TEXAS COUNCIL for
DEVELOPMENTAL
DISABILITIES

Bill of The Week: HB 1535

BotW-HB-1535

For this weekly feature, the Texas Council for Developmental Disabilities (TCDD) profiles a noteworthy bill that is currently going through the legislative process. The bill may relate directly to TCDD’s Public Policy Priorities or another disability-related issue.

Bill: House Bill (HB) 1535, relating to the medical use of low-THC cannabis by patients with certain medical conditions and the establishment of compassionate-use institutional review boards to evaluate and approve proposed research programs to study the medical use of low-THC cannabis in the treatment of certain patients.

Bill Author: Rep. Stephanie Klick, Texas House District 91 (North Richland Hills)

Joint Authors:

Coauthors: HB 1535 has 60 coauthors. They can be found listed on the bill page at Texas Legislature Online.

Senate Sponsor: Sen. Charles Schwertner, Texas Senate District 5 (Georgetown)

Senate Cosponsors:

What does the bill do?
HB 1535 would add the following to the list of diagnoses eligible for licensed physicians to prescribe low-tetrahydrocannabinol (THC) cannabis, which has no psychoactive effects:

  • A condition that causes acute or chronic pain for which a physician would otherwise prescribe an opioid
  • Post-traumatic stress disorder
  • A medical condition approved for an authorized research program
  • A debilitating medical condition designated by the Department of State Health Services

Eligibility would also be expanded to patients diagnosed with cancer rather than just those with terminal cancer.

Under the terms of the bill, one or more compassionate-use institutional review boards would be established to evaluate and approve proposed research programs that would study the medical use of low-THC cannabis in treating specific medical conditions. The board(s) would also oversee patient treatment that was undertaken as part of an approved research program, including the certification of treating physicians.

The bill would require an institutional review board to have an affiliation with a dispensing organization and meet one of the following requirements:

  • Affiliation with a medical school
  • Affiliation with a hospital with at least 150 beds
  • Accredited by the Association for the Accreditation of Human Research Protection Programs
  • Registered by the United States Department of Health and Human Services’ Office for Human Research Protections
  • Accredited by a national accreditation organization acceptable to the Texas Medical Board

Patient treatment in a research program could only be administered by a licensed physician who was certified by an institutional review board. Patient participation in an approved research program would be limited to permanent residents of Texas and would require informed written consent prior to receiving treatment. If a patient is a minor or lacks the mental capacity to provide informed consent, it could be provided by a parent, guardian, or conservator of the individual.

Each institutional review board would be required to submit written reports describing and assessing the findings of each research program. The report would be sent to the Texas Health and Human Services Commission (HHSC) by Oct. 1 of each year, as well as the Legislature by Oct. 1 of each even-numbered year.

Additionally, the bill would amend the definition of low-THC cannabis by increasing the allowable weight of THC from 0.5% to 5% of the cannabis product.

By Dec. 1, 2021, the executive commissioner of HHSC would adopt the rules necessary to implement the bill’s provisions, including rules designating the medical conditions for which a patient could be treated with low-THC cannabis as part of an approved research program.

Also by Dec. 1, 2021, the Department of Public Safety would have to adopt or amend its rules regarding the cultivation, processing, and dispensing of low-THC cannabis by a licensed dispensing organization.

If passed, HB 1535 would take effect Sept. 1, 2021.

Additional Information:
The Texas Compassionate Use Program (TCUP) was established following the 2015 passage of Senate Bill (SB) 339 by Sen. Kevin Eltife and Rep. Stephanie Klick. The program allowed certain physicians, upon the concurrence of a second physician, to prescribe low-THC cannabis to individuals with intractable epilepsy. To do so, SB 339 created an online registry for qualified physicians that tracked the prescriptions and dosing for each patient. Additionally, the bill set forth the parameters of a licensing and regulatory system for a network of dispensing organizations. Due to the stringent eligibility criteria, estimates showed that only a few hundred patients in Texas would benefit from the program at the time.

Four years later, Rep. Klick’s HB 3703 expanded the TCUP eligibility to include all types of epilepsy as well as the following diagnoses:

  • A seizure disorder
  • Multiple sclerosis
  • Spasticity
  • Amyotrophic lateral sclerosis
  • Autism
  • Terminal cancer
  • An incurable neurodegenerative disease

HB 3703 also lowered the required number of physicians whose recommendation is required for a patient to receive a low-THC cannabis prescription from two to one.

At the time, advocates testified that HB 3703 should have expanded the TCUP eligibility criteria even further, as well as increased the THC limits. Both changes are, to some extent, included in HB 1535 this session.


 

Statement from bill author, Rep. Stephanie Klick: 

Texas house representative Stephanie Klick

“In 2015, I had the great honor of creating

 the Compassionate Use Program to make 

low-THC cannabis available to patients … 

My intent was then, and still is, to have a

 truly medical program that follows scientific data.”


Where is the bill in the process?
HB 1535 was passed out of the House on April 29, 2021. It has been sent to the Senate where it awaits consideration by that body. The bill received a public hearing before the House Committee on Public Health on April 7, 2021. You can watch the discussion here, beginning at the 00:03:06 mark.

Who supports the bill and why?
The following comments were taken at the April 7, 2021, public hearing:

  • CTD: Chase Bearden, speaking in his role as deputy executive director of the Coalition of Texans with Disabilities (CTD), offered the following remarks: “[TCUP] does have some issues, and it comes down to the THC cap. Even with the dose that I am currently getting, the amount of product I have to buy to actually meet the amount of milligrams dose that I need to take, basically means I have to buy more products and then ingest them. … After you have to take too much, it creates [gastrointestinal] problems. [Medical cannabis] is what got me off of opioids, when that was the only legal, insured way for me to have pain relief. Cannabis is what helped me work my way down … because the program here didn’t meet that level, it just didn’t have enough of the THC in it.”
  • Cannliv: John David Carrasco, speaking in his role as president and CEO of Cannliv Inc. and chair of the Cannabis Caucus for the Texas Democratic Party, offered these remarks: “[Cannliv] was offered an amazing strategic partnership with the world’s top cancer facility. The project failed and there were two reasons why. One, the rules and regulations for cannabis cultivation were just not there yet; and two, banking issues. As we met with investors … as soon as they went back to their banking institutions, they said, ‘if you give one penny to cannabis research, we’re going to shut you down.’ … I am in support of this bill, but there is still so much more work that needs to be done to be able to address and create solutions for research with cannabinoids.”
  • Vyripharm Texas: Dr. Elias Jackson, speaking in his role as Director of Translational Medicine at Vyripharm Texas: “My son was diagnosed on the spectrum of autism. I am a traditionally trained scientist. When I was offered opioids to give to him, I began to look for alternative medications. In 2014, my company was awarded the only federal patent for the evaluation of cannabinoids and cannabinoid-based products for human consumption. … I think if we can add just a little language in reference to certification of these products, we can really cure all the issues.”

The following groups also registered their support for the bill: DFW Norm Cannabis, CenTex Community Outreach, PharmaCann, Texas NORML, Foundation for an Informed Texas, Revolution, Village Farms, the Libertarian Party of Texas, Texas Cannabis Collective, KK 125 Ovarian Cancer Research Foundation, the Epilepsy Foundation of Texas, the Epilepsy Foundation of Central and South Texas, Mothers Advocating for Medical Marijuana for Autism, Texans for Medical Relief. Additionally, 21 individuals registered support, representing themselves.

Who opposes the bill and why?
No opposition to the bill was registered at the public hearing.

Additional testimony:

  • TAT: Gregory Fowler, speaking on behalf of his daughter and the Tourette Association of Texas (TAT), offered the following remarks on the bill: “One of the things I’m still concerned about is the list of qualifying conditions. My daughter, Stacey, has Tourette syndrome … her diagnosis did not meet the qualifying criteria [of the Compassionate Use Act]. But medical cannabis has changed her life drastically. She used to live a very limited life with very limited socialization and many trips to the hospital. She’s now 18 and has been using medical cannabis for the last three and a half to four years, and she’s about to graduate high school. She’s been accepted to A&M and she’s going to start there in the summer. She’s very active in our community. We shouldn’t move forward on any medical cannabis issues unless we’re going to leave the decisions up to the doctors, for them to treat the symptoms and not necessarily the letter of the diagnosis.”

How much will the bill cost?
The Legislative Budget Board (LBB) determined the bill would not impact the state budget in a significant way.

Is there a Senate companion to the bill?
There is no Senate companion to HB 1535.

Related bills:
Several bills were filed relating to the medical use of low-THC cannabis, but only HB 1535 was passed out of a legislative chamber. These additional bills included the following:

  • HB 1001 by Rep. Eddie Lucio III, relating to the medical use of low-THC cannabis by certain patients with post-traumatic stress disorder under the Texas Compassionate Use Act
  • HB 1108 by Rep. Alex Dominguez, relating to the eligibility of an individual to be issued a license to operate as a dispensing organization under the Texas Compassionate Use Act, or to act as a director, manager, or employee of a dispensing organization, based on a criminal history background check
  • HB 4307 by Rep. Eddie Lucio III, relating to coverage for low-THC cannabis under certain group benefit plans for governmental employees
  • SB 327 by Sen. Eddie Lucio, Jr., relating to the medical use of low-THC cannabis by certain patients with post-traumatic stress disorder under the Texas Compassionate Use Act

Stay informed:
For the latest information about where HB 1535 is in the process, follow the bill on the Texas Legislature Online. To receive future legislative updates from TCDD, subscribe to TCDD eNews or follow us on Twitter.

Bill of the Week Updates:
Due to deadline considerations, we are unable to provide timely updates this week. We will include updates with our next Bill of the Week.

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