Commissioner of health directed to study and report on activities to support innovations in cell and gene therapy to treat rare diseases, report required, and money appropriated.

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.
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STUDY AND REPORT ON ACTIVITIES TO SUPPORT INNOVATIONS

IN CELL AND GENE THERAPIES TO TREAT RARE DISEASES.
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Subdivision 1.

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Legislative intent.

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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.

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Subd. 2.

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State policy.

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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.

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Subd. 3.

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Definitions.

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(a) For purposes of this section, the following terms have the

meanings given.

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(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.

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(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.

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Subd. 4.

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Study on current capacity and strategies to support innovations.

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(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:

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(1) the infrastructure and capabilities of other states in cell and gene therapy development

and delivery;

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(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;

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(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;

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(4) current capacity and future opportunities for biomanufacturing related to cell and

gene therapies;

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(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;

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(6) workforce needs, including the availability of clinical geneticists, gene therapy

specialists, advanced practice providers, and allied health professionals;

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(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;

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(8) regulatory and administrative factors, including licensing requirements, reporting

requirements, and potential barriers based on existing state policies;

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(9) health equity and access issues, including barriers to access experienced by rural and

underserved communities; and

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(10) economic impacts and costs, including short-term and long-term costs to health

systems and to society.

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(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.

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Subd. 5.

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Report and recommendations.

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By January 1, 2028, the commissioner shall

submit a report to the legislature that includes:

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(1) findings from the study conducted under subdivision 4;

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(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

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(3) identification of potential federal funding opportunities, public-private partnerships,

and grant programs to support implementation of the recommendations.

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The report must also be posted on the Department of Health website.

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Sec. 2.
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APPROPRIATION.
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$....... 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.

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