Purpose and policy intent

• The bill directs the Minnesota Department of Health to study and report on activities to support innovations in cell and gene therapies for treating rare diseases.
• It aims to foster scientific progress, accelerate clinical use, and promote economic development in Minnesota’s biomedical sector.

Key definitions

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

What the bill requires

• A comprehensive study on Minnesota’s current capacity and strategies to support innovations in rare-disease cell and gene therapies. The study will look at research, development, delivery, and access, and how to advance these therapies in Minnesota.
• Areas the study must cover:
  • How Minnesota compares with other states in cell and gene therapy development and delivery.
  • Opportunities within existing resources and statutory authority to support innovation.
  • Alignment with state-funded research programs, federal grants, pilot programs, and economic development activities.
  • Current clinical trial and biomedical research capacity, including funding, academic partnerships, and industry presence.
  • Capacity for biomanufacturing related to cell and gene therapies.
  • Health system readiness to deliver therapies (facilities, infusion or transplant capabilities, hospital infrastructure, and support services).
  • Workforce needs (clinical geneticists, gene therapy specialists, advanced practice providers, and allied health professionals).
  • Policies on paying for therapies (Medicaid, commercial payer policies, value-based payment models) and barriers to access.
  • Regulatory and administrative factors (licensing and reporting requirements).
  • Health equity and access concerns, especially for rural and underserved communities; economic impacts and costs to health systems and society.
• The commissioner must gather input from a broad group of stakeholders, including patients and families, advocacy groups, healthcare providers, researchers, payers, industry, and other appropriate parties.

Stakeholder involvement

• Input is to be sought from patients with rare diseases, caregivers, advocacy groups, health care providers, clinical genetics and cell/gene therapy experts, academic institutions, payers, pharmacy benefit managers, and biotechnology/pharmaceutical industries.

Reporting and timing

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

Funding and appropriation

• A one-time appropriation from the general fund to the Department of Health in fiscal year 2027 to fund the study and report. The funds are available through June 30, 2028.

Significance and potential changes to law

• The bill does not immediately change existing laws or regulations. Instead, it creates a structured study and reporting requirement to inform future policy decisions, funding, and regulatory actions to advance cell and gene therapies for rare diseases in Minnesota.

Relevant terms cell and gene therapy; rare disease; Commissioner of Health; Department of Health; University of Minnesota; Minnesota Rare Disease Advisory Council; clinical trials; biomanufacturing; health equity; access; infusion therapy; regulatory actions; licensing; value-based payment; medical assistance; payer policies; public-private partnerships; funding; appropriation; study; report; stakeholders; gene therapy; gene editing; gene silencing; gene replacement; examples of therapies.