Proceedings of the Standing Senate Committee on
Social Affairs,
Science and Technology
Issue 3 - Evidence
OTTAWA, Tuesday, November 30, 1999
[English]
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 the bill.
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 Medical Laboratories.
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 opening remarks.
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 biotech industries.
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 practices.
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 legislation.
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 administrative adjustment.
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 sector.
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 recommendation.
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 stumbling block.
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 patient information.
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 prescribing practices.
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 physicians.
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 infostructure project?
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 advancement.
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 recommendation?
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 pharmacist.
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 issue?
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 information.
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 us.
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 have.
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 me.
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 you said?
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 legislation.
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 form?
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 files.
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 patient records.
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 identified.
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 & Lybrand.
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 collection processes.
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 that correct?
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 well?
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 evening.
We shall now proceed with the next witness who from the Canadian Healthcare Association.
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 later date.
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 this.
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 system.
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 open way.
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 dangerous.
Senator Murray: Do you know anything about the Quebec law that we discussed earlier?
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 worry about.
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 not know.
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 undertake?
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 that.
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 covered?
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 part.
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 information.
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 Industry people.
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 point?
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 bill?"
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 know.
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 was saying?
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 last summer.
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 concerns?
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 intraprovincially.
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 wrong.
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 tested out.
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 be.
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 judgment.
The Chairman: Most members of the committee would judge it to be a good thing as well.
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.
The committee adjourned.