Data Protection in the Pharmaceutical Industry: Concerns and Considerations
Leslie Restaino, General Counsel, Validus Pharmaceuticals, USA
Data protection is an important aspect of the pharmaceutical industry throughout all stages of a product lifecycle – from innovation to exit. In the early stages of product development, manufacturers seek to secure trial data to provide a competitive edge; security issues arising during licensing and collaborative activities in the later stages of product development; after development and approval, patients seek to protect their privacy surrounding use of a drug. This latter issue has seen a large amount of recent press. In Sorrell v. IMS Healthcare, Inc., the U.S. Supreme Court struck down a Vermont law involving the purchase of doctor prescribing records from data mining companies to reveal prescribing histories. These prescribing histories were used by pharmaceutical companies to develop targeted marketing strategies. Vermont’s Prescription Confidentiality Law of 2007 required doctors’ consent for such practices. Data mining companies and pharmaceutical manufacturers protested the law, and the Supreme Court in Sorrell ruled that the law in question was an unconstitutional violation of the First Amendment.
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