SF 100

as introduced - 89th Legislature (2015 - 2016) Posted on 02/03/2015 09:07am

A bill for an act
relating to health; permitting the use of investigational drugs, biological
products, or devices by certain eligible patients; proposing coding for new law in
Minnesota Statutes, chapter 151.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [151.375] INVESTIGATIONAL DRUG USE.
new text end

new text begin Subdivision 1. new text end

new text begin Title; citation. new text end

new text begin This section may be cited as the "Right to Try Act."
new text end

new text begin Subd. 2. new text end

new text begin Definitions. new text end

new text begin (a) For the purposes of this section, the following terms
have the meanings given them.
new text end

new text begin (b) "Eligible patient" means a patient who meets the requirements in subdivision 3.
new text end

new text begin (c) "Investigational drug, biological product, or device" means a drug, biological
product, or device that has successfully completed phase 1 of a clinical trial, but has not
been approved for general use by the federal Food and Drug Administration (FDA), and is
currently under investigation in a FDA clinical trial.
new text end

new text begin (d) "Terminal disease" means an advanced stage of a disease with a terminal
prognosis and no known cure.
new text end

new text begin Subd. 3. new text end

new text begin Eligibility. new text end

new text begin In order for a patient to access an investigational drug, biological
product, or device under this section, a physician must document in writing that the patient:
new text end

new text begin (1) has a terminal disease;
new text end

new text begin (2) has, in consultation with a physician, considered all other treatment options
currently approved by the FDA;
new text end

new text begin (3) has been given a prescription or recommendation by a physician for an
investigational drug, biological product, or device; and
new text end

new text begin (4) has given informed consent, in writing, for the use of the investigational drug,
biological product, or device, or if the patient is under the age of 18, or lacks the mental
capacity to provide informed consent, a parent or legal guardian has given informed
consent, in writing, on behalf of the patient.
new text end

new text begin Subd. 4. new text end

new text begin Availability. new text end

new text begin (a) A manufacturer of an investigational drug, biological
product, or device has the option of making its investigational drug, biological product,
or device available to eligible patients under this section.
new text end

new text begin (b) Nothing in this section shall be construed to require a manufacturer to make an
investigational drug, biological product, or device available.
new text end

new text begin Subd. 5. new text end

new text begin Costs. new text end

new text begin (a) A manufacturer may provide an investigational drug, biological
product, or device without receiving compensation.
new text end

new text begin (b) A manufacturer may require an eligible patient to pay the costs associated with
manufacturing the investigational drug, biological product, or device.
new text end

new text begin Subd. 6. new text end

new text begin Insurance coverage. new text end

new text begin Nothing in this section shall be construed to require
private health coverage, or a state public health care program to cover the cost of an
investigational drug, biological product, or device.
new text end

new text begin Subd. 7. new text end

new text begin Professional licensing. new text end

new text begin A health-related licensing board shall not revoke
a license, fail to renew a license, or take any other disciplinary action against a licensee
solely based on the licensee providing a prescription or recommendation, or providing
treatment to an eligible patient that involves the use of an investigational drug, biological
product, or device in accordance with this section.
new text end

new text begin Subd. 8. new text end

new text begin Penalty. new text end

new text begin Any official, employee, or agent of the state of Minnesota
who attempts to block or who blocks access of an eligible patient to an investigational
drug, biological product, or device shall be guilty of a misdemeanor and sentenced to
imprisonment for not more than six months, payment of a fine of not more than $2,500, or
both.
new text end

new text begin Subd. 9. new text end

new text begin Severability. new text end

new text begin If any provision of this section or its application to any
person or circumstances is held to be invalid, the invalidity of the provision shall not affect
any other provision of this section. The provisions of this section are severable.
new text end