In this case, Celgene judicially reviewed a decision of the
Minister of Health not to list their drug THALOMID thalidomide on
the Register of Innovative Drugs (the Register). The Minister's
decision was that thalidomide is not "innovative". The
Court granted the judicial review and declared that THALOMID
thalidomide is an "innovative drug" and is eligible for
listing on the Register.
Thalidomide was approved in Canada in 1960, however that approval
was withdrawn in 1962. Its sale was then absolutely prohibited. In
the 1990's thalidomide was found to be effective in the
treatment of leprosy and other conditions. It was granted approval
by the FDA, and access to it in Canada was available through Health
Canada's Special Access Program in 1995. A Notice of Compliance
(NOC) in Canada was sought in 2009 and granted in 2010.
The Court's analysis turned on the definition of an
"innovative drug". The Court considered Canada's
international obligations under NAFTA and TRIPS. The Court held
that thalidomide was not approved for any use prior to the issuance
of the NOC, as it had been totally banned in Canada and that the
prior approval of thalidomide should never have been given. The
Court held that the purpose of the Data Protection
Regulations is to encourage and reward innovation.
Furthermore, the Court held that in order to make the TRIPS and
NAFTA obligations meaningful, protection to data must arise when
approval is sought for a product containing a chemical entity that
does not have approval in that jurisdiction.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).