Health Canada Consulting on Drug and Device Fee Increases

On October 13, 2017, Health Canada released a consultation document on proposed changes to fees associated with government activities related to drug (including veterinary drug) submission reviews, medical device submission reviews, Establishment Licences, and annual right-to-sell fees for the same. Recent governmental policy changes on fee setting make this possible for the regulator.

In a very general way, most fees are approximately doubled. Some, however, are reduced. One example of a reduction is in the application fee for Medical Device Establishment Licences, which is currently $8,109 and is proposed to be reduced to $4,500. Some new review categories, and tweaks to review times, are also proposed.

Significantly, the fees are now set to increase yearly in a regular fashion, unlike the fits-and-starts adjustments seen in the past. The regulator also proposes that the right to withhold a service or approval if the fee is not paid be made explicit (although arguably Health Canada has always had the inherent right to do this).

The regulator is seeking comments and will accept the same until January 4, 2018. The full consultation document can be seen at http://tinyurl.com/y7tu7yx5.

Summary By: Gordon Jepson