Even companies that do not yet have products on the market will be impacted, in their research and development programs, alliances with corporate partners and valuations, by regulations directed toward the content, marketing and competition for, and pricing of, drug products. In representing life sciences companies in financing activities and licensing and collaboration transactions, Steve and I work closely with our FDA and antitrust colleagues at Morgan Lewis, and have identified several current regulatory issues that I would like to mention briefly today. Confidentiality and Privacy of Health Information 1. We have seen a sharp increase in the number of emerging companies whose businesses are built on medical information, including the warehousing of patient information and cell storage. Individuals are entitled to inspect their information, and to be notified as to its uses and disclosure.
Patient consent is required for disclosure of health information, whether routine or non-routine.
This exception is detailed in the regulations. Business plans that include the compilation and use of medical information should be reviewed carefully to make sure these rules have been complied with. Extension of Waxman-Hatch to Biologics 1. The existing Waxman-Hatch Act provided for the current abbreviated approval process for generic versions of drugs that no longer have patent protection. In return, the Act provided for 30-month patent protection extension if the innovator company challenges the generic company on patent grounds.