Sec. 8. Prize payments for medical innovation
560 words·~3 min read·
/bill/113/s/626/is/section-8A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
For fiscal year 2015, and each subsequent fiscal year, the Prize Fund Director shall award to persons described in subsection
(b)prize payments for medical innovation relating to a qualifying treatment for HIV/AIDS, or a new manufacturing process for such a qualifying treatment for HIV/AIDS. To be eligible to receive a prize payment under subsection
(a)a person shall be— in the case of a qualifying treatment for HIV/AIDS that is a drug or biological product, the first person to receive market clearance with respect to the drug or biological product; in the case of a manufacturing process for a qualifying treatment for HIV/AIDS, the holder of the patent with respect to such process; or in the case of open source contributions with respect to a qualifying treatment for HIV/AIDS, the persons or communities that openly shared knowledge, data, materials, and technology on a royalty-free and nondiscriminatory basis. The Prize Fund Director shall, by regulation, establish criteria for the selection of recipients, and for determining the amount, of prize payments under this section. Such criteria shall include consideration of the following: The number of patients who benefit from the qualifying treatment for HIV/AIDS or manufacturing process involved. The incremental therapeutic benefit of the qualifying treatment for HIV/AIDS or manufacturing process involved as compared to existing drugs, biological products, and manufacturing processes available to treat the same disease or condition, except that the Prize Fund Director shall provide for cases where drugs, biological products, or manufacturing processes are developed at roughly the same time, so that the comparison is to products that were not recently developed. Improved efficiency of manufacturing processes for drugs or biological processes. The extent to which knowledge, data, materials, and technology that are openly shared have contributed to the successful development of new products or improved processes for manufacturing products. In awarding prize payments under this section, the Prize Fund Director shall comply with the following: In cases where a new qualifying treatment for HIV/AIDS or manufacturing process for a qualifying treatment of HIV/AIDS offers an improvement over an existing qualifying treatment for HIV/AIDS or manufacturing process for a qualifying treatment and such new qualifying treatment or manufacturing process competes with or replaces the existing qualifying treatment or manufacturing process, the Prize Fund Director shall continue to make prize payments for the existing qualifying treatment or manufacturing process to the degree that the new qualifying treatment or manufacturing process was based on or benefitted from the development of the existing qualifying treatment or manufacturing process. The Prize Fund Director may award prize payments for a qualifying treatment for HIV/AIDS or a manufacturing process for a qualifying treatment for HIV/AIDS for not more than 10 fiscal years, regardless of the term of any related patents. For any fiscal year, the Prize Fund Director may not award a prize payment for any single qualifying treatment for HIV/AIDS or manufacturing process for a qualifying treatment in an amount that exceeds 50 percent of the total amount appropriated to the Fund for that year. For every qualifying treatment for HIV/AIDS that receives market clearance, the Prize Fund Director shall determine whether and in what amount to award a prize payment for the qualifying treatment for HIV/AIDS not later than the end of the fourth full calendar-year quarter following the calendar-year quarter in which the qualifying treatment for HIV/AIDS receives market clearance.