Sharing Clinical Trial Data Maximizing Benefits, Minimizing Risk (2015) / Chapter Skim
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Appendix C: Legal Discussion of Risks to Industry Sponsors
Appendix C: Legal Discussion of Risks to Industry Sponsors
Pages 257-266
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From page 257... ...
intellectual property protection laws Trade Secrets and Commercially Confidential Information Outside the regulatory context, the issue of what constitutes a trade secret is addressed as an initial matter by state common law. The Uniform Trade Secrets Act (UTSA)
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only pursuant to agreements wherein the recipient agrees to keep the information confidential. Public access to nonsummary clinical trial data generated by industry sponsors and submitted to government agencies is governed by federal statutory law.
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In the case of these data -- as contrasted with the failed drug data at issue in the 1999 Public Citizen case6 -- the concern about data release leading competitors directly to successful alternative drugs may be diminished. Under FOIA, which applies to clinical trial data submitted to the FDA for approval, a trade secret means "a secret, commercially valuable plan, formula, process, or device that is used for the making, preparing, compounding, or processing of trade commodities and that can be said to be the end product of either innovation or substantial effort."7 Generally speaking, nonsummary clinical trial data should not include this type of formulation and manufacturing information or related information about analytical techniques used to characterize the intervention.
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Pharmaceutical firms argue that in jurisdictions with limited RDP regimes, such as Australia, Brazil, and China, a competitor could take the data package and use it to submit a marketing application. According to PhRMA, "similar regimes are known to exist in several other South American countries including Chile, Mexico, and Peru, and in countries in the Middle East and Asia such as Egypt and Malaysia."12 9 Ibid.
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The detailed provisions of this sample agreement notwithstanding, it is not clear how many economically significant future patents are likely to emerge from clinical trial data on approved drugs. For most drugs, the most important composition of matter patents and method of use patents is generally filed at the time clinical testing begins.
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Although liability concerns are particularly salient for pharmaceutical companies, they may also arise for other actors in the clinical trial system,
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Lietzan, to the Institute of Medicine Committee on Strategies for Responsible Sharing of Clinical Trial Data, regarding report entitled "The Interaction Be tween Open Trial Data and Drug Regulation in Selected Developing Countries," May 23, 2014. such as Data and Safety Monitoring Boards responsible for ensuring patient safety and study validity for subjects enrolled in research studies (DeMets et al., 2004; Tereskerz, 2010)
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From page 264... ...
Opponents argue that because the judicial process does not efficiently weed out spurious cases, pharmaceutical companies often are forced to expend large sums on these cases, with the result being increased drug prices and decreased innovation. Even with respect to liability under the current system, in which clinical trial data are not widely available, the RAND Institute for Civil Justice recently concluded that "there is scant empirical evidence to support the claims asserted on either side of the debate" (Garber, 2013, p. xiv)
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From page 265... ...
Clinical Trials 1(6)
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