Addressing Regulatory Issues Through Pharmaceutical Consortia

Abstract

Areas of uncertainty or differing opinions in the realm of pharmaceutical regulation are as inevitable as the progress of science and technology itself. Regulatory science is continuously evolving in response to advancements, but this process of change is not always smooth. Bridging the differences of opinion and advancing science-based regulation can be greatly facilitated, however, if relevant data are collected and a common understanding of relevant issues is reached by the pharmaceutical scientific community. Pharmaceutical industry consortia dedicated to addressing scientific regulatory issues can expedite the resolution of challenging industry-wide issues. Resolution is achieved by a collective commitment to building consensus, supporting it with data and other relevant information, and communicating it to the larger scientific and regulatory community and other potential stakeholders. However, the benefits that consortia can bring to an industry are not without various hurdles and issues that must be addressed and overcome. Specifically, consortia must address issues relating to legal structure, intellectual property, governance, liability and antitrust regulations.

Key words: :

• Regulatory
• Debate
• Industry consortium
• Facilitation
• Consensus
• Confidential surveys
• Data mining
• Legal considerations

Notes

[9] Updegrove A, Forming, Funding, and Operating Standard Consortia, IEEE Micro (December 1993)

[10] Majewski SE, How Do Consortia Organize Collaborative R&D?: Evidence From the National Cooperative Research Act, Harvard John M Olin Center for Law, Economics, and Business, Discussion Paper No. 483 (June 28, 2004)

[11] National Cooperative Research and Production Act of 1993, USC 15: §§ 4301-06