The Patented Medicine Prices Review Board is
seeking stakeholder comments on proposed changes to its
Compendium of Policies, Guidelines and Procedures related
to thresholds for opening an investigation and offsetting de
minimus excess revenues.
With respect to thresholds for opening an investigation, the
Board is proposing to eliminate the 5% investigation trigger at the
national level for existing drug products. The present criterion
for commencing an investigation for existing drug products when the
National Average Transaction Price exceeds the Non-Excessive
Average Price by 5% will trigger a high number of investigations
with cumulative excess revenues that are less than $50,000. It is
believed that the avoidance of investigations involving amounts of
excess revenue less than $50,000 will result in a more efficient
use of the Board's resources.
For offsetting de minimus excess revenues (i.e., an amount that
does not trigger the investigation criteria), the Board proposes
that the 3-year period that is presently allowed to offset such
revenues through a Voluntary Compliance Undertaking be replaced by
a requirement to offset in a timely manner. Investigations are not
triggered for drug products with a de minimus excess revenue
balance. In the absence of a VCU, the only current option is to
proceed to a public hearing, which has led to delays in collecting
de minimus excess revenues. It is the Board's belief that it
would be more efficient if patentees are required to offset excess
revenues less than the de minimus amount in a timely manner.
The deadline for providing feedback on these proposed changes is
May 14, 2012.
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).