Comparison of numbers and timing of new medication regulatory approvals in Canada and New Zealand.

The Canadian federal government has proposed significant revisions to the way its patented medicines price regulator assesses the excessiveness of medication prices that are to take effect in 2019. The changes have the potential to decrease Canada's attractiveness as a market for innovative medicines. The objective of this analysis was to compare the number of new drugs given regulatory approval in Canada between 2002 and 2017 with the number in New Zealand and, of those approved in both countries, to compare approval dates. Of 374 new drugs approved in Canada between 2002 and 2017, 139 (37.2%) were approved in Canada alone - the percentage increased from 20.2% to 48.2% for drugs approved in 2002-2006 and 2012-2017. Two hundred and thirty-five drugs (62.8%) were approved in both countries of which 182 (77.4%) were approved first in Canada with a median delay of 10 months before approval in New Zealand. Due to lapsed approvals and a lack of availability, less than 70% of the 235 drugs were accessible in New Zealand in mid-2018. Tight drug cost-containment saves money but at the expense of manufacturers either not seeking regulatory approval for new therapies or only doing so after approval in many other countries.