(a)A manufacturer of an individualized investigational treatment operating within an eligible facility and in compliance with all laws applicable to an eligible facility may:
(1)Provide the manufacturer’s individualized investigational treatment to an eligible patient without compensation; or
(2)Require an eligible patient to pay the costs of or associated with the manufacture of the individualized investigational treatment provided to the eligible patient.
(b)(1) The Office of the Attorney General shall develop an informed consent form that:
(i)Complies with the requirements of § 21–2B–01(g)(3) of this subtitle;
(ii)Includes instructions for the physician or patient on how to complete the form; and
(i
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(a) A manufacturer of an individualized investigational treatment operating within an eligible facility and in compliance with all laws applicable to an eligible facility may:
(1) Provide the manufacturer’s individualized investigational treatment to an eligible patient without compensation; or
(2) Require an eligible patient to pay the costs of or associated with the manufacture of the individualized investigational treatment provided to the eligible patient.
(b) (1) The Office of the Attorney General shall develop an informed consent form that:
(i) Complies with the requirements of § 21–2B–01(g)(3) of this subtitle;
(ii) Includes instructions for the physician or patient on how to complete the form; and
(iii) Provides spaces for a physician to include the information relating to a particular patient and the physician’s recommendation for the patient.
(2) This subsection may not be construed to prohibit a treating physician or a manufacturer of an individualized investigational treatment from including additional information or advisements with the informed consent form developed under paragraph (1) of this subsection.