House Bill 25-1270 Engrossed

A Bill for an Act

• Page 1, Line 101Concerning granting eligible patients the right to try

• Page 1, Line 102individualized investigational medical treatments.

Bill Summary

(Note: This summary applies to this bill as introduced and does not reflect any amendments that may be subsequently adopted. If this bill passes third reading in the house of introduction, a bill summary that applies to the reengrossed version of this bill will be available at http://leg.colorado.gov.)

The bill allows, but does not require, an eligible patient to request from a manufacturer the manufacturer's individualized investigational drug, biological product, or device, which is a drug, biological product, or device that is unique and produced exclusively for use by an individual patient based on the patient's own genetic profile. The manufacturer must be operating within an institution that operates under federal rules for the protection of human subjects. An eligible patient is an individual who has:

• A life-threatening or severely debilitating illness, as attested to by the patient's treating physician;
• Considered all other treatment options currently approved by the United States food and drug administration;
• Received a recommendation from the patient's treating physician;
• Given written, informed consent for the use of the individualized investigational drug, biological product, or device; and
• Documentation from the treating physician that the individual meets the definition of "eligible patient".

The bill authorizes, but does not require, a manufacturer to make the individualized investigational drug, biological product, or device available to an eligible patient at no charge, but the manufacturer may require payment to cover the cost.

If any harm is caused to the eligible patient resulting from the use of the individualized investigational drug, biological product, or device, a private right of action cannot be brought against the manufacturer or against any other individual or entity involved in the care of the eligible patient with regard to the eligible patient's use of the individualized investigational drug, biological product, or device, so long as the manufacturer, individual, or entity complied with the law and exercised reasonable care.

The bill prohibits any action against a health-care provider's license based on the health-care provider's recommendations regarding the use of the individualized investigational drug, biological product, or device.

Nothing in the bill affects a health-care insurer's obligation under current law relating to coverage for an insured's participation in a clinical trial.

• Page 2, Line 1Be it enacted by the General Assembly of the State of Colorado:

• Page 2, Line 2SECTION 1.  In Colorado Revised Statutes, 25-45-102, amend (1) introductory portion and (2) as follows:

• Page 2, Line 325-45-102.  Legislative declaration. (1)  For purposes of this part 1, the general assembly finds and declares that:

• Page 2, Line 4(2)  It is the intent of the general assembly for this part 1 to

• Page 2, Line 5allow for terminally ill patients to use potentially life-saving investigational drugs, biological products, and devices.

• Page 3, Line 1SECTION 2.  In Colorado Revised Statutes, 25-45-103, amend the introductory portion as follows:

• Page 3, Line 225-45-103.  Definitions. As used in this article part 1, unless the context otherwise requires:

• Page 3, Line 3SECTION 3.  In Colorado Revised Statutes, 25-45-104, amend (1) and (3)(a) as follows:

• Page 3, Line 425-45-104.  Drug manufacturers - availability of investigational

• Page 3, Line 5drugs, biological products, or devices - costs - insurance coverage.

• Page 3, Line 6(1)  A manufacturer of an investigational drug, biological product, or

• Page 3, Line 7device may make available the manufacturer's investigational drug,

• Page 3, Line 8biological product, or device to eligible patients pursuant to this article

• Page 3, Line 9part 1. This article part 1 does not require that a manufacturer make

• Page 3, Line 10available an investigational drug, biological product, or device to an eligible patient.

• Page 3, Line 11(3) (a)  Nothing in this article part 1 expands the coverage provided in sections section 10-16-104 (20) or 10-16-104.6. C.R.S.

• Page 3, Line 12SECTION 4.  In Colorado Revised Statutes, amend 25-45-107 as follows:

• Page 3, Line 1325-45-107.  No cause of action created. This article part 1 does

• Page 3, Line 14not create a private cause of action against a manufacturer of an

• Page 3, Line 15investigational drug, biological product, or device, or against any other

• Page 3, Line 16person or entity involved in the care of an eligible patient using the

• Page 3, Line 17investigational drug, biological product, or device, for any harm done to

• Page 3, Line 18the eligible patient resulting from the investigational drug, biological

• Page 3, Line 19product, or device, so long as the manufacturer or other person or entity

• Page 3, Line 20is complying in good faith with the terms of this article part 1, unless there was a failure to exercise reasonable care.

• Page 4, Line 1SECTION 5.  In Colorado Revised Statutes, add part 2 to article 45 of title 25 as follows:

• Page 4, Line 2PART 2

• INDIVIDUALIZED TREATMENTS

• Page 4, Line 325-45-201.  Legislative declaration. (1)  For purposes of this part 2, the general assembly finds and determines that:

• Page 4, Line 4(a)  Some public and private entities operating under

• Page 4, Line 5federal standards for the protection of human subjects in

• Page 4, Line 6research develop individualized investigational drugs,

• Page 4, Line 7biological products, and devices that are unique and produced

• Page 4, Line 8exclusively for use by an individual patient based on the

• Page 4, Line 9patient's genetic profile, including individual gene therapy,

• Page 4, Line 10antisense oligonucleotides, and individualized neoantigen vaccines; and

• Page 4, Line 11(b)  A patient who has a life-threatening or severely

• Page 4, Line 12debilitating illness may benefit from these individualized treatments.

• Page 4, Line 13(2)  Therefore, the general assembly declares that, in

• Page 4, Line 14accordance with the recommendation of the patient's treating

• Page 4, Line 15physician and with the safeguards described in this part 2, a

• Page 4, Line 16patient should have the right to try an individualized

• Page 4, Line 17investigational drug, biological product, or device, and the

• Page 4, Line 18treating physician and manufacturer that provides the

• Page 4, Line 19individualized investigational drug, biological product, or

• Page 4, Line 20device, acting in accordance with this part 2, should be

• Page 4, Line 21protected from adverse consequences resulting from the

• Page 5, Line 1patient's decision to try the individualized investigational drug, biological product, or device.

• Page 5, Line 225-45-202.  Definitions.As used in this part 2, unless the context otherwise requires:

• Page 5, Line 3(1)  "Eligible facility" means an institution operating

• Page 5, Line 4under the federalwide assurance for the protection of human subjects in accordance with 45 CFR 46 and 42 U.S.C. sec. 289a.

• Page 5, Line 5(2)  "Eligible patient" means an individual who has:

• Page 5, Line 6(a)  A life-threatening or severely debilitating illness, as attested to by the patient's treating physician;

• Page 5, Line 7(b)  In consultation with the treating physician,

• Page 5, Line 8considered all other treatment options currently approved by the United States food and drug administration;

• Page 5, Line 9(c)  Received a recommendation from the treating

• Page 5, Line 10physician for use of an individualized investigational drug,

• Page 5, Line 11biological product, or device for treatment of the life-threatening or severely debilitating illness;

• Page 5, Line 12(d)  Given written, informed consent for the use of the

• Page 5, Line 13individualized investigational drug, biological product, or

• Page 5, Line 14device, or, if the patient is a minor or lacks the mental capacity

• Page 5, Line 15to provide informed consent, a parent or legal guardian has given written, informed consent on the patient's behalf; and

• Page 5, Line 16(e)  Documentation from the treating physician that the

• Page 5, Line 17patient meets the requirements of this subsection (2), including

• Page 5, Line 18attestation from the treating physician that the treating

• Page 5, Line 19physician was consulted in the creation of the written, informed

• Page 5, Line 20consent given under this part 2.

• Page 6, Line 1(3)  "Individualized investigational drug, biological

• Page 6, Line 2product, or device" means a drug, biological product, or device

• Page 6, Line 3that is unique and produced exclusively for use by an eligible

• Page 6, Line 4patient, based on the patient's own genetic profile, including

• Page 6, Line 5individualized gene therapy, antisense oligonucleotides, and individualized neoantigen vaccines.

• Page 6, Line 6(4)  "Institution" has the meaning set forth in 45 CFR 46.102 (f).

• Page 6, Line 7(5)  "Life-threatening or severely debilitating illness" has the meaning set forth in 21 CFR 312.81.

• Page 6, Line 8(6)  "Minor" means an individual who is under eighteen years of age.

• Page 6, Line 9(7)  "Written, informed consent" means a written

• Page 6, Line 10document signed by an eligible patient; by a parent or legal

• Page 6, Line 11guardian, if the patient is a minor; or by a designated

• Page 6, Line 12health-care agent pursuant to a health-care power of attorney, if the patient is incapacitated, that, at a minimum:

• Page 6, Line 13(a)  Explains the currently approved products and

• Page 6, Line 14treatments for the life-threatening or severely debilitating illness from which the eligible patient suffers;

• Page 6, Line 15(b)  Attests that the eligible patient concurs with the

• Page 6, Line 16treating physician's belief that all currently approved treatments are unlikely to prolong the patient's life;

• Page 6, Line 17(c)  Clearly identifies the specific individualized

• Page 6, Line 18investigational drug, biological product, or device proposed for

• Page 6, Line 19treatment of the eligible patient's life-threatening or severely

• Page 6, Line 20debilitating illness;

• Page 7, Line 1(d)  Describes the potential best and worst outcomes

• Page 7, Line 2resulting from use of the individualized investigational drug,

• Page 7, Line 3biological product, or device, with a realistic description of the

• Page 7, Line 4most likely outcome, including the possibility that new,

• Page 7, Line 5unanticipated, different, or worse symptoms might result and

• Page 7, Line 6that death could be hastened by the proposed treatment, based

• Page 7, Line 7on the physician's knowledge of the proposed treatment in

• Page 7, Line 8conjunction with an awareness of the eligible patient's condition;

• Page 7, Line 9(e)  Makes clear that the patient's eligibility for hospice

• Page 7, Line 10care may be withdrawn if the eligible patient begins treatment

• Page 7, Line 11of the life-threatening or severely debilitating illness with an

• Page 7, Line 12individualized investigational drug, biological product, or

• Page 7, Line 13device and that hospice care may be reinstated if such treatment

• Page 7, Line 14ends and the patient again meets hospice care eligibility requirements;

• Page 7, Line 15(f)  Makes clear that in-home health care may be denied if treatment begins;

• Page 7, Line 16(g)  Makes clear that the eligible patient's health

• Page 7, Line 17insurance provider or health-care provider is not obligated to

• Page 7, Line 18pay for any care or treatments consequent to the use of the

• Page 7, Line 19individualized investigational drug, biological product, or device unless specifically required by law or contract;

• Page 7, Line 20(h)  States that the patient understands that they are

• Page 7, Line 21liable for all expenses consequent to the use of the

• Page 7, Line 22individualized investigational drug, biological product, or

• Page 7, Line 23device, and that this liability extends to the patient's estate,

• Page 8, Line 1unless a contract between the patient and the manufacturer of

• Page 8, Line 2the individualized investigational drug, biological product, or device states otherwise; and

• Page 8, Line 3(i)  States that the eligible patient, or, for an eligible

• Page 8, Line 4patient who is a minor or who lacks capacity to provide informed

• Page 8, Line 5consent, the parent or legal guardian, consents to the use of

• Page 8, Line 6the individualized investigational drug, biological product, or

• Page 8, Line 7device for treatment of the life-threatening or severely debilitating illness.

• Page 8, Line 825-45-203.  Drug manufacturers - authorized access to and use

• Page 8, Line 9of individualized investigational drugs, biological products, or devices

• Page 8, Line 10- costs. (1)  A manufacturer operating within an eligible facility

• Page 8, Line 11and in accordance with applicable federal law may make

• Page 8, Line 12available to an eligible patient, and an eligible patient may

• Page 8, Line 13request, the manufacturer's individualized investigational

• Page 8, Line 14drug, biological product, or device from the eligible facility or manufacturer operating within the eligible facility.

• Page 8, Line 15(2)  A manufacturer of an individualized investigational drug, biological product, or device may:

• Page 8, Line 16(a)  Provide the individualized investigational drug,

• Page 8, Line 17biological product, or device to an eligible patient without receiving compensation; or

• Page 8, Line 18(b)  Require an eligible patient to pay the costs of, or the

• Page 8, Line 19costs associated with, the manufacture of the individualized investigational drug, biological product, or device.

• Page 8, Line 20(3)  Nothing in this part 2 requires a manufacturer of an

• Page 8, Line 21individualized investigational drug, biological product, or

• Page 9, Line 1device to make the individualized investigational drug, biological product, or device available to an eligible patient.

• Page 9, Line 2(4)  If a patient dies while being treated with an

• Page 9, Line 3individualized investigational drug, biological product, or

• Page 9, Line 4device, the patient's heirs are not liable for outstanding debt

• Page 9, Line 5related to the treatment, including costs attributed to lack of insurance coverage for the treatment.

• Page 9, Line 625-45-204.  Action against health-care provider's license or

• Page 9, Line 7medicare certification prohibited.Notwithstanding any other law,

• Page 9, Line 8a licensing board shall not revoke, fail to renew, suspend, or

• Page 9, Line 9take other action against a health-care provider's license

• Page 9, Line 10issued pursuant to title 12 based solely on the health-care

• Page 9, Line 11provider's recommendation to an eligible patient regarding

• Page 9, Line 12access to or treatment with an individualized investigational

• Page 9, Line 13drug, biological product, or device, so long as the

• Page 9, Line 14recommendation is consistent with medical standards of care.

• Page 9, Line 15Action against a health-care provider's medicare certification

• Page 9, Line 16based solely on the health-care provider's recommendation

• Page 9, Line 17that an eligible patient have access to an individualized investigational drug, biological product, or device is prohibited.

• Page 9, Line 1825-45-205.  Access to individualized investigational drugs,

• Page 9, Line 19biological products, and devices - prohibition on state action.An

• Page 9, Line 20official, employee, or agent of this state shall not block or

• Page 9, Line 21attempt to block an eligible patient's access to an individualized

• Page 9, Line 22investigational drug, biological product, or device. Counseling,

• Page 9, Line 23advice, or a recommendation consistent with medical standards

• Page 9, Line 24of care from a licensed health-care provider is not a violation of this section.

• Page 10, Line 125-45-206.  No cause of action created.This part 2 does not

• Page 10, Line 2create a private right of action against a manufacturer of an

• Page 10, Line 3individualized investigational drug, biological product, or

• Page 10, Line 4device, or against an individual or entity involved in the care of

• Page 10, Line 5an eligible patient using an individualized investigational drug,

• Page 10, Line 6biological product, or device, for any harm caused to the

• Page 10, Line 7eligible patient resulting from use of the individualized

• Page 10, Line 8investigational drug, biological product, or device, so long as

• Page 10, Line 9the manufacturer or individual or entity has made a good faith

• Page 10, Line 10effort to comply with the provisions of this part 2 and has

• Page 10, Line 11exercised reasonable care in actions taken pursuant to this part 2.

• Page 10, Line 1225-45-207.  Effect on health-care coverage.Nothing in this

• Page 10, Line 13part 2 affects a health insurance provider's obligation to

• Page 10, Line 14provide coverage for an insured's participation in a clinical trial pursuant to section 10-16-104 (20).

• Page 10, Line 15SECTION 6.  Safety clause. The general assembly finds,

• Page 10, Line 16determines, and declares that this act is necessary for the immediate

• Page 10, Line 17preservation of the public peace, health, or safety or for appropriations for

• Page 10, Line 18the support and maintenance of the departments of the state and state institutions.