VA Medicinal Cannabis Research Act of 2021

II 117TH CONGRESS 1ST SESSION S. 1467 To direct the Secretary of Veterans Affairs to carry out a series of clinical trials on the effects of cannabis on certain health outcomes of veterans with chronic pain and post-traumatic stress disorder, and for other pur- poses. IN THE SENATE OF THE UNITED STATES APRIL 29, 2021 Mr. TESTER (for himself and Mr. SULLIVAN) introduced the following bill; which was read twice and referred to the Committee on Veterans’ Affairs A BILL To direct the Secretary of Veterans Affairs to carry out a series of clinical trials on the effects of cannabis on certain health outcomes of veterans with chronic pain and post-traumatic stress disorder, and for other pur- poses. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘VA Medicinal Cannabis 4 Research Act of 2021’’. 5 VerDate Sep 11 2014 21:51 May 24, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1467.IS S1467 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 1467 IS SEC. 2. DEPARTMENT OF VETERANS AFFAIRS CLINICAL 1 TRIALS ON THE EFFECTS OF CANNABIS ON 2 CERTAIN HEALTH OUTCOMES OF VETERANS 3 WITH CHRONIC PAIN AND POST-TRAUMATIC 4 STRESS DISORDER. 5 (a) CLINICAL TRIALS REQUIRED.— 6 (1) IN GENERAL.—The Secretary of Veterans 7 Affairs shall carry out a series of clinical trials on 8 the effects of medical-grade cannabis on the health 9 outcomes of covered veterans diagnosed with chronic 10 pain and covered veterans diagnosed with post-trau- 11 matic stress disorder. 12 (2) REQUIRED ELEMENTS.—The clinical trials 13 required by paragraph (1) shall include— 14 (A) with respect to covered veterans diag- 15 nosed with chronic pain, an evaluation of the 16 effects of the use of cannabis on— 17 (i) osteopathic pain (including pain in- 18 tensity and pain-related outcomes); 19 (ii) the reduction or increase in opioid 20 use or dosage; 21 (iii) the reduction or increase in 22 benzodiazepine use or dosage; 23 (iv) the reduction or increase in alco- 24 hol use; 25 (v) inflammation; 26 VerDate Sep 11 2014 21:51 May 24, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1467.IS S1467 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 1467 IS (vi) sleep quality; 1 (vii) agitation; and 2 (viii) quality of life; 3 (B) with respect to covered veterans diag- 4 nosed with post-traumatic stress disorder, an 5 evaluation of the effects of the use of cannabis 6 on— 7 (i) the symptoms of post-traumatic 8 stress disorder (PTSD) as established by 9 or derived from the clinician administered 10 PTSD scale, the PTSD checklist, the 11 PTSD symptom scale, the post-traumatic 12 diagnostic scale, and other applicable 13 methods of evaluating symptoms of post- 14 traumatic stress disorder; 15 (ii) the reduction or increase in 16 benzodiazepine use or dosage; 17 (iii) the reduction or increase in alco- 18 hol use; 19 (iv) mood; 20 (v) anxiety; 21 (vi) social functioning; 22 (vii) agitation; 23 (viii) suicidal ideation; and 24 VerDate Sep 11 2014 21:51 May 24, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1467.IS S1467 pbinns on DSKJLVW7X2PROD with BILLS 4 •S 1467 IS (ix) sleep quality, including frequency 1 of nightmares and night terrors. 2 (3) OPTIONAL ELEMENTS.—The clinical trials 3 required by paragraph (1) may include an evaluation 4 of the effects of the use of cannabis to treat chronic 5 pain and post-traumatic stress disorder on— 6 (A) pulmonary function; 7 (B) cardiovascular events; 8 (C) head, neck, and oral cancer; 9 (D) testicular cancer; 10 (E) ovarian cancer; 11 (F) transitional cell cancer; 12 (G) intestinal inflammation; 13 (H) motor vehicle accidents; 14 (I) mania; 15 (J) psychosis; 16 (K) cognitive effects; 17 (L) cannabinoid hyperemesis syndrome; 18 (M) neuropathy; or 19 (N) spasticity. 20 (b) LONG-TERM OBSERVATIONAL STUDY.—The Sec- 21 retary may carry out a long-term observational study of 22 the participants in the clinical trials required by sub- 23 section (a). 24 (c) TYPE OF CANNABIS.— 25 VerDate Sep 11 2014 21:51 May 24, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1467.IS S1467 pbinns on DSKJLVW7X2PROD with BILLS 5 •S 1467 IS (1) IN GENERAL.—In carrying out the clinical 1 trials required by subsection (a), the Secretary shall 2 study varying forms of cannabis, including whole 3 plant raw material and extracts. 4 (2) PLANT CULTIVARS.—Of the varying forms 5 of cannabis required under paragraph (1), the Sec- 6 retary shall study not fewer than seven unique plant 7 cultivars with ratios of tetrahydrocannabinol to 8 cannabidiol in each of the following categories: 9 (A) Less than 1:5. 10 (B) Between 1:2 and 1:5. 11 (C) Approximately 1:2. 12 (D) Approximately 1:1. 13 (E) Approximately 2:1. 14 (F) Between 2:1 and 5:1. 15 (G) More than 5:1. 16 (d) USE OF CONTROL AND EXPERIMENTAL 17 GROUPS.—The clinical trials required by subsection (a) 18 shall include both a control group and an experimental 19 group that shall— 20 (1) be of similar size and structure; and 21 (2) represent the demographics of the veteran 22 population, as determined by the most recent data 23 from the American Community Survey of the Bu- 24 VerDate Sep 11 2014 21:51 May 24, 2021 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1467.IS S1467 pbinns on DSKJLVW7X2PROD with BILLS 6 •S 1467 IS reau of the Census that is available prior to the 1 commencement of the clinical trials. 2 (e) DATA PRESERVATION.—The clinical trials re- 3 quired by subsection (a) shall include a mechanism to en- 4 sure the preservation of all data, including all data sets, 5 collected or used for purposes of such trials in a manner 6 that will facilitate further research. 7 (f) IMPLEMENTATION.—Not later than 180 days 8 after the date of the enactment of this Act, the Secretary 9 shall— 10 (1) develop a plan to implement this section 11 and submit such plan to the Committee on Veterans’ 12 Affairs of the Senate and the Committee on Vet- 13 erans’ Affairs of the House of Representatives; and 14 (2) issue any requests for proposals the Sec- 15 retary determines appropriate for such implementa- 16 tion. 17 (g) EFFECT ON OTHER BENEFITS.—The eligibility 18 or entitlement of a covered veteran to any other benefit 19 under the laws administered by the Secretary or any other 20 provision of law shall not be affected by the participation 21 of the covered veteran in a clinical trial under subsection 22 (a) or a study under subsection (b). 23 (h) PERIODIC REPORTS.—During the five-year pe- 24 riod beginning on the date of the enactment of this Act, 25 VerDate Sep 11 2014 21:51 May 24, 2021 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1467.IS S1467 pbinns on DSKJLVW7X2PROD with BILLS 7 •S 1467 IS the Secretary shall submit periodically, but not less fre- 1 quently than annually, to the Committee on Veterans’ Af- 2 fairs of the Senate and the Committee on Veterans’ Af- 3 fairs of the House of Representatives reports on the imple- 4 mentation of this section. 5 (i) COVERED VETERAN DEFINED.—In this section, 6 the term ‘‘covered veteran’’ means a veteran who is en- 7 rolled in the patient enrollment system of the Department 8 of Veterans Affairs established and operated under section 9 1705(a) of title 38, United States Code. 10 Æ VerDate Sep 11 2014 21:51 May 24, 2021 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S1467.IS S1467 pbinns on DSKJLVW7X2PROD with BILLS