Proceedings of the Standing Senate Committee on Social Affairs,
Science and Technology
Issue 3 - Evidence
OTTAWA, Tuesday, November 30, 1999
The Standing Senate Committee on Social Affairs, Science and Technology, to
which was referred the subject matter of Bill C-6, to support and promote
electronic commerce by protecting personal information that is collected, used
or disclosed in certain circumstances, by providing for the use of electronic
means to communicate or record information or transactions and by amending the
Canada Evidence Act, the Statutory Instruments Act and the Statute Revision
Act, met this day at 3:34 p.m. to give consideration to the subject matter of
Senator Michael Kirby (Chairman) in the Chair.
The Chairman: Our first panel this afternoon comprises Dr. Roger Korman,
President, IMS Health; Mr. Jeff Poston, Executive Director, Canadian
Pharmacists Association; and Ms Virginia Turner, CEO, Ontario Association of
Senator Murray: Is there a copy of the first brief?
The Chairman: I have a copy of the brief from the Canadian Pharmacists
Association and from the Ontario Association of Medical Laboratories.
Senator Murray: Will Dr. Korman be speaking from notes?
Dr. Roger Korman, President, IMS Health: I do not have a prepared text of my
The Chairman: Dr. Korman, please proceed.
Mr. Korman: First, I will give you some background information on IMS. Then I
will outline the problem that this bill creates for health research, and then I
will give you an example of how those problems play out in real life.
IMS is the world's largest health research company operating in more than 90
countries. It is recognized as a leader and an essential partner in the
advancement of health. It serves the government, including Health Canada, the
Patented Medicine Prices Review Board, the Canadian Coordinating Office for
Health Technology Assessment, health researchers, and the pharmaceutical and
IMS has never collected patient identifiable information. In 40 years, we have
never had a breach of patient privacy. We are a Quebec-based company
functioning very well under Bill 68. We were amongst the first make a
representation to the Commission d'access a l'information with whom we continue
to work on an ongoing basis. The CSA privacy code is the foundation for this
bill. IMS is the first company to be certified by the Quality Management
Institute of the CSA for its handling of personal information. In sum, we are a
commercial, health research company that exemplifies the best privacy
We have identified two significant problems in this bill that will affect health
research. The first problem relates to consent. The bill recognizes the value
of research by granting an exemption from the requirement to obtain consent for
the use and disclosure of personal information for research purposes. However,
there is no corresponding exemption for the collection of such information. To
put it simply, you cannot use what you cannot collect, so it makes the exemption
within the bill virtually meaningless and unworkable for research.
Second, the bill affords professional practice information the same protection
as it provides for personal patient information. What are the implications on
professional accountability if providers can deny access to their practice
information, for example, with respect to patient compliance, the ability of a
patient to take medications as instructed by the physician. The literature on
patient compliance has not changed in 20 years since I did my doctorate on the
treatment of epilepsy. It did not change in the 30 years before that. For 50
years we have recognized that one-third of all patients take their medicines as
directed. One-third do not take it to produce the therapeutic effect, and
one-third, perhaps, do.
On a daily basis or on a yearly basis, that means that over $5 billion worth of
medicines go to no effect. The downstream implications for our health care
system total in the billions of dollars. In fact, it is estimated to be in
excess of over $10 billion in terms of emergency room utilization, hospital
utilization and other treatments.
To attack a societal problem of this nature, we must focus on the key linkage
between the physician and the patient. We must collect information about groups
of patients who are most at risk. We need to obtain practice information about
those providers who have the lowest success rate in ensuring patients take
their medication so that the manager of the system can bring the appropriate
education and training materials to those patients and to those practitioners,
so that patient compliance can be increased to the betterment of everyone.
This bill will limit this kind of research which is directed at advancing the
health of Canadians and improving the effectiveness of the system. As a matter
of public policy and ethical theory, it is unhelpful to argue whether a system
of health information that benefits society as a whole is more important than a
person's right to privacy or vice versa. A social contract that reasonably
balances the value of both is necessary for the ultimate benefit of the
individual and society.
The Chairman: You said, "we" need to be able to collect information. I
was unclear if you were using the term "we" to refer to IMS, or if it
was being used as a generic term.
Mr. Korman: I am referring to the societal "we".
Mr. Jeff Poston, Executive Director, Canadian Pharmacists Association: Bill C-6,
if applied as currently written, could have a number of unplanned and
unintended consequences which could seriously undermine the overall aim of the
I represent the Canadian Pharmacists Association. We are the national voluntary
association providing leadership to pharmacists who practice in the community,
but mainly in hospitals, industry and academia. Ours is one of the oldest
health care professions. We have a strong commitment to patient confidentiality
and privacy. The protection is based on our professional codes of ethics and
legal standards of practice, as well as the simple fact that, if our patients
did not trust us, they would find another pharmacy. Consumer surveys have
consistently rated us as one of the most trusted health care professions.
Bill C-6 has a number of fundamental flaws, and to ensure that adequate measures
are put in place to protect the personal health information of patients and at
the same time, ensure the collection of adequate information to enable
cost-effective management of the health care system, we would like to propose
an amendment to suspend the application of Bill C-6 to health care, as defined
by the World Health Organization, for a period of five years. This would allow
for the development of specific health privacy protection provisions for
implementation by the provincial, territorial or central governments to the
whole of the health care system.
Based on legal opinions from Heenan Blaikie and discussions we had with other
health groups, we believe that the bill has the following flaws: First the
definition of commercial activity is vague and its application to health care
services is unclear. This is further confounded by the established public and
private sector divide in the provision of health care services, particularly
with respect to drugs. Since public drug plans in Canada are provided by
provincial governments, and as such would be exempt from the provisions of the
bill, the problem that this creates would be most apparent in a community
pharmacy where a patient receiving a prescription paid for by a private
insurance company would be subject to Bill C-6. The pharmacist would be
required to enter into a dialogue with the patient to obtain express consent to
use and disclose information for a number of clinical, financial and
administrative purposes. The patient with a prescription paid for by the Ontario
Drug Benefit Plan would not fall under the bill and expressed consent would not
be needed. It is a stark two-tier level of privacy protection that we believe
patients and pharmacists would find unacceptable. The bill provides protection
based on the extent to which a transaction is commercial or non-commercial, not
only the inherently sensitive nature of the information itself.
Second, the nature of the consent required is also uncertain. Some assert that
most primary and some secondary uses of data would only need implied consent.
However, the CSA code which is incorporated in the Bill as Schedule 1 states
that almost always health information is sensitive and, as such, requires
expressed consent. In this case, the burden on patients and pharmacists to
ensure consent is informed and expressed would be considerable. Expect long
line ups the next time you go for a prescription. There may be two line-ups,
one for the public-sector patients and one for the private-sector patients.
Sound statistics on utilization of health care services is the bedrock of
effective planning and management in health care. This legislation could result
in several gaps appearing in the information database needed to manage a modern
health care system. In practice today, much of this data is "anonymized".
Many think such uses are appropriate. However, Bill C-6 is silent on the fact
that there is a spectrum of identifiability of health and information. The
issue is further confounded by the fact that use and disclosure is permitted,
but not collection. All information is identifiable at the time of collection,
and expressed consent must be sought unless it is exempted.
The bill has the potential to seriously jeopardize the development of a
sensitive, coherent and harmonized approach to health information in Canada. We
encourage you to consider our amendment so the health care sector may have time
to develop a set of principles, and more importantly, develop agreement on
implementation to truly protect the health information of individuals, while
permitting effective management of the health care system.
Does this bill meet the needs of all Canadians as far as health care is
concerned? No. Is the impact of this bill on the health care sector clear? No.
Have the general public and health care providers been adequately consulted?
No. Provisions created in our amendment would provide the time for these
important considerations to take place.
Ms Virginia Turner, CEO, Ontario Association of Medical Laboratories: On behalf
of the board of directors of the Ontario Association of Medical Laboratories, I
would thank you for the opportunity to be here today. The intent of this bill
is to protect personal information, to take account of new technological
advancements and to support and promote electronic commerce by protecting
personal information as collected, used or disclosed in the course of commercial
activities. My organization and members support and indeed applaud this bill.
In the past I have worked to promote such a bill.
The OAML is the common or collective voice of Ontario's community-based, medical
laboratories and speaks on behalf of those laboratories which are owned and
operated in Ontario and which operate throughout the rest of Canada. Our
members in Ontario alone respond to 13.5 million patient visits per year by
providing nearly 80 million medical laboratory tests. In North America,
diagnostic laboratories provide more than 70 per cent of the objective
information that physicians use in the diagnosis and treatment of patients.
Ontario's community-based laboratories are an integral part of the health care
system. Along with the Canadian Healthcare Association, the Canadian
Pharmacists Association, and the Canadian Healthcare Association, we have
sought an opinion from Heenan Blaikie and have submitted it to the committee
for your deliberations. We fully endorse that. Our members have given much
consideration to the provisions and implications of Bill C-6 for community
laboratories and across the health care sector in general.
However, this bill was not developed with health care and health care providers
in mind. Our concerns fall into two major categories. Our first concern relates
to the confidentiality of health information.
It has been said that health information is intensely sensitive in nature, so
intimately linked to the dignity, integrity and autonomy of the individual and
yet so indispensable to health care providers, researchers, planners, and
managers for the sake of the individual and for the viability and
sustainability of the health care system as a whole.
In Ontario, it is currently required, by regulation, under the Ontario
Laboratory and Specimen Collection Centre Licensing Act that laboratories must
report the results of the test to the person who requested it. It is not clear,
however, if such a requirement to disclose under provincial regulation would be
a permitted disclosure under clause 4.3 of Schedule 1 of Bill C-6.
The impact is that of consent. If such a disclosure were not permitted, our
member laboratories would be required to seek the informed consent of the
patient in order to perform the test or diagnostic procedure, and then to pass
the test results back to the physician. This places the laboratory awkwardly in
the middle of the patient/physician relationship, and will require enormous
The associated costs would increase. The cost of such changes could not be
absorbed by an industry which already provides, with no reimbursement, tests
over and above our provincial cap in the millions of dollars. Increased
patient, laboratory staff time regarding explanations to new changes will add
additional costs and time to our already overburdened system.
There are also language considerations. Currently, the patient and physician
understand each other very well in a particular language. In a laboratory or
specimen collection centre however, where services are provided in either of
our two official languages depending on the location of the centres, patients
presenting for tests may not be able to give informed consent to the procedure
if their understanding is incomplete or in the absence of a translator.
On the matter of disclosure of information, it is not clear if community-based
laboratories would be permitted to disclose information as we currently do to
the Ontario Ministry of Health under the proposed section 4.5 of Schedule 1.
The complexity and gravity of this issue was highlighted by members of this
Chamber earlier this week. One Senator suggested that concerns voiced by "health
professional associations regarding the issue of personal information and other
critical activities connected with that health care system" require that
Bill C-6 be clarified and amended as required to incorporate specific rules
relating to health information.
Our second concern is related to commercial activity. It is unclear in the
legislation whether specific components of an integrated and seamless health
services delivery system would be differently affected by the provisions of the
bill. Our members are specifically troubled by the vague definition of
commercial activity. It is unclear whether that information applies to the
activities of community-based medical laboratories. Opinions from respected
legal counsel and from the Ontario Ministries of Health and the Attorney
General indicate that, under Bill C-6, medical laboratories will be determined
to be commercial and thereby fall within the definition of commercial activity.
The issue for Ontario community-based laboratories is: Is Ontario's private
medical laboratory sector to be deemed to be engaged in commercial activity
because it operates on a so-called "profit basis"? Our members are
funded in a manner similar to that of physicians and other health care
providers. Our members respond to the request from physicians for laboratory
testing in the same manner as hospital-based laboratories. The danger is that
the ambiguity in the wording of Bill C-6 may lead to federal legislation which
treats two similar components of the health services system differently. It
would be regrettable if such a situation were to develop because the requisite
care had not been taken in considering the application of this bill to health
care facilities, both for-profit and not-for-profit.
Issues specifically respecting health information must be addressed. When
information is transferred between non-commercial and commercial settings, do
the rules apply to Bill C-6? It appears to us that there is no clarity as to
where a commercial activity ends and where one begins.
Industry Canada has indicated that, when an individual presents for the
collection of blood, urine, and other types of sample or other medical service,
consent is implied. It is recommended that the government's primary
responsibility be to provide clarity regarding consent, its application, and
consideration of potential administrative and legal cost. In our opinion,
Industry Canada has not provided such clarity.
Our members' concerns can only be superficially covered in the time that you
have graciously afforded me. We are uncertain of the full implications of the
legislation for health care, for the future of health research, and for the
necessary integrated health information system that will anchor the development
of a responsive and responsible health care system.
Our members are gravely concerned at what appear to be significant gaps in the
consideration of the implications of the legislation for the disclosure of
personal health information, and for the fluid operation of the health services
Our members are convinced that the health service sector cannot be justly
treated under generic privacy legislation, and yet, as key health care
providers, we believe in the need for privacy legislation, without question.
Our members have successfully developed and implemented quality assurance
programs and confidentiality standards. It is with regret that we are unable to
support the legislation in its current form. We do ask you to accept our
Senator Murray: Yesterday I told the committee that I had a conversation with
one organization which had indicated that they lived quite happily with the
Quebec law, which is described as being more stringent than the proposed
federal law. However, they could not live with the proposed federal law. The
organization in question was IMS Health represented here by Dr. Korman. What is
the essential difference and approach between the Quebec law and the proposed
federal law? Why is it you can live so comfortably with the Quebec law as
distinct from, or as opposed to, the federal law?
Mr. Korman: Bill 68 in Quebec is held up as a paragon of privacy legislation in
protecting personal privacy. However, it does so at the point that information
is used as opposed to collected. Bill 68 permits the collection of personal
information without consent. Bill C-6 will not. The Quebec legislation allows
comprehensive databases to be compiled. Bill C-6 will not. The Quebec
legislation has an ongoing mechanism.
Senator Murray: What kind of databases?
Mr. Korman: With respect to the prescribing practices of physicians in
particular as well as the general health information of Canadians where the
information has been anonymized.
Bill 68 has an ongoing mechanism to make exemptions with respect to disclosure,
but Bill C-6 does not. Under the Quebec legislation, we can collect
comprehensive databases and then disclose them under the guidance of the
Commission d'access a l'information whereas, under Bill C-6, all such
collection will require patient informed consent. That will be a significant
Senator Murray: Perhaps other senators may want to pursue that in more detail.
What is there in this bill that prevents the compiling of anonymous databases?
Mr. Korman: In order for information to be anonymized, it must be collected in
the first place. It is our contention that, at the point of collection, the
patient must be informed as to the research purposes of such information.
Explaining all of the downstream uses of information for health research simply
cannot be anticipated. If it could be, or if that process were engaged in with a
patient, we anticipate that patients would object to signing a blanket,
far-reaching consent for the release of all kinds of health information. As a
result, we will lose valuable information from such databases. If patients will
not give their consent, the providers will not be able to collect it and,
similarly, to disclose it.
Senator Murray: You said two things about the operation of the Quebec law. The
first is that it contains exemptions with regard to the disclosure of this
personal health information. The second is that you are able to disclose under
the guidance of the Commission d'access a l'information. Which is it? Are you
operating mostly under exemptions that are already in the law, or are you
operating under what you call the "guidance" of the Commission? How
do they provide guidance?
Mr. Korman: It is not an exemption under the law, it is by way of a mechanism to
grant an exemption. The commission has given us an exemption to disclose
personal information. They have done so according to certain guidelines.
Senator Murray: Dr. Korman your organization has been mentioned in dispatches.
Yesterday one of our witnesses told us that IMS Canada is a firm: "...which
purchases customer and physician information from 4,000 retail pharmacies in
Canada. This same firm has a detailed database on daily activities and the
prescribing practices of 1,200 Canadian physicians." Is that a fair
description of your activity?
Mr. Korman: That is a misrepresentation, especially with respect to the term "customers"
implying any patient information. IMS collects no patient information, and we
have voluntarily retained an independent auditor to audit our practice every
two years since 1994. They can attest to the fact that we do not collect any
We collect information about physician prescribing practices from some 4,000
pharmacies. We collect an extract of the prescription record. We compile that
information and, altogether, probably have information on some 30,000 to 40,000
Senator Murray: Do you pay the pharmacies for this information?
Mr. Korman: In some cases we do. In some cases we are paying other service
providers who are in turn passing on a discount to those pharmacies. For
example, there are companies which provide software services to pharmacies and,
with their cooperation, we will pay them and they in turn will pay the
pharmacies or offer some kind of discount on their professional services.
Senator Murray: Do you sell that information to the pharmaceutical companies?
Mr. Korman: We sell it to the pharmaceutical and biotech industries. The
information is available for health research at no charge.
Senator Murray: From you?
Mr. Korman: Yes.
Senator Murray: Does that describe the relationship between IMS Health and your
organization, Mr. Poston?
Mr. Poston: Dr. Korman's description is a fair representation. We have
guidelines in place that permit, in terms of codes of practice, the sale of
data providing it is anonymized. This database represents the only source of
data on public and private utilization of medication in Canada. The data
illustrates the use of medication in the private sector in Canada. It is
captured nowhere else in a statistical format for analysis, other than that
service provided by IMS.
Senator Murray: A physician cannot control where a patient takes the
prescription. Are you aware of objections from physicians about having their
prescribing practices disclosed in this way by your members?
Mr. Poston: There have been criticisms in the past of situations where physician
data was used without consent. You must balance the overall information which
may be gained in many systems, with the feedback of prescribing data to
Senator Murray: Your members imply that the physician has given his or her
consent once he writes a prescription, that his or her prescribing practices
can be disclosed in this way.
Mr. Korman: In 1996, we corresponded with 22,000 physicians in Ontario. We
mailed them a description of what we do and how we do it. We received no outcry
or complaint. In fact, we received 200 requests for their prescribing profiles.
The information is not available anywhere else. In the past few months we have
mailed a similar letter to 17,000 physicians in Quebec. I have this mailing
available if you would like to see it. We received 400 requests back from
physicians requesting information, in particular their own prescribing
profiles. Eight physicians asked that their name no longer be disclosed. In
nearly 40,000 correspondences with physicians, we have found no great hue and
cry with respect to this information being available, but rather a serious
demand for this information from physicians about their own practice.
Senator Murray: Are your members in any kind of commercial relationship with
organizations such as IMS Health?
Ms Turner: I am not personally aware if they are or are not.
Senator Murray: Do you buy information from labs?
Mr. Korman: No, we do not.
Senator Murray: Ms Turner talked in her brief about the necessity for an
integrated health information system. Were you referring to the health
Ms Turner: Not specifically, but I do applaud it. We are looking at it more to
see how information systems in health and technology are moving forward. We
certainly want to ensure that there is nothing in its way which would preclude
Senator Murray: I would like to ask you about two recommendations made on the
final report of the Advisory Council on Health Infostructure. One is demanding
legislation at both levels. They are demanding legislation with a transparent
definition for custodians and trustees of personal health information. Their
obligations should be precisely defined, then they should apply equally to
public and private sector organizations as well as to organizations acting as
an agent or contractor for the custodian. Would you agree with that
Ms Turner: I have not thought of it in those terms. I am not sure I am prepared
to adequately comment on that.
Senator Murray: Do either of the other witnesses have a comment on that?
Mr. Poston: We would see the principles based in the health information report
would serve as a good basis for developing an approach to an integrated health
information system and could provide the basis for collaboration, discussions
and debate with respect to creating a health information privacy approach that
would be acceptable to everybody.
Senator Murray: They say that the obligation should apply equally to public and
private sector organizations.
They recommend that legislative guidance should be provided on how to balance
the right of privacy with the public good for research purposes to implement
the coherent and harmonized Canadian system. They say the legislation should
also contain a clear prohibition against all secondary commercial use of
personal health information. Do you agree with that statement?
Mr. Poston: Certainly I agree with the first three statements. The prohibition
of commercial use would depend on how the data collection from the
public-private sector is proposed to be done. At the moment, there is only one
system for collecting data from the public and private sectors, and that is the
service provided by IMS Health. If the principle of prohibition of collection of
data for commercial purposes were to be introduced, then some other mechanism
would have to be put in place to enable the collection of data from private
insurance. You must remember that at least 40 per cent of prescriptions in
Canada are paid for out of private health insurance. The only mechanism to
capture that data, which is very relevant to the formulation of drug policy in
this country, is through the private sector solution. To implement that
principle, you must find an alternative. The three other principles you
enunciated prior to that one are all ones we would support and that are absent
from Bill C-6.
Mr. Korman: We would support the recommendation as read by Senator Murray
principally because personal health information, as we understand it, applies
to the natural state of an individual, therefore, we can never foresee where
that identified information will be used and carried through to any commercial
purpose. It must be available so it can be anonymized and used for research
purposes. This is where we find the problem in the bill. We do not think that
professional practice information should be regarded and equated with the same
level of protection as personal health information.
The Chairman: You have two thrusts. One is that the bill as it now stands would
create two levels of privacy protection at least until the three years have
expired. I understand why that may bother you as a citizen. Why does that
bother you as a pharmacist since that is not a professional issue? Of course,
you are entitled to express your concern as an individual Canadian. The issue of
a two-tier structure in that instance is not a direct concern to you as a
Mr. Poston: At the implementation level, the places where the rubber would hit
the road on that would be in the community pharmacy. You would treat one group
of patients in one way, and another group of patients in another way. There
would be consternation from patients. A patient would want to know why one
patient is being questioned and not another. That is where the concern would
arise. You would be appearing to be treating patients differently.
The Chairman: The second recommendation seems to deal with your concern about
this bill preventing you from aggregating data in an anonymous fashion without
a patient's consent. You are the only witness who has put forward that argument
to the committee. If you knew that you could collect aggregate data in an
anonymous fashion without patient consent, would that eliminate that concern,
or is there another element?
Mr. Poston: Data is currently used on an anonymized basis. In many cases it is
done on the basis of implied consent. It goes back to the way in which data is
collected. The bill is silent on collection. It talks about use and disclosure,
but not about collection. There is a number of reasons why there would be gaps
in research. Patients would refuse to give consent. The provider may not ask for
consent. As well, the use of data for research purposes at some period in the
future would not be known at that time. The data at the time of collection is
identifiable, therefore express consent must be sought under the requirements
of Bill C-6. Currently, in the situation where there is implied consent, the
data which is used is anonymized, so that step is not required.
The Chairman: You have proposed a period of five years as a period during which
this bill would not apply. That strikes me as an extraordinarily long period.
It seems to me that nothing would persuade the various members of the health
services sector to agree more than being told you had one year before the bill
comes into effect. My general experience of people seeking long delays is that
they hope elections and other things will leak over and the issue will
disappear. However, if someone has a gun at their head, they are much more
inclined to be reasonable than if they do not. Why do you need five years? In
particular, since this bill does not go into effect for a year after it is
proclaimed anyway, why could one not use that 12-month period to deal with that
Ms Noëlle-Dominique Willems, Director of Government and Public Affairs,
Canadian Pharmacists Association: As you will know from your previous
experience, discussion and negotiations with the provinces on harmonizing
legislation is a long process. We would like to see across Canada, instead of
the patchwork quilt we now have as far as privacy protection is, is harmonized
health protection legislation. We feel it is the leadership role of the federal
government to do that. Five years is a bare minimum. That five years
corresponds to the review of this bill. That would be the appropriate time, if
health care has not gotten its act together, to fold it back in.
The Chairman: I understand your desire for federal-provincial harmonization and
agreement. I am much more inclined to subscribe to your theory of leadership. I
do not think leadership means sitting around doing nothing for five years.
Senator Finestone: The Krever report, which cost us millions of dollars,
included a report on the confidentiality of health information. It was released
in Ontario in 1997. That report made a very strong observation that information
revealed about one's self to a doctor in a professional setting remains, in a
fundamental sense, one's own information. You would agree with that.
In the McInerney v. MacDonald Supreme Court judgment, the court developed the
framework on the information as one's own. Mr. Justice Krever said that, in his
opinion, informed consent was appropriate for the release of any kind of health
information. Now you seem to assume that you can use a lot of this material for
secondary purposes without having any kind of informed consent. Would that be
an accurate statement?
Mr. Korman: The key point here that cannot be lost is the ability to anonymize
information. It is the ability to access personal information, and then to
depersonalize it. In our view and in the view of health researchers, not just
in Canada but around the world, it is that critical step which is required in
order to make the best use of that information to advance health. Therefore,
with respect to personal information being used for secondary uses, we are all
in agreement that it is not on. The task before us is how to make the best use
of that information after it has been depersonalized. It is our contention that
it must be available as universal information. Information, once depersonalized,
where the individual's identity cannot be traced back to the information, is
still personal health information.
Senator Finestone: How do you receive this information? You have access and you
have doctors' names linked to patients. Do the patients know? In many cases the
doctors did not know you were collating this information. I do not know who
gave you the right to take my information from my prescriptions which my doctor
gave me. I might have had AIDS and I do not want you to know that. I might be
pregnant and I do not want you to know that. There are many things about me I am
not prepared to tell my mother. Why should I tell you? I want to know who gave
you permission to obtain that information which is already identified. To whom
are you giving this personal information? Obviously you are retaining personal
information that identifies the patient because you are informing doctors. How
do you anonymize that information? Give me a list of who you are giving this
information to since you are the only one in this country collecting information
about me and you.
Mr. Korman: I must stand and correct you. IMS does not collect any personal
identified information. We have not done so in 40 years in Canada. We have not
done so in 50 years around the world.
Senator Finestone: What do you do?
Mr. Korman: We are the only company that I am aware of that has retained an
independent auditor to come in every two years and verify our information
handling practices so that we can tell you that we receive no personal health
information about you or anyone else.
Senator Finestone: How did you receive that information, sir?
Mr. Korman: The information that we receive, for example, with regards to
disease and treatment, has been provided by doctors who fill out a reporting
form, a survey document, which tells us the disease and treatment, but in which
there is no personal identified information. In 40 years, there has never been
a single breach of personal privacy with respect to IMS.
Senator Finestone: Are you receiving your information from doctors?
Mr. Korman: We obtain disease and treatment information from doctors. We obtain
physician prescribing practices from pharmacies.
Senator Finestone: In both instances there are no names attached?
Mr. Korman: In the case of patient information, we receive no patient identified
Senator Finestone: What about the information you receive from pharmacies?
Mr. Korman: With respect to pharmacies, we receive no patient identified
information. Nothing that we have ever received from pharmacies can be linked
to a patient.
Mr. Poston: It is anonymized at the pharmacy level when the data is transferred.
That is when the names are removed.
Senator Finestone: If, as you say the date you receive from pharmaceutical
companies is not personalized then, as a patient, I have no reason to be
concerned because your use of my secondary information will not affect my life.
There is no problem.
Mr. Korman: There is no way of tying back any of the information we collect to
you as an individual. We know Canadians are very concerned about the
improvement of health care and the delivery of health care. Insofar as
aggregate, depersonalized, anonymized information can be used for that purpose,
we believe that is in the best interest of Canadians as they represent that to
Senator Finestone: Is the information irreversibly anonymized?
Mr. Korman: That is an excellent point. We can move one step further and call
upon Coopers & Lybrand to testify to that effect.
Ms Turner: On your question on privacy, it is not about the information sale or
not, but it is about the confidentiality between the physician and the patient,
between your doctor and you. Currently, when you go to your physician and
receive a requisition, that is the end of anyone knowing what test you will
Senator Finestone: I appreciate that. There is a very big difference between
what is confidentiality and what is privacy. The only person I am prepared to
share my privacy of information with is my doctor, not you or anyone else.
Often there is confusion between confidentiality issues and privacy issues. You
have just outlined that difference.
Ms Turner: That is the very point that concerns us because, if there is a
waiver, it must be signed in an open setting.
Senator Finestone: It would require more than a waiver. You would need my
permission to use my information somewhere.
Ms Turner: In the case of medical laboratories it would involve a test that the
patient is aware of, and that is very different. That is what would happen in
our case if we were considered, under the bill, to be a commercial activity.
Currently, that information remains between the physician and the patient.
Senator Pepin: You receive two kinds of information. One is from pharmacists and
relates to the types of medication doctors prescribe, because you can target
groups of patients such as those suffering from AIDS or stomach ulcers and so
on. The other kind of information is from doctors about patients, depending on
what kind of medication has been prescribed and what kind of patients you are
interested in. The doctors provide anonymized information on the patients or the
side effects or the effectiveness of certain medication. Is that correct? Is it
anonymous because you do not give names?
Mr. Korman: You have it right. There are two independent data collection
processes, and in no case is the patient identified.
Senator Finestone: I had wanted to ask Mr. Poston about his concern regarding
the two line-ups for the two kinds of people, because I am concerned about his
having a problem with setting up one booth. If 30 to 40 per cent of the
patients coming in are from the private sector, that sounds pretty strange to
However, my question is for Mr. Korman. What are the revenues of IMS?
Mr. Korman: Insofar as that is germane to this discussion, I would estimate them
to be around $60 million.
Senator Finestone: That is all coming from this one stream. What is your
relationship with the pharmaceutical companies?
Mr. Korman: The pharmaceutical and biotech companies are our clients.
Senator Finestone: Are they clients or customers?
Mr. Korman: They are customers, as are the Government of Quebec, the Government
of Ontario and, within the federal government, Health Canada, including the
Patented Medicines Prices Review Board. They are all paying customers of IMS.
Senator Finestone: Therefore, your contribution to the well-being of society,
which I consider you are doing in a certain way as long as my name is not mixed
up in it, is your gift of research information to Health Canada; is that what
Mr. Korman: Health Canada is a paying customer.
Senator Finestone: Which one is the gifting consumer?
Mr. Korman: The health care community and the research and academic community
have received data from IMS free for 40 years.
Senator Finestone: Is that upon request?
Mr. Korman: We publish some information of our own volition. I can point to IMS
as the authority on blowing the whistle on the rampant use of Ritalin in
children. That is information we have put into the public sector by our own
efforts. We provided the data to academics and health researchers and as well
to the Canadian Coordinating Office for Health Technology Assessment. That
important body assesses the value of health technologies. They are often very
critical of pharmaceutical therapies as well. We make our information available
to health researchers irrespective of their point of view.
Senator Robertson: You suggested that the Quebec legislation protecting personal
information is pretty good?
Mr. Korman: Yes.
Senator Robertson: Do you like it better than this bill?
Mr. Korman: Yes.
Senator Robertson: Can you tell me about the European experience? In 1995 they
had a directive protecting personal information requiring the member states to
get on with it by 1998. Has that happened?
Mr. Korman: That is outside of my field of expertise. The European Union has
recognized that health as a separate sector requires its own privacy
Senator Robertson: Now probably you are aware also that it is being recommended
in some quarters that the CMA privacy code be appended as a code to Bill C-6.
Do you think that is a good way to proceed?
Mr. Poston: There are some issues with respect to the CMA privacy code. A
22-page amendment on health privacy information clearly points to the fact that
health information must be looked at differently and probably points to some of
the inadequacies in Bill C-6.
The CMA code is quite physician-centric. It was developed by physicians to apply
to the rest of the health care sector, but it was done with very little
consultation with other members of the health care sector. There is also the
question of primary uses and secondary uses. They have some extremely strong
measures or barriers and obstacles with respect to secondary uses that could add
significantly to the cost of maintaining the health care system.
Another critical issue for us is the definition of primary use being open and
subject to implied consent. A particular issue for our members is whether
payment for a prescription constitutes primary or secondary use. Many
prescriptions are paid through an on-line billing system. Is that primary or
secondary use? The patient does not get the drug unless it is paid for, so we
see it as primary use.
Senator Robertson: I will double check your answer with the code.
Senator Oliver: Assume that Bill C-6 passes and receives Royal Assent in its
present form within three weeks. If that were the case, what is it that you are
doing now in terms of data collecting that you will not be able to do after the
passage of the bill in its current form?
Mr. Korman: Allowing for whatever delay there is in the implementation of the
bill, with respect to the collection of personal health information that is to
be anonymized, physicians who provide us with that information would have to
request informed, expressed consent from their patients for that information.
Senator Murray: When they write a prescription?
Mr. Korman: No. At the point that they are completing survey documents for us on
disease and treatment patterns.
Senator Oliver: People are used to signing these when they apply for insurance
policies, and at the bank they sign general consents. What would you be unable
to do in terms of your current undertakings if the bill passed in its present
Mr. Poston: The sale of merchandise is not a major issue for community
pharmacies; the amount of money retained is relatively small. A major problem
for us would be the amount of time it would require to explain to patients.
That would add a significant burden at the pharmacy level.
Senator Oliver: Would you have to do things differently?
Mr. Poston: Yes. Patients would still receive medication in a safe and
appropriate manner, but it would add to the resources required to do that and,
ultimately, to the cost of the health care system.
Ms Turner: It would certainly cause a huge upheaval. Could we do what we have
been doing? Probably. However, there would be a considerable amount of
confusion in instances where we have joint ventures in hospitals. For example,
we now provide that service in a lab operated by one of our members in a large
downtown hospital in Toronto. Under this bill, the hospital and the doctors are
exempt, but the lab is not. When a physician orders a test, will that lab be
able to perform the test? Will there be a delay or will that procedure be done
right away? So, within the hospital, in one area you are okay, and then you
walk across the hall into another area and you are not okay.
The Chairman: Dr. Korman, you said that a doctor would have to receive explicit
consent to provide anonymized information to you, correct?
Mr. Korman: To collect information that would then be anonymized.
The Chairman: He does not have to collect the information, it is already in his
Mr. Korman: We are talking about a particular research project that we have had
ongoing for some 40 years. The information is specifically collected outside of
The Chairman: However, the information is identified through an individual
patient known only to the doctor; the identity of the patient does not go to
you or to anybody else. Is that correct?
Mr. Korman: Yes.
The Chairman: If you were satisfied that under this bill the doctor could still
provide you with the information that he does today and you could still receive
that information, which has been anonymized, you would have no objections to
the bill. Is that correct?
Mr. Korman: Not only we would have to be satisfied, but our customers, including
the Government of Canada, would have to be satisfied that we were collecting
comprehensive information on disease and treatment. We are looked to as an
authoritative source for disease treatment patterns in this country. It is
essential that we be able to collect information universally.
The Chairman: All the information you collect is anonymized. I am trying to
understand what your problem is. The more you talk the more I become convinced
you do not have a problem. You think doctors will have to obtain explicit
consent to provide you with some of the information that they now provide, even
though that information is now anonymized, correct?
Mr. Korman: Yes.
The Chairman: Where we disagree is that I do not think we need to obtain that.
Senator Oliver: I am fully aware that IMS Health never obtains or collects
patient identifiers from any of its data sources. What kinds of data do you
actually collect? Do you receive a SIN number, a health card number, the name
of the disease or the name of the doctor, the name of the drug for that
treatment and so on? Let the committee know the details of the kinds of
information that you have in your database.
Mr. Korman: I will talk about two principle kinds of information. The
information that we obtain from physicians is on disease and treatment
patterns. A physician will complete a diary, a report form, a survey document.
That document will contain the person's gender and age but no other personal
information, no SIN number.
Senator Oliver: Does it contain the patient's province or city?
Mr. Korman: As we receive the information, it will be at the level of the
province. The record contains the disease that the doctor diagnoses and, if the
doctor prescribes medication, what the prescription is and what the drug
regimen and the dosage will be.
Senator Oliver: Do you have a sample of the kind of anonymous data you receive?
Mr. Korman: I do not, but I shall provide one at our earliest opportunity.
Senator Oliver: Does the record indicate a general location, whether it was from
Nova Scotia or British Columbia?
Mr. Korman: Yes, by virtue of the fact that we know where the doctor providing
that information is.
Senator Oliver: Therefore, if the doctor was in a community of 5,000 people it
would not be hard to narrow down the type of disease, would it?
Mr. Korman: As we have traced that linkage process, we can do that. I would be
pleased to provide IMS data and reports to show you how impossible the task of
identifying a single individual is. The record speaks for itself. In 40 years
of collecting this data -- and the data collection system is essentially
unchanged -- there has not been a single case where a person has been
With respect to the pharmacy, we extract from the record similar information:
the gender and the age, the drug that has been dispensed, the treatment regimen
and an identifying number as it pertains to the physician.
Senator Oliver: Would you have a person's weight or height?
Mr. Korman: No.
Senator Oliver: Would you have any other identifiers?
Mr. Korman: No. Again, I would refer you to our independent auditor, Coopers &
Senator Oliver: That person comes only once every two years. I do not get much
confidence from that.
Mr. Korman: They are certifying the representations that we make about our data
Senator Oliver: They do not do an audit of your actual --
Mr. Korman: Yes, they do. They literally walk through our shop from one end to
the other inspecting all of the media that we receive -- the paper, the
computer tapes, everything from A to Z -- and they attest to the fact that we
have no patient identified information.
Senator Callbeck: I received in my office this morning a response to comments
made by Canadians in support of Bill C-6. In that paper, under "reality
number 6", you state that this bill will lead to greater divisiveness
rather than uniformity as stakeholders and the health care sector struggle to
escape the requirements of Bill C-6. What stakeholders are you referring to
there? We have had many organizations here, such as the Canadian Medical
Association, the Canadian Dental Association and the Canadian Health Coalition,
that support Bill C-6 or want to have it strengthened.
Mr. Korman: I am not familiar with that document. I certainly did not author it.
Senator Callbeck: All right. Now I have a question for IMS. You have said that
Canada will be out of step with the European Union if Bill C-6 goes through, is
Mr. Korman: Yes. In jurisdictions that have grappled with health information for
some time, we are now seeing a revisiting of some of the implications of the
legislation that has been passed. For example, in Germany, where informed
consent is required to collect information for research purposes, pharmacal
epidemiology research has been devastated by that requirement. It has been
impossible collect information on the scale that is needed. Health is being
treated as a separate sector by virtue of its own legislation. In that way, we
think that legislation that is in a sense cross-sectorial is out of step with
the treatment that is now being conducted in the European Union.
Senator LeBreton: Dr. Korman, are generic drug companies customers of yours as
Mr. Korman: Yes.
Senator LeBreton: When providing research data and following sales trends and
various drugs that are being used, do you get caught up in the debate between
the generics and the pharmaceuticals?
Mr. Korman: If you are asking whether we have enough flack jackets and sand bags
around the place, the answer really touches on what IMS is about and that is
advancing health irrespective of the interest concerned. We provide information
equally to the generic and the branded manufacturers. We provide information to
the manufacturers and we provide information to health researchers who are
critical of the manufacturers. We see our role in society of being able to
describe authoritatively what is happening so that others can make policy to
advance this nation's health. We get caught up in these conflicts, but we are
not here to choose sides on what is good health or good medical practice. We
are here to provide authoritative information.
Senator LeBreton: Both have equal access to your information?
Mr. Korman: Yes.
The Chairman: I should like to thank the witnesses for being here today.
Senators, on Monday we will start at 1:00 p.m., not at 2:30 p.m. as originally
planned, because the constitutional panel we had hoped to do tomorrow afternoon
we will do on Monday. Our in camera session will begin shortly after 2:00 p.m.,
recognizing that a number of the Conservative Senators have an event that
We shall now proceed with the next witness who from the Canadian Healthcare
Ms Sharon Sholzberg-Gray, President and CEO, Canadian Healthcare Association:
The Canadian Healthcare Association appreciates this opportunity to appear
before this Senate committee to share our deep concerns regarding Bill C-6. We
appreciate the opportunity to appear without company at this side of the table.
I should like to explain very carefully to you who and what the Canadian
Healthcare Association is. It is the federation of provincial and territorial
hospital and health organizations committed to preserving and strengthening
Canada's health system. Through our membership, we represent regional health
authorities, hospitals, health care facilities and agencies which employ
approximately 1 million health care providers and serve Canadians across the
country. These organizations are governed by trustees who act in the public
interest. We represent the publicly funded health care system in this country.
We represent a broad continuum of care.
I should like to list the breadth of our membership because it is central to our
concerns regarding Bill C-6. Through our provincial and territorial members,
CHA represents hospitals; long-term care facilities; home and community care
agencies; community health services; public health; mental health; addiction
services; children, youth and family services; housing services; and
professional and licensing bodies. The Canadian Healthcare Association is the
national voice of this health network. Through the breadth of our membership,
CHA brings a systems perspective to our policy analysis, and we speak out in
the public interest.
I should like to start by telling you what CHA and others are recommending
regarding Bill C-6 and then spend some time explaining why. I will not read out
the suspension we are recommending because you have the words in front of you.
We are asking for a suspension and we can discuss how long that should be at a
The suspension we are asking for would support the need for legislation to be
developed regarding the privacy of health information. CHA is not interested in
having health carved out or exempted so that we will not have privacy
legislation. CHA wants legislation that addresses the privacy of health
information. However, as the Heenan Blaikie opinion clearly outlines, Bill C-6
does not provide the appropriate legislative framework to ensure the privacy of
health information. It is fundamentally an e-commerce bill. Heenan Blaikie also
concluded that a few simple amendments could not adequately address the complex
issues related to health care and privacy. This is evident in the lengthy 22
pages of amendments proposed by the Canadian Medical Association. The Canadian
Healthcare Association is committed with others to ensure that appropriate
privacy legislation is developed. We absolutely support the need for health
privacy legislation, we just do not support Bill C-6.
We must tell you that the recommendations of the health minister's Advisory
Council on Health Infostructure which were cited earlier would be an excellent
place to start in having the appropriate legislative framework for privacy
issues with regards to health.
The suspension would enable balance to be achieved, where the need for privacy
of health information, we which we support absolutely, and the need to improve
individual and societal health are both recognized as fundamental principles.
Privacy is very important to the public, but Canadians are also concerned about
maintaining and improving their health through health research and knowledge
development. The government is now supporting huge new investments in health
research that will require information. Canadians are also interested in knowing
that they receive quality care. The only way to examine quality is to look at
outcomes and records in hospitals and other health facilities to ensure that in
fact Canadians are receiving quality care. Canadians want to know that their
tax dollars and their out-of-pocket expenses are being used appropriately with
an effective and efficient health care system. Our members -- individual health
care facilities and agencies -- are committed to providing quality care within
a health care system that is accountable to the public. We fear that Bill C-6
would seriously compromise our ability to do that.
In our view, the principle of protecting the privacy of health information
cannot be seen in isolation from other individual and societal goals. A balance
can and must be achieved.
The suspension we are asking for reflects the complexity of the health care
system, including the fact that there is a broad continuum of care settings,
including home and community care as well as hospitals. There is a broad range
of services, from health promotion to palliation. There is a broad range of
providers that have information about one's self -- not just physicians, but
physiotherapists, for example, and we have heard about pharmacists. There is a
reality about different funding and delivery mechanisms that partner the public
and private sectors -- for example, public funding with private delivery. There
are many permutations and combinations here.
This suspension prevents the creation of two tiers of health privacy
legislation. The amendment to Bill C-54, now Bill C-6, adopted in the summer
creates a situation where health care services that are publicly funded and
publicly delivered require little or no explicit consent -- a notice on the wall
is not sufficient in our view, so more privacy must be introduced into that
side of the health care system -- while the commercialization aspect of the
bill creates information gridlock for the components of the health care system
not covered by the traditional concept of Medicare, namely publicly funded,
privately delivered services such as home care in some provinces, and privately
funded, privately delivered services such as long-term care in many provinces,
and a host of other significant components of the health care system.
This suspension would facilitate the development of a meaningful process and
time frame for all stakeholders in health care -- including public and private
providers, managers, policymakers, researchers, governments and particularly
consumers -- to work together to develop appropriate legislation that would
cover the entire health care sector. We think that the complexity of these
issues will require adequate time for them to be resolved. We have noted five
years in our remarks. We are open to discussion on that.
Everyone must come together to agree on a set of principles, and in fact there
is not that much disagreement between the groups. Everyone wants quality care.
Everyone wants health services to be accredited -- which means to look at
information -- and everyone wants to know that our system is efficient and
effective. Everyone wants to know that we will have good public policy in the
future based on research and effective collection and use of information, but
at the same time we want appropriate protection for the public. We are not sure
that this bill can achieve that.
There is a certain interest and absolute desire on the part of the government to
get the e-commerce component of the bill quickly. By suspending the sections
pertaining to health and by trying to develop in one particular piece of
legislation an appropriate framework for health, we would satisfy the needs of
the Canadian health community and at the same time the Canadian consumers who
value equally all of the principles I stated before. The suspension is the only
way to go.
A flurry of points and counterpoints has been made over the last few days and
weeks regarding Bill C-6 and its impact on health information. We hope that the
discussion today can clarify some of these issues and find common ground for
strong and relevant privacy legislation for health information.
The Chairman: I cannot resist your invitation to enter into a dialogue on the
question of five years, since you were in the room when we had the discussion a
few minutes ago. What is wrong with my year?
Ms Sholzberg-Gray: It is a good start. It might well be that in one year you
could bring all the parties together and come out with an appropriate
legislative framework. However, you will not achieve harmonization with the
provinces in one year. You cannot always have everything. Two years would come
closer to it.
This bill does not satisfy the needs of the publicly funded health care system
at the same time as privacy needs. There are many conflicting opinions as to
what the bill means. Some people say it applies to this or does not apply to
this. Some people say there is implied consent all over the place, while some
say you need informed consent every step of the way. Some people say there is no
problem, you can use unidentifiable or anonymized information anytime, so why
are you so worried? That does not recognize the complexity of the health care
system. There is an awful lot of public funding of privately delivered
services, in fact more than we would like if we look at the recent case in
Alberta. That is an extremely serious issue. We would not have the opportunity
even to assess the quality of those private services if we had a bill like
The Chairman: The advantage of having a time frame in which this bill goes into
effect if a better solution is not worked out is that it puts significant
pressure on the negotiators who want a change to reach a conclusion, otherwise
they are stuck with the bill. Would you not agree?
Ms Sholzberg-Gray: That is true. When you know that the hanging is nearby, you
certainly repent quickly. It would put pressure on people to come to an
agreement more quickly. That is a point to consider in a positive way. However,
I think it is also important to give time for all stakeholders to be committed
to whatever the bill is. There are too many differences and there is an
atmosphere of concern, although in many cases those stakeholders have generally
very similar principles and I think they are saying that this bill does not
contain those principles. If only someone had looked at the health minister's
Advisory Council on Health Infostructure, they might have had principles that
could have been put in the bill. That says very clearly that there must be
descriptions of consent and the way consent must be obtained. When there are
exemptions, they must be very clear, for clear public policy purposes. Those
things are not in the bill, or at least I cannot find them.
Senator Murray: In your introduction you list those you represent through your
provincial and territorial members. Are any of those members engaged in
commercial activity as understood in this bill?
Ms Sholzberg-Gray: Yes. While we represent the publicly funded health care
system in this country, we know that in some provinces there is contracting out
to private delivery. For instance, in most provinces there is contracting out
to private delivery of long-term care and home care services. Whether those
will be deemed commercial activities under this bill we do not know. In fact,
this bill will create quite a disincentive on the part of those providers to
even collect and aggregate information that could measure their quality and
outcomes and that kind of thing.
While we are the publicly funded system, there is a lot of private delivery.
There are private pharmaceuticals, private laboratory testing, private home
care, private long-term care, private housing services, all kinds of things. We
have a publicly funded system, but we all know that there is a lot of private
delivery. If all the private delivery parts of that publicly funded system
cannot, as a result of this bill, have information collected that would benefit
us as individuals and as a society, there would be a real problem.
I am on an advisory committee involving the Canadian Institute for Health
Information's efforts to collect information and indicators regarding home
care. I am not sure, in the context of this bill, how they would be able to
collect information on all these private home care providers. Frankly, I would
think that that is an area where we would want to collect information for the
health and safety of Canadians. Somehow, we have to find a way to achieve those
goals in this publicly funded, sometimes privately delivered health care
Senator Murray: Have we heard from CIHI? Will we hear from them on this bill? Do
you happen to know?
Ms Sholzberg-Gray: They would have to speak for themselves. Clearly they are in
the business of collecting information and I am sure they have had their own
discussions with the government.
Senator Murray: You have mentioned favourably the report of the Advisory Council
on Health Infostructure and you seem to support the principles that they lay
out. That being the case, I am puzzled why your organization could not have
made common cause with the Canadian Medical Association whose witnesses we
heard from yesterday?
As you noted in your brief, they suggested quite a voluminous number of
amendments, but there was also discussion between the chairman and the
witnesses of the possibility of simply appending their code to the bill and
giving that code whatever force of law an appendix to a bill has. It would be
clear that for the purposes of the bill that code would apply to the health
care sector. Why could you not go along with that?
Ms Sholzberg-Gray: It would be inappropriate to take a code from one particular
set of health care providers, physicians, important as they are, and to put it
straight into another code without measuring that first code against the
principles outlined by the Advisory Council on Health Infostructure. While we
understand the importance of patient-doctor confidentiality -- it is a crucial
and important underpinning of our health system -- we think that there are
things in the CMA code that will not permit an orderly review of outcomes in
hospitals or an orderly accreditation process.
I believe members of the committee would have received a letter from the
Canadian Council on Health Services Accreditation, the body that accredits
hospitals, home care agencies, regional health authorities and long-term care
facilities in this country. They have expressed concern that this bill might
make their accreditation process a little difficult. There is no Canadian who
does not want to be assured of quality care.
It is possible that there are nuances here and there, that various associations
will have to come together and change in order to find common ground. We know
very well that the CMA is in favour of reviewing outcomes and having an
efficient, evidence-based system. However, if the value above all that one
holds dear is privacy and even the collection of anonymized, non-personal
information would be considered a negative, I do not see how that could work in
concert with the Advisory Council on Health Infostructure's recommendations,
which are very clear.
For them, the legislation should define what constitutes informed consent and
provide a clear statement of principle to the effect that informed consent
should be the basis for sharing information. We agree with that. In the
publicly funded and private health care sector, there must be knowledge of what
informed consent is and the bill should be clear on what it is. I do not think
this bill is clear on what informed consent means.
Senator Murray: That is the critique the CMA makes.
Ms Sholzberg-Gray: It is, but the wording of that advisory council does not find
its way into their code the way it should.
Senator Murray: We will hear later on from officials, deputy ministers and
others from Health Canada. Did you take your concerns to that department?
Ms Sholzberg-Gray: We discussed this with Health Canada in an open forum with
the minister, who attended our annual conference in June. We expressed concern
that this legislation did not provide the proper balance, which of course is
hard to achieve because privacy is absolutely crucial. At the same time,
however, so is certain information without which a Canadian's health can be
jeopardized. So we must find the balance and we must find it in a clear and
We have expressed our concern to the Department of Health that this bill did not
provide that balance, and it was after those discussions that the amendment
came forward in June. That concerns us even more, because now we have the
publicly funded system without having any consent requirements, and consent
requirements are absolutely essential there.
Then we have the other side. We still do not know whether publicly funded and
privately delivered is within the purview of the bill or not, which is a whole
other issue. We do not have a clear set of circumstances that would govern the
so-called commercial side, in the sense that, if it is publicly funded and
commercial, then what is it? It is open season on privacy on one side of the
bill and on the other side maybe not enough -- in other words, the inability to
even monitor what private-sector providers are doing, which to me would be very
Senator Murray: Do you know anything about the Quebec law that we discussed
Ms Sholzberg-Gray: I do not know much about it, but concerns have been expressed
by the accreditations council about not being able to review, during their
accreditations in Quebec, the health records of individuals in order to know
whether quality care was provided. I think that that is something we have to
In other words, our system depends on the review of outcomes to make sure that
the intended outcomes do occur. Frankly, if you could not do that, that would
be a great problem. So any bill must allow for legitimate processes that
protect the health of individual Canadians.
Senator Carstairs: On Page 3 of your brief, you refer to the amendment of Bill
C-54. Unfortunately, we do not have that amendment in front of us. What was
that amendment, and in your view what did it do?
Ms Sholzberg-Gray: I do not have the exact wording. We expressed concern about
the fact that the bill would prevent some of the objectives that the government
had set for itself. The government is establishing a Canadian institute for
health research. At the same time, it also gave $95 million to the Canadian
Institute for Health Information to collect and aggregate data to understand and
provide information on how the health system is performing from the point of
view of quality as well as quantity and efficiency and effectiveness and that
kind of thing. We felt that somehow this bill would prevent those very
activities that the government wanted from occurring. They put in the amendment
saying that any information that has to be collected for public policy purposes
or publicly funded system purposes can go ahead. They do not have to be
followed in the purview of this bill. To us, that is a danger in itself,
because we want consent.
In other words, we are not assuming that everyone is benign just because they
are in the non-profit sector or because they have public policy goals. If there
will be an exemption for that, we want it spelled out in the way the Advisory
Council on Health Infostructure spells it out. We want to know when there must
be consent. We want the legislative reasons in greater detail as to when that
consent would not be necessary or when it is implied. That was the amendment.
It was in response to various concerns we expressed.
By the way, this bill was never supposed to apply to health in the first place.
We were assured at the outset, frankly, by the Department of Health that it was
not a health bill, but was just an e-commerce bill that had nothing to do with
health. Of course, like everyone else, we would be appalled at the notion that
anybody's health information would be provided to the private sector for
commercial purposes, or that private insurers could use health information and
people's health records for private profit or to reject people for insurance,
or anything like that. So we agreed with all of those things, but we are
concerned about legitimate public goals, and we are afraid, still, that it is
murky in this bill and that the government amendment does not resolve it. It
does not discuss the issue of private delivery within the publicly funded
system, for example.
Senator Carstairs: Two points occur to me as a result of your response. First,
in the House of Commons they made an amendment to this bill which you think
actually made the bill worse for health care.
Ms Sholzberg-Gray: For privacy.
Senator Carstairs: It made it worse for privacy, particularly for health care
issues, rather than better, although its purpose was to make it better.
Ms Sholzberg-Gray: Yes. Its legitimate purpose was to ensure that important
government initiatives related to health research and the collection of health
information could be accomplished; but in doing that it kind of opened up a lot
of the privacy issue in the sense that it did not require the same privacy for
those public purposes as is required generally in the bill. It did not define
what was meant by those public purposes. It did not ask what that meant,
whether it was for publicly funded, privately provided collection, or publicly
funded, non-profit provided collection. What does it apply to? Without putting
some clarity on what it applies to, it did not do the job it was intended to do.
That amendment in the bill is not clear enough. Well, it is not an amendment
anymore, obviously; it was adopted in the bill, and you can read it. It is the
clause in the bill that allows that collection. We did not think it clarified
things enough. We needed more than just that. The bill needs to be a
substantial bill pertaining to health information across a broad continuum of
care, across a broad range of settings, across a broad range of providers,
across the public-private interface that takes place all the time. We just do
not see that bill doing the job.
Senator Carstairs: The other issue you raised was that somehow you were told
that the bill had nothing to do with health and would never have anything to do
with health. I think we need to go into that in some detail.
Ms Sholzberg-Gray: It was because of meetings that other people on my staff had;
it was not face to face, but indirectly we were told. In fact, we did not even
go to the other place to make our concerns known, because at the time the bill
was being considered, we honestly thought it was an e-commerce bill. To the
extent that health was involved, we thought it only had to do with using health
information for sale or for commercial purposes of the kind we mentioned, to
deny insurance or that kind of thing.
However, the knowledge that an activity is commercial just by the fact that
someone is paying for it means that it opened up the entire health sector for
us. At the same time, we would receive information from Health Canada saying, "Don't
worry; health is not very much affected by this bill," and then an
industry saying. "Oh, no, we can't take health out; it has to be special,
because health is a very important part of this bill." So we frankly did
The Chairman: When was all this clarified? When did you finally understand that
this affected you?
Ms Sholzberg-Gray: Just by talking to colleagues, and by understanding that
activities that we did not think of as commercial were all of a sudden being
defined that way. When we looked at the definition, we suddenly realized that
it was commercial. The very fact that Health Canada had to come forward with
that amendment made us realize that the bill did have a health impact, even
though it was not originally meant to. One would ask for instance why that
proposed amendment to collect health information for public policy purposes or
public government purposes was not in the bill to start with? It was because
the bill was not viewed as a health bill.
The Chairman: This was in May or June of last year?
Ms Sholzberg-Gray: Yes, April, May or June.
The Chairman: I am just trying to get a sense of the timing, roughly.
Senator Oliver: She did not go to the other place.
The Chairman: Yes, I know; that is why I wanted to get a sense of the timing.
Ms Sholzberg-Gray: We frankly missed this. It was only by the fall, when
everyone was talking about it, that we decided to seek a legal opinion on the
way in which the publicly funded health care system would find it difficult to
operate within the purview of this bill.
The Chairman: Thank you. That helps me.
Senator Carstairs: In terms of what we have heard over the last few days,
essentially we have four positions: first, pass it as is; it is absolutely
perfect so just get on with it; second, do not pass it; it is awful so throw it
out; third, suspend certain provisions; and, fourth, exempt certain provisions.
From your perspective how do you distinguish between suspending certain
provisions and exempting certain provisions?
Ms Sholzberg-Gray: We are not asking for anything to be exempted. We are just
asking for something to be suspended, knowing that, if we do not come to an
agreement within a specified length of time, the bill will just go forward. So
we are asking for a suspension, and I make that clear.
There have been a lot of cross currents and opinions thrown back and forth, as
you noted. I know that a lot of the people who value health privacy, as we do,
at one and the same time value -- as I am sure everyone around this table also
values -- efforts to secure quality care and to measure the effectiveness of
the health system, because without that we cannot even benefit the health of
Canadians, let alone the system. However, we are not talking from the system's
perspective; we are worried about individual health of Canadians which can only
be assured by measuring outcomes in quality and by doing things based on
information and evidence.
I think that everyone has agreed to those principles. The real issue is that, if
everyone has a different solution on how to fix up the bill, where will that
get us? Some people are saying it needs to be strengthened or weakened in one
part or another; some people are saying it needs to be totally hacked out;
other people are saying, "Suspend," and still others are saying, "Add
22 pages of amendments." Obviously, that in itself indicates that there is
a problem which must be resolved. There are a lot of people of good will who
all want to achieve a similar goal. They just do not think that this bill
achieves it. That is an argument that the bill is not quite right.
There are those who say, "Let's adopt the bill, because it is better than
nothing, but it isn't sufficient." That tells you something as well.
Senator Carstairs: There could also be an argument that, if we have not met the
two extremes and the two in the centre are not that different from one another,
maybe we have hit the right balance.
Ms Sholzberg-Gray: While I am concerned about that, I noted that one of the
senators asked someone: "What would happen if this bill were adopted? How
would that negatively impact on your ability to do things right now?" And
I would say that it would be very difficult for us to measure the impact of
private delivery in the health system, to measure quality in the private
delivery side, which is done through publicly funded contracts. There would be
no incentive on the part of those health care providers to provide information
at all. It might well be that their contracts would require them to do so, but
then they could say, "But we don't have to; there is an e-commerce bill
that says that we are in commerce and therefore we do not have to provide you
with that information."
So I think it would impede our ability to collect information needed to assure
quality in the health care system right away. That would be a problem.
Senator Finestone: You are an excellent advocate and you have brought many
things into sharper focus for me. My colleague Senator Carstairs mentioned the
middle ground. If you have really found the middle ground, then, within the
scope of your vast knowledge and experience, recognizing that the CSA standard
is a generic standard, would you agree that there is nothing to stop the
pharmacists or the medical association or the psychologists or the nurses and
so on from relying on their codes of ethics. They all have codes of ethics. So
if you have the bar set at one level and their bar of performance and
protection of privacy is higher, that means that they are bound by the higher
bar; but the general bar gives the overall protection for my privacy, for your
privacy, for the consumer's privacy, because it is our personal information. I
do not care how you get to that personal information; perhaps you get there
when you go into the doctor's office, or into the bank, or the insurance
company, hospital, health care situation, or nursing home, whether private or
public. In any of these cases it is still our personal information. Is there
anything that is here that does not protect that personal information as
opposed to the best practices, the quality of care and all that?
Ms Sholzberg-Gray: A lot of people are expressing the concerns that in the
absence of this bill, if we did not have it applying to the use of personal
health information, it would be open season on health information and people
would be able to use such information. You are right that there are
professional codes of conduct that ensure a high level of privacy. There is no
profession that does not have such a code, including doctors and pharmacists
and all those kinds of people. In addition to that, there are all kinds of
provincial laws pertaining to hospitals and all kinds of other things that
assure privacy in terms of personal health information. So it is not this bill
that is creating the privacy for health information. Clearly today we have it.
People have to give consent for the use of identified information, except, of
course, if it is for therapeutic purposes. That is a whole other issue, and the
CMA would agree to that as well.
You are asking what this bill could do that might make it the right middle?
Senator Finestone: Let me just interrupt you for a moment. One of the most
pertinent things that you seemed to be concerned about was the quality of care,
the secondary aspects or the secondary fallout, if I may put it that way, of
this personal information. We had IHS in here before; they accumulate and
distribute, for gain, all kinds of information. I suppose, for instance, that
you could contract with them.
Ms Sholzberg-Gray: We could not afford it.
Senator Finestone: There is the potential for the gathering of information that
could indicate if quality of care has been given out of a publicly funded,
private sector undertaking within, for example, the nursing home field. There
is nothing to prevent that along the way, and at some point the government must
look at the nature of that housing; right? Someone is responsible, and certainly
the ball stops at the provincial government level. So what is there in this
bill that for the moment does not give you an acceptable standard with all the
protections that are provided through provincial legislation, through codes of
behaviour of all these various professions and service providers that you feel
is an absolute must?
We have the advantage of having the health ministry coming in right now. The
reality of what this bill is doing has come home to roost. If we can see the
term "informed consent" approved in this process, and the improvement
that you pointed out with respect to the public sector, receiving the right for
the information flow, what other important issues do you believe we need to
Ms Sholzberg-Gray: We are concerned about the fact that there are, whichever way
you look at it, two tiers of consent. On the publicly funded side, it seems to
be implied consent or that consent is not necessary; but consent ought to be
necessary, and it should be spelled out how and when it is exempted and that
kind of thing. This bill does not do that.
As people move through treatment, they weave in and out of the public and
private system. They might be in a hospital and then they are discharged to
long-term care facilities. In the interim, they attend a publicly funded
physiotherapist or a private physiotherapist in a private clinic. They purchase
their pharmaceuticals through the hospital pharmacy or in a private pharmacy.
Because of the nature of the informed consent that is required in the private
sector you might find that a different state was along that continuum. From the
consumer perspective, they are just trying to get the treatment they need
wherever they need it. That is their mind set. They might be asked for consent
and not even understand what they are being asked for. It would not create that
seamless treatment pattern that we like.
There ought to be one rule for consent, so that at the beginning of the
treatment, whether you go into public or private treatment, you give consent to
the fact that at some point along the health continuum, as you weave in and out
of it, there might be the collection and aggregation of anonymized data that
has to be used, first, to assure that you are provided with quality care, and,
second, to assure that the system works the way it should. In my opinion, the
bill does not observe those realities.
Senator Finestone: That is not in there as far as you are concerned?
Ms Sholzberg-Gray: No, it is not. In fact, we all interpret the bill
differently, which is a sign that it is not that good. For example, Health
Canada tends to think it covers everything because everything could be in the
public interest. Obviously, there is considered to be a private sector within
the health care sector, or else the bill would not deal with it.
So there are those problems and it is a seamless continuum. There is also the
accreditation issue. It is still an issue, because we accredit and measure
quality, not only in the publicly funded and publicly provided system
contracted out to the private sector, but we accredit privately paid and
privately delivered health services, and we ought to be able to do that as
well, and I think this bill would have a negative impact on our ability to do
Senator Murray: Mr. Chairman, I just wanted to suggest to Senator Finestone that
she tell Ms Sholzberg-Gray about the amendment she suggested when speaking at
second reading, referring to the definition clause of the bill.
Senator Finestone: Oh, yes, I was looking at section 2, the definition section,
and wondering if it would not have been clearer had we suggested that the term
"organization" include not only "an association, a partnership,
a person and a trade union", but also professionals and NGOs, so that there
would be no lack of understanding about who was covered, whether it was
physicians or doctors, or anybody. In other words, it would cover the whole
thing. Would that make any difference for you in terms of clarity as to who is
Ms Sholzberg-Gray: We would want to go back to the principles, frankly, because
there are so many of them in the Advisory Council on Health Infostructure. I
really would like to look at those. We did not have the ability ourselves to
draft amendments based on those principles; we just did not have the capacity
to do so, and we thought that they were an important place to start. Remember
that that Advisory Council on Health Infostructure recognizes the importance of
privacy and understands that we are living in a different world because of
electronic communications, but it also understands that we have other
objectives that we have to achieve at the same time, and they include, of
course, accountability of our health system to the public, quality care,
effectiveness, and the necessity of carrying out research. We just do not think
this bill will be able to achieve all of those goals.
Senator Finestone: We know that there has to be a starting point, and that no
legislation is perfect. Then you move on to look at mistakes, to see where the
holes and gaps are.
The Netherlands put out an excellent piece of legislation in 1997 on medical
checks. I looked at it briefly but I have not studied it. Have you ever seen
that medical checks legislation?
Ms Sholzberg-Gray: No, I have not, but that points to the need for a separate
bill dealing with health information and health privacy.
Senator Finestone: I am not saying no. It is obvious that I am not rejecting
what you had to say. However, I understand that your group asked Heenan Blaikie
for the legal opinion; is that right?
Senator Oliver: This is just one of several groups.
Senator Finestone: I know there are about five groups. The Heenan Blaikie
opinion just shows that it is hard even for experts in the field to have a
grasp of what is happening. The opinion states that express consent is
necessary each time an organization seeks to use and/or disclose personal
information for a purpose other than the purpose for which the information was
originally collected. Tell me. What is wrong with that?
Ms Sholzberg-Gray: I will give one example involving a pharmacist because you
were having quite an interesting discussion with the pharmacists before I came
to sit at this table.
The public would want to know whether people were repeatedly having adverse
reactions to a particular drug. It would be unsafe not to know that. If 300
people were prescribed a particular drug and 150 of those people had severe,
negative complications, we would want to know that. It is important to review
the histories in those circumstances.
Senator Finestone: If consent is given beforehand, what is the difference? Why
would you not have that information? Why would you be deprived of that
information under the bill as it is presently written?
Ms Sholzberg-Gray: Without casting aspersions on the private sector, we are
concerned about them taking the time, the money, the effort to obtain consent
at each stage of the way. Neither would I cast aspersions on doctors. When we
go to the doctor, we often do not read the consent forms we are asked to sign
before procedures. We sometimes do not discuss, in an informed way, the things
that will be done to us. If we must review that consent every time we turn up
at a counter or an intake centre across our health system, that would be
difficult. That does not mean we ought not to have consent forms at certain
times -- for example, at the beginning of a set of procedures or circumstances
-- and that is what we are proposing.
Senator Finestone: Do you not think that most people, except perhaps those not
in top mental form, like to know what is going on in their lives? The biggest
complaint I have heard from colleagues and friends is that the doctor does not
give patients more than five seconds of time each. There is no explanation of
the medication prescribed, and if there are problems later, patients may have
trouble getting back in touch with the doctor.
Informed consent implies that one knows what is being done with respect to one's
health. Patients should know whether there could be complications, and should
have enough sense to ask if there is a problem in the duplication of drugs that
might be offered. Because there is consent, if a patient is dumb enough to go
to two doctors who have each given different sets of drugs, that person now
might have to think about what he or she is doing. Do you not think that that
would be better for the health of the people?
Ms Sholzberg-Gray: We agree with the notion of consent and privacy. We have said
that over and over again. At the same time, we must find a way, in this bill or
in the context of managing our health care system efficiently, also to collect
information. I am not sure whether obtaining consent at every stage along the
health system would help.
Senator Finestone: You need not do that. Implied consent or informed consent
means that if you start with one doctor, your informed consents will follow.
Ms Sholzberg-Gray: Does that apply even when you go into a private home-care
program along the way? That is the issue I was trying to address. If you give
consent to your doctor at the beginning of the process, it does not mean you
are giving consent to the home-care agency.
Senator Finestone: You do not have to give consent.
Ms Sholzberg-Gray: You do not? Can it be implied?
Senator Finestone: Do you believe that you could live with this bill in
anticipation of the kinds of changes that will come about through natural
evolution, perhaps even before five years have passed?
Ms Sholzberg-Gray: If we accept the fact that we will not be able to collect
information that tells us anything about the quality of privately provided
health care services in this country, then I am not prepared to live with that
possibility. I am worried.
The Chairman: Then the short answer to your question is no?
Ms Sholzberg-Gray: It is no.
The Chairman: Your second bullet point on page 2 of your brief states that the
suspension you recommend would enable balance to be achieved. You then talk
about the balance needed between privacy of health information and the need to
improve individual and societal health through data collection. The committee
members have a lingering concern that rather than achieving balance, an
emphasis will be placed not on the side of privacy but on the side of "Big
Brother", on the government's need for all this information which,
therefore, should be made available.
Is your point that at the moment the emphasis in the bill is excessively on the
side of privacy?
Ms Sholzberg-Gray: The emphasis is on privacy rather than the publicly funded
The Chairman: How do we achieve an acceptable balance? If we must tip the scale
to one side or the other, my sense is that committee members would tip to the
side of individual privacy rather than to the side of the collective use of
information. How do we get there, even if we do get into the kind of
multi-party negotiations that you suggest?
Ms Sholzberg-Gray: We would start with the health minister's Advisory Council on
Health Infostructure which said very clearly that we must strike the right
balance. Stakeholders would all be at the table.
The Chairman: Is that because they are all on the infostructure council?
Ms Sholzberg-Gray: No. The council recommended that we be clear on the meaning
of informed consent. There are different opinions on when implied consent is
okay. There are different opinions on where the bill requires implied consent.
We think it requires absolute, informed consent at every step of the way. That
division regarding interpretation indicates a problem. The Advisory Council On
Health Infostructure recommended that informed consent be clearly defined,
including the stages at which it is required. If there are exceptions for
overwhelming public policy purposes, they should be clearly delineated as well.
Frankly, that is the kind of bill we need, but that is not the kind of bill we
have. That is really the only point we are trying to make. Granted, it will be
difficult to achieve the right balance, but we think that people of goodwill
can achieve it. As to which side it should tip on, we do not think it ought to
tip. Privacy is important but, at the same time, we cannot have a system where
we cannot measure quality or outcomes, because that will harm Canadians' health
more than other things will.
The Chairman: I will concede that getting complete federal-provincial agreement
is, at best, a dream, but, looking for a little reality, is it fair to say,
assuming for the minute that there was a suspension for some period of time,
that your suggested process would be to have the minister's Advisory Council on
Health Infostructure be the body that effectively gets everybody in a room and
tries to reach the agreement?
Ms Sholzberg-Gray: We did not say that that council ought to be the body. We
just said that the principles they put in their report ought to be the starting
point for people who get together, because they make a lot of sense to us and
to many other people. There are several reputable people on that health
infostructure council. That is a good start.
It seems to us that people of goodwill -- and that includes ordinary citizens --
are concerned about privacy, as are those who are entrusted with providing
accountability to Canadians. Frankly, that is why we are concerned. We
represent the publicly funded health system. We are constantly told that we
have to be accountable for the way we spend money, for quality, for outcomes and
for ensuring we provide evidence that what we do is right, and we want to
ensure we have the tools with which to do that. We are nervous that we will not
get them. That is the only reason for coming to this table.
The Chairman: Thank you for an excellent presentation.
Our final witness this afternoon is David Dodge, the Deputy Minister of Health.
Welcome, Mr. Dodge. We are delighted to have you here. Please proceed.
Mr. David A. Dodge, Deputy Minister, Health Canada: Mr. Chairman, let me start
by saying that for us at Health Canada -- and, indeed, I think for everyone in
the health business, as you just heard from the Canadian Healthcare Association
-- quality care, effectively and efficiently delivered, is key, and for that we
really do need good information flows. Thus, it is really important that the
laws governing those information flows do indeed promote good information. In
order to get there, privacy and confidentiality of personal health information
is a priority.
Canadians have impressed upon us their need to be ensured that the information
they give is safe, protected and secure, and if we do not have the trust of
Canadians, we will not be able to build the Canadian health infostructure and
we will not be able to use the modern information and communication
technologies to provide more efficient health services and to build a
strengthened health system in Canada. Physicians and other health care
providers also need to be assured that health information that is collected is
adequately protected in its use and distribution.
As you have just heard from your last witness, Mr. Rock's Advisory Council on
Health Infostructure has made the point very clearly and very passionately in
its reports, and we believe that the OECD principles incorporated in this bill
largely meet the protection concerns of that council with respect to electronic
Currently, the personal health information is afforded protection by the
Charter; by privacy legislation at federal and provincial levels; by specific
health information legislation in some provinces, though not in all; by the
common-law duty of confidentiality; and, of course, by the codes of ethics of
the various health professions. Thus, there is a degree of protection available
at the moment. That degree of protection has been developed largely in the
context of paper records. Bill C-6 is designed to increase the level of
protection of information when that information is collected, used and
disclosed electronically in the course of commercial activities.
In the bill before you, Mr. Chairman, we have tried to ensure that the
disclosure can be made for appropriate purposes as set out by law in that
important subparagraph 7(3)(c.1)(iii), with which you are very familiar. With
this bill, including that particular subparagraph, we have tried to strike the
balance to which you referred earlier, to provide appropriate flows of
information and to reflect the great importance that we attach to people's
knowledge or consent for this flow. As we all know, striking such a balance is
not easy, taking into consideration both the limited jurisdiction of the
federal government and the difficult technical issues involved.
We have got to a point, I think, senators, where the legislation sets out
appropriate principles to strike this balance. Clearly, however, it is
appropriate for provinces, within their sphere, to deal with the principles set
out here in more detail. That is not an easy task, and the provinces will have
many technical issues to overcome in putting out their legislation.
We are working very hard with provincial and territorial ministries on this
issue. It will be discussed at the upcoming meeting of deputies on December 7
and 8. We are pushing forward in the advisory committee on health information
to try to deal with it. It is difficult, technical work. It is more difficult,
frankly, for the provinces than it is for us because they have a wider range of
issues with which to deal. The purpose is to try to get the common principles
and definitions within the framework that the OECD has provided for us.
It may be the case that, over time, this piece of federal legislation will need
to be refined, in light of where we get to in our work over the next three or
four years with the provinces on provincial legislation. How much time will be
necessary for this refinement is really a matter of judgment. As an official, I
can tell you that more time is always better than less, because it is not easy.
Having time to consider things when one is only working an eight- or 10- hour
day is always easier than when one is trying to do so tired after 16 or 20
hours. Thus, more time for us, as technical people, is helpful. We have already
been grappling with this for a year.
Honourable senators, let me conclude with two key points. The privacy and
confidentiality of personal health information is a priority, and it is a
priority that we give a signal to Canadians that the Government of Canada
believes it is a priority. This is difficult territory but, in our view, the
bill sets out appropriate principles and opens the door for provinces to
provide, within their jurisdictions, appropriate legislation. Finally, however
you dispose of this bill, we will continue to work in this area because it is
so fundamental to the future of quality care for Canadians.
The Chairman: Thank you very much, Mr. Dodge.
Senator LeBreton: Mr. Dodge, I have a question about when Health Canada became
involved in all of this. We have heard many witnesses say that it was Industry
and Justice and that it was basically an e-commerce bill and had nothing to do
with health care. The health care element seemed to come into it at a later
point. At what point did Health Canada become seriously involved in the drafting
of this legislation?
Mr. Dodge: Senator, I became involved last fall when my counterpart in the
province of Ontario raised the issue with me. I know we have been working on it
at least that long. Our lawyers from Justice had been working along with the
Senator LeBreton: To clarify, then, it was actually after the original Bill C-54
was introduced and only as a result of concerns expressed to you by your
Ontario counterpart that you became involved in the deliberations surrounding
this bill. Is that correct?
Mr. Dodge: That is when I personally became involved; correct. Senator, I remind
you that I started at in Health Canada in July, so it was not long after.
Senator LeBreton: I am asking about you or your predecessor.
Mr. Dodge: I cannot speak for her. I know it was early in the fall of last year
that I became involved.
Senator LeBreton: Many people were of the view that this was about e-commerce
and had nothing to do with health. All of a sudden health has loomed as the
dominant issue here because Canadians, quite rightly, view their personal
health records as very sacred and personal. I would feel much better about this
legislation if Health Canada had been involved from the very beginning.
Senator Finestone: I should like to refer to a letter I received having to do
with informed consent, which is not in this bill. Many people have been
concerned with the definitions and whether consent is informed or implied.
Banks are now in the business of selling insurance, and therefore they collect
insurance material. There is concern about the firewalls that go up between all
these institutions. There are concerns about where personal information is
gathered because it has a value and it is for sale.
This letter talks about unlimited access to personal health information and the
question of research and mining all the data and cross-matching that data. It
mentions Nuremberg and Helsinki. The author of this letter also wrote to Mr.
Martin about the use of personal information without the knowledge and consent
of the individual if it is used for research and whether it is used in a manner
that will ensure its confidentiality and whether the commissioner is informed of
the use before the information is used. He raised a concern about all this
personal information with the Minister of Finance, who acknowledged with a
letter on September 17 of last year. Where you the deputy minister at that
Mr. Dodge: I was at UBC.
Senator Finestone: Banks collect health information in respect of the sale of
certain insurance products. Restricting the ability of banks to collect such
information would impose unwarranted restraints and reduce the accessibility of
those products to consumers. The writer of this letter believes the Minister of
Finance has clearly spoken in this regard; however, with all due respect to the
honourable Mr. Martin, he disagrees with the need for banks to collect health
information. Consumers have had access to those products for almost a century.
This is not a consumer-access issue but a market-access issue, and it puts
banks on an unfair footing. It puts customers in a very untenable position. The
letter writer quotes the story of the cancer study leading to the foreclosure of
mortgages and small business loans.
The Chairman: Can we get to the question?
Senator Finestone: The banks were informed by their insurance sections about a
number of people who bought insurance who had a potential for cancer or were
suffering with cancer or had heart problems. The next thing you know, the banks
called in the small loans. That happened in the United States, not in Canada.
The potential for that happening if organizations do not have firewalls and if
personal privacy is not guaranteed is serious.
How do you expect us to tell insured people that their personal privacy is
guaranteed and that their personal health information is not being shared and
data matched and cross-informed?
Mr. Dodge: Senator, I cannot answer your entire question. You have put your
finger on the reason it is important to have a bill like this in place. The
insurance arm of the bank collects information with respect to health in order
to issue insurance. It is absolutely critical that customers be assured that
that information will not be used for purposes other than that for which they
consent. Obviously, they want the loan insurance or the mortgage insurance and
so it is appropriate. That is precisely why the domain of commercial health
information ought to be included in this bill without any question whatsoever,
and that is why we support the bill.
Senator Finestone: Mr. Dodge, I asked you that specifically because that is
commercial health. Hospitals and health care are a very different issue. People
are concerned about keeping their personal information about finances, but
their other great issue is their health care. It is no one's business but
theirs. How carefully did Health Canada review this bill and test it in terms of
the general public good?
Mr. Dodge: I would reiterate that the principles embodied in the bill are the
OECD principles. We have tested those against our own health information
advisory committee. The principles appear to be the right ones. The more
difficult issue is the one to which I alluded earlier -- the mechanics of
actually making it work on the ground. Am I sure that the mechanics we have to
make it work on the ground are fully and appropriately there? No, I cannot give
you that assurance, senator. Indeed, those mechanics will develop over time.
However, it is important that we give to the Canadian public a clear statement
that we will protect that information and that it is only with their consent
that the information will be used for commercial uses. Can I give you a 100 per
cent guarantee that we have all the mechanics right? No.
Senator Finestone: First, no one expects bills to be perfect at the outset, but
we would like them to be as good as possible. Second, you keep referring to the
OECD. I believe the Netherlands is part of the OECD.
Mr. Dodge: That is correct.
Senator Finestone: They did not think those principles were good enough. I am a
strong proponent of this bill. I want us to have personal private protection. I
also think privacy is the key. It is the next-generation issue anyway. It is a
vital issue. However, the Dutch found those principles, which are in this bill,
not to be effective enough. Have you looked at the Dutch program?
Mr. Dodge: There are at least two or three countries that have standards above
the OECD norm. The basic principles are there but they have gone to tighter
standards. Others have programs that, while they basically conform, would be
more at the bottom of the range. The current standards under the Quebec
legislation would barely make it into the range, but they are basically founded
on that set of principles. I do not know where the right place to start is.
However, I think it is appropriate that we get started. Over time, undoubtedly,
the Government of Canada will be back to Parliament for amendments, and I think
that is appropriate.
Senator Murray: Mr. Dodge, what did you or your department tell Ms
Sholzberg-Gray's organization and other health care organizations that came
knocking on your institutional door with their concerns about this bill? Did
you really tell them, "Do not worry. Be happy. It is really an e-commerce
Mr. Dodge: I do not think so. Certainly, no one that I know in the department
did that. I was a little surprised to hear Ms Sholzberg-Gray say that here.
Senator Murray: She is not the first, I believe. Other witnesses who appeared at
the Commons committee alluded to different advice that they were receiving
about the bill and the impact of it from your department and from the
sponsoring department, the Department of Industry.
Mr. Dodge: I really cannot go back much before last summer. I really do not
Senator Murray: Can your colleague help us?
Mr. Dodge: Unfortunately, she is even more recent to the department.
Senator Oliver: Have you talked to Mr. Manley to find out what his department
Mr. Dodge: I got involved quite strongly a year ago, when it became clear that
some real problems might emerge. I can only give you information beginning from
Senator Murray: We will have to try the institutional memory, if there is one,
in the department on that at some point.
Mr. Dodge, you mentioned Ontario having been in touch with you about problems
with this bill. Have other provinces been in touch with you with similar
Mr. Dodge: We have been working quite closely with Saskatchewan, Alberta and
British Columbia on electronic information issues.
Senator Murray: What about the bill, Mr. Dodge?
Mr. Dodge: In the course of those discussions, they also raised some concerns.
Senator Murray: Do you know a single province that is supporting the bill?
Mr. Dodge: The principles of it or the precise wording of it?
Senator Murray: To be fair, it is not the ministers of health but, I understand,
the attorneys general of the 10 provinces who asked that it be withdrawn.
Mr. Dodge: There is not always total agreement between the ministers of health
and the attorneys general. I think it is fair to say, first, that every
province believes that it is important in order to secure health information
that we have appropriate confidentiality. Not all of them have, but they think
it is important. Second, they are all worried that they really have not had
time to work out the appropriate rules governing the transmission of data
Senator Murray: I think all of us here appreciate, understand and agree that
there must be a federal leadership role here. That being said, you are aware
that we have had at this committee representatives from everywhere in the
health care sector. I cannot think of one organization -- although, perhaps
there was one -- that supports the passage of the bill as is. I think I am
correct in saying that. They come at it from different perspectives. Some of
them, such as the doctors and the dentists, say that the bill must be
strengthened; others, as you have heard, want an exemption; and still others
want a suspension for a while. However, they are agreed on one point: the bill
as it is presently written was not written with the health sector in mind at
all and, in fact, is completely inappropriate to the health sector. That is
their position. That must be a matter of concern to you, to your minister and
to your department.
What analysis have you done about the legal impact of this bill? How do you
answer all these people who talk about the impossibility and the
impracticability -- and they seem to be speaking as one on this -- of
disentangling the commercial from the non-commercial in terms of the health care
sector? You have correctly stated that it is the provinces that have a big
problem. Still, this is our bill -- that is, the federal Parliament's bill. You
are the deputy minister of what used to be called Health Canada.
Mr. Dodge: I go back to what I said earlier. Technically, this is a difficult
area. As a good technician and a bureaucrat, one would always plead for more
time to get the details worked out. In effect, we have provided four years for
the provinces to do that. However, we have a guillotine at the end of those
four years, because as long as what they do within that four-year period is
within this rather broad band, as Senator Finestone pointed out, of the OECD
principles, then it will fit.
Thus, we have two chores over that period of time. First, we must try to figure
out how we can deal technically with some of these rather difficult issues
intraprovincially; and, second, we must try to get the provinces as close as
they can to one another. If the provinces all have similar legislation, then
our job with respect to the transborder transmission becomes relatively easy. We
do have four years in which to accomplish this.
The key issue that is of concern at this point in time is whether the fact that
this legislation will have application after one year with respect to
transborder disclosure of those data will create problems intraprovincially.
Fundamentally, when you cut through everything, that is the issue at hand, that
is the question with which we have been seized. The answer is that it probably
will create problems. That means that there is an obligation on us over the
next period of time, however long that is, to try to iron those difficulties
out. We may need to return to Parliament and say, "We need some amendments
to deal with specific problems that have come up."
Senator Murray: Would you do that before the bill is proclaimed?
Mr. Dodge: We would do that before the bill is proclaimed, because we have given
ourselves a year.
The Chairman: Your four years includes the one year after passage, at which
point the bill comes into effect generally, and then the three years beyond
that for intraprovincial activities; is that right?
Mr. Dodge: Right.
The Chairman: I believe that clarifies your question, Senator Cook, does it not?
I will ask my next question carefully so as to not put you in a position of
commenting on another department's bill. Given your last statement in response
to Senator Murray, from a health policy standpoint, in other words from the
standpoint of the function of the federal Department of Health, are there any
negative consequences to you in your capacity as Deputy Minister of Health if
the application of this bill to the health care sector did not go into effect
for a period of, say, two years?
Mr. Dodge: May I answer that question in two parts, Mr. Chairman? First, I have
been asking for about six months for some specific examples of things that
would really go wrong if the bill comes into effect, as indicated, in a year's
time. I have been pressing to determine what things would actually fall down,
what we really could not do. Frankly, I have been surprised that despite the
general criticism and uncertainty I have not been given examples of things that
would go wrong. There is an unease and uncertainty because we are into new
territory. However, I have not had examples of things that would actually go
The fact that there is unease and uncertainty is of course worrisome. Thus, if
one wishes to mitigate that worry, a little more time is always helpful. The
amount of time ends up being the tricky balance that you as legislators must
make between standing up firmly and saying to citizens, "We are ensuring
that you are given reasonable assurance that electronic data will be used for
the purposes for which they were intended."
On the other hand, while giving a little longer to work out the details is
probably helpful to us as technicians, what message are we then sending to
Canadians and to health care providers about our real commitment to ensure that
data are only disclosed appropriately? Fortunately, that is not the
bureaucrat's job but yours as legislators.
Senator Carstairs: In your statement you say clearly that it is appropriate for
provinces within their sphere to deal in more detail with the principles set
out here. You have given a whole new meaning to the phrase, "After you,
Alphonse;" it is now, "Over to you, Alphonse."
Is the reason for this the nature of the health care delivery system? The health
care delivery system is provincial. The funding may come from the federal
government, but the delivery system is at the provincial level. The
confidentiality issues, therefore, are primarily at the provincial level. Where
do you see federal involvement in the confidentiality issues?
Mr. Dodge: Let us start off where we clearly have jurisdictional competence --
trade and commerce -- and where we are dealing with transborder issues. That is
where we start. The trouble, as we all know, is that over time that really does
not work unless the same sorts of rules apply where the data are generated, and
that is within the province. Therefore, we come to the fact that individual
provinces must deal with this, both because they are the operators of the health
care systems, as you have just said, senator, and because it is provincial
competence so to do. I have a bit of a hard time answering your question
because, in the end, the action must be at the level of the province.
Senator Carstairs: The Canadian Medical Association has a wonderful code of
ethics, a standard that they wanted to append to the bill. However, by their
own admission they do not enforce violations of doctors' breaches of that code
of ethics. That is done by the provincial medical associations. All the CMA can
do is establish a guideline which they hope the provinces will adopt then
enforce. It seems to me that you are in the same kind of dilemma here.
Mr. Dodge: Not quite, senator. Once data that are generated within a province
are transmitted electronically, they often cross borders -- much more than we
had realized, in fact -- even if they end up back in that province. That is an
important issue, because in transmitting data appropriately from a physician in
Kingston, for example, to a hospital in Toronto, that data may well go via
Atlanta. We have no idea. Indeed information could, in theory, be taken off the
system once it is outside the borders. It is actually very important that we do
have legislation that governs transborder transmission. That is just to ensure
the integrity of data within provinces.
Senator Carstairs: You have obviously had some discussion with some of the
provinces. You mentioned that four provinces came to you with problems with
this piece of proposed legislation.
Mr. Dodge: Begging for time is what they were really all doing.
Senator Carstairs: What if anything is your department doing about ensuring that
provinces are moving forward with adequate protection at the provincial level
for issues such as informed consent and proper documentation so that if the
process begins there, it cannot go further?
Mr. Dodge: Senator, ministers agreed at their last meeting in Charlottetown, in
September, to set up a brand new advisory committee. Federal-provincial health
operations have traditionally operated with three so-called advisory committees
who are really the ones that do all the work: health human resources, health
services and population health. Deputies agreed last June and ministers
concurred in September that we would set up a new advisory committee on health
information. Indeed, the very first task of the committee on health information
is to deal with this very issue. Our first report will be received on December
7 and 8.
That is how we work. Starting last spring, we agreed that we must focus on the
area of health information with as much vigour as we focused on human resources
or health services in the past.
Senator Finestone: You said that you had not been able to find a specific
example where there was an impediment to the goal of personal privacy and the
needs of Canadian society, but I think you were in the room during the
discussion with the last group of witnesses, so you did hear a specific example.
Mr. Dodge: We tested that very example, senator, and it does not seem to hold up
to be an impediment.
Senator Finestone: Why then was that organization not given that advice so that
they would have felt more comfortable? It is often a matter of perception when
dealing with something new. It would have been helpful, had they known that you
took them seriously, you looked at the issue, you tested it out and you found
that contrary to their concern there is no need to worry so much.
Mr. Dodge: I believe you are right, and we have been moving at a fairly quick
pace in the last little while as we have tried to find examples of where the
bill would make something fall down. You are absolutely correct in chastising
us for not having had everyone back in the room to go through the examples we
Senator Finestone: Have you been able to cross-check the examples from the CMA,
the pharmacists and the dentists so that there is recognition that there may be
a problem but, on the other hand, the problem is not so devastating or so
serious that it will jeopardize the right to personal privacy?
Mr. Dodge: Let us be a little careful here, senator. I apologize. I may have
been misleading. There are, I think, two sides to this matter. We have been
testing to ensure that putting Bill C-6 into place would not damage the quality
of care provided to Canadians because information could not flow. That is where
you could actually get an immediate deterioration of services. We have been
testing what in the system would fall apart because of Bill C-6.
The other side, the CMA side, is that we should be stronger in terms of privacy.
That is not a matter of something falling apart; instead it is perhaps a
question of the appropriate philosophical point of view about where we ought to
Senator Finestone: The IMS Health group that appeared expressed some
hesitations. I understand much of the service they provide is necessary to the
health distribution system in Canada in order to evaluate the quality of
service. Have you addressed those hesitations and are they being looked at in a
way that will be helpful to the service of Canadian citizens, as opposed to the
industry? I know there are two lenses.
Senator Murray: Health Canada is a client.
Mr. Dodge: Although we are a client for their aggregate statistics.
Senator Oliver: There is nothing for which you pay?
Mr. Dodge: Yes. That is volumes of drugs and all those kinds of things.
The Chairman: That is not affected by this bill.
Senator Finestone: They have appeared twice now with some serious concerns about
how this bill will interfere with them in terms of the information that is
provided as they render a public service for quality of life. The other groups
that have appeared have also said that this bill will interfere. Have you
examined all those issues and are you happy or fairly sure that it will work?
Mr. Dodge: Senator, you know me, I am never happy. IMS has come to us a couple
of times on these issues. I believe it is true that for some of the things they
do they will need a tighter consent form than they currently have. Will it all
fall down? The answer is no. Is having a tighter consent form good or bad? I
suppose on balance I would judge it to be a good thing, but that is a personal
The Chairman: Most members of the committee would judge it to be a good thing as
Senator Oliver: As I listen to your evidence, my general impression,
notwithstanding the fact that you are a very senior bureaucrat and you have a
job to defend your department and to defend this bill, is that it has come upon
you rather quickly. You have been involved for a year or less. Many people in
the health care services have appeared before this committee and others and have
made representations to your department. My overall impression is that if you
had more time to work out many of the details, concerns and complaints that
people had, you would not be disappointed.
Mr. Dodge: I believe that is fair, senator, and that is largely true on many of
the bills that I have brought forward to Parliament. You know better than I
that writing legislation is not an easy task. In an area like this, it is
extraordinarily difficult. You will have a bill before you soon, I hope, with
respect to the Canadian Institutes of Health Research. Technically, with the
exception of perhaps one issue, that was rather an easy bill to write, but it
was not necessarily easy to get agreement on everything it contained.
This is not an easy bill. Technically, it is a rather difficult bill. Any
professional public servant bringing forward a technically difficult bill will
always be somewhat nervous, just as I was always nervous when I brought forward
tax bills. One is never entirely comfortable. Time is often extraordinarily
helpful in working out some of those issues.
Senator Murray: If it is time you are looking for, you have come to the right
place. We have all the time in the world.
The Chairman: On that note, thank you very much for taking the time to be with
us today, Mr. Dodge.