The proposed bill introduces Chapter 25.7, "Preserving Access to Affordable Drugs," into Title 23 of the General Laws, focusing on enhancing transparency and competition in the pharmaceutical industry. It establishes definitions related to drug applications and patent infringement claims, and outlines the responsibilities of pharmaceutical manufacturers regarding the introduction of generic medications. A key provision mandates that any pharmaceutical manufacturer entering into an agreement to delay the introduction of a generic drug must notify the attorney general within 30 days, providing specific details about the drug and the nature of the delay. The attorney general is then required to disseminate this information to relevant health programs within the same timeframe, aiming to prevent undue delays in the availability of affordable medications.

Furthermore, the bill introduces new legal language addressing anticompetitive practices, particularly concerning patent infringement settlements. It establishes a presumption of anticompetitive effects for agreements where a nonreference drug filer receives value from a brand company in exchange for limiting their product development or sales. Exceptions are provided for agreements that demonstrate direct procompetitive benefits or fair compensation for goods or services. The bill also clarifies the responsibilities of factfinders in determining relevant product markets and outlines penalties for violations, including civil fines up to three times the value received or a maximum of $20 million. Importantly, the legislation does not alter existing antitrust laws and includes a severability clause to maintain the enforceability of remaining provisions if any part is deemed invalid.