Do you want even LESS proof of safety from Canada's Drug Regulators?
Do you want even LESS proof of safety from Canada's Drug Regulators?
April 26 is the deadline for citizen feedback into
UPDATE:
Please listen to these two amazing experts from the Canadian Covid Care Alliance explain the situation and see the direct link to what needs doing associated with this first video:
Dr. Susan Natesh (retired paediatrician) https://brightlightnews.com/doctors-urgent-message-to-canadians/
+ an explanation from Deanna McLeod, pharmaceutical researcher: https://rumble.com/v2jdoq2-deanna-mcleod-testifies-about-vaccine-development-and-risks-day-1-winnipeg-.html
To attract global companies and foster further investment in the Canadian economy, the Advisory Council for Economic Growth began to dismantle Canada’s long history of holding to the highest regulatory standards for medical and pharmaceutical products. Since 2016, our government has flipped the focus from protection of the people of Canada to partnering with industry to incentivize global companies to invest in Canada.
For background and expert analysis, please view this interview that features two members of the Canadian Covid Care Alliance, Deanna Mcleod and Judy Stinson. Ms. Mcleod is the founder of an independent medical research firm that prepares evidence-based reviews in the areas of oncology, premed immunology and psychology. Ms. Stinson is a former broadcast journalist, researcher and assignment editor for CBC National TV News.
The following points have been compiled for widespread sharing among Canadians to support the government’s invitation for citizen feedback by Wednesday, APRIL 26, 2023.
● Canada historically held to the highest regulatory standards by ensuring all medical products were PROVEN SAFE and effective PRIOR to market authorization. This required Randomized Controlled Trials (RCTs) to ensure that the benefits outweigh the risks.
● At the behest of Big Business the Federal government has created an alternative regulatory framework to expedite market access of high-risk novel products and devices such as gene editing, 3D bioprinting and artificial intelligence applications thus enhancing pharma’s bottom line.
● This industry-devised backdoor -- the 2019 “Advanced Therapeutic Products (ATP) Pathway” – permits the use of lower safety standards for “advanced therapeutics” or novel potentially high-risk therapies. They now need only “provide evidence to support that the benefits outweigh the risks and that risks will be managed” rather than PROVING drug safety and efficacy.
● Positioned as “advancing innovation” and “promoting life-saving therapies” or “agile licensing,” this subjective, arbitrary, and more centralized process places an inappropriate level of control in the hands of the Health Minister.
● Further changes to our Food and Drugs Act are now being proposed that would formalize and expand the types of products granted backdoor access potentially resulting in these novel, under-tested, high-risk drugs being given to healthy Canadians as well as introduced into their food supply through veterinary use.
● Inviting Big Pharma to rewrite the very regulations that were supposed to protect Canadians from Big Pharma abuse, is like asking criminals to redesign your alarm system.
URGENT ACTION IS REQUIRED !
● Say NO to any and all food and drug regulatory amendments that would permit the authorization of any product or device that has not first been PROVEN safe and effective through rigorously conducted randomized and controlled trials.
● Insist on an immediate re-examination of the ATP framework and all proposed regulatory changes to the Food and Drugs Act by qualified, INDEPENDENT health professionals and public representatives who are free from conflicts of interest
● Demand that Canadian safety be re-prioritized by setting prudent, transparent, objective safety criteria for all products and devices that cannot be manipulated for political or economic gain.
● Send a clear message: The “speed of science” should never outpace public safety. The government should not let Big Pharma cut corners on safety, with people suffering as a result.
1. Take 5 minutes to express the concerns above to Health Canada.
Submit a ‘General Comment' about “Agile Licensing” at the top of this Canada Gazette webpage by April 26, 2023
- AND –
Send that same comment to: Bruno Rodrigue, Executive Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health, 3000A, 11 Holland Avenue, Suite P2108, Ottawa, Ontario K1A 0K9 (email: lrm.consultations-mlr@hc-sc.gc.ca)
2. Contact your MP to express your concern about “Agile Licensing”!Demand an immediate re-examination of all Agile Licensing regulations and proposed amendments and demand an investigation into the individuals involved in creating this industry-favoring backdoor that places Canadians at risk of product harm by rushing novel products to the market without first proving their safety and efficacy.
Find your Member of Parliament here: https://www.ourcommons.ca/members/en/search
Here is sample letter / text for submission to the Gazette/Mr. Bruno Rodrigue:
Attn: Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Health Products and Food Branch
Department of Health, 3000A
11 Holland Avenue
Suite P2108
Ottawa, Ontario K1A 0K9
lrm.consultations-mlr@hc-sc.gc.ca
I am contacting you to express my concerns about these proposed regulatory changes and the attempt to push innovation over safety.
Historically Canada has held to the highest regulatory standards by ensuring all medical products were PROVEN SAFE and effective prior to being released to the public, using Randomized Controlled Trials to ensure that the benefits outweigh the risks.
I am opposed to the Part I, Volume 156, Number 51: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) and any other regulatory changes that would remove the requirement that all drugs, medical devices, veterinary and similar products are first PROVEN safe through rigorously conducted randomized controlled trials BEFORE market authorization. I am also opposed to changes that centralize the process and increase the control of a single individual, such as the Minister of Health.
No civilized society would ever sacrifice the safety of their citizens on the altar of innovation.
All Canadians deserve to have a government and bureaucracy that are committed to putting their interests first and maintaining the highest safety standards. Therefore, I insist on an immediate re-examination of the Advanced Therapeutic Products Pathway and all proposed regulatory changes to the Food and Drugs Act, by qualified independent health professionals and public representatives who are free from conflicts of interest and who will ensure that all products are proven safe before being given market authorization.
Health Canada has a fiduciary responsibility to protect Canadians from pharmaceutical abuse and not to promote innovation.
I further insist that the safety of Canadians be re-prioritized by setting prudent, transparent, objective, safety criteria for ALL products and devices that cannot be manipulated for political or economic gain.
Sincerely,
RELATED LINKS:
The stated goal of the Agile Nations Charter is to "create a regulatory environment in which innovation can thrive" by making it easier for businesses within their jurisdictions to introduce and scale innovations across their markets while upholding protections for citizens and the environment.
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Since the OECD’s Global Conference on Governance Innovation in January 2020, and as part of the development of the OECD principles on Effective and Innovation Friendly Rule-Making in the Fourth Industrial Revolution, the Organisation for Economic Cooperation and Development (OECD) and the World Economic Forum (WEF) have been co-operating to look deeper into the interlinkages between regulation and emerging technologies. As a result and in a world first, an agreement titled “Agile Nations” was paved to unlock the potential of emerging tech among countries.
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Ms. Deanna McLeod provides an overview of the gaps in the checks and balances in the creation of guidelines surrounding the management of COVID-19. She takes a deep look at the influence of the pharmaceutical companies on the process of promoting their products.
https://www.canadiancovidcarealliance.org/all/conflicts-of-interest-a-case-study-of-canada/
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Questions asked by MP Leslyn Lewis (Haldimand/Norfolk) October 21, 2022:
With regard to the government’s participation in the Agile Nations network: (a) what was Canada’s role in the initiation and development of the Agile Nations concept and its charter, signed in November 2020; (b) what were the policy imperatives and rationale to sign the charter; (c) with which stakeholders did consultations on a proposed Agile Nations Charter take place; (d) how was each stakeholder in (c) consulted and what feedback did they provide; (e) what are the terms of Canada’s participation in the Agile Nations network, including the participation length; (f) what are the specific results, outcomes, and measurable objectives expected to be achieved as a result of Canada’s participation in the network; (g) what projects has the government participated in or funded as part of the Agile Nations, including, for each project, the (i) name, (ii) agency or department responsible, (iii) objectives, (iv) project summary, (v) reason the project received funding, (vi) location, (vii) partners; (h) what are the total expenditures related to Canada’s participation in the Agile Nations since 2020, broken down by (i) department or agency, (ii) project (if applicable), (iii) type of expenditure; (i) what are the project details of the Digital Credentials and Digital Trust Services, including the (i) description, (ii) latest status of the project, (iii) anticipated completion date, (iv) implementation risks or issues identified, (v) projected outcomes; and (j) what are the project details of the National Digital Trust Service, including the (i) description, (ii) latest status of the project, (iii) anticipated completion date, (iv) implementation risks or issues identified, (v) projected outcomes?
https://leslynlewismp.ca/wp-content/uploads/sites/28/2023/01/Q-911-2022-12-07-Agile-Nations.pdf
Please also read the insightful comments being added at the bottom of this post for discussion on more aspects of this issue.
Thank you for the reminder and done :)
Petitions, whether individual like you suggest or mass signed petitions, are a mystery to me, and probably to many other people. I would like to support the goals, but I have no idea of the impact of these petitions. In fact, I fear that we can be targeted by government. For example, the government froze the bank accounts of people who merely donated to the Freedom Convoy movement.... this was pretty draconian and beyond expectation.
So it would be great if you can address these two issues... SPECIFIC consequences of mass petitions (eg reaching 100,000 signatures forces X to happen), and what guarantees are there that we would not be targeted. Thank you for your active role in fighting our clown world.