A4671

An Act concerning the availability of investigational therapies to certain patients and supplementing Title 26 of the Revised Statutes, P.L.1945, c.162 (C.54:10A-1 et seq.), and Title 54A of the New Jersey Statutes.

Be It Enacted by the Senate and General Assembly of the State of New Jersey:

1. a. As used in this section:

“Eligible patient” means an individual who:

(1) has a terminal illness, attested to by the individual’s treating physician;

(2) has considered all other treatment options currently approved by the United States Food and Drug Administration in consultation with the individual’s treating physician;

(3) has received a recommendation from the individual’s treating physician for the use of an investigational therapy; and

(4) has provided, or has had a parent or legal guardian provide, informed consent for the use of the investigational therapy.

“Investigational therapy” means any drug, biological product, device, or other treatment or therapy that has successfully completed Phase I of a clinical trial but has not yet been approved for general use by the United States Food and Drug Administration and which remains under investigation or in a clinical trial approved by the United States Food and Drug Administration.

“Informed consent” shall have the same meaning as in section 4 of P.L.2007, c.316 (C.26:14-4).

“Terminal illness” means a medical condition that may result in a patient's life expectancy being 12 months or less as determined by a physician.

b. A manufacturer of an investigational therapy may make the investigational therapy available to eligible patients.

c. The State Board of Medical Examiners shall not revoke a license, fail to renew a license, or take any other disciplinary action under Title 45 of the Revised Statutes against a physician solely based on the physician’s recommendation, prescription, or treatment of an eligible patient with an investigational therapy.

2. a. As used in this section, “eligible patient” and “investigational therapy” shall have the same meanings as set forth in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

b. In privilege periods commencing after the effective date of P.L. , c. (C. ) (pending before the Legislature as this bill), the director shall allow a taxpayer a credit against the tax imposed pursuant to section 5 of P.L.1945, c.162 (C.54:10A-5) in an amount equal to 25 percent of the cost incurred by the taxpayer in manufacturing an investigational therapy that is made available to eligible patients.

c. A taxpayer shall apply the credit awarded against the taxpayer’s liability under section 5 of P.L.1945, c.162 (C.54:10A-5) for the current privilege period as of the date of the credit's approval. A taxpayer may carry forward an unused credit resulting from the limitations of subsection d. of this section, if necessary, for use in the seven privilege periods following the privilege period for which the credit is allowed.

d. The director shall prescribe the order of priority of the application of the credit allowed under this section and any other credits allowed by law against the tax imposed under section 5 of P.L.1945, c.162 (C.54:10A-5). The amount of the credit applied under this section against the tax imposed pursuant to section 5 of P.L.1945, c.162 (C.54:10A-5) for a privilege period, together with any other credits allowed by law, shall not exceed 50 percent of the tax liability otherwise due and shall not reduce the tax liability to an amount less than the statutory minimum provided in subsection (e) of section 5 of P.L.1945, c.162 (C.54:10A-5).

e. The director shall not allow a taxpayer a credit pursuant to this section for the value of an investigational therapy made available by the taxpayer to eligible patients that is included in the calculation of a credit allowed against the “New Jersey Gross Income Tax Act,” N.J.S.54A:1-1 et seq., allowed pursuant to section 3 of P.L. , c. (C. ) (pending before the Legislature as this bill).

3. a. As used in this section, “eligible patient” and “investigational therapy” shall have the same meanings as set forth in section 1 of P.L. , c. (C. ) (pending before the Legislature as this bill).

b. In taxable years commencing after the effective date of P.L. , c. (C. ) (pending before the Legislature as this bill), the director shall allow a taxpayer a credit against the tax otherwise due pursuant to the “New Jersey Gross Income Tax Act,” N.J.S.54A:1-1 et seq., in an amount equal to 25 percent of the cost incurred by the taxpayer in manufacturing an investigational therapy that is made available to eligible patients.

c. A taxpayer shall apply the credit awarded against the taxpayer’s liability under N.J.S.54A:1-1 et seq. for the current taxable year as of the date of the credit's approval. A taxpayer may carry forward an unused credit resulting from the limitations of subsection d. of this section, if necessary, for use in the seven taxable years following the taxable year for which the credit is allowed.

d. The director shall prescribe the order of priority of the application of the credit allowed under this section and any other credits allowed by law against the tax imposed under N.J.S.54A:1-1 et seq. The amount of the credit applied under this section against the tax imposed pursuant to N.J.S.54A:1-1 et seq. for a taxable year, together with any other credits allowed by law, shall not exceed 50 percent of the tax liability otherwise due and shall not reduce the tax liability to an amount less than zero.

e. The director shall not allow a taxpayer a credit pursuant to this section for the value of an investigational therapy made available by the taxpayer to eligible patients that is included in the calculation of a credit against the tax imposed pursuant to section 5 of P.L.1945, c.162 (C.54:10A-5), allowed pursuant to section 2 of P.L. , c. (C. ) (pending before the Legislature as this bill).

4. This act shall take effect immediately, and sections 2 and 3 shall apply to taxable years or privilege periods commencing on or after January 1 next following the date of enactment.

STATEMENT

This bill would permit patients who are terminally ill to access investigational therapies that the United States Food and Drug Administration (FDA) has not yet approved. The bill also allows corporation business tax credits and gross income tax credits for a portion of the cost incurred in manufacturing certain investigational therapies made available to terminally ill patients.

The bill permits only eligible patients, as defined by the bill, to access investigational therapies. An eligible patient has a medical condition that results in a life expectancy of less than 12 months. Additionally, to be an eligible patient, an individual must have consulted with a physician and considered all other treatment options currently approved by the FDA; received a prescription or recommendation from the individual’s treating physician for the investigational therapy; and provided informed consent to use of the investigational therapy.

The bill defines “investigational therapy” as any drug, biological product, device, or other treatment or therapy that has successfully completed Phase I of a clinical trial but has not yet been approved by the FDA for general use and which remains under investigation or in a clinical trial approved by the FDA.

The bill would prohibit the State Board of Medical Examiners from revoking a license, failing to renew a license, or taking any other disciplinary action against a physician solely based on the physician’s recommendation, prescription, or treatment of an eligible patient with an investigational therapy.

Moreover, this bill allows a corporation business tax and gross income tax credit for manufacturing an investigational therapy made available to eligible patients. The bill enables a taxpayer under either tax to take a credit equal to 25 percent of the cost incurred by the taxpayer in manufacturing an investigational therapy, which is made available to an eligible patient. The credits created by this bill under the corporation business tax and gross income tax are mutually exclusive such that no taxpayer may take a credit under both impositions for the production of the same investigational therapy. The credits afforded under this bill will be available in the privilege period and taxable year commencing after the effective date, but the bill allows a taxpayer to carry over certain unused credits to future privilege periods or taxable years.