SF4189

Purpose

• Directs the Commissioner of Health to study and report on activities to support innovations in cell and gene therapy to treat rare diseases.

Main provisions

• Policy goal: Minnesota should support the advancement, commercialization, and clinical use of cell and gene therapies, including research, development, workforce training, public-private partnerships, regulatory science, and biomanufacturing infrastructure.

• Definitions:

  • Cell and gene therapy: a biological product that modifies or manipulates gene expression or living cells for therapeutic use, including gene addition, editing, silencing, replacement, and cell-based therapies.
  • Rare disease: a disease or condition affecting fewer than 200,000 people in the United States that is chronic, serious, life-altering, or life-threatening.

• Comprehensive study (Subdivision 4):

  • The Commissioner of Health, with the University of Minnesota, the Minnesota Rare Disease Advisory Council, and other stakeholders, will assess:
  • Current capacity for rare-disease CGT research, development, delivery, and access; and strategies to support innovations.
  • How Minnesota compares to other states and how existing resources and authority could support CGT innovation, including alignment with state-funded programs, federal grants, pilot programs, and economic development efforts.
  • Current state capacity for clinical trials and biomedical research on CGT, including funding, academic partnerships, and industry presence.
  • Capacity and future opportunities for biomanufacturing related to CGT.
  • The ability of health systems to deliver CGT (facilities, infusion therapy, transplants, hospital infrastructure, support services).
  • Workforce needs (clinical geneticists, gene therapy specialists, advanced practice providers, allied health professionals).
  • Policies on covering and paying for CGT (Medicaid, commercial payers, value-based payment models) and potential access barriers.
  • Regulatory and administrative factors (licensing, reporting, and other barriers under current state policies).
  • Health equity and access issues, including barriers for rural and underserved communities, plus economic costs to health systems and society (short-term and long-term).
  • Stakeholder input: The commissioner must seek input from patients with rare diseases, caregivers, advocacy groups, healthcare providers, genetics and CGT experts, academic researchers, payers, pharmacy benefit managers, the biotech and pharmaceutical industries, and other relevant groups.

• Report and recommendations (Subdivision 5):

  • By January 1, 2028, the commissioner must submit a report with:
  • Findings from the study.
  • Short-term and long-term recommendations for strategic state investments.
  • Suggested state policy and regulatory actions to help Minnesota lead in rare-disease CGT.
  • Identification of potential federal funding opportunities, public-private partnerships, and grant programs to support implementation.
  • The report must also be posted on the Department of Health website.

• Timing and location: The study and ensuing report are coordinated through the Department of Health.

Fiscal note / appropriation

• A one-time general fund appropriation in fiscal year 2027 is provided for the study and report related to rare-disease CGT. The funds are available until June 30, 2028. The bill does not specify an appropriation amount in the summary.

Significant changes to existing law

• No immediate regulatory changes are enacted. The bill creates a mandatory, multi-stakeholder study and a formal report with recommendations and possible future policy actions, comprehensive enough to influence future legislation and funding decisions.

Note on partnerships and institutions

• The University of Minnesota and the Minnesota Rare Disease Advisory Council are explicitly named as collaborators in the study.

Relevant Terms - cell and gene therapy - rare disease - comprehensive study - Commissioner of Health - University of Minnesota - Minnesota Rare Disease Advisory Council - clinical trials - biomanufacturing - health systems capacity - infusion therapy - regulatory science - licensing - payer policies - Medicaid / Medical Assistance - value-based payment models - public-private partnerships - federal funding opportunities - pilot programs - health equity - rural access - economic impact - stakeholders - patients and caregivers - advocacy groups - payers and pharmacy benefit managers - biotechnology industry - pharmaceutical industry - legislation report due date (January 1, 2028)