Substitute Bill No. 8 is a legislative proposal aimed at improving drug affordability through the establishment of a Canadian prescription drug importation program. The bill, effective from July 1, 2024, mandates the creation of a program to import cost-saving prescription drugs from Canada, with provisions for laboratory testing and compliance with safety and quality standards. It outlines the process for FDA approval, specifies the types of drugs eligible for importation, and details the roles of Canadian suppliers and wholesalers, including compliance with track-and-trace requirements. The bill grants authority to the executive director of the Office of Health Strategy to suspend importation and distribution for non-compliance, order recalls or seizures of adulterated or misbranded drugs, and convene hearings as contested cases. It also establishes the Prescription Drug Affordability Board within the Office of Health Strategy to advise on drug affordability and monitor prices.

Furthermore, the bill introduces regulations to prevent state entities, health benefit plans, and participating ERISA plans from purchasing drugs at costs higher than the upper payment limits set by the Prescription Drug Affordability Board. Retail pharmacies must adhere to these limits, and savings must be used to reduce healthcare costs for consumers. Manufacturers are required to provide notice before withdrawing drugs from the market and notify the board of impending shortages. The bill also mandates hospitals and drug purchasing agencies to establish drug shortage prevention strategies and comply with the 340B drug pricing program. New legal provisions are added without deletions from current law, and the bill ensures alignment with federal law and regulations. The majority of the bill's sections are set to take effect on July 1, 2024, with some on January 1, 2025, and from the date of passage.

Statutes affected:
HS Joint Favorable Substitute:
File No. 309:
JUD Joint Favorable: