|
The Move to the term “Therapeutic Products”
Bill C-51 moves away from the use of the term “drug” and introduces the term
“therapeutic products”. Indeed even the name of the “Food and Drugs Act” will
be changed to “An Act respecting foods, therapeutic products and cosmetics.”
The definition of “drug” remains unchanged but a new definition of “therapeutic
product” is added which includes drugs, medical devices and cells, tissues or
organs. However, the term “drug” is replaced throughout the old Food and Drugs
Act with the term “therapeutic products”.
Natural Health Products remain “drugs” under the Act. The only change is that
now all drugs are referred to as “therapeutic products” in the Act instead of as
drugs.
I have found this to be a very interesting change, and perhaps the most significant
of all of the changes.
The change certainly affects the dynamics of the debate over regulating NHPs as
foods or as a third category separate from drugs. Let’s use the NHPPA’s position
on regulatory change as an example. The NHPPA Advisory Board has given the
NHPPA the goal of obtaining a regulatory environment where:
(1) NHPs are presumed to be safe. A NHP cannot be taken off of the
market unless the Government can prove that it is unsafe;
(2) there are different claims structures so that:
a) manufacturers do not have to make claims;
b) manufacturers can make limited claims, such as structure function
claims with a low evidence threshold, and
c) manufacturers can make specific health claims if they can meet a
higher evidence threshold;
(3) NHPs are not regulated as drugs. They are either regulated as food or as
a third category separate from drugs and food;
(4) there are Good Manufacturing Processes that are appropriate for the low
risk profile of NHPs, and
(5) there is a conflict resolution mechanism to settle disputes between the
Government and industry members.
The last time consumers and the industry rebelled against Health Canada
enforcement actions against NHPs, the rallying cry was “don’t treat our foods as
drugs”. That rallying cry created the most successful petition drive in Canadian
history. It was a large factor leading then Minister of Health Allan Rock to refer
the issue to the Standing Committee on Health. The result was the 53
Recommendations which the industry would still like to see implemented.
Would the rallying cry have been successful with the new term: “don’t treat our
foods as therapeutic products”? Or to be more accurate: “don’t treat or natural
health products as therapeutic products”?
My point in all of this is simply to communicate that terms and language are
important as they determine the parameters of how we think and can affect debate.
The change in terms is being introduced deliberately by Health Canada and we
need to consider what the implications for the industry are.
Introduction of the term “Controlled Activity”
The Bill creates the following term:
“’controlled activity’ means
(a) in relation to a therapeutic product manufacturing, collecting,
processing, preserving, labelling, packaging, importing for sale,
distributing, wholesaling or testing, and
(b) in relation to a designated therapeutic product manufacturing
collecting, processing, preserving, labelling, packaging, importing,
distributing or testing.
My initial thoughts on the introduction of this term is that it is again directed at
natural health practitioners such as naturopathic and homeopathic doctors.
The Bill introduces the following section:
“13. No person shall conduct a controlled activity unless they are
authorized by an establishment license to do so.”
The change from our current regulatory scheme is the expansion of the site licence
requirements. Section 27 of the Natural Health Products Regulations does not
include: collecting, processing, preserving. Section 27 already includes
manufacturing. By adding processing and preserving Health Canada is targeting
something other than manufacturing.
Allowing Trade Agreements to become law without
Parliamentary Approval – and the Sharing of
Confidential Information with Foreign Governments
and Agencies.
The following term is added to the Act:
“’government’ means any of the following or their institutions, as
applicable:
(a) the federal government;
(b) a corporation named in Schedule III to 10 of the Financial
Administration Act,
|