Microsoft word - backgroundereng.doc

Backgrounder
The Impact of Bill C-51 on the Natural Health Products Regulatory Regime

ISSUE:
There are misconceptions that the proposed Bill C-51 will significantly impact the manner in
which natural health products are regulated in Canada. More specifically some stakeholders
feel that the Bill targets natural health products with increased fines and enforcement actions
and additional regulatory hurdles before products are licenced.
BACKGROUND:
On April 8, 2008 the Government of Canada tabled Bill C-51 - An Act to Amend the Food and
Drugs Act - into the House of Commons. The proposed amendments to the Food and Drugs
Act will:
a)
Help modernize the regulation of health products and food; Provide new tools to more quickly and effectively protect Canadians; and Provide better information that allows Canadians to play a more active role in their own health and safety.
A regulatory framework specific to natural health products has been in place since January 1,
2004. The Natural Health Products Regulations establish pre-market requirements for the
safety, efficacy and quality of the products and require a site licence as evidence of compliance
with good manufacturing practices in sites where these products are manufactured, packaged,
or labelled.
CURRENT STATUS:
Regulatory Framework for Natural Health Products in Canada
The fundamental basis for the NHP Regulations is solid. It is the result of extensive
consultations (1997 – 2004) with stakeholders from across the spectrum (industry, consumers,
patient groups, academics). The NHP framework provides Canadians access to products that
are safe, effective and of high quality in a manner that is commensurate with the level of risk.
The 2007 Natural Health Product Regulatory Review re-affirmed stakeholder support for the
regulations and identified ‘regulation proportional to risk’ as the issue of greatest concern to
stakeholders. (87 % supported the Regulations with some modifications; 5% indicated their
products fit better under other Regulations; 4% indicated the Regulations should not apply to
either high or low risk NHPs; 2% think the Regulations do not meet the original intent; 2% think
the Regulations are not based in science).
Backgrounder

NHPD is moving forward with a new Risk-Based Approach (RBA) which will further address
regulation proportional to risk through a combination of operational, policy and regulatory
modifications.
Impact on the Regulation of Natural Health Products

Bill C-51 is not focussed on NHPs and will not affect the manner in which these products are
regulated in Canada. The Act is not intended to alter how NHPs are currently approved for
market release, their availability /access to the consumer; or to increase enforcement against
the NHP industry.
Bill C-51 is intended to allow for the flexibility of individual product lines (such as NHPs) to
continue to be regulated proportional to their risk and accounting for their unique product
profiles.
Impact on the Regulation of Natural Health Products - Access
There is misconception that this Bill will remove the majority of natural health products from the
market. This is incorrect as the Bill specifically recognizes that different product classes have
different standards of evidence. The standards of evidence for NHPs, which allow for a full
range of evidence from traditional use to full clinical trials, will remain unchanged.
Furthermore, under Bill C-51 the benefits of having specific NHP regulations will continue.
Some examples of products which were granted licenses and market access under the NHP
Regulations and which were previously not approved include: melatonin (for sleep),
glucosamine sulfate (for joint pain) and 5HTP (for reducing pain, headaches and aiding in
sleep).
Impact on the Regulation of Natural Health Products - Definitions

Bill C-51 will also not move the review of natural health products into a more drug-like
framework. The term “therapeutic product” is an umbrella definition intended to capture
products sold for therapeutic purposes, that is, NHPs, drugs, veterinary drugs, medical devices,
cells, tissues and organs, blood and vaccines. The new definition does not change the
designation of an NHP nor the separate regulatory framework for NHPs.
Concerns regarding the Bill affecting the practitioner or caregiver / patient relationship, are
unfounded. The definition of sale and distribution will not impact the practitioner / patient
relationship with regard to the practices of compounding or the caregiver / patient relationship.
The relationship between practitioner and patient, specifically with regard to the activity of
compounding, falls under provincial / territorial jurisdiction, relating to the definition of “practice
of medicine”.
Impact on the Regulation of Natural Health Products -Compliance & Enforcement

Bill C-51 does not specifically target NHPs for compliance and enforcement action and
recognizes that compliance and enforcement activities must be commensurate to the level of
risk. In addition, compliance and enforcement activities will continue to be guided by the
Backgrounder

Compliance Policy for Natural Health Products and the Health Products and Food Branch Policy
Branch’s Policy 001. This policy sets out a risk-based approach to compliance activities in
which those products posing the highest risk to the health and safety of Canadians will be
subject to compliance action first.

These new powers bring Canada up to par with other international regulators. It is accepted
that most companies, including NHP companies, do comply with requests for product recalls.
However, without this Bill, if companies choose not to recall, Canada will remain unable to
require them to recall their products even in situations when there are clear health and safety
concerns.
Increased Fines & Penalties
While fines under the new Bill have increased, the highest fines are intended to be applied for
the most severe contraventions. The highest penalties are reserved for wilful or reckless
behaviour, where there is never an intent to follow the law (such as with many counterfeit
products).
The Sentencing Criteria, which direct the courts towards what should be considered higher risk
offences. 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. Prosecution is not always the
best, or first intended, recourse.
Compliance under the NHP Regulations
Under the NHP Regulations and with the application of the Compliance Policy, Health Canada
has addressed a number of health and safety issues, as was found with adulterated products
such as benzodiazepines in sleep aids and drugs such as sildenafil in products for erectile
dysfunction. There have been substitution problems as found with diethylene glycol in
fluoridated toothpaste, and incorrect plants being used in Black Cohosh products (for relief of
the symptoms of menopause). Also, where good manufacturing practices have not been
respected there have been safety issues around bacterial contamination, and heavy metals,
including arsenic and lead. Unacceptable amounts of containments can pose a significant risk
to health. Infants and children are particularly vulnerable.
CONCLUSION:
Stakeholder concerns that the intent and application of Bill C-51 will substantially alter the
present regulatory regime for NHPs are unfounded. Bill C-51 is not focussed on NHPs and will
not affect the manner in which these products are regulated in Canada. The modernization of
the Act does not disproportionately target NHP products or industry.

Source: http://www.leonbenoit.ca/media/20080619-Benoit-C51-Backgrounder.pdf