HF 4064
Introduction - 94th Legislature (2025 - 2026)
Posted on 03/18/2026 11:49 a.m.
1.6 1.7 1.8 1.9 1.10 1.11 1.12 1.13 1.14 1.15 1.16 1.17 1.18 1.19 1.20 1.21 1.22 1.23 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 2.10 2.11 2.12 2.13 2.14 2.15 2.16 2.17 2.18 2.19 2.20 2.21 2.22 2.23 2.24 2.25 2.26 2.27 2.28 2.29 2.30 2.31 2.32 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13 3.14 3.15 3.16 3.17 3.18 3.19
3.20 3.21 3.22 3.23
A bill for an act
relating to health; directing the commissioner of health to study and report on
activities to support innovations in cell and gene therapy to treat rare diseases;
requiring a report; appropriating money.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
Section 1. new text begin STUDY AND REPORT ON ACTIVITIES TO SUPPORT INNOVATIONS
IN CELL AND GENE THERAPIES TO TREAT RARE DISEASES.
new text end
new text begin Subdivision 1. new text end
new text begin Legislative intent. new text end
new text begin
The legislature finds that the development of cell and
gene therapies offers significant promise to treat and potentially cure a wide range of diseases,
including cancer, rare genetic disorders, and autoimmune conditions. The legislature
recognizes that the state of Minnesota is a national leader in biomedical research and health
care innovation and recognizes the importance of fostering scientific progress and promoting
economic development in cell and gene therapy.
new text end
new text begin Subd. 2. new text end
new text begin State policy. new text end
new text begin
It is the policy of the state of Minnesota to support and encourage
the advancement, commercialization, and clinical translation of new technologies and
applications in the fields of cell and gene therapy. These activities include but are not limited
to research and development activities, workforce training programs, public-private
partnerships, regulatory science initiatives, and infrastructure to support clinical trials and
biomanufacturing.
new text end
new text begin Subd. 3. new text end
new text begin Definitions. new text end
new text begin
(a) For purposes of this section, the following terms have the
meanings given.
new text end
new text begin
(b) "Cell and gene therapy" means a biological product intended to modify or manipulate
the expression of one or more genes or to alter biological properties of living cells for
therapeutic use, including but not limited to gene addition, gene editing, gene silencing,
gene replacement, and cell-based therapies.
new text end
new text begin
(c) "Rare disease" means a disease, disorder, or condition that affects fewer than 200,000
individuals in the United States and is chronic, serious, life-altering, or life-threatening.
new text end
new text begin Subd. 4. new text end
new text begin Study on current capacity and strategies to support innovations. new text end
new text begin
(a) The
commissioner of health, in consultation with the University of Minnesota, the Minnesota
Rare Disease Advisory Council, and other stakeholders, shall conduct a comprehensive
study on the state's current capacity for rare disease cell and gene therapy research,
development, delivery, and access and on strategies to support innovations in rare disease
cell and gene therapy research, development, delivery, and access. The study must include
but is not limited to an assessment of:
new text end
new text begin
(1) the infrastructure and capabilities of other states in cell and gene therapy development
and delivery;
new text end
new text begin
(2) opportunities within existing resources and statutory authority to support innovation
in cell and gene therapies in the state, including alignment with state-funded research
programs, participation in federal grant programs and pilot programs, and coordination with
economic development programs;
new text end
new text begin
(3) current capacity in the state for clinical trials and biomedical research on rare disease
cell and gene therapies, including funding sources, academic partnerships, and industry
presence;
new text end
new text begin
(4) current capacity and future opportunities for biomanufacturing related to cell and
gene therapies;
new text end
new text begin
(5) the ability of health systems to deliver cell and gene therapies, including of facilities
performing infusion therapy or transplants, hospital infrastructure, and necessary support
services;
new text end
new text begin
(6) workforce needs, including the availability of clinical geneticists, gene therapy
specialists, advanced practice providers, and allied health professionals;
new text end
new text begin
(7) policies regarding covering and paying for cell and gene therapies, including policies
under the medical assistance program, policies of commercial payers, value-based payment
models, and potential barriers to access resulting from these policies;
new text end
new text begin
(8) regulatory and administrative factors, including licensing requirements, reporting
requirements, and potential barriers based on existing state policies;
new text end
new text begin
(9) health equity and access issues, including barriers to access experienced by rural and
underserved communities; and
new text end
new text begin
(10) economic impacts and costs, including short-term and long-term costs to health
systems and to society.
new text end
new text begin
(b) In conducting this study, the commissioner must seek input from patients with a rare
disease, caregivers of patients with a rare disease, advocacy groups for patients with a rare
disease, health care providers and clinical experts in genetics and cell and gene therapies,
academic research institutions, payers, pharmacy benefit managers, the biotechnology
industry, the pharmaceutical industry, and other appropriate stakeholders identified by the
commissioner.
new text end
new text begin Subd. 5. new text end
new text begin Report and recommendations. new text end
new text begin
By January 1, 2028, the commissioner shall
submit a report to the legislature that includes:
new text end
new text begin
(1) findings from the study conducted under subdivision 4;
new text end
new text begin
(2) short-term and long-term recommendations for strategic investments by the state,
changes to state policies, and regulatory actions by the state to support the state in leading
on rare disease cell and gene therapies; and
new text end
new text begin
(3) identification of potential federal funding opportunities, public-private partnerships,
and grant programs to support implementation of the recommendations.
new text end
new text begin
The report must also be posted on the Department of Health website.
new text end
Sec. 2. new text begin APPROPRIATION.
new text end
new text begin
$....... in fiscal year 2027 is appropriated from the general fund to the commissioner of
health for a study and report on activities to support innovations in rare disease cell and
gene therapies. This is a onetime appropriation and is available until June 30, 2028.
new text end