HB 1223: ECONOMIC DEVELOPMENT: Establishes the Louisiana Clinical Trial Competitiveness and Patient Access Act - Louisiana

HB1223 Original → HB1223 Act 886 · 5 edits

MODERATE

The bill was renamed from the 'Early-Phase Clinical Trial Acceleration Framework' to the 'Clinical Trial Competitiveness and Patient Access Act,' shifting the focus from speeding up specific early-stage trials to creating a broader statewide system that supports all types of clinical trials. The new version expands the definition of covered projects to include federally supported trials and clarifies that the act does not grant any entity exclusive status or interfere with federal designations like NCI cancer centers. Additionally, the statutory range was reduced from R.S. 51:3301-3310 to 51:3301-3306, indicating a more streamlined set of rules.

Scope change

The bill's scope was broadened to include federally supported interventional clinical trials (not just industry-sponsored ones) and explicitly excluded purely observational studies and expanded-access treatments. The act also added strong non-discrimination clauses to ensure no entity is designated as the exclusive provider or patient-referral destination.

SCOPE

The bill title and purpose changed from focusing solely on 'early-phase' acceleration to a broader 'competitiveness and patient access' framework.

DEFINITION

The definition of 'covered clinical project' was expanded to include federally supported trials and voluntarily included observational studies, while explicitly excluding retrospective chart reviews and expanded-access treatments.

The specific definition for 'benchmark category' and the detailed list of 'patient-access support' activities were removed from the final act text.

REQUIREMENT

New provisions were added to explicitly state that the act does not designate any entity as the exclusive or preferred provider, nor does it interfere with federal cancer center designations.

TECHNICAL

The bill's statutory range was shortened from R.S. 51:3301 through 3310 to 51:3301 through 3306.

HB1223 Enrolled → HB1223 Original · 6 edits

MODERATE

The bill was renamed from the 'Clinical Trial Competitiveness and Patient Access Act' to the 'Early-Phase Clinical Trial Acceleration Framework' to better reflect its specific focus on early-stage research. The scope of the law was expanded to include new trial phases like first-in-human and gene therapy, while the statutory range was adjusted to accommodate these additions. Several definitions were updated to clarify terms like 'covered clinical project' and 'contract research organization' to ensure they align with the new focus on early-phase trials.

Scope change

The bill's scope was narrowed to specifically target early-phase and first-in-human trials rather than all clinical trials, and the list of eligible trial types was expanded to include specialized categories like gene therapy and cell therapy.

SCOPE

The bill title and chapter name were changed to emphasize 'Early-Phase Clinical Trial Acceleration' instead of general competitiveness.

The range of affected statutes was extended from R.S. 51:3301-3306 to 3301-3310 to accommodate new content.

DEFINITION

The definition of 'covered clinical project' was updated to explicitly list early-phase, first-in-human, dose-escalation, and gene-therapy trials.

New definitions were added for 'benchmark category' and 'complete submission' to standardize how projects are tracked and reported.

The definition of 'research entity' was broadened to include research organizations and academic institutions, not just hospitals.

The definition of 'contract research organization' was expanded to include a wider range of services like feasibility assessments and data management.

HB1223 Reengrossed → HB1223 Enrolled · 4 edits · May 31, 2026

MODERATE

The bill was finalized into its enrolled version, removing the 'Reengrossed' status and updating page counts. Substantively, the definitions section was expanded to clarify that 'covered clinical projects' include federally supported trials designated by rule or voluntary election, while explicitly excluding purely observational studies and retrospective chart reviews unless voluntarily included. The bill also added new protections ensuring no research entity is designated as an exclusive statewide provider or broker, and clarified that nothing in the law impairs federal designations like National Cancer Institute status.

Scope change

The scope of 'covered clinical projects' was narrowed by explicitly excluding observational studies and retrospective reviews, while adding a mechanism for voluntary inclusion of expanded-access treatments.

DEFINITION

Refined the definition of 'covered clinical project' to exclude purely observational studies, retrospective chart reviews, and registry-only studies unless voluntarily included by the research entity.

Added a new provision stating that the chapter cannot designate any entity as the exclusive or preferred statewide provider, gateway, or broker for clinical trials.

Added a new provision ensuring the chapter does not impair a research entity's status regarding federal designations like the National Cancer Institute.

Updated the definition of 'covered clinical project' to clarify that federally supported trials are included only if designated by rule or voluntary written election by the research entity.

HB1223 Engrossed → HB1223 Reengrossed · 5 edits · May 26, 2026

MODERATE

The bill was reengrossed to rename the initiative from the 'Early-Phase Clinical Trial Acceleration Framework' to the 'Clinical Trial Competitiveness and Patient Access Act.' The scope was significantly broadened to include all FDA-regulated interventional trials (including Phase IV) rather than just early-phase studies, and the legislative purpose was updated to emphasize statewide visibility and collaboration while explicitly preserving patient choice and institutional independence.

Scope change

The bill's scope expanded from a narrow focus on early-phase and first-in-human trials to cover all interventional clinical trials, including Phase IV studies, provided they are designated by rule or voluntary election.

SCOPE

Renamed the act from 'Early-Phase Clinical Trial Acceleration Framework' to 'Clinical Trial Competitiveness and Patient Access Act' to reflect a broader mandate.

Expanded the definition of covered clinical projects to include Phase IV trials and other FDA-regulated interventional studies, removing the previous restriction to only early-phase research.

DEFINITION

Added a new definition for 'Confidential business information' to protect trade secrets, pricing, and sponsor-specific strategies shared during the trial process.

REQUIREMENT

Added explicit provisions ensuring that participation in the program does not designate any entity as the exclusive or preferred statewide provider, thereby preserving patient choice and institutional autonomy.

ENFORCEMENT

Replaced specific performance benchmarks with a focus on sharing information and establishing external institutional review board reliance to streamline the review process.

ECONOMIC DEVELOPMENT: Establishes the Louisiana Clinical Trial Competitiveness and Patient Access Act

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