Bill Text: MN SF2985 | 2013-2014 | 88th Legislature | Introduced
Bill Title: Right to Try Act
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced - Dead) 2014-05-13 - Referred to Health, Human Services and Housing [SF2985 Detail]
Download: Minnesota-2013-SF2985-Introduced.html
1.2relating to health; permitting the use of investigational drugs, biological
1.3products, or devices by certain eligible patients;proposing coding for new law in
1.4Minnesota Statutes, chapter 151.
1.5BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.6 Section 1. [151.375] INVESTIGATIONAL DRUG USE.
1.7 Subdivision 1. Title; citation. This section may be cited as the "Right to Try Act."
1.8 Subd. 2. Definitions. (a) For the purposes of this section, the following terms
1.9have the meanings given them.
1.10(b) "Eligible patient" means a patient who meets the requirements in subdivision 3.
1.11(c) "Investigational drug, biological product, or device" means a drug, biological
1.12product, or device that has successfully completed phase 1 of a clinical trial, but has not
1.13been approved for general use by the federal Food and Drug Administration (FDA), and is
1.14currently under investigation in a FDA clinical trial.
1.15(d) "Terminal disease" means an advanced stage of a disease with a terminal
1.16prognosis and no known cure.
1.17 Subd. 3. Eligibility. In order for a patient to access an investigational drug, biological
1.18product, or device under this section, a physician must document in writing that the patient:
1.19(1) has a terminal disease;
1.20(2) has, in consultation with a physician, considered all other treatment options
1.21currently approved by the FDA;
1.22(3) has been given a prescription or recommendation by a physician for an
1.23investigational drug, biological product, or device; and
2.1(4) has given informed consent, in writing, for the use of the investigational drug,
2.2biological product, or device, or if the patient is under the age of 18, or lacks the mental
2.3capacity to provide informed consent, a parent or legal guardian has given informed
2.4consent, in writing, on behalf of the patient.
2.5 Subd. 4. Availability. (a) A manufacturer of an investigational drug, biological
2.6product, or device has the option of making its investigational drug, biological product,
2.7or device available to eligible patients under this section.
2.8(b) Nothing in this section shall be construed to require a manufacturer to make an
2.9investigational drug, biological product, or device available.
2.10 Subd. 5. Costs. (a) A manufacturer may provide an investigational drug, biological
2.11product, or device without receiving compensation.
2.12(b) A manufacturer may require an eligible patient to pay the costs associated with
2.13manufacturing the investigational drug, biological product, or device.
2.14 Subd. 6. Insurance coverage. Nothing in this section shall be construed to require
2.15private health coverage, or a state public health care program to cover the cost of an
2.16investigational drug, biological product, or device.
2.17 Subd. 7. Professional licensing. A health-related licensing board shall not revoke
2.18a license, fail to renew a license, or take any other disciplinary action against a licensee
2.19solely based on the licensee providing a prescription or recommendation, or providing
2.20treatment to an eligible patient that involves the use of an investigational drug, biological
2.21product, or device in accordance with this section.
2.22 Subd. 8. Penalty. Any official, employee, or agent of the state of Minnesota
2.23who attempts to block or who blocks access of an eligible patient to an investigational
2.24drug, biological product, or device shall be guilty of a misdemeanor and sentenced to
2.25imprisonment for not more than six months, payment of a fine of not more than $2,500, or
2.26both.
2.27 Subd. 9. Severability. If any provision of this section or its application to any
2.28person or circumstances is held to be invalid, the invalidity of the provision shall not affect
2.29any other provision of this section. The provisions of this section are severable.
1.3products, or devices by certain eligible patients;proposing coding for new law in
1.4Minnesota Statutes, chapter 151.
1.5BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.6 Section 1. [151.375] INVESTIGATIONAL DRUG USE.
1.7 Subdivision 1. Title; citation. This section may be cited as the "Right to Try Act."
1.8 Subd. 2. Definitions. (a) For the purposes of this section, the following terms
1.9have the meanings given them.
1.10(b) "Eligible patient" means a patient who meets the requirements in subdivision 3.
1.11(c) "Investigational drug, biological product, or device" means a drug, biological
1.12product, or device that has successfully completed phase 1 of a clinical trial, but has not
1.13been approved for general use by the federal Food and Drug Administration (FDA), and is
1.14currently under investigation in a FDA clinical trial.
1.15(d) "Terminal disease" means an advanced stage of a disease with a terminal
1.16prognosis and no known cure.
1.17 Subd. 3. Eligibility. In order for a patient to access an investigational drug, biological
1.18product, or device under this section, a physician must document in writing that the patient:
1.19(1) has a terminal disease;
1.20(2) has, in consultation with a physician, considered all other treatment options
1.21currently approved by the FDA;
1.22(3) has been given a prescription or recommendation by a physician for an
1.23investigational drug, biological product, or device; and
2.1(4) has given informed consent, in writing, for the use of the investigational drug,
2.2biological product, or device, or if the patient is under the age of 18, or lacks the mental
2.3capacity to provide informed consent, a parent or legal guardian has given informed
2.4consent, in writing, on behalf of the patient.
2.5 Subd. 4. Availability. (a) A manufacturer of an investigational drug, biological
2.6product, or device has the option of making its investigational drug, biological product,
2.7or device available to eligible patients under this section.
2.8(b) Nothing in this section shall be construed to require a manufacturer to make an
2.9investigational drug, biological product, or device available.
2.10 Subd. 5. Costs. (a) A manufacturer may provide an investigational drug, biological
2.11product, or device without receiving compensation.
2.12(b) A manufacturer may require an eligible patient to pay the costs associated with
2.13manufacturing the investigational drug, biological product, or device.
2.14 Subd. 6. Insurance coverage. Nothing in this section shall be construed to require
2.15private health coverage, or a state public health care program to cover the cost of an
2.16investigational drug, biological product, or device.
2.17 Subd. 7. Professional licensing. A health-related licensing board shall not revoke
2.18a license, fail to renew a license, or take any other disciplinary action against a licensee
2.19solely based on the licensee providing a prescription or recommendation, or providing
2.20treatment to an eligible patient that involves the use of an investigational drug, biological
2.21product, or device in accordance with this section.
2.22 Subd. 8. Penalty. Any official, employee, or agent of the state of Minnesota
2.23who attempts to block or who blocks access of an eligible patient to an investigational
2.24drug, biological product, or device shall be guilty of a misdemeanor and sentenced to
2.25imprisonment for not more than six months, payment of a fine of not more than $2,500, or
2.26both.
2.27 Subd. 9. Severability. If any provision of this section or its application to any
2.28person or circumstances is held to be invalid, the invalidity of the provision shall not affect
2.29any other provision of this section. The provisions of this section are severable.
