and inserting:

(H) "Department" means the Department of Public Health or any person authorized to act on behalf of the Department of Public Health.

This I like. I commented on this at the beginning of the S.54 discussion may posts back.

(Author’s note: The following paragraph uses the word “undesignated.” In the original text it is designated; it is “(R) “Qualifying health condition” means:” and in S.54 the (R) is (S).)

Amend the bill further, SECTION 6, Section 44-4-130, by striking the undesignated paragraph and inserting:

(1) a natural disaster; or

(2) an illness or health condition that may be caused by terrorism, epidemic or pandemic disease, widespread illness, or a an novel infectious agent or biological or chemical agent and that poses a substantial risk of a significant number of human fatalities, widespread illness, or incidents of permanent or long-term disability.

I like these changes.

Amend the bill further, SECTION 8, by striking Section 44-4-520(A) and inserting:

(A) For purposes of this section, "informed consent" means a written document that is signed and dated by an individual sixteen years of age or older; or, if the individual is a minor under the age of sixteen, by a parent or legal guardian; or, if the individual is incapacitated or without sufficient mental capacity, by a designated health carehealthcare agent pursuant to a health care healthcare power of attorney, that at a minimum includes:

(1) an explanation of the vaccine or treatment that is written in language that is understandable to the average lay person;

(2) a description of the potential risks and benefits resulting from vaccine or treatment, along with a realistic description of the most likely outcome;

(3) a statement acknowledging risks associated with the vaccine or treatment if the vaccine or treatment is an indemnified product as defined in Section 44-1-55(A)(7); and

(4) language that clearly indicates that the individual agrees to the administration of the vaccine or treatment, that the individual has had time to thoughtfully and voluntarily accept or decline the vaccine or treatment free from coercion.

All they did was add an age of 16 to the language. Presumably this is use elsewhere in the law. You know, as someone who has studied the brain for years and practiced AI for six decades, the brain of a 16 year old is just not ready to make “informed consent” decisions. Yes, you can argue that they might be more “informed” and have more facts than older folks, including their parents, but the frontal lobes are still growing and there is a kind of “judgement” required within the framework of informed consent that I’m not willing to give, in general, to 16 year olds. 21 is kind of when the brain’s maturation process is at the point where judgement is “there.” And, I know, people can be sent to war at 18. But 16: I don’t know.

Amend the bill further, SECTION 9, by striking Section 44-4-530(B)(4) and inserting:

(4) an asymptomatic quarantined individual must be released from quarantine after twenty-one days or at the end of the incubation period for the disease, whichever is soonerconfined for no more than twenty-one days;

Amend the bill further, SECTION 9, by striking Section 44-4-530(B)(6) and inserting:

(5)(6) isolated and quarantined individuals must be immediately released when they no longer pose noa substantial risk of transmitting a contagious disease to others;

I was present at the hearing. The time of quarantine was discussed, and one of the Senators said that the longest incubation period he could find for infectious disease was 21 days. So that is where the 21 days came from. Adding the “whichever is sooner” is to not make the quarantine a strict 21 days.

Though I don’t support quarantine, I like the change of wording to “substantial risk” rather than “no risk.”

I don’t at all like the infectious disease quarantine idea implemented by a governmental organization. I believe quarantine is between a healthcare provider and a patient. The governmental organization might recommend quarantine procedures, including limits, but patients have different situations. Group quarantine is not a good idea.

By the way, I do support a kind of quarantine process where there is a natural disaster and a group has been exposed to a chemical or infectious agent. In that case, quarantine might be necessary to triage the impacted group. For this reason, I recommended that natural disasters should be treated in a separate law Title and the processes not grouped with infectious disease.

In following posts I am going to drop back and examine the bill as a whole: there are such gaping holes in the language and the concepts established in this bill that it should never have seen the light of day without both language and concepts that I will discuss (again, in some cases, repeating what I have been saying from the beginning in previous posts). Nevertheless, I am told that adding what is missing to the bill would kill it. I’m not sure why, or at least I haven’t heard an answer that seems reasonable to me. I’ll let you be the judge. Comments?