Judicial Review of the Regulations Amending the Food and Drug Regulations (Data Protection) to Proceed — Rx&D Granted Intervener Status

The Attorney General of Canada has failed in an attempt to strike the Canadian Generic Pharmaceutical Association's (CGPA) application for judicial review of the data protection provisions of the Food and Drug Regulations, CRC c 870 as amended by the Regulations Amending the Food and Drug Regulations (New Regulations). (For more information regarding the application, see E-TIPS®, "Canadian Generic Pharmaceutical Association Challenges the Regulations Amending the Food and Drug Regulations (Data Protection)" Vol 5, No 12, December 6, 2006). The Attorney General argued that the CPGA lacked standing because the New Regulations were directed at drug manufacturers and not the CPGA, and that the application was premature, since a drug submission has yet to be evaluated under the New Regulations. Justice Harrington of the Federal Court declined to rule on these issues, noting that an application for judicial review should be determined in a summary manner, and that interlocutory motions are to be discouraged. Further, the CGPA had raised serious issues that warranted that the application proceed. Another Canadian association, Research-Based Pharmaceutical Companies (Rx&D), was granted intervener status in a concurrently decided motion. It was given the same status as a party, with the exception of a right of appeal. Any such right would be decided if and when the issue arises. With the application proceeding and intervention by Rx&D, the upcoming judicial review application would appear to have set the stage for another head-to-head battle between the generic and branded industries. For the full reasons for judgment (Canadian Generic Pharmaceutical Association v Governor in Council et al, 2007 FC 154), visit: http://decisions.fct-cf.gc.ca/en/2007/2007fc154/2007fc154.html Summary by: Michael Migus