- Data Protection Regulations Apply When Comparison Added After NDS Filed
- November 27, 2015 | Authors: Adrian J. Howard; Beverley Moore; Chantal Saunders
- Law Firm: Borden Ladner Gervais LLP - Ottawa Office
- Hospira Healthcare Corporation v. Canada (Health), 2015 FC 1205
In this case, Hospira applied for judicial review of a decision of the Minister of Health, refusing to issue it a Notice of Compliance (NOC) for its drug oxaliplatin. The Minister had found that Hospira compared to Sanofi's innovative drug ELOXATIN oxaliplatin, and thus the data protection provisions of the Food and Drug Regulations applied. The Federal Court dismissed the application.
Oxaliplatin has been available in Canada through the special access program (SAP) since 1999. Hospira worked on a way to file a NDS from 2004-2006. However, it did not have clinical trial data, and could no longer ethically perform clinical trials, as it was already recognized by oncologists around the world as a ‘standard of care' drug for colorectal cancer. After a number of unsatisfactory meetings with the Minister, Hospira filed a NDS on October 27, 2006. Sanofi also filed a NDS for oxaliplatin on November 20, 2006. The Sanofi NDS was given priority status.
Hospira's NDS was rejected at the screening stage as it only contained literature references; no pre-clinical or clinical data. Hospira judicially reviewed that decision, and it was sent back to the Minister for redetermination. Meanwhile, Sanofi obtained its NOC. It was granted data protection, and a 6-month paediatric extension. Hospira's NDS was deemed acceptable for examination in June 2011. However, a notice of non-compliance was issued in 2012. Hospira responded to the Minister's concerns, and was told that a DIN number would be assigned in October 2013. The executive summary recommending approval of the NOC did not contain a data protection assessment. When this was performed, Hospira was told that it could not receive its NOC due to Sanofi's data protection.
The Court held that the standard of correctness applies to the review of the Minister's decision. However, in this case, the decision was held to be both reasonable and correct. In answering the question of whether the Minister breached procedural fairness by failing to inform the applicant earlier in the approval process that the data protection provisions would apply, the Court held that this regulatory process is more akin to an administrative process, and, as such, the degree of procedural fairness owed is low. The question is whether the applicant knew the case it had to meet and was afforded an opportunity to respond. As Hospira waived its right to make written submissions in response to a letter from Health Canada, the Court rejected this ground of judicial review.
Hospira argued that Health Canada required addition of the comparisons to ELOXATIN oxaliplatin, and as such the original NDS did not seek an NOC on the basis of comparison. However, the Court held there was no basis for such a distinction in the Regulations. Post-filing amendments to the NDS are subject to the data protection provisions. Furthermore, this conclusion is confirmed by the purpose behind the data protection provisions, and to interpret the Regulations otherwise would run contrary to NAFTA and TRIPS.