Comments on the Amendments to Bill C-51

Summary
Right before Heath Minister announced a third category to be added to Bill C-51, he proposed an amendment to the members of parliament on June 9, 2008. The amendments were, again, not made available to a wider population.
In the amendments, Health Minister included the words “natural health products” as a subcategory of therapeutic products, which did not indicate a third category. He even added a subcategory of a combination that includes any of the previous subcategories, such as drugs, devices, cells/tissues/organs, could become subject to drug-style regulation.
In the amendments, “natural health product” is redefined and TCM is not mentioned in the wording. The definition of a natural health product include all plants and all animals, which means all food is to be a natural health product regulated under therapeutic products and is subject to drug-style regulation.
The Minister granted himself the power to define a natural health product based on the intended use, instead of its ingredients or safety. Risk is also defined in terms of the intended use.
The inspector is still granted the power to dispose of the thing within what they determine as reasonable.
The amendments use non-directive words, such as “shall,” “may” in many clauses to make excuses not to implement what they suggest for actions. A few terminologies require further understanding. For example, does the word value of traditional knowledge mean necessity of including traditional knowledge?
The amendments suggest the establishment of one or more committees for the purpose of providing advice to the Minister. The criteria include expertises in consumer issues, patient or caregiver issues, and industry issues. Unfortunately, the experience of the committee doesn’t guarantee the inclusion of TCM experts.
Overall, the amendments indicate that the Minister doesn’t intend to make any changes for natural health products that would protect them as a third category and will continue forcing Bill C-51. Therefore, we propose a resolution on Bill C-51 Natural Health Products Category and endorse a Natural Health Products Act that includes traditional Chinese medicine.

Detail Information

Preamble Page 1
That Bill C-51, in the preamble, be amended by adding after line 19 on page 1 the following:

Whereas the Parliament of Canada recognizes the value of traditional knowledge
and of the history of use of natural health products in the assessment of their benefits
and risks;
Whereas the Parliament of Canada recognizes that the type and amount of information
required to establish that the benefits associated with a therapeutic product
outweigh the risks depend on the nature of the therapeutic product and its intended
use;
Whereas the Parliament of Canada recognizes that risk of injury to health is a
factor relevant to the taking of administrative and enforcement measures;

Comment: Some of the terminology requires further understanding. For example, does the word value mean necessity, is risk and risk of injury defined by intended use.


Clause 3 Page 6
That Bill C-51, in Clause 3, be amended by adding after line 22 on page 6 the following:

“natural health product”

“natural health product” means, subject to regulations made under paragraph
30(1)(c.1), any of the following that is manufactured, sold or represented for use in
the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal
physical state, or its symptoms, in human beings or for use in restoring, correcting
or modifying organic functions in human beings:
(a) a homeopathic medicine,
(b) a plant, any plant material, an alga, a bacterium, a fungus or any non-human
animal material,
(c) any substance that is extracted or isolated from a thing referred to in paragraph
(b) if the primary molecular structure of the substance is identical to the primary
molecular structure of the substance before being extracted or isolated from the
thing,
(d) a vitamin,
(e) an amino acid,
(f) an essential fatty acid,
(g) a synthetic duplicate of anything referred to in any of paragraphs (c) to (f),
(h) a mineral,
(i) a probiotic, and
(j) any product whose medicinal ingredients consist entirely of things referred to
in any of paragraphs (b) to (i);

Comment: TCM is not mentioned in the wording, and the definition of a natural health product includes all plants and animals, which means all food is to be a NHP regulated under therapeutic products and is subject to drug-style regulation.

 

Clause 3 Pages 6 and 7
That Bill C-51, in Clause 3, be amended by replacing line 36 on page 6 to line 12 on page 7 with
the following:
(b) a natural health product,
(c) a device,
(d) cells, tissues or organs that are distributed or represented for use in
(i) the diagnosis, treatment, mitigation or prevention of a disease, disorder or
abnormal physical state, or its symptoms, in human beings or animals, or
(ii) restoring, correcting or modifying the body structure of human beings or
animals or the functioning of parts of the bodies of human beings or animals,
or
(e) a combination of two or more of the things referred to in paragraphs (a) to (d);

Comment: The inclusion of the words natural health product doesn’t indicate a third category but a subset of therapeutic products. Now even a combination that includes any of the previous subcategories could become subject to drug-style regulation


Clause 8 Page 15
That Bill C-51, in Clause 8, be amended by adding after line 37 on page 15 the following:
Type and amount of information required
(1.1) For greater certainty, the type and amount of information required to establish
that the benefits associated with a therapeutic product outweigh the risks depends
on the nature of the therapeutic product and its intended use.

Comment: Risk is defined in terms of intended use.


Clause 8 Page 20
That Bill C-51, in Clause 8, be amended by replacing lines 4 and 5 on page 20 with the following:
Committees 20.4 (1) The Minister shall establish one or more committees for the purpose of providing advice to the Minister concerning the development of guidelines that relate
to the interpretation of this Act or the regulations and may establish other committees
for the purpose of providing advice to the Minister concerning any other matter.
Membership (1.1) The membership of each committee established for the purpose of providing advice to the Minister concerning the development of guidelines that relate to the interpretation of this Act or the regulations must reflect a range of experience or
expertise relevant to the committee’s mandate including, but not limited to,
(a) experience or expertise in consumer issues;
(b) experience or expertise in patient or caregiver issues;
(c) specialized knowledge, such as the knowledge possessed by scientists and
academics;
(d) practical or clinical experience as a health professional; and
(e) experience or expertise in industry issues.

Comment: “Shall” and “may” are non-directive words.? This allows the minister to make an excuse not to establish committees. The experience of the committee doesn’t guarantee the inclusion of TCM experts.


Clause 10 Page 25
That Bill C-51, in Clause 10, be amended by replacing lines 5 to 7 on page 25 with the following:
(c) if the inspector reasonably believes that the thing could be injurious to human
health and that the thing must be disposed of to prevent injury to health,

Comment: The inspector is granted the power to dispose of the thing within what they determine as reasonable.

 

Clause 11 Page 29
That Bill C-51, in Clause 11, be amended by adding after line 3 on page 29 the following:
(c.1) subject to subsection (1.01), specifying any thing or class of things as not
being a natural health product;
Page 33
That Bill C-51, in Clause 11, be amended by adding after line 19 on page 33 the following:
Restriction —
exemptions from natural health products
(1.01) In specifying any thing or class of things as not being a natural health
product in regulations made under paragraph (1)(c.1), the Governor in Council must
take into account the risk of injury to health and the intended use of the thing or of
things of that class.

Comment: The government grants themselves the power to define a natural health product based on the intended use not its ingredients or safety .


Clause 11
Page 33
That Bill C-51, in Clause 11, be amended by adding after line 33 on page 33 the following:
Obligation in respect of information in applications relating to natural health products
(1.3) In making regulations under paragraph (1)(y) relating to the information that
is required in an application for a market authorization for natural health products,
the Governor in Council shall specify that the information to be provided may include
information based on
(a) traditional knowledge relating to the product; or
(b) the history of use of the product or any of its ingredients.

Comment: “may” is an uncertain word that does not ensure the inclusion of traditional or historical information.


A Coalition Against Bill C-51
29.05.2008