What is the government's position on Bill C51?

I wrote my MP (Member of Parliament) regarding Canada's Bill C-51, which didn't pass the Second reading in the house of Parliament.

I voted for you the last election. There is a Bill, Bill C-51, that is being introduced that is of concern to myself and many other Canadians. Bill C-51 would restrict access to many nutrients (carbohydrates, lipids, proteins, vitamins, minerals, water, trace elements) for people who need them. This would be equivalent to restricting access to food, as nutrients are derived from food. Bill C-51, if passed would be restrict the right of Canadians to choose Natural Medicine to heal themselves. Bill C-51 is being pushed by the Pharmaceutical Industry, whose drugs kill thousands of Canadians each year. In the U.S. , prescription drugs killed 231,000 in 2006-- 106,000 when used as prescribed by their doctors and 125,000 by misuse.

I was diagnosed with bipolar in April, 2007 and cured myself of the disorder with natural supplements (minerals, vitamins, amino acids), some of which Bill C-51 would restrict access to. Almost every pharmaceutical drug is synthesized from substances found in Nature; these drugs mimic the effects of nutrients and active ingredients found in plants, such as herbs. These synthetic drugs are formed in laboratories and patented for profit. The pharmaceutical industry would like to see these nutrients and herbs banned because it threatens their profit.

If passed, Bill C-51 would bring harm to many Canadians who need nutrients and herbs to heal themselves, as I have. No one has died taking nutrients (ie water) or herbs but over 10,000 Canadians die each year taking prescription drugs.

Would your Office be kind enough to let me know what your position is regarding Bill C-51?

Posted Answers

A:

"Drugs cure diseases"

Name a drug that cures a disease.


 Answer by email

A:

The following post responds to Cynthia's concerns in the comment trail below:

Cynthia writes:
"read the list of the 20,000 products that have been removed from Canada through either not beign allowed to be sold within since NHP rules came up in 2004 (which [are] a subsid [sic] of drugs, not a 3rd section as erroneously mentioned below)"

20,000 NHPs have not been "removed" from Canada. Canada's NHP inventory is undergoing product licensing. Licensing is a collaborative process. Health Canada reviews product license applications, and NHP producers submit the license applications and supporting evidence. The entire inventory has not been reviewed yet. Many of those 20,000 products have not been submitted yet. In some cases, the applications have been improperly completed or sufficient evidence has not been submitted. As well, I'm sure that there are cases where Health Canada reviewers are being overly bureaucratic. Such is the unfortunate nature of government. However, this situation is not evidence of some dark Big Pharma conspiracy nor an indication of a covert government plot to eliminate NHPs in Canada.

Cynthia writes:
"... Naturopaths, homeopaths, herbalists, massage therapists, natural healers are also not legally registered to practice medicine as only physicians and surgeons can have that legal definition. ... Other things like chiropractic, midwifery, homeopathy, herbalists, acupuncturists etc are not legally defined ways of practicing medicine."

That's a good thing. Many of these practitioners (excluding midwifery) are based on pseudoscience or, as in the case of homeopathy, no science at all. Regardless, the identification of medical practitioners is a provincial licensing matter and is only salient to Bill C-51 for the prescribing of therapeutic products. NHPs do not effectively fall into the category of prescribed therapeutic products since no NHPs will require prescriptions.

Cynthia writes, in response to the statement "Under this Bill, NHPs will continue to fall under their own unique set of regulations":
"No, they are a subsid [sic] of drugs and not a 3rd catergory"

NHPs do continue to remain a subset of drugs as they currently are in the Food and Drugs Act, but the original statement is not wrong. NHPs do have their own regulations that are unique to drugs. This will not change after Bill C-51 is passed. In fact, with Health Canada's amendments to Bill C-51, NHPs will be uniquely identified in the law as opposed to at the regulatory level, even though they will continue to be, effectively, a sub-class of drugs.

Cynthia writes:
"included in the bill is the ability to have search and seizure without warrant for any and all classes in this bill (undefined at this point in the bill which means it can be applied to all or none) which is contrary to rights of the Charter and makes me illegal."

These provisions already exist in the current Food and Drugs Act:
"23.(1) ... an inspector may at any reasonable time enter any place where the inspector believes on reasonable grounds any article to which this Act or the regulations apply is manufactured, prepared, preserved, packaged or stored, and may ... (d) seize and detain for such time as may be necessary any article by means of or in relation to which the inspector believes on reasonable grounds any provision of this Act or the regulations has been contravened."

Cythia writes:
"it includes in the bill that international laws will [become] law in Canada without debate in the house of Commons "

Not true. All laws are debated and voted on in Parliament. Regulations are different. Regulations can be implemented by the Governor in Council (i.e., the Cabinet), but this is true for all areas of federal jurisdiction for which there exists an Enabling Act under which the regulations can be established. Under the current Food and Drugs Act, the federal Cabinet has the power to implement regulations, for whatever reason, related to food, NHPs, drugs, cosmetics or medical devices without referring the regulations to Parliament for a vote. All regulation are subject to review by Parliamentary committees though. In the case of NHPs, the House of Commons Standing Committee on Health, which has members from all parties, has juridiction.

Cynthia writes:
"In the US they implemented a law that allows a 3rd grouping for NHPS called the The Dietary Supplement Health and Education Act (DSHEA, 1994), an American law classifying our supplements and herbs as foods (which can have no upper limit set on their use), was passed by unanimous Congressional consent following massive grass-roots support organized by health food stores."

US DSHEA is comparable to Canada's NHP Regulations, except that our regulations do a better job of protecting the safety, quality and effectiveness of NHPs for consumers. It is a myth that DSHEA was passed unanimously. A good summary of the passing of the Act can be found at "DSHEA Ten Years Later: Now What?" (Nutrition Business Journal. 30 June 2004)

The concern about "no upper limits" is mystifying. In Canada, NHP dosage limits are established by the NHP manufacturers when they submit the safety and effectiveness evidence during product licensing. Our NHP Regulations do not artificially set upper limits.

Cynthia writes:
"what the law says is that fines of up to 5million can be implemented, it does not give a scale of how the fines will be imposed, therefore without a legally binding list of how fines will be imposed they can impose the max on anyone. This is the difference between law and reality, what is written down has to be followed in law, if it's not written down it can be interpreted as the government wants without recourse."

The 5 million dollar fine is a maximum fine, which is why the words "fine not exceeding" are used. At the legislative level, fines are typically defined in these terms. Detailed scales of fines and offences are not included in legislations. They can be detailed in the underlying regulations. Otherwise, they are established over time by judicial cases.

Barry Green
Ottawa Skeptics


 Answer by Ex-drone

A:

Anonymous writes:
"Bill C-51, which didn't pass the Second reading in the house of Parliament"

While this statement is not wrong, it implies that Bill C-51 was defeated in the House. In reality, the Bill was still in debate at Second Reading when the election was called and Parliament ended.

Anonymous writes:
"Bill C-51 would restrict access to many nutrients"

Natural health products (NHPs) have been regulated in Canada since 2004 when the NHP Regulations came into force. Bill C-51 does not amend these regulations and does not otherwise change how NHPs are regulated. Over the last four years, Health Canada has been working with the NHP industry to license these products. Any NHP that is currently for sale in Canada will continue to be on the shelf after Bill C-51 is passed.

Anonymous writes:
"Bill C-51 is being pushed by the Pharmaceutical Industry"

Not so. Bill C-51 is the latest step in a strategy to ensure the safety, quality and effectiveness of NHPs in the Canadian marketplace. This strategy was developed in collaboration with the NHP community, as can be seen from the previous steps:

* Natural Health Products: A New Vision

* Blueprint for Renewal: Transforming Canada's Approach to Regulating Health Products and Food

* Food and Consumer Safety Action Plan

* Access to Therapeutic Products: The Regulatory Process in Canada

Anonymous writes:
"the Pharmaceutical Industry, whose drugs kill thousands of Canadians each year"

Drugs and NHPs do have different risk profiles, but then again, they also have vastly different capabilities. Drugs cure diseases and mitigate serious conditions and are mandated to demonstrate those capabilities through scientific trials. NHPs do not have the capability to address the acute diseases for which drugs are prescribed and are not mandated to prove their health claims scientifically. US NCCAM has been rigorous testing NHP health claims for a decade now and has not uncovered any substantial disease-curing capability for them. Because drugs do have higher risks, Health Canada is implementing Progressive Licensing in Bill C-51 so that these risks can be monitored throughout the lifespan of the drug and not just at initial licensing.

Barry Green
Ottawa Skeptics


 Answer by Ex-drone

A:

Bill C-51 Myths and Realities

Access to Products

MYTH: Bill C-51 will remove 75% of NHPs from the market through the use of strict risk/ benefit standards.

FACT: This is completely false. Bill C-51 was specifically drafted in order to allow for increased flexibility to regulate products proportional to their relative risk. The Bill specifically recognizes that different product classes have different standards of evidence. As such, the standards of evidence for NHPs, which allow for a full range of evidence from traditional use to full clinical trials, will remain unchanged.

Cynthia: read the list of the 20,000 products that have been removed from Canada through either not beign allowed to be sold within since NHP rules came up in 2004 (which as a subsid of drugs, not a 3rd section as erroneously mentioned below)

Definition of Sale

MYTH: The definition of sale and distribution of NHPs within Bill C-51 will impact the practitioner / patient relationship with regard to the practices of compounding and will prevent caregivers from distributing NHPs to patients.

FACT: No, this is false. The relationship between practitioner and patient, specifically with regard to the activity of compounding falls under provincial jurisdiction, relating to the definition of "practice of medicine". Therefore, the federal government cannot legislate in this area.

Cynthia: in 1996 after 10 years of fighting with the federal government Gloria Lemay made it impossible for a midwife to be labeled as having practiced medicine. Naturopaths, homeopaths, herbalists, massage therapists, natural healers are also not legally registered to practice medicine as only physicians and surgeons can have that legal definition. Medicine in the legal term is defined as
" Physicians and surgeons are medical practitioners who treat illness and injury by prescribing medication, performing diagnostic tests and evaluations, performing surgery, and providing other medical services and advice. Physicians and surgeons are highly trained and duly authorized by law to practice medicine."

Other things like chiropractic, midwifery, homeopathy, herbalists, acupuncturists etc are not legally defined ways of practicing medicine.

Read legal definition at

http://legal-dictionary.thefreedictionary.com/Physicians+and+Surgeons

Furthermore, the concept of "distribution" in Bill C-51 refers only and specifically to cells, tissues and organs and will not apply to the caregiver / patient relationship when it comes to NHP distribution.

Cynthia: When you write a law and do not define distribution as pertaining only to cells, tissues and organs, the intent of the law has the ability to be applied to anything that they want. That is one of the big problems with this bill is that most this are undefined and undefinition when trying to implement laws means that it can be made up by the legislator after it's accepted and turned into whatever the legislator wants it to apply to.

Regulating NHPs as Drugs

MYTH: Use of the term "therapeutic product" in Bill C-51 is intended to move NHPs fully into the drug category.

FACT: This claim is false and misleading. The term "therapeutic product" is an umbrella definition applied not only to NHPs and drugs but to veterinary drugs, medical devices, cells, tissues and organs, blood and vaccines.
Yes, as well it will apply to these.

Under this Bill, NHPs will continue to fall under their own unique set of regulations and the provisions for safety, efficacy and quality (including GMPs) that will continue to be appropriate to the relatively low risk profile of this class of products.
No, they are a subsid of drugs and not a 3rd catergory, read this letter composed by John Biggs of Optimum Health Options for me to send out with peoples permission (below in new post) and Shawn Buckleys analysis of the bill link below as well. (A lawyer that I'm using to help research this).

Increased Compliance and Enforcement Powers

MYTH: The increased powers around recalls, enforcement, fines and penalties are specifically targeting the NHP industry.

FACT: This is incorrect, and misleading as these powers apply to all product classes regulated under the Act and are not directed to any single group.

Cynthia: Although somewhat true, this bill does not apply to drug companies as they are handled under a separate import bill and drug permissions bill. However, included in the bill is the ability to have search and seizure without warrant for any and all classes in this bill (undefined at this point in the bill which means it can be applied to all or none) which is contrary to rights of the Charter and makes me illegal. Funny thing as well is that it includes in the bill that international laws will be come law in Canada without debate in the house of Commons and simply by regulation which means that they need to publish for 2 weeks in a government publication on Parliament Hill the international bill as it stands and if no one formally contests to it (legally binding contest submitted to the house) then ANY INTERNATIONAL LAW that has to do with food, drugs, herbs, vitamins, devices, tissues will automatically become law in Canada. This supercedes our abilities as a country to debate our own laws.

These new powers bring Canada up to par with other international regulators. Without this Bill, Canada will remain unable to require recall of products even in situations when there are clear health and safety concerns.

Cynthia: In the US they implemented a law that allows a 3rd grouping for NHPS called the The Dietary Supplement Health and Education Act (DSHEA, 1994), an American law classifying our supplements and herbs as foods (which can have no upper limit set on their use), was passed by unanimous Congressional consent following massive grass-roots support organized by health food stores.

Increased Fines and Penalties

MYTH: NHP companies will be subject to multi-million dollar fines for minor infractions which will result in the bankruptcy of many companies.

FACT: While fines under the new Bill have increased, the highest fines will be applied only for the most severe contraventions. A minor contravention would not be treated in the same manner as an incident that has significant impacts on the health and safety of Canadians.

Cynthia: what the law says is that fines of up to 5million can be implemented, it does not give a scale of how the fines will be imposed, therefore without a legally binding list of how fines will be imposed they can impose the max on anyone. This is the difference between law and reality, what is written down has to be followed in law, if it's not written down it can be interpreted as the government wants without recourse.


 Answer by email

A:

Thank you for your email expressing your concerns about the impact of Bill C-51 (which amends the Food and Drugs Act) on Natural Health Products (NHPs). There is a lot of mis-information being spread about this piece of legislation and I hope that this letter will help to clarify some points you raised.

I want to emphasize at the outset that this Bill is part of our strategy to ensure that food and products that are available on the Canadian Market are safe for consumers. The legislation is designed to ensure access to safe, effective Natural Health Products, not to keep them from Canadians.

First, Bill C-51 is not focussed on NHPs and will not affect the manner in which these products are regulated in Canada. NHPs are not regulated as food or as drugs; they have been regulated as a unique category since 2004. Bill C-51 won't change that. For your information, the Natural Health Products Regulations can be found at http://laws.justice.gc.ca/en/showdoc/cr/SOR-2003-196///en?page=1. Under Bill C-51 Canadians will continue to have access to NHPs that are safe, effective and of high quality.

Second, I want to clarify the term 'therapeutic product' in the legislation. This term is general in nature because it includes drugs, natural health products, medical devices, veterinary drugs, and blood and blood products. They all share one common element: they claim to enhance human health, and Canadians rely on them to do that. When a health claim is made, it needs to be tested in order to ensure public safety. The regulations to make this possible for Natural Health Products have been working now for five years.

There has also been some misunderstanding regarding the approach of government toward Natural Health Products. I want to clarify that the legislation now before the House of Commons requires that compliance and enforcement measures be gauged to the degree of risk of the product. On products of low risk, which includes the vast majority of Natural Health Products, pharmaceutical standards of evidence are not required. On the other hand, the legislation also requires vigilance to ensure that tainted products are found and recalled, that what is on the label is actually in the bottle, and that health claims are supported by evidence.

There are many cases of adulterated Natural Health Products, such as the pills "Sleepees" that were the subject of national media stories, and Canadians want us to make sure they're safe. Products that make health claims must be regulated; otherwise they can be sold as food.

In response to concerns raised by constituents, amendments will be proposed to clarify some of the facets of the bill to alleviate those concerns.

Finally, in the future, under a modernized Food and Drugs Act, the numbers and variety of Natural Health Products will continue to grow, and Canadians can be confident that they will be able to access innovative, safe and effective Natural Health Products.

Thank you again for taking the time to write to me to express your views on this legislation. For your convenience, I have also attached a list of "Myths and Realities" to clarify other common misconceptions about Bill C-51. I hope that this information is helpful for you.

Sincerely,

Laurie Hawn, MP

Edmonton Centre

Parliamentary Secretary to the Minister of National Defence

Bill C-51 Myths and Realities

Access to Products

MYTH: Bill C-51 will remove 75% of NHPs from the market through the use of strict risk/ benefit standards.

FACT: This is completely false. Bill C-51 was specifically drafted in order to allow for increased flexibility to regulate products proportional to their relative risk. The Bill specifically recognizes that different product classes have different standards of evidence. As such, the standards of evidence for NHPs, which allow for a full range of evidence from traditional use to full clinical trials, will remain unchanged.

Definition of Sale

MYTH: The definition of sale and distribution of NHPs within Bill C-51 will impact the practitioner / patient relationship with regard to the practices of compounding and will prevent caregivers from distributing NHPs to patients.

FACT: No, this is false. The relationship between practitioner and patient, specifically with regard to the activity of compounding falls under provincial jurisdiction, relating to the definition of "practice of medicine". Therefore, the federal government cannot legislate in this area.

Furthermore, the concept of "distribution" in Bill C-51 refers only and specifically to cells, tissues and organs and will not apply to the caregiver / patient relationship when it comes to NHP distribution.

Regulating NHPs as Drugs

MYTH: Use of the term "therapeutic product" in Bill C-51 is intended to move NHPs fully into the drug category.

FACT: This claim is false and misleading. The term "therapeutic product" is an umbrella definition applied not only to NHPs and drugs but to veterinary drugs, medical devices, cells, tissues and organs, blood and vaccines.

Under this Bill, NHPs will continue to fall under their own unique set of regulations and the provisions for safety, efficacy and quality (including GMPs) that will continue to be appropriate to the relatively low risk profile of this class of products.

Increased Compliance and Enforcement Powers

MYTH: The increased powers around recalls, enforcement, fines and penalties are specifically targeting the NHP industry.

FACT: This is incorrect, and misleading as these powers apply to all product classes regulated under the Act and are not directed to any single group.

These new powers bring Canada up to par with other international regulators. Without this Bill, Canada will remain unable to require recall of products even in situations when there are clear health and safety concerns.

Increased Fines and Penalties

MYTH: NHP companies will be subject to multi-million dollar fines for minor infractions which will result in the bankruptcy of many companies.

FACT: While fines under the new Bill have increased, the highest fines will be applied only for the most severe contraventions. A minor contravention would not be treated in the same manner as an incident that has significant impacts on the health and safety of Canadians.


 Answer by email

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