Natural Health Products (NHPs) and Bill C-51
Previous articles have looked at NHP regulation and NHP health claims. The original intent of this series of articles was to question the credibility of Health Canada in legitimizing NHPs. During the writing of the articles, Bill C-51 received first reading, but since the Bill is generally consistent with the decade-long development of the NHP regulatory framework, it was not going to feature highly in the discussion, except as a follow-on article. Then the inanity of StopC51 popped up.
Timing is everything. Suddenly, concerns about the clarity of health claims and the incursion of CAM practitioners in Health Canada paled in comparison to StopC51’s over-the-top rantings about a government and “big pharma” conspiracy. Now we find ourselves in the odd position of supporting NHPs, or at least of supporting a rational approach to regulating them as a sane alternative to StopC51’s insinuation of total deregulation. Possibly, those in Health Canada who helped draft the Bill are also surprised that they are now having to defend their position on NHPs given that the Bill focuses on food and drug safety, not changes to NHP regulation. And who could be against food and drug safety? Truehope and StopC51, it seems.
Bill C-51 is a law that will create a police state bent on destroying the Canadian NHP industry, killing thousands of Canadians by preventing their access to life-saving herbal products and eliminating Canadians’ Charter Rights. … Sorry, that’s the StopC51 muddled interpretation. Actually, the stated purpose of the Bill is:
“to protect and promote the health and safety of the public and encourage accurate and consistent product representation by prohibiting and regulating certain activities in relation to foods, therapeutic products and cosmetics.”
It’s an entirely more accurate statement but sadly more mundane.
Motivated in part by recent product recall scandals, such as the tainted toothpaste and bagged spinach incidents last year, Health Canada developed a Food and Consumer Safety Action Plan (see the overview and discussion paper), which identifies the need for the legislative changes in Bill C-51. If you click on either of these links, you will have done more to understand the Bill than the average StopC51 ranter.
In developing Bill C-51, Health Canada faced a 50-year-old Food and Drugs Act, associated regulations (e.g., Natural Health Products Regulations) and related agricultural and consumer product Acts (e.g., Canadian Food Inspection Agency Act). The Department had to rationalize the assorted policies, procedures and regulations that had accreted over time.
To ensure product safety and quality, many of the actions needed are similar – regardless of the product being a drug, NHP, cosmetic or food – but how the actions need to be applied depend on the nature, risk and benefit of the product. Health Canada’s efficient answer to this is to establish a similar legislative framework in Bill C-51 for all products and then address the technical details and differences through regulations.
In addition to rationalizing the laws, Health Canada needed to address their lack of enforcement power. Currently, the Department cannot even order product recalls but must instead negotiate them with industry. Similarly, their limit for fines is $250K for a food-related offence and only $5K otherwise – hardly a deterrent for even the smallest NHP industry bad actor.
Finally, the recent adverse drug reaction incidents, such as Vioxx, point out the need to monitor products throughout their life cycles and not just approve them at their outset after clinical trials. This concept of continually collecting and assessing information on product safety has been dubbed progressive licensing.
One controversial change in Bill C-51 is the use of the term “therapeutic product” to refer collectively to drugs, devices, cells, tissues or organs, or combinations of these items used for specified purposes. Noticeably absent is the term “natural health product,” a term that had been carefully developed in regulations and served as a compromise between the pro-science and pro-NHP interest groups.
Seemingly, NHPs are to fall under the drug classification. In the Bill, a “drug” is defined as:
“any substance or mixture of substances manufactured, sold or represented for use in
(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
(b) restoring, correcting or modifying organic functions in human beings or animals, or
(c) disinfection in premises in which food is manufactured, prepared or kept.”
Presumably, Health Canada has recognized that drugs and NHPs form a continuum of therapeutic products that vary in risk and benefit. In previous documentation (e.g., Access to Therapeutic Products: The Regulatory Process in Canada from 2006), Health Canada has used the term “therapeutic product” to refer to drugs and NHPs and indicated a similarity in their regulatory lifecycles. It is likely that the Department is acknowledging that drugs and NHPs should follow the same regulatory steps (specified by legislation) but under different degrees of stringency (specified by regulations). An example of this continuum is that, under current regulations, any product that contains both drug and NHP ingredients is to be regulated as a drug, but certain low risk, long-standing, over-the-counter drugs, called TPD Category IV products, are treated like NHPs.
However, to the StopC51 mob, grouping NHPs with drugs can only mean the extermination of NHPs through the imposition of draconian drug-style regulations. Reality check – the current NHP regulations (SOR/2003-196,SOR/2007-288 and SOR/2007-289) are still in force with no indication of change. This means that NHPs are considered to be drugs for the high-level provisions of the Food and Drugs Act but are treated specifically as NHPs for the application of regulations. That’s a good thing. It would otherwise be too embarrassing and silly to start referring to homeopathic products as drugs.
Provisions of the Bill
Bill C-51 tightens up provisions in the Food and Drugs Act for therapeutic products, food and cosmetics. For NHPs, many of these provisions had already been covered by regulations, but the Bill certainly makes the provisions more explicit and enforceable. Here is a high-level overview of the Bill, somewhat focused on NHPs.
Prohibitions. Prohibitions are established against tampered, unsanitary and counterfeit products, as well as for false product information. Therapeutic products cannot be clinically trialled or marketed without authorization, and they cannot be manufactured, distributed or sold without an establishment license. These latter authorizations and licenses for NHPs had already been required by regulations.
Powers of the Minister. The Minister of Health is empowered to issue, amend and suspend clinical trial authorizations, market authorizations and establishment licenses; to designate a product as a prescription therapeutic product; to require information, tests, studies, revisions and reassessments; to establish advisory committees; and to disclose personal and commercial information.
Regulatory Authority. The Governor in Council is authorized to make regulations for virtually every aspect of the Bill.
Enhanced Enforcement. Increased powers are defined for entering premises, conducting inspections, ordering seizures and forfeiture, halting operations, and issuing recalls and injunctions.
Increased Penalties. Maximum penalties for offences under the Act are increased to $5M and two years imprisonment.
Information. Health Canada is required to maintain a publicly accessible register on specified information about therapeutic products. Health care institutions are required to report adverse drug reactions.
Transitional Provisions. Pre-existing applications, authorizations and licenses are to be carried forward and recognized after the Bill is enacted.
Criticisms and Fear Mongering about the Bill
Police State Powers. One of the favourite rants of the StopC51 mob is that the Bill will authorize Health Canada to conduct warrantless search and seizure, presumably unleashing SWAT team raids on grannies brewing up herbal teas for their grandchildren. In debates, Liberal MP Larry Bagnell credulously read this e-mail for one of his constituents:
“The search and seizure, as well as the fine possibilities are frankly scary. I feel that this Bill could be trying to limit our access to natural food products and potentially put natural food stores out of business. In these days of recession, this is hardly time to be putting legitimate businesses into receivership, not to mention the risk to Canadian rights and freedoms. … Will this new law be used to abuse and punish special interest groups, minorities, religious groups or others? … Why do bureaucrats want to bypass Parliament and Senate’s approval to create new laws? … Why do bureaucrats want seizure warrants without judge approval? … With fines being increased a 1000 times, and seizing authority without a warrant, is Bill C-51 meant to bankrupt and silence its target audience?”
So the Bill is all about cultural suppression and NHP eradication policy? Or could it just be empowering inspectors to do their jobs – just like public health, food safety and fire inspectors across Canada – and to take immediate action when unsafe products and conditions are discovered?
Article 23 of the Bill does allow inspectors to enter a place or conveyance or pass through private property at a reasonable time “for the purpose of verifying compliance or preventing non-compliance with [the Food and Drugs] Act or the regulations.” However, if the place is a “dwelling-house,” then the inspector must obtain a warrant if the occupant does not consent to the inspection. Since the NHP industry has had four years to meet regulations and since due diligence is an accepted defence against prosecution for an offence under the provisions of this Bill, it is doubtful that Health Canada is targeting more than wilful perpetrators and the criminally negligent.
Overreaching Ministerial Authority. Some critics express general concern about the powers granted to the Minister of Health in the Bill, while others focus on the Minister’s ability to issue, amend or suspend authorizations and licenses. The cynical suggestion usually made here is that the Minister, being in the back-pocket of “big pharma,” will ignore scientific evidence and either shortcut clinical trials or disregard their results in order to allow drugs to be marketed quickly and inexpensively. In reality, these powers enable the Minister to fast-track promising or needed experimental drugs under special circumstances and to discontinue the sale of drugs that are discovered to be unsafe at some point later in their lifecycle.
Unfettered Regulatory Authority. Some critics are amazed that Health Canada will be able to establish regulations, demonstrating an alarming degree of ignorance or disingenuousness about the parliamentary system. Take for example this statement by Bloq MP Nicole Demers:
“I think that the health minister would have far too much power. The bill says that the health minister would have the power to modify the regulations. That is saying a lot because all the definitions in this bill are basically regulations. The health minister would have the ability, therefore, to change the regulations without coming before Parliament. That is very serious and we should be very worried about it.”
Okay, Civics 101 – regulations define how legislations are to be applied. Regulations are made under the authority of an Act (in this case the Food and Drugs Act) by the person or group granted authority to do so by the Act. Typically, that group is the Governor in Council (i.e. the Cabinet). Despite Ms Demers pronouncement, it is the Governor in Council and not the Minister of Health who has been granted regulatory authority, although the Cabinet will undoubtedly defer to the Minister.
Regulatory authority enables subject matter experts to sort out and update the technical and practical details of a legislative framework without having to continually amend the legislation. The same technical regulatory situation applies for environmental, income tax, and occupational health and safety regulations, to name a few. So there is no mystery, no magic, no novelty, no surprises, no hidden agenda here.
Often, there is a tug of war between parliament and the departments over the balance between legislation and regulation. Given the wholesale nature of regulatory authority proposed in the Bill, it is likely that there will be some claw back recommended by the Standing Committee. However, the less regulatory authority given the department, the less able they will be to carry out their mandate or adapt to the changing environment.
Lenient Pharmaceutical Licensing. Critics claim that progressive licensing will allow pharmaceutical companies to shortcut drug approvals. There is no indication in the Bill that this is true. However, the move from an initial-licensing-only model to one that includes deliberate lifetime monitoring of drug safety implies that more risk can be taken in the initial licensing decision since mechanisms will be in place to catch problems. Critics characterize progressive licensing as a move from “do no harm” to risk management. For NHPs, there is no change here. NHPs have always had a reduced licensing burden because of their reasonably safe track record. Nevertheless, the information reporting and tracking provisions of the Bill should improve Health Canada’s ability to identify any adverse reactions that NHPs have when used with drugs.
Direct to Consumer Advertising. Currently, Article 3 of the Food and Drugs Act states that:
“No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.”
Schedule A is a list of relatively serious diseases and disorders. This prohibition effectively applies to NHPs as well because their market authorization limits advertising to the health claims approved in their product license and NHPs are incapable of treating the Schedule A diseases and disorders, at least in the real world of evidence-based science.
Bill C-51 seems to be dispensing with the Schedule A prohibition approach in favour of the market authorization approach developed for NHPs. This may mean that direct to consumer advertising will now be allowed for drugs. Nevertheless, NHPs have always been allowed to advertise directly to consumers as long as that advertising is limited to the health claims or recommended use claims approved by Health Canada in the product’s license.
No Independent Research and Testing. The criticism here is what is not in the Bill. NDP MP Judy Wasylycia-Leis points out:
“former minister of health, Allan Rock, … killed the federal drug laboratory, the only independent federal research lab in this country for testing on a post-market surveillance basis. It tested whether drugs that were on the market were safe and whether there were any negative consequences when that drug was combined with certain foods, other drugs or natural health products. It was a lab that performed a very important safety function in our country. … That was the beginning of a whole string of actions taken … to dismantle our regulatory system and move us away from the do no harm model toward a system where corporations pay for their drug approval processes.”
Minus the political jibes and slippery slope allusion, it is a fair point. Certainly, skeptics favour rigorous testing and would love to subject NHPs to scientific scrutiny. Whether people want to fund that testing publicly is a political decision, though.
In fact, Ms Wasylycia-Leis should be applauded for saying:
“Whatever happened to the government being a bastion of independent, objective science that operated on the basis of the constituents it is supposed to serve?”
This is a strange statement to come from a committed NHP supporter.
Threat to NHPs. The StopC51 mob seems convinced that the government, prompted by “big pharma,” is bent on eliminating NHPs in Canada. Given the general support of NHPs by the voting public, it is hard to imagine anyone but the most fevered of conspiracy theorists giving that idea any credibility. There is absolutely nothing in the Bill that supports this “hidden agenda” either. In fact, the legislative framework in the Bill mirrors and is likely based on the regulatory framework that was developed for NHPs. That is a strange way to get rid of them.
A great debunking source for Bill C-51 anti-NHP myths is the Health Canada webpage Bill C-51 and Natural Health Products – The Facts.
Hope for Skeptics
Supporting Bill C-51 at times seems counter-intuitive. It has the feeling of supporting NHPs. More accurately, though, support for the Bill is support for effective regulation, improved enforcement and increased accountability. There are hidden gems for skeptics in the Bill, such as in the Preamble:
“Whereas the Parliament of Canada recognizes that the assessment of benefits and risks is to be based on scientific and objective evidence”
“Whereas the Parliament of Canada recognizes the objective of promoting accurate and consistent product representation”
And in Article 14:
“No person shall manufacture, process, label, package, sell, import for sale or advertise a therapeutic product in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its benefits, risks, conditions of use, quality, quantity, composition, design, construction, performance, origin or authorization status.”
These principles and provisions, coupled with the substantial enforcement measures in the Bill, give hope to skeptics that Health Canada will have the ability to address the quackery end of the NHP spectrum in the unlikely event that they will ever rise to the challenge.
Status of the Bill
The Bill is in early days right now. It received first reading in the House of Commons on 8 April and was debated on 30 April and 1 May. All parties seemed to support passing the Bill on second reading in order to send it to committee for review. Given this support, the Bill should pass second reading sometime this month before parliament
prorogues adjourns for the summer. Time has been allocated all next week (9-13 June) for further debate on the Bill.
The Bill’s status can be tracked on its page of the LEGISinfo website. It should be referred to the House Standing Committee on Health this fall, where the committee will hear from numerous witnesses from the medical, pharmaceutical, NHP and food communities. Despite StopC51’s noisemaking to date, public pressure will be felt most keenly during the committee hearings. It is doubtful that StopC51 will be granted standing at the hearings, but it will not be difficult for them to work through a surrogate group.
The NHP community has some soul-searching to do. Back in 1997, they started the process to regulate NHPs as a means of legitimizing them and guaranteeing their safety and quality. It would be disingenuous for the NHP industry now to jealously guard the legitimacy gained but reject the enforcement measures proposed.
Skeptics need to continue to get the real facts out and to elicit support from their MPs. At the hearings, skeptics will hopefully be able to count on representation from such groups as the Canadian Medical Association and Health Canada itself to counterbalance conspiratorial rantings with rational observation and judicious advice.