Campaign launched September 15, 2017 and closed December 31, 2017
Health Canada continues to push forward with their new regulations on the “modernization” of self-care products.
At this time, now that the consultations are done, it is unknown when, or how, the new regulations will be released.
On an August 18, 2017 call, NHPPA was advised by a senior policy advisor with the Consumer Health Product Modernization Branch at Health Canada that it could be another year before the final recommendations are provided to Health Canada’s senior management for review, and that it could be upwards of two years for the regulations to be enacted into law. NHPPA believes this timeline is disputable. We believe it could be anytime. Tomorrow, next week or a few months from now. Next year is a possibility but having full confidence from one call, and one person, at Health Canada would be naive.
All we are certain of, is that now that the consultations are over, the machinations to announce the changes are in motion.
The senior policy advisor also told us that the information presented at the consultation meetings in June is what will form the proposed regulation changes, but that their review of ongoing feedback may shift things. Apparently, Health Canada is still seeking additional comments from the public and we were provided with a copy of the workbook that was handed out at June meetings. We encourage manufacturers, retailers, practitioners and the public to complete a copy and send it to Health Canada at email@example.com as soon as possible.
A significant challenge for concerned citizens is that many of the questions in the workbook are difficult to respond to. One would have to fully understand the existing regulations and laws to be able to connect the threat level facing the NHP community by the new proposed “modernization”. Shawn Buckley will be reviewing the consultation material and drafting a preliminary analysis to support how we can articulate our concerns. In the meantime, please download the workbook and listen to the June consultation meeting (1 hour and 32 minutes in length). View all of the accompanying slides.
It is critical that we show Health Canada that we are waiting, we are watching, and we are ready to take action as soon as the new regulations are published for comment… if they are published for comment here.
We are calling on you to monitor the Canada Gazette on a weekly basis for publication of the new regulations, be on alert and ready to act if and when the first notice is released.
Mark your calendars, create a notification in your email managers, set a task in your smart phone or tablet every week or post a reminder on your refrigerator to:
Creep the Canada Gazette for Health Canada’s Publishing of “Self-Care” Regulations!
Part 1 of the Gazette is updated and published online every Saturday.
As soon as any proposed regulations or amendments are posted you will be invited to send in your comments.
Click on the link now and you will see a short list of the current consultations.
Each regulation, in the last stages before being enacted, is listed the following way:
- The name of the proposed regulation with a link to the regulation contents.
- The date of publication.
- The number of days that the regulations will be open for comment.
- The contact person to whom you’ll write or fax your comments to.
If Health Canada releases its new regulations on self-care products, it will be under the heading “Department of Health”.
The link to the regulations will likely include the words “Food and Drugs Act” and/or “Self-Care”.
Email firstname.lastname@example.org immediately.
If the regulations are published we may have as little as 15 days to submit comments to the designated contact person. It is imperative that we join forces, commit to monitor the Gazette each week and to take action when the time comes.
When Shawn Buckley receives a copy of the regulations he will provide his response as soon as it is available along with several unreserved actions for everyone to take.
He remains one of the most sought after legal experts in Canada to educate us on the scope of consequences the proposed new regulations have on public and industry.
PUBLISH OR PARLIAMENT
NHPPA believes that the regulations should be given the full process that parliamentary democracy allows.
This involves tabling them as a brand new bill in the House of Commons subject to multiple readings and debates, review by the Standing Committee on Health (this process includes hearings and witness testimony) as well as further review and debate by the Senate before being enacted into law. This is the path that takes time and is in the best interest of all Canadians.
Tabling the regulations as a bill to the House of Commons will also afford Shawn Buckley the time to conduct a comprehensive review and analysis. An NHPPA Discussion Paper would then be released on the threat level that the proposed changes to the regulations would have on public and industry. Shawn would address how the changes would impact Canadians’ personal and professional lives. There would be suitable time for citizens and the NHP community to communicate to the law makers that they may want to reject the changes entirely.
This meaningful democratic process was the protection that stopped Bill C-51 in 2008. It was also the process that had NHPs removed from being captured under Bill C-36 in a campaign to get Shawn to Senate as a witness.
WHY “WATCHDOG” THE CANADA GAZETTE
The regulations could be enacted through publication in the Canada Gazette, the official newspaper of the Government of Canada. It includes, among other things, notices of new and proposed statutes and regulations.
Most Canadians are not aware that all new and proposed regulations are required to be published in Part 1 of the Gazette and must be open for public review and comment before they can officially be passed into law through publication in Part 2.
The Gazette website states:
“Pre-publication in Part I of the Canada Gazette gives various interested groups and individuals, as well as Canadians in general, a final opportunity to review and comment on a proposed regulation at the last stages of the regulation-making process, before it is enacted and published in Part II of the Canada Gazette.
Pre-publication also gives interested parties, those stakeholders previously consulted at the beginning of the regulatory process, the opportunity to see how the final draft proposal is in keeping with previous consultation drafts.”
Publication in the Gazette is a much faster way to slide laws through.
There are no votes by either the House of Commons or the Senate to regulation changes, and there is only a brief window of opportunity for comment from the public. This seemingly benign process is dangerous and even threatening since it often goes unnoticed or ignored by the public. If the Gazette is the chosen route this may not provide Shawn Buckley sufficient time to prepare a thorough review and analysis so that we can formulate an effective response.
FREEDOM TO CHOOSE
Up to this point, all we have heard is Health Canada’s perspective. What they write and publish runs through filters parallel to their predefined outcomes. There can be no freedom if Health Canada is making treatment options illegal and difficult to produce and access. There is no freedom to choose if our options to make a choice have been removed. NHPPA insists on the inclusion of natural health products and practices,without restrictive and inappropriate interference, at the Canadian societal table.