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Abstract
Pharmacogenomics is the use of genomic science to study human variability in drug response. Proponents of pharmacogenomics suggest that it will lead to a new era of personalized medicine through a fundamental transformation in the drug discovery and development process. Uncertainty about the regulatory standards and processes for this emergent technology have been widely cited as an obstacle to more widespread and rapid adoption of pharmacogenomics. Pharmacogenomics thus presents an ideal case study of the role of regulators in the co-production of new biomedical technologies. This paper describes the attempt to create a new transnational regulatory regime for pharmacogenomics through the creation of novel regulatory experiments by a transnational network encompassing regulatory agencies, academic scientists and industry. This process has been marked by the creation of new socio-technical spaces in the regulatory regimes for pharmaceuticals – a pre-regulatory space for the sharing of data outside the regulatory decision-making process and a pre-competitive space for the sharing of data between companies. It is marked also by the expansion of a transnational regulatory space for sharing data and setting standards across jurisdictional boundaries.
Notes
1. Hood et al. use the term behavior modification, rather than implementation, but the other terms are theirs.
2. This situation is likely to change as a result of new pharmacovigilance legislation adopted in the European Union (EU) in 2010 (Regulation (EU) No 1235/2010 and Directive 2010/84/EU). When fully implemented, this legislation will enhance EMA's authority, giving it the power to address safety issues concerning medicines regardless of whether they were approved by the centralised or national procedures.